On February 17, 2022 Enveric Biosciences (NASDAQ: ENVB)("Enveric" or the "Company), a cutting-edge neuroscience company developing next-generation, psychedelic-inspired mental health medicines, reported that it is working with the University of Calgary’s Hotchkiss Brain Institute ("HBI"), a leading neurosciences center of excellence, at the Cumming School of Medicine in Calgary, Canada that is dedicated to advancing brain and mental health research and education, to establish a groundbreaking clinical trial of EVM-101 for the treatment of Cancer Related Distress ("CRD") (Press release, Enveric Biosciences, FEB 17, 2022, View Source [SID1234608227]).

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Approximately 50% of cancer patients report clinical levels of psychological distress having depressed mood, anxiety, demoralization, stress-induced clinical manifestations, and reduced quality of life1. Up to 40% of cancer patients meet the criteria for a mood disorder requiring treatment2. CRD is a significant unmet medical need with no current regulatory approval of pharmacotherapies and an urgent need to optimize the current standard of care for patients with cancer.3

A clinical trial, expected to launch later this year, of EVM-101, a first-generation psychedelic treatment, for CRD will be led by HBI researcher, Dr. Valerie Taylor, Head of the Department of Psychiatry, in Calgary, Canada.

"We are excited to collaborate with Enveric to study next-generation medicines that we hope will help people cope with the mental health challenges of a cancer diagnosis. This work will allow us to mobilize our combined resources to research options for cancer patients living with CRD," says Dr. Valerie Taylor.

The EVM-101 study will directly assess the core features of CRD that are most affected and amenable to improvement following a psilocybin-based treatment.

"With the rising rates of cancer and its associated psychological ailments that have been underestimated and underdiagnosed until recently, we are working hard to develop new treatments that help cancer patients suffering from CRD" said Dr. Bob Dagher, Enveric’s Chief Medical Officer. "Our collaboration with the research team at the University of Calgary’s Hotchkiss Brain Institute and IMPACT Clinical Trial Accelerator will help us to demonstrate the potential benefits of these novel treatments and get them to market as quickly as possible."

A regulatory submission to Health Canada is expected to soon be finalized. Patient enrollment in the clinical trial is expected to begin late in 2022 or early in 2023. The study design will employ proprietary psychiatry and psychotherapy-focused treatments for cancer patients with CRD. Patients will receive a single oral dose of EVM-101 in a supportive environment with psychotherapy to improve outcomes.

Enveric is committed to discovering and developing more effective treatments for cancer patients living with psychological distress and is currently working on three classes of new medicines: EVM-101, a first-generation oral psilocybin; EVM-201, a second-generation pro-drug; and EVM-301, a third-generation psychedelic-inspired and optimized new molecule.

References:

Mehnert, A., Hartung, T. J., Friedrich, M., Vehling, S., Brahler, E., Harter, M., et al. (2018). One in two cancer patients is significantly distressed: prevalence and indicators of distress. Psychooncology 27, 75-82. Doi: 10.1002/pon.4464
Holland et al. (2013). Distress Management. J Natl Compr Cancer Network 2013 Feb 1;11(2):190-209. doi: 10.6004/jnccn.2013.0027
Peters, L., Brederecke, J., Franzke, A., Zwaan, M., Zimmermann, T. (2020). Psychological Distress in a Sample of Inpatients with Mixed Cancer-A Cross-Sectional Study of Routine Clinical Data. Front Psychol. 2020 Nov 30; 11:591771. doi: 10.3389/fpsyg.2020.591771

On February 17, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, reported that BeiGene’s BTK inhibitor BRUKINSA (zanubrutinib) received approval from Swissmedic for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior line of therapy, or for treatment-naïve patients who are not suited for standard chemo-immunotherapy (Press release, BeiGene, FEB 17, 2022, View Source [SID1234608243]). BRUKINSA had previously been granted orphan drug status.

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"The authorization of BRUKINSA will bring a new option and an innovative medicine that has potential to offer deep and durable response for eligible patients with WM in Switzerland," said Pr. Davide Rossi, Deputy Head of the Division of Hematology of the Oncology Institute of Southern Switzerland IOSI. "BRUKINSA is a next-generation BTK inhibitor which has also provided meaningful improvements in tolerability for some patients with WM compared to ibrutinib, as treatment discontinuation remains a concern."

Reto Kessler, Country Manager, Switzerland at BeiGene added, "This approval is a significant development for people living with WM in Switzerland and for BeiGene’s expansion in Europe. Our teams are committed to collaborating with the Federal Office of Public Health and healthcare professionals to ensure access to BRUKINSA for patients in Switzerland."

The Marketing Authorization Application (MAA) is supported by data from the global Phase 3 ASPEN clinical trial, a Phase 3 randomized, open-label, multicenter trial (NCT03053440) that evaluated BRUKINSA compared to ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT). In the ASPEN trial, BRUKINSA demonstrated a numerically higher very good partial response (VGPR) rate and a favorable safety profile over ibrutinib, although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met. As assessed by independent review committee (IRC) per adaptation of the response criteria updated at the Sixth International Workshop on Waldenström’s Macroglobulinemia (IWWM), the combined complete response (CR) + VGPR rate in the overall intention-to-treat (ITT) population was 29% with BRUKINSA (95% CI: 20, 40), compared to 19% with ibrutinib (95% CI: 12, 30).

In the ASPEN trial, of the 101 patients with WM randomized and treated with BRUKINSA, four percent of patients discontinued due to adverse events, including cardiomegaly, neutropenia, plasma cell myeloma, and subdural hemorrhage. Adverse events leading to dose reduction occurred in 14% of patients, with the most common being neutropenia (3%) and diarrhea (2%).

The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

About Waldenström’s Macroglobulinemia

WM is a rare B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin lymphomas.2 The disease usually affects older adults and is primarily found in bone marrow, although lymph nodes and the spleen may be involved.1 Throughout Europe, the estimated incidence rate of WM is approximately seven for every one million men and four for every one million women.2

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the U.S., European Union, China, Australia, Great Britain and Switzerland. Currently, more than 40 additional regulatory submissions are in review around the world.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On February 17, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the acquisition of a majority ownership of Zhengzhou Fortune Bioscience Co., Ltd. ("FortuneBio") (Press release, Sorrento Therapeutics, FEB 17, 2022, View Source [SID1234608260]). This acquisition is in response to dramatically increasing demands worldwide and planned product build-up in anticipation of potential additional approvals for Sorrento’s COVISTIXTM COVID-19 VIRUS Rapid Antigen Detection Test.

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FortuneBio specializes in the manufacture of lateral flow diagnostic tests with numerous approved products marketed in over 20 countries for pregnancy tests, fecal occult blood test, and drug abuse test kits. FortuneBio has an ISO 13885 facility and is capable of producing tens of millions of lateral flow tests per month. FortuneBio is currently expanding production capabilities to meet COVISTIX demand worldwide.

COVISTIX is a sensitive and rapid antigen diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients. "While most rapid antigen tests are negatively impacted with a reduced LoD sensitivity to the Omicron variant1, in a laboratory setting with live Omicron viruses, COVISTIX demonstrated the ability to detect the Omicron variant at an even lower LoD as compared to that of the original SARS-CoV-2 strain. Our lateral flow antigen test uses a platinum colloid coupled with a pair of specific antibodies to give a clear black line if virus is present, in contrast to many tests which use a gold colloid which results in a pink or red line. This proprietary platinum colloid technology is what contributes to our improved Omicron LoD sensitivity," said Brian Cooley, Sorrento’s SVP for Drug Delivery and Diagnostics.

"COVISTIX demand is increasing rapidly worldwide due to its high sensitivity as compared with other EUA-approved tests. By acquiring a majority stake in FortuneBio, Sorrento is in a better position to rapidly respond to the ever-changing demand of rapid COVID testing and broaden our diagnostic product offering to other areas such as early cancer diagnostics," stated Dr. Henry Ji, Chairman and CEO of Sorrento. "In addition to providing product revenue from an established portfolio of approved diagnostic tests, FortuneBio gives Sorrento an experienced diagnostic research, development and manufacturing team and an ISO-certified facility to rapidly advance and commercialize our antibody-enabled diagnostic products in synergy with our antibody therapeutics."

1SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests | FDA https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests

On February 17, 2022 Philogen S.p.A. ("Philogen" or "the Company"), a clinical-stage biotechnology company focused on antibody and small molecule-based targeted therapeutics, reported that France’s National Agency for the Safety of Medicines and Health Products (ANSM) has authorized the Company to run a Phase II study of Nidlegy in patients affected by different nonmelanoma skin cancer indications (Press release, Philogen, FEB 17, 2022, View Source [SID1234608209]). A favourable opinion about the study had already been obtained by one of the country’s ethic committees (Comité de Protection des Personnes Sud-Est III) in January 2022.

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Patients affected by Basal Cell Carcinoma (BCC), cutaneous Squamous Cell Carcinoma (cSCC), Merkel Cell Carcinoma, Keratoacanthoma, tumoral cutaneous T-Cell Lymphoma, Kaposi’s Sarcoma or Adnexal Tumors of the Skin, for whom available alternatives have already been exhausted or who are no candidates to such alternative approaches will be eligible for the clinical study.

Nidlegy, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional treatment of patients with advanced melanoma and in BCC and cSCC in an ongoing Phase II study. The durable responses, excellent safety profile and favourable cosmetic outcome of injected lesions have encouraged the investigation of efficacy and safety of Nidlegy in injectable lesions of numerous non-melanoma skin cancer indications, which are underserved by alternatives presently available.

Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen said: "We are delighted to start this clinical Phase II study in non-melanoma skin cancers in France under the leadership of Prof. Jean-Jacques Grob, a world-class expert in this group of tumors and to explore the potential of Nidlegy in patients for whom existing therapeutic alternatives are not or no longer practicable."

On February 17, 2022 Remix Therapeutics (Remix), a biotechnology company developing small molecule therapies designed to reprogram RNA processing and address the underlying drivers of disease, reported a strategic collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the discovery and development of small molecule therapeutics that modulate RNA processing using Remix’s REMaster drug discovery platform (Press release, Janssen Pharmaceutica, FEB 17, 2022, View Source [SID1234608228]). The agreement was facilitated by Johnson & Johnson Innovation.

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Under the terms of the agreement, Remix will receive an initial payment of $45 million in cash for upfront and research funding, and may also receive preclinical, clinical, commercial, and sales milestone payments and tiered royalties for any resulting products. In exchange, Janssen will have exclusive rights to three specific targets with applications in immunology and oncology. Remix will have the ability to opt into a portion of the costs of clinical development on one program in exchange for higher royalties. Under the agreement, Remix is eligible to receive total payments potentially exceeding $1 billion, subject to regulatory approvals and other conditions.

"We look forward to collaborating with this innovative team," said Peter Smith, Ph.D., Co- Founder and Chief Executive Officer of Remix Therapeutics. "Janssen is an ideal strategic partner for our REMaster platform. This collaboration further validates the therapeutic potential of our proprietary REMaster drug discovery platform and provides additional resources to translate our cutting-edge science into new medicines."