Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly 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:
Aptevo Therapeutics is focused on developing novel immunotherapies for the treatment of cancer. APVO436 is a bispecific CD3xCD123 ADAPTIR currently in Phase 1b development in a multi-center, multi-cohort trial designed to evaluate safety, tolerability and efficacy in combination therapy and monotherapy for patients with acute myeloid leukemia, or AML. The company plans to initiate a Phase 2 trial, evaluating APVO436 in combination with venetoclax and azacitidine in patients with AML who are venetoclax treatment naive, in 2H23.
Alterity Therapeutics is a clinical stage biotechnology company that says it is "dedicated to creating an alternate future for people living with neurodegenerative diseases." The company's lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also has a "broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases," the company states.
Adverum Biotechnologies is a clinical-stage company that is evaluating its novel gene therapy candidate, ixoberogene soroparvovec, as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, "the company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products," the company states.
Aslan Pharmaceuticals is a clinical-stage, immunology-focused biopharmaceutical company developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b dose-ranging study in moderate-to-severe AD patients. Aslan is currently investigating eblasakimab in dupilumab-experienced, moderate-to-severe AD patients in the TREK-DX Phase 2 trial, with topline data expected at the end of 2024. Aslan is also developing farudodstat, a potent oral inhibitor of the enzyme dihydroorotate dehydrogenase as a potential first-in-class treatment for alopecia areata in a Phase 2a, proof-of-concept trial with an interim readout expected in Q3 2024.
Precigen's AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens designed to modulate the immune system. Precigen's gorilla adenovectors, part of the AdenoVerse library, "have potentially superior performance characteristics as compared to current competition. AdenoVerse immunotherapies have been shown to generate high-level and durable antigen-specific T-cell immune responses as well as an ability to boost these responses via repeat administration," the company says.
BioXcel Therapeutics is utilizing artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. The company's drug re-innovation approach "leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices," BioXcel states. The company's commercial product, IGALMI, developed as BXCL501, is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Allogene Therapeutics is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
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. The SER-109 program is being advanced to prevent further recurrences of C. difficile infection. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation to reduce incidences of gastrointestinal infections, bloodstream infections and graft-versus-host disease as well as additional preclinical stage programs targeting Infection Protection in medically compromised patients.
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.
Recent news on these stocks:
July 17
Alterity Therapeutics announced positive interim data from the ATH434-202 open-label Phase 2 clinical trial in patients with multiple system atrophy. ATH434 has been shown preclinically to reduce alpha-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. The interim analysis included clinical and biomarker data on 7 participants treated with ATH434 for 6 months and neuroimaging data on 3 participants who were treated for 12 months. After 6 months of treatment, 43% of participants showed improvement on the UMSARS1, indicating reduced disability on activities of daily living. Over the same period, 29% of participants had stable or improved neurological symptoms as assessed by both the treating physician and the patient. Importantly, the clinical responders on average had reduced accumulation of iron on MRI in the substantia nigra, putamen and globus pallidus and stable levels of NFL, a marker of axonal injury, when compared to participants who declined. A total of 10 participants have been enrolled in the trial. The interim data reported today is from the 7 patients who have completed six months of treatment with ATH434, 3 of whom have also completed 12 months of treatment. Only neuroimaging data are available from month 12. The participants in the trial were diagnosed with MSA using a multimodal approach and treated with oral ATH434 75 mg twice daily. Clinical, biomarker and safety assessments were conducted during the study. While the data are preliminary, the Company sees a positive trend with the current participant patient outcomes. Clinical Assessments at Month 6: Unified MSA Rating Scale Part I, historical review: 43% of participants had lower scores on the UMSARS that assesses activities of daily living affected in MSA, such as speech, swallowing, walking and urinary/bowel function. In the trial, mean UMSARS scores increased from baseline to 6 months by 1.7 points. These study data compare favorably to historical data in a similar MSA population that demonstrated an increase of 3.9 points over 6 months. Global Impression of Change: 29% of participants stabilized or improved on the Clinical Global Impression of Change scale, which asks the investigator to evaluate overall neurological symptoms as compared to immediately before starting therapy. 29% of participants also stabilized or improved on the Patient Global Impression of Change scale which asks the patient to evaluate their overall neurological symptoms as compared to immediately before starting therapy. Safety: In general, ATH434 was well tolerated by study participants and most adverse events were mild to moderate in severity. No serious adverse events related to study drug were reported. Biomarker Assessments at Month 6 and Month 12: MRI Biomarkers: Brain Volume: At Month 6, there were similar declines in brain volume, as assessed by the MSA-atrophy index in all participants consistent with the nature of MSA. However, in the clinical responders, brain volume assessed by the MSA-AI was stable between Month 6 and Month 12. Iron content in the substantia nigra was stable over 12 months in the clinical responders. Myoinositol is an exploratory biomarker of glial cell pathology in MSA. Treatment with ATH434 led to smaller increases in myoinositol in clinical responders compared to participants who worsened. Fluid Biomarkers: Neurofilament Light Chain is a marker of axonal injury in neurons and has been shown to correlate with disease severity in many neurological diseases. In the trial, clinical responders had stable spinal fluid NfL levels on average whereas those who declined clinically had increased spinal fluid NfL levels.
Adverum Biotechnologies announced results from the landmark 26-week interim analysis of the ongoing LUNA Phase 2 trial of Ixo-vec in patients with wet age-related macular degeneration, or AMD. These data are being presented by Charles Wykoff at the 42nd annual meeting of the American Society of Retinal Specialists in Stockholm, Sweden. Both the 6E10 and 2E11 doses demonstrated maintenance of visual and anatomic outcomes. Notably, both doses resulted in a potentially best-in-class percentage of patients remaining free of anti-vascular endothelial growth factor, or VEGF, injections and reduction in annualized anti-VEGF injections and, with data trending similar to or better than the OPTIC study. Ixo-vec demonstrated a significant proportion of patients injection free at both doses at week 26. 6E10: 76% of patients injection free; 2E11: 83% of patients injection free; Ixo-vec demonstrated a significant reduction in mean annualized anti-VEGF injections at week 26. 6E10: 90% reduction in mean annualized anti-VEGF injections and 2E11: 95% reduction in mean annualized anti-VEGF injections. Visual, or BCVA, and Anatomic, or CST, Outcomes: Visual acuity was maintained at both dose levels - least squares mean BCVA change from baseline at week 26: 6E10: -1.1, 2E11: -2.2. Fluid control was maintained at both dose levels - least squares mean CST change from baseline at week 26: 6E10: -12.6, 2E11: -12.0. Sub-group with CST greater than 300 microm at baseline: -30.2. Ixo-vec was well tolerated at both doses. No Ixo-vec-related serious adverse events. No episcleritis, vasculitis, retinitis, choroiditis, vascular occlusion, or hypotony. All Ixo-vec-related adverse events were either mild or moderate. The most common Ixo-vec-related adverse events were dose-dependent anterior inflammation responsive to local corticosteroids and anterior pigmentary changes with no impact on vision. Improved inflammatory profile observed with enhanced corticosteroid prophylaxis in LUNA as compared to OPTIC. Oral prednisone did not demonstrate incremental benefit. Ozurdex without difluprednate did not provide adequate prophylaxis. All of the patients receiving the difluprednate-alone prophylactic regimen have completed their prophylaxis, enabling evaluation of this regimen at the interim analysis. Inflammation was dose-dependent and, when present, was responsive to local corticosteroids. 6E10: 100% of patients have no or minimal inflammation at the 26-week timepoint. No participants at 6E10 received corticosteroids for treatment of inflammation beyond the scheduled prophylaxis. 2E11: 90% of patients have no or minimal inflammation at the 26-week timepoint. Topical difluprednate effectively managed inflammation when present. For the LUNA interim analysis, a pre-specified Patient Preference Survey was performed at week 26 to understand patient preferences after receiving Ixo-vec, including whether patients preferred Ixo-vec, along with the accompanying prophylactic regimen, over prior treatments and whether patients would elect to receive Ixo-vec in the fellow eye. At the 26-week landmark analysis, 88% of the entire LUNA patient population responded that they would prefer Ixo-vec therapy over the prior treatment(s) they received, and 93% responded that they would want to receive Ixo-vec in the fellow-eye if they had bilateral disease. Of the patients receiving 6E10 and the difluprednate-alone prophylactic regimen: 100% responded that they would prefer Ixo-vec therapy over the prior treatments received; and, 100% responded that they would want to receive Ixo-vec in the fellow eye.
Aslan Pharmaceuticals announced that its Singapore-incorporated, sole operating subsidiary, Aslan Pharmaceuticals, has filed for voluntary liquidation. The decision follows a comprehensive review by the board of the company of Aslan SG's financial position and strategic alternatives. Effective immediately, all employees of Aslan SG and fellow subsidiary Aslan Pharmaceuticals have been terminated. By a resolution in writing passed by the directors of Aslan SG on July 17, 2024, it was resolved that Aslan SG cannot by reason of its liabilities continue its business, and Mr Luke Anthony Furler and Mr Tan Kim Han of Quantuma were appointed as joint and several provisional liquidators of Aslan SG. The Provisional Liquidators will be responsible for the orderly winding up of Aslan SG's affairs, including seeking potential strategic alternatives for its development programs and the company's primary assets, eblasakimab and farudodstat, settling outstanding obligations, and distributing any remaining proceeds, if any, to creditors and shareholders, including the company, in accordance with Singaporean law. Following the resolution in writing of the directors of Aslan SG, the board of the company also resolved by a resolution in writing that the company cannot by reason of its liabilities continue its business and that the company will apply for liquidation under Cayman law procedures. As previously disclosed on July 15, 2024, the company has received a staff delisting determination from the Nasdaq Stock Market due to its failure to meet continued listing requirements, and determined not to request a hearing before the Nasdaq Hearings Panel. As such, the company expects its American Depository Shares will be suspended from trading in due course with trading moved to the over-the-counter market.
Cassava Sciences announced that the board has appointed Richard Barry as executive chairman and as the company's principal executive officer, effective immediately. The company is undertaking a search for a new permanent CEO. Barry succeeds Remi Barbier, the company's chairman, president and CEO, who resigned from the company and the board. Barbier will remain employed by the company until September 13, in a non-executive capacity, without duties or responsibilities. Lindsay Burns, Ph.D., SVP, Neuroscience, at Cassava is also leaving the employ of the company. Cassava and Burns have agreed that she step down from her role with the company, effective immediately. Following her separation from the company and for a one-year period, Dr. Burns will furnish consulting services as, and to the extent, reasonably requested by Cassava for purposes of providing information and support for scientific research and/or obtaining governmental approval for the company's products. Cassava may, in its sole discretion, extend the term of the consulting agreement for up to an additional year.
July 16
BioXcel Therapeutics announced preliminary estimated unaudited net revenue results from sales of IGALMI sublingual film for the second quarter ended June 30. The company expects unaudited revenue of approximately $1.1M for the three months ended June 30, representing an increase of approximately 90% quarter over quarter and approximately 141% compared to the same period in 2023. Revenue growth was driven by an increase in contracting with psychiatric care clinics and behavioral health facilities using a small commercial team.
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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.
