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: 

• Innate Pharma (IPHA), 3,633% surge in interest
• Chimerix (CMRX), 2,511% surge in interest
• Kodiak Sciences (KOD), 559% surge in interest
• Seres Therapeutics (MCRB), 172% surge in interest
• Agios Pharmaceuticals (AGIO), 102% surge in interest

Pipeline and key clinical candidates for these companies:

Innate Pharma is a clinical-stage biotechnology company developing immunotherapies for cancer patients. The company says its “innovative approach aims to harness the innate immune system through three therapeutic approaches: monoclonal antibodies, multi-specific NK Cell Engagers via its ANKET proprietary platform and Antibody Drug Conjugates.” Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca (AZN) in non-small cell lung cancer, several ANKET drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors.

Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company’s most advanced clinical-stage development program, ONC201, is in development for H3 K27M-mutant glioma.

Kodiak Sciences is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. The company is focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally.

Seres Therapeutics is a microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved “the first-ever positive pivotal clinical results for a targeted microbiome drug candidate,” according to the company, and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA.

Agios says it is “the pioneering leader in PK activation and is dedicated to developing and delivering transformative therapies for patients living with rare diseases.” In the U.S., Agios markets a first-in-class pyruvate kinase, PK, activator for adults with PK deficiency, the first disease-modifying therapy for this rare, lifelong, debilitating hemolytic anemia. Building on the company’s deep scientific expertise in classical hematology and leadership in the field of cellular metabolism and rare hematologic diseases, Agios is advancing a robust clinical pipeline of investigational medicines with programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. In addition to its clinical pipeline, Agios is advancing a preclinical TMPRSS6 siRNA as a potential treatment for polycythemia vera, and a preclinical PAH stabilizer as a potential treatment for phenylketonuria.

Recent news on these stocks:

December 10

Nona Biosciences announced a collaboration with Kodiak Sciences. This partnership aims to advance the discovery of novel multi-target antibodies to treat ophthalmic diseases, leveraging Nona’s proprietary Harbour Mice fully human antibody platform. The Harbour Mice platform generates fully human monoclonal antibodies in both the two heavy and two light chains format and the heavy chain-only format, eliminating the need for additional engineering or humanization. The HCAb Harbour Mice platform, in particular, is transforming antibody development by producing unique, fully human heavy chain-only antibodies that are approximately half the size of conventional IgGs, offering significant advantages for next-generation antibody therapies. Under the agreement, Kodiak Sciences gains the right to use both the H2L2 and HCAb Harbour Mice platforms in multiple programs for therapeutic antibody discovery and development.

December 9

Innate Pharma announced new data highlighting the quality-of-life improvements observed in patients with cutaneous T-cell lymphoma, or CTCL, treated with lacutamab in the TELLOMAK Phase 2 clinical study. These data were presented at the 66th American Society of Hematology, or ASH, annual meeting in San Diego, California. The TELLOMAK study addresses an unmet need for patients with advanced-stage CTCL, particularly Sezary syndrome and mycosis fungoides, who often experience debilitating symptoms such as severe itching and recurrent skin infections that profoundly impact their physical and social well-being. Patients with relapsed or refractory CTCL face limited treatment options and often report lower health-related quality of life, particularly those in advanced stages. TELLOMAK’s findings reveal signs that lacutamab may help alleviate some of the most distressing symptoms of this disease early on treatment. The TELLOMAK trial enrolled 163 patients with advanced CTCL, including 56 with SS and 107 with MF. The study’s quality of life measures included the Visual Analogue Scale, or VAS, for itch intensity and the Skindex-29 score, a validated tool for assessing the impact of skin conditions on patient quality of life.

Chimerix announced that, following extensive dialogue with the FDA, the company plans to submit a complete new drug application, or NDA, seeking accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the United States before year-end.

Seres Therapeutics announced that the FDA has granted Breakthrough Therapy designation to SER-155, the company’s lead investigational program, for the reduction of bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant for the treatment of hematological malignancies. In September 2024, Seres reported topline clinical data from Cohort 2 of its SER-155 Phase 1b placebo-controlled study in patients undergoing allo-HSCT, in which SER-155 was associated with a significant reduction in BSIs, a significant reduction in systemic antibiotic exposure, and lower incidence of febrile neutropenia, in each case as compared to placebo, through day 100 post-HSCT. Additionally, SER-155 was generally well tolerated, with no observed treatment-related serious adverse events. The receipt of Breakthrough Therapy designation for SER-155, the company’s second program to receive such designation, grants Seres access to FDA senior management and a commitment from FDA to work closely with the company, facilitating an efficient drug development process. In December 2023, SER-155 received FDA Fast Track designation for reducing the risk of infection and GvHD in this patient population. The SER-155 Breakthrough Therapy designation was supported by positive data from our recent SER-155 Phase 1b clinical trial. Patients who received SER-155 experienced a significantly lower incidence of bacterial BSIs as compared with the placebo arm, representing a 77% relative risk reduction. In addition, while antibiotic starts were similar in each arm, patients administered SER-155 were treated with antibiotics for a significantly shorter duration compared to patients in the placebo arm. Further, the incidence of febrile neutropenia was reduced, and gastrointestinal pathogen domination was substantially lower compared to a historical control cohort, providing further evidence of SER-155’s activity in modulating the microbiome to address critical post-transplant complications. SER-155 was well tolerated with no treatment related serious adverse events and engrafted as expected in the gastrointestinal tract. Bloodstream infections in allo-HSCT patients are frequent, serious, and potentially fatal. In clinical practice, HSCT patients who experience a BSI or febrile neutropenia are aggressively treated, often with broad-spectrum antibiotics, as infections are a leading cause of death in these patients in the first 100 days post-transplant. While prophylaxis of BSIs with antibiotics is common, antibiotics do not address the root cause as SER-155 is designed to do. Recent market research conducted by Seres characterized a significant commercial opportunity for SER-155 in allo-HSCT. Health Care Providers treating allo-HSCT patients indicated a high level of concern regarding BSIs. Additionally, HCPs stated that they would rapidly add a product providing similar efficacy to what we have observed in our SER-155 study to standard treatment protocols. The approximately 40,000 worldwide allo-HSCT patients are treated in a subset of large oncology centers across the globe, enabling rapid and efficient education of HCPs about SER-155, if approved. In addition to allo-HSCT, bloodstream infections are a common and serious complication in many other medically vulnerable populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. Seres intends to explore development of SER-155 and additional pipeline candidates for these populations. The targeted patient populations for SER-155 and Seres’ other pipeline candidates could represent multiple blockbuster commercial opportunities. Seres is actively seeking a partner to provide financial resources and other capabilities to support the company’s goal to maximize the SER-155 program opportunity, while pursuing a capital-efficient development approach.

December 8

Agios Pharmaceuticals presented positive results from the Phase 3 ENERGIZE-T study investigating mitapivat, an oral, small molecule PK activator, in adults with transfusion-dependent alpha- or beta-thalassemia. These findings were shared in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition in San Diego, California. In the ENERGIZE-T trial, mitapivat demonstrated a statistically significant reduction in transfusion burden compared to placebo in patients with transfusion-dependent alpha- or beta-thalassemia, achieving its primary endpoint. Additionally, the ENERGIZE-T study met all the key secondary endpoints, with mitapivat demonstrating a statistically significant reduction in additional measures of transfusion reduction response compared to placebo. In June 2024, Agios also presented positive results from the Phase 3 ENERGIZE study, which evaluated mitapivat in adults with non-transfusion-dependent alpha- or beta-thalassemia. The study’s primary endpoint of transfusion reduction response was defined as a greater than or equal to 50% reduction in transfused red blood cell units with a reduction of greater than or equal to2 units of transfused RBCs in any consecutive 12-week period through Week 48 compared with baseline. A TRR was achieved by 30.4% of patients in the mitapivat arm compared to 12.6% of patients in the placebo arm. Additionally, mitapivat demonstrated statistically significant reductions in transfusion burden compared with placebo as measured by the three key secondary endpoints of transfusion reduction response reflective of durability of response up to 36 weeks during the 48-week double-blind period. The key secondary endpoint TRR2, defined as a greater than or equal to 50% reduction in transfused RBC units in any consecutive 24-week period through Week 48 compared with baseline, was achieved in 13.5% versus 2.3% of patients in the mitapivat and placebo arms, respectively. The key secondary endpoints TRR3 and TRR4 were defined as a greater than or equal to 33% and greater than or equal to 50% reduction in transfused RBC units, respectively, from Week 13 through Week 48 compared with baseline. TRR3 was achieved in 14.6% versus 1.1% of patients in the mitapivat and placebo arms, respectively, and TRR4 was achieved in 7.6% versus 1.1% of patients in the mitapivat and placebo arms, respectively. The results for the primary and key secondary endpoints were not driven by any of the individual prespecified subgroups, including but not limited to genotype and baseline transfusion burden, highlighting the overall robustness of the efficacy results. Further, 17 patients in the mitapivat arm compared with one patient in the placebo arm achieved the secondary endpoint of transfusion independence. Three patients in the mitapivat arm did not receive any transfusions during the 48-week double-blind period. Overall, during the 48-week double-blind period, incidence of adverse events was similar across the mitapivat and placebo arms. The proportion of patients with any treatment-emergent adverse events was 90.1% in patients on mitapivat and 83.5% in patients on placebo. The TEAEs leading to discontinuation of mitapivat, each of which occurred in one patient, were diarrhea, paresthesia oral, concurrent anxiety and insomnia, initial insomnia, supraventricular tachycardia, fatigue, hypertransaminasemia, hepatitis C, hepatic cancer, and renal mass. The TEAE that led to discontinuation of the one patient on placebo was blood creatine phosphokinase increased.

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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.