Boehringer Ingelheim Pharma GmbH & Co., KG

The product is suitable for patients 12 years and above weighing a minimum of 40kg. Credit: Melnikov Dmitriy via Shutterstock. The US Food and Drug Administration (FDA) has granted approval for Boehringer Ingelheim’s SPEVIGO injection to treat generalised pustular psoriasis (GPP). The treatment is indicated for use in adult and paediatric patients 12 years and above with a minimum weight of 40kg. This development follows a similar approval by the Chinese National Medical Products Administration for reducing GGP occurrence in patients of the same age group. A humanised selective IgG1 antibody, SPEVIGO attaches to the interleukin-36 receptor, which plays a crucial role in the immune system’s signalling pathway and is implicated in the pathogenesis of GPP. The FDA’s decision was largely based on the positive outcomes of the EFFISAYIL 2 clinical trial. See Also: Johnson & Johnson’s paediatric HIV-1 treatment secures FDA approval Everest receives Singapore HSA approval for NEFEGAN to treat IgAN The 48-week study, involving 123 patients, demonstrated that SPEVIGO significantly reduced GPP flare risk by 84% versus placebo. Remarkably, after week four, no flares were observed in the high-dose SPEVIGO group. However, the trial also reported an increased incidence of certain adverse events associated with SPEVIGO treatment. These included reaction at the injection site, urinary tract infection, arthralgia, and pruritus, occurring at a rate of at least nine cases per 100 patient-years compared to the placebo arm. Boehringer Ingelheim Human Pharma head Carinne Brouillon said: “SPEVIGO’s new approvals constitute a fundamental change for people living with GPP, addressing their huge need for acute and chronic treatment. “Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode. Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.” This month, Boehringer signed a global collaboration and exclusive option-to-license agreement with Sosei Heptares for the development of a new class of therapies for all schizophrenia symptoms. Under the deal, the companies will develop and market a portfolio comprising G protein-coupled receptor 52 agonists from Sosei Heptares to treat positive, negative, and cognitive symptoms linked to schizophrenia.

Novel antagonist anti-SIRPα monoclonal antibody (mAb) targeting both V1 and V2 SIRPα alleles makes SIRPα antagonists an option for more cancer patients. First clinical results of BI 770371 in monotherapy and in combination presented at ESMO 2023 conference. NANTES, France--(BUSINESS WIRE)-- Regulatory News: OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced that first Phase 1 results for BI 770371, a novel anti-SIRPα monoclonal antibody evaluated in advanced solid tumors, have been presented, at the European Society for Medical Oncology conference, held in Madrid, Spain (October 20 – 24, 2023). BI 770371 is an IgG1 mAb that recognizes both the V1 and V2 variants of SIRPα. In many cancer types, CD47 forms a potent ‘don’t eat me’ signaling complex with SIRPα that triggers a cascade of events that enables cancer cells to avoid detection by the innate immune system and inhibits the ability of macrophage cells to fight cancer. By blocking the interaction between SIRPα and cluster of differentiation 47 (CD47), SIRPα antagonism enhances innate immunity and restores the immune function of myeloid cells in the tumor microenvironment. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented: “We congratulate our partner Boehringer Ingelheim for this important new achievement, performed in the frame of our global collaboration and license agreement, which demonstrates their commitment to selective SIRPα inhibitors targeting myeloid cells. We are very pleased to potentially make our selective SIRPα inhibitor technology available to more patients through this strategic collaboration. With the V1 and V2 alleles being similarly expressed across humans in western countries, and V2 being more prevalent in the Asian region, the additional BI 770371 program highlights a new step forward in our partnership with Boehringer Ingelheim aiming to provide this selective SIRPα innovation for the benefits of more patients.” The BI 770371 development program will extend the therapeutic potential of selective SIRPα antagonists in various diseases or disorders, covering the most prevalent allelic variants* of SIRPα, V1 SIRPα and V2 SIRPα expressed on myeloid cells. Boehringer Ingelheim is currently evaluating BI 770371 as monotherapy and in combination with ezabenlimab, a PD1 inhibitor (BI 754091), in an open-label, dose escalation/dose expansion Phase I clinical trial (NCT05327946) conducted in Canada, USA and Japan in patients with advanced solid tumours. The first clinical results of BI 770371 presented at ESMO 2023 conference (Madrid, Abstract #697P) showed that adverse events were manageable during the on-treatment period, Maximal Tolerated Dose (MTD) has not been reached. This clinical trial is ongoing. Boehringer Ingelheim is also evaluating BI 765063 (formerly OSE-172) in different combinations with patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or hepatocellular carcinoma (HCC) in a Phase 1b trial conducted in the United States, Europe and Asia (NCT05249426). ESMO, Abstract #697P title: Open-label, Phase I dose escalation/expansion trial of the anti-SIRPa monoclonal antibody BI 770371 in patients with advanced solid tumours, alone or in combination with the anti-PD-1 monoclonal antibody ezabenlimab -NCT05327946 Martin E. Gutierrez1*, Rahima Jamal2, Noboru Yamamoto3, Toshihiko Doi4, Gunther Kretschmar5, Javier Ferrada5, Stephan Wojciekowski6, Manish R. Patel7 1 Hackensack University Medical Center at Hackensack Meridian Health, Hackensack, NJ, USA; 2 Centre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, QC, Canada; 3 National Cancer Center Hospital, Tokyo, Japan; 4 National Cancer Center Hospital East, Kashiwa, Japan; 5 Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA; 6 Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany; 7 Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA * Qu et al. Biomarker Research (2022) ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation. The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors. OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors. OSE-279 is the backbone therapy of the BiCKI® platform. OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics). FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); Phase 1 ongoing in the US (sponsor Veloxis Pharmaceuticals, Inc.). BI 765063 and BI 770371 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapeutics: BiCKI® platform focused on immuno-oncology (IO) is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced BiCKI® candidate targeting anti-PD1xIL-7. Myeloid platform focused on optimizing the therapeutic potential of myeloid cells in IO and immuno-inflammation (I&I). OSE-230 (ChemR23 agonist mAb) is the most advanced candidate generated by the platform, with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: Click and follow us on Twitter and LinkedIn Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on May 2, 2023, including the annual financial report for the fiscal year 2022, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

NAPLES, Italy, Sept. 6, 2023 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) today forged a unique collaboration with Mark Cuban Cost Plus Drug Company (Cost Plus Drugs), a pioneer in affordable medicines, and the COPD Foundation, dedicated to enhancing the lives of COPD patients. This collaboration aims to bolster access to healthcare by expanding the availability of Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, to COPD patients in the US. Lupin's Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, is currently the only generic product available that is therapeutically equivalent to Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule by Boehringer Ingelheim Pharmaceuticals, Inc. Chronic obstructive pulmonary disease (COPD) affects over 15 million adults in the US and ranks as the fourth leading cause of death in the country. This collaboration marks a significant milestone in countering the disease burden by enhancing access to products for patients in the US. Spiro Gavaris, President US Generics, Lupin, said, "We believe there is a large unmet need for improved and affordable products for patients in the US. As a leading healthcare organization, we are committed to increasing access for patients, seeking treatment options for respiratory conditions like COPD, with our respiratory portfolio and pipeline. Our collaboration with Mark Cuban Cost Plus Drug Company and the COPD Foundation reflects our intent to provide quality treatment options for patients." "We are excited to work with Lupin and the COPD Foundation to bring lower prescription drug prices to consumers," said Alex Oshmyansky, CEO of Mark Cuban Cost Plus Drug Company. "Cost Plus Drugs, Lupin and the COPD Foundation all share a common goal of providing consumers the lowest possible price for their prescription medication. With Cost Plus Drugs, consumers can be confident they are getting a fair price and the convenience of medication mailed directly to their homes." "Accessible and affordable medications are a pathway to a healthier, more empowered life for COPD patients," said Jean Wright, M.D., CEO of the COPD Foundation. "Breathing freely shouldn't come at the cost of financial strain. Having a generic option will ensure that vital treatments remain within reach, allowing patients to prioritize their health." About COPD Foundation The COPD Foundation is a not-for-profit organization established to improve the lives of people with COPD, bronchiectasis, and nontuberculous mycobacterial (NTM) lung disease through initiatives that expand services and speed innovations to make treatment more effective and affordable. The Foundation does this through scientific research, education, advocacy, and awareness to prevent disease, slow progression, and find a cure. For more information, visit copdfoundation.org, or follow us on Twitter and LinkedIn. About Mark Cuban Cost Plus Drug Company The Mark Cuban Cost Plus Drug Company, PBC () aims to fundamentally change the way the pharmaceutical industry operates. As a public-benefit corporation, its social mission of improving public health is just `as important as the bottom line. Cost Plus Drugs transparently charges a standard markup on every drug it sells. The costplusdrugs.com online pharmacy launched in January 2022 now carries over 1,000 prescription products, delivered by mail to thousands of happy customers every day. Cost Plus Drugs is working with health plans, managed-care organizations, pharmacy benefits managers (PBMs) and self-insured employers to bring these same savings to employer-sponsored benefit plans nationwide. About Lupin Pharmaceuticals Lupin Pharmaceuticals, Inc. is the U.S. based wholly-owned subsidiary of Lupin Limited and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals Inc.'s branded pharmaceuticals division, is the provider of products designed to help prevent and manage women's health conditions with serious health consequences. © 2023 Lupin Pharmaceuticals, Inc. All rights reserved. Spiriva® and HandiHaler® are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co. KG Logo: SOURCE Lupin Pharmaceuticals, Inc.