Cumulus Oncology Ltd. is in the thick of raising a $50 million series A round as its model of sourcing novel drug targets emerging from academia, shaping them up for clinical development, and spinning them into startups, gathers pace. At the same time, Nodus Oncology Ltd., the first spinout created around an acquired asset, has just reached in vivo proof of concept with its lead DNA damage response inhibitor, and it, too, is looking to raise a series A to take the program through to the end of phase I.
Telix Pharmaceuticals Ltd. filed an NDA with the U.S. FDA for its radiopharmaceutical glioma imaging product, TLX-101-CDx (Pixclara, 18F-floretyrosine, 18F-FET), for the characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients.
Diakonos Oncology Corp. has developed a process to manufacture dendritic cell vaccines that the company believes are substantially more potent than its predecessors.
Microbiotica Ltd. is poised to advance two of its microbiome-derived products into the clinic after securing regulatory approval and fresh finance. The first live bacterial therapeutic, MB-097, will be tested in combination with Keytruda (pembrolizumab) in patients with advanced melanoma who have not responded to treatment with immune checkpoint inhibitors. The second product, MB-310, is a once-daily oral therapy for treating the inflammatory bowel disease, ulcerative colitis.
Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.
With biopharma IPO volume at a 10-year low, two companies are bucking the trend with plans to plunge into the public market. Bifunctional antibody drug developers Bicara Therapeutics Inc. and Zenas Biopharma Inc. have filed with the SEC to go public though neither has named share-price ranges.
As Bridgebio Pharma Inc. awaits word from the U.S. FDA regarding the small-molecule transthyretin (TTR) stabilizer acoramidis for TTR-mediated amyloidosis cardiomyopathy, the firm closely followed this week’s headline about another spinout with news that the Palo Alto, Calif.-based company has signed a joint research pact with Hitgen Ltd., of Chengdu, China.
The National Medical Products Administration (NMPA) has approved Innovent Biologics Inc.’s Dupert (fulzerasib) as the first KRAS G12C inhibitor in China to treat select patients with non-small-cell lung cancer (NSCLC).
Regeneron Pharmaceuticals Inc. suffered an unsurprising hitch in the form of a complete response letter (CRL) related to linvoseltamab, a bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells containing CD3-expressing T cells, for relapsed/refractory multiple myeloma.
Adcendo ApS has inked a deal with Multitude Therapeutics Inc. and is licensing Multitude’s phase I-ready antibody-drug conjugate (ADC), ADCE-T02, which targets tissue factor. Under the deal, Copenhagen, Denmark-based Adcendo gains exclusive development and commercialization rights for the ADC globally, excluding greater China (mainland China, Hong Kong, Macao and Taiwan) where Multitude retains all rights.
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