Bio Roundup: SeaGen Scores, Dyne’s Debut, Microbiome Moves & More

Xconomy National — 

Gilead Sciences CEO Daniel O’Day has spoken openly about acquisitions as a way to build up the company’s drug pipeline. This week, it made its biggest buy yet.

The $21 billion Immunomedics acquisition brings to Gilead a cancer drug that many analysts project will become a blockbuster seller. Some of those analysts think Gilead might have overpaid but the company says there were competing offers. The drug, sacitizumab govitecan (Trodelvy), is what’s called an antibody drug conjugate (ADC). This drug class has seen a lift in recent years. Four years ago, there were just three FDA-approved ADCs. The FDA has approved five ADCs since June 2019. It’s easy to forget, but the Immunomedics drug almost ended up in the hands of ADC specialist Seattle Genetics, which struck a deal for its rights in 2017 but then backed away amid shareholder opposition and litigation.

SeaGen (NASDAQ: SGEN) has since had better dealmaking luck. This week the Bothell, WA-based company struck two deals with Merck; in the larger one, the pharmaceutical giant is paying $600 million cash and making a $1 billion equity investment to begin a partnership to co-develop a SeaGen ADC. This week also brought news of startups emerging from stealth, corporate shakeups at two biotechs, and more life science IPOs. Let’s get to those stories in this week’s roundup.

LET’S MAKE A DEAL

—Gilead Sciences (NASDAQ: GILD) agreed to pay $21 billion to acquire Immunomedics (NASDAQ: IMMU) and its FDA-approved triple negative breast cancer drug sacitizumab govitecan, which is being studied for applications in other cancers.

Seattle Genetics struck two deals with Merck (NYSE: MRK) that brought the company $1.72 billion total up front, one for a cancer drug that’s still in development and the other for a cancer drug that won FDA approval in April.

—Qiagen (NYSE: QGEN) is paying $238 million to acquire the 80.1 percent of NeuMoDx Molecular that it doesn’t already own. Ann Arbor, MI-based NeuMoDx makes diagnostics instruments based on PCR technology.

—Vertex Pharmaceuticals (NASDAQ: VRTX) is paying Moderna (NASDAQ: MRNA) $75 million up front to kick off a three-year research collaboration focused on discovering and developing lipid nanoparticles and messenger RNAs that can deliver gene-editing therapies to the lungs for potential applications in cystic fibrosis (CF). The companies previously teamed up in lung and CF research in 2016.

—Moderna also began an alliance with Italy-based Chiesi Farmaceutici aimed at discovering and developing mRNA-based therapies for pulmonary arterial hypertension. Moderna received $25 million up front.

—Boehringer Ingelheim inked a deal for rights to a Click Therapeutics mobile app that will be developed as a digital therapeutic for schizophrenia. Germany-based Boehringer Ingelheim is paying Click an unspecified upfront payment plus research funding. The New York startup is potentially eligible for milestone payments in a deal whose total value could reach up to $500 million.

—AstraZeneca (NYSE: AZN) is acquiring from Dogma Therapeutics an oral version of a type of cholesterol-lowering drug called a PCSK9 inhibitor. Currently available PCSK9 drugs are injectable. Cambridge, MA-based Dogma will receive an unspecified upfront payment plus additional payments tied to the progress of the preclinical compound.

BIOTECH CASH

—Amsterdam-based Neogene Therapeutics raised $110 million in Series A financing to advance its research on neoantigen-targeting cell therapies intended to treat solid tumors.

—Three months after reporting positive Phase 2 data for its microbiome treatment for recurrent C. diff infection, Finch Therapeutics raised $90 million for further development of that drug and others in its pipeline.

—Escape Bio, a South San Francisco-based biotech developing therapies for neurodegenerative disorders, raised $73 million in crossover financing to advance development of its research programs.

—Attralus, a South San Francisco-based biotech, launched with a $25 million Series A financing that will support its development of drugs for systemic amyloidosis, a group of disorders caused by protein misfolding.

Escient Pharmaceuticals, a biotech developing G protein-coupled receptor-targeted drugs, closed a $77.5 million Series B financing to support clinical development of its lead program in cholestatic and uremic pruritus, as well as a second program for mast cell-related diseases.

—The Column Group led a $47 million Series A investment in Hexagon Bio, a Menlo Park, CA, company that is analyzing fungal genomes to develop new small molecule drugs.

—Graphite Bio of San Francisco emerged with a $45 million Series A financing to develop its gene-editing technology, which it says precisely inserts genetic payloads.

—AbbVie (NYSE: ABBV) subsidiary Allergan Aesthetics led a $7.5 million seed financing for Stemson Therapeutics, a company developing a cell therapy for hair loss.

—XWPharma closed a $40M Series C financing to support clinical development of a XW10172, a potential treatment for sleep disorders in neurodegenerative diseases, and XW10508, which is being evaluated in major depressive disorder and chronic pain.

—Novo Ventures and Sanofi Ventures led an $83 million Series C investment in Lava Therapeutics, which is developing bispecific antibody drugs that treat cancer by engaging gamma-delta T cells. The Netherlands-based company says these cells, the natural surveillance cells of the immune system, are an untapped opportunity in cancer treatment.

—Palleon Pharmaceuticals closed a $100 million Series B round as it prepares to advance to the clinic next year with a cancer drug that targets glycans, sugar molecules on the surface of tumors that help them evade the immune system.

—Stanford University spinout Synthekine launched with an $82 million Series A round to support its development of engineered cytokine drugs that have enhanced therapeutic effects for treating cancer and autoimmune diseases.

—Questa Capital closed a $348 million fund that the firm says will invest in later-stage companies in healthcare services, technology, and medical devices.

DRUG DEVELOPMENTS

—Unity Biotechnology (NASDAQ: UBX) laid off about 30 percent of its staff in a restructuring that focuses the company on advancing a potential treatment for diabetic macular edema through Phase 1 testing. The corporate shakeup comes a month after the company’s former lead drug failed a mid-stage study in osteoarthritis.

—MiRagen (NASDAQ: MGEN) shook up its C-suite and announced a strategic review of its pipeline, as well as a plan by the board of directors to explore strategic alternatives that include possible sale, merger, or licensing transaction.

—Cullinan Oncology announced its latest subsidiary, Cullinan Florentine, which is focused on developing a bispecific antibody drug for treating acute myeloid leukemia. Cullinan Florentine licensed its drug from the University of Tübingen and the German Cancer Research Center.

—Takeda Pharmaceutical (NYSE: TAK) opened a new 24,000 square-foot cell therapy manufacturing facility at its Boston location. The company says the site will manufacture its clinical-stage cell therapies, which are initially focused on cancer.

—Marinus Pharmaceuticals (NASDAQ: MRNSreported that ganaxolone met the main goals of a pivotal study testing it as a treatment for a rare, inherited form of epilepsy. The Radnor, PA-based biotech is planning to seek FDA approval in mid-2021.

—An FDA advisory panel concluded that a harder-to-crush version of OxyContin appeared to reduce abuse by snorting or injection. But the committee also voted overwhelmingly that data did not show that Purdue Pharma’s reformulation of its opioid painkiller reduced overall abuse or overdoses.

—Cassava Sciences (NASDAQ: SAVA) reported encouraging data from a 64-patient placebo-controlled Phase 2 study testing sumifilam, an Alzheimer’s disease drug designed to restore the brain protein filamin A. The Austin, TX-based company said 98 percent of those who received the small molecule drug showed a response, including improvements in memory and cognition.

THIS WEEK IN BIOTECH IPOS

—Dyne Therapeutics (NASDAQ: DYN) raised $233 million in an upsized IPO that will fund its development of targeted genetic medicines for rare muscular disorders.

—Metacrine (NASDAQ: MTCR) raised $85 million from its IPO for its drug pipeline, including two mid-stage compounds with potential applications in nonalcoholic steatohepatitis.

—Athira Pharma raised $204 million from its IPO, which priced at $17 per share, the top of its projected price range. Those shares are expected to begin trading on the Nasdaq Friday under the stock symbol “ATHA.” The Seattle developer of drugs for neurodegenerative diseases will use the proceeds to advance its lead drug candidate to a pivotal study in Alzheimer’s disease.

—Cambridge-based Oncorous, an early-stage biotech developing cancer therapies based on oncolytic viruses, set a preliminary $86 million goal for its IPO.

COVID-19 R&D

—Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) amended their COVID-19 vaccine clinical trial, expanding the 30,000-patient study to about 44,000. The companies said the expansion will diversify the representation in the study, adding teenagers as well as people with HIV, hepatitis C, and hepatitis B.

—Early data from a Phase 2 clinical trial testing an Eli Lilly (NYSE: LLY) antibody drug candidate for COVID-19 showed that the middle dose met the study’s main goal of reducing viral loads after 11 days. Lilly added that the rate of hospitalization or emergency room visits for patients treated with its drug was 1.7 percent compared to 6 percent for those given a placebo—a risk reduction rate of 72 percent.

—In manufacturing news, BioNTech acquired a GMP site from Novartis (NYSE: NVS) to expand its COVID-19 vaccine manufacturing capacity. Separately, Eli Lilly and Amgen (NASDAQ: AMGN) announced a collaboration to boost the capacity for manufacturing Lilly’s potential COVID-19 drugs.

PEOPLE ON THE MOVE

Synlogic (NASDAQ: SYBX) appointed David Hava its chief scientific officerMark Rothera joined Silence Therapeutics (NASDAQ: SLN) as president and CEO… Trevi Therapeutics (NASDAQ: TRVI) Chief Commercial Officer Yann Mazabraud plans to resign… X4 Pharmaceuticals Chief Scientific Officer Renato Skerlj is resigningEQRx appointed Rona Anhalt its chief people officer; Christian Antoni chief development officer; Eric Hedrick chief physician executive; and Daniel Hoy chief of technical operations… Terry Lo joined Vizgen as president and CEO… Pacific Biosciences (NASDAQ: PACB) appointed Susan Kim chief financial officer… Aravive (NASDAQ: ARAV) tapped Reshma Rangwala as chief medical officer… Adicet Bio (NASDAQ: ACET) added Nick Harvey as chief financial officer… Vedanta Biosciences appointed Jeffrey Silber chief medical officer… Dicerna Pharmaceuticals (NASDAQ: DRNA) named Ling Zeng chief legal officer and secretary… Charles Hughes-Jones joined Volastra Therapeutics as CEO… Cygnal Therapeutics appointed John Wagner chief medical officer… David Dismuke joined Forge Biologics as chief technical officer… Leonard Blum joined XWPharma as CEO… Obsidian Therapeutics tapped Jan ter Meulen as its chief scientific officer… Sean Bohen was appointed president and CEO of Olema Oncology… and Praxis Precision Medicines appointed Nicole Sweeny chief commercial officer.

Image: iStock/artisteer

 

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