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: 

• Medicinova (MNOV), 9,967% surge in interest
• NanoString Technologies (NSTG), 545% surge in interest
• Hookipa Pharma (HOOK), 197% surge in interest
• Iovance Biotherapeutics (IOVA), 72% surge in interest
• Anavex Life Sciences (AVXL), 66% surge in interest
• Seres Therapeutics (MCRB), 61% surge in interest
• Altamira Therapeutics (CYTO), 61% surge in interest
• Fortress Biotech (FBIO), 56% surge in interest

Pipeline and key clinical candidates for these companies:

MediciNova is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 and MN-001, with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166, is currently in Phase 3 for amyotrophic lateral sclerosis and degenerative cervical myelopathy and is Phase 3-ready for progressive multiple sclerosis. MN-166 is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis and a second Phase 2 trial in non-alcoholic fatty liver disease is ongoing.

NanoString Technologies says it offers “an ecosystem of innovative discovery and translational research solutions” to map the universe of biology – including the GeoMx Digital Spatial Profiler, the CosMx Spatial Molecular Imager and the AtoMx Spatial Informatics Platform. The CosMx SMI and AtoMx SIP platforms are expected to launch in 2022.

Hookipa Pharma is focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. Hookipa’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, prostate cancers, and other undisclosed programs.

Iovance Biotherapeutics is focused on developing and delivering tumor infiltrating lymphocyte, or TIL, therapies for patients with cancer. Its lead late-stage TIL product candidate, lifileucel for metastatic melanoma, “has the potential to become the first approved one-time cell therapy for a solid tumor cancer,” said the company, adding that its TIL platform has “demonstrated promising clinical data across multiple solid tumors.”

Anavex Life Sciences is a biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, and other central nervous system diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX2-73, has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX2-73 for the treatment of Parkinson’s disease. 

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.

Altamira Therapeutics is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets via the OligoPhore/SemaPhore platforms; nasal sprays for protection against airborne allergens and, where approved, viruses or for the treatment of vertigo; and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss.

Fortress Biotech is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy.

Recent news on these stocks:

November 22

Anavex Life Sciences announced that the United States Patent and Trademark Office, USPTO, granted U.S. Patent No. 11,813,242 entitled “A2-73 AS A THERAPEUTIC FOR INSOMNIA, ANXIETY, AND AGITATION”. This patent expands Anavex’s existing patent coverage of ANAVEX2-73, including U.S. Patent No. 11,337,953 to cover Anavex’s leading drug candidate, ANAVEX2-73, ANAVEX1-41 and ANAVEX19-144, for treating insomnia, anxiety or agitation. This newest patent is expected to remain in force at least until July 2037, not including any patent term extension. Together with Anavex U.S. Patent No. 11,337,953, which is expected to remain in force at least until 2038, not including any patent term extension, the two patents provide extensive coverage of ANAVEX2-73 for use in treating either insomnia or anxiety, used alone or in combination with ANAVEX19-144 or ANAVEX1-41. The two patents broadly cover a range of dosage forms in treating known co-morbidities in Alzheimer’s disease including but not limited to oral, injectable, topical, inhalable, subcutaneous, intranasal and sublingual dosage forms. “This granted USPTO patent is not only another important milestone in protecting the commercial potential of ANAVEX2-73 and Anavex’s other lead compounds with the practical value of delivering holistic care for patients with Alzheimer’s dementia or Parkinson’s diseases, who often concurrently suffer from insomnia and/or anxiety, but along with other recent allowances, demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our entire product portfolio,” said Christopher Missling, PhD, CEO of Anavex.

November 20

TD Cowen downgraded NanoString to Market Perform from Outperform with a price target of $1.40, down from $6, after NanoString on Friday withdrew its FY23 guidance after 10x Genomics (TXG) won a verdict in a patent case against the company as the U.S. District Court for the District of Delaware found that NanoString’s GeoMx Digital Spatial Profiler products infringe patents licensed to 10x Genomics. The company’s prospects are less visible following this and other patent losses and pending upcoming case decisions, the analyst told investors.

HOOKIPA Pharma announced that the company has received clearance from the FDA for its Investigational New Drug application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV. HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial. Gilead has the exclusive right to assume further development of the program thereafter. Nature Partner Journals Vaccines recently published the joint-preclinical research by HOOKIPA and Gilead, which served as the foundation for the IND submission. The analyses published were conducted with a simian immunodeficiency virus model, commonly used in a preclinical setting as a surrogate to HIV. The data show that: Arenaviral therapeutic vaccination was well tolerated and generated robust, high-quality and durable immune responses in non-human primates; and, Arenaviral therapeutic vaccination significantly reduced SIV viral load and clinical illness in those animals compared to placebo. HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine for the treatment of HIV. One vector is based on lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on Pichinde virus. Both encode the same HIV antigens. The alternating 2-vector approach is designed to further focus the immune response against the target antigen.

Goldman Sachs initiated coverage of Iovance Biotherapeutics with a Buy rating and $12 price target. The company is developing autologous tumor-infiltrating lymphocyte therapies for solid tumor cancers with lead asset lifileucel under regulatory review, the analyst tells investors in a research note. The firm says the upcoming approval of the first TIL therapy will transition Iovance to a commercial company and it is constructive on the near- and long-term launch potential given lifileucel’s “best-in-class” profile and early signs of key opinion leader enthusiasm.

November 19

MediciNova announced that the company’s collaborator has presented new data and results of a Phase 2 clinical trial of MN-166 in glioblastoma patients at the 28th Annual Meeting of the Society for Neuro-Oncology held November 15 – 19, 2023 in Vancouver, Canada. The presentation also included data from preclinical studies which evaluated the combination of MN-166 and anti-PD1 or anti-PD-L1 therapy in GBM models. The primary endpoints of this Phase 2 clinical trial were safety and tolerability of MN-166 and temozolomide combination treatment and efficacy of the combination treatment defined as progression-free survival rate at 6 months using the RANO criteria. MN-166 and TMZ combination treatment was safe and well-tolerated, and no unexpected adverse effects were reported. The trial enrolled a total of 62 patients, including 36 newly diagnosed GBM patients and 26 recurrent GBM patients. Progression-Free Survival at 6 months was 44% for new GBM and 31% for recurrent GBM. Immunohistochemistry evaluation was performed for the patients whose pre-treatment tumor tissue samples were available from resected tumors at the initial surgery or biopsy to evaluate MIF, pERK, Ki67, CD3, CD11b, and CD74. CD3 expression was a good predictor for tumor progression at five months in recurrent glioblastoma subjects treated with MN-166 and TMZ as subjects with progression had higher CD3 tumor infiltration than subjects with no progression.

November 17

Altamira Therapeutics has entered into a binding agreement for the sale of a 51% stake in its subsidiary Altamira Medica AG to a Swiss private equity investor as part of its strategic repositioning around its RNA delivery technology. Medica’s key asset is Bentrio, a drug-free OTC nasal spray utilized for the treatment of allergic rhinitis, which has been cleared by the FDA and is being commercialized in a growing number of countries. Altamira has agreed to sell the 51% stake in Medica for a cash consideration of CHF 2,040,000 and will retain 49% of the company’s share capital. Further, Altamira will be entitled to receive 25% of Medica’s future licensing income. In addition, the transaction includes the sale of Auris Medical Pty Ltd, Melbourne and a cash contribution of CHF 1,000,000 in total to Medica’s capital by its two shareholders pro rata of their shareholdings following the closing. Medica will continue its operations under its current name and with current staff in collaboration with Altamira. The transaction is set to close on November 21, 2023, subject to customary closing conditions. The Company anticipates recording a financial gain of approximately $5.2 million from the transaction in accordance with International Financial Reporting Standards.

November 14

Fortress Biotech reported Q3 EPS (94c), consensus ($3.21), and reported Q3 revenue $34.8M, consensus $14.58M. CEO Lindsay Rosenwald, M.D., said, “In the third quarter of 2023, Fortress and our partner companies and subsidiaries continued to advance our diverse portfolio of drug candidates. Our total consolidated net revenue this quarter was $34.8M, which includes an upfront payment of $19M that Journey Medical received upon entering into an exclusive license agreement with Maruho for commercialization of Qbrexza in additional territories in Asia. We’re looking forward to multiple significant near-term milestones, including potentially up to four New Drug Application and Biologics License Application submissions to the U.S. Food and Drug Administration between 2023 and 2025, one of which is a NDA for DFD-29 to treat rosacea around the end of this year. We are also anticipating the PDUFA goal date of January 3 for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ”

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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.