On November 21, 2019 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by BeiGene to be a specialty pharmacy network partner for BRUKINSA (zanubrutinib), a new oral treatment for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (Press release, Onco360, NOV 21, 2019, View Source [SID1234551594]).

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"The approval of BRUKINSA as a second-line therapy option for patients with relapsed and refractory MCL is an important advancement in fighting this devastating disease"

"The approval of BRUKINSA as a second-line therapy option for patients with relapsed and refractory MCL is an important advancement in fighting this devastating disease," said Paul Jardina, President and CEO, Onco360. "As a specialty pharmacy dedicated to serving people with cancer, Onco360 is pleased to be one of a few pharmacies bringing this new innovative treatment to MCL patients."

According to the American Cancer Society, Mantle cell lymphoma is a type of non-Hodgkin’s lymphoma representing 3-10% of all non-Hodgkin’s lymphomas in the United States. By the time it is diagnosed, mantle cell lymphoma has usually spread to the lymph nodes, bone marrow and other organs. In relapsed lymphoma, the disease reappears or grows again after a period of remission, while in refractory lymphoma, the disease does not respond to treatment or responds only briefly.

BRUKINSA is manufactured by BeiGene, a global, commercial-stage, research-based biotechnology company, and was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with MCL on November 14, 2019. The FDA’s approval of BRUKINSA is based on efficacy results from two single-arm clinical trials, with independent review committee (IRC)-assessed ORR per 2014 Lugano Classification as the primary endpoint. Across both trials, BRUKINSA achieved an ORR, which is the sum of complete responses and partial responses, of 84%. For full prescribing information, visit BRUKINSA.com.

On November 21, 2019 Azeria Therapeutics (Azeria), a newly formed pioneer factor drug discovery company, reported a £32 million Series B financing in which Syncona has committed £29.5 million alongside existing investor the CRT Pioneer Fund (Press release, Azeria Therapeutics, NOV 21, 2019, View Source [SID1234551575]).

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Azeria was originally founded in 2017 by Sixth Element Capital, manager of the CRT Pioneer Fund and Cancer Research UK’s Commercial Partnerships team with the aim of building a world class pioneer factor1 oncology company, developing breakthrough treatments for hormone resistant breast cancer patients. It was based on the work of leading expert in the field, Professor Jason Carroll at the Cancer Research UK Cambridge Institute, University of Cambridge, UK, whose scientific insights have led to a new approach to target FOXA1 driven cancer.

FOXA1 is an essential pioneer factor which has been shown to be pivotal in the tumour growth, progression and maintenance of oestrogen receptor positive luminal breast cancer. This is an area of significant unmet patient need where approximately 30 per cent of patients progress to late stage endocrine resistant disease2 and where there is potential for new treatments to have significant impacts for patients not addressed by existing therapeutics. Extensive target validation and drug discovery work to date supports the lead programme, with a plan to take the programme into the clinic over the course of the Series B funding. Azeria is seeking to develop the programme to commercialisation and to explore a pipeline of further programmes in oncology.

Azeria received initial investment of £5.5 million in Series A financing from the CRT Pioneer Fund, which focuses on early stage investments in highly innovative oncology programmes. Syncona is the largest investor in the CRT Pioneer Fund and will now participate directly in the next stage of growth and development. Magda Jonikas and Martin Murphy of Syncona will now join the Board of Azeria.

Stephen Myatt, Chief Executive Officer of Azeria Therapeutics said:

"Azeria is the product of more than ten years of research by Professor Jason Carroll at Cancer Research UK’s Cambridge Institute, University of Cambridge and was created to accelerate research and development into pioneer factors, a completely new target class in oncology including FOXA1. We would like to thank Sixth Element Capital for their continued support and look forward to working closely with Syncona to accelerate the development of breakthrough treatments for hormone resistant breast cancer patients."

Martin Murphy, Chief Executive of Syncona Investment Management Limited, said:

"Azeria is an exciting company and a perfect fit for Syncona’s long term strategy building globally leading healthcare companies. Based on unique, proprietary scientific insight, with a world class academic founder and high-quality team, the company has an opportunity to develop and commercialise treatments which could make a significant difference for patients. The Sixth Element team did an excellent job in identifying and investing in this science to take it to the point where it became an exciting and appropriate opportunity for Syncona."

1 A pioneer factor is a specialised type of transcription factor, able to ‘open’ compacted DNA to which is a protein that can initiate the expression of genes to make sure they are expressed in the right cell at the right time. Changes in these specific expression patterns can drives certain cancers.

On November 21, 2019 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY),reported that it will publish its third quarter financial results and a business update for the period ended September 30, 2019 on Thursday, November 28, 2019, in the form of an interim management report (Press release, Vivoryon Therapeutics, NOV 21, 2019, View Source [SID1234551556]).

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On November 21, 2019 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next-generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it expanded its research collaboration with the Karolinska Institutet in Stockholm, Sweden (Press release, Phio Pharmaceuticals, NOV 21, 2019, View Source [SID1234551577]). The collaboration thus far has focused on the use of the Company’s self-delivering RNAi compounds against targets involved in T cell and NK cell differentiation and/or tumor-induced stress response, with the aim of producing anti-tumor adoptive cell therapy grafts with improved functionality and persistence. Based on compelling results, Phio Pharmaceuticals and Karolinska have agreed to extend and expand the collaboration to research aimed at decreasing immune-inhibitory factors in the tumor micro-environment and/or arming T cell, NK cell, dendritic cells and macrophages to overcome tumor immunosuppression utilizing Phio Pharmaceuticals’ INTASYL platform.

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This work will further align with ongoing translational research at the Karolinska Institutet, which combines adoptive T cell therapy and dendritic cell vaccination. The focus of the expanded collaboration will include developing a pathway to the clinic and establishing the utility of Phio Pharmaceuticals’ self-delivering RNAi in these therapeutic applications.

Dr. Gerrit Dispersyn, President and CEO of Phio Pharmaceuticals, stated, "Over the last year, our collaboration with Dr. Kiessling’s group at the Karolinska Institutet has led to exciting results with several compounds in both T cells and NK cells, including the results presented earlier this month at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting showing that INTASYL technology can be used to expand T cells with superior anti-tumor potential for adoptive cell therapies. Our continued collaboration will build upon these findings and expand to additional targets and cell types. We are very pleased to be working with Dr. Kiessling and his team on the advancement of our self-delivering RNAi immuno-oncology therapeutics towards clinical application in areas of Karolinska’s ongoing clinical research."

Rolf Kiessling, MD, PhD, Senior Professor in Experimental Oncology at the Karolinska Institutet, Senior Chief Physician at the Oncology clinic at the Karolinska University Hospital and member of Phio Pharmaceuticals’ Scientific Advisory Board stated, "Our results to date show that we can use self-delivering RNAi to modulate targets outside of checkpoints to improve efficacy of immune effector cells such as T cells and NK cells. The flexibility and ease of use of the platform means that we can also integrate this technology with other types of cells used in immuno-oncology therapy, including those that are currently being used in ongoing Karolinska clinical practice and clinical research."

On November 21, 2019 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported the closing of the issuance of an additional 318,750 shares of its common stock pursuant to the exercise in full of the underwriters’ over-allotment option in connection with its initial public offering (the "IPO") (Press release, CNS Pharmaceuticals, NOV 21, 2019, View Source [SID1234551596]). The additional shares were sold at the IPO price of $4.00 per share, before underwriting discounts and commissions.

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The gross proceeds from the sale of the additional shares, before deducting underwriting discounts and commissions, was $1.3 million, bringing the total gross proceeds from the IPO to $9.8 million. The Company’s shares of common stock trade on the NASDAQ Capital Market under the ticker symbol "CNSP."

The Benchmark Company, LLC acted as sole Book Running Manager for the offering.

A registration statement on Form S-1 (File No. 333-232443) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on November 7, 2019. The offering was made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, 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.

About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.