The OncoSignature® test developed based on Acrivon’s AP3 platform is a first-of-its-kind spatial signature assay to identify patients most likely to respond to ACR-368, an advanced Phase 2 targeted oncology agent for solid cancers
The OncoSignature® test will run on Akoya’s PhenoImager™ Solution
MARLBOROUGH, Mass., and WATERTOWN, Mass., June 28, 2022 — Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company®, and Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary technologies driving a new era of precision-based medicine, today announced an agreement to co-develop, validate, and commercialize Acrivon’s OncoSignature® test, a first-of-its-kind companion diagnostic. The test will be used to identify cancer patients most likely to respond to treatment with ACR-368, a targeted DNA damage response inhibitor therapy being developed by Acrivon. ACR-368 has been cleared by the FDA to be advanced in a Phase 2 master protocol trial to treat patients with ovarian, endometrial, and urothelial cancer based on predicted sensitivity to ACR-368.
ACR-368 has been evaluated in over 1,000 patients and has demonstrated durable monotherapy activity, including complete responses, in a proportion of patients with platinum-resistant ovarian cancer. These patients currently have no effective treatment options, and the median survival time with this disease is less than one year. In addition to ovarian cancer, ACR-368 is being evaluated as a treatment for endometrial and urothelial cancers — two other high unmet need solid tumor types predicted by OncoSignature® to be highly sensitive to the drug. The OncoSignature® test, developed by Acrivon, will be run on Akoya’s PhenoImager solution during clinical development and, pending ACR-368 approval and commercialization, will enable physicians to identify and treat the patients most likely to respond to the therapy.
Akoya, in partnership with Acrivon, will develop, clinically validate, and seek regulatory co-approval for the OncoSignature® test, and, pending ACR-368 approval, commercialize the test as the exclusive provider of the companion diagnostic required for prescribing ACR-368. The test will leverage the spatial phenotyping capabilities of the PhenoImager solution to localize and quantify the expression of a signature of clinically relevant protein biomarkers within the tumor.
“The ability to select patients for ACR-368 is a foundational part of our efficient clinical development strategy and is a critical part of our mission to bring our targeted therapies to the patients most likely to benefit from treatment,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and president of Acrivon. “We believe that Akoya is an ideal partner to develop and commercialize this next-generation companion diagnostic with their technically advanced, quantitative PhenoImager solution. We look forward to working with Akoya towards bringing this companion diagnostic to patients and clinicians around the world.”
In the initial phase of this co-development agreement, studies were conducted in collaboration with Acrivon at Akoya’s CLIA-certified Advanced Biopharma Solutions (ABS) lab to complete the analytical validation of the clinical trial assay version of the OncoSignature® test on the PhenoImager platform. ABS is a premium high-value partner for biopharmaceutical companies enabling the use of Akoya’s platform in clinical trials. In the next phase of the agreement, the companion diagnostic for ACR-368 will be developed and clinically validated.
“We are honored to partner with Acrivon in the advancement of their promising therapy ACR-368, which has the potential to substantially impact the well-being of these patients,” said Brian McKelligon, chief executive officer of Akoya. “We believe that the next generation of personalized medicines will go beyond the genetic markers currently being used today. Our spatial phenotyping technology and complete workflow solution with the PhenoImager platform can enable the sophisticated analyses necessary to achieve diagnostic capabilities required for patient selection, and we are excited to have Acrivon’s leading-edge OncoSignature test run on our solution.”
About Acrivon’s Precision Predictive Proteomics (AP3) and OncoSignature Tests
Acrivon Predictive Precision Proteomics, AP3, is a proprietary, streamlined approach to develop patient selection tumor biopsy tests, called OncoSignature® tests. The technology is engineered to be agnostic to underlying genetic alterations and designed to enable identification and treatment of the patients whose tumors are regulated by and sensitive to the drug based on direct protein measurement of the critical tumor-driving mechanisms. The AP3 approach leverages unbiased differential global phosphoproteomic drug profiling using mass spectrometry, biased tumor model analyses, and quantitative multispectral in situ imaging of patient derived xenograft (PDX) in vivo models and intended-use tumor samples and clinical trial biopsies, to identify and evaluate biomarkers. The output of AP3 is clinically actionable, drug-tailored, proprietary OncoSignature® tests. These are automated, quantitative protein multiplex imaging tests applied to pretreatment tumor biopsies as a companion diagnostic (CDx) to select and treat the patients predicted to benefit from the drug candidate. The AP3 method is broadly applicable across drugs and drug candidates and is a transformative, efficient method to accurately match the right therapy to the right patient.
About Akoya Biosciences
As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research via its key platforms: PhenoCycler™, PhenoImager™ Fusion and PhenoImager HT. To learn more about Akoya, visit www.akoyabio.com
About Acrivon
Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that are being developed to be used to identify patients most likely to benefit from Acrivon’s product candidates. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The company’s pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Eli Lilly and Company which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the company’s website at https://acrivon.com for more information.
Acrivon Contacts:
Alexandra Santos
asantos@wheelhouselsa.com
Aljanae Reynolds
areynolds@wheelhouselsa.com
Akoya Biosciences Contacts:
Investor Contact:
Priyam Shah
Sr. Director, Investor Relations
Akoya Biosciences
investors@akoyabio.com
Media Contact:
Christine Quern
(617) 650-8497
media@akoyabio.com
–Pioneering trial will be using a first-of-its-kind OncoSignature® companion diagnostic to identify and treat patients that are predicted most likely to benefit from treatment—
–OncoSignature®-positive patients will receive ACR-368 monotherapy in a single-arm Phase 2 study and OncoSignature®-negative patients will receive ACR-368 in combination with low-dose gemcitabine in a concurrent Phase 1b/2 study—
–ACR-368 is a DNA Damage Response (DDR) inhibitor that will be evaluated at the recommended Phase 2 dose based on extensive clinical safety and efficacy data, including previously demonstrated durable single-agent activity and complete responses in platinum-resistant ovarian cancer, as well as other high unmet need solid tumors—
WATERTOWN, Massachusetts, June 22, 2022 – Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary proteomics-based technologies driving a new era of precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead asset ACR-368 in a Phase 2 master protocol trial to treat patients with ovarian, endometrial and urothelial cancer based on predicted ACR-368 sensitivity. ACR-368 is a potent, selective inhibitor of checkpoint kinase 1 and 2 (CHK1/2) which has previously shown durable monotherapy efficacy in a proportion of patients across several high unmet need solid tumor types. Acrivon will stratify patients for its trial into two treatment groups using its pioneering OncoSignature® proteomic companion diagnostic. OncoSignature®-positive patients will receive ACR-368 monotherapy in a Phase 2 Simon two-stage study design at the recommended Phase 2 dose, while OncoSignature®-negative patients will receive ACR-368 in combination with low-dose gemcitabine in a Phase 1b/2 study design.
Acrivon’s Predictive Precision Proteomics (AP3) technology platform enables the development of drug-tailored OncoSignature® companion diagnostics, which apply quantitative protein multiplex imaging tests to pretreatment tumor biopsies and are designed to enable the identification of the patients whose tumors are regulated by and sensitive to the drug. Acrivon’s AP3 platform was also used to identify key mechanisms associated with ACR-368 resistance, and that the addition of low-dose gemcitabine substantially re-sensitizes resistant tumors to ACR-368, which was subsequently confirmed in multiple preclinical studies.
“Our clinical development approach is quite different than the industry norm, and this clinical trial design is equally unprecedented,” said Peter Blume-Jensen, M.D., Ph.D., president and chief executive officer of Acrivon. “Acrivon’s next generation proteomics-based precision medicine platform is engineered to uncover the disease-driving mechanisms that are uniquely sensitive to our drugs or rational drug combinations in individual patient tumors, independent of genetic alterations. Our strategy is to apply the ACR-368-tailored OncoSignature® test to a tumor biopsy from the patient before the start of treatment and use that result to direct ACR-368 to only those patients predicted to be most likely to benefit from either monotherapy treatment or the combination therapy.”
“Acrivon’s OncoSignature® tests are designed to predict drug sensitivity regardless of tumor type,” said Erick Gamelin, M.D., Ph.D., chief medical officer of Acrivon. “By using OncoSignature® to screen across human cancer tissue samples, we found that a proportion of endometrial and urothelial cancers is also sensitive to the drug, and following further confirmation in preclinical patient-derived xenograft models, we have included these together with platinum-resistant ovarian cancer in our upcoming trial. With Acrivon’s rigorous science-based and selective methodologies, we aim to forge a paradigm change in personalized medicine for optimal patient care.”
The Phase 2, multicenter, open-label study will enroll patients with histologically confirmed, locally advanced or metastatic, recurrent platinum-resistant high-grade ovarian cancer, or endometrial adenocarcinoma, or platinum-resistant urothelial. Based on the results of the company’s proprietary OncoSignature® predictive test, patients will be allocated to one of two treatment arms. Patients who test positive for predicted sensitivity to ACR-368 monotherapy will be enrolled into a single-arm Phase 2 study to assess primarily the anti-tumor activity (confirmed overall response rate) of the recommended Phase 2 dose of ACR-368 (105 mg/m2) for each of the three cancers. Patients who test negative on the OncoSignature® test will be enrolled in a single-arm Phase 1b/2 study. The Phase 1b portion of the study will evaluate the safety and tolerability of the combination of the recommended Phase 2 dose of ACR-368 with escalating doses of low-dose gemcitabine for each of the three cancers. Once the recommended Phase 2 dose of low-dose gemcitabine has been determined, the study will expand into a Phase 2 study to assess the anti-tumor activity (confirmed overall response rate) of ACR-368 and low-dose gemcitabine for each of the three cancers.
About ACR-368
ACR-368 is a potent, selective inhibitor of CHK1 and CHK2 which has shown deep durable single agent activity, including complete responses, in a proportion of patients across several Phase 2 studies of platinum-resistant ovarian cancer and in squamous cell cancers, including anal cancer for which FDA has granted orphan drug designation. ACR-368 has been tested in >1,000 patients as monotherapy and in combination, showing excellent pharmacokinetic and pharmacological properties and a favorable safety profile at the recommended Phase 2 dose across monotherapy studies. Acrivon has obtained exclusive, world-wide rights to develop and commercialize ACR-368 (also known as prexasertib) under a license agreement with Eli Lilly and Company.
About Acrivon
Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that are being developed to identify patients most likely to benefit from Acrivon’s product candidates. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The company’s pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Eli Lilly and Company which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the company’s website at https://acrivon.com for more information.
Acrivon Contacts:
Alexandra Santos
asantos@wheelhouselsa.com
Aljanae Reynolds
areynolds@wheelhouselsa.com
WATERTOWN, Massachusetts, April 20, 2022 – Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary technologies driving a new era of precision-based medicine, today announced the appointments of Rasmus Holm-Jorgensen as the company’s chief financial officer, as well as other senior executives to its management team.
“It is with great pleasure that I welcome Rasmus who brings to Acrivon broad expertise and a proven track record of more than twenty-five years of successfully driving strategy and operations, including finance, portfolio management, and business development, which will be invaluable as we pursue our growth aspirations,” said Peter Blume-Jensen, M.D., Ph.D., president and chief executive officer of Acrivon. “In addition to Rasmus, I am excited to announce that we have augmented our management team with top talent and accomplished executives in key leadership roles across several functional areas. A critical part of our execution strategy is the strengthening of domain expertise and human resources to further expand on the broad potential of our next generation precision oncology platform and advance our promising pipeline of best-in-class, clinically efficacious targeted oncology agents.”
Prior to his appointment as the chief financial officer of Acrivon, Mr. Holm-Jorgensen was part of the founding team and chief strategy and portfolio officer of Kiniksa Pharmaceuticals since its inception in 2015 and through the IPO to the launch of its first product. Previously, he was group vice president and general manager at Synageva BioPharma, where he created a new business unit with a portfolio of multiple rare disease programs following the company’s IPO in 2011 and culminating in the company’s sale for $9 billion. From 2008 to 2011, Mr. Holm-Jorgensen drove the successful turnaround of the global commercial audiology organization of the GN Group, a global leader in intelligent audio solutions. From 1996 to 2008, Mr. Holm-Jorgensen worked for Novo Nordisk in Denmark, U.S., Brazil and Mexico, where he held positions of increasing responsibility within general management, economy and planning, portfolio analysis, investor relations for North America and finance for LATAM. Mr. Holm-Jorgensen received an M.S. in Economics from the University of Copenhagen and has completed executive training at INSEAD, Stanford University and Harvard Business School.
Mr. Holm-Jorgensen added, “I am very impressed by the company’s proprietary AP3 precision medicine platform, which defines a whole new era of precision medicine and initially is being applied for the accelerated, derisked development of a robust pipeline of precision oncology therapeutics. I look forward to working with the high caliber team at Acrivon to bring our therapies to the patients who can benefit from them the most.”
Additional Appointed Senior Executives
Bruce Close, vice president of Quality and Compliance, is a leader in the design, implementation and oversight of quality management systems and compliance operations. He has over 20 years of experience in GxP quality roles at large biopharmaceutical companies such as Celgene/BMS, Schering Ag/Bayer, and Regeneron. Additionally, he has worked with more than 35 different regulatory health authorities across the Americas, Europe, Asia, the Middle East, Russia, Africa, Australia, and Japan.
James P. Dunyak, Ph.D., vice president of Biostatistics is an experienced statistician, modeler, engineer and mathematical scientist with a focus on realizing the promise of precision medicine and translating research achievements to viable commercial products in a highly regulated environment. His prior experience includes leadership roles in biostatistics, research and development, bioinformatics, and clinical pharmacometrics at Certara, AstraZeneca, Metamark Genetics, Novartis, and MITRE.
Joon Jung, Ph.D., vice president and head of Data Science, is a leader in computational and translational science with a track record of successful drug discovery and development, including experience in target identification and optimization, clinical biomarker and patient stratification strategies, and systems biology. He has led data science, translational discovery and informatics at Theonys, Cyclerion Therapeutics/Ironwood Pharmaceuticals, and has been a senior research scientist at Merck, Johnson & Johnson, and Triad Therapeutics.
Crystal Mercado, global head of Human Resources, is an accomplished human resources executive with expertise in addressing key business opportunities and challenges to develop an engaged workforce, including experience in global talent acquisition and retention across North America, LATAM, EMEA and APAC regions. She previously held positions at Kira Pharmaceuticals, SpringWorks Therapeutics, Purdue Pharma, and Alexion Pharmaceuticals.
Thomas P. Nifong, M.D., head of Clinical CDx Operations, has extensive experience leading clinical operations and as a medical director providing strategic and technical expertise, with responsibilities spanning corporate strategy, laboratory operations, regulatory compliance and biomarker development, with direct involvement in commercialization and business development activities. He was a member of the executive management team for companies such as Pacific Edge Diagnostics, Definiens (acquired by MedImmune/AstraZeneca), and Metamark Genetics.
Sam Rua, vice president of CDx Regulatory, is a regulatory affairs and quality assurance executive with experience in global regulatory submissions and registration strategies, having successfully taken investigational product candidates through regulatory processes and to the market in the U.S., Canada, Europe, and Australia. He held positions in regulatory and clinical affairs, quality systems and operations at HTG Molecular Diagnostics, Roche Tissue Diagnostics, Beckman Coulter, Third Wave Technologies, and Ventana Medical Systems.
John van Duzer, Ph.D., vice president of CMC, is a senior pharmaceutical industry executive with over 30 years of experience in medicinal chemistry research, chemical development programs, and GMP manufacturing to support IND filing and clinical trials. He is the inventor of Lumiracoxib, a marketed cyclooxygenase 2 inhibitor, as well as ricolinostat and citarinostat, which are HDAC6 inhibitors for treatment of multiple myeloma. He held manufacturing and technical operations leadership roles at Collegium Pharmaceutical, Eloxx Pharmaceuticals, Acetylon Pharmaceuticals, Mersana Therapeutics, and ActivBiotics Corporation, in addition to being a consultant to Celgene.
About Acrivon
Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that can be used to identify patients most likely to benefit from Acrivon’s medicines. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The company’s pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Eli Lilly and Company which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the company’s website at https://acrivon.com for more information.
Acrivon Contacts:
Alexandra Santos
asantos@wheelhouselsa.com
Aljanae Reynolds
areynolds@wheelhouselsa.com
WATERTOWN, Massachusetts, March 16, 2022 – Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary technologies driving a new era of precision-based medicine, today announced that Peter Blume-Jensen, M.D., Ph.D., Acrivon’s chief executive officer and founder, will present at the Oppenheimer 32nd Annual Healthcare Conference on Thursday, March 17, 2022 at 9:20 a.m. ET.
To access the live webcast or archived recording of the presentation, please visit the Events & Presentations section of Acrivon’s website at https://acrivon.com/news-press. The replay will be available for 30 days following the event.
About Acrivon
Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that can be used to identify patients most likely to benefit from Acrivon’s medicines. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The company’s pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Eli Lilly and Company which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the company’s website at https://acrivon.com for more information.
Acrivon Contacts:
Alexandra Santos
asantos@wheelhouselsa.com
Aljanae Reynolds
areynolds@wheelhouselsa.com
WATERTOWN, Massachusetts, December 8, 2021 – Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary, proteomics-based technologies driving a new era of precision-based medicine, today announced the establishment of its scientific advisory board.
“We are delighted to have these distinguished thought leaders in oncology research and development join our scientific advisory board,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and founder of Acrivon. “Combined, they represent expertise across Acrivon’s key pillars of excellence including phospho-proteomics, predictive protein biomarkers, and oncology precision medicine. The caliber of this group, in addition to the high-quality investors who participated in our recent oversubscribed $100 million Series B financing, is a testament to the promise of our unique precision medicine platform.”
George Demetri, M.D., professor at Harvard Medical School, co-director of the Ludwig Center, and senior vice president at the Dana-Farber Cancer Institute, added, “I am very enthusiastic to help advance the potential benefit to patients from Acrivon’s pioneering proteomics-based precision medicine platform. The future of precision medicine lies in the ability to identify the right patients with complex cancers who can derive the maximal benefit from specific targeted therapies and rational combinations. Acrivon’s platform enables a unique approach to patient selection with the promise to be broadly applicable beyond the limitations of current tumor genome tests. We hope this will allow identification of direct mechanistic matching between the drug action with the primary drivers of malignancy in an individual patient’s tumor to predict treatment benefit with far less empiricism than current standards of care.”
Scientific Advisory Board Members
George Demetri, M.D., FACP, FASCO, FAACR
Dr. Demetri is co-director of the Ludwig Center at Harvard and professor of Medicine at Harvard Medical School and serves as senior vice president for experimental therapeutics at the Dana-Farber Cancer Institute (DFCI). Dr. Demetri was instrumental in the development of Gleevec® (imatinib) as the first effective therapy for gastrointestinal stromal tumor (GIST) as a mutationally-driven solid tumor. His collaborative research efforts have contributed to worldwide regulatory approval of several other therapies, including sunitinib and regorafenib for GIST, as well as pazopanib, trabectedin, eribulin, and tazemetostat for other sarcomas. He is a member of the board of directors for Blueprint Medicines.
Dr. Demetri received his A.B. in Biochemistry at Harvard College and M.D. from Stanford Medical School. He completed his residency and chief residency at the University of Washington Hospitals in Seattle and his medical oncology fellowship at DFCI and Harvard Medical School. Dr. Demetri was the 2020 recipient of the David A. Karnofsky Memorial Award from the American Society of Clinical Oncology (ASCO).
Robert (Bob) Abraham, Ph.D.
Dr. Abraham is executive vice president and head of cancer biology at Odyssey Therapeutics. Before that, he was most recently chief scientific officer at Vividion Therapeutics. Prior to Vividion, he was the senior vice president and world-wide head of the oncology R&D group at Pfizer. From 2005-2009, he was the head of oncology discovery research at Wyeth. During his tenure at Wyeth and Pfizer, Dr. Abraham contributed to the development of eight FDA-approved cancer drugs. Prior to joining industry, Dr. Abraham was a professor at the Sanford-Burnham-Prebys Medical Discovery Institute (SBPMDI) in La Jolla, CA, where he served as the director of the NCI-designated SBPMDI Cancer Research Center. Prior to SBPDMI, he was endowed chair in the Department of Pharmacology and Cancer Biology at the Duke University Medical Center. Prior to Duke University, Dr. Abraham held dual professorships in the departments of Immunology and Pharmacology at the Mayo Clinic in Rochester, MN. He maintains adjunct professor appointments at U.C. San Diego (Department of Pharmacology), and at the Sanford Burnham Prebys Institute.
Dr. Abraham began his career as an academic investigator, with enduring interests in cancer biology and immunology. His major research interests included characterization and functional analysis of the mammalian Target of Rapamycin (mTOR) signaling pathway, cancer metabolism, cellular signaling and DNA damage responses. Dr. Abraham has authored over 225 scientific publications, and his published work has been cited over 48,000 times. Dr. Abraham received his B.S. in Biology from Bucknell University and his Ph.D. in Pharmacology at the University of Pittsburgh, and he completed his postdoctoral training in Pharmacology and Immunology at the Mayo Clinic.
Timothy A. Yap, M.B.B.S., Ph.D., F.R.C.P.
Dr. Yap is an associate professor in the departments for Investigational Cancer Therapeutics and Thoracic/Head and Neck Medical Oncology at the MD Anderson Cancer Center. He is also the medical director of the Institute for Applied Cancer Science, a drug discovery biopharmaceutical unit where drug discovery and clinical translation are seamlessly integrated. He is also an associate director of translational research at the Institute for Personalized Cancer Therapy, an integrated research and clinical trials program. Previously, Dr. Yap was a consultant medical oncologist at The Royal Marsden Hospital in London, UK and National Institute for Health Research BRC clinician scientist at The Institute of Cancer Research, London, UK.
Dr. Yap´s primary research focuses on development of targeted agents and their acceleration through biomarker-driven clinical trials. His main interests include targeting of the DNA damage response as well as the development of novel immunotherapeutics, and past and current he is and/or has been a principal investigator for multiple clinical trials evaluating novel strategies for targeting the DNA damage response in cancer. Dr. Yap obtained his B.Sc. degree in Immunology and Infectious Diseases at Imperial College London, UK, and subsequently went on to attain his medical degree from Imperial College London, UK. He has a Ph.D. in Molecular Pharmacology from the Division of Cancer Therapeutics at the Institute of Cancer Research, London, UK.
David Berman, M.D., Ph.D.
Dr. Berman is a professor and chair of the department of Pathology and Molecular Medicine at Queen’s University in Kingston, Ontario. He is board certified in Anatomic Pathology and practices urologic surgical pathology at Kingston Health Sciences Centre while also running a biomarker discovery laboratory focused on urologic cancers. Dr. Berman earned his M.D. and Ph.D. (Genetics and Development) degrees from the University of Texas, Southwestern Medical Center. He completed residency training and a postdoctoral research fellowship at Johns Hopkins where he established his independent research laboratory, which moved to Canada in 2012. The Berman laboratory focuses on basic, translational, and clinical aspects of prostate and bladder cancer. His research has helped identify bladder cancer stem cells and druggable targets in embryonic signaling pathways, and it has helped improve surgical pathology practice.
Dr. Berman was director of the Queen’s Cancer Research Institute from 2015-2021 and has served on research advisory committees for the Canadian Cancer Society (ACOR), the Canadian Cancer Trials Group, and Bladder Cancer Canada. He currently leads a translational research effort for the Canadian Bladder Cancer Research Network.
Jesper Olsen, Ph.D.
Dr. Olsen is an academic co-founder and head of phosphoproteomics at Acrivon Therapeutics, Inc. He is a professor in quantitative proteomics at the University of Copenhagen and vice director of the Novo Nordisk Foundation Center for Protein Research. Dr. Olsen is a pioneer in mass spectrometry based phosphoproteomics and its applications to decipher cell-signaling networks at a systems-wide scale, and his research interest is developing and applying phosphoproteomics technologies for comprehensive kinase drug profilings with clinical actionability. Dr. Olsen is the most cited phosphoproteomics expert world-wide and among top 0.1% in protein sciences.
Dr. Olsen received his M.Sc. in Analytical Chemistry at the University of Southern Denmark and his Ph.D. in Biochemistry and Molecular Biology at the same place under the supervision of Prof. Matthias Mann. Dr. Olsen completed his post-doctoral training in proteomics and cell signaling at the Max Planck Institute for Biochemistry in Munich. He is based in Copenhagen since 2009, where he joined the newly established Center for Protein Research, initially as group leader and since 2014 as vice director.
About Acrivon Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that can be used to identify patients most likely to benefit from Acrivon’s medicines. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The company’s pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Lilly which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the company’s website at https://acrivon.com for more information.
Acrivon Contacts:
Alexandra Santos
asantos@wheelhouselsa.com
Aljanae Reynolds
areynolds@wheelhouselsa.com
WATERTOWN, Massachusetts, November 29, 2021 – Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary technologies driving a new era of precision-based medicine, today announced that Peter Blume-Jensen, M.D., Ph.D., Acrivon’s chief executive officer and founder, will present at the Evercore ISI 4th Annual HealthCONx Virtual Conference on Tuesday, November 30, 2021 at 8:00 a.m. ET.
To access the live webcast or archived recording of the presentation, please visit Acrivon’s website at https://acrivon.com/news-press. The replay will be available for 30 days following the event.
About Acrivon
Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that can be used to identify patients most likely to benefit from Acrivon’s medicines. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The company’s pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Eli Lilly and Company which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the company’s website at https://acrivon.com for more information.
Acrivon Contacts:
Alexandra Santos
asantos@wheelhouselsa.com
Aljanae Reynolds
areynolds@wheelhouselsa.com
- Proceeds to support the clinical development of advanced Phase 2 lead asset ACR-368, a potent DNA Damage Response (DDR) inhibitor clinically validated in solid cancers, and in-house drug pipeline driven by the company’s proprietary platform technology, Acrivon Predictive Precision Proteomics (AP3)
- Company to expand headcount and pipeline to further realize the broad applicability of its powerful AP3 precision medicine platform
WATERTOWN, Massachusetts, November 11, 2021 – Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary technologies driving a new era of precision-based medicine, today announced the successful completion of an oversubscribed $100 million Series B financing. The financing was co-led by Wellington Management Company and Surveyor Capital (a Citadel company), with key participation from RA Capital Management and Perceptive Advisors. Additional new investors in the financing included Sands Capital, HBM Healthcare Investments, Marshall Wace, HealthCor Management, BB Pureos Bioventures, Acorn Bioventures, and existing investors, including Alexandria Venture Investments and Chione Ltd. In connection with the financing, Derek DiRocco, Ph.D., partner at RA Capital Management, will join the company’s Board of Directors.
Acrivon’s Predictive Precision Proteomics (AP3) technology platform enables the development of drug-tailored OncoSignature® companion diagnostics that link drug mechanisms to the active disease-driving processes of cancer in patients, uncovering drug sensitivity not achievable through traditional genomics analyses. Acrivon’s pipeline will be advanced in clinical trials selectively enrolling patients predicted to benefit from treatment based on its proprietary OncoSignature® companion diagnostics. The company’s clinically advanced lead product candidate ACR-368 (also known as prexasertib, in-licensed from Eli Lilly and Company) is a potent, second generation CHK1/2 inhibitor which has shown durable, single-agent anticancer activity, including complete responses, in a proportion of patients across multiple cancers in Phase 2 studies.
“On the heels of the company’s recent public launch in late June, we are pleased to have attracted a top-tier syndicate of leading private/public investors that recognize the transformative potential of our platform and pipeline,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and founder of Acrivon. “Appropriate patient selection is one of the biggest unmet needs for targeted oncology therapeutics and is currently not possible for the majority of common solid cancers. We are excited to now leverage the broader potential of our AP3 platform, which enables us to decipher a drug’s true mechanism-of-action at high resolution and accurately match that with the disease-driving processes in a patient’s tumor. This allows us to not only predict individual patient response, but also identify new indications and rational drug combinations, as well as hurdles that block patient responses, such as resistance mechanisms. The initial application of our technology is for the development of ACR-368 and two other undisclosed pipeline programs targeting solid tumors.”
Derek DiRocco, Ph.D., partner at RA Capital and member of the board added, “Acrivon’s lead asset ACR-368 has demonstrated impressive monotherapy activity in several cancers, and the late-stage Phase 2 development strategy using their proprietary patient selection methodology can lead to multiple accelerated approval opportunities in these high unmet need cancers. We are impressed by the company’s foundational technologies and believe they are broadly applicable to therapeutics beyond ACR-368 and have the potential to usher in a new era of precision-based medicine beyond the industry’s current approaches, which are largely limited to the use of genomic biomarkers.”
“We are thrilled by the support from these notable investors,” said Kristina Masson, Ph.D., co-founder and site head of Acrivon AB, Acrivon’s phospho-proteomic and drug discovery hub located in Medicon Village, Lund, Sweden. “We have strategically built our phospho-proteomics capabilities here to leverage the proximity to our academic co-founder, professor Jesper Olsen at the University of Copenhagen, Denmark, who is a recognized leader in the field of phospho-proteomics. Likewise, our structure-guided drug discovery programs benefit from local expertise in structural biology and medicinal chemistry. The excellent infrastructure and world-leading proteomics expertise established at our hub in Scandinavia remains a major competitive advantage for Acrivon, and we are excited to also welcome several European investors to join our investor syndicate.”
About Acrivon Precision Predictive Proteomics
Acrivon Predictive Precision Proteomics, AP3, is a proprietary, streamlined approach to develop patient selection tumor biopsy tests, called OncoSignature® tests. The technology is engineered to be agnostic to underlying genetic alterations and enables identification and treatment of the patients whose tumors are regulated by and sensitive to the drug based on direct protein measurement of the critical tumor-driving mechanisms. The AP3 approach leverages unbiased differential global phosphoproteomic drug profiling using mass spectrometry, biased tumor model analyses, and quantitative multispectral in situ imaging of patient derived xenograft (PDX) in vivo models and intended-use tumor samples and clinical trial biopsies, to identify and evaluate biomarkers. The output of AP3 is clinically actionable, drug-tailored, proprietary OncoSignature® tests. These are automated, quantitative protein multiplex imaging tests applied to pretreatment tumor biopsies as a companion diagnostic (CDx) to select and treat the patients predicted to benefit from the drug. The AP3 method is broadly applicable across drugs and is a transformative, efficient method to accurately match the right therapy to the right patient.
About ACR-368 (also known as prexasertib)
ACR-368 is a potent, selective inhibitor of CHK1 and CHK2 which has shown deep durable single agent activity, including complete responses, in a proportion of patients across several Phase 2 studies of platinum-resistant ovarian cancer and in squamous cell cancers, including anal cancer for which FDA has granted orphan drug designation. ACR-368 has been tested in >1,000 patients as monotherapy and in combination, showing excellent pharmacokinetic and pharmacological properties and a favorable safety profile at the recommended Phase 2 dose across monotherapy studies. Acrivon has obtained exclusive, world-wide rights to develop and commercialize ACR-368 under a license agreement with Eli Lilly and Company.
About Acrivon
Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that can be used to identify patients most likely to benefit from Acrivon’s medicines. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The company’s pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Eli Lilly and Company which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the company’s website at https://acrivon.com for more information.
Acrivon Contacts:
Alexandra Santos
asantos@wheelhouselsa.com
Aljanae Reynolds
areynolds@wheelhouselsa.com
- Acrivon signs exclusive worldwide license agreement with Eli Lilly and Company to develop and commercialize prexasertib, a clinically advanced, selective inhibitor targeting DNA Damage Response (DDR) kinases CHK1 and CHK2, which has shown durable activity, including complete responses in a proportion of patients across multiple cancers in Phase 2 studies
- Acrivon aims to accelerate development and improve clinical success rate of prexasertib and pipeline of oncology drugs through its proteomics-based, drug-specific OncoSignature® companion diagnostics for prospective identification of patients most likely to benefit from treatment
- Company also discloses equity investors and announces experienced founding and executive leadership team to advance precision oncology drugs in multiple solid tumor types with high unmet need
WATERTOWN, Massachusetts, June 29, 2021 – Acrivon Therapeutics, Inc., a clinical-stage precision oncology therapeutics company with a unique patient selection platform, today announced its launch with multiple key catalysts, including the execution of an exclusive license with worldwide rights from Eli Lilly and Company (Lilly) for a clinically-advanced DNA Damage Response (DDR) inhibitor called prexasertib, advancement of internal pipeline programs targeting DDR, and appointment of its executive leadership team. Existing equity investors and shareholders include Chione Ltd., NEA, Alexandria Venture Investments, and Lilly.
Acrivon is surpassing traditional precision oncology by harnessing the power of proteomics to accurately match its therapies with patients who will benefit from treatment. Leveraging its proprietary platform technology, Acrivon Predictive Precision Proteomics (AP3), the company generates drug-tailored OncoSignature® companion diagnostics that link drug mechanisms to the active disease-driving processes of cancer in patients, uncovering drug sensitivity not achievable through traditional genomics analyses. Acrivon’s pipeline will be advanced in clinical trials selectively enrolling patients predicted to benefit from treatment based on its proprietary OncoSignature® companion diagnostics. These automated, quantitative protein tissue imaging tests are applied to pretreatment tumor biopsies to determine a patient’s likelihood of responding to therapy based on the drug’s mechanism of action.
The company’s newly licensed clinical asset, prexasertib, is a second-generation, dual inhibitor of the DDR kinases CHK1 and CHK2 which in multiple Phase 2 trials has demonstrated durable, potent single agent activity, including complete responses in a proportion of patients across several cancers with high unmet need, such as platinum-resistant ovarian, head and neck, and anal cancers. Acrivon intends to develop prexasertib (also called ACR-368) in accelerated clinical trials treating patients whose tumors are driven by, and depend on, dysregulated CHK1 and CHK2 using the OncoSignature® test. The lead indications are platinum-resistant ovarian cancer as well as two additional solid tumor types not previously treated with ACR-368 but identified by OncoSignature® to be highly sensitive to the drug. The company also announced it is rapidly advancing its proprietary pipeline of structure-based drug programs targeting critical nodes in the DDR and cell cycle regulation.
“We are excited to gain worldwide rights to prexasertib from Lilly given promising deep and durable clinical responses observed in solid tumors,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and founder of Acrivon, and the inventor of the AP3 platform and OncoSignature® patient selection method. “We are committed to its successful development for the many cancer patients that truly can benefit from it. Our transformative AP3 approach is broadly applicable allowing us to develop drugs for high unmet need cancers beyond the small subset of cancers driven by single gene mutations or synthetic lethal context, where genetics has proven challenging for patient selection.”
In addition to Peter Blume-Jensen, Acrivon’s additional co-founders include Kristina Masson, Ph.D., senior vice president of operations and site head for its Scandinavian drug discovery and phosphoproteomics hub in Medicon Village, Lund, Sweden, and Jesper Olsen, Ph.D., professor at the Novo-Nordisk Foundation Protein Institute in Copenhagen, Denmark, and a pioneer of global phosphoproteomics and systems biology.
Separately, the company announced the recent appointment of Erick Gamelin, M.D., Ph.D., as chief medical officer. Dr. Gamelin, a veteran drug developer of cancer therapeutics, joins Acrivon from clinical leadership roles at Amgen and Pfizer. Previously a professor of clinical oncology at University of Angers Pays de Loire, France, Dr. Gamelin has led over 150 clinical oncology trials.
Dr. Gamelin commented, “I am very excited about the AP3 platform as an efficient, streamlined way to develop precision oncology therapeutics that are matched to the patients who need them agnostic of underlying genomic alterations. Appropriate patient selection is the biggest unmet need in our industry for targeted oncology therapeutics. We intend to apply OncoSignature® patient selection tests to pretreatment tumor biopsies in prospectively designed patient selection trials aiming to significantly accelerate clinical oncology development.”
In addition to Drs. Blume-Jensen, Masson, and Gamelin, Acrivon’s leadership also includes:
- Jeremy Barton, M.D., chief medical advisor, who was previously global head of early clinical oncology, Pfizer, and CMO for Biogen, Effector, and Mirati Therapeutics.
- Chris LeMasters, M.B.A., chief business advisor, who brings broad oncology-specific transactional and executive business leadership experience, including most recently at Amplyx and at Mirati Therapeutics.
- Eric Devroe, Ph.D., senior vice president of business operations, with strong drug and diagnostics business, operational, and founding leadership experience from MD Anderson Cancer Center, Metamark Genetics, Xione, and Opsonix.
- Mary Rose Keller, vice president of clinical operations, who was previously head of Global Clinical Operations at Pfizer, Shire, and Heron, and has led clinical operations for over 400 clinical programs.
- Kelly Gordon, Ph.D., vice president of Companion Diagnostics, who previously led companion diagnostic product development and regulatory strategy for multiple oncology drugs, including Tecentriq® from Roche and Vitrakvi® from Loxo Oncology.
- Michail Shipitsin, Ph.D., senior director and head of Clinical Biomarker Development who is a pioneering expert on automated, digital imaging clinical biomarker tests, and was the scientific lead on ProMark®, a marketed prostate cancer test.
About Acrivon Precision Predictive Proteomics
Acrivon Predictive Precision Proteomics, AP3, is a proprietary, streamlined approach to develop patient selection tumor biopsy tests, called OncoSignature® tests. The technology is engineered to be agnostic to underlying genetic alterations and enables identification and treatment of the patients whose tumors are regulated by and sensitive to the drug based on direct protein measurement of the critical tumor-driving mechanisms. The AP3 approach leverages unbiased differential global phosphoproteomic drug profiling using mass spectrometry, biased tumor model analyses, and quantitative multispectral in situ imaging of patient derived xenograft (PDX) in vivo models and intended-use tumor samples and clinical trial biopsies, to identify and evaluate biomarkers. The output of AP3 is clinically actionable, drug-tailored, proprietary OncoSignature® tests. These are automated, quantitative protein multiplex imaging tests applied to pretreatment tumor biopsies as a companion diagnostic (CDx) to select and treat the patients predicted to benefit from the drug. The AP3 method is broadly applicable across drugs and is a transformative, efficient method to accurately match the right therapy to the right patient.
About Prexasertib (ACR-368)
Prexasertib, originally discovered by Array BioPharma and developed by Lilly, is a potent, selective inhibitor of CHK1 and CHK2 which has shown deep durable single agent activity, including complete responses, in a proportion of patients across several Phase 2 studies of platinum-resistant ovarian cancer and in squamous cell cancers, including anal cancer for which FDA has granted orphan drug designation. Prexasertib has been tested in >1,000 patients as monotherapy and in combination, showing excellent pharmacokinetic and pharmacological properties and a favorable safety profile at the recommended Phase 2 dose across monotherapy studies. Acrivon has obtained exclusive, world-wide rights to develop and commercialize prexasertib under a license agreement with Lilly. It is being advanced at Acrivon under the name ACR-368.
About Acrivon
Acrivon is a clinical stage oncology company leveraging its unique, proprietary phosphoproteomics technology called Acrivon Precision Predictive Proteomics, or AP3, in development of its pipeline of oncology drugs. The AP3 platform enables the creation of drug-specific proprietary OncoSignature® companion diagnostics that can be used to identify patients most likely to benefit from Acrivon’s medicines. Through its highly specific patient selection, the company seeks to accelerate clinical development and increase the probability of successful treatment outcome for patients. The company’s pipeline includes the clinically advanced lead program, ACR-368 (also known as prexasertib), a targeted oncology asset in-licensed from Lilly which has demonstrated evidence of durable responses, in solid cancers in Phase 2 trials. Acrivon is also developing additional pipeline programs targeting critical nodes in DNA Damage Response (DDR) and cell cycle regulation. Please visit the company’s website at https://acrivon.com for more information.
Acrivon Contacts:
Alexandra Santos
asantos@wheelhouselsa.com
Aljanae Reynolds
areynolds@wheelhouselsa.com
