MEDICAL

Targeting Chronic Infections in Cystic Fibrosis, Cystic Fibrosis Foundation Invested in Felix Biotechnology

Felix Biotechnology | March 07, 2022

Targeting_Chronic_Infections
Felix Biotechnology, a biopharmaceutical business focusing on developing first-in-class, long-lasting antibacterial medicines to treat chronic drug-resistant infections, announced that it has received a Therapeutics Development Award from the Cystic Fibrosis Foundation. The funding will aid Felix's efforts to develop a novel medication to treat chronic Pseudomonas aeruginosa lung infections.

Chronic P. aeruginosa infections affect half of the persons with cystic fibrosis, many of whom are multidrug-resistant. Since infections are the leading cause of death in cystic fibrosis patients, innovative treatments are urgently needed. Felix offers a novel strategy by turning bacteria's natural predators, microscopic viruses known as bacteriophage (or phage), into long-lasting, broadly effective medicines.

Felix's phage therapies are specifically designed to examine and drive positive evolutionary effects of phage treatment, based on foundational research by Yale University's Drs. Paul Turner, Ben Chan, and Jon Koff. This results in a more long-lasting treatment, which is essential given the requirement to regularly deliver phage to treat chronic infections. This medication is now being tested in a clinical trial at Yale University. More information about the experiment can be found here, and interested patients are encouraged to enroll if they are eligible.

We are incredibly honored and excited to receive this support from the CF Foundation, This award will speed Felix in its mission to provide new therapeutic options to patients dealing with life-threatening infections and to develop phage as a broadly applicable antibacterial therapy."

Dr. Paul Turner, Ph.D., co-founder of Felix.

Spotlight

“GMOs are not saving farmers money, they’re not producing higher yields, and perhaps most significantly they’re wrecking the environment and human health,” the anti-biotech outfit Natural News warned in December 2014. Such claims are recycled endlessly by environmental activists and widely circulated thanks to social media, but they are wholly unsupported by the evidence, according to a new reportpublished by the The International Service for the Acquisition of Agri-biotech Applications (ISAAA).


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MEDICAL

Ratio Therapeutics Launches to Discover and Drive Early Clinical Development of Best-in-Class Targeted Radiopharmaceuticals for Treatment of Cancers

Ratio Therapeutics | June 13, 2022

Ratio Therapeutics Inc. today announced its launch with a mission to develop best-in-class targeted radiopharmaceuticals for the treatment of cancers. Founded by entrepreneurial scientists Jack Hoppin, Ph.D., and John Babich, Ph.D., Ratio emerges from stealth mode with more than $20 million in seed funding, fully funded development alliances with Bayer AG and Lantheus Holdings Inc., a robust portfolio of assets developed with two proprietary technologies, and a growing team of world-class experts in radiopharmaceuticals discovery and development. The company's near-term plans call for the submission of its first investigational new drug (IND) applications, which are expected this quarter, and the initiation of clinical trials later this year. Based in Boston, Ratio is set to move to a new 19,000-square-foot headquarters and research facility in the Seaport District in January. Ratio's radiopharmaceuticals strategy is focused on optimizing tumor localization while minimizing uptake by normal tissues. To achieve this, the company uses its proprietary technology platform called Trillium™ that is based on Dr. Babich's prior research at Weill-Cornell Medical College and first developed and validated by the founders in a previous venture. Trillium is a trifunctional small molecule scaffold that can be fine-tuned to alter its plasma clearance, target affinity and therapeutic payload. Each component of the scaffolding can be independently optimized to boost tumor uptake over normal tissue uptake, thereby maximizing therapeutic index. Ratio has successfully applied this framework to several tumor targets and multiple therapeutic payloads. In addition, Ratio is developing a technology platform to take advantage of the tumor killing power of the alpha emitter, Actinium-225. This proprietary technology is called the Macropa™ chelate platform. Ratio's scientists have already successfully incorporated Macropa into the Trillium platform as well as several peptides and antibodies. Macropa's unique chemistry enables ease of manufacture and robust in vitro and in vivo stability of the resulting radiotherapeutic compound. The ability to fine-tune our targeted radiotherapeutics using Trillium and Macropa enables us to address head-on the trifecta of typical challenges we see with most radiopharmaceuticals: delivery, safety and efficacy, Over the past year, we have generated significant preclinical data that demonstrate our ability to create excellent performing drug candidates that now are advancing into the clinic. Our goal is to become the partner of choice for pharmaceutical companies committed to this area of cancer therapy by enabling the optimization of a broad array of targeting compounds. We will shepherd these therapies through early clinical studies on our own or in collaboration." Dr. Babich, Ratio's President and Chief Scientific Officer. Targeted radiotherapy is an exciting and emerging field where chemistry meets physics meets medicine. We have assembled and will continue to build a world-class interdisciplinary team of researchers and developers with a singular focus on delivering these treatments to cancer patients. It isn't often that a start-up company has in place the early financial backing and industry support to advance entirely new drug discoveries to clinical development at this pace. It is with great pride that we announce our formal launch and exit from stealth mode." Dr. Hoppin, Ratio's Chairman and Chief Executive Officer. In collaboration with Bayer, Ratio has leveraged its Trillium platform for the identification of lead prostate-specific membrane antigen (PSMA)-targeted therapeutic compounds for prostate cancer. At the same time, Ratio is working with Lantheus to develop a lead fibroblast activation protein (FAP)-targeted PET diagnostic compound for a broad array of epithelial-derived cancers, such as breast, pancreatic, lung and stomach cancer. Both collaborations are fully funded and reflect the types of partnerships that Ratio is currently pursuing with other companies. About Ratio Therapeutics Ratio Therapeutics Inc. is a Boston-based pharmaceutical company with the mission to accelerate the development of next-generation precision radiopharmaceuticals for solid tumors and transform oncology treatment paradigms. Founded by John Babich, Ph.D., and Jack Hoppin, Ph.D., the company currently employs a growing team of radiopharmaceuticals discovery and development experts with backgrounds in the life science industry. Ratio's fully integrated proprietary R&D platforms, Trillium™ and Macropa™, enable the imaging, discovery and advancement of novel radiopharmaceuticals that have first/best-in-class delivery, safety and efficacy properties. The tunable nature of the company's platforms enables the efficient and timely generation of numerous novel radiopharmaceuticals for a broad range of high unmet need in solid tumors. Built to be the radiopharmaceuticals discovery and development partner of choice, Ratio currently collaborates with Bayer and Lantheus.

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INDUSTRIAL IMPACT

Four New Sets of Pre-Clinical Data Further Expands the Evidence Supporting Abelacimab

Anthos Therapeutics | July 14, 2022

Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced that four new research updates were presented on abelacimab during the Venous Thromboembolism poster session at the ongoing International Society on Thrombosis and Haemostasis 2022 Congress in London, UK. "Coagulation is a complex multilayered process and the potential benefits of inhibiting Factor XI are becoming increasingly clear. These preclinical studies add important information characterizing the pharmacodynamic effects of abelacimab and further extend our understanding of the biological effects of Factor XI inhibition. With a growing body of evidence from ongoing studies both in the clinic and the lab, and a recent FDA Fast Track designation granted for abelacimab in thrombosis associated with cancer, we are becoming increasingly confident about the potential of our novel dual-acting Factor XI/XIa inhibitor may offer in the future as a treatment advance." Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics PB0927 - Abelacimab does not influence the effects of two commonly used antiplatelet agents in vitro This study investigated the effects of clinically relevant doses of abelacimab on the inhibition of platelet aggregation by commonly used antiplatelet agents, aspirin and ticagrelor, in vitro. It demonstrated that abelacimab did not affect the level of antiplatelet inhibition achieved either by aspirin or ticagrelor confirming that abelacimab will not interfere with the benefits of these antiplatelet agents. PB0925 - Abelacimab has no effect on platelet aggregation induced by TRAP-6 and collagen FXI has been identified as a ligand to platelet receptors ApoER2 and GPIbα on the surface of stimulated platelets. This study demonstrated that abelacimab did not interfere with normal platelet aggregation following stimulation with collagen or thrombin receptor activating peptide-6 (TRAP-6) and compared with vehicle and active control (abciximab, anti-GP2b3a) suggesting that the binding of FXI to the platelet surface has no effect on primary hemostasis. PB0548 - Abelacimab, a Factor XI/XIa Antibody Inhibits Clotting in Hemodialysis Circuits Ex Vivo This study compared the effect of a combination of abelacimab and enoxaparin with enoxaparin alone, in an ex vivo model of hemodialysis that is aggressive due to the frequent re-circulation of blood and a lack of endothelial cells. Inhibition of FXI/FXIa by abelacimab combined with enoxaparin (but not enoxaparin alone) reduced and prevented device malfunction. This provides support for testing abelacimab in patients on hemodialysis. While patients with severe factor XI (FXI) deficiency rarely have spontaneous bleeding, low doses of recombinant activated factor VII (rFVIIa) have been used and are effective in managing bleeding should it occur. This study was designed to evaluate whether low concentrations of rFVIIa could revert the changes in abelacimab-induced coagulation parameters as measured by rotational thromboelastometry (ROTEM) in whole blood in vitro assays from healthy individuals. As expected and similar to what has been observed in patients with Factor XI deficiency, these data suggest that low doses of rFVIIa can be used to manage bleeding in Factor XI inhibited patients being treated with abelacimab. About Anthos Therapeutics Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic (CVM) diseases. Anthos Therapeutics aims to combine the agility of a biotech with the rigor of a large pharmaceutical company. Anthos Therapeutics was launched by Blackstone Life Sciences in 2019. About Abelacimab Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Abelacimab targets the active domain of Factor XI, demonstrating dual inhibitory activity against both Factor XI and its activated form, Factor XIa. Abelacimab can be administered intravenously (IV) to achieve rapid inhibition of Factor XI activity and then used subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting. In a PK/PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days. 1,2 In a Phase 2 study whose results were published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.

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MEDTECH

Enveric Biosciences Announces Reverse Stock Split

Enveric Biosciences | July 15, 2022

Enveric Biosciences, Inc. a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, announced that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 50 pre-split shares. The reverse stock split will become effective at 4:05 p.m., New York time, on Thursday, July 14, 2022. Enveric’s common stock will continue to be traded on the Nasdaq Capital Market under the symbol “ENVB” and will begin trading on a split-adjusted basis when the market opens on Friday, July 15, 2022. At a special meeting of stockholders held on July 14, 2022, Enveric’s stockholders granted the Company’s Board of Directors the discretion to effect a reverse stock split of Enveric’s common stock through an amendment to its Amended and Restated Certificate of Incorporation, as amended, at a ratio of not less than 1-for-10 and not more than 1-for-100, such ratio to be determined by the Company’s Board of Directors. At the effective time of the reverse stock split, every 50 shares of Enveric’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock without any change in the par value per share. Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1-for-50 reverse stock split. It is not necessary for stockholders holding shares of the Company’s common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in connection with the reverse stock split, although stockholders may do so if they wish. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. Any fractional share of a stockholder resulting from the reverse stock split will be rounded up to the nearest whole number of shares. The reverse stock split will reduce the number of shares of Enveric’s common stock outstanding from 52,684,548 shares to approximately 1,053,691 shares. Proportional adjustments will be made to the number of shares of Enveric’s common stock issuable upon exercise or conversion of Enveric’s equity awards and warrants, as well as the applicable exercise price. Stockholders whose shares are held in brokerage accounts should direct any questions concerning the reverse stock split to their broker. All stockholders of record may direct questions to the Company’s transfer agent, American Stock Transfer & Trust Company, LLC, at 1-877-248-6417 or 1-718-921-8317. About Enveric Biosciences Enveric Biosciences, Inc. is a neuroscience-focused pharmaceutical company developing next-generation, psychedelic-inspired mental health medicines. Enveric’s robust pipeline supports drug development from the clinic to commercialization aimed to help millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more.

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MEDICAL

Ochre Bio Launches ‘Liver ICU’ in the United States to Evaluate Effects of RNA Therapies on Human Liver Performance

Ochre Bio | May 12, 2022

Ochre Bio, a biotech company developing RNA medicines for chronic liver diseases, announced today the launch of their ‘Liver ICU’. Housed in BioLabs@NYULangone, a biopharma incubator in New York City, this research site will evaluate the efficacy of new RNA therapeutics on whole human livers maintained on machines. The use of discarded donor livers for research is expected to enhance timelines and accuracy of liver medicine research by testing interventions directly in human livers maintained under conditions mimicking human physiology. This site is a part of a network of three leading liver perfusion research sites across the US. The other two US research sites are the laboratory of Greg Tietjen, Ph.D at Yale University, a pioneer in the field of ex vivo organ research, and LifeShare of Oklahoma, a leading US organ procurement organization. In addition, Ochre Bio is also announcing a partnership with OrganOx, a company at the forefront of changing the way donor livers are preserved in the critical time between donation and transplantation, and one of the first companies to have a liver perfusion device approved by the FDA. This research will involve hundreds of donor livers being kept alive outside the body for multiple days each. These are donor livers that cannot be used for transplant patients for various reasons, and so would be otherwise discarded. The livers will be maintained in human physiological conditions and used to test therapeutic interventions, with the goal of finding new therapies to improve liver transplant outcomes, in the hopes of thereby increasing the supply of transplantable livers, as well as uncovering insights relevant to a wider set of liver diseases. Greg Tietjen’s research group at Yale and LifeShare of Oklahoma will work with the Ochre research team towards being able to consistently perfuse organs for several days to study the effects of RNA therapy on liver performance. We’re excited to announce this new research site in the US, as well as these partnerships with world leaders in liver perfusion research and transplant medicine, This collaboration to evaluate the effects of RNA therapy directly in human livers preclinically is a step change for liver research, that we hope will lead to treatments for a number of liver diseases, and one day reduce the burden of liver transplantation for patients.” Jack O’Meara, CEO & Co-Founder at Ochre Bio. Thanks to the collaborative efforts of Ochre Bio, OrganOx, Yale University and, LifeShare of Oklahoma, the unique capabilities of the OrganOx metra are enabling multi-day isolated organ perfusion research and facilitating a new and exciting approach to developing novel therapeutics for liver diseases. We look forward to seeing the results of this approach leave research and enter the clinic in the future.” Craig Marshall, CEO, OrganOx. We view this work as an opportunity to honor the profound gift that every donor organ represents. While the organs enrolled in this study may not save the life of one transplant recipient, they have the potential to save hundreds of thousands of lives in the future by enabling breakthrough new therapies from Ochre Bio to treat end stage liver disease.” Gregory Tietjen, Ph.D., Assistant Professor of Transplant Surgery, Yale School of Medicine About Ochre Bio Ochre Bio is a biotechnology company developing RNA therapies for chronic liver diseases. Using a combination of genomic deep phenotyping, precision RNA medicine, and testing in live human donor livers, Ochre is developing therapies for important liver health challenges, from increasing donor liver supply to reducing cirrhosis complications. With laboratories across the UK, Asia and North America, the team has decades of experience leading liver genomics research and bringing advanced therapies to market.

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Spotlight

“GMOs are not saving farmers money, they’re not producing higher yields, and perhaps most significantly they’re wrecking the environment and human health,” the anti-biotech outfit Natural News warned in December 2014. Such claims are recycled endlessly by environmental activists and widely circulated thanks to social media, but they are wholly unsupported by the evidence, according to a new reportpublished by the The International Service for the Acquisition of Agri-biotech Applications (ISAAA).

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