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: 

• Iterum Therapeutics (ITRM), 3,143% surge in interest
• Wave Life Sciences (WVE), 786% surge in interest
• Adaptimmune (ADAP), 700% surge in interest
• Arcus Biosciences (RCUS), 534% surge in interest
• Oramed (ORMP), 426% surge in interest
• Brainstorm Cell (BCLI), 325% surge in interest
• Vaxart (VXRT), 320% surge in interest
• Oragenics (OGEN), 221% surge in interest
• Genprex (GNPX), 140% surge in interest
• KalVista (KALV), 138% surge in interest

Pipeline and key clinical candidates for these companies:

Iterum Therapeutics is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem also has an IV formulation. Iterum has received Qualified Infectious Disease Product and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Wave Life Sciences is a biotechnology company “focused on unlocking the broad potential of RNA medicines to transform human health” whose RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders, the company says. Wave’s pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. 

Adaptimmune’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.

Arcus Biosciences is a clinical-stage biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis, HIF-2a, CD39 and AXL, the company says.

Oramed Pharmaceuticals calls itself “a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection.” The company’s novel Protein Oral Delivery technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel.

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.

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart believes that its proprietary pill vaccine delivery platform is “suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications,” the company has stated. Vaxart’s development programs currently include pill vaccines designed to protect against norovirus, coronavirus, seasonal influenza, and respiratory syncytial virus, or RSV, as well as a therapeutic vaccine for human papillomavirus, or HPV, Vaxart’s first immune-oncology indication.

Oragenics is a development-stage company focused on nasal delivery of pharmaceutical medications including in neurology and fighting infectious diseases including coronaviruses and multidrug-resistant organisms. It’s ONP-002 product candidate is a fully synthetic neurosteroid being developed to treat Mild Traumatic Brain Injury. Its NT-CoV2-1 product candidate is an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health and the National Research Council of Canada with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration.

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.

KalVista Pharmaceuticals is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista is developing sebetralstat as an oral on-demand therapy for HAE and anticipates providing data from the phase 3 KONFIDENT clinical trial in early 2024. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases.

Recent news on these stocks:

January 31

Adaptimmune disclosed that the FDA has accepted for priority review the company’s Biologics License Application, or BLA, for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The application has a Prescription Drug User Fee Act, or PDUFA, target action date of August 4.

B. Riley upgraded Vaxart to Buy from Neutral with a price target of $2, up from $1.50. The analyst cited the “long-awaited” receipt of $9.27M from BARDA’s Project NextGen award and the CEO resignation for the upgrade. The firm believes “upside is in the details while downside risk has diminished,” noting an incremental $300M is highly likely to be received as part of Rapid Response Partnership Vehicle for Phase IIb study execution with the performance period beginning Q2. It anticipates Vaxart to be among those leading NextGen vaccination efforts as visibility on next steps remain unclear for the two other intra-nasal programs also funded as part of the broader $5B Health and Human Services initiative.

Genprex announced that on February 2, the company will implement a 1-for-40 reverse split of its issued and outstanding common stock, par value 0.1c per share. The company’s common stock will trade on a post-split adjusted basis at the beginning of trading on February 2 under the existing trading symbol “GNPX.” As a result of the reverse stock split, every 40 shares of common stock issued and outstanding as of the effective date will be automatically combined into one share of common stock.

January 30

Iterum Therapeutics announced positive topline results from its REASSURE Phase 3 clinical trial comparing oral sulopenem to oral Augmentin in adult women with uncomplicated urinary tract infections. With the positive data from this trial, Iterum plans to resubmit its New Drug Application for oral sulopenem for the treatment of uUTI in Q2. At the same time, Iterum will focus on selling, licensing, or otherwise disposing of its rights to sulopenem with the goal of maximizing value for its stakeholders. Results demonstrate that oral sulopenem was non-inferior to Augmentin with respect to the trial’s primary endpoint, overall response at the test-of-cure visit in the microbiological-modified-intent-to-treat susceptible population. Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin, demonstrating statistically significant superiority of oral sulopenem versus Augmentin. Both oral sulopenem and Augmentin were well tolerated in this study with discontinuations due to adverse events occurring in less than1% of patients on both regimens. No serious adverse events were reported in patients receiving oral sulopenem, while five SAEs occurred in patients receiving Augmentin, with no drug-related SAEs. The safety profile for oral sulopenem was consistent with those observed in each of the previously conducted Phase 3 trials, with no new safety signals noted beyond those associated with beta-lactams. Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA, or during Q4.

January 29

Gilead (GILD) and Arcus Biosciences announced an amendment to their collaboration agreement and a separate equity investment by Gilead of $320M in Arcus common stock at $21.00 per share. The equity investment and collaboration amendment enable accelerated growth of the companies’ joint development programs that span multiple indications. Additionally, Johanna Mercier, chief commercial officer at Gilead Sciences, will join the Arcus board, bringing Gilead’s total director designees to three. The amendment also includes governance enhancements enabling streamlined decision-making and reflecting the continued growth of the collaboration. Gilead and Arcus have reprioritized the joint domvanalimab development program to focus on advancing and potentially accelerating the Phase 3 studies STAR-121 and STAR-221, which are both expected to be fully enrolled by year-end. This prioritization focuses on domvanalimab-containing regimen research in areas where it may have significant impact in combination with chemotherapy and in settings with high unmet need through all-comer study designs. The companies also plan to initiate STAR-131, a new registrational Phase 3 lung cancer study that includes the domvanalimab plus zimberelimab regimen. This prioritization reflects the companies’ continued conviction in the TIGIT pathway and the Fc-silent design of domvanalimab, which has the potential for differentiation in both efficacy and safety. Additional changes during this prioritization will include discontinuing further enrollment in the Phase 3 ARC-10 study evaluating domvanalimab plus zimberelimab compared to pembrolizumab monotherapy in first-line locally advanced or metastatic, PD-L1-high NSCLC. The discontinuation of the ARC-10 study is based on strategic prioritization to advance and potentially accelerate the Phase 3 studies STAR-121 and STAR-221, which have the potential to address a higher unmet need for patients with lung and gastrointestinal cancers. Gilead and Arcus are grateful to the patients and investigators who have made the choice to participate in ARC-10, which will continue to generate data and insights that will be shared at future scientific conferences. Patients currently enrolled in ARC-10, or who consented prior to January 29 and choose to enroll in the study, may continue their treatment and be monitored according to the study protocol. No changes to the safety and efficacy profile of domvanalimab and zimberelimab have been observed. Also, under the terms of the amended collaboration agreement, the planned Phase 3 first-line study in pancreatic cancer evaluating the investigational small molecule CD73 inhibitor quemliclustat will become an Arcus independent study. Domvanalimab, zimberelimab and quemliclustat are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of lung, gastrointestinal and pancreatic cancers have not been established.

Hear more from InvestingChannel by signing up for The Spill.

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.