China’s NMPA approved Shanghai Shengdi Pharmaceutical Co. Ltd.’s adebrelimab (SHR-1316) for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. The approval in mainland China makes adebrelimab the third domestic PD-L1 monoclonal antibody to make it to the domestic market. Shanghai Shengdi is a subsidiary of Jiangsu Hengrui Medicine Co. Ltd.
Researchers from Meiji Seika Pharma Co. Ltd. and affiliated organizations reported the discovery and preclinical evaluation of a novel PD-1 agonist antibody, HM-266, being developed for the treatment of various inflammatory disorders, including autoimmune diseases.
Researchers from Nordic Nanovector ASA presented the discovery of a novel humanized anti-CD37 monoclonal antibody, NNV-024, engineered to exhibit a strong antibody-dependent cellular cytotoxicity (ADCC).
Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
After more than two decades of working together, Genmab A/S has entered a new licensing agreement with Scancell Holdings plc to gain the exclusive rights to develop and commercialize an anti-glycan monoclonal antibody. All potential disease areas except cell therapy applications are on the table in the deal. Genmab will make an up-front payment of an undisclosed amount to Scancell as well as covering milestone payments of up to $208 million for each candidate that’s developed and commercialized. The amount is capped at $624 million to Scancell if Genmab manages to develop and commercialize products across all modalities the companies have defined. Scancell could also receive single-digit royalties on the net sales of products.
Carcinoembryonic antigen (CEA) is an antigen that is overexpressed in colorectal cancers and is considered a suitable target for its treatment. Uppsala University discussed research in the development of the lutetium-177-radiolabeled anti-CEA hT84.66-M5A monoclonal antibody (MAb) 177Lu-DOTA-M5A for the treatment of colorectal cancers and its combination studies with the HSP90 inhibitor onalespib.
It’s been a rough year at Macrogenics Inc., but times may be changing. Having terminated a phase II study due to fatalities, dropped 15% of its workforce and closed research and manufacturing sites in the past year, the company has taken the helping hand of Gilead Sciences Inc. The pair have agreed to develop the bispecific MGD-024, which has a CD3 component for minimizing cytokine release syndrome, as an oncology candidate along with two additional bispecific research programs, a potential treatment for certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes.
Immunoprecise Antibodies Ltd.'s subsidiary, Talem Therapeutics LLC, has shared promising results of a new study conducted by the National Institute of Allergy and Infectious Diseases (NIAID) showing continued resilience of Polytope TATX-03 in broadly neutralizing SARS-CoV-2 variants, including two omicron sublineages that had not been previously tested.
Invivyd Inc. (formerly Adagio Therapeutics Inc.) has generated multiple next-generation candidate antibodies for the prevention and treatment of COVID-19, including two molecules designated for near-term clinical development in combination as NVD-200.
