ArriVent Biopharma, Inc., dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the first patient has been enrolled in its Phase 1b trial of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) or HER2 mutations, including exon 20 insertion mutations. Furmonertinib, an oral, irreversible, pan-EGFR mutant selective inhibitor—which has been shown to be highly brain penetrant—was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) in this indication.

“This is an important milestone for ArriVent as it represents the initiation of our Company’s first clinical trial and the first global study for furmonertinib—a promising therapy for patients with NSCLC,” said Stuart Lutzker, M.D., Ph.D., President of R&D at ArriVent. “Furmonertinib was initially developed and approved in China for EGFR T790M mutant NSCLC, and more recently was approved in China as a first-line treatment for classical EGFR mutant NSCLC by our partners Allist Pharmaceuticals, who continue to advance its development in other indications including EGFR exon 20 insertion mutant NSCLC.”

Continued Dr. Lutzker: “In parallel to the important clinical research ongoing by our partners in China, we look forward to further developing furmonertinib globally in a broad spectrum of EGFR and HER2 mutant NSCLC patients, including those with brain metastases, which occurs in 50-60% of patients during the course of their disease. With this FDA designation, we will be able to expedite the development and regulatory review process of furmonertinib, and if successful, deliver this EGFR inhibitor as a meaningful treatment option for the thousands of patients impacted by this serious and life-threatening disease.”

The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

 

About Furmonertinib

 Furmonertinib is an oral, small molecule, highly brain-penetrant, pan-EGFR mutant inhibitor that targets both classical (exon 19 deletion and L858R) and atypical EGFR mutations, including exon 20 insertion mutations as well as HER2 exon 20 insertion mutations. Furmonertinib is approved in China as an anticancer therapy for EGFR T790M NSCLC patients, and more recently, as a first-line treatment for classical EGFR mutant NSCLC patients. Furmonertinib is being developed in China by Allist Pharmaceuticals and in the rest of the world by ArriVent Biopharma.

 

About EGFR mutant NSCLC

Globally, lung cancer is the leading cause of cancer-related deaths among men and women. Non-small cell lung cancer (NSCLC) is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the epidermal growth factor receptor (EGFR) is a common and early event in the development of NSCLC and is present in approximately 32% of NSCLC patients. The most common EGFR activating mutations are exon 19 deletions and a point mutation in exon 21 (L858R), which together are termed classical EGFR mutations and account for approximately 67% of all the EGFR mutations. 31% of EGFR activating mutations are termed atypical EGFR mutations of which exon 20 insertion mutations constitute 9% of EGFR activating mutations overall.

 

About the Phase 1b Clinical Trial

The furmonertinib Phase 1b, open-label, multi-center, dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations, including Exon 20 insertion mutations. Patients will be enrolled into two stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion). For more information about the trial, please visit clinicaltrials.gov (NCT05364073).

 

About ArriVent Biopharma

ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical products. With a deep and global network, ArriVent seeks to access unique and best-in-class drug candidates at various development stages, including those coming from China and other emerging biotech hubs. Through strategic collaborations with innovative biopharma companies, ArriVent aims to globalize medicines for patients with unmet medical need in a broad range of diseases, with an initial focus in oncology.

For additional information, visit www.arrivent.com.

 

Media

Amy Bonanno, Managing Director, Solebury Trout

abonanno@nullsoleburytrout.com

914-450-0349

 

ArriVent Biopharma, Inc., industry leaders dedicated to accelerating the global development of innovative biopharmaceutical products, today announced the appointment of Bahija Jallal, Ph.D. to its Board of Directors. Dr. Jallal has more than 25 years of experience across research and clinical development, operations, regulatory, commercialization and finance, and currently serves as Chief Executive Officer and Director of the Board at Immunocore, a leading T Cell Receptor biotech company.

“We are pleased to welcome an executive with Bahija’s extensive senior leadership experience to our Board of Directors,” said Bing Yao, Chairman, Co-founder and Chief Executive Officer of ArriVent. “Bahija is an internationally recognized biopharmaceutical leader, known for her entrepreneurial approach to discovering and delivering innovative biologics products to patients. Her expertise in expedient drug development and commercialization across global markets, including the launch of many important therapeutics, will be invaluable as we work toward accelerating the development of internationally discovered first- and best-in-class compounds for patients with difficult to treat cancers who presently lack viable treatment options.”

Prior to joining Immunocore in January 2019, Dr. Jallal was President of MedImmune, AstraZeneca’s global biologics research and development unit. She also served as Executive Vice President of AstraZeneca and a member of its senior executive team. Under her leadership, MedImmune/AstraZeneca developed and launched five new biologic medicines in three therapeutic areas.

Dr. Jallal presently serves on the Boards of Anthem, Inc. and Guardant Health. She is also a member of the Board of Trustees of the Johns Hopkins University and the Board of Directors of the University of Maryland Health Sciences Research Park Corporation.

“While a relatively new venture, ArriVent has already made considerable progress in forging critical partnerships, acquiring assets foundational to its growing pipeline and building a team of diverse and highly experienced professionals,” said Dr. Jallal. “I look forward to contributing to ArriVent’s continued growth and further honing its unique global drug development strategy to help maximize the potential of internationally discovered innovative oncology drugs.”

Dr. Jallal earned her Ph.D. in Physiology from Université de Paris VI, France and conducted her post-doctorate work in molecular biology and oncology at the Max Planck Institute for Biochemistry in Germany.

About ArriVent Biopharma
ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical products. With a deep, global network of biotechs and big Pharmas, ArriVent has access to unique and best-in-class drug candidates at various development stages, including those coming from China and other emerging biotech hubs. Through strategic collaborations with innovative biopharma companies, ArriVent aims to globalize medicines for patients with a broad range of diseases, with an initial focus in oncology.

For additional information, visit www.arrivent.com.

Media
Amy Bonanno, Managing Director, Solebury Trout

914-450-0349

Aarvik Therapeutics and ArriVent Biopharma Inc. today announced a strategic research collaboration to develop and commercialize an undisclosed oncology-focused drug

As part of the collaboration, Aarvik is responsible for the discovery and preclinical development of the novel molecule that is based on its unique modular platform that combines multiple target mechanisms. ArriVent will be responsible for clinical development and commercialization of the collaboration drug candidate that successfully achieves target criteria. For this program, Aarvik will receive an upfront payment and research funding, along with the opportunity for option fees, as well as development and commercial milestones for a potential total value of approximately $100 million, plus royalties.

“Aarvik’s innovative platform enables us to rapidly create a pipeline of differentiated programs across a range of therapeutic targets,” said Jagath Reddy Junutula, Ph.D., Co-founder, President and CEO of Aarvik Therapeutics. “This collaboration with ArriVent leverages their strong global development expertise, enabling us to expeditiously advance a novel cancer therapeutic into the clinic. We are excited to partner with ArriVent’s team, which brings a proven clinical track record in this space. Collaborations such as this one will help Aarvik execute its mission to deliver transformative therapeutics to patients in an accelerated timeframe.”

“Our main business focus at ArriVent is to identify and secure strategic partnerships with companies such as Aarvik who share a similar vision of advancing highly innovative molecules for difficult to treat diseases such as cancer,” said Bing Yao, Ph.D., Chairman, Co-founder and CEO of ArriVent Biopharma. “Developed with their proprietary modular antibody technology, we believe the molecule resulting from this research collaboration will demonstrate enhanced efficacy and safety over available therapies. Coupled with ArriVent’s expertise in global drug development, we aim to rapidly advance this highly novel therapy for patients to benefit globally.”

About Aarvik Therapeutics

Aarvik Therapeutics combines a unique, proprietary modular platform with multiple target mechanisms to develop novel molecules with an improved therapeutic index for oncology and other diseases. Backed by Aarvik’s extensive scientific, research, drug development and business expertise from its founders, team members, SAB and Board, Aarvik Therapeutics is applying its vision and passion to create transformational benefit for patients with cancer and other diseases.

About ArriVent Biopharma

ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical products. With a deep, global network of biotechs and big Pharma, ArriVent has access to unique and best-in-class drug candidates at various development stages, including those coming from China and other emerging biotech hubs. Through strategic collaborations with innovative biopharma companies, ArriVent aims to globalize medicines for patients with a broad range of diseases, with an initial focus in oncology.

For additional information, visit www.aarviktx.com and www.arrivent.com.

Contacts

Media (Aarvik)
Pradeep Fernandes
Email: 

Media (ArriVent)
Amy Bonanno, SVP Solebury Trout

914-450-0349

Arrivent Biopharma, Inc., industry leaders dedicated to accelerating the global development of innovative biopharmaceutical products, today announced the launch of its company with up to $150 million in Series A financing and a potential best-in-class epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), furmonertinib, licensed from Shanghai-based, Allist Pharmaceuticals.

The financing, which provides the Company with $90 million upfront and additional proceeds upon completion of certain milestones, was led by Hillhouse Capital Group, with participation from Lilly Asia Ventures, OrbiMed, Octagon Capital Advisors, Boyu/Zoo Capital, and Lyra Capital.

“We are launching our company with a strong, expanding team that has in-depth scientific and clinical development expertise as well as substantial capital from leading healthcare investors. This financing has supported the in-licensing of our first asset, furmonertinib, and will continue to support the buildout of our portfolio of innovative medicines,” said Bing Yao, Chairman, Co-founder and Chief Executive Officer of ArriVent. “Our strategy focuses on identifying compounds, such as furmonertinib, that have been validated through rigorous discovery and development processes in China and other emerging biotech hubs to help bridge these global biopharma innovations to the U.S., EU and beyond. Securing ex-China development, manufacturing and commercialization rights to furmonertinib—a clinical-stage asset with best-in-class potential—is an important initial step toward potentially accelerating its global development for patients with difficult to treat cancers who presently lack viable treatment options.”

Allist Pharma received approval for furmonertinib in EGFR T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) indications in China in March 2021. The company— which is focused on R&D, manufacturing and commercialization of targeted cancer therapies—is actively studying furmonertinib’s potential in other EGFR mutant NSCLC patient populations in China, both in the metastatic as well as adjuvant clinical settings.

ArriVent intends to file an investigational new drug application with the U.S. FDA to further develop furmonertinib in patients with EGFR mutant NSCLC, and potentially other solid tumors, by year-end and is exploring global development opportunities.

Commented Stuart Lutzker, M.D., Ph.D., Chief Medical Officer and Co-founder of ArriVent: “In the short time since our inception, ArriVent has built an impressive team of drug developers with established and broad expertise in clinical development, including registrational strategies, and deep experience working with biotech partners around the globe. We believe our company is well-positioned to realize the full potential of innovative drugs, broadening their reach to patients.”

About ArriVent Biopharma

ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical products. With a deep, global network of biotechs and big Pharmas, ArriVent has access to unique and best-in-class drug candidates at various development stages, including those coming from China and other emerging biotech hubs. Through strategic collaborations with innovative biopharma companies, ArriVent aims to globalize medicines for patients with a broad range of diseases, with an initial focus in oncology.

Media
Amy Bonanno, SVP Solebury Trout

914-450-0349

Posted in Press Release