Bio Roundup: Grail Acquisition, Libra’s Launch, Tau Trial Results & More

Xconomy National — 

In biotech, you can go home again. Four years ago, Illumina spun out cancer diagnostics startup Grail. This week, the gene sequencing giant announced it is acquiring Grail in an $8 billion cash and stock deal.

Grail set out with the goal of developing a diagnostic test that detects cancer from the genetic snippets tumors shed into the blood. The idea is to diagnose cancer well before symptoms show, giving clinicians a better chance to treat the disease. Grail has tested its technology in tens of thousands of patients and is now preparing to launch its first product next year.

By acquiring Grail, Illumina plants a foot firmly in clinical applications—a move that puts it in direct competition with some of its customers that are selling or developing diagnostics based on Illumina technology. Illumina CEO Francis deSouza says the cancer diagnostics market is big enough for multiple players but investors are reserving judgement. Illumina’s stock price dropped last week in anticipation of a deal and it slipped again on after the acquisition was announced.

In other news this week, one Alzheimer’s disease drug developer saw its fortunes rise while another’s sank, two more COVID-19 vaccines began Phase 3 testing, and a startup emerged with novel approach to Lou Gehrig’s disease. Let’s get to those stories and more in this week’s news roundup.

LET’S MAKE A DEAL

—Illumina (NASDAQ: ILMN) is paying $8 billion to acquire Grail, a liquid biopsy developer that it spun out in 2016. Menlo Park, CA-based Grail expects to launch its first cancer diagnostic next year.

—Roche agreed to pay €380 million (about $443 million) up front to acquire Inflazome and its portfolio of small molecule drug candidates designed to block the NLRP3 inflammasome to treat inflammatory disorders.

—Bausch Health (NYSE: BHC) reached a deal to pay $50 million for the option to acquire Allegro Ophthalmics including risuteganib, a drug in Phase 3 testing for the dry form of age-related macular degeneration.

BIOTECH CASH

Monte Rosa Therapeutics closed $96 million in Series B financing to advance its pipeline of protein degradation drugs toward human testing expected to begin in late 2021.

Libra Therapeutics emerged from stealth with a $29 million Series A financing and drug programs in development for treating amyotrophic lateral sclerosis and other neurodegenerative disorders.

—Siolta Therapeutics of San Carlos, CA, closed $30 million in Series B financing to support development of STMC-103, a live biotherapeutic product candidate in early-stage testing as a treatment for a range of allergic diseases.

—Immetas Therapeutics raised $11 million in Series A financing to support its research on inflammation pathways in aging as a way to develop new treatments for cancer and inflammatory diseases.

—NeuroTherapia of Cleveland emerged with an $8.8 million Series A round to back NTRX-07, a compound in development to treat neuroinflammation.

—Longitude Capital closed a $585 million fund that will invest in biotech, medical technology, and health companies.

—Six months after Silverback Therapeutics closed a $79 million Series B financing, the Seattle cancer immunotherapy developer added $85 million more in a Series C round to advance to Phase 1 tests of its lead drug candidate.

—Arch Venture Partners led a $60 million Series C financing for Nutcracker Therapeutics, a biotech that’s developing messenger RNA (mRNA) therapies based on its proprietary technology for discovering, developing, and manufacturing mRNA therapies and vaccines.

—Morningside Ventures led a £40.6 million (about $53.4 million) Series B round of funding for Immune Regulation, a biotech developing drugs that “reset” the immune system to address the inflammation caused by autoimmune and allergic diseases.

—Samsara BioCapital led a $20 million Series B round of funding for Palladio Biosciences, a Horsham, PA-based company developing treatments for rare kidney disorders. The cash will support Phase 3 testing of lixivaptan, an experimental treatment for autosomal dominant polycystic kidney disease.

DRUG DEVELOPMENTS

—AC Immune (NASDAQ: ACIU) antibody drug semorinemab, designed to treat Alzheimer’s disease by targeting aggregation of the brain protein tau, failed a Phase 2 study. Shares of the Switzerland-based company sank more than 40 percent on the news.

—The FDA is requiring Novartis (NYSE: NVS) to do another pivotal study to support expansion of the approval of its spinal muscular atrophy gene therapy to older patients. The regulatory nod for Zolgensma last year covered children under the age of two.

—A confirmatory Phase 3 study for Seattle Genetics (NASDAQ: SGEN) drug enfortumab vedotin (Padcev) met the main goal of overall survival compared to chemotherapy. In April, the FDA granted accelerated approval for the antibody drug conjugate as a treatment for urothelial cancer that has spread.

—The FDA accepted the resubmitted application for idecabtagene vicleucel, a cell therapy that Bluebird Bio (NASDAQ: BLUE) and partner Bristol Myers Squibb (NYSE: BMY) developed for multiple myeloma. In May, the regulator refused to review the application and asked the companies to submit additional information.

—Preliminary data from a Phase 2 test of avapritinib (Ayvakit) showed the drug met the main goal of improving overall survival in patients with advanced systemic mastocytosis, and its maker, Blueprint Medicines (NASDAQ: BPMC) now plans to seek an additional FDA approval. The drug was initially approved in January for gastrointestinal stromal tumor.

—Flagship Pioneering unveiled new drug discovery company Valo Health. Last year, Valo acquired drug discovery startup Numerate and purchased some assets from Forma Therapeutics.

COVID-19 R&D

—Johnson & Johnson (NYSE: JNJ) began a Phase 3 study testing its COVID-19 vaccine candidate, JNJ-78436735. The study is designed to enroll up to 60,000 people across three continents.

—Novavax (NASDAQ: NVAX) started a Phase 3 study in the testing its COVID-19 vaccine candidate, NVX-CoV2373. The study in the UK is expected to enroll up to 10,000 people ages 18 to 84.

THIS WEEK IN BIOTECH IPOS

—After Athira Pharma (NASDAQ: ATHA) completed its $204 million IPO, Xconomy talked with the company’s executives about the science underlying its approach regenerate neurons to treat Alzheimer’s and the clinical trial plans for the coming year.

—Less than five months after launching with $30 million in Series A financing, Taysha Gene Therapies (NASDAQ: TSHA) raised $157 million from its IPO. The Dallas-based biotech is developing gene therapies for rare central nervous system disorders.

—Cancer drug developer PMV Pharmaceuticals priced its IPO at $18 per share and raised about $211.8 million. Shares of the Cranbury, NJ-based biotech are expected to begin trading on the Nasdaq Friday under the stock symbol “PMVP.”

—Eye disease drug developer Graybug Vision raised $90 million in its IPO, which was priced at $16 per share. Those shares are expected to begin trading Friday on the Nasdaq under the stock symbol “GRAY.”

—Prelude Therapeutics, a Wilmington, DE-based cancer drug developer, priced its IPO at $19 per share, raising $158.2 million. The company’s shares are expected to begin trading on the Nasdaq Friday under the stock symbol “PRLD.”

Cancer immunotherapy developer Shattuck Labs of Austin, TX, filed IPO paperwork and set a preliminary a $100 million goal.

—San Mateo, CA-based Kronos Bio also set a $100 million IPO target to fund Phase 2/3 development of entospletinib, which the company is evaluating in acute myeloid leukemia characterized by a particular genetic mutation.

—Spruce Biosciences aims to raise $86 million from a planned IPO intended to finance clinical development of tildacerfont, an experimental drug for congenital adrenal hyperplasia, an inherited enzyme deficiency.

—Opthea Limited, a clinical-stage biotech that is already publicly traded in its native Australia, filed to list American depositary shares on the Nasdaq. The company is developing treatments for retinal diseases.

AND THE WINNERS ARE….

—From a field of more than 600 nominations spanning 10 categories, the winners were announced in the annual Xconomy Awards.

PEOPLE ON THE MOVE

Legend Biotech (NASDAQ: LEGN) appointed Ying Huang interim CEO… Peter Collins joined Inivata as chief business officer… BeyondSpring (NASDAQ: BYSI) named Elizabeth Czerepak as chief financial officer… Decibel Therapeutics tapped Elisabeth Leiderman as chief financial officer… Silverback Therapeutics promoted Valerie Odegard to president and chief scientific officer and Naomi Hunder to chief medical officer… Nutcracker Therapeutics named Madhavan Balachandran its chief operating officer… Jose Carmona stepped down as chief financial officer of Radius Health (NASDAQ: RDUS)… Novan (NASDAQ: NOVN) appointed John Gay as chief financial officer… and Philippe Lopes-Fernandes joined Ipsen as executive vice president and chief business officer.

Image: iStock/rvlsoft

 

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