Bio Roundup: Moderna Publishes, Life Science Cash, AdComm Votes & More

Xconomy National — 

If it seems like biotech investments have defied the financial headwinds of the pandemic, maybe it’s because they have. In the second quarter, 16 of the top 25 largest early-stage venture capital deals were investments in life science companies.

The figures come from the National Venture Capital Association and financial research firm Pitchbook. This week they released their quarterly analysis of dealmaking, which shows that the tally of big biotech transactions tops the second quarter of 2019 when biotech and pharmaceutical investments accounted for just 10 of the top 25 deals. It’s the biotech sector’s largest proportion of the top 25 venture capital deals in a quarter in the last five years, according to the NVCA-Pitchbook report. COVID-19 is helping, putting corporate venture capital investment in biotech companies on pace to set a new record in 2020, the report says. In the first half of this year, biotech investments surpassed software deals—the first time that’s happened in 10 years.

The third quarter is continuing the dealmaking momentum, which includes mega-deals this week for cancer and HIV treatments. This week also saw a pair of drugs inch closer to FDA approval and progress in the pursuit of a COVID-19 vaccine. Let’s get to those stories and more in our news roundup.

DOLLARS & DEALS

—Blueprint Medicines (NASDAQ: BPMC) landed Roche as a partner to commercialize pralsetinib, a cancer drug candidate currently under FDA review. The Swiss pharmaceutical giant agreed to pay $775 million to partner on the targeted cancer therapy, developed to treat tumors driven by alterations to the RET gene.

—Amgen (NASDAQ: AMGN) invested $421 million in BeiGene (NASDAQ: BGNE) to maintain its one-fifth equity stake in the Beijing-based firm, with which it has partnered to expand its oncology presence in China.

Dewpoint Therapeutics signed its second biopharma deal, partnering with Merck (NYSE: MRK) to use its understanding of biomolecular condensates to develop a treatment for HIV infection.

Glympse Bio, a startup that employs nanoparticles to detect disease, raised $46.7 million in Series B financing to apply its technology to NASH, cancer, and infectious diseases.

—Morningside Ventures led a $32 million Series A financing for Arctic Bio, a Shanghai-based biotech developing eye drugs for the Asian markets.

—Philadelphia-based Imvax raised a $112 million Series C financing led by Hp Wild Holding AG. The company is developing immunotherapies for solid tumors, and the money will allow it to advance its lead candidate, for an aggressive type of brain cancer, through Phase 2 testing.

—San Mateo, CA-based oncology drug developer Kronos Bio agreed to acquire a set of investigational spleen tyrosine kinase inhibitors from Gilead Sciences (NASDAQ: GILD). Financial terms of the deal weren’t disclosed. Kronos CEO Norbert Bischofberger joined the company in 2018 after nearly 30 years at Gilead.

DRUG DEVELOPMENTS

—The FDA rejected a Verrica Pharmaceuticals (NASDAQ: VRCA) drug developed as a potential treatment for molluscum contagiosum, a viral skin disease. The West Chester, PA-based biotech said the regulator raised no safety concerns but did flag questions about chemistry, manufacturing, and controls.

—CytoDyn’s submission seeking approval of leronlimab as part of a combination HIV treatment has stalled after the FDA notified the firm its application “lacks certain information.” The Vancouver, WA-based company said the agency did not ask for more clinical testing.

—An FDA advisory committee voted 8-7 to recommend regulatory approval of terlipressin, an experimental Mallinckrodt Pharmaceuticals (NYSE: MNK) drug for a rare type of kidney failure. Despite meeting the goal of a pivotal study, the results also showed a high rate of complications and patient deaths.

—A separate FDA advisory panel voted unanimously to recommend approval for belantamab mafodotin, an experimental GlaxoSmithKline (NYSE: GSK) drug developed to treat multiple myeloma.

—The FDA expanded its approval of the Johnson & Johnson (NYSE: JNJ) drug guselkumab (Tremfya) to adult patients with active psoriatic arthritis. Previously the drug was OK’d for patients with moderate-to-severe plaque psoriasis.

— Roche said a potential combination treatment for women newly diagnosed with later-stage ovarian cancer didn’t meet a Phase 3 study’s main goal of improving progression-free survival compared to a placebo. The company was evaluating the addition of its immunotherapy atezolizumab (Tecentriq)—first approved in 2016 to treat a form of bladder cancer—to bevacizumab (Avastin) and chemotherapy.

—Atox Bio is planning an FDA submission after reporting encouraging preliminary Phase 3 data for reltecimod, an experimental treatment for necrotizing soft tissue infection, also known as “flesh-eating disease.”

COVID-19 R&D

—Moderna (NASDAQ:MRNA) gave a fuller picture of the Phase 1 data for its COVID-19 vaccine candidate and published the preliminary results in the New England Journal of Medicine. A Phase 3 study is expected to begin by the end of July.

—Equillium (NASDAQ: EQ) saw its share price spike after Biocon, the company from which it licensed certain development rights to its lead drug candidate, received emergency authorization in India for treating patients hospitalized with COVID-19. Now the San Diego biotech plans a clinical trial testing the drug in patients with the virus in the US and other infection hotspots.

Adagio Therapeutics launched with $50 million to develop a portfolio of anti-coronavirus antibodies developed by a team at Adimab, the drug discovery and optimization firm from which the new company recently spun out.

—Novartis (NYSE: NVS) announced it would sell 15 generic and over-the-counter medications used to treat symptoms of COVID-19 to the governments of those on the World Bank’s list of low-income and lower-middle-income countries at zero profit until a vaccine or curative treatment becomes available.

THIS WEEK IN BIOTECH IPOS

—Relay Therapeutics (NASDAQ: RLAY) hauled in $400 million from its IPO to back its development of cancer drugs based on computational analysis of “protein motion.” The Cambridge, MA-based biotech, company priced its offering of 20 million shares at $20 apiece, topping its upwardly revised price range.

— Pandion Therapeutics priced its IPO at $18 per share, the top of its projected range. The Watertown, MA-based company raised about $135 million for clinical and preclinical development of its experimental treatments for autoimmune diseases. Pandion shares are expected to start trading Friday under the stock symbol “PAND.”

—ALX Oncology raised $161.5 million in an upsized IPO. The Burlingame, CA-based cancer drug developer offered 8.5 million shares at $19 after initially planning to sell 8 million shares in the range of $15 to $17 each. ALX shares will trade on the Nasdaq under the stock symbol “ALXO.”

—Berkeley Lights, whose cell analysis technology is used in drug research, raised about $178.2 million from its IPO. The Emeryville, CA-based company priced its offering of 8.1 million shares at $22 each, exceeding its upwardly revised price range of $19 to $20 per share. Those shares are expected to start trading on the Nasdaq Friday under the stock symbol “BLI.”

—Two US-based oncology biotechs Nkarta (NASDAQ: NKTX) and Poseida Therapeutics (NASDAQ: PSTX) and French firm Inventiva (NASDAQ: IVA), which is developing drugs for nonalcoholic steatohepatitis (NASH) and other diseases, collectively raised more than $500 million in their recent IPOs.

PEOPLE ON THE MOVE

Guillaume Pfefer was appointed CEO-partner of Flagship Pioneering, and chief executive of Flagship portfolio company Kintai Therapeutics… Nagesh Mahanthappa is stepping down as CEO of Scholar Rock (NASDAQ: SRRK) and will be succeeded by Tony Kingsley … Vor Biopharma appointed Christopher Slapak its permanent chief medical officer … Andrew Partridge joined Turning Point Therapeutics (NASDAQ: TPTX) as chief commercial officer … ViaCyte appointed Brittany Bradrick chief financial officerRay Barlow was named chief business officer of Kiadis Pharma … ImCheck Therapeutics appointed Claude Knopf its chief business officer … Eyepoint Pharmaceuticals hired Jay Duker as chief strategic scientific officer … Phathom Pharmaceuticals appointed Todd Branning chief financial officer … Cerevel Therapeutics named Kathleen Tregoning its chief corporate affairs officer … Myron Czuczman joined Citius Pharmaceuticals as chief medical officerKeith Sullivan was named president and CEO of Neuronetics (NASDAQ: STIM) … C4 Therapeutics added William McKee as chief financial officer and Jolie Siegel as chief legal officer … and Anaptys Bio (NASDAQ: ANAB) hired Dennis Mulroy as chief financial officer and Eric Loumeau as chief operating officer.

Sarah de Crescenzo contributed to this report.

Image: iStock/Bet_Noire

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