ArriVent Biopharma, Inc., a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for furmonertinib for the treatment of patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
“Breakthrough Therapy designation is an important step forward in our development of furmonertinib and highlights its exciting potential as a first-line therapy for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations,” said Bing Yao, Chairman, Co-founder and Chief Executive Officer of ArriVent.
Stuart Lutzker, Co-founder and President of R&D added: “This FDA designation underscores the encouraging clinical activity we have seen with furmonertinib in the FAVOUR study and reflects the critical need for effective and tolerable therapeutic options for these patients. We look forward to continuing our work with the agency as we progress our furmonertinib clinical development program in NSCLC, including our ongoing pivotal, global Phase 3 FURVENT trial evaluating furmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations.”
The Breakthrough Therapy designation was granted based on interim results from FAVOUR trial (NCT04858958), a Phase 1b, randomized, open-label, multi-center clinical trial evaluating the efficacy and safety of furmonertinib in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. FDA’s Breakthrough Therapy designation is designed to expedite development and review of drugs intended to treat a serious or life-threatening condition for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies. Interim results from the trial demonstrated furmonertinib has promising anti-tumor activity as a single agent with a well-tolerated safety profile in the first-line and previously treated patients. The pivotal Phase 3 FURVENT trial (NCT05607550) of furmonertinib for the treatment of first-line NSCLC with EGFR exon 20 insertion mutations is currently enrolling patients globally.
About ArriVent
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.
About Furmonertinib
Furmonertinib is a novel, oral, highly brain-penetrant, EGFR kinase inhibitor designed for broad activity and selectivity across EGFR mutations. Furmonertinib targets both classical (exon 19 deletion and L858R) and uncommon EGFR mutations, including exon 20 insertion mutations. 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. EGFR mutations occur in approximately 24% of NSCLC cases in the Americas and up to 50% in Asian populations. The most common EGFR mutations are exon 19 deletions and a point mutation in exon 21 (L858R), which together are termed classical EGFR mutations and account for approximately 70% of all EGFR mutations. The remaining EGFR mutations are termed uncommon EGFR mutations of which exon 20 insertion mutations constitute approximately 9% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy.
Contact for Investors & Media:
Argot Partners
212.600.1902
ArriVent@nullargotpartners.com
ArriVent BioP-harma, Inc., a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced the appointment of Chris Nolet to its Board of Directors. Mr. Nolet has extensive leadership experience as an audit partner, business advisor and independent board director in the life sciences industry, and currently serves on the Boards of public companies Revance Therapeutics and Jasper Therapeutics.
“The addition of Chris Nolet to our Board of Directors comes at an important time for ArriVent as we advance our global development plans for furmonertinib in non-small cell lung cancer, including an ongoing Phase 3 study, and continue to broaden our pipeline,” said Bing Yao, Chairman, Co-founder and Chief Executive Officer of ArriVent. “Chris has worked with a wide range of life science companies, from rapidly growing startups to Fortune 100 multinational organizations. He brings significant insight into financial markets and substantial experience in capital structuring and operating strategies. His expertise and counsel as a member of our Board will be invaluable as we pursue our mission of identifying, developing, and commercializing innovative drug candidates.”
Mr. Nolet is the former West Region Life Sciences Industry Leader and Partner at Ernst & Young {EV), retiring in June 2019 after over 38 years in the industry. In addition to client services, his responsibilities included serving as a member of the Global EV Life Sciences Executive Leadership Group, which established policies and operating strategies for EY Life Sciences practice worldwide. Prior to joining EY, Mr. Nolet was a partner at PricewaterhouseCoopers, where he developed and led the life sciences practice in the western U.S. Previously, Mr. Nolet was a member of the Finance & Investment Committee and Emerging Companies Section of the Biotechnology Innovation Organization.
About ArriVent
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.
Allist Pharmaceuticals Co., Ltd. (“Allist”) and ArriVent Biopharma, Inc. (“ArriVent”) together announced that interim results from the Phase Ib, randomized, open-label, multi-center clinical study (FAVOUR), evaluating the efficacy and safety of furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, were presented by Professor Baohui Han from Shanghai Chest Hospital during an oral session on September 10, 2023 at the 2023 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC).
Key Results
As of the data cutoff date of June 15, 2023, a total of 86 patients were enrolled in the FAVOUR study and were included in the safety analysis; 80 evaluable patients were analyzed for efficacy. Based on IRC assessments, the confirmed objective response rate (cORR) was 78.6% in the treatment-naïve patients who received furmonertinib at 240 mg daily dose, 46.2% in previously treated patients who received furmonertinib at 240 mg daily dose, and 38.5% in previously treated patients who received furmonertinib at 160 mg daily dose. The median duration of response were 15.2 months, 13.1 months, and 9.7 months in the treatment-naïve 240 mg, previously treated 240 mg, and previously treated 160 mg patient groups, respectively. Anti-tumor responses were observed across near-loop, far-loop and helical EGFR exon 20 insertion mutations.
A well-tolerated safety profile has been observed to-date in the FAVOUR study. Most of the treatment-related adverse events (TRAEs) were Grades 1 and 2. TRAEs leading to treatment discontinuation occurred in 0%, 4%, and 4% of patients in the 240 mg treatment-naïve, 240 mg previously treated, and 160 mg previously treated patient groups, respectively. The safety profile of furmonertinib in the FAVOUR study is overall consistent with that of approved dosage (80 mg) of furmonertinib in China for patients with advanced NSCLC with classical EGFR mutations with no new safety findings. The most common treatment related adverse events include diarrhea, anemia, and liver enzyme elevation.
Based on the FAVOUR study results, furmonertinib has shown promising anti-tumor activity as a single agent, good tolerability, and a manageable safety profile in treatment naïve and previously treated patients with advanced NSCLC who have EGFR exon 20 insertion mutations. Allist and ArriVent are currently collaborating on a global registrational Phase III study to compare furmonertinib to platinum-based chemotherapy for patients with locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations (FURVENT, NCT05607550 / CTR20231409). The trial is currently enrolling patient in the US, China and other countries.
About Furmonertinib
Furmonertinib is a novel, oral, highly brain-penetrant, EGFR kinase inhibitor designed for broad activity and selectivity across EGFR mutations.
Furmonertinib targets both classical (exon 19 deletion and L858R) and uncommon 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 first-line treatment for classical EGFR mutant NSCLC patients and EGFR T790M NSCLC patients. Furmonertinib is being developed in China by Allist Pharmaceuticals and in the rest of the world by ArriVent Biopharma.
About Allist
Shanghai Allist Pharmaceuticals Co., Ltd is co-founded by Mr. Du Jinhao, a renowned entrepreneur, and Dr. Guo Jianhui, tenured scientist of The United States National Institutes of Health (NIH). Headquartered in Zhangjiang Hi-Tech Park since its founding in March 2004, Allist has built itself into an innovative pharmaceutical company, discovering, developing, manufacturing and commercializing innovative medicines.
Under the development concept of “advancing long life with innovation of science and technology”, it is oriented by the unmet clinical demands in the global pharmaceutical market, with special focus on tumor treatment. Allist seeks to develop first-in-class and best-in-class medicines with uncompromised devotion to produce safe, effective, and inclusive innovative drugs with independent intellectual property rights.
After the A and A+ rounds of financing in 2019, Allist was formally listed on the Sci-Tech Innovation Board (STAR) market via the Shanghai Stock Exchange on December 2, 2020 (Stock code: 688578).
About ArriVent
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.
BEIJING, China, July 14, 2023, and NEWTOWN SQUARE, PA, U.S. July 13, 2023 – InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases and ArriVent Biopharma, a clinical stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced a clinical development collaboration to evaluate the combination of InnoCare’s novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor.
Under the agreement, InnoCare and ArriVent will jointly conduct a clinical study to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC).
Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR or HER2 mutations, including exon 20 insertion mutations. It is approved in China as a first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, where it is being further developed for additional indications with Allist Pharmaceuticals who discovered furmonertinib.
ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed by InnoCare for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. In a dose escalation study, ICP-189 demonstrated favorable PK, long half-life and safety and tolerability.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said: “NSCLC is the major subtype of lung cancer with huge unmet medical needs. We are glad to work with ArriVent to push forward the combination study and expect this innovative therapy to benefit global patients early.”
“We are excited to announce this clinical development collaboration with InnoCare,” said Bing Yao, Ph.D., Chairman, Co-founder and Chief Executive Officer of ArriVent. “Combining furmonertinib with ICP-189 represents the growing opportunity for our furmonertinib clinical development program, in addition to ongoing studies in the monotherapy setting. If successful in clinical trials and approved, the combination of furmonertinib with SHP2 inhibitors could be another potential treatment option to help improve the lives of people living with advanced or metastatic lung cancer.”
NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. For more information, please visit: http://www.innocarepharma.com.
About ArriVent
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.
Forward-looking Statements
This contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.
NEWTOWN SQUARE, PA—March 27, 2023—ArriVent Biopharma, Inc., dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced the completion of a $155 million oversubscribed Series B financing. The proceeds will be used to support pivotal Phase 3 and additional studies with the Company’s lead product candidate furmonertinib – a highly brain penetrant, mutant-specific EGFR kinase inhibitor – as well as the continued expansion of its pipeline.
The financing was led by Sofinnova Investments and General Catalyst, with participation from additional new investors including Catalio Capital Management, HBM Healthcare Investments, Shanghai Healthcare Capital, Sequoia China, AIHC Capital, Terra Magnum Capital Partners, Unicorn Capital Partners Limited, and Infinitum Asset Management. All existing investors—which include Lilly Asia Ventures, OrbiMed, Octagon Capital Advisors, Sirona Capital, and Boyu/Zoo Capital—also participated in the round. Commensurate with this financing, Jim Healy, Sofinnova Investments, and Carl Gordon, Orbimed Advisors, will be joining ArriVent’s board of directors.
“We are pleased to have attracted capital and support from leading new and existing investors, and to welcome two new distinguished board members, who recognize the urgency and value of globalizing innovative medicines for patients who have limited treatment options,” said Bing Yao, Ph.D., Chairman, Co-founder and Chief Executive Officer of ArriVent. “With this Series B financing, we have now raised more than $300 million to date, resulting in a strong financial position to further advance and broaden our global development plans for furmonertinib, as well as support our growing pipeline of best and first-in-class oncology therapeutics.”
“ArriVent is accessing innovations on a global scale and pursuing a more capital efficient path for drug development, while improving treatment options for patients,” said Jim Healy, M.D., Ph.D., Managing Partner of Sofinnova Investments. “We look forward to working with the ArriVent management team and investors to accelerate the approval of potentially life-changing therapies for patients with cancer.”
“We are proud to partner with ArriVent in their mission to provide global access to life-improving medicines. With multiple FDA-approved products over the course of their careers, we believe the ArriVent team is uniquely positioned to globalize cancer medicines,” said Elena Viboch, Partner at General Catalyst.
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.
About Sofinnova Investments
Since 1976, Sofinnova has been active in life science investing. We are a biopharmaceutical investment firm with approximately $3.1B in assets under management and committed capital as of 12/31/22. We invest in both private and public equity of therapeutics-focused companies. Our goal is to actively partner with entrepreneurs in both the U.S. and Europe, across all stages of company formation. From drug development and navigating the regulatory process to company building and IPO, we strive to be collaborative, meaningful board members, and excellent partners at every level. We seek to build world class companies that aspire to dramatically improve the current state of medical care today and ultimately, the lives of patients. For more information, please visit www.sofinnova.com.
About General Catalyst
General Catalyst is a venture capital firm that invests in powerful, positive change that endures — for our entrepreneurs, our investors, our people, and society. We support founders with a long-term view who challenge the status quo, partnering with them from seed to growth stage and beyond to build companies that withstand the test of time. With offices in San Francisco, Palo Alto, New York City, London, and Boston, the firm has helped support the growth of businesses such as: Airbnb, Deliveroo, Guild, Gusto, Hubspot, Illumio, Lemonade, Livongo, Oscar, Samsara, Snap, Stripe, and Warby Parker. For more: www.generalcatalyst.com.
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
abonanno@nullsoleburytrout.com
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: contact@nullaarviktx.com
Media (ArriVent)
Amy Bonanno, SVP 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 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
abonanno@nullsoleburytrout.com
914-450-0349