Introduction: new coronavirus highly contagious new variant BQ series appears; BIO falls into chaos, and the CEO suddenly resigns; Phase III clinical failure of major depression, Relmada's stock price plummeted by 80%... Bio Exploration will follow the "drug" news with you and explore the value of biotechnology!
01 The new coronavirus is highly contagious
New variant BQ series is now in the world
According to the " San Francisco Chronicle ", data released by the U.S. Centers for Disease Control and Prevention shows that although the cases of Omicron subtype variant BA.5 seem to be decreasing, accounting for 67.9% of all cases last week, the new virus strain has spread rapidly. According to statistics, this new sub-variants BQ.1 and BQ.1.1 have accounted for 11.4% of all new cases, and their growth rate has exceeded that of the BA.5 variant virus.
UK BQ.1.1 variant cases are doubling every week, resulting in a sharp increase in hospitalizations. The number of cases in the two new sub-variants in the United States is almost four times that of the variant BA.2.75 (1.3%), and it has also exceeded the number of cases in the variant BF.7 (5.3%). In addition, the study said that the BQ.1 variant was the first variant to prove resistant to existing COVID-19 antibody therapies - AstraZeneca (evusheld) and bebtelovimab.
02 BIO in chaos
CEO suddenly resigns
BIO CEO Michelle McMurry-Heath is about to leave after a short and difficult two-year term. A few days after the news of her vacation came out, she suddenly resigned. The COVID-19 pandemic, spending cuts and new pricing legislation are widely seen as a disaster in the field of biotech and have also affected the development of BIO.
So far, there is no clear explanation for the problems facing BIO, and the group refuses to participate in reports on internal disputes. Longtime biotech executive Rachel King will take over her position until they find a full-time replacement.
03 Phase III clinical failure of major depression
Relmada stock price plummeted 80%
Recently, the Phase III trial of Relmada Therapeutics' major depression (MDD) drug REL-1017 failed, causing the stock to plummet 80%. A total of 232 participants in the trial (Reliance III) were treated with REL-1017 for 28 days. Finally, the study did not meet its primary endpoint, with the average drop of the Montgomery-Asperger Depression Scale (MADRS10) score of the patients decreased by 14.8 points, while the average drop of 13.9 points in the placebo group.
This shows that the placebo response is higher than expected, and some studies have found that placebo is "significantly better" than REL-1017. The company is investigating the results of the trial, which aims to recruit 400 patients. REL-1017 is a novel NMDA receptor channel blocker that preferentially targets the GluN1-GluN2D hyperactive channel and maintains physiological glutamategic neurotransmission.
04 Kunshi Biotechnology completed
tens of millions of yuan angel round financing
Recently, Kunshi Biotechnology (Shenzhen) Co., Ltd. (hereinafter referred to as "Kunshi Biotechnology" or company) - an engineered macrophage treatment solid tumor technology platform driven by gene editing , biological material and synthetic biology , has announced that it has completed angel round financing of tens of millions of yuan. This round of investment is jointly invested by well-known venture capital institutions in the industry such as AUB Capital and Riemann Conjecture. The funds obtained will be used for laboratory platform construction, pipeline research and development, preclinical experiments, patent layout, and company operations.
Kunshi Biotech was established in Shenzhen in April 2021. It is the first engineered macrophage technology platform in China driven by gene editing, biological materials and synthetic biology, and focuses on the development and clinical application of solid tumors for macrophage drug treatment. It has pioneered the world's first closed-loop industrial chain with macrophages as the core. Its core platform includes the "24H-CAR" technology platform that can complete the preparation of chimeric antigen receptor macrophages (CAR-M) on the same day; the enhanced synthesis platform "ADM-CAR" based on iterative screening of macrophage activation domains; the "Del-M" macromolecular delivery platform with macrophages as a vector, and the subtype database and target database platform "M-DB" that can serve as the source of innovation for solid tumors in different tissues. Relying on these four platforms, the company has the core ability to batch build a CAR-M-based clinical pipeline for solid tumors.
05 Inotrem Septic
Shock Drug Passed Intermediate Test
Recently, Paris-based biotechnology company Inotrem announced that its septic shock drug has passed the intermediate test, but is only suitable for some patients.
This is a phase IIb trial in 361 patients at two doses and placebo plus standard care methods to test the effectiveness of nangibotide. The trial also specifically investigated the subgroup of septic shock patients with high soluble TREM-1 levels. For patients in this subgroup, a high dose of nangibotide of 1.0 mg/kg/h was statistically significant for the SOFA score, which measures the severity of organ failure, at 5 days. In terms of day 28 mortality, the group taking nangibotide improved numerically compared to placebo, but was not statistically significant. The next step for
Inotrem is to conduct phase III testing for the main candidates for septic shock, but Inotrem still needs to discuss with regulators the design of the phase III study: Can it be specifically designed for high TREM-1 patients?
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