Less than a week after approving Johnson & Johnson’s bispecific antibody, Talvey (talquetamab-tgvs), for relapsed or refractory multiple myeloma (r/r MM) under accelerated review, the U.S. FDA has followed suit with Pfizer Inc.’s equivalent, Elrexfio (elranatamab-bcmm). The accelerated clearance of Elrexfio – a B-cell maturation antigen (BCMA) bispecific antibody that targets BCMA on myeloma cells and the CD3 receptor on T cells – covers it for adult patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

A bridge just far enough: Arcellx’s phase II is back on track

An updated trial protocol providing expanded bridging therapies are part of the agreement between the U.S. FDA and Arcellx Inc. that allows the lifting of the partial clinical hold on the company’s pivotal phase II study. The company received the FDA’s notification on June 16, following a patient’s death in the clinical trial of a CAR T-cell therapy for treating relapsed or refractory multiple myeloma. At the time, the cause of death had not been determined, though the patient had symptoms consistent with high-grade cytokine release syndrome along with a number of confounding factors. The company’s stock (NASDAQ: ACLX) reacted favorably at midday with shares trading 7% upward at $36.06 each.

Galecto stock craters on phase IIb miss in IPF

Shares in Galecto Inc. plummeted by more than 65% in premarket trading on news that its lead drug candidate, GB-0139, flamed out in a phase IIb trial in idiopathic pulmonary fibrosis (IPF). The inhaled galectin-3 inhibitor actually performed considerably worse than placebo on the 52-week placebo-controlled study, the endpoint of which was the annual rate of decline from baseline in forced vital capacity (FVC). In absolute terms, the mean decline from baseline in FVC was 316.6 ml for patients in the active treatment arm, who received a 3-ml once-daily dose, as compared with just 127.4 ml for those in the placebo arm.

Design’s phase I in FA disappoints; new formulation in the works

Shares of Design Therapeutics Inc. (NASDAQ:DSGN) plunged 68%, or $5.03, to trade midday at $2.30, after the firm reported first results from the phase I multiple ascending-dose trial with DT-216 in patients with Friedreich's ataxia (FA). As of the Aug. 7 data cutoff, results showed that DT-216 was generally well-tolerated and achieved a statistically significant and dose-related increase in frataxin (FXN) mRNA levels in skeletal muscle biopsies. But muscle FXN protein expression proved variable and concentration in the tissues was lower than expected. Also, five adverse events of injection-site thrombophlebitis turned up. Design isn’t giving up on DT-216, which designed to zoom in on the GAA repeat expansion mutation and restore FXN expression in FA. The company is pursuing a new formulation of the drug, with plans to start another phase I study in the second half of next year.

Adalta gears up for phase II IPF trials for its i-body derived from shark antibodies

Adalta Ltd. is gearing up to begin phase II trials of its lead i-body candidate, AD-214, in idiopathic pulmonary fibrosis (IPF), but it is hoping to find a pharma partner to fund the trials. Adalta’s i-body platform was discovered from the shark antibody and then developed into a human protein. AD-214 is designed to target and block the chemokine receptor CXCR4 that is involved in several cellular processes involved in fibrosis, including the migration of immune, inflammatory and fibrotic cells to the sites of injury and disease.

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