These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
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- Genprex (GNPX), 4,021% surge in interest
- Aptevo Therapeutics (APVO), 691% surge in interest
- Cue Biopharma (CUE), 278% surge in interest
- ELEVAI Labs (ELAB), 173% surge in interest
Pipeline and key clinical candidates for these companies:
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options, the company says.
Aptevo Therapeutics is focused on developing novel immunotherapies for the treatment of cancer. APVO436 is a bispecific CD3xCD123 ADAPTIR currently in Phase 1b development in a multi-center, multi-cohort trial designed to evaluate safety, tolerability and efficacy in combination therapy and monotherapy for patients with acute myeloid leukemia, or AML. The company plans to initiate a Phase 2 trial, evaluating APVO436 in combination with venetoclax and azacitidine in patients with AML who are venetoclax treatment naive, in 2H23.
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT, and biologics are “designed to harness the body’s intrinsic immune system as T cell engagers without the need for ex vivo manipulation or broad systemic modulation,” Cue says.
Elevai Labs specializes in medical aesthetics and biopharmaceutical drug development, focusing on innovations for skin aesthetics and treatments tied to obesity and metabolic health. Driven by a commitment to scientific research, Elevai aims to transform personal health and beauty, the company states.
Recent news on these stocks:
October 22
Elevai Biosciences has engaged KCRN Research to support the Company’s initial efforts to prepare for an Investigational New Drug application to the FDA for EL-22 in the treatment of obesity and muscle loss preservation. KCRN specializes in bridging the regulatory gap for Korean-originated assets like EL-22 and preparing early phase drug development projects for the FDA. The Company and CRO partner KCRN are gathering the development work required for the IND submission, including preparing and scheduling a pre-IND meeting with the FDA to determine the path forward for EL-22. The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity. EL-22, an engineered probiotic expressing myostatin on its surface, targets a clinically validated myostatin pathway that plays an important role in regulating muscle. Preclinical results of EL-22 from a 2022 study demonstrated physiological, physical and functional improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy. The company believes that EL-22 offers a differentiated, oral approach as compared to other injection myostatin strategies being tested in obesity. It is believed that the mechanism of EL-22 induces mucosal immunity through the body’s own anti-myostatin antibodies and has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass.
October 15
Genprex has completed the 0.09 mg/kg dose group of the Phase 1 dose escalation portion of the Acclaim-3 clinical trial of Reqorsa Gene Therapy in combination with Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer. In addition, the Safety Review Committee has approved escalation to the highest dose group of 0.12 mg/kg. The combination of REQORSA and atezolizumab previously received FDA Fast Track Designation for the treatment of the Acclaim-3 patient population and the FDA has also granted Orphan Drug Designation to Reqorsa for the treatment of SCLC. There were no dose limiting toxicities in this dose group and the SRC recommended moving up to the highest dose group planned in the trial. The first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 trial had a partial remission from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. The company believes this suggests that Reqorsa may be providing clinical benefit. The primary endpoint of the Phase 1 escalation portion is to determine the maximum tolerated dose or recommended Phase 2 dose. After the Phase 1 portion is complete, the Phase 2 expansion portion will enroll 50 patients at 10 to 15 U.S sites.
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About “Biotech Alert”
The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.
This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.
This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.