Bio Roundup: Gilead’s Pionyr Grab, Relay to IPO, Unicorn Sana & More

Xconomy National — 

Uncertainty related to the continued spread of the pandemic continued to consume most of the oxygen in the room this week, but life sciences news outside of that arena continued apace.

Once considered all but shuttered, the IPO market again saw an active week between new public debuts and more companies joining the queue. Indeed, nearly two-thirds of IPO activity in the second quarter stemmed from healthcare, driven primarily by biotech firms. IPO research firm Renaissance Capital says it anticipates—what else—a “renaissance” in the public markets come third quarter. That remains to be seen, especially as the US continues to struggle in its response to COVID-19 compared with many other countries.

In other money moves, a stealthy cell therapy developer revealed its unicorn status and one M&A move squelched a prospective IPO. The FDA too, stayed busy, with a drumbeat of decisions. These stories, and more, in this week’s roundup.

DOLLARS & DEALS

—Foster City, CA-based Gilead Sciences (NASDAQ: GILD) is paying antibody drug developer Pionyr Immunotherapeutics $275 million up front for nearly half of the company, plus the option to pay another $315 million to acquire the rest. Pionyr says it will soon ask the FDA for permission to move its lead programs into the clinic.

—Gene testing company Invitae (NASDAQ: NVTA) agreed to pay $886 million in cash and stock to acquire ArcherDx. The deal ends the Boulder, CO-based cancer diagnostics developer’s bid to go public.

Johns Hopkins University spinout AsclepiX Therapeutics raised $35 million in Series A financing to start clinical testing of its lead peptide drug for vascular eye diseases.

—La Jolla Pharmaceutical (NASDAQ: LJPC) outbid Melinta Therapeutics to acquire ailing antibiotics company Tetraphase Pharmaceuticals (NASDAQ: TTPH).

—Cambridge, MA-based Codiak Biosciences and neuromuscular disease drug developer Sarepta Therapeutics (NASDAQ: SRPT) inked a deal to explore using exosomes to develop up to five new genetic drugs. Terms make Codiak eligible for up to $72.5 million in upfront and near-term license payments.

—Sana Biotechnology revealed that it has raised $700 million since its 2019 launch—enough to put its valuation in “unicorn” territory. But the Seattle-based cell therapy developer is still keeping mum about its research.

—Philadelphia-based cell therapy developer Century Therapeutics acquired Empirica Therapeutics, a preclinical-stage biotech advancing potential glioblastoma cell therapies. No financial terms were disclosed.

—Sanofi (NYSE: SNY) agreed to pay $425 million to expand its messenger RNA vaccine R&D partnership with Translate Bio (NASDAQ: TBIO). The amended pact gives Sanofi exclusive global rights to develop, manufacture, and commercialize infectious disease vaccines based on Translate’s technology.

—Netherlands-based biopharma investment firm BioGeneration Ventures closed its fourth fund at €105 million (about $119 million). BioGeneration’s investments are focused on science and technology that comes from Europe.

—Merck (NYSE: MRK) is teaming up with Yumanity Therapeutics to develop new treatments for neurodegenerative diseases, getting the rights to two of the biotech’s preclinical programs. The deal included an undisclosed upfront payment; Merck also invested in Yumanity’s Series C financing round.

—New Haven, CT-based Simcha Therapeutics launched with $25 million in Series A financing and a plan to develop biologic drugs that modulate cytokine pathways.

—Paris-based Enterome, which has US operations in Cambridge, MA, netted €46.3 million (about $52.6 million) to advance its pipeline of cancer immunotherapies based on its understanding of the interaction between the gut microbiome and the immune system, or the “microbiome-immunoinflammation axis.”

—San Diego’s Illumina (NASDAQ: ILMN) selected seven early-stage companies to join the first global cohort of Illumina Accelerator, its incubator program for genomics startups. Three are in the UK; the four others are joining the San Francisco Bay Area program.

Poseida Therapeutics, which is creating “next generation” cell and gene therapies, closed a Series D financing round of $110 million.

—CSL Behring is paying uniQure (NASDAQ: QURE) $450 million up front to acquire a hemophilia B gene therapy currently in Phase 3 testing.

DRUG & DEVICE DECISIONS

—A week after Akili Interactive secured FDA clearance for its prescription video game for attention deficit hyperactivity disorder, European regulators granted marketing authorization for the Boston company’s product.

—The FDA rejected Nabriva Therapeutics (NASDAQ: NBRV) antibiotic fosfomycin (Contepo) for the second time. As it did last year, the agency cited manufacturing issues. But this time, the FDA said travel restrictions prevented it from conducting onsite inspections of Nabriva’s contract manufacturers.

—Karyopharm Therapeutics (NASDAQ: KPTI) drug selinexor (Xpovio) snared a second FDA approval as a treatment for relapsed or difficult to treat diffuse large B-cell lymphoma. The drug was initially approved last year for treating multiple myeloma.

—The FDA expanded the use of Merck blockbuster cancer immunotherapy pembrolizumab (Keytruda) to patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

—Zogenix (NASDAQ: ZGNX) won FDA approval for fenfluramine (Fintepla) as a treatment for a rare form of epilepsy called Dravet syndrome.

DRUG DEVELOPMENTS

—Moderna (NASDAQ: MRNA), which is testing a messenger RNA vaccine for COVID-19, and Catalent (NYSE: CTLT) will collaborate to make the biotech’s investigational vaccine at its biologics facility in Bloomington, IN.

Reneo Pharmaceuticals said encouraging data from an early-stage study of a compound it is advancing for rare diseases characterized by impaired mitochondria is guiding it in its design of a large global study of the investigational drug in patients with primary mitochondrial myopathies.

—Sangamo Therapeutics (NASDAQ: SGMO) is separating its research and development unit into two divisions. The biotech is searching for a head of development; Jason Fontenot, senior vice president, cell therapy, is serving as interim head of research.

—The US Attorney’s Office for the District of Massachusetts is suing Regeneron Pharmaceuticals (NASDAQ: REGN), alleging the drug maker paid tens of millions in kickbacks for its eye drug aflibercept (Eylea) through a charitable foundation that covers patient co-pays. Regeneron says the complaint has no merit and its charitable contributions help elderly patients obtain prescribed medicines.

—Biohaven Pharmaceutical (NASDAQ: BHVN) drug troriluzole fell short of the main goals of a mid-stage study in obsessive-compulsive disorder. But Biohaven says the data show a consistent benefit over time and the company is hoping for better results in a larger Phase 3 study that will also include a higher dose.

THIS WEEK IN BIOTECH IPOS

—Cambridge, MA-based Relay Therapeutics plans to tap the public markets for funds to get its two lead drug candidates into mid-stage clinical trials as potential treatment for cancers. The company set a preliminary target of $200 million for its IPO.

—Nkarta, a developer of allogeneic natural killer cell therapies for cancer, is preparing to go public to finance clinical trials. The South San Francisco company set a preliminary $100 million IPO goal.

—Irish biopharma Amryt Pharma is looking to list on the Nasdaq exchange. The commercial-stage company develops drugs for orphan diseases. Its US office, in Cambridge, MA, operates as Aegerion Pharmaceuticals.

—Compass Therapeutics, which is developing antibody therapeutics intended to treat both solid tumors and blood cancers, completed a reverse merger with Olivia Ventures and closed a $60 million private placement financing to advance programs.

Less than three months after raising $125 million, Iteos Therapeutics unveiled its plans to join the public markets.

—Akouos priced its IPO at $17 per share, the top end of its anticipated price range, raising $212.5 million. The Watertown, MA-based biotech’s lead candidate is a gene therapy for an inherited form of hearing loss.

—Renalytix AI, a Cardiff, Wales-based maker of AI-based diagnostic tests for kidney disease, is seeking a US listing on the Nasdaq exchange.

—Fusion Pharmaceuticals priced its IPO at $17 per share, topping its projected range and raising $212.5 million. The Hamilton, Ontario-based company plans to use the proceeds to continue development of its pipeline of cancer drugs.

PEOPLE ON THE MOVE

Chimerix (NASDAQ: CMRX) appointed Allen Melemed as its new chief medical officer … FibroGen (NASDAQ: FGEN) tapped Thane Wettig as its first chief commercial officer … Seres Therapeutics (NASDAQ: MCRB) added Terri Young as its chief commercial and strategy officer … Neuraptive Therapeutics announced Robert (Bob) S. Radie as its new CEO … Storm Therapeutics appointed Josefin-Beate Holz as clinical advisor and chief medical officer … and BioXcel Therapeutics (NASDAQ: BTAI) named Reina Benabou senior vice president and chief development officer.

Frank Vinluan contributed to this report.

Image: iStock/AndreyPopov