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. 

 

Ceapro Inc. Reports Fourth Quarter and Full Year 2021 Financial Results and Operational Highlights

Research, News, and Market Data on Ceapro

 

– FY 2021 record sales of $17,200,000 compared to $15,100,000 for FY 2020, representing a 14% increase year over year; Ceapro’s best sales performance in Company history

– Net profit of $2,842,000 for the full year of 2021 compared to a net profit of 1,856,000 in 2020, a year over year increase of 53%

– R&D activities focused on the development of avenanthramide pills for a Phase 1 study, on advancing the development of innovative delivery systems with new chemical complexes and on processing yeast beta glucan from various sources for the development of an immune booster and as a potential inhalable therapeutic for COVID-19

– Achieved record production levels despite COVID-19 pandemic situation, supply chain and transportation logistic challenges

EDMONTON, Alberta, April 13, 2022 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO, OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced operational highlights and financial results for the fourth quarter and full year ended December 31, 2021.

“We are thrilled with achievements made in 2021 on all fronts from production operations to research and development, allowing us to expand our pipeline to build a high value life sciences Company focused on immune and inflammation-based diseases. A 14% year over year increase in sales for our base business is absolutely remarkable especially during such a year marked by a continued COVID-19 pandemic, inflationary pressure, issues related to availability of inputs, persistently high logistical transportation costs and labour scarcity. Despite these challenges, our team worked tirelessly to meet strong demand for our products and deliver one of the best ever performances in the Company’s history. I thank everyone wholeheartedly for their resilience and dedication,” stated Gilles Gagnon, M.Sc., MBA, President and CEO, of Ceapro. “In addition to excellent financial and operational results, we had many key highlights over the course of the year and are committed to building on these achievements.”

2021 Corporate and Operational Highlights

Pipeline Development

Avenanthramides:

• Announced expanded collaboration with Montreal Heart Institute (MHI) with new clinical study evaluating flagship product, avenanthramides, as a new potential pharmaceutical product. This Phase 1 safety and tolerability study will be led by renowned Dr. Jean-Claude Tardif. Published positive results from Ceapro’s previously conducted study evaluating anti-inflammatory properties of low doses of avenanthramides in exercise-induced inflammation paved the way for this clinical trial.

• Agreement signed with Corealis to formulate 30mg and 240mg dosage pills to be used in Phase 1 study with MHI.

• Completed physical characterization of avenanthramides and continued to monitor stability studies with new powder formulations.

• Completed the Phase 1 study protocol which expects to enroll approximately 72 patients.
  

Oat Beta Glucan:

• Completed pilot clinical trial evaluating oat beta glucan in patients with high cholesterol levels. While there were positive signals that beta glucan nutraceutical formulation may offer appreciable health benefits as indicated with approved Health Canada’s beta glucan monograph (Natural Product Division), the study did not achieve in a statistically significant manner the expected primary endpoint related to a decrease of low-density lipoproteins cholesterol when using Ceapro’s pill dosage form.

• Announced research agreement with Boston-based Angiogenesis Foundation to assess in vivo bioefficacy of oat beta glucan and avenanthramides in angiogenesis, blood vessel repairs, and wounds to assess healing and tissue regeneration in various inflammation-based diseases and conditions like COVID-19 presenting damages of the lung blood vessels.
  

Yeast Beta Glucan (YBG)

• Analyzed and screened YBG feedstock from numerous global suppliers to select ideal sources for best possible product.

• Identified process conditions for YBG improving morphology of YBG processed using PGX Technology (PGX-YBG) to boost immunomodulating activity.

• Further developed custom-shape formulations of PGX-YBG for oral administration.

• Obtained further evidence confirming that PGX-YBG is suitable for lung inhalation.

• Demonstrated, in vitro, that PGX processed YBG can prevent the activation of macrophages toward a pro-fibrotic phenotype which, according to experts in the field, is seen as a viable therapeutic strategy toward fibrotic disease.
  
  
  • PGX-YBG binds to specific receptors (Dectin 1) located on macrophages responsible for the cascade of immunomodulating events when activated.
  • McMaster’s research team discovered a new mechanism of action as per PGX-YBG’s ability to reprogram macrophages on its own.
    
• Continuing PGX-YBG project with McMaster University to assess preclinical animal models to determine posology.

• Initiated studies with a medical device manufacturer to assess aerosol/nebulizer device for inhalation of YBG.

• Proved, using an in vitro study, that the Company’s PGX Technology maintains the integrity of the YBG molecular structure and enhances its microscopic morphology which leads to a boost in its immunomodulatory activity without generating proinflammatory reaction. Based on these attributes PGX-YBG is poised to become a key strategic asset for the Company.
  

New Chemical Complexes / Delivery Systems:

• Announced the successful completion of a long-term research program conducted with University of Alberta. This screening program allowed Ceapro to retain the most promising products, such as PGX-alginate, and expand the PGX-processed products pipeline. Combination of alginate and YBG, leading to tunable PGX composites, are now viewed as the most promising products developed from this research program.

• Pursued bioavailability studies with University of Alberta for new chemical complexes YBG-CoQ10, alginate-CoQ10 and the newly formed alginate-YBG-CoQ10. Results are expected in Q3 2022.
  

Technology:

• Continued significant technical improvements of the existing PGX plant in Edmonton to develop equipment for the production of PGX-YBG for the purpose of generating material suitable for nutraceutical and lung delivery.

• Ongoing engineering design in collaboration with experts in the field for designing and building a PGX processing commercial unit. Alginate and yeast beta glucan would be the first products to be processed at large scale level. Given regulatory requirements and to accelerate market entry, yeast beta glucan as a standalone and/or in combination with alginate will be developed at first as a nutraceutical/immune booster.

• Pursued installment in Edmonton of a commercial scale unit for loading of bioactives onto PGX-processed biopolymers. This system allows loading of active pharmaceutical ingredients, like ibuprofen, onto thin soluble PGX alginate strips for wound healing or oral applications.

• Continued projects with University of Alberta and McMaster University for the development of potential delivery systems for multiple applications in healthcare.
  

Bioprocessing Operations

• Ceapro’s dedicated production team successfully responded to the growing market demand for the cosmeceutical base business by producing over 290 metric tons of active ingredients in 2021, a 20% increase over the previous year.

• Received renewal of the Site License from the Health Canada Natural Product Directorate. This License enables the Company to manufacture, package, label, release and distribute final products.

Corporate

• Fully repaid loan with Canadian Agricultural Adaptation Program (CAAP).
• Effective December 31, 2021, the Company wound up Ceapro Technology Inc., Ceapro Active Ingredients Inc. and Ceapro BioEnergy Inc. into the Company and dissolved Ceapro USA Inc. JuventeDC Inc. remains the only active fully owned subsidiary of Ceapro Inc.

• Announced expansion of a grant from National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) to further develop the patented PGX Technology to increase its innovation capacity by designing the first pharmaceutical PGX processing unit along with bioactive impregnation and loading units.

• Pursued out-licensing discussions for PGX-processed new chemical complexes.
  

Subsequent to Year End

• Signed a Supply and Distribution Agreement with Symrise securing the long-term sustainability of Ceapro’s base business.

• Appointed Mr. Ronnie Miller, former President & CEO of Roche Canada for the last 22 years, to the Company’s Board of Directors.
  

Financial Highlights for the Fourth Quarter and the Full Year 2021 Ended December 31, 2021

• Total sales of $3,562,000 for the fourth quarter of 2021 and $17,200,000 for the full year of 2021 compared to $2,706,000 and $15,100,000 for the comparative periods in 2020. These respective increases of 32% for Q4, 2021 and 14% for the full year 2021 were driven by volume sales increases in all of the Company’s primary products. The increase in revenue occurred despite being offset by a lower U.S. dollar relative to the Canadian dollar compared to the prior year, which negatively impacted revenue by approximately $1,358,000 for the full year 2021.

• Net profit of $776,000 for the fourth quarter of 2021 and a net profit of $2,842,000 for the full year of 2021 compared to a net loss of $539,000 and a net profit of 1,856,000 for the comparative periods in 2020, a year over year increase of 53.1% for the full year 2021. These results reflect a full year of operations in one production site only as compared to year 2020 that was marked by the completion of the decommissioning of Leduc manufacturing site and the final integration of production operations in the Edmonton facility. Margins improved on an annual basis from 50% in 2020 to 56% in 2021.

• Cash generated from operations of $3,510,000, for the full year 2021.

• Positive working capital balance of $10,755,000 as of December 31, 2021.
  

“While the Company’s business has not been significantly impacted by the COVID-19 pandemic, management remains very vigilant in ensuring the highest level of safety for Ceapro’s employees. Depending on the evolution of this pandemic situation and assuming minimal supply chain disruptions, I strongly believe the prospects for the Company remain very strong for the upcoming year. We expect Ceapro’s cosmeceuticals base business to continue growing and provide positive cash flows to support the expansion to a new business model to a high value life science/biopharmaceutical company involved in nutraceuticals and pharmaceuticals. We then expect to further invest into R&D to initiate an early clinical trial with our newly developed pill of avenanthramide, to continue the development of new chemical complexes as potential delivery systems for bioactives and to emphasize our current efforts for the development and assessment of yeast beta glucan as immune booster and as potential inhalable therapeutics for lung fibrotic diseases including COVID 19 conditions,” added Mr. Gagnon.

“Additionally, results from bioavailability studies with new chemical complexes and results with yeast beta glucan as an immune booster will drive decisions for the magnitude of capital expenditures to be incurred for the building of a commercial scale unit for PGX Technology. Based on a very solid foundation, a highly competent team, a healthy balance sheet and a very strong technology and product portfolio with the potential to access key large markets, we have all the key components for success,” concluded Mr. Gagnon.

CEAPRO INC.
Consolidated Balance Sheets
	December 31,		December 31,
	2021		2020
	$		$
ASSETS
Current Assets
Cash and cash equivalents	7,780,989		5,369,029
Trade receivables	2,092,842		2,019,723
Other receivables	45,850		102,224
Inventories (note 3)	1,644,893		1,210,079
Prepaid expenses and deposits	162,919		348,845
Total Current Assets	11,727,493		9,049,900
Non-Current Assets
Investment tax credits receivable	766,629		607,700
Deposits	79,539		82,124
Licences (note 4)	15,551		18,514
Property and equipment (note 5)	17,499,774		18,591,189
Deferred tax assets (note 13 (b))	439,063		874,304
Total Non-Current Assets	18,800,556		20,173,831
TOTAL ASSETS	30,528,049		29,223,731
LIABILITIES AND EQUITY
Current Liabilities
Accounts payable and accrued liabilities	682,057		1,067,622
Current portion of lease liabilities (note 6)	290,055		250,658
Current portion of CAAP loan (note 8)	–		72,263
Total Current Liabilities	972,112		1,390,543
Non-Current Liabilities
Long-term lease liabilities (note 6)	2,358,862		2,648,917
Deferred tax liabilities (note 13 (b))	–		874,304
Total Non-Current Liabilities	2,358,862		3,523,221
TOTAL LIABILITIES	3,330,974		4,913,764
Equity
Share capital (note 7 (b))	16,557,401		16,511,067
Contributed surplus (note 7 (e))	4,680,690		4,682,393
Retained earnings	5,958,984		3,116,507
Total Equity	27,197,075		24,309,967
TOTAL LIABILITIES AND EQUITY	30,528,049		29,223,731

CEAPRO INC.
Consolidated Statements of Net Income and Comprehensive Income
	2021		2020
Years Ended December 31,	$		$
Revenue (note 15)	17,195,329		15,121,282
Cost of goods sold	7,506,036		7,498,996
Gross margin	9,689,293		7,622,286
Research and product development	3,779,102		1,881,883
General and administration	3,239,672		3,282,754
Sales and marketing	47,119		111,044
Finance costs (note 11)	206,891		231,271
Income from operations	2,416,509		2,115,334
Other income (expense) (note 10)	202,281		(259,234	)
Income before tax	2,618,790		1,856,100
Income taxes
Current tax expense (note 13 (a))	215,376		–
Deferred tax benefit (note 13 (a))	(439,063	)	–
Income tax benefit	(223,687	)	–
Total net income and comprehensive income for the year	2,842,477		1,856,100
Net income per common share (note 20):
Basic	0.04		0.02
Diluted	0.04		0.02
Weighted average number of common shares outstanding (note 20):
Basic	77,673,804		77,594,629
Diluted	78,590,706		78,143,033

CEAPRO INC.
Consolidated Statements of Cash Flows
	2021		2020
Years Ended December 31,	$		$
OPERATING ACTIVITIES
Net income for the year	2,842,477		1,856,100
Adjustments for items not involving cash
Finance costs	140,270		153,538
Transaction costs	–		1,108
Depreciation and amortization	1,880,748		1,841,033
Gain on disposal of equipment	(5,000	)	–
Accretion	11,621		21,625
Income tax benefit	(439,063	)	–
Share-based payments	17,906		136,796
	4,448,959		4,010,200
CHANGES IN NON-CASH WORKING CAPITAL ITEMS
Trade receivables	(73,119	)	1,639,818
Other receivables	56,374		(55,412	)
Investment tax credits receivable	(158,929	)	–
Inventories	(434,814	)	(541,074	)
Prepaid expenses and deposits	111,044		(88,839	)
Accounts payable and accrued liabilities relating to operating activities	(298,765	)	(358,136	)
	(798,209	)	596,357
Net income for the year adjusted for non-cash and working capital items	3,650,750		4,606,557
Interest paid	(140,270	)	(153,538	)
CASH GENERATED FROM OPERATIONS	3,510,480		4,453,019
INVESTING ACTIVITIES
Purchase of property and equipment	(689,431	)	(528,707	)
Purchase of leasehold improvements	(19,472	)	(12,870	)
Proceeds from sale of equipment	5,000		353
Deposits relating to the purchase of equipment	–		(77,467	)
Accounts payable and accrued liabilities relating to investing activities	(86,800	)	134,554
CASH USED IN INVESTING ACTIVITIES	(790,703	)	(484,137	)
FINANCING ACTIVITIES
Stock options exercised	26,725		4,897
Repayment of long-term debt	–		(112,973	)
Repayment of CAAP loan	(83,884	)	(83,884	)
Repayment of lease liabilities	(250,658	)	(265,088	)
CASH USED IN FINANCING ACTIVITIES	(307,817	)	(457,048	)
Increase in cash and cash equivalents	2,411,960		3,511,834
Cash and cash equivalents at beginning of the year	5,369,029		1,857,195
Cash and cash equivalents at end of the year	7,780,989		5,369,029

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Issuer:
Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release 

Source: Ceapro Inc.

Engineered Bacteria Could Help Protect “Good” Gut Microbes from Antibiotics

 

Anne Trafton | MIT
News Office

Antibiotics are life-saving drugs, but they can also harm the beneficial microbes that live in the human gut. Following antibiotic treatment, some patients are at risk of developing inflammation or opportunistic infections such as Clostridiodes difficile. Indiscriminate use of antibiotics on gut microbes can also contribute to the spread of resistance to the drugs.

In an effort to reduce those risks, MIT engineers have developed a new way to help protect the natural flora of the human digestive tract. They took a strain of bacteria that is safe for human consumption and engineered it to safely produce an enzyme that breaks down a class of antibiotics called beta-lactams. These include ampicillin, amoxicillin, and other commonly used drugs.

When this “living biotherapeutic” is given along with antibiotics, it protects the microbiota in the gut but allows the levels of antibiotics circulating in the bloodstream to remain high, the researchers found in a study of mice.

“This work shows that synthetic biology can be harnessed to create a new class of engineered therapeutics for reducing the adverse effects of antibiotics,” says James Collins, the Termeer Professor of Medical Engineering and Science in MIT’s Institute for Medical Engineering and Science (IMES) and Department of Biological Engineering, and the senior author of the new study.

Andres Cubillos-Ruiz PhD ’15, a research scientist at IMES and the Wyss Institute for Biologically Inspired Engineering at Harvard University, is the lead author of the paper, which appears today in Nature Biomedical Engineering. Other authors include MIT graduate students Miguel Alcantar and Pablo Cardenas, Wyss Institute staff scientist Nina Donghia, and Broad Institute research scientist Julian Avila-Pacheco.

Protecting the Gut

Over the past two decades, research has revealed that the microbes in the human gut play important roles in not only metabolism but also immune function and nervous system function.

“Throughout your life, these gut microbes assemble into a highly diverse community that accomplishes important functions in your body,” Cubillos-Ruiz says. “The problem comes when interventions such as medications or particular kinds of diets affect the composition of the microbiota and create an altered state, called dysbiosis. Some microbial groups disappear, and the metabolic activity of others increases. This unbalance can lead to various health issues.”

 

One major complication that can occur is infection of C. difficile, a microbe that commonly lives in the gut but doesn’t usually cause harm. When antibiotics kill off the strains that compete with C. difficile, however, these bacteria can take over and cause diarrhea and colitis. C. difficile infects about 500,000 people every year in the United States, and causes around 15,000 deaths.

Doctors sometimes prescribe probiotics (mixtures of beneficial bacteria) to people taking antibiotics, but those probiotics are usually also susceptible to antibiotics, and they don’t fully replicate the native microbiota found in the gut.

“Standard probiotics cannot compare to the diversity that the native microbes have,” Cubillos-Ruiz says. “They cannot accomplish the same functions as the native microbes that you have nurtured throughout your life.”

To protect the microbiota from antibiotics, the researchers decided to use modified bacteria. They engineered a strain of bacteria called Lactococcus lactis, which is normally used in cheese production, to deliver an enzyme that breaks down beta-lactam antibiotics. These drugs make up about 60 percent of the antibiotics prescribed in the United States.

When these bacteria are delivered orally, they transiently populate the intestines, where they secrete the enzyme, which is called beta-lactamase. This enzyme then breaks down antibiotics that reach the intestinal tract. When antibiotics are given orally, the drugs enter the bloodstream primarily from the stomach, so the drugs can still circulate in the body at high levels. This approach could also be used along with antibiotics that are injected, which also end up reaching the intestine. After their job is finished, the engineered bacteria are excreted through the digestive tract.

Using engineered bacteria that degrade antibiotics poses unique safety requirements: Beta-lactamase enzymes confer antibiotic resistance to harboring cells and their genes can readily spread between different bacteria. To address this, the researchers used a synthetic biology approach to recode the way the bacterium synthetizes the enzyme. They broke up the gene for beta-lactamase into two pieces, each of which encodes a fragment of the enzyme. These gene segments are located on different pieces of DNA, making it very unlikely that both gene segments would be transferred to another bacterial cell.

These beta-lactamase fragments are exported outside the cell where they reassemble, restoring the enzymatic function. Since the beta-lactamase is now free to diffuse in the surrounding environment, its activity becomes a “public good” for the gut bacterial communities. This prevents the engineered cells from gaining an advantage over the native gut microbes. 

“Our biocontainment strategy enables the delivery of antibiotic-degrading enzymes to the gut without the risk of horizontal gene transfer to other bacteria or the acquisition of an added competitive advantage by the live biotherapeutic,” Cubillos-Ruiz says.

Maintaining Microbial Diversity

To test their approach, the researchers gave the mice two oral doses of the engineered bacteria for every injection of ampicillin. The engineered bacteria made their way to the intestine and began releasing beta-lactamase. In those mice, the researchers found that the amount of ampicillin circulating the bloodstream was as high as that in mice who did not receive the engineered bacteria.

In the gut, mice that received engineered bacteria maintained a much higher level of microbial diversity compared to mice that received only antibiotics. In those mice, microbial diversity levels dropped dramatically after they received ampicillin. Furthermore, none of the mice that received the engineered bacteria developed opportunistic C. difficile infections, while all of the mice who received only antibiotics showed high levels of C. difficile in the gut.

“This is a strong demonstration that this approach can protect the gut microbiota, while preserving the efficacy of the antibiotic, as you’re not modifying the levels in the bloodstream,” Cubillos-Ruiz says.

The researchers also found that eliminating the evolutionary pressure of antibiotic treatment made it much less likely for the microbes of the gut to develop antibiotic resistance after treatment. In contrast, they did find many genes for antibiotic resistance in the microbes that survived in mice who received antibiotics but not the engineered bacteria. Those genes can be passed to harmful bacteria, worsening the problem of antibiotic resistance.

The researchers now plan to begin developing a version of the treatment that could be tested in people at high risk of developing acute diseases that stem from antibiotic-induced gut dysbiosis, and they hope that eventually, it could be used to protect anyone who needs to take antibiotics for infections outside the gut.

“If the antibiotic action is not needed in the gut, then you need to protect the microbiota. This is similar to when you get an X-ray, you wear a lead apron to protect the rest of your body from the ionizing radiation,” Cubillos-Ruiz says. “No previous intervention could offer this level of protection. With our new technology we can make antibiotics safer by preserving beneficial gut microbes and by reducing the chances of emergence of new antibiotic resistant variants.”

 

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Tonix Pharmaceuticals to Participate in the NobleCon18 Investor Conference

Research, News, and Market Data on Tonix Pharmaceuticals

CHATHAM, N.J., April 12, 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 and conduct investor meetings at NobleCon18, Noble Capital Markets’ Eighteenth Annual In-Person Small & Microcap Investor Conference being held April 19-21, 2022, in Hollywood, Florida.

Details of the Tonix Pharmaceuticals Presentation

Event	NobleCon18, Noble Capital Markets’ Eighteenth Annual In-Person Small & Microcap Investor Conference
Date	Thursday, April 21
Time	9:30 a.m. ET
Location	Hard Rock Hotel & Casino, Hollywood, Florida
Track	Seminole Ballroom C

A webcast of the Company’s presentation will be available under the IR Events tab of the Tonix website at www.tonixpharma.com starting April 22.   

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, an antiviral to treat COVID-19, and a potential treatment for Long COVID. 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-3500
⁵ (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-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half 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 expected to start in the first half of 2022. Finally, TNX-1300⁷ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half 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-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.

electroCore Provides Business Update and Select First Quarter 2022 Financial Guidance

News and Market Data on electroCore

April 12, 2022 at 8:00 AM EDT

• Record revenue
  from product sales will be approximately $1.9M;
  approximately 60% growth over first quarter 2021
• March 31, 2022,
  cash balance of approximately $29.9M

ROCKAWAY, N.J.
, 
April 12, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc.
 (the “Company”) (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided an operating and business update as well as select unaudited preliminary financial guidance for the first quarter of 2022.

“We are pleased to announce preliminary first quarter results, recording approximately 60% growth over same period last year, and approximately 27% growth over the fourth quarter of 2021,” stated  Dan Goldberger , Chief Executive Officer of electroCore. “Revenue from product sales in the quarter ended 
March 31, 2022, will be approximately 
$1.9 million
. This is the second consecutive quarter where our total revenue growth over the prior year quarter was approximately 60% indicating that our continued investment in our sales channels and marketing initiatives are expanding consumer awareness and building momentum into the remainder of 2022.” 

Government
Channels: During the first quarter of 2022, the Company expects to recognize revenue of approximately 
$1,260,000 pursuant to the 
Department of Veterans Affairs (“VA”) and 
Department of Defense (“DoD”) originating prescriptions, compared to 
$858,000 or 47% growth from the fourth quarter of 2021 and 
$679,000 or 86% growth over the first quarter of 2021. 105 
VA and 
DoD military treatment facilities have purchased gammaCore products through 
March 31, 2022, as compared to 100 through the fourth quarter of 2021 and 79 through the first quarter of 2021.

Commercial: During the first quarter of 2022, the Company expects to recognize revenue of approximately 
$300,000 from our commercial channels, dominated by our cash pay initiatives and representing approximately an 11% increase over Q4 2021 and a 107% increase from Q1 2021.

Outside
of the U.S.: The Company expects to recognize revenue of approximately 
$300,000 outside of the 
U.S. for the first quarter ended 
March 31, 2022
, representing approximately 15% decrease from Q4 2021 and 20% decrease from Q1 2021. Our international business was impacted by COVID in January and February of this year, but the channel started to rebound in 
March 2022
.

Financial
Guidance
Preliminary unaudited financial guidance for the first quarter of 2022:

Revenue: The Company anticipates first quarter 2021 revenue from product sales will be approximately 
$1.9 million. This represents an approximately 27% increase over fourth quarter 2021 revenue of 
$1.5 million and approximately 60% growth over first quarter 2021 revenue of 
$1.2 million
.

Cash
Position: The Company ended the first quarter of 2022 with approximately 
$29.9 million
 of cash, cash equivalents, and marketable securities, compared to 
$34.7 million as of the end of 2021. 

Mr. Goldberger  further commented, “Our business grew robustly in the first quarter, despite the headwinds faced overseas as a result of COVID. With our strong balance sheet and discipline around targeted investment in sales and marketing, we will be able to educate and improve physician and patient awareness, which will ultimately lead to the successful adoption of gammaCore globally.”

The Company intends to provide a detailed operational and financial update during its first quarter of 2022 earnings call in 
May 2022
.

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 about electroCore’s expectations for revenue and cash used in operations during the first quarter 2022, growth through acquisitions, its expectations for future performance, as well as electroCore’s business prospects (including its e-commerce initiative, and gConcierge and gCDirect programs) and clinical and product development plans for 2022 and beyond, its pipeline or potential markets (including cash pay programs) for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to 
Canada, 
Western Europe
, 
Qatar, 
Taiwan, and 
China) and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “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 raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the 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 consult all of the information set forth herein and should also refer to the risk factor disclosure 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 Reports Favorable Preliminary Data from Phase 1 Initial Cohorts with CC-42344, a Novel, Broad-Spectrum Influenza A antiviral

Research, News, and Market Data on Cocrystal Pharma

CC-42344 administered
orally as a single 100 mg or 200 mg dose in healthy adults showed a
favorable safety and pharmacokinetic profile

BOTHELL, Wash., April
12, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reported preliminary results of a Phase 1 study with CC-42344, demonstrating a favorable safety and pharmacokinetic profile. CC-42344 is a broad-spectrum oral antiviral for the treatment of pandemic and seasonal influenza A with a novel mechanism of action.

The ongoing Phase 1 clinical trial plans to enroll 56 healthy adults. Results from the first two single-ascending dose 100 mg and 200 mg cohorts showed a favorable pharmacokinetic profile of CC-42344. To date, CC-42344, has demonstrated excellent oral bioavailability, dose-dependent plasma exposures, and a half-life supportive of oral daily dosing. The Phase 1 study is designed to evaluate CC-42344 administered in single-ascending and multiple-ascending doses. Cocrystal expects to report full results from the study in 2022.

“Today’s update reinforces Cocrystal’s progress in developing best-in-class antiviral medicines. Influenza is one of the most serious worldwide public health threats. Important concerns remain about the emergence of pandemic strains and resistance to available drugs. We are encouraged by the safety and pharmacokinetic profile observed to date with single oral doses of CC-42344 and look forward to initiating the next portion of the trial,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “Based on a novel mechanism of action and high barrier to resistance, we believe CC-42344 could provide a potentially best-in-class oral candidate for the treatment of pandemic and seasonal influenza infection.”

About CC-42344
CC-42344 is an oral PB2 inhibitor that blocks an essential step of viral replication and was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains, including pandemic strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu^® and Xofluza^™, while also demonstrating favorable pharmacokinetic and safety profiles.

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 plans to enroll 56 new subjects for the Company’s influenza A Phase 1 study, expectations of reporting full results of the study later in 2022, and the potential of CC-42344 to be a best-in-class candidate for the treatment of seasonal and pandemic influenza. 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 Australian and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, 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.