These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
Prothena Corporation is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics which it says have "the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases." Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets. Prothena's pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer's disease, Parkinson's disease and a number of other neurodegenerative diseases.
Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2b clinical trial for lupus nephritis and a Phase 2a clinical trial for autoimmune hepatitis.
Gritstone Oncology is "working to create the world's most potent vaccines" by leveraging its "innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets," the company says. Gritstone has programs in viral diseases and solid tumors.
PDS Biotechnology is a clinical-stage immunotherapy company developing a pipeline of targeted cancer and infectious disease immunotherapies based on its proprietary Versamune and Infectimune T cell-activating technology platforms. To date, its lead Versamune clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials.
IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, autoimmune and inflammatory diseases and infectious diseases. IGM's pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets.
Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma and leptomeningeal metastases.
BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, the company is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations.
Corcept's focus on cortisol modulation and its potential to treat patients across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept's advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis and non-alcoholic steatohepatitis. In February 2012, the company introduced Korlym, the first medication approved by the FDA for the treatment of patients with Cushing's syndrome.
Recent news on these stocks:
October 2
PDS Biotechnology announced that updated data from the IMMUNOCERV Phase 2 clinical trial evaluating Versamune HPV, formerly PDS0101, with chemoradiation to treat locally advanced cervical cancer were presented at the American Society for Radiation Oncology, or ASTRO, Annual Meeting 2024 in an oral presentation by Adam Grippin, of The University of Texas MD Anderson Cancer Center. The abstract was granted Basic/Translational Science Award from the ASTRO Annual Meeting Steering Committee." The IMMUNOCERV Phase 2 clinical trial evaluated the efficacy, safety and tolerability of Versamune HPV in combination with standard-of-care chemoradiotherapy for the treatment of locally advanced cervical cancer. The investigator-initiated study enrolled 17 newly diagnosed high-risk patients with large tumors of at least 5 cm in size. Highlights from the presentation include: All patients received at least 2 doses of Versamune(R) HPV; Median follow-up was 19 months, 36-month overall survival rate was 84.4%, and 100% for the eight patients who received all five doses of Versamune HPV. Historical published data show 36-month OS rate with chemoradiation in this population of approximately 64%.
October 1
Plus Therapeutics presented an update on the ongoing ReSPECT-GBM Phase 1/2 clinical trial evaluating the company's lead asset Rhenium Obisbemeda for the treatment of recurrent glioblastoma. The data highlights the continued favorable safety profile and encouraging efficacy results of Rhenium Obisbemeda in a patient population with historically poor prognosis. ReSPECT-GBM is a first-in-human, open-label, Phase 1/2 study investigating feasibility, dose escalation, and critical convection enhanced delivery parameters to determine the maximum tolerated dose, maximum feasible dose, safety, and potential efficacy of Rhenium (186Re) Obisbemeda in recurrent adult glioma. Rhenium (186Re) Obisbemeda continues to show a favorable safety profile in the 42 enrolled patients; one dose-limiting toxicity has been reported, which was observed in Cohort 8. In Phase 2, most adverse events were mild or moderate, and largely unrelated or unlikely related to the drug. To date, 88.9% of Phase 2 patients met key CED drug delivery parameters shown to correlate with overall survival, achieving a tumor absorbed dose greater than100 Gy and radiation coverage of greater than70%. In terms of objective tumor response based on quantitative image analysis, a statistically significant reduction in tumor volume rate change was seen in tumors receiving greater than 100 Gy absorbed dose. Sufficient tumor coverage correlated with tumor control, while regrowth occurred outside treated areas.
September 30
Kezar Life Sciences announced the voluntary cessation in enrollment of new patients and dosing of ongoing patients in the Phase 2b PALIZADE clinical trial, pending further evaluation. PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib in patients with active lupus nephritis, or LN. Patients in the trial are randomly assigned to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or placebo subcutaneously once weekly for 52 weeks, in addition to standard background therapy. To date, 84 patients have been enrolled in the PALIZADE trial, and patient safety data are reviewed by an Independent Data Monitoring Committee, or IDMC. Kezar has suspended enrollment and dosing in PALIZADE at the recommendation of the IDMC after their recent review of emerging safety data, including an assessment of four Grade 5 serious adverse events that have occurred during the course of the trial in patients enrolled in the Philippines and Argentina. Review of the data by the IDMC revealed that three of the fatalities showed a common pattern of symptoms and proximity to dosing, and additional non-fatal SAEs showed a similar proximity to dosing. Kezar remains blinded as to which patients were on the zetomipzomib or placebo treatment arms. Kezar has not observed any instances of death or serious opportunistic infections in prior clinical studies of zetomipzomib. Kezar's ongoing Phase 2a PORTOLA clinical trial of zetomipzomib in patients with autoimmune hepatitis has completed enrollment and remains active at this time. To date, no Grade 4 or 5 SAEs have been observed in the PORTOLA clinical trial. Kezar's decision to pause enrollment and dosing on PALIZADE enables time to evaluate the totality of data regarding the SAEs and determine next steps and potential risk mitigation strategies. The company has notified all study investigators and is notifying regulatory authorities, including the FDA and the European Medicines Agency, of its decision. At this time, a formal Investigational New Drug clinical hold has not been issued. If Kezar receives a clinical hold letter from the FDA, it will review the content and determine next steps.
Gritstone announced interim Phase 2 data from the ongoing Phase 2 study evaluating GRANITE, its individualized neoantigen targeting immunotherapy, in frontline microsatellite stable colorectal cancer, or MSS-CRC. The randomized, controlled study is designed to evaluate the clinical benefit of maintenance therapy with GRANITE in combination with immune checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression-free survival data show an encouraging benefit for GRANITE patients. As expected, the greatest benefit was observed in the 50% of patients with lower disease burden at study entry, as measured by circulating tumor DNA at study baseline. Continued follow-up is needed to fully assess GRANITE effects and determine whether a plateau of improved PFS is achieved. The most recent ctDNA assessments for the 20 patients who remain without disease progression were supportive of potential benefit from treatment with GRANITE: 12 of 13 GRANITE patients had stable ctDNA titers below the assay limit of quantitation; 4 of 7 control patients exhibited the same characteristic. Interim data demonstrated an emerging PFS benefit to all GRANITE recipients 21% relative risk reduction of progression or death with GRANITE vs. standard of care control in all treated population 33% GRANITE and 23% of control patients remain on study and free of progression. Last ctDNA assessment is below the assay LOQ in 12/13 GRANITE and 4/7 control patients. Clinical benefit was most notable in patients with low disease burden. 38% relative risk reduction of progression or death with GRANITE vs. SOC control with low ctDNA subgroup. Low baseline ctDNA is a likely prognostic and predictive factor. Immune data were consistent with clinical activity. Functional neoantigen-specific T cells were observed in all 16/16 GRANITE patients tested by ELISPOT. Association of PFS and peak ex vivo ELISPOT responses was apparent, suggesting that ex vivo ELISPOT may be a surrogate for PFS. GRANITE demonstrated a favorable safety and tolerability profile. No patients discontinued study treatment due to an adverse event. Common adverse events were the mild systemic and local effects associated with any potent vaccine, i.e. transient flu-like illness. One treatment-related serious AE occurred in the GRANITE arm. Gritstone plans to review the PFS data with FDA in the coming months and agree on next steps to advance GRANITE, including a potential Phase 2 or 3 trial using ctDNA levels as eligibility criteria.
IGM Biosciences announced a strategic pivot and pipeline transformation. The company's lead candidates include imvotamab, a CD20 x CD3 bispecific T cell engager being developed in rheumatoid arthritis, systemic lupus erythematosus and myositis, and IGM-2644, a CD38 x CD3 bispecific T cell engager, which is expected to enter into a clinical study for generalized myasthenia gravis by the end of 2024. IGM also announced today that Mary Beth Harler has been appointed as CEO and to the board of directors. Harler joined IGM in 2021 as president, autoimmunity and inflammation.
In light of the emerging data from IGM's ongoing randomized clinical trial of aplitabart in second-line metastatic colorectal cancer, together with the significant opportunity in autoimmunity, the company has decided to immediately begin taking steps, including a reduction in force, to minimize its future spending on the research and clinical development of aplitabart and other oncology candidates. Final data from the randomized clinical trial of aplitabart in second-line metastatic colorectal cancer will be shared in an appropriate forum in the future. As a result of these actions, IGM believes it can extend its current cash runway into 2027.
September 27
Prothena announced that Chad Swanson, Ph.D., has been appointed Chief Development Officer and will assume leadership of clinical development and medical functions. Chief Medical Officer Hideki Garren, M.D., Ph.D., will pursue an opportunity at a large pharmaceutical company to lead a global product development division. Prothena will initiate a search for a world-class healthcare leader as its next Chief Medical Officer.
September 26
BeiGene announced the FDA Oncologic Drugs Advisory Committee recognizes the favorable benefit-risk profile of PD-1 inhibitors, including TEVIMBRA, for the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma expressing PD-L1 and gastric/gastroesophageal junction cancers expressing PD-L1 greater than1%. The committee reviewed efficacy and safety data from the Phase 3 RATIONALE-305 and RATIONALE-306 studies, as well as other pivotal studies from the two other PD-1 inhibitors approved in these indications. The Advisory Committee voted 10 to 2, with one abstaining, that the risk benefit assessment was not favorable for the use of PD-1 inhibitors in G/GEJ with PD-L1 expression less than 1%. The ODAC members voted 11 to 1, with one abstaining, that the risk benefit profile was not favorable for ESCC patients with a PD-L1 expression less than 1%. The vote represents a recommended class-wide PD-L1 expression level cut-off across PD-1 inhibitors reviewed during the meeting for these patient populations. "The survival rates for gastric and esophageal cancer remain strikingly low for the majority of patients who are diagnosed with late-stage disease and there is a need for additional treatments that can extend life," said Sally Werner, RN, BSN, MSHA, CEO at Cancer Support Community. "We appreciate the FDA's recognition of the need for safe and effective treatments for these cancers. Additional treatment options offer physicians and their patients choices on the treatment that is right for them."
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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.
Prothena
-0.29 (-1.74%)
Kezar Life Sciences
+
Gritstone
+
PDS Biotechnology
+0.046 (+1.12%)
IGM Biosciences
-0.345 (-2.41%)
Plus Therapeutics
-0.12 (-8.39%)
BeiGene
+1.825 (+0.78%)
Corcept Therapeutics
-0.09 (-0.20%)