Tonix Pharmaceuticals to Present at B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference

Research, News, and Market Data on Tonix Pharmaceuticals

 

CHATHAM, N.J., April 25, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, President and Chief Executive Officer of Tonix Pharmaceuticals, will present at B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference on Wednesday, April 27, 2022, at 1:00 p.m.ET.

A webcast of the presentation will be available under the IR Events tab of the Tonix website at www.tonixpharma.com.

About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500¹ which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-2900² for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-801³, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850⁴, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-3500⁵ (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL⁶, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-1300⁷ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

¹TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
²TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
³TNX-801 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
⁴TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
⁵TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
⁶TNX-102 SL is an investigational new drug and has not been approved for any indication.
⁷TNX-1300 is an investigational new biologic and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Ocugen, Inc. Announces Positive DSMB Recommendation For OCU400-101 Clinical Trial

Research, News, and Market Data on Ocugen

 

PHASE 1/2 STUDY TO ASSESS THE SAFETY AND EFFICACY OF OCU400 MODIFIER GENE THERAPY CANDIDATE TO TREAT RETINITIS PIGMENTOSA ASSOCIATED WITH NR2E3 AND RHO MUTATIONS

MALVERN, Pa., April 25, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines, announced today that the independent Data and Safety Monitoring Board (DSMB) for its Phase 1/2 clinical trial of OCU400, the Company’s flagship modifier gene therapy candidate for the treatment of Retinitis Pigmentosa (RP), reviewed safety data based on dosing to date and recommended that the study proceed with enrolling additional subjects.

The OCU400-101 clinical study to assess the safety and efficacy of modifier gene therapy candidate OCU400 for RP resulting from mutations in the nuclear receptor subfamily 2 group E member 3 (NR2E3) and Rhodopsin (RHO) genes recently dosed its first patient. The DSMB recommended that the Company continue enrolling the remaining study subjects in this current cohort at the target dose level.

Ocugen’s modifier gene therapy platform targets nuclear hormone receptors (NHRs) that regulate multiple functions within the retina, giving it the potential to address many different gene mutations – and in turn, multiple retinal diseases – with a single product. Traditional gene therapy, which transfers a functional version of a non-functional gene into target cells, addresses only one individual gene mutation at a time.

“It’s a positive first step that the DSMB review of the current OCU400-101 study results identified no serious adverse events and recommended that the study proceed with enrollment,” said Mark Pennesi, MD, PhD, Professor of Ophthalmology and Chief of the Paul H. Casey Ophthalmic Genetics Division, Oregon Health & Science University, and member of Ocugen’s Retina Scientific Advisory Board. “We’re looking forward to understanding how this modifier gene therapy platform could treat inherited retinal degeneration, potentially bringing an option to people affected with this disease.”

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including with respect to our Phase 1/2 trial included in our Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for OCU400, which is actively enrolling patients following review of preliminary safety data by the independent Data and Safety Monitory Board. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; and the risk that the Orphan Drug Designations from the FDA and broad Orphan Medicinal Product Designation from the European Commission for OCU400 may not result in a faster approval timeline for OCU400 or increase the likelihood of any such approvals These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

 

Lineage Announces A Fifth Cell Therapy Program: Allogeneic Photoreceptor Transplants For The Treatment Of Diseases Which May Lead To Blindness

Research, News, and Market Data on Lineage Cell Therapeutics

 

Dynamic Culturing Process Developed by Lineage Offers Path to Clinical- and Industrial-Scale Production of Photoreceptors

CARLSBAD, Calif.–(BUSINESS WIRE)–Apr. 25, 2022– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced a new cell therapy development program: photoreceptor neural cell (PNC) transplants for the treatment of vision loss due to photoreceptor dysfunction or damage. Similar to the company’s recently announced pipeline expansion into auditory neurons for the treatment of hearing loss, Lineage has filed for intellectual property protection covering the composition and methods for generating PNCs. Based on recent in vivo data generated using the company’s PNCs, these cells may be capable of forming reconstructed retina with high survivability and neural connectivity to surrounding functional layers. Notably, Lineage has demonstrated feasibility which could support a large-scale method for producing both types of photoreceptors, known as rods and cones.

“It is natural that, on the heels of the announcement of our alliance with Roche and 
Genentech for our RPE cell therapy, a deal worth up to 
$670 million dollars plus double-digit royalties if certain development, approval, and sales milestones are achieved and other conditions are met, that we also would pursue treatments for vision loss through the other major cell type of the retina, the photoreceptors,” stated  Brian Culley, Lineage’s CEO. “Our fundamental technology and accumulated know-how give us the opportunity to make many different cell types, and we have demonstrated our ability to create new programs rapidly and efficiently in two distinct areas, expanding our cell therapy pipeline to five separate preclinical and clinical programs, while still maintaining what we believe is an appropriate and responsible rate of investment for a company of our size. This latest program is part of our long-term planning for clinical and commercial success and serves as another example of the capability of our technology platform. We believe our ability to, in just a matter of months, advance from a product concept to generating new intellectual property and manufacturing the desired cell types, is illustrative of the power and efficiency of our platform. We believe the combination of our capital discipline and current balance sheet will support multiple years of further progress, during which we anticipate reaching achievements with each of our clinical and preclinical programs.”

Dr.  Rami Skaliter, who leads the manufacturing function for Lineage, added, “I’m exceptionally proud of the team’s success at overcoming obstacles related to the limited scale of photoreceptor production. Building upon our experience with other cell lineages, we have developed intellectual property, and filed for patent protections, on a manufacturing process which is compatible with large-scale production of photoreceptors in a closed system, improvements which could enable industrial manufacturing. We believe this accomplishment will provide new opportunities for clinical, and ultimately commercial, production of photoreceptors in areas of large unmet need such as Retinitis Pigmentosa, Stargardt’s Macular Dystrophy, and retinal detachments, either independently or through strategic alliances.”

As part of a scientific collaboration with Professors  Benjamin Reubinoff, M.D., Ph.D. and  Eyal Banin, M.D., Ph.D., of the 
Hadassah-Hebrew University Medical Center, the differentiation of pluripotent cells into photoreceptors with clinically compatible characteristics was established utilizing a novel differentiation protocol which generated positive identity of key markers of both rods and cones photoreceptor populations. The data generated by the company further demonstrated that a single cell suspension of photoreceptor precursor cells has the potential to survive and mature post-transplantation in a rodent model of retinal degeneration.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and
Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy, and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to (i) the potential amount of payments to Lineage under the alliance with 
Hoffman-La Roche Ltd. (“Roche”) and 
Genentech, Inc., (ii) the potential for new opportunities for clinical, and ultimately commercial, production of photoreceptors in areas of large unmet need, (iii) Lineage’s position to become a leader in the emerging field of regenerative medicine and anti-aging technology, and (iv) future areas of potential treatment using PNC transplant. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen, which could materially adversely affect the payments payable to Lineage under the Roche/
Genentech collaboration and license agreement, the risk that Roche/
Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; the risk that Lineage might not succeed in developing products and technologies that are useful in medicine and demonstrate the requisite safety and efficacy to achieve regulatory approval in accordance with its projected timing, or at all; the risk that Lineage’s intellectual property may be insufficient to protect its assets; risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Mike Biega
(Mbiega@soleburytrout.com)
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Image Credit: Bridget Samuels (Flickr)

The NobleCon18 Panel of Psilocybin Experts Clearly Demonstrated Potential Medical Benefits

 

The panel discussion on psilocybin at NobleCon18 was led off by one of the most credible people I have heard speaking at any investor conference about the possibilities of their industry. He was a former professional athlete whose brain function, as a result of his career choice, left him a shell of who he had been. On stage with three other CEOs, from different corners of this growing mental health field, the panel provided excitement for both the future of helping people overcome brain health issues and providing investment opportunities in an industry that is sure to mushroom.

The Line-up

Eric Bolling, TV Personality and Host of Eric Bolling The Balance (Moderator)

Daniel Corcillo, CEO, Wesana Health (Panelist)

Evan Levine, CEO, Psybio Therapeutics (Panelist)

Ben Lightburn, CEO, Filament Health (Panelist)

Justin Dye, CEO, Schwazze (Panelist)

 

Expert Thoughts

Daniel Corcillo spoke directly to the audience at the open as someone who has benefitted from psilocybin treatments. Corcillo, who is now the CEO of Wesana Health (WSNAF) had played professional hockey for 12 years. During that time he had suffered seven concussions. This forced Dan’s early retirement. As a husband and dad, he pushed himself to find the cure for his brain fog, depression, and dementia-like symptoms.

After five years of trying all the clinical therapies that modern medicine has to offer, he sought supervised treatment with psilocybin. Dan laid out for the NobleCon investor audience, in the kind of detail that demonstrated that his mind was now extremely sharp, his very short successful treatment. A treatment that he said, after two weeks, had him “feeling the way I should.” And after six months having bloodwork that showed everything had equalized.

From Left to Right: Justin Dye (SHWZ), Ben Lightburn (FLHLF), Evan Levine (PSYBF), Dan Corcillo (WSNAF) and Eric Bolling (Newsmax)

 

It was after Mr. Corcillo shared his story that prompted him to become involved in the business itself to help others, that he was joined by Evan Levine of Psybio Therapeutics (PSYBF), Ben Lightburn of Filament Health (FLHLF), and Justin Dye of Schwazze (SHWZ).

The discussion ventured beyond mushrooms to at times include other psychedelic drugs and highly regulated substances like, MDNA, LSD, and Cannabis. 

Mr. Levine’s company Psybio creates biosynthetic psilocybin in a lab at a fraction of the price of growing mushrooms. From a medical treatment perspective, he and his firm emphasize the benefit of knowing exactly what the measurement is for dosing.

While agreeing that precise dosing measurements are important, Mr. Lightburn expressed that botanicals (not synthetic) allow all the chemicals to make it into the final product. He said this provides what he called the “entourage effect.” Other panelists referred to the interplay between chemicals as the “innate synergy.”                         

We learned from Mr. Dye that he does not expect the “magic mushroom” market to eat into the cannabis market either from a recreational or medicinal standpoint. He explained that it is additive as medical caregivers operating on the West coast now have options as to how to best treat individual patients.

The Industry

The antidepressant industry is $100 billion and growing. SSRIs have been the standard of care since the 1980s and are fraught with problems. Opioid use is a problem that is not going away, and more research should be done concerning this problem.

Having a legal framework under which to operate could allow for faster research on products that don’t have the addictive tendencies of problem drugs, have a history of safety, and are not prone to overdosing.

The industry of providing psilocybin therapeutic centers could create the need for many therapists, as the oversight is hands-on and interactive for about 42 hours.

While most panelists see more decriminalization of magic mushrooms locally, they don’t expect full legalization, especially as it relates to recreational use. One panelist did point out that in Vancouver, un-regulated mushrooms are sold openly and even advertised in store windows.

 

Paul Hoffman

Managing Editor, Channelchek

 

Suggested Reading:

Psychedelic Laws and Investments May Follow Cannabis’ Success

The Lasting Benefit of Psilocybin Treatment for Extreme Depression

Mapping Psilocybin’s Effect on the Brain

Acceptance of Psychedelics for Wellness and Recreation

 

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electroCore Announces Publication of Investigator-Initiated Trial Data for SAVIOR-1 in COVID-19 Patients in Frontiers in Neurology

News and Market Data on electroCore

 

ROCKAWAY, N.J., 
April 21, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that Frontiers in Neurology has published results from an investigator-initiated trial, SAVIOR-1, a prospective, randomized, controlled study evaluating non-invasive vagus nerve stimulation (nVNS) using gammaCore Sapphire™ in patients admitted to the hospital for treatment of COVID-19. 

The SAVIOR-1 trial was conducted by principal investigator Dr.  Carlos Tornero, Head of the 
Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Clínico Universitario de 
Valencia, Spain, between 
April 2020 and 
February 2021. The trial targeted patients over 18 years of age and enrolled 110 patients, randomly assigned, with 55 patients in each group. Of the 110 patients, 97 patients (47 in the nVNS treatment group, 50 in the control group) provided baseline demographic and medical history data and were the evaluable population. The study evaluated the safety and feasibility of nVNS when administered in addition to the then-standard of care in patients hospitalized with active SARS-CoV-2 infection compared with the standard of care alone.

The study identified significant treatment differences for certain biomarkers of inflammation. Decreases from baseline in C-reaction protein (CRP) levels were significantly greater in the nVNS treatment group as compared to the control group throughout the five-day period combined (p=0.011) and on day 5 compared to the day 1 baseline period alone (p=0.015). On day 1, CRP levels were highly elevated for 90% of all subjects, but by days 3 and 5, the percentage of subjects with normal CRP levels improved markedly in the nVNS group with day 3 CRP levels at 17.9% vs. 52.2% in the control (p=0.010). Additionally, the nVNS group had a significantly greater decrease from baseline in procalcitonin level at day 5 (p=0.012) as compared to the control group. Increased levels of CRP, procalcitonin, and d-dimer have all been reported to be associated with more severe disease and the lower levels of these markers in the nVNS treated group may represent the initial impact of nVNS therapy to potentially improve the course of a patients’ COVID-19 symptoms.

nVNS was well tolerated with no major device-related adverse events and the therapy was administered three times daily to most patients as outlined in the study protocol.

“We are thrilled that the SAVIOR-1 article has been peer-reviewed and published in the Frontiers in Neurology journal,” mentioned Dr.  Peter Staats, Chief Medical Officer at electroCore. “We are encouraged by this publication as Frontier’s rigorous process for peer-reviewing articles further strengthens and validates our nVNS technology and its relevancy and potential to mitigate some of the symptoms associated with COVID-19.” 

The Frontiers in Neurology publication is available here.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore is self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

For more information, please visit gammaCore.com

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements regarding electroCore’s business prospects, the results from investigator-initiated trials, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat COVID-19, and other statements that are not historical in nature, particularly those using terminology such as “anticipates,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to obtain additional financing necessary to continue electroCore’s business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the
SEC, available at www.sec.gov.

Contact:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

Cocrystal Pharma Collaborates with the National Institute of Allergy and Infectious Diseases to Evaluate COVID-19 Protease Inhibitors

Research, News, and Market Data on Cocrystal Pharma

 

BOTHELL, Wash., April 21, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces a Non-Clinical Evaluation Agreement (NCEA) with the National Institute of Allergy and Infectious Diseases (NIAID) for exploratory preclinical studies to evaluate the potential of Cocrystal’s 3CL protease inhibitors for the treatment of COVID-19. Cocrystal applied its proprietary drug discovery platform technology to develop novel, broad-spectrum SARS-CoV-2 3CL protease inhibitors. Under the NIAID collaboration, Cocrystal has provided its 3CL protease inhibitors, and the NIAID will be responsible for in vitro and in vivo studies evaluating the antiviral activity of the compounds.

“We are pleased to collaborate with NIAID to further evaluate Cocrystal’s SARS-CoV-2 3CL protease inhibitors. Cocrystal is committed to identifying safe and effective treatments for infectious diseases including those caused by SARS-CoV-2 and other coronaviruses,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “We are pleased that the NIAID has researched our novel, broad-spectrum protease inhibitors and has determined that further evaluation in an animal model is warranted. Studies to date show that our protease inhibitors exhibit superior in vitro potency against SARS-CoV-2 and variants of concern including Omicron.”

A division of the National Institutes of Health (NIH), NIAID conducts and supports basic and applied research to better understand, treat and ultimately prevent infectious, immunologic and allergic diseases. Dr. Anthony S. Fauci, M.D. was appointed Director of the NIAID in 1984. More information is available at niaid.nih.gov/.

About Cocrystal SARS-CoV-2/Coronavirus Programs
Cocrystal is developing COVID-19 drug candidates that specifically target proteins involved in viral replication. Despite the various strains of virus that may exist or emerge, these enzymes are required for viral replication and are essentially similar (highly conserved) among all strains. By targeting these highly conserved regions of the replication enzymes, Cocrystal’s antiviral compounds are designed and tested to be effective against major virus strains. Additionally, Cocrystal believes it is possible to develop an effective treatment for all coronavirus diseases including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). The Company’s main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that frequently cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our collaboration with NIAID and our ability to develop an effective treatment for all coronavirus diseases. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from any future impact of the COVID-19 pandemic and the Russian invasion of Ukraine on the global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, the results of NIAID’s preclinical research of our 3CL protease inhibitors for the treatment of COVID-19, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2021. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

Source: Cocrystal Pharma, Inc.

Tonix Pharmaceuticals Announces Results of Retrospective Observational Database Study In Over 50,000 Long COVID Patients

Research, News, and Market Data on Tonix Pharmaceuticals

 

Over 40% of Long COVID Patients Had Fibromyalgia-Like Multi-Site Pain Symptoms

Rate of Opioid Use in Long COVID Patients with Multi-Site Pain is a Potential Health Concern

CHATHAM, N.J., April 20, 2022 (GLOBE NEWSWIRE) —  Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today the results of a retrospective observational database study in over 50,000 patients diagnosed with Long COVID^1-2. Long COVID is known officially as Post-Acute Sequelae of COVID-19 (PASC³). Tonix recently announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-102 SL⁴ (cyclobenzaprine HCl tablets for sublingual administration) as a potential treatment for a subset of patients with Long COVID whose symptoms overlap with fibromyalgia, and expects to initiate this study in the second quarter. The goal of the retrospective database study was to assess the proportion of Long COVID patients who experience fibromyalgia-like multi-site pain and to measure their use of opiates.

In the study, over 40% of patients with symptoms of Long COVID had fibromyalgia-like multi-site pain ^1,2. In addition, the study reported on the rate of opioid use in Long COVID patients. Opioid use noted was in 36% of Long COVID patients with multi-site pain symptoms relative to 19% of Long COVID patients without multi-site pain. In patients with multisite pain, opiate use increased to 39% of patients when fatigue was present, and 50% of patients when insomnia was present.

“We undertook this retrospective analysis in part to determine the feasibility and representative nature of our upcoming Phase 2 study of TNX-102 SL in patients with Long COVID who present with fibromyalgia-like multi-site pain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The finding that more than 40% of Long COVID patients in this sample have fibromyalgia-like multi-site pain symptoms suggests that we should be able to recruit a robust cohort of participants to test the effects of TNX-102 SL in treating this condition. Further, these findings suggest that the group of Long COVID patients with fibromyalgia-like multi-site pain represents a significant portion of this underserved population. Finally, the high level of opiate use reveals the urgency to provide effective non-opioid analgesia that is targeted toward widespread pain thought to be nociplastic in nature, meaning that augmented CNS pain and sensory processing, as well as altered pain modulation, play a role. The primary efficacy endpoint of the upcoming Phase 2 study will therefore be change from baseline in the weekly average of daily self-reported worst pain intensity scores.”

The study queried data from the TriNetX Dataworks USA Network. The network is a federated network of de-identified inpatient and outpatient electronic medical records from 48 U.S. healthcare organizations. From 75 million people in the network, approximately 1 million adults (18-65) had been diagnosed with acute COVID-19. Of these, approximately 260,000 followed up with a healthcare provider in the network within six months of having acute COVID-19. Of these, approximately 52,000 had Long COVID symptoms in the period between 3 and 6 months after acute COVID-19, which was the time-frame for the analysis for diagnostic codes consistent with multi-site pain, fatigue and insomnia.

¹Harris, H, et al. Tonix data on file. 2022
²TriNetX Analytics
³Feb. 24, 2021 – White House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from the World Health Organization on long COVID.
⁴TNX-102 SL is an investigational new drug and has not been approved for any indication.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500¹ which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-2900² for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-801³, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850⁴, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-3500⁵ (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-1300⁶ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022.

¹TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
²TNX-2900 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
³TNX-801 is a live horsepox virus vaccine for percutaneous administration in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
⁴TNX-1840 and TNX-1850 are live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. 
⁵TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
⁶TNX-1300 is an investigational new biologic and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

About TriNetX, LLC

TriNetX is a global health research network that connects the world of drug discovery and development from pharmaceutical company to study site, and investigator to patient by sharing real-world data to make clinical and observational research easier and more efficient. TriNetX combines real time access to longitudinal clinical data with state-of-the-art analytics to optimize protocol design and feasibility, site selection, patient recruitment, and enable discoveries through the generation of real-world evidence. The TriNetX platform is HIPAA and GDPR compliant.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Monday, April 18, 2022

Tonix Pharmaceuticals (TNXP)
A Broad Pipeline With Many Product Milestones Ahead

Tonix Pharmaceuticals Holding Corp is a clinical-stage pharmaceutical company. The company is engaged in discovering, licensing, acquiring and developing drugs and biologics to treat and prevent human disease and alleviate suffering. Its portfolio includes biologics to prevent infectious diseases and small molecules and biologics to treat pain, psychiatric and addiction conditions. While the company is also developing a potential vaccine to protect against the novel coronavirus disease. Its main products are used for treating fibromyalgia, or FM, and posttraumatic stress disorder, or PTSD.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Initiating Coverage With An Outperform Rating.  Tonix has developed a pipeline of products in Immunology, CNS, and Infectious Diseases. Several pipeline products are expected to reach clinical milestones or data announcements over the next 12 months, including the Phase 3 RESILIANT trial in fibromyalgia.

The Phase 3 RESILIANT Trial Is Underway.  Tonix has started patient enrollment in the Phase 3 RESILIANT trial, testing TNX-102 SL in fibromyalgia. The previous Phase 3 RELIEF trial met its primary endpoint, and if successful, RESILIANT would give Tonix the two trials needed to apply for FDA approval. An interim analysis has been scheduled for 1Q23 …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

 

Ocugen, Inc. to Commercialize COVAXIN™ in Mexico, Rights Now Encompassing All of North America

Research, News, and Market Data on Ocugen

 

•  Ocugen responsible for commercialization of COVAXIN™ in Mexico

•  COVAXIN™, already authorized for emergency use in adults by health regulators in Mexico, has been submitted for Emergency Use Authorization for children aged 2-18 years

MALVERN, Pa. and HYDERABAD, India, April 18, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines, and Bharat Biotech (BBIL), a global leader in vaccine innovation, today announced that they have entered into an amendment to their Co-development, Supply and Commercialization Agreement to expand Ocugen’s exclusive territory to include commercialization of COVAXIN™ in Mexico. This gives Ocugen COVAXIN™ commercialization rights for all of North America.

“We’re excited to commercialize COVAXIN™ in Mexico, as authorities there have made conquering this pandemic a major priority. After meeting with Mexico’s Secretary of Foreign Affairs, Marcelo Ebrard, in Delhi, we are encouraged by the role COVAXIN™ can play in Mexico’s continuing efforts to defeat the COVID-19 pandemic. COVAXIN™ is currently under review by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) for emergency use among children between 2 and 18 years of age, and Ocugen is prepared to collaborate with the public health community to help their efforts. We also thank Bharat Biotech for helping make this opportunity a reality,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-founder of Ocugen, Inc.

COVAXIN™ can be an ideal vaccination option for Mexico at this stage of the pandemic. As a whole virion, inactivated vaccine, it elicits robust cellular immune memory to SARS-CoV-2 and Variants of Concern. It offers logistical advantages that could support vaccine access in hard-to-reach communities.

“We are delighted to announce our partnership with Ocugen for Mexico, along with the United States and Canada. COVAXIN™ is a safe and efficacious inactivated vaccine for all age groups as evident from its data from global introduction. We are fully supportive of team Ocugen in our endeavor to expedite technology transfer activities towards commercial scale manufacturing of COVAXIN™ in North America,” said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.

The license extension between Ocugen and Bharat Biotech with respect to commercialization in Mexico includes the same profit share structure as in the United States.

About COVAXIN™ (BBV152)
COVAXIN™ is a whole virion, inactivated vaccine that combines an inactivated SARS-CoV-2 antigen with an adjuvant (6?g + Algel–IMDG[TLR7/8]). It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. With supplies of more than 350 million doses globally for adults and children, COVAXIN™ is currently authorized under emergency use in more than 25 countries, including Mexico, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) added COVAXIN™ to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN™.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

About Bharat Biotech
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Prequalifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. Having delivered more than 5 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis (JENVAC^®), Rabies, Chikungunya, Zika, Cholera, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO^®, ROTAVAC^®, ROTAVAC 5D^®, and Typbar TCV^® combatting polio, rotavirus, typhoid infections, respectively. As a leader of pandemic vaccines, Bharat Biotech has successfully delivered COVAXIN^®, India’s 1st indigenous vaccine against COVID-19. In November 2021, COVAXIN^® received WHO EUL. The acquisition of Chiron Behring Vaccines has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer with Chirorab^® and Indirab^®. To learn more about Bharat Biotech, visit www.bharatbiotech.com

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, Ocugen’s plans with respect to development and commercialization of COVAXIN™ in Mexico. Ocugen may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in Ocugen’s periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

Structures Considered Key to Gene Expression are Surprisingly Fleeting

 

Anne Trafton | MIT News Office

 

In human chromosomes, DNA is coated by proteins to form an exceedingly long beaded string. This “string” is folded into numerous loops, which are believed to help cells control gene expression and facilitate DNA repair, among other functions. A new study from MIT suggests that these loops are very dynamic and shorter-lived than previously thought.

In the new study, the researchers were able to monitor the movement of one stretch of the genome in a living cell for about two hours. They saw that this stretch was fully looped for only 3 to 6 percent of the time, with the loop lasting for only about 10 to 30 minutes. The findings suggest that scientists’ current understanding of how loops influence gene expression may need to be revised, the researchers say.

“Many models in the field have been these pictures of static loops regulating these processes. What our new paper shows is that this picture is not really correct,” says Anders Sejr Hansen, the Underwood-Prescott Career Development Assistant Professor of Biological Engineering at MIT. “We suggest that the functional state of these domains is much more dynamic.”

Hansen is one of the senior authors of the new study, along with Leonid Mirny, a professor in MIT’s Institute for Medical Engineering and Science and the Department of Physics, and Christoph Zechner, a group leader at the Max Planck Institute of Molecular Cell Biology and Genetics in Dresden, Germany, and the Center for Systems Biology Dresden. MIT postdoc Michele Gabriele, recent Harvard University PhD recipient Hugo Brandão, and MIT graduate student Simon Grosse-Holz are the lead authors of the paper, which appears today in Science.

 

Out of the Loop

Using computer simulations and experimental data, scientists including Mirny’s group at MIT have shown that loops in the genome are formed by a process called extrusion, in which a molecular motor promotes the growth of progressively larger loops. The motor stops each time it encounters a “stop sign” on DNA. The motor that extrudes such loops is a protein complex called cohesin, while the DNA-bound protein CTCF serves as the stop sign. These cohesin-mediated loops between CTCF sites were seen in previous experiments.

However, those experiments only offered a snapshot of a moment in time, with no information on how the loops change over time. In their new study, the researchers developed techniques that allowed them to fluorescently label CTCF DNA sites so they could image the DNA loops over several hours. They also created a new computational method that can infer the looping events from the imaging data.

“This method was crucial for us to distinguish signal from noise in our experimental data and quantify looping,” Zechner says. “We believe that such approaches will become increasingly important for biology as we continue to push the limits of detection with experiments.”

The researchers used their method to image a stretch of the genome in mouse embryonic stem cells. “If we put our data in the context of one cell division cycle, which lasts about 12 hours, the fully formed loop only actually exists for about 20 to 45 minutes, or about 3 to 6 percent of the time,” Grosse-Holz says.

“If the loop is only present for such a tiny period of the cell cycle and very short-lived, we shouldn’t think of this fully looped state as being the primary regulator of gene expression,” Hansen says. “We think we need new models for how the 3D structure of the genome regulates gene expression, DNA repair, and other functional downstream processes.”

While fully formed loops were rare, the researchers found that partially extruded loops were present about 92 percent of the time. These smaller loops have been difficult to observe with the previous methods of detecting loops in the genome.

“In this study, by integrating our experimental data with polymer simulations, we have now been able to quantify the relative extents of the unlooped, partially extruded, and fully looped states,” Brandão says.

“Since these interactions are very short, but very frequent, the previous methodologies were not able to fully capture their dynamics,” Gabriele adds. “With our new technique, we can start to resolve transitions between fully looped and unlooped states.”

The researchers hypothesize that these partial loops may play more important roles in gene regulation than fully formed loops. Strands of DNA run along each other as loops begin to form and then fall apart, and these interactions may help regulatory elements such as enhancers and gene promoters find each other.

“More than 90 percent of the time, there are some transient loops, and presumably what’s important is having those loops that are being perpetually extruded,” Mirny says. “The process of extrusion itself may be more important than the fully looped state that only occurs for a short period of time.”

 

More Loops to Study

Since most of the other loops in the genome are weaker than the one the researchers studied in this paper, they suspect that many other loops will also prove to be highly transient. They now plan to use their new technique study some of those other loops, in a variety of cell types.

“There are about 10,000 of these loops, and we’ve looked at one,” Hansen says. “We have a lot of indirect evidence to suggest that the results would be generalizable, but we haven’t demonstrated that. Using the technology platform we’ve set up, which combines new experimental and computational methods, we can begin to approach other loops in the genome.”

The researchers also plan to investigate the role of specific loops in disease. Many diseases, including a neurodevelopmental disorder called FOXG1 syndrome, could be linked to faulty loop dynamics. The researchers are now studying how both the normal and mutated form of the FOXG1 gene, as well as the cancer-causing gene MYC, are affected by genome loop formation.

 

Suggested Reading

What is the Approval Process for Medical Devices?

Scientists Now Better Understand Viral Mutations

The Basket of Goods Will Become Financially Heavier

Detailed Data Sharing Plans for Medical Research are Soon Due

 

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Izotropic CEO John McGraw provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info News and Advanced Market Data on IZOZF NobleCon18 Presenting Companies About Izotropic Izotropic Corporation is the only publicly traded company commercializing a dedicated breast CT imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers. To expedite patient and provider access to IzoView, Izotropic’s initial clinical study intends to demonstrate superior performance of diagnostic breast CT imaging over diagnostic mammography procedures and will initiate in Q2 2022. In follow-on clinical studies, Izotropic intends to validate platform applications, including breast screening in radiology, treatment planning and monitoring in surgical oncology, and breast reconstruction and implant monitoring in plastic and reconstructive surgery. More information about Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR at sedar.com.

Cocrystal Pharma to Present at the Noble Capital Markets’ NobleCon18 Conference

Research, News, and Market Data on Cocrystal Pharma

 

BOTHELL, Wash., April 14, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that James Martin, Chief Financial Officer and co-interim Chief Executive Officer, will present a Company overview at the NobleCon18—Noble Capital Markets’ Eighteenth Annual Investor Conference on Thursday, April 21, 2022 at 9:30 a.m. Eastern Time. The conference is being held at the Hard Rock Hotel & Casino in Hollywood, Fla.

A video webcast of the presentation will be available the following day on the Company’s https://www.channelchek.com/, as well as at the Noble Capital Markets’ Conference website and on the Channelchek website. The webcast will be archived for 90 days following the event.

About Noble Capital Markets, Inc.
Noble Capital Markets is a research-driven investment bank that has supported small and microcap companies since 1984. As a FINRA and SEC licensed broker dealer, Noble provides institutional-quality equity research, merchant and investment banking, and order execution services. In 2005, Noble established NobleCon, an investor conference that has grown substantially over the past decade. In 2018, Noble launched Channelchek—an investor community dedicated exclusively to public small and micro-cap companies and their industries. Channelchek is the first service to offer institutional-quality research to the public for free without a subscription.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

Source: Cocrystal Pharma, Inc.

Wednesday, April 13, 2022

Cocrystal Pharma Inc. (COCP)
First Results From Influenza Program Announced

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First Data From Influenza Program Reported.  Cocrystal reported preliminary data from the Phase 1 clinical trial testing CC-42344, its oral antiviral for pandemic and seasonal influenza A. This is an orally administered drug that targets viral polymerase, blocking an early step in the viral lifecycle. The first two cohorts receiving single ascending doses of CC-42344 showed favorable safety and pharmacokinetic profiles.

The Phase 1 Trial Continues.  The announcement was based on the first two cohorts treated with single doses of 100mg and 200mg and demonstrated safety with a favorable pharmacokinetic profile. To date, CC-42344 has shown strong bioavailablity, plasma levels that correlated with doses given, and a half-life that supports oral daily dosing. The trial has a target enrollment of 56 healthy adults and is …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.