Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: 

• Cellectis (CLLS), 2,886% surge in interest
• Leap Therapeutics (LPTX), 1,714% surge in interest
• Redhill Biopharma (RDHL), 750% surge in interest
• PDS Biotechnology (PDSB), 239% surge in interest
• Novavax (NVAX), 187% surge in interest
• BioXcel Therapeutics (BTAI), 176% surge in interest
• Cassava Sciences (SAVA), 82% surge in interest
• Gritstone Oncology (GRTS), 52% surge in interest
• BrainStorm Cell (BCLI), 47% surge in interest
• Intellia Therapeutics (NTLA), 41% surge in interest

Pipeline and key clinical candidates for these companies:

Cellectis is a clinical-stage biotechnology company that utilizes an allogeneic approach for CAR-T immunotherapies in oncology, “pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients,” and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. Cellectis is developing product candidates utilizing TALEN, its gene editing technology, and PulseAgile, its electroporation system to “harness the power of the immune system in order to treat diseases with unmet medical needs,” the company says.

Leap Therapeutics is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. Leap has entered into a strategic collaboration with BeiGene (BGNE) for the rights to develop DKN-01 in Asia excluding Japan, Australia, and New Zealand.

RedHill Biopharma is primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik for opioid-induced constipation in adults, Talicia for the treatment of Helicobacter pylori infection in adults, and Aemcolo for the treatment of travelers’ diarrhea in adults.

PDS Biotech is a clinical-stage immunotherapy company developing a pipeline of targeted cancer and infectious disease immunotherapies based on its proprietary Versamune and Infectimune T cell-activating technology platforms. To date, its lead Versamune clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials.

Novavax says it promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response.

BioXcel Therapeutics is utilizing artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. The company’s drug re-innovation approach “leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices,” BioXcel states. The company’s commercial product, IGALMI, developed as BXCL501, is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Cassava Sciences is a clinical-stage biotechnology company that says its mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. “Its novel science is based on stabilizing-but not removing-a critical protein in the brain. The company’s product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established,” Cassava has stated.

Gritstone is “working to create the world’s most potent vaccines” by leveraging its “innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets,” the company says. Gritstone has programs in viral diseases and solid tumors.

BrainStorm Cell Therapeutics is a developer of autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the FDA and the EMA for the treatment of amyotrophic lateral sclerosis, ALS. BrainStorm has completed a Phase 3 pivotal trial in ALS; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine.

Intellia Therapeutics, a clinical-stage genome editing company, is developing novel, potentially curative therapeutics using CRISPR/Cas9 technology. “Intellia’s deep scientific, technical and clinical development experience, along with its robust intellectual property portfolio, have enabled the company to take a leadership role in harnessing the full potential of CRISPR/Cas9 to create new classes of genetic medicine,” the company says.

Recent news on these stocks:

October 6

JonesResearch initiated coverage of Gritstone with a Buy rating and $10 price target. The analyst sees Gritstone as a “highly underappreciated story,” especially given the post-pandemic pullback of COVID-related names. The company’s vaccine candidates in oncology and infectious disease are differentiated from mRNA vaccines in both immunogenicity and durability, the analyst told investors in a research note.

October 4

Truist downgraded BioXcel Therapeutics to Hold from Buy without a price target. The analyst sees “significant near-term funding and clinical development headwinds” for the company. However, if BioXcel can secure adequate funding to develop Igalmi for expanded indications, there is “significant value” potential, the analyst tells investors in a research note. The firm is looking for a favorable FDA feedback on the company’s clinical programs, secure non-dilutive capital and material hospital sales for Igalmi to get more constructive on the shares.

October 3

RedHill Biopharma announced that novel, twice daily, oral opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day in a U.S. Army Medical Research Institute of Infectious Diseases in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. The U.S. Army study tested three doses of opaganib against an inactive vehicle control arm. The in vivo study results showed a statistically significant survival increase in mean survival time of 11.2 days in the 150 mg/kg opaganib group compared to a mean survival time of 5.5 days in the inactive vehicle control group. A 30% mice survival was observed in the 150 mg/kg treated group compared to the vehicle control. Twice daily administered opaganib has previously demonstrated antiviral benefit in late-stage clinical studies of patients hospitalized with moderate to severe COVID-19 and was selected by the NIH Radiation and Nuclear Countermeasures Program for Acute Radiation Syndrome development.

PDS Biotechnology announced updated interim data based on an August 2nd cut off from the VERSATILE-002 Phase 2 clinical trial evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in patients with unresectable, recurrent, or metastatic HPV16-positive head and neck squamous cell carcinoma, HNSCC. VERSATILE-002 is investigating two patient populations whose cancer has returned or spread – ICI naive and ICI refractory. The ICI naive group had not responded to standard-of-care treatments but had not yet been treated with an ICI. The ICI refractory group included patients who had not responded to multiple prior treatments, including ICI therapy. Data presented at ASCO was based on a January 13th cut off. VERSATILE-002: ICI Naive. Highlights of the interim data from the ICI naive cohort include: 24-month overall survival rate is 74%; published 24-month survival rate of less than 30% for approved ICI; 12-month OS rate is 80%; published results of 30-50% with approved ICIs; Tumor shrinkage seen in 60% of patients; Confirmed overall response rate is 27% to date; Median progression-free survival is 8.1 months to date; published results of 2-3 months PFS with approved ICIs; 13% of patients experienced Grade 3 treatment-related adverse events and 0% experienced Grade 4 or 5 TRAE; published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy; 60% of patients have CPS score of 1-19, and 40% have CPS score greater than20. VERSATILE-002: ICI Refractory: The goal of this ICI refractory cohort was to confirm and to better understand the role of PDS0101 in prolonging the survival of advanced HPV16-positive head and neck cancer patients who received PDS0101 in combination with KEYTRUDA. This analysis is also intended to provide insight to the contribution of PDS0101 to overall survival in the National Cancer Institute-led study evaluating the combination of PDS0101, PDS0301, and an ICI. Highlights of the interim data from the ICI refractory cohort include: The 12-month OS rate is 56%. The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI; 0% confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage; 4% of patients experienced Grade 3 TRAE and 0% patients experienced Grade 4 and 5 TRAE.

Novavax announced that the Novavax COVID-19 Vaccine, Adjuvanted has received Emergency Use Authorization from the U.S. Food and Drug Administration for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, Novavax’s vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention on September 12, 2023. Doses will be available nationwide at thousands of locations, including national and local retail pharmacies and physicians’ offices, following the Center for Biologics Evaluation and Research release of vaccine batches, expected in the coming days. “COVID-19 is once again on the rise with infections and hospitalizations increasing, so it’s important that individuals get vaccinated to protect themselves and their loved ones,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “Novavax’s authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves against COVID-19, which is now the fourth leading cause of death in the U.S. In the coming days, individuals in the U.S. can go to pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.”

Regeneron Pharmaceuticals (REGN) and Intellia Therapeutics announced an expanded research collaboration to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases. This builds on the success of the companies’ existing collaboration and continues to combine both companies’ deep biology and technology expertise. The collaboration will leverage Regeneron’s proprietary antibody-targeted adeno-associated virus vectors and delivery systems and Intellia’s proprietary Nme2 CRISPR/Cas9 systems adapted for viral vector delivery and designed to precisely modify a target gene. Under the terms of the expanded agreement, the companies will initially research two in vivo non-liver targets. Intellia will lead the design of the editing methodology and Regeneron will lead the design of the targeted viral vector delivery approach. Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.

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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.