Ferring, Rebiotix and MyBiotics Collaborate to Develop Live Microbiome-Based Therapeutics in Reproductive Medicine and Maternal Health

On February 17, 2021 Ferring Pharmaceuticals, Rebiotix Inc., a Ferring Company, and MyBiotics Pharma Ltd. reported a multi-year strategic collaboration to develop live microbiota-based biotherapeutics to address bacterial vaginosis, a common vaginal infection among women of reproductive age linked to increased risk of miscarriage and complications for pregnancy and fertility (Press release, MyBiotics, FEB 17, 2021, View Source [SID1234577655]). 1,2,3 The collaboration is an important step forward in harnessing the power of the human microbiome in this area of women’s health.

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Currently bacterial vaginosis is treated with antibiotics, which can disrupt the vaginal microbiome, and it’s common for bacterial vaginosis to return following treatment.4 The aim of a microbiota-based treatment would be to reduce the need for antibiotic use and provide a long-term treatment solution.

The multi-year agreement combines MyBiotics’ unique culturing, delivery and colonisation technologies aimed at restoring microbiome equilibrium with Rebiotix’s expertise in developing clinical-stage live microbiota-based biotherapeutic products and Ferring’s therapeutic development and commercial expertise. The new agreement builds on the existing collaboration between Ferring and MyBiotics, initiated in 2017, which has already successfully piloted technologies intended to stabilise selected bacterial species critical to the health of the female reproductive tract using MyBiotics’ MyCrobe technology.

"We are proud to be undertaking this collaboration, as it is a critical step forward in meeting patient needs through the potential of the microbiome," said Ken Blount, Chief Scientific Officer, Rebiotix and Vice President of Microbiome Research, Ferring Pharmaceuticals. "This collaboration with MyBiotics not only harnesses our collective expertise in developing live microbiota-based biotherapeutic technologies, but also reaffirms Ferring’s deep commitment to building families worldwide through innovations in reproductive medicine and maternal health."

The collaboration announced today also stands to add several firsts to Ferring’s microbiome product pipeline, including the company’s first non-donor derived formulation, and a live microbiota-based product specific to reproductive medicine.

"Today’s agreement is an important evolution of our long-standing relationship with Ferring in the field of microbiota-based therapies for the benefit of women’s health, including reproduction and pregnancy," said MyBiotics’ CEO, David Daboush. "We look forward to combining our innovative MyCrobe live bacteria culturing, delivery and colonisation technology with the world-leading development experience of Rebiotix for the benefit of women. The collaboration with Rebiotix builds on our successful collaboration with Ferring, and we are excited to build on that strong relationship targeted to bringing novel treatments to patients through our tailor-made microbiome technology platform."

MyBiotics has developed breakthrough and robust culturing, fermentation and delivery technologies for generating a highly stable and diverse bacterial community that can be efficiently delivered to different sites across the human body for restoring microbiome equilibrium. These technologies are effective for single microbes, complex microbial consortia and whole microbiome products, and are integrated with a computational AI platform, which enables the design of unique microbial consortia and whole microbiome profiles. The technologies are highly potent and suitable for patients with microbiome-related medical conditions.

The potential of live microbiota-based biotherapeutic products is an expanding frontier. The most clinically advanced formulations, derived from the human gut microbiome, are currently being developed to address Clostridioides difficile (C.diff) infection and have opened the door to harnessing the power of the microbiome to address other unmet medical needs. As the future of microbiome-based therapeutics expands, the potential extends beyond the gut to reproductive medicine. The ability to generate standardised, stabilised, approved formulations, created to serve patient needs in reproductive medicine and maternal health, connects to the core vision of both companies.

NexImmune Announces Closing of Upsized Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On February 17, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent and durable immune response, reported the closing of its previously announced upsized initial public offering of 7,441,650 shares of its common stock at a price to the public of $17.00 per share, which includes the exercise in full by the underwriters of their option to purchase 970,650 additional shares (Press release, NexImmune, FEB 17, 2021, View Source [SID1234576168]). Including the option exercise, the gross proceeds to NexImmune from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses, were approximately $126.5 million.

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Barclays Capital Inc., Cantor Fitzgerald & Co., Raymond James & Associates, Inc. and Allen & Company LLC acted as the joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on February 11, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from: Barclays Capital Inc., Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (888) 603-5847, or email: [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets Department, 499 Park Avenue, New York, NY 10022, or email: [email protected]; Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, FL 33716, telephone: (800) 248-8863, or email: [email protected]; or Allen & Company LLC., Attention: Prospectus Department, 711 Fifth Avenue, New York, NY 10022, telephone: (212) 339-2220, or email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

INOVO : the Oncofactory’s new project with the Carnot Calym Institute and Astrazeneca

On February 17, 2021 Astrazeneca, The Carnot Calym Institute and Inserm Transfert for Inserm sign a framework agreement for research collaboration in lymphomas (Press release, OncoFactory, FEB 17, 2021, View Source [SID1234575981]).

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In order to accelerate the search for therapeutic solutions for lymphoma patients, the three partners have decided to pool their expertise by signing a tripartite agreement. This partnership sets up the conditions for the collaboration between the pharmaceutical group AstraZeneca, research teams from the Carnot CALYM Institute network and Inserm Transfert, Inserm’s private subsidiary, representing the research teams. This 3-year collaboration will allow the funding of up to two projects per year.

This agreement defines the terms of the collaboration with respect to governance, funding, intellectual property, exploitation of results and eligibility of research projects. It provides a platform facilitating the alliance between AstraZeneca’s R&D, bringing new drug candidates from its technology platforms of excellence, and the world-renowned expertise of the academic teams of the CALYM’s network, dedicated to the pathophysiology of lymphomas.

According to Bertrand Nadel, Director of CALYM, "Successful therapeutic innovation today requires interfacing academic expertise with R&D practices and the drug development value chain and intensifying the dialogue between public and private players. AstraZeneca’s commitment to connecting the Discovery/Innovation/Transfer segments makes it a partner of choice for our Carnot CALYM Institute to meet this challenge".

PRESS RELEASE: Generating recommendations for the design, analysis and interpretation of patient- reported outcome (PRO) data for cancer clinical trials: the launch of SISAQOL-IMI

On February 17, 2021 An international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), reported that has been convened to generate recommendations to standardize the use, analysis, and interpretation of patient reported outcome (PRO) data in cancer clinical trials (Press release, EORTC, FEB 17, 2021, View Source [SID1234575348]).

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SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) will establish guidance on how to use patient-reported outcomes in cancer clinical trials so that they can be used in a methodologically sound way, analysed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and a better comparability of results across clinical trials.

SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI). Forty-one stakeholder groups are involved in the partnership, including researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators, and patient advocacy organisations. The project aims to improve the interpretability of cancer clinical trials and thereby (in the long run) also provide a more solid and reliable basis for shared decision making between patients and physicians to improve outcomes, treatment satisfaction, and care treatment decisions in clinical practice.

Andrew Bottomley, Assistant Director and Head of the Quality of Life Department at the EORTC and SISAQOL-IMI project coordinator said,

"Outcomes from this project will help us understand more about the impact of treatment on the lives of patients. We are looking forward to working with our project partners to generate recommendations that will be useful to so many different stakeholders "

Kathy Oliver, Chair and Co-Director of the International Brain Tumour Alliance also commented,

"The SISAQOL-IMI initiative is a ground-breaking project which will set much-needed international standards for PRO data analysis in cancer clinical trials. We look forward to WECAN’s involvement with this exciting initiative"

Dr Ingolf Griebsch Head of Corporate Market Access Oncology at Boehringer Ingelheim and SISAQOL-IMI project leader said,

"SISAQOL-IMI is a great example of how researchers from academia and industry can truly partner with regulators and patient organisations to develop useful recommendations for interpreting PRO data in the future"

SISAQOL-IMI kicked off at the beginning of January and will run for four years.

Cannabics Pharmaceuticals’ in-vivo Tumor Inhibitory Effect Study Concludes with a Statistical Significance of p ? 0.016

On February 17, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported that further clarifies with regards to the final study results released on February 16, 2021, that said study results showing "a significant and robust inhibitory effect on tumor growth, as evidenced by a 33% reduction in tumor volume in mice exposed to RCC-33 in comparison with sham control mice," are said to have statistical significance with p ≤ 0.016 (Press release, Cannabics Pharmaceuticals, FEB 17, 2021, View Source [SID1234575344]).

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