In a deal that could total about $602 million, Syndax Pharmaceuticals Inc. will collaborate with Incyte Corp. to develop axatilimab, Syndax’s anti-CSF-1R monoclonal antibody. Syndax is to receive $117 million up front, a $35 million equity investment and could bring in another $350 million in regulatory, development and commercial milestone payments. The two will share development costs tied to clinical trials, which are expected to be in backbone therapy for treating chronic graft-vs.-host disease (GVHD) and in diseases that contribute to organ fibrosis. Axatilimab was granted orphan drug designation for treating idiopathic pulmonary fibrosis in April. In December, Waltham, Mass.-based Syndax also posted phase I data showing axatilimab produced responses in 60% of evaluable patients with refractory GVHD.

Microbial-focused Evelo touts phase II psoriasis data with lead prospect

Evelo Biosciences Inc. disclosed phase II data testing EDP-1815 vs. placebo for the treatment of mild and moderate psoriasis. The trial turned up a statistically significant reduction in the Psoriasis Area and Severity Index (PASI) score, as measured by the proportion of patients achieving at least 50% improvement in PASI from baseline at 16 weeks. Evelo develops orally delivered microbial candidates that target the small intestinal axis to drive systemic effects. Lead inflammation candidate EDP-1815 is in the works not only for psoriasis but also for atopic dermatitis and COVID-19. Shares of the Cambridge, Mass.-based firm (NASDAQ:EVLO) were trading midday at $6.61, down 64 cents.

Delix raises $70M for quest to deliver psychedelics' benefits without the trip

Preclinical neuroscience firm Delix Therapeutics Inc., a Boston-based startup developing non-hallucinogenic analogues of psychedelics, has closed a $70 million series A financing to advance two lead candidates through phase I trials. Pre-IND safety and toxicology studies are laying the groundwork for trials for the company's first two candidates, DLX-1 and DLX-7, to begin in 2022. Potential indications could include depression, addiction and other psychiatric disorders. Artis Ventures, RA Capital Management and founding investor OMX Ventures led the round.

Newco news: Startup Accession aiming to create new generation of immunotherapy

LONDON – The scientific pioneer behind T-cell receptors has taken the helm of a new biotech he believes has the technology to overcome current shortcomings of cancer immunotherapy. Bent Jakobsen, co-founder and long-term chief scientific officer of Immunocore plc and of CAR T-cell specialist Adaptimmune plc, is now CEO of Accession Therapeutics Ltd., set up to develop what is claimed as the first oncolytic virus to be genetically engineered to exclusively infect cancer cells.

Antikickback claims continue for Biogen

Biopharma companies that have agreed to pay the U.S. Department of Justice (DoJ) millions of dollars to resolve allegations that they illegally used charities to cover patients’ Medicare copays for brand drugs are finding those settlements may be just the beginning of their legal woes. After reaching a $22 million settlement with DoJ last December in a whistleblower suit alleging antikickback violations involving multiple sclerosis drugs Tysabri (natalizumab), Avonex (interferon beta-1a) and Tecfidera (dimethyl fumarate), Biogen Inc. is now facing a lawsuit filed by Humana over basically the same allegations.

WHO: Equitable access needed to COVID-19 drugs

While much of the global pandemic response has focused on COVID-19 vaccines, the World Health Organization (WHO) is now calling on drug manufacturers to ramp up the supply of monoclonal antibodies used to treat infections. Much of that call is directed at Regeneron Pharmaceuticals Inc., with a request for it to share its technology so biosimilar versions of its REGEN-COV (casirivimab and imdevimab) can be developed in an effort to make the combination therapy globally accessible. Noting the high cost and low availability of the therapy, WHO said Unitaid is negotiating with Roche Holding AG, which is manufacturing the antibody treatment, for lower prices and equitable distribution, especially in low- and middle-income countries.

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