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), 3,408% surge in interest
• Morphosys (MOR), 454% surge in interest
• Connect Biopharma (CNTB), 426% surge in interest
• Blueprint Medicines (BPMC), 423% surge in interest
• Onconova Therapeutics (ONTX), 378% 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.

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

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.

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.

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.

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.

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.