Results from the global phase III Harmoni trial presented at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer (WCLC) showed a statistically significant increase in progression-free survival after treatment with ivonescimab plus chemotherapy compared to chemotherapy alone, but failed to show a statistically significant benefit in overall survival (OS).
Summit Therapeutics Inc.’s presentation for bispecific antibody ivonescimab in non-small-cell lung cancer could draw some extra attention at next month’s World Conference on Lung Cancer meeting thanks to promising overall survival data from partner Akeso Pharmaceuticals Inc.’s China study of the PD-1/VEGF candidate.
Minghui Pharmaceutical Ltd. announced it is raising $131 million in a pre-IPO financing round Aug. 7. The funds will be used to advance its cancer and inflammatory disease pipeline, which include a PD-1/VEGF bispecific antibody, antibody-drug conjugates (ADCs) and a topical Janus kinase inhibitor.
Minghui Pharmaceutical Ltd. announced it is raising $131 million in a pre-IPO financing round Aug. 7. The funds will be used to advance its cancer and inflammatory disease pipeline, which include a PD-1/VEGF bispecific antibody, antibody-drug conjugates (ADCs) and a topical Janus kinase inhibitor.
T-cell engagers (TCEs) are a new class of immuno-oncology therapies that have proven effective for the treatment of both solid tumors and hematological malignancies. Among validated targets in this field, claudin 18.2 (CLDN18.2) is one of the most clinically established. Researchers from Astrazeneca plc and collaborators reported the preclinical evaluation of AZD-5863, a bispecific fully human monoclonal antibody targeting claudin CLDN18.2 and CD3.
Regeneron Pharmaceuticals Inc. disclosed within a positive second-quarter earnings report that it had received a complete response letter (CRL) two days earlier from the U.S. FDA for its bispecific antibody, odronextamab, for relapsed/refractory follicular lymphoma following two or more lines of systemic therapy.
Crossbow Therapeutics Inc. has nominated its second development candidate, CBX-663, a T-cell engager for the treatment of a broad range of solid tumors and hematologic malignancies.
Sino Biopharmaceutical Ltd. agreed to fully acquire Lanova Medicines Ltd. by buying an additional 95.09% stake in Lanova at a valuation of up to $950.92 million. Considering Lanova’s estimated cash and deposit of $450 million, Hong Kong-headquartered Sino agreed to pay $500.9 million to Lanova on the date of the transaction, set to close within 30 days of all conditions being satisfied, or July 31, 2025.
In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
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