VEGFR2

David Epstein, formerly CEO of Seagen, joins as Chair & Chief Executive Officer Mehdi Shahidi, previously SVP and Chief Medical Officer at Boehringer Ingelheim, joins as Head of Development & Chief Medical Officer James Sabry, ex-Head of Pharma Partnering at Roche, joins the Board as Vice-Chair LONDON and BOSTON, Oct. 28, 2024 /PRNewswire/ -- Ottimo Pharma, a private biotech company, announces the appointment of world class industry veterans David Epstein as Chair & Chief Executive Officer, Mehdi Shahidi as Head of Development & Chief Medical Officer and James Sabry as Vice-Chair of the Board of Directors. Ottimo Pharma, co-founded by Medicxi and Jonny Finlay in 2020, is developing Jankistomig, a PD1-VEGFR2 bi-functional antibody, designed as a dual-pathway, single agent, IgG therapy targeting immune checkpoint inhibition and angiogenesis in the treatment of cancer. David Epstein, Chair & Chief Executive Officer of Ottimo Pharma, said: "This new medicine is exquisitely designed and offers large potential benefits to patients across a wide range of solid tumors. It will be exciting to scale the team and deliver on the promise to patients." James Sabry, Vice-Chair of the Board of Ottimo Pharma, said: "I am excited to join the Board of this highly innovative company with a beautifully designed medicine that has the potential to change the face of cancer immunotherapy." Jankistomig's unique mode of action blocks the PD1 and VEGF pathways, leveraging its high affinity for PD1 to enhance tumor immune cell biodistribution while minimizing VEGF-related adverse effects, specifically due to its intentionally designed interaction with VEGFR2. Ottimo Pharma's goal is to improve cancer treatment outcomes and reduce healthcare burden through this novel combination of mechanisms of action. Over the last three years, Ottimo Pharma has been running the full pre-clinical characterization of the molecule and anticipates filing an IND in late 2025. Francesco De Rubertis, Board Member at Ottimo Pharma & Partner at Medicxi, commented: "As we launch Ottimo Pharma, I am confident that the combined expertise of this stellar leadership team will help accelerate the transformation of the original insight by Jonny Finlay in his Scottish lab into a best-in class asset in cancer therapy." Jonny Finlay, Scientific Founder & Advisor at Ottimo Pharma, added: "I am extremely excited to see Ottimo Pharma come out of stealth. I can't wait to see the scientific and clinical breakthroughs made by this superb team and this deeply differentiated molecule." David Epstein, newly appointed Chair of the Board of Directors & Chief Executive Officer, brings over 30 years of experience in drug development, deal making and commercialization, with a strong track record of success. Most recently, David served as CEO of Seagen, and as a member of its Board, until its acquisition by Pfizer in late 2023. From 2010 to 2016, he served as CEO of Novartis Pharmaceuticals, a division of Novartis AG, and earlier in his career, he founded and led Novartis' Oncology and Molecular Diagnostics units. Mehdi Shahidi, MD, joins Ottimo Pharma as Head of Development & CMO, bringing a wealth of expertise in oncology drug development. With over two decades of experience in pharma, including Global Head of Medicine, Oncology and SVP & Chief Medical Officer at Boehringer Ingelheim, he has overseen the clinical development, regulatory filing and registration of multiple drugs. Mehdi completed his clinical oncology training at the Royal Marsden Hospital in London and had a successful clinical and research career in oncology before transitioning to the pharmaceutical industry. James Sabry, MD, PhD, joins Ottimo Pharma's Board as non-executive Vice-Chair, with over 30 years of experience in business development and partnering. He currently serves as EVP, Chief Business Officer of BioMarin Pharmaceutical Inc. Prior to this, James was previously Global Head and EVP of Roche Pharma Partnering where he was instrumental in securing key deals that have significantly advanced the company's R&D pipeline and led to the launch of numerous new medicines. From 2010, he was Senior Vice President of Genentech Partnering. About Ottimo Pharma Ottimo Pharma is a private biotechnology company, co-founded in 2020 by Medicxi and Jonny Finlay, focused on the development of pioneering innovative cancer therapies for solid tumors. The Company's lead program, Jankistomig, is a PD1-VEGFR2 bi-functional antibody designed to target both immune checkpoint inhibition and angiogenesis in a single IgG therapy. By advancing this dual-pathway approach, Ottimo Pharma aims to improve cancer treatment outcomes and reduce overall healthcare burden. The Company boasts a world-class leadership team, including David Epstein as Chair and CEO, Mehdi Shahidi as Head of Development and CMO, and James Sabry as Vice-Chair of the Board. Ottimo Pharma anticipates filing an IND in late 2025. About Medicxi Medicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Leveraging deep expertise in drug development and company creation spanning over two decades, Medicxi invests in early and late-stage therapeutics with a product vision that can fulfill a clear unmet medical need. For more information, please visit: . SOURCE Ottimo Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The former head of cancer drugmaker Seagen has joined a new startup involved in whats recently become a competitive corner of oncology research.The startup, Ottimo Pharma, emerged from stealth Monday with the backing of U.K. venture firm Medicxi and David Epstein as its chairman and CEO. It is developing a type of cancer drug that blocks two molecular pathways PD-1 and VEGF implicated in tumors ability to grow and evade detection from the immune system. The company intends to ask regulators next year to begin its first clinical trial.The startup hasnt said how much money its raised from investors so far or which tumors it intends to target. Nonetheless, its emergence, and Epsteins involvement, is the latest sign of interest in a potential advance for cancer immunotherapy.Drugs designed to stifle immune checkpoints like PD-1 have changed how dozens of cancers are treated since first coming to market over a decade ago. These drugs, like Merck & Co.s Keytruda and Bristol Myers Squibbs Opdivo, spur the immune system to fight tumors. When they work well, they can significantly extend lives of people with advanced cancers. But the majority of people dont durably respond to treatment, leading drugmakers to search for combinations that can boost immunotherapys effects.That hunt has yielded mixed results. Outside of chemotherapy, many drugs tested in immunotherapy pairings have failed to outperform immunotherapies alone in clinical testing.One approach that could be different is a single therapy designed to block both PD-1 and VEGF. This year, a drug discovered by China-based Akeso and co-developed by biotechnology company Summit Therapeutics significantly outperformed Keytruda in a late-stage trial in lung cancer.While that trial took place only in China and likely wont support a U.S. approval, the result has still sparked interest in developers of other, similar types of medicines. BioNTech, Instil Bio and a few startups have drugs in the works. Ottimos drug, a bi-functional antibody called jankistomig, targets PD-1 and the protein receptor VEGFR2. The company says targeting that specific receptor should minimize side effects related to VEGF inhibition, which are associated with hypertension and increased levels of protein in the urine.This new medicine is exquisitely designed and offers large potential benefits to patients across a wide range of solid tumors, said Epstein, in a statement. It will be exciting to scale the team and deliver on the promise to patients.“Epstein will take on that task after a short stint as the CEO of Seagen, a cancer drugmaker Pfizer acquired for $43 billion last year. Prior to that, Epstein had spent more than two decades in executive roles at Novartis and then another five years advising and building startup companies at Flagship Pioneering.Former Boehringer Ingelheim Chief Medical Officer Mehdi Shahidi also joined the startup as head of development and CMO. James Sabry, a longtime dealmaking executive at Roche who retired earlier this year, is Ottimos vice chairman.Ottimos drug has the potential to change the face of cancer immunotherapy, Sabry said in a statement. '

FDA sets a PDUFA target action date of March 20, 2025Resubmission is supported by the final survival analysis of CARES-310 study, presented at ASCO 2024 FORT LEE, N.J., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) accepted the resubmission of a new drug application (NDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2025. “We believe rivoceranib plus camrelizumab has the potential to change the clinical practice in the first-line setting for patients with advanced liver cancer. The results of the pivotal CARES-310 trial demonstrated significant improvements in overall survival, with a very manageable safety profile compared with currently approved uHCC therapies. Elevar is committed to working with the FDA to bring this combination to market for patients and healthcare providers,” commented Chris Galloway, M.D., senior vice president of clinical and medical affairs at Elevar Therapeutics. The resubmission included the final analysis of the Phase 3 CARES-310 study presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, which reported median overall survival (mOS) of 23.8 months, the longest mOS for any treatment in a global Phase 3 trial for patients with uHCC, confirming the combination of camrelizumab and rivoceranib continued to show sustained long-term survival as a first-line treatment for patients with uHCC.i With the efficacy results generally consistent across all subgroups, the data suggest the combination has the potential to benefit a global uHCC population. The data also demonstrated consistent efficacy across patients with both viral and non-viral etiologies. About CARES-310 The CARES-310 study, an international, randomized, open-label, Phase 3 trial, with 543 patients with uHCC who had not previously received systemic treatment was the first to demonstrate significant progression-free survival (PFS) and overall survival (OS) benefits with immunotherapy plus an anti-angiogenic tyrosine kinase inhibitor (TKI) over standard TKI as first-line treatment for uHCC. In the primary analysis of PFS (data cut-off [DCO], May 10, 2021) and interim analysis of OS (DCO, Feb. 8, 2022), significant improvements were observed with camrelizumab (C; anti-PD-1 antibody) + rivoceranib (R; VEGFR2-TKI) vs. sorafenib (S). In the final analysis (FA) of the CARES-310 study, after an additional follow-up of ~16 months, median OS was significantly prolonged with C+R vs. S (23.8 mo [95% CI 20.6-27.2] vs. 15.2 mo [95% CI 13.2-18.5]; hazard ratio (HR) 0.64 [95% CI 0.52-0.79]; 1-sided p <0.0001). OS rate with C+R vs. S was 49.0% vs. 32.6% at 24 mo, and 37.7% vs. 24.8% at 36 mo. OS benefits with C+R was generally consistent across subgroups, regardless of geographical region, race, and etiology. Benefits in PFS, objective response rate (ORR) and duration of response (DoR) with C+R vs. S were also sustained after prolonged follow-up. Safety data aligned with the interim OS analysis, with no new signals noted. In the FA, C+R continued to show clinically meaningful survival improvement compared with S, with manageable safety. The extended follow-up further confirmed the favorable benefit-to-risk profile of C+R, supporting it as a new first-line treatment option for uHCC. About Hepatocellular Carcinoma Worldwide each year more than 800,000 people are diagnosed with liver cancerii and the disease is the cause of more than 830,000 deaths.iii Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. About Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib, under the name apatinib (Aitan®), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), is the Chinese -territory license-holder of rivoceranib. About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the European Medicines Agency in August 2024. In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, for commercialization from Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) worldwide excluding Greater China and Korea. To learn more, visit ElevarTherapeutics.com. Media Contact Jeanette Bressi Head, Corporate Communications, Elevar Therapeutics jbressi@elevartherapeutics.com609-439-3997 Investor Relations Contact Wade Smith Chief Financial & Business Officer, Elevar Therapeutics wsmith@elevartherapeutics.com i CARES-310 study final analysisii Key Statistics About Liver Cancer | American Cancer Societyiii Key Statistics About Liver Cancer | American Cancer Society