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: 

• Rapt Therapeutics (RAPT), 8,025% surge in interest
• Emergent Biosolutions (EBS), 1,369% surge in interest
• Evogene (EVGN), 811% surge in interest
• Kazia Therapeutics (KZIA), 748% surge in interest
• Iovance Biotherapeutics (IOVA), 431% surge in interest
• Ocugen (OCGN), 240% surge in interest
• Vaxart (VXRT), 219% surge in interest
• Celldex Therapeutics (CLDX), 188% surge in interest
• Summit Therapeutics (SMMT), 176% surge in interest

Pipeline and key clinical candidates for these companies:

Rapt Therapeutics is focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology. Rapt has discovered and advanced two unique drug candidates, RPT193 and FLX475, each targeting C-C motif chemokine receptor 4, for the treatment of inflammation and cancer, respectively. The company is also pursuing a range of targets that are in the discovery stage of development.

Emergent provides solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that the company develops and manufactures for governments and consumers. Emergent also offers a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.

Evogene is a computational biology company that says it is “aiming to revolutionize the development of life-science based products by utilizing cutting edge technologies to increase the probability of success while reducing development time and cost.” Evogene established three unique tech-engines – MicroBoost AI, ChemPass AI and GeneRator AI – leveraging Big Data and Artificial Intelligence and incorporating deep multidisciplinary understanding in life sciences, the company states.

Kazia Therapeutics is an oncology-focused drug development company. Its lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. 

Iovance Biotherapeutics is focused on developing and delivering tumor infiltrating lymphocyte, or TIL, therapies for patients with cancer. Its lead late-stage TIL product candidate, lifileucel for metastatic melanoma, “has the potential to become the first approved one-time cell therapy for a solid tumor cancer,” said the company, adding that its TIL platform has “demonstrated promising clinical data across multiple solid tumors.”

Ocugen is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The company’s “breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product,” says Ocugen, which adds that it is advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.

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.

Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. The company’s pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic and autoimmune and other devastating diseases.

Summit Therapeutics is initiating development activities for SMT112 and will do so first in NSCLC indications. Summit plans to start treating patients in clinical studies by the second quarter of 2023.

Recent news on these stocks:

February 22

Ocugen announced that dosing is complete in the first cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)-a modifier gene therapy candidate being developed for Stargardt disease. Stargardt disease is an orphan blindness disease that affects approximately 35,000 people in the United States alone. “This is an important clinical milestone for our first-in-class, potential one-time therapy for the treatment of Stargardt disease,” said Dr. Arun Upadhyay, Chief Scientific Officer and Head of R&D at Ocugen. “Although Stargardt is one of the most common inherited retinal diseases, there remains no treatment option to address this condition. OCU410ST provides hope to these patients who may eventually lose their vision.”

February 21

Emergent BioSolutions announced that its board appointed Joseph Papa as president and CEO, effective February 21 Papa succeeds Haywood Miller, who will step down from his role as interim CEO, effective February 21. Papa brings over 35 years of experience in the healthcare and pharmaceutical industry, having most recently served as CEO and chairman at Bausch and Lomb Corporation.

AgPlenus, a subsidiary of Evogene, announced the signing of a licensing & collaboration agreement with Bayer (BAYRY). In collaboration with Bayer’s Crop Science division, having an industry-leading R&D pipeline and portfolio of seeds & traits, crop protection, and digital farming solutions, AgPlenus will use its AI-driven computational modeling technology to design and optimize molecules identified for their broad-spectrum herbicidal activity targeting the APTH1 protein, a new mode of action identified by AgPlenus. The two companies will collaborate to optimize new molecules, identified by AgPlenus and tested by Bayer, into commercially viable candidates. The collaboration will leverage AgPlenus’ proprietary computational technology, powered by Evogene’s ChemPass AI tech engine, together with Bayer’s extensive expertise in research, development and commercialization of crop protection products. Under the agreement, Bayer will have the exclusive license for the development and commercialization of products developed within the collaboration. AgPlenus will be entitled to receive an upfront payment, ongoing research funding, milestone payments, and royalties based on future product sales.

Kazia Therapeutics announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial. This investigator-initiated trial evaluated the use of paxalisib, an oral PI3K/mTOR dual inhibitor, with radiation therapy for the treatment of patients with PI3K pathway mutation brain metastases from solid tumors. Part I of the study established the maximal tolerated dose of paxalisib in combination with radiation therapy, while also demonstrating promising signs of clinical activity in all nine evaluable patients. Part II was a follow-on expansion cohort to further evaluate safety and efficacy of the MTD (45mg daily) combined with radiation therapy in up to 12 additional patients. After reviewing the Part II patient data generated to date, the three lead investigators have determined that the primary endpoint of the study has been reached. Last year, paxalisib was awarded Fast Track Designation on the basis of the Part I clinical data by the FDA for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. Approximately 200,000 cancer patients develop brain metastases in the U.S. each year.

February 20

RAPT Therapeutics announced that the FDA has verbally notified the company that a clinical hold has been placed on the company’s Phase 2b trial of zelnecirnon, RPT193, in atopic dermatitis and its Phase 2a trial in asthma. The company expects to receive a formal clinical hold letter from the FDA. The clinical hold determination was based on a serious adverse event of liver failure in one patient in the atopic dermatitis trial, the cause of which is currently unknown but which has been characterized as potentially related to zelnecirnon. Dosing of zelnecirnon has been halted in both clinical trials, as has enrollment of new trial participants. The clinical hold does not apply to RAPT’s ongoing trial of tivumecirnon, FLX475, in oncology.

Summit Therapeutics filed a $450M mixed securities shelf, and to sell 2.98M shares of common stock for holders.

February 16

Iovance Biotherapeutics announced that the FDA has approved Amtagvi, or lifileucel, suspension for intravenous infusion. Amtagvi is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate, or ORR, and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit. “Amtagvi is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer,” the company stated.

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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.