News & Publications

• Proceeds will support the advancement of Atavistik Bio’s oral allosteric AKT1-selective inhibitor for Hereditary Hemorrhagic Telangiectasia (HHT) and the JAK2 V617F mutant-selective inhibitor program for myeloproliferative neoplasms (MPNs) through clinical proof of concept
• Atavistik Bio anticipates initiating its clinical trial in HHT in the first half of 2026

Cambridge, Mass., December 18, 2025 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics, today announced that it has raised a $120 million Series B financing to support the advancement of selective allosteric small molecule therapeutics for the treatment of HHT and MPNs. The financing was led by Nextech Invest and The Column Group, with participation from existing investor Lux Capital and new investor Regeneron Ventures. Atavistik Bio will use the proceeds from the Series B financing to advance its oral allosteric AKT1-selective inhibitor for HHT and its JAK2 V617F mutant-selective inhibitor program for MPNs through clinical proof of concept.

“We’re thrilled to announce our Series B financing, and grateful for the support of both our existing and new investors. With this capital, we are well-positioned to advance both our HHT and MPN programs through key clinical proof-of-concept milestones, with the HHT program expected to enter the clinic in the first half of 2026,” said Bryan Stuart, Chief Executive Officer at Atavistik Bio. “Our precision allostery approach holds tremendous potential to deliver best-in-class therapeutics with superior efficacy and tolerability profiles. Our team is working with tremendous passion and momentum to translate that promise into meaningful outcomes for patients.”

HHT is a severe bleeding disorder that affects more than 1.6 million people globally, with no approved therapies currently available. This condition often leads to frequent bleeding episodes, resulting in chronic anemia, organ damage, and a reduced lifespan. AKT1 hyperactivation is a hallmark of HHT and has been shown to drive the vascular pathology of HHT. Selectively inhibiting AKT1, the primary AKT isoform and driver of abnormal endothelial growth implicated in HHT, offers a novel and potentially disease-modifying therapeutic approach for this difficult disease. Although there has been substantial investment in pan-AKT inhibitors, their use is limited by AKT2-driven toxicities, most notably hyperglycemia, which impact tolerability and restrict their use for chronic dosing. Atavistik Bio has developed an oral allosteric inhibitor that selectively inhibits AKT1, overcoming the shortcomings of pan-AKT inhibitors and offering improved therapeutic potential and tolerability.

MPNs are a group of rare chronic blood cancers for which current treatment options are limited. The JAK2 V617F mutation is the most common driver mutation in patients living with MPNs, affecting approximately 95% of patients with polycythemia vera, 60% of patients with essential thrombocythemia, and 55% of patients with myelofibrosis. Approved pan-JAK inhibitors, such as ruxolitinib, provide symptom relief, but non-selectively inhibit both mutant and wild-type JAK2. This limits the ability to reduce JAK2 V617F mutant allele burden and can disrupt normal blood cell production regulated by wild-type JAK2, contributing to adverse events and treatment discontinuation. Selectively targeting the JAK2 V617F mutation has the potential to reduce mutant allele burden, preserve normal bone marrow function, and have a disease modifying impact that will substantially improve long term outcomes for patients with MPNs.

“We’ve been continually impressed by the exceptional quality of the compounds discovered from Atavistik Bio’s proprietary AMPS™ platform and by the team’s ability to consistently execute against critical milestones,” said John A. Josey, PhD, Atavistik Board Chair. “Atavistik Bio’s HHT and MPN programs would represent enormous advancements in the treatment of these respective diseases. We look forward to seeing Atavistik Bio move these programs into the clinic and bring them closer to patients in need.”

About Atavistik Bio

Atavistik Bio is a clinical stage biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Since its inception, Atavistik Bio has rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery.

Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, Lux Capital, and Regeneron Ventures. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

 

• Atavistik Bio to present the discovery and characterization of novel allosteric JAK2 V617F selective inhibitors that suppress mutant-dependent signaling and proliferation while sparing wild-type JAK2
• Atavistik Bio’s JAK2 V617F mutant-selective inhibitors have the potential to address the significant unmet needs of patients with myeloproliferative neoplasms by providing disease-modifying efficacy while avoiding off-target hematological effects associated with wild-type JAK inhibition

Cambridge, Mass., December 4, 2025 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics, today announced that it will unveil the discovery of its novel, potent, and selective allosteric inhibitors of JAK2 V617F for the treatment of myeloproliferative neoplasms (MPNs) and present compelling, supportive preclinical data for the program at the 67th American Society of Hematology (ASH) Annual Meeting and Exhibition to be held in Orlando December 6-9, 2025.

The JAK2 V617F mutation is the most common driver mutation in patients living with MPNs, affecting approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Selectively targeting the JAK2 V617F mutation has the potential to reduce mutant allele burden, modify disease progression, and significantly enhance treatment outcomes for MPN patients. Approved pan-JAK inhibitors, such as ruxolitinib, target the active site in the JH1 kinase domain of JAK2. Though they have demonstrated clinical benefit and symptomatic relief, pan-JAK inhibitors non-selectively inhibit both mutant and wild-type JAK2. This limits the ability to significantly reduce JAK2 V617F mutant allele burden that is correlated with disease progression. Additionally, inhibition of wild-type JAK2 disrupts normal hematopoiesis, leading to adverse events, and contributes to treatment discontinuation. These limitations underscore the need for mutant-selective, disease-modifying therapies. A highly selective allosteric JAK2 V617F mutant-inhibitor that spares wild-type JAK2 has the potential to provide disease-modifying efficacy, enable molecular remission by reducing mutant JAK2 allele burden and improve hematologic tolerability.

At ASH, Atavistik Bio will present the identification of JAK2 V617F mutant-selective inhibitors that bind the allosteric pseudokinase JH2 domain, which harbors the V617F mutation. These compounds were developed using the company’s proprietary AMPS™ platform and structure-based drug design and demonstrate picomolar affinity for the JAK2 V617F JH2 domain and >100-fold selectivity over related JAK family kinases (TYK2, JAK1). In preclinical models, these compounds show potent inhibition of JAK2 V617F-dependent signaling and proliferation in multiple human hematopoietic cancer cell lines harboring the mutations while sparing wild-type JAK2 cells. Additionally, these compounds demonstrated more than ten-fold selective inhibition of cytokine-independent JAK2 V617F signaling over cytokine-dependent wild-type JAK2 signaling in an isogenic cell model in which the JAK2 V617F mutation was edited to wild-type. In a mouse model bearing JAK2 V617F-expressing SET2 tumors, Atavistik JAK2 V617F selective inhibitors demonstrated strong target engagement, evidenced by reduced phosho-STAT5 levels. Compounds with favorable PK properties, good tolerability, and limited off target activity are being advanced for further development.

“We are pleased to share the discovery of our novel JAK2 V617F mutant-selective allosteric inhibitor program and compelling preclinical data at the upcoming ASH meeting,” said Marion Dorsch, Ph.D., President and Chief Scientific Officer, Atavistik Bio. “Unlike pan-JAK inhibitors that broadly target JAK2 and can only manage symptoms of myeloproliferative neoplasms, our highly selective allosteric JAK2 V617F mutant-selective inhibitors have the potential to deliver durable responses and mitigate off-target hematological effects, offering a powerful disease-modifying benefit and addressing the unmet needs of this patient population.”

Atavistik Bio Poster Presentation Details

Poster Title: Discovery of JAK2V617F mutant specific allosteric inhibitors for the treatment of myeloproliferative neoplasms
Session Name: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster I
Session Date and Time: Saturday, December 6, 2025, 5:30 PM – 7:30 PM ET
Location: Orange County Convention Center – West Halls B3-B4
Poster #: 1977

About Atavistik Bio

Atavistik Bio is a clinical stage biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Since its inception, Atavistik Bio has rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery. Atavistik Bio is currently conducting a Phase 1 clinical trial of ATV-1601, an allosteric selective inhibitor for solid tumors.

Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

• Dr. Pandya brings 20 years of drug development expertise in precision medicine in both oncology and hematology, with previous senior leadership roles at Servier Pharmaceuticals and Agios Pharmaceuticals
• Her appointment follows Atavistik Bio’s recent initiation of a Phase 1 clinical trial evaluating ATV-1601, an allosteric selective inhibitor for AKT1 E17K-driven solid tumors
• She will also play a critical role in advancing the company’s preclinical pipeline programs toward the clinic

Cambridge, Mass., September 15, 2025 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics, today announced the appointment of Susan Pandya, M.D., as Chief Medical Officer (CMO). Dr. Pandya brings 20 years of drug development experience including successful regulatory approvals. She has a track record of building and leading highly effective teams and delivering novel precision medicines for unmet patient needs. As CMO, Dr. Pandya will lead all clinical development strategy and execution for Atavistik Bio, including the ongoing Phase 1 clinical trial of its lead program, ATV-1601, an allosteric selective inhibitor for AKT1 E17K-driven solid tumors. She will also play a central role in advancing the company’s preclinical pipeline into efficient and well-designed clinical trials.

“We are very excited to welcome Susan to the Atavistik Bio team as we transition to a clinical stage organization,” said Bryan Stuart, Chief Executive Officer at Atavistik Bio. “Susan’s expertise in guiding oncology programs through early development, global registration studies, and marketing approval will be instrumental as we progress the ongoing clinical study of our lead precision allosteric candidate, ATV-1601, while continuing to rapidly advance our other pipeline programs toward the clinic.”

“Atavistik Bio’s commitment to discovering and developing both best-in-class and first-in-class allosteric therapeutics for significantly underserved patient populations represents an important advancement in the field of precision oncology medicine,” said Dr. Pandya. “I am thrilled to join this exceptional team at such a pivotal time for the company, and I look forward to helping advance this exciting portfolio of novel precision allosteric therapeutics for patients in dire need of new therapeutic options.”
Dr. Pandya most recently served as Vice President, Clinical Development and Global Head of late-stage oncology at Servier Pharmaceuticals where she led all late-stage clinical development programs in oncology and hematology and played an integral role in corporate business development and portfolio strategy. Before joining Servier, Dr. Pandya led the clinical development of the isocitrate dehydrogenase (IDH) inhibitor portfolio at Agios Pharmaceuticals, acquired by Servier in 2021 and oversaw multiple global drug approvals across a range of oncology indications. Earlier in her career, she focused on early-phase development at Acceleron Pharma.

Dr. Pandya earned her M.D. from Tufts University School of Medicine and completed her residency in internal medicine and fellowship in hematology/oncology and held a clinical practice at Beth Israel Deaconess Medical Center. She also serves on the Board of Directors of MOMA Therapeutics.

About Atavistik Bio

Atavistik Bio is a clinical stage biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Since its inception, Atavistik Bio has rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery. Atavistik Bio is currently conducting a Phase 1 clinical trial of ATV-1601, an allosteric selective inhibitor for solid tumors.

Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

 

• ATV-1601 is a first-in-class allosteric selective inhibitor of AKT1 E17K
• Pan-AKT inhibitors offer limited efficacy for patients with AKT1 E17K-driven mutant tumors due to insufficient inhibition of the AKT1 E17K mutation and AKT2-driven tolerability issues
• In preclinical studies, ATV-1601 has demonstrated enhanced target inhibition, superior efficacy, and improved tolerability compared to pan-AKT inhibitors

Cambridge, Mass., August 4, 2025 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, today announced the dosing of the first patient in its Phase 1 study of ATV-1601 in adults with AKT1 E17K-mutant solid tumors.

ATV-1601 is a first-in-class selective inhibitor of AKT1 E17K, which leverages a reversible allosteric mechanism of action. Preclinically, ATV-1601 has demonstrated greater target engagement, superior efficacy, and improved tolerability compared to pan-AKT inhibitors. AKT1 E17K is a clinically validated oncogene that impacts greater than 40,000 cancer patients per year in the United States, with the highest prevalence in breast, endometrial, and prostate cancers. In addition, early evidence indicates that the AKT1 E17K mutation appears to be an emerging mechanism of resistance to PI3Kα-targeted cancer therapies. A selective allosteric AKT1 E17K inhibitor has the potential to be a transformative therapy against the validated AKT1 E17K oncogenic driver.

“Dosing the initial patient in our first-in-human study of ATV-1601 represents a significant milestone as we transition to a clinical stage biotechnology company and an important step forward in our efforts to develop innovative treatments for patients,” said Bryan Stuart, Chief Executive Officer at Atavistik Bio. “As a selective allosteric AKT1 E17K inhibitor, ATV-1601 has generated a highly differentiated preclinical profile, which we believe has the potential to address significant unmet need for patients. We look forward to evaluating ATV-1601 in the clinic and moving rapidly toward early proof-of-concept data for this program.”

The only approved AKT-targeted therapy is a pan-AKT inhibitor that blocks all three isoforms of AKT (AKT1, AKT2, and AKT3). Pan-AKT inhibitors offer limited efficacy for patients with AKT1 E17K-driven mutant tumors due to insufficient inhibition of the AKT1 E17K mutation. Additionally, pan-AKT inhibitors can cause significant adverse events, which leads to treatment discontinuation or dose-reductions in a considerable subset of patients. As a selective allosteric AKT1 E17K inhibitor, ATV-1601 has the potential to provide greater efficacy and tolerability compared to pan-AKT inhibitors for AKT1 E17K-driven cancers.

The first-in-human, open-label Phase 1a/1b study (NCT07038369) will evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic AKT1 E17K-mutant solid tumors, and in combination with fulvestrant in participants with AKT1 E17K-mutant HR-positive/HER2-negative breast cancer. The Phase 1 study has a dose escalation and expansion phase with AKT-1601 monotherapy, and an escalation and expansion phase with AKT-1601 in combination with fulvestrant.

ATV-1601 was developed leveraging Atavistik Bio’s AMPS™ technology, which is seamlessly integrated with its AI-enabled drug discovery engine to rapidly advance programs from discovery into development. Atavistik Bio is advancing a pipeline of precision allosteric oncology candidates, all discovered in-house, against a broad range of target classes.

About Atavistik Bio

Atavistik Bio is a clinical stage biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Since its inception, Atavistik Bio has rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery. Atavistik Bio is currently conducting a Phase 1 clinical trial of ATV-1601, a selective allosteric inhibitor for solid tumors.

Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

• Dr. William Sellers is a leading cancer researcher who currently serves as a Core Institute member and Director of the cancer program at the Broad Institute and a professor of medicine at Dana-Farber Cancer Institute and Harvard Medical School
• He brings deep expertise and experience in cancer biology and cancer therapeutics to Atavistik Bio as the company advances its pipeline of precision allosteric small molecule therapeutics

Cambridge, Mass., March 31, 2025 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, today announced that it has appointed renowned cancer scientist William Sellers, M.D. to its Scientific Advisory Board. Dr. Sellers joins Atavistik Bio as the company rapidly advances a pipeline of next generation allosteric small molecules for high-value clinically validated targets that have the potential to address significant unmet needs.

“We’re thrilled to welcome Dr. Bill Sellers to our SAB at this pivotal moment for the company as we advance our pipeline and transition to the clinic with ATV-1601, a selective inhibitor targeting AKT1 E17K driven cancers,” said Marion Dorsch, Ph.D., President and Chief Scientific Officer, Atavistik Bio. “As an accomplished industry and academic leader, Bill’s many contributions have led to a deeper understanding of cancer biology and cancer genomics that, in turn, has yielded transformative therapeutic advancements for patients. With his extensive experience in oncology, Bill will provide invaluable guidance as we work to develop innovative therapies and advance our pipeline of next-generation precision allosteric therapeutics for patients.”

“Precision small molecule medicines have transformed the cancer treatment landscape, resulting in better outcomes for many patients. Despite this notable progress, as we continually unfold the relentless intricacies of cancer biology, we have only scratched the surface of what’s possible,” said Dr. Sellers. “I am impressed with Atavistik Bio’s pipeline and novel approach to discover next-generation precision small molecule medicines that leverage the power of allostery, and I look forward to helping further the team’s pursuit of high-value targets aimed at addressing serious unmet needs.”

Dr. Sellers currently serves as a core institute member and director of the cancer program at the Broad Institute and a professor of medicine at Dana-Farber Cancer Institute and Harvard Medical School. At the Broad Institute, Dr. Sellers directs a research group focused on translating genomic discoveries into new therapeutics.

Previously, Dr. Sellers directed cancer drug discovery and early cancer clinical development at the Novartis Institutes for Biomedical Research. Prior to joining Novartis, Dr. Sellers was an associate professor of medicine at Dana-Farber Cancer Institute and Harvard Medical School and an associate member of the Broad Institute.

Dr. Sellers has spent his academic career at the intersection of cancer biology and cancer genomics, investigating the basic mechanisms of tumor development. He collaborated with his Dana-Farber and Broad colleague Matthew Meyerson to lead the Broad’s first major foray into cancer genome sequencing. Their work, as well as work by other groups including investigators at Massachusetts General Hospital, led to the identification of EGFR mutations in lung cancer – work that paved the way for EGFR-inhibiting drugs becoming standard-of-care for patients.

Among other achievements in his career, Dr. Sellers was the founder of Civetta Therapeutics, a co-founder of Delphia Therapeutics and currently serves on the Scientific Advisory Boards of Ideaya Bioscience and Epidarex Capital. Additionally, Dr. Sellers was a previous member of the National Cancer Advisory Board.

About Atavistik Bio

Atavistik Bio is a biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Since its inception, Atavistik Bio has rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery. ATV-1601, a selective allosteric inhibitor for solid tumors, is anticipated to enter the clinic in early 2025. Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

• Collaboration will leverage Atavistik Bio’s proprietary AMPS™ platform to rapidly identify and validate novel allosteric binders against two undisclosed, Pfizer-designated targets
• Atavistik Bio has rapidly identified novel, functional, allosteric binding pockets across a broad range of intractable target classes
• Collaboration with Pfizer will enable Atavistik Bio to extend the reach of its platform to potentially address a broader range of oncology indications, while simultaneously progressing its internal pipeline of precision oncology small molecule therapies

Cambridge, Mass., January 2, 2025 – Atavistik Bio, a biotechnology company committed to discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, today announced that it has entered into a research collaboration with Pfizer (NYSE: PFE) to accelerate the discovery of novel precision allosteric therapeutics to address significant unmet medical needs.

Under the terms of the collaboration, Atavistik Bio will leverage its proprietary AMPS™ platform to identify novel allosteric binders against two undisclosed, targets selected by Pfizer. At the completion of the research period, Pfizer will have the option to license the programs. The financial terms of the collaboration are undisclosed.

“Allostery holds the key to targeting disease-causing proteins and delivering highly selective, better tolerated, and more effective therapies. We’re excited to collaborate with Pfizer to harness the tremendous promise of allostery to advance the opportunity for therapeutic innovations for patients in need,” said Bryan Stuart, CEO of Atavistik Bio. “Our internal pipeline has been enabled by our ability to identify novel, functional allosteric binding pockets that allow us to rapidly progress novel chemical matter. We look forward to applying the efficiency and productivity of our platform to our collaboration with Pfizer as we simultaneously advance our internal pipeline of precision oncology small molecule therapies.”

About Atavistik’s Platform

Atavistik Bio’s proprietary AMPS™ platform is a highly integrated discovery engine that combines proprietary computational and experimental techniques to rapidly unlock functional cryptic pockets across a broad range of target classes. By leveraging insights from these novel allosteric chemical starting points, the platform enables the design of small molecules against historically challenging targets. Our highly integrated team and automated data infrastructure makes rapid iteration and progression of chemistry possible, while the versatility of its platform allows the company to accelerate the development of groundbreaking medicines across any therapeutic area.

About Atavistik Bio

Atavistik Bio is a biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs, with a focus on oncology. Since its inception, Atavistik Bio has rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery. ATV-1601, a selective allosteric inhibitor for solid tumors, is anticipated to enter the clinic in early 2025. Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

 

• Data demonstrate that ATV-1601, a selective allosteric inhibitor of AKT1 E17K, provides enhanced target inhibition, superior efficacy and improved tolerability compared to pan-AKT inhibitors in preclinical models
• Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K mutant tumors in early 2025

Cambridge, Mass., October 23, 2024 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, today presented preclinical data at the 36^th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Meeting 2024 in Barcelona for ATV-1601, the company’s orally bioavailable selective allosteric small molecule inhibitor for AKT1 E17K-driven cancers. The preclinical data demonstrated that as a selective allosteric AKT1 E17K inhibitor, ATV-1601 provides enhanced target inhibition, superior efficacy and improved tolerability compared to pan-AKT inhibitors in preclinical models. Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K mutant tumors in early 2025.

AKT1 E17K is a clinically validated oncogene that impacts greater than 40,000 cancer patients per year in the United States, with the highest prevalence in breast, endometrial, and prostate cancers. In addition, early evidence indicates that the AKT1 E17K mutation appears to be an emerging mechanism of resistance to PI3Kα-targeted cancer therapies. The only approved AKT-targeted therapy is a pan-AKT inhibitor that blocks all three isoforms of AKT (AKT1, AKT2, and AKT3). Pan-AKT inhibitors offer limited efficacy for patients with AKT1 E17K-driven mutant tumors due to insufficient inhibition of the AKT1 E17K mutation. Additionally, pan-AKT inhibitors can cause significant adverse events, such as AKT2-driven hyperglycemia, rash, and diarrhea, which lead to treatment discontinuation or dose reductions in a considerable subset of patients.

Data presented in today’s poster entitled, “ATV-1601 is a Potent and Selective Allosteric Inhibitor of AKT1 E17K and Shows Profound and Durable Regressions in AKT1 E17K-Driven Patient-Derived Xenograft Models,” demonstrates that the selectivity profile of ATV-1601 enables greater than 90% target engagement without inducing hyperglycemia in preclinical models. As a result of this potent target engagement and selectivity, ATV-1601 demonstrated profound and durable tumor regression in multiple AKT1 E17K driven patient-derived breast and endometrial tumor models and was well tolerated.

“We are pleased to share these exciting preclinical data for our ATV-1601 program with the oncology community,” said Marion Dorsch, Ph.D., President and Chief Scientific Officer, Atavistik Bio. “As a selective allosteric AKT1 E17K inhibitor, ATV-1601 has the potential to be a transformative precision therapy against the validated AKT1 E17K oncogenic driver. The patient populations impacted by the AKT1 E17K mutation have a significant unmet need, which we are working with urgency to address. We look forward to transitioning into the clinic in our planned first-in-human study.”

About Atavistik Bio

Atavistik Bio is a biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs, with a focus on oncology. Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

• AKT1 E17K mutation is a clinically validated oncogene that impacts greater than 40,000 cancer patients per year in the United States, with the highest prevalence in breast, endometrial, and prostate cancers
• As a selective allosteric AKT1 E17K inhibitor, ATV-1601 has the potential to provide enhanced target inhibition, superior efficacy and improved tolerability compared to pan-AKT inhibitors
• Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K mutant tumors in early 2025
• Preclinical data on ATV-1601 to be presented at the EORTC-NCI-AACR Symposium on October 23, 2024
• The company continues to leverage the AMPS^TM platform to bring forward additional high-value precision oncology programs

Cambridge, Mass., October 15, 2024 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, today announced its precision oncology development candidate ATV-1601, an orally bioavailable selective allosteric small molecule inhibitor for AKT1 E17K-driven cancers. ATV-1601 was developed leveraging the company’s AMPS^TM technology, which is seamlessly integrated with its AI-enabled drug discovery engine to rapidly advance programs from discovery into development.

“ATV-1601’s nomination as our first oncology development candidate is a major milestone for the company, validating the capabilities of our proprietary platform to rapidly discover and advance novel precision allosteric therapeutics for targets that have historically been hard to drug. We anticipate significant progress in our portfolio in the upcoming year for high value oncology targets that address the unmet needs of large patient populations,” said Bryan Stuart, Chief Executive Officer, Atavistik Bio. “We are working to quickly advance ATV-1601 to the clinic and to achieve early clinical proof of concept for this program. We believe our precision allosteric small molecule offers several advantages to target the difficult-to-drug AKT1 E17K mutation, with the potential to improve the lives of many cancer patients.”

AKT1 E17K mutation is a clinically validated oncogene that impacts greater than 40,000 cancer patients per year in the United States, with the highest prevalence in breast, endometrial, and prostate cancers. In addition, early evidence indicates that the AKT1 E17K mutation appears to be an emerging mechanism of resistance to PI3Kα-targeted cancer therapies. A selective allosteric AKT1 E17K inhibitor has the potential to be a transformative therapy against the validated AKT1 E17K oncogenic driver as well as resistance mutations emerging from PI3Kα-targeted therapies.

The only approved AKT-targeted therapy is a pan-AKT inhibitor that blocks all three isoforms of AKT (AKT1, AKT2, and AKT3). Pan-AKT inhibitors offer limited efficacy for patients with AKT1 E17K-driven mutant tumors due to insufficient inhibition of the AKT1 E17K mutation. Additionally, pan-AKT inhibitors can cause significant adverse events, such as AKT2-driven hyperglycemia, rash, and diarrhea, which leads to treatment discontinuation or dose-reductions in a considerable subset of patients. ATV-1601, a selective allosteric AKT1 E17K inhibitor, has the potential to provide enhanced target inhibition, superior efficacy and improved tolerability compared to pan-AKT inhibitors for AKT1 E17K-driven cancers. Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K-mutant tumors in early 2025.

“Behind ATV-1601, we have a robust pipeline of precision oncology programs derived from our AMPS platform, said Marion Dorsch, Ph.D., President and Chief Scientific Officer, Atavistik Bio. “We look forward to advancing our internal pipeline with urgency while also broadening the reach of our platform through partnerships to discover important new allosteric therapeutics across other diseases.”

Atavistik Bio EORTC-NCI-AACR Symposium Data Presentation Details

Date: Wed., October 23, 2024
Time: 12.00 – 19.00 CET
Poster Session: New Drugs
Poster Title: ATV-1601 is a Potent and Selective Allosteric Inhibitor of AKT1 E17K and Shows Profound and Durable Regressions in AKT1 E17K-Driven Patient-Derived Xenograft Models
Poster #: PB128

About Atavistik Bio

Atavistik Bio is a biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs, with a focus on oncology. Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

• Dr. Hirmand brings more than 20 years of clinical development expertise as Atavistik Bio continues to advance its portfolio of oncology-focused precision allosteric small molecule therapeutics into the clinic

Cambridge, Mass., September 25, 2024 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, today announced that Mohammad Hirmand, M.D. has joined its Board of Directors. With more than 20 years of clinical development experience and multiple executive leadership roles, Dr. Hirmand will strengthen Atavistik Bio’s board as the company continues to advance its portfolio of oncology-focused precision allosteric small molecule therapeutics into the clinic.

“We’re thrilled to welcome Mohammad Hirmand to Atavistik Bio’s board at this pivotal moment for the company as we advance our programs into the clinic. Mohammad brings deep clinical leadership experience from several biotech companies that successfully advanced novel oncology medicines,” said Bryan Stuart, Chief Executive Officer, Atavistik Bio. “Mohammad’s insights will prove invaluable to achieve our vision of bringing transformative precision allosteric therapeutics to large populations with unmet need.”

“I’m excited to join Atavistik Bio’s board as the company prepares for its rapidly approaching clinical development milestones,” said Dr. Hirmand. “As an industry, we’ve made important progress delivering breakthrough cancer treatments. However, there is enduring unmet need for significant patient populations, which underscores the opportunity to deliver more effective and safer treatment options. I believe Atavistik Bio’s focus on precision allostery, its pipeline of high value oncology targets, and its highly experienced team hold tremendous potential to fulfill many of these unmet needs.”

Dr. Hirmand is currently co-founder, Executive Vice President and Chief Medical Officer (CMO) of Avenzo Therapeutics. Previously, Dr. Hirmand served as Executive Vice President and CMO for Turning Point Therapeutics, which was acquired by Bristol Myers Squibb. Prior to joining Turning Point, Dr. Hirmand was CMO of Peloton Therapeutics, which was acquired by Merck. Prior to joining Peloton, Dr. Hirmand served as CMO of Medivation through its acquisition by Pfizer. Before his 10-year tenure at Medivation, he held clinical development roles of increasing responsibility at Nuvelo, Inc. (now ARCA Biopharma), SuperGen, Inc. (now Astex Pharmaceuticals, Inc.), Tularik, Inc. (now part of Amgen), and Theravance Biopharma, Inc.

Dr. Hirmand received his M.D. from Harvard Medical School and his B.A. in Biological Sciences and Economics from Cornell University.

About Atavistik Bio

Atavistik Bio is a biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs, with a focus on oncology. Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com

• Dr. Bruno will leverage his diverse industry and scientific expertise to lead Atavistik Bio’s strategic business and corporate development efforts
• Atavistik Bio continues to advance its portfolio of oncology-focused precision allosteric small molecule therapeutics toward the clinic while pursuing a robust partnering strategy to maximize the broad potential of its platform across therapeutic areas

Cambridge, Mass., August 12, 2024 – Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, today announced the appointment of Paul Bruno, Ph.D., as Chief Business Officer. Dr. Bruno will lead strategic execution of Atavistik Bio’s business and corporate development efforts as the company advances its portfolio of oncology-focused precision allosteric small molecule candidates toward the clinic and leverages its platform to address a broad spectrum of diseases.

“We’re thrilled to welcome Paul Bruno as Chief Business Officer and strengthen our leadership team with this critical role,” said Bryan Stuart, Chief Executive Officer at Atavistik Bio. “Paul’s business and corporate development acumen, scientific aptitude, collaborative approach, and authentic desire to help patients make him an extraordinary addition to our team. As we approach key upcoming milestones, both advancing our internal pipeline of precision allosteric product candidates and expanding our partnering initiatives to mine the expansive potential of our platform, I look forward to Paul’s leadership and impact.”

“I’m excited to join the highly experienced Atavistik Bio team and contribute to the company’s mission of delivering a new generation of allosteric medicines to address serious unmet patient needs,” said Dr. Bruno. “Allostery holds the key to targeting numerous disease-causing proteins that, to date, have been intractable. I’m extremely impressed with Atavistik Bio’s success leveraging its proprietary platform to rapidly progress programs towards the clinic and build a high-value oncology pipeline. I believe Atavistik Bio is poised to transform the lives of countless patients in the years ahead through a powerful combination of internal and partnered programs.”

Dr. Bruno joins Atavistik Bio from Fulcrum Therapeutics, Inc., where he most recently served as Senior Vice President, Business and Corporate Development. While at Fulcrum, Paul successfully executed several licensing and financing transactions, including the collaboration and license agreement with Sanofi in May 2024. Prior to Fulcrum, Dr. Bruno was at ClearView Healthcare Partners, a life sciences strategy firm that specializes in working with biotech, pharma, and medtech companies. At ClearView, he worked with clients on corporate strategy, portfolio management, pipeline prioritization, and business development engagements.

Dr. Bruno received his Ph.D. in chemistry from the University of Michigan and completed his postdoctoral fellowship at Boston Children’s Hospital. He also holds a BS from Santa Clara University, where he double majored in chemistry and public health.

About Atavistik Bio

Atavistik Bio is a biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs, with a focus on oncology. Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, and Lux Capital. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.

Media Contact:

Liz Melone
Melone Communications, LLC
liz@melonecomm.com