Biotech Alert: Searches spiking for these stocks today

Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly

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

• Ocular Therapeutix (OCUL), 7,766% surge in interest
• Frequency Therapeutics (FREQ), 3,552% surge in interest
• Kaleido Biosciences (KLDO), 2,800% surge in interest
• G1 Therapeutics (GTHX), 1,376% surge in interest
• Veracyte (VCYT), 803% surge in interest

Pipeline and key clinical candidates for these companies:

Ocular Therapeutix is focused on the formulation, development, and commercialization of therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, Dextenza, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets include: OTX-TKI, currently in Phase 1 clinical trials for the treatment of wet AMD and diabetic retinopathy; OTX-TIC, currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-CSI for the chronic treatment of dry eye disease and OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, both of which have completed Phase 2 clinical trials.

Frequency Therapeutics is pioneering a new category in regenerative medicine that aims to restore human function by developing therapeutics that activate a person’s innate regenerative potential within the body through the activation of progenitor cells. The company’s lead preclinical program is designed to activate oligodendrocyte precursor cells with the goal of driving remyelination and potential functional recovery for individuals living with multiple sclerosis.

G1 Therapeutics is a commercial-stage biopharmaceutical company whose first commercial product is COSELA, or trilaciclib. G1 is executing a tumor-agnostic development plan evaluating trilaciclib in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers.

Veracyte is a global diagnostics company with a menu of advanced diagnostic tests. In addition to making its tests available in the United States through its central laboratories, its exclusive license to its diagnostics instrument, the nCounter Analysis System, "positions the company to deliver its tests to patients worldwide through laboratories that can perform them locally," Veracyte said.

Recent news on these stocks:

February 15

Veracyte announced that data published in the International Journal of Radiation Oncology, Biology, Physics demonstrate that the company’s Decipher Prostate Genomic Classifier can improve risk stratification among men with clinically high-risk prostate cancer. The data, from a pre-specified analysis of three phase 3 trials, represent the first validation of any gene-expression biomarker on pre-treatment biopsy samples from prospective randomized trials, and suggest the Decipher test provides clinically useful prognostic information to help personalize shared treatment decision-making. Approximately 30% of men with newly diagnosed localized prostate cancer present with high-risk disease, meaning they have an increased risk of disease recurrence, metastasis and death compared to men with lower-risk disease. However, previous studies have shown that more than 70% of men with high-risk prostate cancer who receive standard-of-care definitive radiotherapy and long-term androgen deprivation therapy will never develop metastatic disease.

February 13

Frequency Therapeutics announced clinical results from the placebo-controlled Phase 2b study of FX-322 in individuals with acquired Sensorineural Hearing Loss, or SNHL. The study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of an improvement in speech perception. Data showed no statistically meaningful difference at day 90 between those administered FX-322 versus those receiving placebo in the proportion of individuals that demonstrated an improvement in speech perception. There were also no measurable improvements observed in any of the study’s secondary endpoints. Prior FX-322 studies had been designed to best understand patient etiologies and severities where a hearing signal could be observed. FX-322-208 was statistically powered with a balanced placebo and active group. The safety profile associated with FX-322 was favorable and no study participants experienced a serious adverse event that was associated with treatment. The company will now discontinue the FX-322 development program. In addition, while dosing of FX-345, a second program to treat SNHL, has been completed in the initial safety cohort of an ongoing Phase 1b trial, that development program will also be discontinued. The company will now focus its resources to advance its remyelination in MS program into the clinic. Frequency’s efforts now will focus on continuing to develop novel therapeutics to induce remyelination for individuals living with MS. The company previously reported that it had identified a novel target relevant to myelination. Modulation of this target drives robust oligodendrocyte differentiation and expression of myelin proteins in vitro. The Company has identified multiple novel chemical entities that induce robust remyelination following demyelination in an adult in vivo animal model. The MS program is independent of the hearing program, with a distinct molecular target, mechanism, progenitor cell population, and small molecule drug candidates. Further, a well-defined clinical path with objective biomarkers such as visual evoked potential, or VEP, and magnetic resonance imaging exist for studying the performance of remyelination therapies in MS patients. Frequency’s agents substantially outperform other clinically studied remyelination agents in head-to-head in vivo studies. Frequency plans to begin its clinical program for remyelination in 1H 2024. The company will immediately reduce headcount as part of an overall restructuring, downsizing personnel by approximately 55% . The company believes that the restructuring will generate sufficient cost savings to extend its runway into 2025 and enable it to complete a first clinical trial of its MS program in 2H 2024. As of December 31, 2022, Frequency had cash, cash equivalents and marketable securities of $83.1M.

G1 Therapeutics announced topline results from its pivotal Phase 3 PRESERVE 1 trial showing that the trial achieved its co-primary endpoints related to severe neutropenia with statistical significance; however, early anti-tumor efficacy data, including overall response rate, or ORR, and preliminary measures of survival, favored the placebo arm. Other clinical trials of trilaciclib in combination with different chemotherapies in patients with extensive-stage small cell lung cancer and triple negative breast cancer did not demonstrate this adverse survival signal. Given that placebo outperformed trilaciclib in these analyses of PRESERVE 1, the Company has made the decision to discontinue the colorectal, or CRC, trial. The Data Monitoring Committee, or DMC, has independently reached the same conclusion. PRESERVE 1 was designed to evaluate the efficacy and safety of trilaciclib administered in addition to triplet therapy with FOLFOXIRI + bevacizumab in patients with metastatic CRC. Detailed Phase 3 results will be presented at an upcoming scientific congress and submitted for publication. PRESERVE 1 achieved its co-primary endpoints showing clinically meaningful and statistically significant reductions in both occurrence of severe neutropenia during induction and mean duration of severe neutropenia in Cycles 1 through 4. In addition, patients receiving trilaciclib had a clinically meaningful reduction in the rate of chemotherapy-induced diarrhea, including a 50% reduction in the rate of Grade 3/4 diarrhea and a 30% reduction in the rate of any grade diarrhea, compared to placebo. Further, patients receiving trilaciclib experienced fewer chemotherapy dose reductions and delays. Other secondary measures of myeloprotection also favored trilaciclib, including reductions in Febrile Neutropenia and ESA administration. However, despite the achievement of the co-primary endpoints and other secondary measures of myeloprotection and tolerability, early anti-tumor efficacy data, including ORR, favor patients receiving placebo compared to trilaciclib, 61% and 50% ORRs, respectively. Given the differential in these anti-tumor efficacy metrics and the low likelihood of achieving the progression-free survival, or PFS, and overall survival, OS, endpoints, G1 has made the decision to discontinue PRESERVE 1.

February 12

Ocular Therapeutix announced interim 10-month data from its U.S. Phase 1 clinical trial evaluating OTX-TKI, the company’s axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration, diabetic retinopathy and other retinal diseases. The ongoing U.S.-based Phase 1 clinical trial is a prospective, multi-center, randomized, controlled study in subjects previously treated with anti-VEGF therapy that is evaluating a 600 microgram dose of OTX-TKI in a single implant, with a 2 mg aflibercept injection four weeks after the implant, compared to 2 mg aflibercept injections administered every 8 weeks. The trial is designed to assess the safety, durability and tolerability of OTX-TKI, and to assess biological activity in subjects by measuring best corrected visual acuity and central subfield thicknessof the retina. The clinical trial enrolled a total of 21 subjects at six clinical sites in the U.S., who were randomized 3:1 to an arm receiving a single OTX-TKI implant, with a 2 mg aflibercept injection after implant, and an arm receiving aflibercept injections every 8 weeks. One subject in the OTX-TKI arm was not treated per protocol and has been removed from the efficacy analysis, as the subject incorrectly received aflibercept instead of a sham injection at Month 3 and 5 visits. As of the data cutoff of December 12, 2022, in the U.S.-based Phase 1 clinical trial, the single OTX-TKI implant continued to be generally well tolerated with no drug-related ocular or systemic serious adverse events observed through 10 months. As the company previously announced at the 7-month readout, one SAE of endophthalmitis was observed in the OTK-TKI arm which occurred following the mandated aflibercept injection at Month 1 and was assessed by the investigator as related to the injection procedure. There were no elevated IOP, retinal detachment, retinal vasculitis, or implant migration into the anterior chamber adverse events observed in the OTX-TKI arm, and no subjects had dropped out of either arm as of the data cutoff. The interim results showed subjects treated with a single OTX-TKI implant demonstrated stable and sustained and CSFT in the OTX-TKI arm at 10 months, which was comparable with the aflibercept arm. The 73% of subjects who were rescue-free up to Month 7, continued to demonstrate OTX-TKI’s extended duration of action and remained rescue-free up to Month 10. Overall, a 92% reduction in treatment burden was observed in OTX-TKI treated subjects for up to 10 months.

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 15-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.

Keywords: biotech, biotech sector, biotech alert, investingchannel, XBI, SPDR S&P Biotech ETF