Healthcare Roundup – G1 Therapeutics jumps 16.9% as trilaciclib wins FDA approval; Bionano Genomics shares hit all-time high, spiking nearly 23%

Published on: February 12, 2021
Author: Amy Liu

G1 Therapeutics jumps 16.9% as trilaciclib wins FDA approval

G1 Therapeutics (NASDAQ:GTHX) has jumped 16.9% after hours following FDA approval for the company’s Cosela (trilaciclib) as the first therapy in its class to “reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer.”

That news came ahead of the drug’s PDUFA date of Feb. 15, 2021.

Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase 4/6, a type of enzyme, the FDA says.

Cosela received Priority Review and Breakthrough Therapy designations from the FDA.

Bionano Genomics shares hit all-time high, spiking nearly 23%

Shares of Bionano Genomics (NASDAQ:BNGO) have hit an all-time high this afternoon, breaking the $14 barrier for the first time.

In the past 30 days, shares have more than doubled, up 106%.

Today alone, shares are up 22.8% to $14.37 in afternoon trading.

An article published in InvestorPlace this morning talked about the importance of the company’s Saphyr genome-imaging system.

“Researchers are using the Saphyr system to increase their understanding of the genome structures that make certain tumors so aggressive,” the article says. “By conducting such a study, researchers will be able to develop targeted therapies, better classify cancer subtypes, and make existing cancer treatments more efficient.”

In January, Bionano shares skyrocketed following publication of a study that showed optical genomic mapping with Saphyr identified structural variants that affect genes in pathways that control immune and inflammatory response, viral reproduction and mucosal function, which could provide insights into the pathogenesis of COVID-19.

Earlier this week, the company reported that Toronto’s University Health Network’s Laboratory Medicine Program in Toronto — Canada’s largest hospital diagnostic testing lab — has begun piloting Saphyr.

NantKwest surges on FDA clearance to expand Phase 1 trial for COVID-19 vaccine

NantKwest, Inc. (NASDAQ:NK) is up ~12.9% in the premarket after the company and its privately-held partner, ImmunityBio announced the FDA approval to expand the Phase I study of its T cell-based COVID-19 vaccine candidate.

The cohort C expansion to the Phase 1 trial evaluating the subcutaneous version of the experimental bivalent hAd5 T-cell COVID-19 vaccine will study the effect of the addition of sublingual boosts.

And a second Phase I study will also commence to evaluate the addition of an oral boost to the subcutaneous prime administration.

Based on the amended trial involving additional 105 participants in the U.S., the companies will determine the optimal combination of the route of administration and the dose suitable for the Phase 2 / 3 design.

The first two cohorts of the Phase Ib, open-label, dose-ranging study of the vaccine received two different dose levels (.5 and 1ml) in two subcutaneous injections 21 days apart.

The additional group of 40 subjects will be enrolled to evaluate the combination of hAd5 in four different cohorts receiving sublingual and subcutaneous formulations.

The second Phase 1b trial will be a four-cohort study and is expected to begin in Q1 2021 with up to 65 subjects.

In December, NantKwest announced a merger agreement with ImmunityBio.

Biotechnology Genomics Healthcare Services Life Science Pharmaceutical