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: 

• Genprex (GNPX), 8,592% surge in interest
• Aptevo Therapeutics (APVO), 1,368% surge in interest
• Allakos (ALLK), 1,138% surge in interest
• Mustang Bio (MBIO), 715% surge in interest
• Immunic (IMUX), 545% surge in interest
• Cue Biopharma (CUE), 519% surge in interest
• CNS Pharmaceuticals (CNSP), 410% surge in interest
• Oncternal Therapeutics (ONCT), 379% surge in interest
• Cyclacel Pharmaceuticals (CYCC), 372% surge in interest
• Syros Pharmaceuticals (SYRS), 358% 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.

Allakos is a clinical stage biotechnology company developing therapeutics which target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The company’s most advanced antibody in ongoing clinical development is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed selectively on mast cells.

Mustang Bio is a clinical-stage biopharmaceutical company that says it is “focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers.” Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, to fund research and development, and to outlicense or bring the technologies to market. Mustang has partnered with medical institutions to advance the development of CAR-T therapies, the company notes.

Immunic has a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products. Its lead development program, vidofludimus calcium, is a selective immune modulator that is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935 is targeted for development in psoriasis and castration-resistant prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction.

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.

CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The company’s lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme, or GBM, an aggressive and incurable form of brain cancer.

Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies for the treatment of patients with cancers that have critical unmet medical need. Oncternal pursues drug development targeting promising, yet untapped biological pathways implicated in cancer generation or progression, focusing on hematological malignancies and prostate cancer.

Cyclacel is a clinical-stage, biopharmaceutical company developing cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the epigenetic/anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel’s strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications.

Syros says it is “committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies, driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches.” Syros is developing tamibarotene, an oral selective RARalpha agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression.

Recent news on these stocks:

October 24

Cyclacel Pharmaceuticals received a written notice from The Nasdaq Stock Market granting the company an extension until December 24 to regain compliance with Nasdaq’s minimum stockholders equity requirement under Nasdaq Listing Rule 5550(b)(1). This notice has no immediate effect on the listing of the company’s common stock on Nasdaq. As previously reported, on August 26, the Listing Qualifications Staff of Nasdaq determined that the company was not in compliance with the Equity Standard Rule because the company reported stockholders’ equity of less than $2.5M as of June 30.

October 22

Mustang Bio was granted orphan designation from the FDA for a treatment of malignant glioma, according to a post to the agency’s website.

Immunic announced the outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program, investigating lead asset, nuclear receptor related 1, or Nurr1, activator, vidofludimus calcium, or IMU-838, for the treatment of relapsing multiple sclerosis, or RMS. Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee, or IDMC, has recommended that the trials are not futile and should continue as planned. The interim futility analysis of the phase 3 ENSURE program was performed by an unblinded IDMC and based on a pre-specified assessment after approximately half of the planned first relapse events occurred in the double-blind treatment periods of each of the twin ENSURE-1 and ENSURE-2 trials. The analysis was intended to inform potential sample size adjustment and help prevent the final study readout from occurring before sufficient events have been achieved. The unblinded IDMC was asked to make two decisions: The first question, as to whether the trials are futile, was answered by the IDMC with “futility criteria have not been met.” The second question, as to whether the sample size in each trial should be increased, was answered by the IDMC with “continue as planned.” Both decisions were based on the conditional power of the trials at the time of the interim analysis. Immunic has remained blinded during the interim analysis and has not seen any of the data available to the IDMC to make their recommendations. The ongoing ENSURE program comprises two identical multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, is expected to enroll approximately 1,050 adult patients with active RMS at more than 100 sites in more than 15 countries, including the United States, India and countries in Latin America, Central and Eastern Europe. Patients are being randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks. Key secondary endpoints include time to confirmed disability worsening based on Expanded Disability Status Scale disability progression, volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and percentage of whole brain volume change, grey matter volume and white matter volume. As previously reported, completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.

Oncternal Therapeutics announced updated data from its Phase 1/2 Study of ONCT-534 for the treatment of patients with relapsed or refractory metastatic Castration-Resistant Prostate Cancer, mCRPC. Based on initial pharmacokinetic results, two additional dosing cohorts with twice daily, BID, oral dosing of ONCT-534 had been incorporated in the Phase 1/2 study ONCT-534-101. Overall, fifteen patients received ONCT-534 once daily in six dosing cohorts and six patients received ONCT-534 BID in two dosing cohorts. Based on a data cut off of September 30, 2024, the BID dosing schedule was well tolerated, with no related Grade 3 or higher toxicities. One patient, who experienced a rising PSA on ONCT-534 at 160 mg BID, had a subsequent 50% reduction in PSA after four weeks of ONCT-534 at 300 mg BID, and at the same time the CAT Scan showed a 16% reduction in target lesions compared to baseline. Enumeration and biomarker analysis of circulating tumor cells showed promising effects on expression of androgen receptor-regulated genes, and AR nuclear translocation in six additional patients. CTC analysis also showed that some patients who did not respond to ONCT-534 had prostate cancer that had developed neuroendocrine features, which are associated with AR independent disease.

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.