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UBX, CYCN, GMDA...
3/29/2023 11:03am
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:

  • Unity Biotechnology (UBX), 653% surge in interest
  • Cyclerion Therapeutics (CYCN), 629% surge in interest
  • Gamida Cell (GMDA), 344% surge in interest
  • Jounce Therapeutics (JNCE), 213% surge in interest
  • Oncosec Medical (ONCS), 119% surge in interest


Pipeline and key clinical candidates for these companies:

Unity Biotechnology is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. Unity Biotechnology’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases.

Cyclerion Therapeutics is working to develop treatments for mitochondrial diseases, including MELAS. Cyclerion’s lead molecule is CY6463, a novel, first-in-class, CNS-penetrant sGC stimulator that modulates a key node in a fundamental signaling network. CY6463 is currently in clinical development for MELAS where it has shown rapid improvement in multiple disease-relevant biomarkers, the company says.

Gamida Cell is at work on an immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. The company applies a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapy candidates with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies.

Jounce Therapeutics is a clinical-stage immunotherapy company that currently has multiple development stage programs ongoing. Jounce’s highest priority program, JTX-8064, is a LILRB2 receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. JTX-8064 is currently being investigated alone and in combination with pimivalimab, Jounce’s internal PD-1 inhibitor, in one monotherapy and eight indication-specific combination therapy cohorts in the Phase 1/2 INNATE trial and is currently enrolling patients with advanced solid tumors in the Phase 2 portion of the study. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. Additionally, Jounce exclusively licensed worldwide rights to GS-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences (GILD).

OncoSec Medical is focused on developing intratumoral immunotherapies to stimulate the patient's immune system to target cancer cells and eradicate disease. OncoSec's lead immunotherapy investigational product candidate – TAVO, tavokinogene telseplasmid – enables the intratumoral delivery of DNA-based interleukin-12, a naturally occurring protein with immune-stimulating functions. OncoSec's clinical pipeline is utilizing TAVO as a potential treatment for multiple cancer indications either as a monotherapy or in combination with checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. Results from completed clinical trials of TAVO have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with a well-tolerated safety profile, warranting further development of TAVO-EP.


Recent news on these stocks:

March 28

H.C. Wainwright analyst Vernon Bernardino lowered the firm's price target on Gamida Cell to $5 from $22 and keeps a Buy rating on the shares. The company provided a business update that was highlighted by outlines for plans to restructure operations, prioritize resources for an expected omidubicel launch, and explore strategic options to support the launch of omidubicel, a candidate hematopoietic stem cell transplant therapy for patients with blood cancers, the analyst tells investors in a research note. The firm continues to assume Gamida launches omidubicel independently, saying it may take time for potential partnership discussions to result in a licensing deal. It assumes the company conducts potential financings of $15M in 2023, and $50M in 2024, "which at current share prices would be significantly dilutive."

OncoSec files to sell 11.66M shares of common stock, and also files to sell common warrants to purchase 11.66M shares of common stock. A.G.P./Alliance Global Partners is acting as sole placement agent.

March 27

Unity Biotechnology announced results from Part A of the Phase 2 ENVISION study of UBX1325 in patients with wet age-related macular degeneration, AMD, who were not achieving optimum benefit with their ongoing anti-VEGF therapy. UBX1325 treatment generally maintained visual acuity for 6 months, with a majority of patients not requiring any anti-VEGF rescue. Patients in the every 8-week aflibercept arm had an early and unexpected gain of 3.5 letters at week 2 which was mostly maintained for the duration of the study. As a result of the strength on the control arm, the study did not meet the non-inferiority threshold compared to aflibercept through 24 weeks. Phase 2 ENVISION data through 24 weeks: UBX1325 demonstrated a favorable safety and tolerability profile with no cases of intraocular inflammation, retinal artery occlusion, endophthalmitis, or vasculitis; Patients treated with UBX1325 had a mean change from baseline in BCVA of -0.8 ETDRS letters at 24 weeks compared to +3.1 ETDRS letters in the aflibercept control arm; Patients treated with UBX1325 had a mean change from baseline in CST of +87.3 microm at 24 weeks compared to +30.5 microm in the aflibercept control arm; 52% of UBX1325-treated patients went at least 24 weeks without receiving anti-VEGF treatment; 92% of UBX1325-treated patients achieved a maximal anti-VEGF treatment-free interval of 12 weeks or longer; The ENVISION study did not meet the non-inferiority margin of -4.5 letters compared to aflibercept with an 85% confidence interval.

Cyclerion Therapeutics announced that the U.S. Food and Drug Administration has granted orphan drug designation to zagociguat for the treatment of mitochondrial diseases. "Orphan drug designation underscores the FDA's recognition of zagociguat's potential promise as a first-ever therapy for patients with MELAS, a rare, genetic mitochondrial disease," said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion. "Cyclerion is working expeditiously to advance this potential treatment to help address the immense unmet needs of patients with MELAS, a patient population in desperate need of therapies."

Jounce Therapeutics entered into a definitive merger agreement whereby Concentra Biosciences will acquire Jounce for $1.85 in cash per share plus a non-tradeable contingent value right. The $1.85 per share upfront consideration represents a premium of approximately 75% to Jounce's closing share price immediately prior to the March 14, 2023 public disclosure of Concentra's acquisition proposal. In conjunction with the merger agreement, Jounce is implementing a workforce reduction of approximately 84% of its employees. This reduction is expected to be completed within the next month and Jounce will incur restructuring costs totaling approximately $6.5M.


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 15-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.

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