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: 

• Vaccinex (VCNX), 1,360% surge in interest
• Genprex (GNPX), 1,064% surge in interest
• Adaptimmune (ADAP), 335% surge in interest
• AC Immune (ACIU), 172% surge in interest
• Cyclacel Pharmaceuticals (CYCC), 166% surge in interest

Pipeline and key clinical candidates for these companies:

Vaccinex says it is “pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D.” The company’s lead drug candidate, pepinemab, is designed to block SEMA4D, a potent biological effector that is believed to trigger damaging inflammation in chronic diseases of the brain and inhibit immune infiltration and activation in tumors. In neurodegenerative diseases, pepinemab is being studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in Alzheimer’s Disease, with ongoing exploration of potential Phase 3 development in Huntington’s disease. In oncology, pepinemab is being evaluated in combination with KEYTRUDA in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer and in combination with BAVENCIO in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma.

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.

Adaptimmune says the company’s “drive is to redefine the treatment of some of the most challenging-to-treat solid tumors.” The company’s proprietary cell therapy platform engineers a patient’s own cells to fight cancer. The company’s robust pipeline of cell therapies has the potential to significantly improve the patient’s treatment experience.

AC Immune is a clinical-stage biopharmaceutical company that calls itself “a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins.” The company’s pipeline currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3.

Cyclacel is a clinical-stage, biopharmaceutical company developing innovative 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.

Recent news on these stocks:

June 3

Cyclacel Pharmaceuticals announced that new clinical, pharmacokinetic and pharmacodynamic data from the CYC065-101 study of fadraciclib as oral monotherapy was presented at a poster at the American Society of Clinical Oncology Annual Meeting from May 31-June 4, 2024 in Chicago, IL. “We are excited to report data with fadraciclib monotherapy from the entire Phase 1 population at ASCO. Clinical benefit was observed in heavily pretreated patients with several tumor types, including endometrial, lung, ovarian, pancreatic cancer, and T-cell lymphoma,” said Spiro Rombotis, President and CEO. “Retrospective analysis suggests that this activity may be associated in part with alterations in certain tumor suppressor genes forming a hypothesis which we are testing in the ongoing Phase 2 part of the study. We look forward to reporting initial proof of concept data in the second half of 2024.” New clinical, PK and PD data were presented at ASCO from the fully enrolled, Phase 1, dose escalation part of the CYC065-101 study of fadraciclib as monotherapy. The patients were heavily pretreated, having received a median of four prior lines of therapy. Fadraciclib was generally well tolerated with good compliance between dose levels 1 and 5. The most common treatment related adverse events reported were nausea, vomiting, diarrhea, fatigue, and hyperglycemia. A total of 25 drug-related SAEs were reported in 8 patients, with most common being hyperglycemia, platelet count decrease, and accidental overdose. There were no drug-related SAEs at dose level 5 which was selected for the Phase 2 proof of concept part of the 065-101 study. PKs were dose-proportional and exceeded the preclinical efficacy targets for both CDK2 and CDK9. PDs evaluated in peripheral blood showed suppression of CDKN2A/B by four hours post treatment in most patients who received 100 mg bid or higher. A total of 34 patients had measurable target lesions at baseline. Two partial responses were reported in patients with T-cell lymphoma, one of whom had CDKN2A loss. A squamous non-small cell lung cancer patient with CDKN2A and CDKN2B loss achieved 22% reduction in tumor burden at 4 weeks per RECIST 1.1 criteria. In addition, clinical benefit was reported in two patients with endometrial cancer, and one each with ovarian and pancreatic cancers. The proof of concept part of the study is now enrolling patients with CDKN2A/B loss or T-cell lymphoma.

May 30

Galapagos (GLPG) and Adaptimmune Therapeutics announced that they have entered into a clinical collaboration agreement with an option to exclusively license Adaptimmune’s next-generation TCR T-cell therapy uza-cel, targeting MAGE-A4 for head & neck cancer and potential future solid tumor indications, using Galapagos’ decentralized cell manufacturing platform. The Adaptimmune sponsored Phase 1 SURPASS trial with centrally manufactured uza-cel has shown encouraging results in head & neck cancer with an overall response rate of 80%. Initial in vitro results suggest that uza-cel, produced on Galapagos’ decentralized manufacturing platform, yields early phenotype T-cells that could improve efficacy and durability compared to uza-cel centrally manufactured on Adaptimmune’s platform.2 In addition, Galapagos’ decentralized manufacturing platform offers the potential for the delivery of fresh, fit cells with a vein-to-vein time of seven days in a patient population in which rapid access to treatment is vital.

BTIG initiated coverage of AC Immune with a Buy rating and $8 price target. AC Immune is a clinical-stage biotechnology company with a broad pipeline of agents to both detect and clear the toxic proteins that drive neurodegenerative disease, the analyst tells investors in a research note. The firm noted that the lead program is an anti-alpha beta vaccine that targets species with a precision-engineered focus on toxic oligomers.

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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.