→ Celgene $CELG and its partners at bluebird bio $BLUE can add boasting rights to the FDA’s breakthrough drug program for their closely watched work on the multiple myeloma CAR-T bb2121. Regulators are making a commitment to help speed along a new BCMA-targeting therapy that has posted some stellar clinical results in an early-stage study. It will also help establish its position in what is emerging as a race with Legend Biotech and its partners at J&J on a rival program that has also wowed investigators in the field.
→ A river of venture cash is coursing its way into a long lineup of biotech startups this week. Cambridge, MA-based Elstar Therapeutics has rounded up a $39 million launch round to back its work on antibody-based therapies that can coordinate a range of I/O activities — a popular field these days. The company was founded by Andreas Loew, a NIBR vet who had worked on the CAR-T program at Novartis. Apple Tree Partners provided the cash.
→ Looking to complete an NDA submission in the first quarter as previously promised, Paratek Pharma $PRTK has taken its antibiotic omadacycline into rolling submission. The focus here is on acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. If accepted, the previously-granted Qualified Infectious Disease Product and Fast Track designations will put Paratek’s submission on the priority review path. Meanwhile, the biotech is at work with the first of two planned Phase II studies evaluating omadacycline for urinary tract infections, which will involve 200 patients across multiple sites. In other news, Paratek has pocketed $5 million in milestone payment from partner Allergan, as the FDA accepted the NDA for Seysara (sarecycline) a couple weeks back.
→ CMAB Biopharma, a biologic contract development and manufacturing organization based in Suzhou, China, has brought in $38 million in a Series A funding. C-Bridge Capital and BioBAY (which houses the CDMO) led the round, joined by I-Bridge and Qianhai FoF fund. With a focus on preclinical and PhI/II clinical products, CMAB plans to expand its staff from 65 to 180 within the next year.
→ Barely a year after its own launch, Cambridge, MA-based Cue Biopharma has closed its IPO at $66.2 million – up from the $40 million it filed for back in September. The company, developing T cell immuno-oncology therapies, is based on work done at Albert Einstein College of Medicine. The biotech IPO window has opened considerably in 2017, and a fledgling company like Cue (still doing preclinical work) proves that investors’ are still quite ravenous for biotech.
→ Swiss company Addex Therapeutics has inked a licensing and collaboration deal with Indivior for global development and commercialization of ADX71441 for the treatment of addiction. ADX71441 is a potent, selective positive allosteric modulator (PAM) that potentiates GABA responses at the GABAB receptor. In addition, Indivior will fund a research program at Addex to discover additional GABAB PAM compounds. Addex will get $5 million upfront, $4 million in research funding over the next two years, and up to $330 million in milestones and royalties.
With additional reporting by Brittany Meiling.
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