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: 

• BiondVax Pharmaceuticals (BVXV), 2,087% surge in interest
• Replimune Group (REPL), 1,600% surge in interest
• Bellerophon (BLPH), 926% surge in interest
• Kura Oncology (KURA), 779% surge in interest
• Tiziana Life Sciences (TLSA), 485% surge in interest

Pipeline and key clinical candidates for these companies:

BiondVax Pharmaceuticals is a biotechnology company focused on developing, manufacturing, and commercializing immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, the company has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its vaccine candidate and is "aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody pipeline," the company stated.

Replimune Group is focused on the development of novel tumor-directed oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a HSV-1 backbone with payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform’s dual local and systemic mechanism of action is "expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile the RPx platform has the versatility to be developed alone or combined with a variety of other treatment options," the company stated.

Bellerophon Therapeutics is focused on developing therapies that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The company is currently developing multiple product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery system.

Kura Oncology is a clinical-stage biopharmaceutical company whose pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. The company is currently enrolling patients in a Phase 2 registration-directed trial of ziftomenib in NPM1-mutant relapsed or refractory AML and is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company that says its "innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous delivery." Tiziana’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 mAb, according to the company, which adds that it has "demonstrated a favorable safety profile and clinical response in patients in studies to date."

Recent news on these stocks:

June 6

Replimune Group announced initial data from ARTACUS, a Phase 1/2 trial evaluating RP1 for the treatment of cutaneous malignancies in patients who have had a kidney, liver, heart, lung, and/or a hematopoietic cell transplant. This data from the ARTACUS trial will be presented at the ATC 2023 Meeting being held in San Diego. "Cutaneous cancer represents the most common post-transplant malignancy in highly immuno-compromised solid organ transplant patients. The challenge treating this high-risk population is that the use of anti-PD1 therapies can lead to organ transplant rejection in these patients," said Robert Coffin, President and Chief Research & Development Officer of Replimune. ARTACUS is Replimune’s multicenter, open-label, 2-part Phase 1b/2 study evaluating RP1 for the treatment of locally advanced or metastatic cutaneous malignancies in solid organ transplant recipients. This initial analysis includes kidney transplant recipients. This is the first clinical trial assessing single-agent RP1 in immunocompromised patients. No immune-mediated adverse events or evidence of allograft rejection were observed. RP1 monotherapy was well tolerated, and the safety profile was similar to non-immunocompromised patients with advanced skin cancers. RP1 monotherapy showed clear anti-tumor activity, with a preliminary overall response rate for the 11 evaluable patients with cutaneous squamous cell carcinoma and Merkel cell carcinoma of 27.3%, with 3 patients achieving a confirmed complete response. One of the non-evaluable patients also showed a clear reduction in tumor size before death due to COVID-19-related pneumonia at 7 weeks following initiation of RP1.

June 5

BiondVax Pharmaceuticals announces that as part of its ongoing broad-based collaboration with the Max Planck Society and the University Medical Center Gottingen, it has signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies targeting Interleukin-17 as treatments for all potential indications, starting with psoriasis and psoriatic arthritis. Under the BiondVax-MPG-UMG research collaboration agreement, NanoAb candidates must satisfy rigorous criteria relating to binding affinity, neutralization of the target and other attributes prior to being in-licensed by BiondVax. An ex vivo proof-of-concept for psoriasis using the anti-IL-17 NanoAb in a psoriatic human skin model is expected later this year. BiondVax plans to initiate a preclinical in vivo efficacy study in 2024 followed later by human clinical trials. As an initial target indication, BiondVax plans to test the antibody in humans with local, intradermal injections directly to psoriatic lesions to test the NanoAb’s ability to provide a safe and affordable biologic treatment for mild to moderate psoriatic patients for whom the available mAbs are not authorized, and who represent 85% of plaque psoriasis cases. BiondVax is working on plans to develop the drug also as a subcutaneous injection for systemic treatment targeting patients with moderate to severe plaque psoriasis.

Bellerophon Therapeutics announced top-line results from its pivotal Phase 3 REBUILD clinical trial evaluating the safety and efficacy of INOpulse for the treatment of fibrotic Interstitial Lung Disease. The REBUILD clinical trial was designed as a randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of INOpulse for the treatment of patients with fILD. A total of 145 fILD patients were enrolled and treated with either INOpulse at a dose of iNO45 or a placebo. The primary endpoint was the change in moderate to vigorous physical activity as measured by actigraphy after 16 weeks of chronic treatment. The trial did not meet its primary endpoint, with iNO45 performing worse than placebo by 5.49 minutes per day. The secondary endpoints demonstrated minimal difference between the two groups with none approaching statistical significance. Overall, INOpulse was well-tolerated with no safety concerns, consistent with what has been observed in the prior Phase 2 studies. Key REBUILD clinical trial secondary endpoints and safety outputs assessed over 16 weeks of blinded treatment included: Overall Activity showed 3.51 count/min benefit in favor of iNO45; 6 Minute Walk Distance showed 0.19 meter benefit in favor of iNO45; Patient reported outcomes were slightly in favor of placebo, while time to event assessments showed little difference and none were statistically significant; Subjects with treatment emergent adverse events was slightly in favor of placebo; Subjects with serious treatment emergent adverse events was balanced; Deaths were balanced.

Tiziana Life Sciences announced a reduction in microglial activation as seen in 3-month Positron Emission Tomograpy scans that has now been seen in a total of 5 of the 6 patients with non-active secondary-progressive multiple sclerosis treated with intranasal foralumab in its Expanded Access program. Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory diseases including multiple sclerosis, Alzheimer’s disease and amyotrophic lateral sclerosis. A reduction in microglial activation is associated with lowered inflammation in the brain. Inflammation in the brain drives the disease pathology in multiple sclerosis. In SPMS, inflammation in the brain occurs in microglia, the brain’s immune cells, which drive the neurodegeneration of brain cells. During the inflammatory process associated with SPMS, microglia are involved in the destruction of myelin, the protective sheath covering of nerve fibers, and contribute to the formation of MS lesions. Tarun Singhal, M.B.B.S., M.D., Director of PET Imaging Program in Neurologic Diseases, associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Assistant Professor of Neurology at Harvard Medical School, commented, "After review of the baseline and 3-month PET scans of the latest cohort of 4 Expanded Access patients, I have determined that 3 out of the 4 patients had a reduction in the microglial PET signal. When combined with my assessment of the first 2 Expanded Access patients, a total of 5 out of the 6 had a reduction in qualitative microglial PET signal, which appears to be clearly more significant than what we have identified in our test-retest assessments. I look forward to studying more patients, with full quantitation, and particularly, the next 4 patients in the Expanded Access program to see if this finding is replicated. We are preparing to submit the important results from this trial for publication."

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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.

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