The best news in biotech, September 16-22

The current pre-US election financing window continues to remain open, for now, with a healthy mix of early biotech financings, 2 IPO announcements and several follow on public raises. Let's hope for a positive close out to Q3 before we see an inevitable financing slowdown in the weeks prior to November 5th.

A new cell therapy company launched with $75M, demonstrating that there is still some fight left in the out-of-favor modality and a sign that investors are not only interested in safer bets.

The FDA was busy with approvals, including the world's first self-administered vaccine, and there were many exciting clinical updates including AI discovered drugs and late stage novel gene therapies.

Enjoy!

?? New Biotech Launches & Private raises…

• YK Bioventures , led by San Francisco based founders Mitch Kossar & Gary Yeung, CFA , announced plans to raise $100M in an SEC filing. Link
• Another George Church start-up emerges… Boston based GC Therapeutics launched, led by founding CSO Alex Ng, Ph.D. and founding CEO Parastoo Khoshakhlagh, Ph.D. , with $75M and the world’s first “plug-and-play” iPSC cellular programming platform to develop potential best-in-class cell therapies across diverse therapeutic areas. Link
• California based Nura Bio , led by CEO Shilpa Sambashivan , closed a $68M series A extension to advance its brain penetrant SARM1 inhibitor into phase 2 trials. Link
• Switzerland based Basilea Pharmaceutica announced a fundraising agreement with BARDA for $29M initially, including up to $268M, to develop novel antifungals and antibacterials. Link
• Belgium based early obesity biotech Tanai Therapeutics secured aditional financing from 诺和诺德 and BGV (BioGeneration Ventures) to bring its total seed round to EUR 6M. Link
• Montreal based Nomic Bio , led by founding CEO Milad Dagher , secured a $42M series B financing to expand its protein profiling platform. Link
• France based Brenus Pharma , led by CEO Paul Bravetti , raised €22.2 million series A to fund a first-in-human cancer vaccine study. Link
• Women's health biotech Cercle , led by CEO Juan Carlos Riveiro , secured a $6M seed funding to advance its AI platform. Link
• Switzerland based ImmunOs Therapeutics AG raised an $11M series C to fund ongoing clinical trials for its lead cancer program. Link
• Chicago based Syntax Bio , led by CEO John Flavin , launched with $15M?and backing from Astellas Pharma to develop its Cellgorithm platform generating therapeutic-grade cells from stem cells leveraging its novel technology. Link
• Sweden based Cellevate AB , led by CEO Laura Chirica, PhD , closed its 2nd seed round, raising EUR 3.2M to develop its cell culture biomanufacturing platform. Link

?? Deals deals deals…

• Boston based Korro Bio, Inc. , led by CEO Ram Aiyar , announced a collaboration with 诺和诺德 to develop RNA editing drugs for two undisclosed cardiometabolic targets, in a deal worth up to $530M. Link
• Vancouver BC based NanoVation Therapeutics? , led by CEO Dominik Witzigmann, PhD , also initiated a collaboration with 诺和诺德 , focused on developing LNP technologies for extra-hepatic delivery targeting cardiometabolic and rare diseases. The deal is worth up to $600M. Link
• Roivant sold its dermatology business Dermavant Sciences, an Organon company to New York based women's health company Organon for up to $1.2B. Link
• Vancouver BC based Rakovina Therapeutics announced an AI drug discovery collaboration with Variational AI to research DNA-damage response kinase targets to identify potential drug candidates for the treatment of cancer. Link
• Boston based Harvard spinout company Unravel Biosciences , led by founding CEO Richard Novak , entered into a research collaboration with The Jackson Laboratory to combine their AI discovery and preclinical disease modelling platforms to speed up drug discovery. Link

??Other investments and expansions…

• Oregon based Serán BioScience announced a $200M investment from Bain Capital to build a state of the art particle engineering and finished dose manufacturing facility. Link
• City of Hope received a $150M gift from philanthropists A. Emmet Stephenson Jr. and his daughter Tessa Stephenson Brand to fund new pancreatic cancer research. Link
• The NIH announced plans to invest up to $100M per year in pandemic preparedness research. Link?

?? IPO News…

• Boston based RNA biotech CAMP4 Therapeutics , led by CEO Josh Mandel-Brehm , are the latest biotech to file for an IPO, only a week after a handful of startup biotechs saw strong market debuts. Link
• Boston based inflammation biotech Upstream Bio , led by CEO Rand Sutherland , announced plans to file for an IPO, underscoring a resurgence in the IPO market. Link?

?? Other Public Raises…

• Denmark based Ascendis Pharma , a biotech with a pipeline of endocrinology and oncology drugs, announced the pricing of a $281M public offering. Link
• Boston based Nuvalent, Inc. , a biotech with a pipeline of novel cancer drugs, announced the closing of a $575M public offering. Link

?? Positive clinical development updates…

• 罗氏公司 announced positive phase III results show Xofluza significantly reduces the transmission of influenza viruses. Link
• Incyte shared data from the pivotal trial of Niktimvo (axatilimab-csfr) in Chronic Graft-Versus-Host Disease. Link
• Sanofi published data for Tolebrutinib demonstrating a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study. Link
• Insilico Medicine announced positive phase 2 results for its AI discovered first-in-class Idiopathic Pulmonary Fribrosis drug. Link
• 拜耳 's Darolutamide plus ADT significantly reduced the risk of radiological progression or death in a phase 3 study in patients with metastatic hormone-sensitive prostate cancer. Link
• 强生公司 presented new data for its targeted release system for gemcitabine showing 84 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer. Link
• 诺和诺德 announced positive topline data for a phase 2a trial of its obesity CB1 targeting drug. Link
• San Francisco based Aligos Therapeutics announced positive topline results from a phase 2 study of its MASH drug. Link
• Colorado based Edgewise Therapeutics announced positive topline results from a phase 1 study of its heart disease drug. Link
• Sweden based XSPRAY PHARMA AB (PUBL) announced a positive FDA meeting and plans to file an NDA resubmission for its oral cancer therapy. Link
• California based 4D Molecular Therapeutics announced positive results from its phase 3 for its dual transgene genetic medicine for the treatment of Wet AMD. Link
• Merck Group & Daiichi Sankyo 's patritumab deruxtecan ADC demonstrated positive results in an EGFR-mutated non-small cell lung cancer population phase 3 trial following prior EGFR TKI treatment. Link
• 诺华 shared more detailed and long term data demonstrating the benefit of Kisqali for the treatment of breast cancer. Link
• Exelixis published positive phase 3 data for its study treating Advanced Neuroendocrine Tumors with Cabozantinib. Link

? Regulatory Approvals…

• The FDA approves 罗氏公司 's OCREVUS ZUNOVO? as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis. Link
• 阿斯利康 had a double week of FDA approvals, with its influenza vaccine FluMist being approved for self-administration in the US, the first ever self-administered flu vaccine (Link), as well as Fsenra being approved in the US for eosinophilic granulomatosis with polyangiitis. Link
• Sanofi 's Sarclisa was FDA approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant. Link
• 强生公司 's RYBREVANT? (amivantamab-vmjw) was approved in the U.S. as first and only targeted regimen to cut risk of disease progression by more than half in second-line EGFR-mutated advanced lung cancer. Link
• The FDA approved Florida based Zevra Therapeutics 's rare disease drug MIPLYFFA? (arimoclomol) for Niemann-Pick Disease Type C disease, the first and only drug approved for the ultra-rare neurodegenerative disease. Link
• Merck Group 's Keytruda received an additional approval form the FDA, as First-Line Treatment for Adult Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma (MPM). Link
• FDA approved 诺华 ' Kisqali? to reduce risk of recurrence in people with HR+/HER2- early breast cancer. Link

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That's all for this week, thanks for tuning in. Subscribe for alerts to the latest positive news in the biotech industry delivered to your inbox every Monday ????

About the author: Max Robinson is an ex-scientist turned talent leader in the biotechnology industry, and currently Global Head of Discovery & Preclinical Research at Proclinical.