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: 

• Can Fite Biopharma (CANF), 4,763% surge in interest
• vTv Therapeutics (VTVT), 1,106% surge in interest
• Connect Biopharma (CNTB), 629% surge in interest
• Tracon Pharma (TCON), 304% surge in interest
• CASI Pharmaceuticals (CASI), 282% surge in interest
• Brainstorm Cell (BCLI), 253% surge in interest
• Leap Therapeutics (LPTX), 222% surge in interest
• Aquestive Therapeutics (AQST), 133% surge in interest
• Rigel Pharmaceuticals (RIGL), 106% surge in interest
• Madrigal Pharmaceuticals (MDGL), 103% surge in interest

Pipeline and key clinical candidates for these companies:

Can-Fite BioPharma is an advanced clinical stage drug development company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma, the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis, or NASH, the company says.

vTv Therapeutics is focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer.

Connect Biopharma is a U.S. and China-based clinical-stage biopharmaceutical company focused on treating inflammatory diseases with therapies derived from T cell research. The company’s lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha in development for the treatment of atopic dermatitis and asthma. The company’s second most advanced product candidate, CBP-307, is a modulator of S1P1 T cell receptor and is in development for the treatment of ulcerative colitis, or UC. The company’s third product candidate, CBP-174, is a peripherally acting antagonist of histamine receptor 3, in development for the treatment of pruritus associated with atopic dermatitis, or AD.

Tracon is advancing a pipeline of novel targeted cancer therapeutics and seeks to partner with other life science companies. The company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. Tracon has said it believes it “can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent.”

CASI Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The company intends to execute its plan to become a leader by launching medicines in the greater China market, leveraging the company’s China-based regulatory and commercial competencies and its global drug development expertise.

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.

Leap Therapeutics is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. Leap has entered into a strategic collaboration with BeiGene (BGNE) for the rights to develop DKN-01 in Asia excluding Japan, Australia, and New Zealand.

Aquestive Therapeutics is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

Rigel Pharmaceuticals is dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer, and rare immune diseases. Rezlidhia is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia, or AML, with a susceptible isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test.

Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis, or NASH, a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.

Recent news on these stocks:

November 21

Can-Fite BioPharma announced that a patient who participated in the Phase II Liver Cancer Study and was treated with namodenoson has a complete response and overall survival of 6.9 years. Liver Cancer designated as hepatocellular carcinoma HCC is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. A patient with advanced HCC that was enrolled in the former Can-Fite Phase II study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response. Can-Fite has received agreement from both the FDA and EMA on a pivotal Phase III clinical study which is now enrolling patients in Israel, Europe and the US. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. “We are currently enrolling patients for the pivotal Phase III clinical study and hope that if the interim analysis data will be positive, we will be able to get a conditional approval, and that patients who suffer from this devastating disease will enjoy our drug,” stated Can-Fite CEO Motti Farbstein.

Connect Biopharma announced positive topline results from the Stage 2 – maintenance period – of its China pivotal trial evaluating rademikibart’s – formerly known as CBP-201 – efficacy and safety in patients with moderate-to-severe atopic dermatitis – AD -. These results follow the previously reported Stage 1 results of the trial, which met all primary and key secondary endpoints. Positive Stage 2 results at Week 52 show the potential of rademikibart as a Q4W treatment for AD. Both Q2W at Q4W dosing regimens, 76%-87% of them maintained their IGA 0/1 and 92% of patients maintained their EASI-75 at Week 52, respectively. All patients that achieved EASI-50 at Week 16 with rademikibart showed continued improvement from Week 16 to Week 52. 21%-28% more patients achieved IGA 0/1, and 11%-16% more patients achieved EASI-75 at Week 52. With respect to quality of life, a greater than or equal to 5-point reduction on the dermatology life quality index is considered clinically important and 93.4% and 90.0% were able to maintain this level at the end of the 52-week study. Treatment with 300 mg Q2W and Q4W of rademikibart was generally well tolerated, and there were no new safety signals. The company separately granted the development and commercial rights of rademikibart in Greater China to Simcere Pharmaceutical, a large pharmaceutical company in China. Simcere will be responsible for rademikibart’s new drug application in China, which is still on track for submission by the end of 1Q24. Additionally, Connect Biopharma remains on track for the topline readout next month from its global Phase 2 trial of rademikibart in patients with moderate-to-severe asthma.

Connect Biopharma announced that two of its wholly owned subsidiaries, Connect Biopharma Hong Kong Limited and Suzhou Connect Biopharma Co., Ltd., have entered into an exclusive license and collaboration agreement with Simcere Pharmaceutical Co., Ltd., a subsidiary of Simcere Pharmaceutical Group Ltd, to develop and commercialize Connect Biopharma’s rademikibart in Greater China. Under the agreement, Connect Biopharma will complete all of rademikibart’s ongoing China clinical trials and related analysis in atopic dermatitis, which is on track for a new drug application submission for AD in China by the end of Q1 2024. Simcere has been granted exclusive rights to develop, manufacture and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, while Connect Biopharma retains rights in all other markets. Simcere will be responsible for rademikibart’s new drug application for AD in China and will also conduct and be responsible for the costs of all future clinical studies in all additional disease indications for rademikibart in Greater China. According to the terms of the agreement, Connect Biopharma will receive a $21M upfront payment, up to $120M upon achieving certain development and commercial milestones, in addition to royalties up to low double-digit percentages of net sales.

Madrigal Pharmaceuticals announced that Ronald Filippo has been appointed Chief Information Officer. Filippo has more than 25 years of digital experience in the biopharmaceutical industry and was previously Senior VP Digital at Moderna (MRNA), where he was responsible for technology leadership and digital transformation across core operations during the commercialization of the company’s COVID-19 vaccine.

November 20

TRACON Pharmaceuticals announced it has licensed its proprietary PDP of CRO-independent clinical research to a clinical stage biotech company for a $3.0 million upfront payment. “We are excited to announce the first license of our PDP to a company that recognizes the value of internalizing its clinical operations to reap the benefits of CRO-independent clinical trial implementation that we enjoy at TRACON,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “We are now in a position to widely license our PDP to allow clinical stage biotechnology and pharmaceutical companies to transform their clinical operations with the expectation of potentially dramatic cost reductions and shorter clinical trial timelines.” Under the terms of the Agreement, TRACON granted a non-exclusive and non-transferable license of its PDP to the clinical stage biotech company for the design, conduct and administration of clinical trials and related research and development activities, including activities relating to regulatory filings, submissions and approvals.

BrainStorm announced that the FDA has granted the company a meeting to discuss the regulatory path forward for NurOwn in amyotrophic lateral sclerosis, or ALS. The meeting is scheduled to take place on December 6. Brainstorm will discuss plans for a Special Protocol Assessment with the FDA to agree on the overall protocol design for a confirmatory Phase 3 trial in ALS.

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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.