What You May Have Missed: Top Biotech Stories for the Month of August

August 28, 2018 |

5 min read |

The biotech industry is fast-moving and dynamic, and staying on top of all the news can be hard for our busy readers. Here’s a look back at some of the top stories you may have missed this month.

Business/Industry

Genentech Cut 223 Jobs at Bay Area HQ

Genentech announced on August 16 that it was cutting 223 jobs at its headquarters in South San Francisco. The cuts go into effect on August 31. The layoffs are, according to a company spokesperson, in response to a “business evaluation” and are expected to be completed by the end of November.

Magnolia Neurosciences Corporation, co-founded by Accelerator Life Science Partners and The University of Texas MD Anderson Cancer Center, closed on a Series A financing worth $31 million. Investors included AbbVie Ventures, Alexandria Venture Investments, Eli Lilly and Company, Johnson & Johnson Innovation, Pfizer Ventures and others. Magnolia will focus on embryonic development and programmed cell death in neurological conditions, such as Alzheimer’s disease.

BIO and TEConomy Partners Report Rounds Up Biopharma Hiring Trends

BIO and TEConomy Partners published their 2018 “Investment, Innovation and Job Creation in a Growing U.S. Bioscience Industry” report. In addition to noting the bioscience industry directly employed 1.74 million people in 2016, it listed some of the companies expected to hire this year. A short list of those companies includes Precipio Diagnostics, Ra Medical Systems, MED-ALLY, Amneal Pharmaceuticals and Dracen Pharmaceuticals.

The death of Sen. John McCain from glioblastoma, an aggressive type of brain cancer, highlighted industry focus on battling the disease. The National Institutes of Health (NIH) reports there are currently 275 glioblastoma multiforme studies underway or recruiting in the U.S. Companies taking aim at the disease include Bexion Pharmaceuticals, AiVita Biomedical, CANBridge Life Sciences, Celgene, and Regeneron.

Clinical/Research

FDA Rejects Pain Therapeutics Remoxy ER

The U.S. Food and Drug Administration (FDA) rejected Pain Therapeutics’ Remoxy ER, an extended-release oxycodone capsule. The agency argued that the benefits of the drug did not outweigh the risk. Remi Barbier, the company’s president and chief executive officer, lashed out, stating, “This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction.”

Vincent Lynch with the University of Chicago led research that identified additional genes that help explain why elephants rarely get cancer. A 2015 paper by Joshua Schiffman at the University of Utah first described additional copies of a tumor-suppressor gene called P53 in elephants—humans have a single copy, elephants have 20. Lynch’s group have that most mammals only have only a single copy of the Leukemia Inhibitory Factor (LIF) gene, which is linked to enhanced fertility. In elephants, they identified LIF6, unique to the large mammals, which is known for killing damaged cells.

Bexion’s BXQ-350 showed dramatic results in animal studies and presented preliminary data of a Phase Ia clinical trial at the American Society for Clinical Oncology meeting in June. In one glioma patient, the drug showed significant success—the patient has already lived with glioblastoma multiforme for almost five years. Patients with the disease have an average life expectancy of less than two years.

The FDA gave Regeneron’s Eylea a thumbs-down for Eylea as a once-per 12-week treatment for wet age-related macular degeneration (wet AMD). The agency indicated it had rejected the supplemental Biologics License Application (sBLA) over “ongoing labeling discussions.” Regeneron indicates it expects to respond within the next two months.

Merck’s Keytruda was approved in combination with Alimta (pemetrexed) and platinum chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. This is less a story about how great Keytruda is—it is—but about the FDA’s new Real-Time Oncology Review (RTOR) Pilot Program. It is part of the agency’s efforts to streamline approvals. This approval was the third to be approved under the RTOR. The first two were two Novartis combinations for Kisqali against breast cancer.

The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Onpattro (patisiran) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. It is the first and only RNA interference (RNAi) therapeutic to ever be approved.

People

Roche’s Chen Heads to IgM Biosciences

Daniel S. Chen, formerly vice president, Global Head of Cancer Immunotherapy for Genentech/Roche, left to be the chief medical officer at IGM Biosciences, a privately-held biotech company in Mountain View, California. William Strohl is also joining the company’s board of directors. Strohl was vice president and Head, Janssen Biotech, Janssen R&D. IgM focuses on developing the next generation of immunoglobulin-based monoclonal antibody therapies.

Roland Diggelman, Roche’s chief executive officer of its diagnostics division, is leaving the company at the end of September. Not much information was provided, other than he is looking “to pursue his career outside of the company.” Diggelman joined Roche in 2008 and took over the diagnostics division in 2012.

Patients often benefit from support groups. Not surprisingly, this can be even more beneficial for people suffering from rare illnesses. Akcea Therapeutics, which develops drugs for rare and ultra-rare diseases, highlighted their FCSFocus.com educational resource for patients with familial chylomicronemia syndrome (FCS). A recent paper published in Expert Opinion on Orphan Drugs found that FCS patients who connected with each other saw significant positive impacts on their quality of life.

Martin Shkreli’s attorney and accomplice in committing wire fraud, Evan Greebel, was sentenced to 18 months in prison. Shkreli was sentenced to seven years. Greebel was found guilty in the scheme to defraud investors and potential investors in two hedge funds once run by Shkreli, MSMB Capital and MSMB Healthcare, in addition to a scheme to defraud pharma company Retrophin, which Shkreli founded.

Clinical research Phase III People

Genentech, Inc. Merck & Co. Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA) Cassava Sciences Inc. Alnylam Pharmaceuticals

Mark Terry