Bio Roundup: Pharma M&A, AbbVie’s Cancer Bet, Biofourmis Bucks & More

Labor Day is just around the corner and many people are looking forward to a last chance to celebrate the waning days of summer. But ahead of the holiday weekend, biopharmaceutical companies were hard at work closing deals.

Food conglomerate Nestlé is delving deeper into pharmaceuticals with its $2.6 billion deal to acquire Aimmune Therapeutics, developer of immunotherapies for food allergies. Earlier this year, Brisbane, CA-based Aimmune’s peanut allergy treatment, Palforzia, became the first FDA-approved food allergy immunotherapy. The deal activity extended to cancer immunotherapy as Gilead Sciences and AbbVie each struck up alliances to shore up their respective drug pipelines.

This week also gave us a look at the changing definition of what constitutes a drug. Biofourmis raised $100 million in financing, part of which will support a pipeline of digital therapeutics that the company plans to submit to the FDA for review as drugs, not medical devices. Before you shut down for the long weekend, take a moment to look back at those stories and more in our news roundup.

LET’S MAKE A DEAL

Nestlé is acquiring Aimmune Therapeutics (NASDAQ: [[ticker:AIMT]]), along with its FDA-approved peanut allergy immunotherapy, in a $2.6 billion deal.

—Gilead Sciences (NASDAQ: [[ticker:GILD]]) is committing $120 million to Jounce Therapeutics (NASDAQ: [[ticker:JNCE]]) for rights to a preclinical antibody cancer drug that’s nearing human testing.

—Ionis Pharmaceuticals (NASDAQ: [[ticker:IONS]]) reached a $500 million deal to buy the remaining shares of Akcea Therapeutics (NASDAQ: [[ticker:AKCA]]) that it doesn’t already own. The buyout brings Akcea back within the fold of Ionis, which spun the company out three years ago.

—AbbVie (NYSE: [[ticker:ABBV]]) is paying $200 million to secure global rights to lemzoparlimab, a CD47-targeting cancer drug that I-Mab (NASDAQ: [[ticker:IMAB]]) has taken through Phase 1 testing. The North Chicago, IL drug giant could pay Shanghai-based I-Mab up to $1.74 billion more in milestone payments tied to the antibody drug’s progress.

—Immediately after the lemzoparlimab deal was announced, I-Mab disclosed a $418 million private placement with a group of investors led by Hillhouse Capital Group.

—Boston Pharmaceuticals licensed a Novartis (NYSE: [[ticker:NVS]]) nonalcoholic steatohepatitis (NASH) drug candidate, the fourth molecule the company has picked up from the pharma giant. No financial terms were disclosed.

—Lodo Therapeutics of New York acquired Hibiskus BioPharma and its preclinical proteasome inhibitor with potential applications treating solid tumors. No financial terms were disclosed.

STARTUP CASH

SoftBank Group led a $100 million Series C financing for Biofourmis, whose pipeline includes a digital therapeutic that the company is developing as a monotherapy for heart failure.

—Seattle startup Lumen Bioscience closed $16 million in Series B funding to advance development of antibody drug candidates made from engineered spirulina.

— Rain Therapeutics of Newark, CA, raised $63 million in Series B financing to support its pipeline, including lead candidate RAIN-32, a liposarcoma treatment in mid-stage clinical testing.

—Shine Medical Technologies, a Janesville, WI-based company that produces a radioisotope used in medical diagnostic imaging, closed an $80 million Series C round of funding.

—Tokyo-based Luca Science, a company developing mitochondria-based therapies, raised $9.8 million in Series A financing.

—Waltham, MA-based Pyramid Biosciences secured $28 million in funding to support clinical development of its drug candidates, which are designed to modulate the tropomyosin receptor kinase family of enzymes as a way of treating cancers and skin disorders.

THIS WEEK IN BIOTECH IPOS

—A week after raising $42.5 million in Series D financing, Clene Nanomedicine announced plans to go public via a merger with Tottenham Acquisition I Limited (NASDAQ: [[ticker:TOTA]]), a special purpose acquisition company (SPAC). Clinical-stage Clene, based in Salt Lake City, is developing treatments for neurodegenerative disorders.

—Another SPAC, BCTG Acquisition Corp., went public, pricing its offering of 14.5 million shares at $10 apiece.

—CM Life Sciences, a SPAC sponsored by Casdin Capital and Corvex Management, went public with its offering of 38.5 million shares priced at $10 apiece.

Four months after launching and nearly one month after raising $95 million in a Series B round that included crossover investors, Dallas-based Taysha Gene Therapies filed paperwork for an IPO.

DRUG DEVELOPMENTS

—Intercept Pharmaceuticals (NASDAQ: [[ticker:ICPT]]) laid off 25 percent of its staff, a move that comes two months after the FDA rejected the New York biotech’s NASH drug candidate.

—A US appeals court upheld a ruling finding that a Hikma Pharmaceuticals version of Amarin Pharma (NASDAQ: [[ticker:AMRN]]) cardiovascular drug icosapent ethy (Vascepa) does not infringe on Amarin’s patents, opening the door to generic competition. Amarin says it expects to petition for review of the decision by the full panel of 12 active US Court of Appeals judges.

—Novo Nordisk (NYSE: [[ticker:NVO]]) drug somapacitan (Sogroya) was approved by the FDA for treating growth hormone deficiency in adults. The decision makes the injectable human growth hormone the first once-weekly injectable treatment for the condition; previously approved therapies are given daily.

—Neuroscience biotech startup Amylyx published data in the New England Journal of Medicine showing that its amyotrophic lateral sclerosis drug candidate, AMX0035, met a clinical study’s main goal of reducing the rate of muscle decline compared to a placebo.

—Shares of Akebia Therapeutics (NASDAQ: [[ticker:AKBA]]) plummeted more than 72 percent after the company reported its drug candidate for anemia in chronic kidney disease patients failed a pivotal study. But Akebia had reported positive preliminary results from a separate Phase 3 study testing the drug, vadadustat, and the company still plans to seek FDA approval based on the totality of clinical data.

—Lung disease drug developer Savara (NASDAQ: [[ticker:SVRA]]) ended a clinical study testing its experimental cystic fibrosis (CF) treatment due in part to the COVID-19 pandemic. The launch of Vertex Pharmaceuticals (NASDAQ: [[ticker:VRTX]]) drug Trikafta is another factor. The triple combination therapy addresses about 90 percent of patients who have the inherited disorder and “has become a preferred treatment for many CF patients,” Savara said.

COVID-19 R&D

—Phase 1 results for a COVID-19 vaccine candidate from Novavax (NASDAQ: [[ticker:NVAX]]) published in the New England Journal of Medicine showed that all subjects in the study developed neutralizing antibodies to the virus after a second dose. No major safety problems were reported.

—Sanofi (NYSE: [[ticker:SNY]]) and GlaxoSmithKline (NYSE: [[ticker:GSK]]) started a Phase 1/2 clinical trial testing a potential COVID-19 vaccine. The vaccine candidate combines recombinant protein technology used in a Sanofi influenza vaccine with adjuvant technology from GSK.

—GSK started Phase 2/3 testing with another COVID-19 partner, Vir Biotechnology (NASDAQ: [[ticker:VIR]]). That clinical program is evaluating an antibody treatment intended to prevent hospitalization due to the novel coronavirus.

PEOPLE ON THE MOVE

Recce Pharmaceuticals named James Graham its CEO… Dov Goldstein joined Indapta Therapeutics as chief financial and business officer… Hoth Therapeutics (NASDAQ: [[ticker:HOTH]]) appointed Stefanie Johns its chief scientific officer… Unity Biotechnology (NASDAQ: [[ticker:UBX]]) tapped Lynne Sullivan as chief financial officer… Alex Pinto joined Zentalis Pharmaceuticals (NASDAQ: [[ticker:ZNTL]]) as chief legal officer… Magenta Therapeutics (NASDAQ: [[ticker:MGTA]]) appointed Lisa Olson chief scientific officer and said that Jason Ryan, chief operating and financial officer, will transition to a consulting role… Amarna Therapeutics appointed Steen Klysner as its CEO… Ed Rebar joined Sana Biotechnology as chief technology officer… and Graybug Vision appointed Robert Breuil as chief financial officer.

Image: iStock/Pongasn68

 

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Author: Frank Vinluan

Xconomy Editor Frank Vinluan is a business journalist with experience covering technology and life sciences. Based in Raleigh, he was a staff writer at the Triangle Business Journal covering technology, biotechnology and energy before joining MedCityNews.com as North Carolina bureau chief. Prior to moving to North Carolina’s Research Triangle in 2007 he held business reporting positions at The Des Moines Register and The Seattle Times.