Atezolizumab

SAN JOSE, Calif., April 09, 2026 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced the appointment of Dr. Sara Kenkare-Mitra as a Strategic Advisor. Dr. Kenkare-Mitra brings nearly three decades of experience in biologics and small molecule drug discovery and development, with a proven track record of global regulatory approvals and commercial launches across oncology, immunology, neurodegeneration, ophthalmology, and respiratory diseases. “Sara is a highly accomplished leader and respected drug developer, and we are thrilled to welcome her as a Strategic Advisor,” said Talat Imran, Chief Executive Officer of Rani. “Her experience across discovery, development, and commercialization of biologics will be invaluable as we refine our platform and asset strategy and prioritize the programs with the greatest potential to drive meaningful clinical and commercial impact. Her perspective will be particularly important as we build on our recent progress, including encouraging preclinical data with oral semaglutide and other RaniPill® programs.” In her advisory role, Dr. Kenkare-Mitra will provide strategic counsel across platform and clinical strategy, including therapeutic area focus, product and drug candidate selection, and development prioritization. She will also advise on aligning development plans with regulatory and market landscape considerations, with a focus on advancing programs that maximize the probability of clinical success and long-term value creation. Dr. Kenkare-Mitra is a seasoned biotechnology and pharmaceutical executive who most recently served as President and Head of Research and Development at Alector. Prior to that, she spent more than 20 years at Genentech, a member of the Roche Group, where she played a central role in the preclinical to clinical translation, development and approval of multiple first-in-class and best-in-class therapies and helped advance the company’s antibody-drug conjugate platform. Her teams contributed to the global development and approval of therapies including Xolair®, Tarceva®, Avastin®, Lucentis®, Kadcyla®, Venclexta®, Perjeta®, Tecentriq®, Ocrevus®, and Polivy®. Dr. Kenkare-Mitra is an elected member of the National Academy of Medicine and a Fellow of the American Association for the Advancement of Science. She currently serves on the Board of Directors of Unicycive Therapeutics and holds a Ph.D. in Pharmaceutical Chemistry from the University of California, San Francisco, where she also completed her postdoctoral training and Clinical Pharmacology fellowship. “I have been deeply impressed by the scientific foundation of the RaniPill platform and the consistency of the human pharmacokinetic data generated to date,” said Dr. Kenkare-Mitra. “The potential to deliver biologics orally with reproducible exposure has broad implications across multiple therapeutic areas. Oral delivery of biologics, once considered impossible, is now inevitable. I look forward to working with the team to prioritize and advance the programs with the greatest opportunity to benefit patients.” About Rani Therapeutics Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill® capsule, a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill® capsule technology. Investors Contact: investors@ranitherapeutics.com Media Contact: media@ranitherapeutics.com

Clinical trial collaboration and supply agreement between Boehringer and BioNTech to conduct a Phase Ib/II clinical trial to explore complementary immuno-oncology mechanisms in extensive‑stage small cell lung cancer. Study combines DLL3‑targeting T-cell engager obrixtamig with pumitamig (BNT327/BMS986545), an investigational PD‑L1/VEGF‑A bispecific antibody being jointly developed by BioNTech and Bristol Myers Squibb Clinical trial collaboration aims to develop a novel treatment regimen that delivers more sustained tumor control in SCLC, a cancer of very high unmet need. Ingelheim, Germany – 9 April, 2026 – Boehringer Ingelheim today announced a clinical trial collaboration with BioNTech to evaluate a novel immuno‑oncology combination in extensive‑stage small cell lung cancer (ES-SCLC), one of the most aggressive and underserved forms of cancer. Under the agreement, BioNTech will supply pumitamig (BNT327/BMS‑986545), a PD‑L1/VEGF‑A bispecific antibody being jointly developed by BioNTech and Bristol Myers Squibb, and Boehringer Ingelheim will be the regulatory sponsor of the Phase Ib/II study. The aim is to assess safety, tolerability and early clinical activity of obrixtamig (BI 764532), Boehringer Ingelheim’s investigational DLL3/CD3 T‑cell engager, in combination with pumitamig. SCLC is the most aggressive subtype of lung cancer and represents around 15–20% of all lung cancer cases. It progresses rapidly, metastasizes early and almost always recurs within a year after initial treatment. While the addition of immune checkpoint inhibitors to chemotherapy has led to improved survival outcomes for patients with extensive-stage disease, most patients progress within months after treatment, and the prognosis remains poor. The collaboration combines two complementary immunotherapeutic mechanisms to explore a potential new path to enhance and sustain antitumor immunity. Obrixtamig redirects T-cells to kill DLL3 expressing tumor cells, while pumitamig aims to restore T-cells’ ability to recognize and destroy tumor cells while cutting off the blood and oxygen supply that feeds the tumor with the intention of preventing it from growing and proliferating. “By uniting T‑cell redirection against DLL3 with PD-L1 and VEGF pathway modulation, we aim to address two central barriers in SCLC – immune evasion and an immunosuppressive, pro‑angiogenic microenvironment,” said Itziar Canamasas, Global Head of Oncology at Boehringer Ingelheim. “We are committed to advancing combinations that could deliver more durable benefit for people living with ES‑SCLC.” Obrixtamig is Boehringer Ingelheim’s investigational bispecific DLL3/CD3 T‑cell engager, designed to direct immune cells to attack DLL3‑expressing cancer cells, a hallmark of small cell lung cancer and other neuroendocrine carcinomas. In the global Phase I first‑line ES‑SCLC study DAREON®‑8, in combination with chemotherapy and atezolizumab, obrixtamig achieved a 68% confirmed objective response rate, 89% disease control rate, and a 9‑month progression‑free survival rate of 52%, with a favorable safety profile 1 . Obrixtamig is being evaluated across multiple global studies and is advancing into a global Phase III trial (DAREON®‑Lung‑1, NCT07472517 ). It has received FDA Fast Track and Orphan Drug Designations, as well as Orphan Drug status from the European Commission for neuroendocrine carcinomas. Pumitamig is an investigational PD‑L1/VEGF‑A bispecific antibody being jointly developed by BioNTech and Bristol Myers Squibb that combines two complementary, validated mechanisms in one single molecule – immune checkpoint inhibition and anti-angiogenesis. In a global Phase II first‑line ES‑SCLC study in combination with chemotherapy, pumitamig demonstrated a 76.3% confirmed objective response rate, 100% disease control rate, and median progression-free survival of 6.8 months, with a manageable safety profile 2 . The program has advanced into a global Phase III trial (ROSETTA LUNG‑01, NCT06712355 ) and received FDA Orphan Drug Designation in 2025 for the treatment of SCLC. Under the terms of the agreement, BioNTech will supply pumitamig and Boehringer Ingelheim will be the regulatory sponsor of the study. Both companies retain full rights to their respective assets, and the agreement is mutually non-exclusive. The trial will begin dosing patients in the second half of 2026. Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at Intended Audiences Notice This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. 1 Solange Peters et al. DAREON®-8: a Phase I trial of first-line obrixtamig plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC). ESMO 2025 Peters | Globalmedcomms (Accessed: March 2026) 2 Heymach, J.V. et al. OA13.02 Global Phase 2 Randomized Trial of BNT327 (Pumitamig; PD-L1 x VEGF-A bsAb) + Chemotherapy for 1L ES-SCLC: Dose Optimization Analysis. Journal of Thoracic Oncology. 20. S38-S39. DOI: .