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What’s in Today’s Brief? (June 24th Preview)
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ADC Therapeutics reorganizes amid Zynlonta safety concerns
ADC Therapeutics is cutting about 17% of staff as it focuses resources behind Zynlonta after safety concerns surfaced in a confirmatory study, the company said in a June 24 release. The Swiss ADC developer expects ~$10 million in annual savings and a one-time ~$3 million charge tied to severance and termination costs. The restructuring is explicitly tied to operational timing: ADC said it expects completion of the LOTIS-5 and LOTIS-7 trials this year. LOTIS-5 is the confirmatory phase intended to convert Zynlonta’s accelerated nod in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) into full approval, while LOTIS-7 is an early-stage study exploring Zynlonta in combination with Roche’s bispecific Columvi (glofitamab) in DLBCL. ADC also said it is preparing for an August meeting with the FDA to discuss a path forward following the LOTIS-5 results, while keeping its externally facing medical affairs and commercial footprint intact. The company estimates the plan will extend its cash runway to at least 2028.
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Nature retracts timing-based PD-1 trial
Nature Medicine has retracted a randomized phase 3 study that claimed time-of-day dosing of PD-1 immunochemotherapy for non-small cell lung cancer improved outcomes, after an investigation found serious problems with result integrity. The LungTIME-C01 paper had reported a benefit for patients receiving their first four cycles before 3 p.m., but the journal said editors no longer had confidence in the data. The retraction note cited the “amount and nature of the problems identified,” following earlier concerns about trial design changes, protocol inconsistencies, and unusual efficacy and safety patterns. The study compared two PD-1 drugs—Merck’s Keytruda and Innovent’s Tyvyt—combined with chemotherapy, and originally reported large differences in progression-free survival and overall survival between early and late treatment groups. Eric Topol had amplified the study on social media shortly after publication. In the weeks that followed, the journal published an editor’s note and ultimately pulled the article after a four-month review.
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Pfizer ADC stumbles in Phase 3 NSCLC
Pfizer’s first ADC following its Seagen acquisition, sigvotatug vedotin (SV), failed to meet the primary overall survival endpoint in a Phase 3 trial in advanced, metastatic non-squamous NSCLC. The setback adds to pressure on Pfizer’s ADC strategy and complicates expectations for the asset’s future development. In the SigVie-002 study (formerly Be6A-Lung-01), SV did not achieve statistical significance versus docetaxel in the overall population. Pfizer reported a stronger trend in patients who had received only one prior line of systemic therapy, a subgroup representing about two-thirds of enrolled patients. Pfizer said safety was manageable and consistent with prior studies, but it did not identify a clear response relationship to integrin beta-6 expression. The company is continuing with subgroup-based analysis and also running an ongoing Phase 3 Keytruda combination effort.
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China clears first CAR T for solid tumors
China’s National Medical Products Administration (NMPA) approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T received approval for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of therapy. Carsgen said the pivotal data showed significant efficacy benefit and an acceptable safety profile compared with physician’s choice chemotherapy, with reported median progression-free survival of 3.25 months versus 1.77 months and median overall survival of 7.92 months versus 5.49 months. The approval also introduces an associated preconditioning regimen that combines low-dose nab-paclitaxel with lymphodepletion chemotherapy. The milestone matters for the CAR T field because solid tumors have historically been a tougher regulatory and clinical hurdle for cell therapies.
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Ollin Biosciences raises $330M for Phase 3 Vabysmo challenger
Ollin Biosciences raised $330 million in a Series B to advance a Phase 3 program for its eye-disease therapy targeting both diabetic macular edema and wet age-related macular degeneration. The company said it plans to begin the pivotal trial soon, framing the raise as funding for late-stage execution. The Series B was co-led by TCGX and ARCH Venture Partners and included participation from established biotech investors, a pension fund, and crossover investors. Ollin told investors the funding follows head-to-head data suggesting its licensed-from-a-China-developer drug had advantages over Roche’s Vabysmo. Ollin is positioning the asset against a large retinal market where late-stage data and regulatory strategy will be decisive. The financing underscores that investors are still backing differentiated ocular programs moving toward Phase 3.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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