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: 

• Marker Therapeutics (MRKR), 4,800% surge in interest
• Connect Biopharma (CNTB), 1,274% surge in interest
• Evofem Biosciences (EVFM), 1,047% surge in interest
• Morphosys (MOR), 908% surge in interest
• Achieve Life Sciences (ACHV), 860% surge in interest
• Blueprint Medicines (BPMC), 707% surge in interest
• Onconova Therapeutics (ONTX), 480% surge in interest
• Evelo Biosciences (EVLO), 468% surge in interest
• Cassava Sciences (SAVA), 338% surge in interest
• Seagen (SGEN), 303% surge in interest

Pipeline and key clinical candidates for these companies:

Marker Therapeutics is dedicated to the development and commercialization of next-generation T cell-based immunotherapies for patients with a wide range of blood and solid tumor cancers and “believes it can develop more precise and safer therapies capable of resulting in broad, potent and durable anti-cancer activity.” Marker is currently enrolling patients in the safety lead in portion of its multicenter randomized Phase 2 study in post-transplant acute myeloid leukemia, or AML.

Connect Biopharma is a global, clinical-stage biopharmaceutical company that says it is “applying its expertise in T cell biology and deep knowledge of the drug discovery industry to develop innovative therapies to treat chronic inflammatory diseases.” Its lead product candidate, rademikibart, is an antibody designed to target interleukin-4 receptor alpha in development for the treatment of atopic dermatitis and asthma. The company’s second product candidate, icanbelimod, is a modulator of S1P1 T cell receptors and is in development for the treatment of ulcerative colitis. Connect’s third product candidate, CBP-174, is an investigational antagonist of histamine receptor 3 designed to act peripherally, in development for the treatment of pruritus associated with AD.

Evofem Biosciences is commercializing products to address unmet needs in women’s sexual and reproductive health. The company’s first FDA-approved product, Phexxi — lactic acid, citric acid and potassium bitartrate — is a hormone-free, on-demand prescription contraceptive vaginal gel.

MorphoSys is a global commercial-stage biopharmaceutical company, focused on developing and delivering innovative medicines, and aspiring to redefine how cancer is treated.

Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline, a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the FDA for any indication in the United States.

Blueprint Medicines is a global precision therapy company that says it “invents life-changing therapies for people with cancer and blood disorders” by “applying an approach that is both precise and agile.” Blueprint is globally advancing multiple programs for mast cell disorders, including systemic mastocytosis and chronic urticaria, breast cancer and other cancers vulnerable to CDK2 inhibition, as well as EGFR-mutant lung cancer.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The company’s product candidates, narazaciclib and rigosertib, are proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Narazaciclib, Onconova’s novel, multi-kinase inhibitor, is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole in advanced endometrial cancer. Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa, and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.

Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. The company’s product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles, or EVs. Evelo initially is developing EDP1815 in psoriasis and atopic dermatitis and EDP2939 in psoriasis. “If shown to be effective in inflammatory disease mediated by the Th1, Th2 or Th17 inflammatory pathways, these same investigational medicines could be effective in additional inflammatory diseases, such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease,” the company says.

Cassava Sciences is a clinical-stage biotechnology company that says its mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. “Its novel science is based on stabilizing-but not removing-a critical protein in the brain. The company’s product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established,” Cassava has stated.

Seagen discovers, develops, manufactures and commercializes targeted cancer therapeutics, with antibody-drug conjugates at its core. As “an ADC technology trailblazer,” approximately one-third of FDA-approved and marketed ADCs use Seagen technology, the company has noted. Seagen is headquartered in Bothell, Washington and has locations in California, Canada, Switzerland and across Europe.

Recent news on these stocks:

December 12

Connect Biopharma announced positive topline results from the global Phase 2b trial evaluating rademikibart efficacy and safety in adult patients with moderate-to-severe persistent asthma. The trial met its primary endpoint of absolute change from baseline in pre-bronchodilator – BD – forced expiratory volume over one second showing that at Week 12, lung function significantly improved over placebo with both rademikibart doses. The significant improvements seen compared to placebo with both rademikibart 150 mg and 300 mg started as early as Week 1 and were sustained through 24 weeks of treatment. A predefined exploratory analysis showed further improvement in lung function was achieved in patients with eosinophil levels of greater than or equal to 300 cells/microl. Strong and significant improvement in asthma control was also observed. Improvement was evident as early as Week 1 and statistically significant starting at Week 2 through Week 24 for both doses of rademikibart. Treatment with rademikibart showed strong trends toward reduced exacerbations with more than half of all exacerbations during the 24-week study occurring in the placebo group. Treatment with 150 mg and 300 mg Q2W of rademikibart was generally well tolerated.

Aditxt (ADTX) and Evofem announced the signing of a definitive agreement under which Aditxt is to acquire Evofem in consideration of the issuance of a combination of common stock and preferred stock, and the assumption of certain senior indebtedness, having an aggregate amount of approximately $100M. Pending a successful transaction, it will also mark the establishment of a women’s health mission within Aditxt’s platform, aligning with global healthcare needs. The boards of directors of both companies have unanimously approved the transaction. Aditxt has assumed Evofem’s senior secured debt that was issued to the investor under the securities purchase and security agreement dated April 2020, as amended, and shall pay $5M to Evofem’s senior secured debtholder by year-end 2023, $8M by September 2024, and up to an additional $5M thereafter. Aditxt has also agreed to provide a $3M loan to Evofem between the date of signing of the agreement and closing and to cover Evofem’s legal costs related to the transaction. At closing, the holders of Evofem’s common stock will exchange their shares for an aggregate of 610,000 shares of Aditxt common stock. In addition, Aditxt has agreed to issue up to an aggregate of 89,126 shares of preferred stock to the holders of Evofem’s currently outstanding unsecured notes, purchase rights, certain warrants, and preferred stock. Upon closing of the Transaction, which is currently anticipated to occur in the first half of 2024, Evofem will be a wholly owned subsidiary of Aditxt, with the Evofem management team to receive equity grants in the subsidiary of up to ten percent on a fully diluted basis after closing, and will continue to be led by Saundra Pelletier, CEO of Evofem, and the current management team. The boards of directors of Aditxt and Evofem have unanimously approved the proposed Transaction. The transaction is subject to, among other things, the approval of both Aditxt and Evofem stockholders and satisfaction or waiver of the conditions stated in the agreement.

Blueprint Medicines announced the European Commission has approved AYVAKYT for thetreatment of adult patients with indolent systemic mastocytosis with moderate to severe symptoms inadequately controlled on symptomatic treatment. AYVAKYTis the first and only approved therapy for people living with ISM in Europe.

Onconova Therapeutics announced preclinical data, highlighting narazaciclib’s preclinical activity in Bruton’s kinase inhibitor-resistant mantle cell lymphoma, Narazaciclib showed safety and efficacy as a single agent in preclinical MCL models, including ibrutinib-resistant settings, with significant reductions in cell viability. The narazaciclib plus ibrutinib combination showed synergy in vitro and in vivo, especially in ibrutinib-resistant models, with overall greater synergy, measured by lower “Combination Index” values, versus ibrutinib-sensitive cells. The combination of narazaciclib plus ibrutinib induces a superior G1 cell cycle blockade in both ibrutinib-sensitive and ibrutinib-resistant MCL cells. In ibrutinib-resistant cases, the synergy between narazaciclib and ibrutinib triggers metabolic reprogramming alongside DNA damage, mediated by the USP24 and P53 axis, as evidenced by several assays to assess mitochondrial metabolism. Together, these preclinical data suggest that narazaciclib has important single agent activity and the potential to restore ibrutinib sensitivity in BTKi-resistant models, successfully meeting the primary objective of the study.

December 11

Marker Therapeutics reported a clinical update on the APOLLO study. The Phase 1 APOLLO study is investigating MT-601, a multi-tumor associated antigen-specific T cell product, for the treatment of patients with lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell therapy. The company previously reported first enrollment in the dose escalation stage of the Phase 1 trial. The patient had diffused large B cell lymphoma and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy. Marker reported in September that the study participant tolerated the treatment well without treatment-related adverse events and achieved a complete metabolic response eight weeks after the second infusion of MT-601. Marker reported that six months following the initial treatment with MT-601 the study participant has maintained complete response to treatment. These clinical results are reinforced by non-clinical proof-of-concept data demonstrating that MT-601 has the potential to eradicate lymphoma cells resistant to anti-CD19 CAR T cells, highlighting the therapeutic potential of MT-601 in vitro/ Although CD19-targeting CAR T cell therapies have gained acceptance as treatment for patients with lymphoma, up to 60% of patients treated with CAR T therapies relapse within one year. This APOLLO study participant relapsed within 90 days after CAR T cell therapy, yet maintained a complete response for at least six months after treatment with MT-601, suggesting that MT-601 is more durable compared to CAR T cells in this study participant.

In a regulatory filing, Achieve Life Sciences stated: “As previously reported, Achieve Life Sciences recently conducted a pre-New Drug Application, or ‘NDA,’ meeting with the U.S. Food and Drug Administration for the company’s drug product candidate, cytisinicline, during which agreement was reached on many of the submission requirements for an NDA. During that meeting, the FDA expressed support for an NDA submission based on adequate data to assess efficacy from the two randomized and controlled Phase 3 trials. In addition, the FDA advised that long-term exposure data beyond 12 weeks would be needed to adequately assess safety risk given that it views smoking cessation drugs as products for chronic, intermittent use because patients may relapse and require subsequent courses of treatment over a lifetime. The FDA advised that long-term safety data could be collected on a patient’s cumulative treatment over time and could also be collected in the vaping cessation program. The company is participating in ongoing discussions with the FDA to clarify the requirements and timing for the long-term exposure safety data to support an NDA submission and the company’s NDA filing timing may be delayed to address this FDA feedback. Following receipt of additional input from the FDA, anticipated in the first quarter of 2024, the company will provide an update on its projected NDA submission timing.”

December 10

MorphoSys announced comprehensive results from the Phase 3 MANIFEST-2 study investigating pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naive patients with myelofibrosis. These findings were presented in an oral presentation at the 65th American Society of Hematology Annual Meeting and Exposition in San Diego, California. Myelofibrosis is characterized by four hallmarks: an enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms. In MANIFEST-2, all hallmarks were improved with the pelabresib and ruxolitinib combination versus placebo plus ruxolitinib, which is the standard of care in myelofibrosis. Ruxolitinib dosing was similar in both arms of the study and was determined based on its approved myelofibrosis indication.

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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.