Bio Roundup: Gilead’s $4.9B Deal, COVID-19 Collabs, IPO Plans & More

Xconomy National — 

Last month, Gilead Sciences CEO Daniel O’Day announced plans to introduce 10 “transformative medicines” over the next 10 years. Acquisitions would help meet that ambitious goal, and this week Gilead announced one of them: a nearly $5 billion deal for cancer immunotherapy developer Forty Seven.

Forty Seven’s lead CD47-blocking drug—the company is named after the signaling molecule— is being tested in combination with chemotherapy as a treatment for blood cancers, although O’Day noted it could potentially apply to solid tumors, as well as be part of drug combinations with other therapies. O’Day emphasized the company’s interest in more “small to medium-sized” deals. (For Gilead, Forty Seven’s $4.9 billion price tag places it in the medium category.)

That story and more—including a look at COVID-19 developments at pharmas and biotechs, plus a gander at companies laying IPO plans amid uneven market conditions as coronavirus-related impacts to business mount—in this week’s biotech roundup. Let’s get to it.

DOLLARS & DEALS

—Gilead Sciences (NASDAQ: GILD) reached a $4.9 billion deal to acquire Forty Seven (NASDAQ: FTSV), a biotech whose lead program blocks a signaling molecule that tumors use to evade detection by immune cells.

Xilio Therapeutics unveiled its new name and $100.5 million in Series B funding to advance its two lead cancer immunotherapies into Phase 1 testing.

—Novartis (NYSE: NVS) led a $100 million Series C financing for Pliant Therapeutics, which will use the cash to continue clinical development of its experimental treatment for fibrosis.

—Amunix, which has built a business licensing its half-life extending, low-immunogenicity drug delivery technology to biopharma companies, raised $73 million to use its in-house know-how to develop its own drugs. The company is focused on making safer T cell engagers and cytokines to treat solid tumor cancers.

—The bankruptcy auction of Melinta Therapeutics (OTC: MLNT) drew no bidders. Under a prior agreement, the antibiotics developer’s assets are now set to go to creditor Deerfield Management.

—Akouos, a Boston company developing gene therapies for hearing, closed a $105 million Series B round. The biotech will use the cash to advance its lead program, AK-OTOF, into clinical testing as a treatment for an inherited form of hearing loss.

—Immunocore, which is developing T cell receptor drugs to treat cancer, infection and autoimmune disease, raised $130 million in a Series B financing round. The UK-based company, which also has offices in Pennsylvania and Maryland, said the round was led by growth equity firm General Atlantic, a new Immunocore investor.

—Lipidio Pharmaceuticals, which is developing drugs to treat diseases associated with excess body fat, debuted with Series A financing from investors including the Foundation for Prader Willi Research, several family offices, and high net-worth individuals. The San Diego biotech didn’t disclose the amount it raised, but said the money would allow it to advance its lead program into proof-of-concept studies.

DRUG DEVELOPMENTS

—Sanofi (NYSE: SNY) antibody drug isatuximab-irfc (Sarclisa), a treatment for multiple myeloma, was OK’d by the FDA for adults whose disease hasn’t responded to two prior therapies. The drug, to be given in combination with two other commonly used drugs, targets a protein that is widely expressed on multiple myeloma cells.

—Karyopharm Therapeutics (NASDAQ: KPTI) reported that its multiple myeloma drug selinexor (Xpovio) met the main goals of a Phase 3 study, which could support expansion of the drug’s approval to a broader group of patients. Last July, the FDA OK’d the drug as a treatment for multiple myeloma patients whose cancer failed to respond to four earlier treatments.

—The FDA approved Cerovene’s generic version of pyrimethamine (Daraprim). Four years ago, Martin Shkreli’s former company, Turing Pharmaceuticals (since renamed Vyera Pharmaceuticals), sparked public outcry by raising the drug’s price 5,000 percent.

—The European Commission approved Alnylam Pharmaceuticals (NASDAQ: ALNY) drug givosiran (Givlaari), a treatment for the inherited metabolic disorder acute hepatic porphyria. The RNA interference drug won the FDA’s nod last November.

—AbbVie (NYSE: ABBV) drug venetoclax (Venclexta) failed a Phase 3 study in acute myeloid leukemia. In 2018, the FDA granted accelerated approval for the drug based on Phase 1/2 data, a decision that required the company to do more testing in order to maintain approval status.

—Allergan (NASDAQ: AGN) and Editas Medicine (NASDAQ: EDIT) enrolled the first patient in a clinical trial testing AGN-151587, which uses the CRISPR technology to do its gene-editing work inside the body. The therapy is an experimental treatment for Leber congenital amaurosis 10, an inherited form of blindness.

—Unum Therapeutics (NASDAQ: UMRX) is laying off about 60 percent of its workforce in a restructuring that refocuses the company on BOX1030, a preclinical cell therapy being developed as a treatment for solid tumors.

—Durvalumab (Imfinzi), an AstraZeneca (NYSE: AZN) immunotherapy that won accelerated FDA approval in 2017 for treating bladder cancer, has failed a Phase 3 test.  The pharmaceutical giant reported that its drug did not meet the main goal of helping patients live longer compared to treatment with chemotherapy.

COVID-19 DEVELOPMENTS

—Vir Biotechnology (NASDAQ: VIR) and Alnylam Pharmaceuticals (NASDAQ: ALNY) announced a plan to expand an existing collaboration between the companies to include the development and commercialization of RNAi therapeutics targeting SARS-CoV-2, the virus that causes the disease COVID-19. The partnership will focus on development of siRNAs that Alnylam recently identified that target highly conserved regions of coronavirus RNAs.

—Takeda Pharmaceutical (NYSE: TAK) kicked off development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin, a therapy derived from plasma that has been used to treat respiratory infections, to treat high-risk individuals who have COVID-19. The Japanese pharma giant also said it was studying its currently marketed and pipeline products to determine whether any may be effective treatments for the rapidly spreading virus.

—Pennsylvania biotech Inovio Pharmaceuticals (NASDAQ: INO) said it would accelerate its timeline for developing a DNA vaccine for COVID-19. During a meeting at the White House, executives said the company’s experimental vaccine for a related coronavirus laid the foundation for its investigational COVID-19 vaccine, which is now slated to begin US clinical testing in April.

—The Fred Hutchinson Cancer Research Institute put its Seattle-based employees under a mandatory remote work policy Thursday based on the growing number of COVID-19 diagnoses in the community and other factors. The organization said none of its employees had been diagnosed with the virus, but that the policy would remain in effect through at least month’s end.

THIS WEEK IN IPOs

—South San Francisco-based ORIC Pharmaceuticals, which has an investigational cancer drug in Phase 1 testing and another approaching the clinic, set a preliminary target of about $86 million for its initial public offering. ORIC stands for “overcoming resistance in cancer.”

—NLS Pharmaceutics, a Switzerland-based company developing drugs for central nervous system disorders, is seeking a US stock listing. The company aims to raise about $40 million by offering shares on the Nasdaq.

Sickle cell disease drug developer Imara set terms for its planned IPO. The Cambridge, MA-based biotech aims to offer 4.45 million shares priced in the range of $16 to $18 apiece.

—Pulmonx filed for an IPO to support sales and marketing of its Zephyr Valves, an implantable device approved to treat hyperinflated lungs in emphysema patients.

PEOPLE ON THE MOVE

Julie Krop, chief medical officer of AMAG Pharmaceuticals (NASDAQ: AMAG) is stepping down… BlueRock Therapeutics named Seth Ettenberg its chief scientific officer… Anirvan Ghosh is leaving Biogen (NASDAQ: BIIB) to become CEO of Unity Biotechnology (NASDAQ: UBX)… Marcia de Souza Lima has been appointed chief medical officer of Oculis… MacroGenics’ Jon Wigginton is stepping down from his role as chief medical officer… Senti Biosciences added Jose Iglesias as its chief medical officer… and PsiOxus Therapeutics appointed Tom Lillie as its chief medical officer.

Frank Vinluan contributed to this report.

Image: iStock/maxsattana