Long-term follow-up of chemoradiotherapy treatment in glioma patients shows significantly increased survival

ON June 22, 2022 EORTC reported that Glioma is a type of brain cancer that is rare and difficult to treat (Press release, EORTC, JUN 22, 2022, View Source [SID1234616174]). Until quite recently, gliomas were considered to be incurable and often became rapidly fatal, but now two trials have shown that the addition of chemotherapy to radiotherapy (RT) can improve both disease control and survival in the long term for patients with a glioma. The results* are reported in the Journal of Clinical Oncology today (Wednesday 22 June).

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The two trials (EORTC 26951 and RTOG 9402) were launched 25 years ago. Patients with two types of glioma who had not undergone radiotherapy or chemotherapy were enrolled, and randomised to either RT with or without six cycles (EORTC) or four cycles (RTOG) of the chemotherapy drugs procarbazine, lomustine, and vincristine (PCV). In a joint paper, the researchers have now provided updates of these trials.

After a very long-term follow-up – a median of nearly 20 years – results from the EORTC trial showed that overall survival among patients randomised to PCV-RT as opposed to RT alone was 57% at 10 years, 51% at 15 years, and 37% 20 years after treatment in the first group as opposed to 43%, 26%, and 14% in the group that received RT alone. Results from the RTOG study were very similar. Progression-free survival (the time the patient lives without the disease getting worse) was also improved among patients with PCV-RT as opposed to RT alone.

"These trials have provided exciting, practice-changing results," said Dr Martin van den Bent, from the Brain Tumour Centre, Erasmus University Hospital, Rotterdam, The Netherlands. "They also demonstrate the critical importance of publicly funded networks in conducting clinical trials, particularly where long intervals are required for the data to be fully mature. Such long-term trials are not feasible for a commercial sponsor, but they are essential if we are to be able to make progress in the treatment of rare diseases."

It will be important to understand any long-term adverse effects of PCV-RT, the researchers say. Will there be effects on cognitive function? How long will patients be able to continue to live independently after treatment? Further trials are underway to study these issues. "But in the meantime, we are delighted to have been able to provide robust proof of the extension of disease-free and overall survival for these patients through the use of PCV-RT, and to show that the outlook for them is very much more promising than was thought as recently as a decade ago," says Dr van den Bent.

CytoDyn to Hold Webcast to Provide a Quarterly Company Update

On June 22, 2022 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that Tanya Urbach, Board Chair, Antonio Migliarese, Chief Financial Officer and Interim President, Scott Kelly, Chief Medical Officer and Head of Business Development, and Christopher Recknor, M.D., Senior Director of Research & Development, will host an investment community webcast to provide a quarterly Company update on Thursday, June 30, 2022 (Press release, CytoDyn, JUN 22, 2022, View Source [SID1234616173]).

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Following the update, questions submitted prior to the webcast as directed below will be addressed to the extent appropriate.

This is a livestream presentation. Participants are encouraged to login early prior to the start of the event. The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until July 30, 2022.

Cancer Research Institute Names Newest Class of Lloyd J. Old STARs, Today’s Visionaries in Cancer Immunotherapy Research

On June 22, 2022 The Cancer Research Institute (CRI), a nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all types of cancer, reported the newest cohort of scientists chosen for the CRI Lloyd J. Old STAR Program (Scientists Taking Risks) (Press release, Cancer Research Institute, JUN 22, 2022, View Source [SID1234616171]). Each STAR will receive a grant of $1.25 million payable over five years to carry out high-risk/high-reward research that has the potential to produce transformative leaps forward in tumor immunology. This long-term funding provides a degree of flexibility and freedom for CRI STARs to explore new and disruptive avenues of cancer research.

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"The competitive CRI Lloyd J. Old STAR program supports gifted, mid-career scientists working at the intersection of immunology, technology, and bioinformatics to identify specific molecular and genetic factors that influence patient responses to immunotherapy, discovering answers to the field’s key scientific questions to potentially effect a sea change in how cancer patients are diagnosed and treated," said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute, which now actively supports twenty-two STARs throughout the U.S. and Europe.

The announcement comes during the tenth annual Cancer Immunotherapy Month celebrations in June of scientists who are driving new and lifesaving advances in the immunological treatment and prevention of cancer. This year’s Cancer Research Institute Lloyd J. Old STARs include:

Iliyan D. Iliev, Ph.D., of Weill Cornell Medicine, who is breaking new ground in efforts to understand the role fungi play in cancer development and immunotherapy, characterizing how different fungal strains promote or inhibit cancer growth through interaction of their metabolites and toxins with the immune system, and determining how the presence of fungi within the tumor microenvironment and blood influences – and may even predict – patient responses to treatment with immunotherapy
Philip J. Kranzusch, Ph.D., of the Dana-Farber Cancer Institute and Harvard Medical School, who has discovered and is exploring thousands of previously uncharacterized signaling enzymes from the cGAS family involved in immune cell responses to threats, using biochemistry and structural biology to uncover the functions of these enzymes and their related cellular pathways in order to define at the molecular level how they are activated, potentially leading to new, more effective therapeutic strategies
Kole T. Roybal, Ph.D., of the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center and Gladstone-UCSF Institute of Genomic Immunology, who has developed a synthetic biology approach to modifying immune cell receptor and signaling gene programs to create "smart cell" therapeutics with enhanced abilities to target tumors more precisely and more safely than current cell therapies, which have so far proven largely ineffective against solid tumors despite their successes in treating cancers of the blood
Brian Ruffell, Ph.D., of the H. Lee Moffitt Cancer Center and Research Institute, who aims to improve patient responses to immunotherapy by using CRISPR-Cas9 genetic screens to define specific molecular pathways involved in suppression of dendritic cells – key orchestrators of the immune response to cancer and other threats – in order to identify and validate targets of immunotherapy for preclinical development
Ansuman T. Satpathy, M.D., Ph.D., of Stanford University School of Medicine, Stanford Cancer Institute, and Gladstone-UCSF Institute of Genomic Immunology, who is using new genetic analysis technologies capable of scanning and profiling the entire genome of immune cells to understand how transcription and expression of specific genes affects immune cell behavior or leads to dysfunctions in specific cellular pathways that contribute to T cell exhaustion, and is developing and using tools from functional genomics and mass spectrometry to study fundamental properties of the immune system in search of new regulators of anti-tumor immune responses
Matthew H. Spitzer, Ph.D., of the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center and Gladstone-UCSF Institute of Genomic Immunology, who is using cutting-edge experimental and computational technologies to explore the role of immune cells circulating outside tumors – rather than those within the tumor microenvironment – in conferring long-term protection against cancer and infection, leading potentially to the identification of therapeutic targets involved in tumor-mediated immune suppression throughout the body.
The Cancer Research Institute named this program in honor of Lloyd J. Old, M.D., the "Father of Modern Tumor Immunology," who served as CRI’s founding scientific and medical director from 1971 to 2011. A mentor to generations of immunologists and tumor immunologists who flourished under his guidance and went on to make significant contributions to the field, Dr. Old embodies the ideals of the STAR program, through which CRI identifies and funds high-impact scientists whose outstanding work has distinguished them as today’s visionaries in cancer immunology.

The following members of CRI’s Scientific Advisory Council leadership comprise the CRI Lloyd J. Old STAR Program Selection Committee:

Carl F. Nathan, M.D., (Committee Chair), R.A. Rees Pritchett Professor of Microbiology and Chair, Department of Microbiology and Immunology, Weill Cornell Medicine
James P. Allison, Ph.D., Regental Professor and Chair of Immunology; Olga and Keith Wiess Distinguished University Chair for Cancer Research; Executive Director of the Immunotherapy Platform; Deputy Director for Applied Research of Genitourinary Cancers; Director of the Parker Institute for Cancer Immunotherapy, University of Texas MD Anderson Cancer Center; and 2018 Nobel Laureate
Glenn Dranoff, M.D., Global Head of Immuno-Oncology, Novartis Institutes for Biomedical Research
Kunle Odunsi, M.D., Ph.D., FRCOG, FACOG, Director, University of Chicago Medicine Comprehensive Cancer Center; Dean of Oncology and Professor of Obstetrics and Gynecology, Division of Biological Sciences, University of Chicago
Ellen Puré, Ph.D., Professor of Pharmacology; Grace Lansing Lambert Professor of Biomedical Science and Chair, University of Pennsylvania School of Veterinary Medicine; Director, Penn Vet Cancer Center; and Member, Abramson Cancer Center, University of Pennsylvania
Robert D. Schreiber, Ph.D., Andrew M. and Jane M. Bursky Distinguished Professor, Pathology and Immunology; Interim Chief, Division of Immunobiology; Director, Center for Human Immunology and Immunotherapy Programs; Co-Leader, Tumor Immunology Program, Siteman Cancer Center, Washington University School of Medicine
E. John Wherry, Ph.D., Chair, Department of Systems Pharmacology & Translational Therapeutics; Richard and Barbara Schiffrin President’s Distinguished Professor; Director, Institute for Immunology; Co-Program Leader, Immunobiology Program, Abramson Cancer Center, and Co-Director, Parker Institute for Cancer Immunotherapy, University of Pennsylvania
Jedd D. Wolchok, M.D., Ph.D., Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation; Chief, Immuno-Oncology Service, Human Oncology and Pathogenesis Program; Director, Parker Institute for Cancer Immunotherapy at MSK; and Associate Director, Ludwig Center for Cancer Immunotherapy, Memorial Sloan Kettering Cancer Center.
Applications to the next CRI Lloyd J. Old STAR Program funding round are due January 15, 2023. To learn more about the program, including eligibility and application instructions, go to cancerresearch.org/star.

Entry into a Material Definitive Agreement

On June 22, 2022, bluebird bio, Inc. (the "Company") reported that entered into an Equity Distribution Agreement (the "Equity Distribution Agreement") with Goldman Sachs & Co. LLC ("Goldman") to sell shares of the Company’s common stock, par value $0.01 per share (the "Common Stock"), with aggregate gross sales proceeds of up to $75.0 million, from time to time, through an "at the market" equity offering program under which Goldman will act as manager (Filing, 8-K, bluebird bio, JUN 22, 2022, View Source [SID1234616170]). The Equity Distribution Agreement also provides for the sale of shares to Goldman directly as principal, in which case the Company and Goldman will enter into a separate terms agreement ("Terms Agreement").

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Under the Equity Distribution Agreement, the Company will set the parameters for the sale of shares, including any price, time or size limits or other customary parameters or conditions. The Company intends to sell shares pursuant to the Equity Distribution Agreement from time to time in varying amounts, which may be limited, based upon factors including (among others) market conditions, trading liquidity, the trading price of the Company’s Common Stock, and determinations by the Company of its need for, and appropriate sources of, additional capital. Subject to the terms and conditions of the Equity Distribution Agreement, Goldman may sell the shares by any method permitted by law, including without limitation (i) by means of ordinary brokers’ transactions (whether or not solicited), (ii) to or through a market maker, (iii) directly on or through any national securities exchange or facility thereof, a trading facility of a national securities association, an alternative trading system, or any other market venue, (iv) in the over-the-counter market, (v) in privately negotiated transactions, or (vi) through a combination of any such methods. The Company will pay Goldman a commission equal to up to 3.0% of the gross proceeds of any Common Stock sold through Goldman under the Equity Distribution Agreement, and also has provided Goldman with customary representations, warranties, covenants and indemnification rights. The Equity Distribution Agreement may be terminated by the Company upon written notice to Goldman or by Goldman upon written notice to the Company. In the case of any purchase of shares by Goldman directly as principal pursuant to a Terms Agreement, such Terms Agreement may be terminated by Goldman upon notice to the Company under certain circumstances, including but not limited to the occurrence of a material adverse effect in the Company.

Any sales of shares under the Equity Distribution Agreement will be made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-236489) filed with the Securities and Exchange Commission (the "Commission") on February 18, 2020, which was automatically effective upon filing. The Company filed a prospectus supplement with the Commission on June 22, 2022 in connection with the offer and sale of the shares pursuant to the Equity Distribution Agreement.

The foregoing is only a brief description of the material terms of the Equity Distribution Agreement and is qualified in its entirety by reference to the full agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated June 22, 2022, regarding the validity of the shares of Common Stock to be issued and sold pursuant to the Equity Distribution Agreement. A copy of the opinion is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Avid Bioservices to Report Financial Results for Quarter and Fiscal Year Ended April 30, 2022 After Market Close on June 29, 2022

On June 22, 2022 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the quarter and fiscal year ended April 30, 2022 on June 29, 2022 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, JUN 22, 2022, View Source [SID1234616169]). Members of Avid’s senior management will discuss financial results for the quarter and FY ended April 30, 2022 and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.