Cosibelimab-ipdl

UNLOXCYT is an evolution in checkpoint inhibition and is now available for the treatment of adults in the U.S. with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT offers a balanced treatment approach; the recently updated label now includes long-term data confirming durable efficacy and a proven tolerability profile. UNLOXCYT has a multifaceted mechanism of action (MOA)*; the first and only checkpoint inhibitor in aCSCC that helps restore the adaptive immune response and engages the innate immune system while preserving PD-L2 signaling. UNLOXCYT SUPPORT™ is focused on providing essential support for HCPs and aCSCC patients. *The MOA of UNLOXCYT is based on in vitro data. Preclinical in vitro data may not translate to clinical outcomes. MUMBAI, India and PRINCETON, N.J., Jan. 15, 2026 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) today announced UNLOXCYT™ (cosibelimab-ipdl) is now available in the U.S. for healthcare professionals to prescribe for adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation. "Patients with unresectable or metastatic CSCC now have a new and important treatment option to manage their disease. UNLOXCYT is a novel anti–PD-L1 antibody that is capable of antibody-dependent cellular cytotoxicity and associated with clinically meaningful efficacy, as shown by a disease control rate of 71%," said Ann W. Silk, MD, MS, medical oncologist at Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School. "Because these patients tend to be older and have multiple comorbidities, it's extremely valuable to have a therapy that offers durable disease control and proven tolerability." "UNLOXCYT is an evolution in checkpoint inhibition, combining durable efficacy with a proven tolerability profile for a group of aCSCC patients who traditionally would struggle to strike that therapeutic balance," said Richard Ascroft, CEO of Sun Pharma North America. "Sun Pharma is committed to ensuring access from day one with the UNLOXCYT SUPPORTTM patient access and affordability program." The U.S. Food and Drug Administration (FDA) recently approved an updated label for UNLOXCYT to reflect long-term follow-up data from the pivotal CK-301-101 clinical trial. This study showed improvements in objective response rates (including more patients who achieved a complete response [CR]) and duration of response. The safety data did not change from the original UNLOXCYT label. Many patients in the pivotal trial experienced durable responses with UNLOXCYT. At least 50% demonstrated an objective response (complete or partial response), including 13% of mCSCC patients and 26% of laCSCC patients who achieved complete response. 71% of patients achieved disease control with UNLOXCYT, including patients with stable disease. The median duration of response has not yet been reached in either treatment group. Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, during or after discontinuation of treatment. Females should use effective contraception and avoid breastfeeding during treatment. The most common adverse reactions (ARs) were fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism. Immune-mediated adverse reactions (imARs) were primarily Grade 1 or 2; 0.9% were Grade 3 (dermatologic only), with no Grade ≥4 imARs. Of particular note, no patients developed Grade 3 or 4 pneumonitis. Just 0.9% (two patients) experienced pneumonitis (Grade 2). UNLOXCYT is available through a limited distribution network of authorized specialty distributors and one contracted specialty pharmacy. Healthcare professionals can visit UNLOXCYTPro.com for additional information. Sun Pharmaceuticals does not recommend the use of any particular distributor or specialty pharmacy. For comprehensive support, UNLOXCYT SUPPORT is dedicated to supporting healthcare professionals and patients by providing resources for their journey on UNLOXCYT. About Cutaneous Squamous Cell Carcinoma Cutaneous squamous cell carcinoma is among the most common skin cancers worldwide. While early stages are treatable, an estimated 40,000 US patients each year progress to advanced disease, resulting in nearly 15,000 deaths. Important risk factors for CSCC include chronic ultraviolet radiation exposure and immunosuppressive conditions. In addition to being life threatening, CSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region and that invade blood vessels, nerves, and vital organs such as the eye or ear. INDICATIONS AND USAGE UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. It is not known if UNLOXCYT is safe and effective in children. The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks. IMPORTANT SAFETY INFORMATION WARNING AND PRECAUTIONS Immune-mediated Adverse Reactions : Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis and renal dysfunction, and solid organ transplant rejection. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. While such adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue UNLOXCYT based on the severity of reaction. Infusion-Related Reactions : Infusion-related reactions were reported in 11% (24/223) of patients, including Grade 2 in 5.8% (13/223) of patients receiving UNLOXCYT. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue UNLOXCYT based on severity of reaction. Consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins. Complications of Allogeneic HSCT : Fatal and other serious complications can occur in patients who receive allogeneic Hematopoietic Stem Cell Transplantation (HSCT) before or after being treated with a PD-1/PDL1 blocking antibody. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT. Embryo-Fetal Toxicity /Females and Males of Reproductive Potential: UNLOXCYT can cause fetal harm when administered to a pregnant woman. Verify pregnancy status in females of reproductive potential prior to initiating UNLOXCYT. Females should use effective contraception during treatment with UNLOXCYT and for 4 months after the last dose. Advise female patients not to breastfeed during treatment with UNLOXCYT and for 4 months after the last dose. ADVERSE REACTIONS The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. To report side effects of UNLOXCYT to FDA: visit or call 1-800-FDA-1088. Report SUSPECTED ADVERSE REACTIONS or any side effects or ADEs (adverse drug events) to our Drug Safety Department at 1-800-406-7984 or [email protected] (preferred) with as much information as available. Please see Full Prescribing Information for additional Important Safety Information. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in innovative medicines, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global Emerging Markets. Sun Pharma's high-growth global Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for about 20% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). INVESTOR/MEDIA CONTACTS : U.S. Media: Jeremy Allen Mobile: +1 640 230 1397 Email: [email protected] © 2026 Sun Pharmaceutical Industries, Inc. All rights reserved. UNLOXCYT and UNLOXCYT SUPPORT are trademarks of Checkpoint Therapeutics, Inc. PM-US-ULX-0107 01/26 SOURCE Sun Pharma 21% more press release views with Request a Demo

– 11 New Clinical Programs in 2025 – – 6 Partner Programs Have Reached the Market – – 89 Total Clinical Programs Initiated to Date – LEBANON, N.H., Jan. 13, 2026 /PRNewswire/ -- Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, today announced that 11 new programs entered clinical trials in 2025. These 11 programs bring the total number of partner programs that have entered clinical trials to 89, including six therapeutic products containing molecules discovered or optimized using the Adimab platform which have been authorized for commercial sale. Partners with new clinical programs in 2025 include Abogen, GSK, iTeos, Innovent, Invivyd, Kelonia Therapeutics, and Triveni Bio, among others. Adimab's latest partner program to receive approval is GSK's Exdensur (depemokimab), approved in the US for the treatment of severe asthma with an eosinophilic phenotype and in the UK and Japan for two indications: (severe) asthma and CRSwNP. Other commercial products containing molecules from Adimab include: Innovent's TYVYT® (sintilimab injection), a PD1 program approved in China for the treatment of multiple cancers. Innovent's SINTBILO® (tafolecimab injection), a PCSK9 program approved in China for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia. IASO Bio's FUCASO® (equecabtagene autoleucel), a BCMA CAR-T program approved in China for the treatment of patients with multiple myeloma. Invivyd's PEMGARDA™ (pemivibart), a SARS-CoV-2 monoclonal antibody authorized for prophylactic emergency use in the United States to prevent COVID-19 infection. Sun Pharma's UNLOXCYT™ (cosibelimab), a PD-L1 program approved in the United States for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma. There are numerous additional Adimab-associated programs that are currently in pivotal Phase II or Phase III clinical trials. "We are awed by the incredible work our partners do in developing these molecules and bringing them to market to benefit patients around the world, and it is gratifying to realize that we have played a role in that process," said Philip T. Chase, Chief Executive Officer of Adimab. "Our success is dependent upon our partners having the expertise, capital, and perseverance to navigate all of the challenges of drug development and we applaud them for it." "This first wave of approvals generating revenue for Adimab Royalty Company (ARC), is exactly what we envisioned when we created this structure in 2024," said Ryan McGovern, Chief Financial Officer of Adimab. "By housing royalties from nearly 500 completed Adimab therapeutic programs in a distinct business unit, we've given shareholders—current and future—the flexibility to participate in the compounding value of our royalty portfolio, our profitable operating company, or both." Adimab partners have exercised more than 125 commercial licenses to option rights to advance programs into clinical development. In 2025, 10 partners exercised commercial options including Bambusa, Biogen, Ikaika, Meiji Seika Pharma, Montis Biosciences, Novartis, SixPeaks Bio, and Werewolf, among others. Technologies Antibody Discovery: Adimab discovers therapeutic antibodies in IgG and VHH formats through its proprietary yeast-based technology. Adimab can utilize its fully human synthetic diversity as well as additional diversities from in vivo sources. Antibodies from the Adimab platform have exquisite specificity and are utilized in a variety of modalities, including monoclonal and multispecific formats, CAR-Ts, ADCs, and more. Engineering: Adimab has developed and refined its engineering capabilities over thousands of lead antibody optimization efforts. The process starts with one or more partner-selected lead antibodies with the goal of optimizing potency, specificity, and/or developability. In addition to Adimab-discovered antibodies, engineered antibodies can originate from outside sources, typically to fix undesirable properties of antibodies from in vivo and phage-based technologies. Adimab also applies its engineering expertise to cytokines, TCRs, and other proteins. Multispecifics: Adimab has extensive bispecific and multispecific know-how and capabilities, including proprietary solutions for both Fc (HC:HC) and Fab (HC:LC) heterodimerization, to allow for the generation of numerous bispecific and multispecific product designs with excellent developability properties. More than 20 partners are using the heterodimerization mutation sets, either through Funded Discovery projects at Adimab or in their own labs, without restriction. Additionally, Adimab can perform common light chain and fragment-based discovery and engineering necessary for certain partner-desired formats. T Cell Engagers: Adimab has a highly characterized suite of functional and diverse CD3 and CD28 antibodies (both IgG and VHH binders) to generate bi- and multispecific T cell engagers. Adimab has partnered this program non-exclusively with more than 25 partners to date. Recently, anti-TCR HCAbs have been added to this toolkit and are available for licensing. Complex Targets: Certain membrane-obligate proteins (e.g., GPCRs and ion channels) are often poorly behaved outside their native membrane environment. For these targets, Adimab has developed proprietary in vitro and in vivo discovery workflows that rely solely on the target being expressed in its native membrane and without the need for antigen mimetics. These workflows have been employed numerous times to generate initial panels of functional and specific antibodies to classically difficult targets, which are then further engineered with the yeast platform into robust therapeutic candidates. About Adimab Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. Our suite of technologies includes naïve discovery from synthetic libraries in yeast or B cells (mice, llamas, and humans), antibody engineering and optimization, bi- and multispecific antibody engineering, and a portfolio of proprietary CD3 and CD28 antibodies with complementary heterodimerization mutations that are licensed non-exclusively for bi- and multispecific applications. Adimab focuses solely on its partners and not on developing an internal product pipeline. Since 2009, Adimab has partnered with over 140 pharmaceutical and biotechnology companies, generating more than 650 therapeutic programs, 89 clinical programs, and 6 approved products. The Adimab technology has been transferred and implemented at GSK, Biogen, Novo Nordisk, Merck, Lilly, and Takeda. Funded discovery partners include leading pharmaceutical companies, such as Alnylam, Bristol Myers Squibb, Innovent, Novartis, Regeneron, Vertex, and others. Adimab has also partnered with many early-stage venture-backed companies, including Dragonfly, NextPoint Therapeutics, Santa Ana Bio, Tizona, Kelonia Therapeutics, and others, as well as mid-size public biopharmaceutical companies such as Alector, Cullinan Therapeutics, Scholar Rock, and others. Adimab's integrated antibody discovery and engineering platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most demanding standards for affinity, epitope coverage, species cross-reactivity, and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, visit . Guy Van Meter Chief Business Officer Adimab, LLC (603) 653-5775 [email protected] SOURCE Adimab, LLC 21% more press release views with Request a Demo