Garda Therapeutics

Gilead opts in on Kymera's molecular glueOxford BioTherapeutics tapped for target discovery tie-up with BMSGarda to acquire Assertio in $125M dealMacroGenics gets FDA green light to resume mid-stage DART studyIdorsia appoints new medical chiefGilead opts in on Kymera's molecular glue Kymera Therapeutics has secured a $45-million milestone payment after Gilead Sciences exercised its option to license the oral CDK2 degrader KT-200. The compound will now advance into IND-enabling studies, with an IND filing targeted for 2027.The opt-in stems from a drug development deal inked with Gilead last year potentially worth up to $750 million, and included $85 million upfront."KT-200 is expected to be the first molecular glue discovered by Kymera to enter the clinic," said CEO Nello Mainolfi, adding the drug's "compelling preclinical profile demonstrates its potential to transform the therapeutic landscape for patients with cancers that remain difficult to treat."According to Kymera, CDK2-directed molecular glues offer a novel way to selectively eliminate CDK2 — a cyclin E binding partner that drives CCNE1‑amplified cancers — while sparing other CDK family proteins. In preclinical testing, the company said KT-200 demonstrated low-nanomolar CDK2 degradation, activity across tumour models, brain penetration potential and a favourable safety profile.-Anna BratulicOxford BioTherapeutics tapped for target discovery tie-up with BMSLooking to pad its preclinical pipeline, Bristol Myers Squibb on Thursday partnered with Oxford BioTherapeutics to discover T-cell engagers (TCEs) for solid tumours using the latter's OGAP-Verify platform.Under the multi-year collaboration, the British biotech will use OGAP-Verify to find highly sensitive oncology targets with improved therapeutic attributes, then design development candidates. BMS will be responsible for additional R&D activities, as well as commercialisation. While specific financial details were not disclosed, Oxford BioTherapeutics said it will receive an upfront payment including research funding, and is eligible for "significant" milestones, plus royalties. The deal with BMS is at least the biotech's eighth with a major pharma, following tie-ups with GSK and Roche last year. -Elizabeth EatonGarda to acquire Assertio in $125M dealGarda Therapeutics has agreed to acquire Assertio Holdings for $18 per share in cash — totalling $125.1 million — plus a contingent value right tied to future milestones for the latter's pain treatment Sprix (ketorolac tromethamine). The transaction represents a 34.6% premium to Assertio's share price on March 20.The agreement, unanimously approved by both companies' boards, also includes a concurrent divestiture of Assertio's assets other than Rolvedon (eflapegrastim) to Cosette Pharmaceuticals for $35 million upfront."We evaluated multiple strategic pathways — including a potential sale of the company, merger opportunities, monetisation of Rolvedon, and continuing as a standalone entity," said Heather Mason, chair of Assertio's board of directors, adding that the board finally "determined that these transactions with Cosette and Garda provide the best outcome for our shareholders." -Pavan KamatMacroGenics gets FDA green light to resume mid-stage DART studyMacroGenics said Thursday the FDA has lifted a partial clinical hold on the Phase II LINNET study evaluating lorigerlimab, a bispecific DART molecule that targets PD-1 and CTLA-4, in patients with platinum-resistant ovarian cancer or clear cell gynaecologic cancer. Patient enrollment was paused in February after safety events occurred across four patients who received lorigerlimab, including two cases of grade 4 thrombocytopenia, one report of grade 4 myocarditis, and one patient with grade 4 neutropenia and concurrent septic shock, which resulted in their death.MacroGenics will now resume enrolling patients, albeit under a revised protocol that includes additional risk-mitigation measures for potential haematologic and cardiac toxicities. The company said it is on track to provide a mid-year update on lorigerlimab.-Elizabeth EatonIdorsia appoints new medical chiefIdorsia Pharmaceuticals has appointed Amer Joseph as chief medical officer and head of global clinical development, effective May 1. Joseph succeeds Alberto Gimona, who is retiring after more than seven years at the Swiss biopharma.In his most recent role, Joseph led clinical development efforts at Chiesi Farmaceutici, and previously spent nine years at Bayer where he helped develop kidney disease drug Kerendia (finerenone)."Amer brings exactly the vision, discipline, and patient-focused mindset we need as we sharpen our scientific priorities and accelerate progress on our most promising assets," said Idorsia's interim CEO Jean-Paul Clozel.Having dealt with financial uncertainty in the past, Idorsia undertook cost-cutting measures, including sizeable layoffs in 2023 and 2024, and recently saw the departure of its CEO Srishti Gupta.-Pavan Kamat