Bio Roundup: Race and Pharma, ASCO Recap, Warp Speed Ahead & More

Xconomy National — 

Race is not a topic that often comes up in pharmaceutical discussions but perhaps it should. Disease doesn’t discriminate by race, but health and economic disparities put some groups at higher risk than others. And yet clinical trials fail to reflect the broad spectrum of patients that drug makers aim to treat.

Racial disparities are evident in the COVID-19 pandemic, which is hitting the African American community hardest. Inequality has been thrust front and center following the death of George Floyd. The twin storms of the pandemic and civil unrest will eventually pass, Merck (NYSE: MRK) CEO Ken Frazier—one of the few African American chief executives in pharma—told CNBC.

“And then the question is are we going to rebuild this country together?” he said. “Are we going to go our separate ways again as we have in the past? The fact of the matter is no one of us can rebuild this great country, and the good news is none of us has to do it on our own. Together we can actually make this the country that stands for the ideals that have always been behind it.”

On that note, let’s take a look back at the life science headlines from this week.

DOLLARS & DEALS

Cullinan Oncology closed a $98.5 million Series B round to advance R&D of its pipeline of seven cancer drugs, including two now in early-stage clinical trials.

—Regeneron Pharmaceuticals (NASDAQ: REGN) agreed to pay $100 million to Intellia Therapeutics (NASDAQ: NTLA) to add hemophilia to their drug R&D partnership.

NodThera raised $55 million in a round led by the investment arm of Novo Nordisk (NYSE: NVO) to advance its investigational drugs, which are intended to inhibit complexes of proteins called inflammasomes.

—Liquid biopsy developer Grail unveiled plans to invest $100 million in a new lab and warehouse facility in Research Triangle Park, NC.

Atlas Venture unveiled a $400 million fund for more investments in life science companies developing new medicines across a wide range of therapeutic areas.

—Bristol Myers Squibb (NYSE: BMY) ended an alliance with Jounce Therapeutics (NASDAQ: JNCE) and returned rights to JTX-0864, a preclinical cancer drug. The antibody was the last piece of Jounce’s partnership with Celgene, which Bristol acquired last year.

—Seattle-based Athira Pharma raised $85 milllion to advance Alzheimer’s disease drug candidate NDX-1017 into Phase 2/3 testing. The Series B financing follows positive Phase 1 results reported last December.

—AbbVie (NYSE: ABBV) of North Chicago, IL, and China-based Jacobio Pharmaceuticals announced a partnership developing a type of cancer drug called a SHP2 inhibitor. No financial terms were disclosed.

—Prilenia Therapeutics, a biotech with offices in Israel and the Netherlands, raised $62.5 million to launch late-stage trials of its investigational treatments for Huntington’s disease and amyotrophic lateral sclerosis.

—Pfizer (NYSE: PFE) launched a program called the Pfizer Breakthrough Growth Initiative through which it plans to invest a total of up to $500 million to take non-controlling equity stakes in clinical-stage public biotechs.

—Belgian pharmaceutical company UCB paid $125 million up front to acquire Engage Therapeutics, a Summit, NJ, company developing a drug/device combination product that administers alprazolam to treat epileptic seizures.

THIS WEEK IN BIOTECH IPOS

—Pliant Therapeutics (NASDAQ: PLRX) made its stock market debut, raising $144 million for mid-stage tests of its experimental fibrosis drugs.

—In other IPO news, Applied Molecule Transport went public at the top of its projected range, raising $154 million for clinical development of biologic drugs that hit disease targets in the gut. Meanwhile, Calliditas Therapeutics, a developer of drugs for rare liver and kidney diseases, raised $90 million in its Nasdaq debut.

—Watertown, MA-based Forma Therapeutics revealed plans for an initial public offering to raise money to advance an investigational Phase 1 treatment for sickle cell disease and a preclinical-stage prostate cancer drug.

Repare Therapeutics laid the groundwork for an IPO to advance R&D of cancer drugs based on a concept called “synthetic lethality.”

—Belgium-based Hyloris Pharmaceuticals announced that it plans to go public on the Euronext Brussels exchange.

ASCO IN REVIEW

—A cell therapy that Johnson & Johnson (NYSE: JNJ) is developing in partnership with Legend Biotech appeared to strengthen its case for treating multiple myeloma. J&J reported that 25 of 29 patients treated with JNJ-4528 had “complete responses” to the therapy. Vantage has more.

—Forty Seven (NASDAQ: FTSV) reported Phase 1b data showing that its lead drug candidate, magrolimab, achieved an objective response in 30 of the 33 patients. Of those patients, a complete response was observed in 14 of them, providing justification for the $4.9 billion Gilead Sciences (NASDAQ: GILD) agreed to pay to acquire the cancer immunotherapy developer.

—Arvinas (NASDAQ: ARVN), which is developing a type of drug known as a targeted protein degrader, reported evidence of reductions of in-tumor androgen receptor in some of the patients in a Phase 1/2 clinical trial of ARV-110, its investigational treatment for men with metastatic castration-resistant prostate cancer.

—Results from a Phase 3 trial of AstraZeneca’s osimertinib (Tagrisso) showed patients with early-stage non-small cell lung cancer with EGFR mutations after surgery saw an 83 percent reduction in risk of disease recurrence or death compared to a placebo.

Initial data from a Phase 1 study of an allogenic, or off-the-shelf, CAR T therapy being developed by Allogene Therapeutics (NASDAQ: ALLO) and Servier showed that 12 of 19, or 63 percent, of evaluable lymphoma patients responded to the investigational cancer cell therapy as of the data cutoff. Seven of those patients achieved a complete response.

DRUG DATA AND DECISIONS

—The FDA approved AbbVie drug elagolix (Oriahnn) as a treatment for heavy menstrual bleeding associated with uterine fibroids. The drug previously cleared the regulatory bar as a treatment for endometriosis pain.

—Eli Lilly (NYSE: LLY) drug ixekizumab (Taltz) won FDA approval as a treatment for axial spondyloarthritis, a chronic inflammatory condition. The biologic drug’s previous approvals include plaque psoriasis and psoriatic arthritis.

—Nearly six months after failing a pivotal study, experimental Iterum Therapeutics (NASDAQ: ITRM) antibiotic sulopenem flunked another Phase 3 clinical trial.

—Bristol Myers Squibb reported preliminary data from a Phase 3 study evaluating ozanimod (Zeposia) as a treatment for ulcerative colitis. The FDA approved the drug in March as a treatment for multiple sclerosis.

—Genentech’s atezolizumab (Tecentriq) plus bevacizumab (Avastin) earned an FDA nod as a treatment for patients with an advanced and aggressive form of liver cancer who have not previously received any systemic therapies.

—The FDA approved AstraZeneca drug ticagrelor (Brilinta) for high-risk patients with coronary artery disease to reduce their risk of a first heart attack or stroke. The approval was based on a trial that showed a reduction in major adverse cardiovascular events at 36 months in patients who received the drug and aspirin compared to aspirin alone.

—A Merck antibiotic won an additional regulatory nod for treating bacterial pneumonia acquired in a hospital or from a ventilator. The decision for the combination of imipenem, cilastin, and relebactam (Recarbrio) covers patients age 18 and older.

COVID-19 NEWS

—The Trump administration reportedly selected five vaccine developers as finalists in its Operation Warp Speed project: Johnson & Johnson, Merck, Pfizer, Moderna (NASDAQ: MRNA), and a joint Oxford University-AstraZeneca (NYSE: AZN) effort. Those selected will be eligible for more government funds.

—In a sign of how quickly COVID-19 vaccine research is moving, Moderna sketched out plans for a Phase 3 study while its Phase 2 study just started to dose patients.

—Equity crowdfunding platform OurCrowd said it planned to raise a $100 million fund to invest in new startups and companies in its portfolio that are developing tech solutions for needs triggered by the coronavirus pandemic and other health emergencies.

PEOPLE ON THE MOVE

Moderna tapped Amgen’s David Meline to become its new CEO… Aruvant Sciences appointed V. “Palani” Palaniappan its chief technology officerSteven Zelenkofske joined SwanBio Therapeutics as chief medical officer… Cytovia Therapeutics appointed Wei Li as chief scientific officer… Exact Therapeutics named Rafiq Hasan its CEO… Confo Therapeutics tapped Paolo Vicini as chief development officer… Anika Therapeutics (NASDAQ: ANIK) Chief Financial Officer Sylvia Cheung is stepping down.

Sarah de Crescenzo contributed to this report.

Image: iStock/ktsimage