NMPA approved phase Ib/II clinical trial application of ImmuneOnco for IMM01 combined with PD-1 antibody in the treatment of relapsed and refractory malignant tumors

On February 22, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") reported that National Medical Products Administration (NMPA) approved Phase Ib/II clinical trial application of the first domestic SIRPα-Fc fusion protein drug candidate targeting human CD47 (IMM01) combined with PD-1 antibody for the treatment of relapsed/ refractory malignant tumors (Press release, ImmuneOnco Biopharma, FEB 22, 2022, View Source [SID1234655638]). So far, 6 clinical trial applications related to IMM01 have been approved, which further establishes leading position of the company in the field of drug R&D targeting CD47.

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The preliminary data from IMM01 phase I clinical trial is encouraging. At the low dose levels, it has benefited some advanced lymphoma patients with a good safety profile. These clinical manifestations are based on the differentiated molecular design of IMM01. IMM01 is designed and screened not binding to human erythrocytes so as to avoid the "antigen sink effect". The molecule itself has low immunogenicity so that there is no ADA after administration in human. IMM01 has only half of the regular IgG molecular weight so has good tissue permeability and bioavailability. What is more, in preclinical in vivo efficacy tests, when IMM01 was used in combination with targeting drugs and immunotherapy drugs, it demonstrated strong tumor-inhibiting activity and synergistic effect against solid tumors.

PD-1 antibody has also been shown to have superior curative effect on a variety of tumors, but limited by the content of T cells in tumor tissue (such as "cold tumor"), most patients do not have a good response to PD-1 antibody therapy.

It is well proven that strong synergistic effects happen when PD1 antibody combined with CD47/SIRPa inhibitors. Macrophages are innate immune cells and antigen-presenting cells. After activation, they can improve the efficacy of PD-1 antibody and maintain the durability of the efficacy through the following ways:

1) By directly phagocytosing tumor cells, macrophages can present the processed tumor antigens to T cells to induce tumor antigen-specific T cell responses.

2) Macrophages release chemokines (such as CXCL9/CXCL10) to induce T cells to the tumor tissue, thereby transforming "cold tumors" into "hot tumors".

Dr. Tian Wenzhi, Founder, Chairman and CEO of ImmuneOnco, said: "I am very pleased to see that clinical trial application of our IMM01 combined with PD-1 antibody for the treatment of relapsed and refractory malignant tumors approved by the National Medical Products Administration (NMPA). Preclinical studies have shown that IMM01 combined with PD-1 antibody has a strong synergistic effect. We are optimistic and confident that synergistic use of IMM01 with PD-1 antibody will have superior clinical performance and will bring good news to the cancer patients."

Akoya to Report Fourth Quarter and Full Year 2021 Financial Results on March 14th, 2022 and Present at the Cowen Annual Health Care Conference on March 8th, 2022

On February 22, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the fourth quarter and full year of 2021 after the market close on Monday, March 14th, 2022 (Press release, Akoya Biosciences, FEB 22, 2022, View Source [SID1234608791]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call may do so by dialing (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 5291099. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

Akoya also announced that it will be virtually participating in the Cowen Annual Health Care Conference. Brian McKelligon, CEO, and Joe Driscoll, CFO, are scheduled to present on Tuesday, March 8th, 2022 at 9:50 a.m. ET. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

Oncorus Announces Promotion of John Goldberg, M.D. to Chief Medical Officer

On February 22, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported the promotion of John Goldberg, M.D. to Chief Medical Officer (Press release, Oncorus, FEB 22, 2022, View Source [SID1234608807]). Dr. Goldberg joined Oncorus in October 2018 as Senior Vice President of Clinical Development with responsibilities including oversight of all clinical studies, drug development and regulatory strategies.

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"We are delighted to announce John’s promotion to Chief Medical Officer as he has been an integral part of our company’s progress thus far. His first-hand experience as a practicing oncologist with over 15 years of experience enrolling patients into clinical trials, coupled with expertise across a range of immunotherapies, have been crucial to our pipeline progress and we are incredibly pleased to have his continued guidance in this new role," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We look forward to John’s leadership as we continue to advance our viral immunotherapy candidate, ONCR-177, through the clinic with additional data from multiple cohorts expected later this year, in addition to progressing our ONCR-GBM program and selectively self-amplifying viral RNA (vRNA) product candidates ONCR-021 and ONCR-788."

"It’s an honor to take on the role of Chief Medical Officer at Oncorus, and I’m incredibly excited and motivated by the unique opportunity that Oncorus has to make a meaningful difference in cancer patients’ lives via its dual platform approach to unleashing the full potential of viral immunotherapies," said Dr. Goldberg. "Both the HSV and selectively self-amplifying vRNA platforms create a uniquely diverse pipeline rooted in compelling science and promising future growth. I believe that Oncorus has the potential to meaningfully impact the current standard of care in oncology, and, in partnership with the rest of the executive team, I look forward to advancing this innovative technology."

Dr. Goldberg has served as Senior Vice President of Clinical Development since he joined Oncorus in 2018. Prior to joining Oncorus, Dr. Goldberg served as Senior Medical Director of H3 Biomedicine, a developer of genomics-based cancer therapies. While at H3 Biomedicine, he supervised the clinical development of H3B-8800, the first-in-human spliceosome modulator. Previously, Dr. Goldberg held clinical roles in cancer drug development, leading the pediatric oncology Phase 1 program at the University of Miami and working as Medical Director for Agenus. His immunotherapy experience includes first-in-human neo-antigen vaccines, dendritic cell vaccine and GVAX trials, as well as check point inhibitors and costimulatory agonists. Dr. Goldberg is also a pediatric oncologist with 15 years of experience treating children with cancer and enrolling patients in clinical trials. He received his pediatric hematology oncology training from the Dana-Farber Cancer Institute and Children’s Hospital Boston and his general pediatrics training from the University of Rochester. Dr. Goldberg holds an M.D. from the University of Massachusetts Medical School and a A.B. in Biological Sciences from the University of Chicago. In addition to his current role at Oncorus, Dr. Goldberg is a Medical Advisory Board Member for the Sarcoma Foundation of America and a member of the Advisory Group at MassBio.

Cumulus Oncology Secures £4.1m ($5.6m) Investment Led by Eos Advisory

On February 22, 2022 Cumulus Oncology, Europe’s first oncology biotech creation company, reported that it has secured a £4.1 million ($5.6 million) investment led by St Andrews-based investment firm Eos Advisory (Press release, Cumulus Oncology, FEB 22, 2022, View Source [SID1234608825]). Scottish Enterprise invested alongside Eos as Cumulus plans further scale, while an additional £1.5 million ($2 million) will follow in the coming months.

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Cumulus was founded in 2017 to identify novel oncology assets to de-risk and add value to, before creating spin-out companies to commercialise novel cancer therapies. After founding Nodus Oncology in April 2020 to conduct research into DNA damage response (DDR), Cumulus formed Modulus Oncology in September 2020 alongside the University of Sheffield.

CEO and co-founder Clare Wareing said: "With the support of our cornerstone investors, we will accelerate our business model to identify and develop new oncology treatments that target the unmet medical needs of specific cancer patient populations."

Andrew McNeill, Managing Partner, Eos Advisory, said: "Clare and her team have made tremendous progress over the last few years, are at the forefront of their field in the European context, and we are pleased to continue our support of the business as Cumulus enters its next phase of growth."

Kerry Sharp, Director of Growth Investments at Scottish Enterprise, said: "It’s fantastic to see the progress Cumulus Oncology is making in the field of cancer therapies. With Scottish Enterprise investment, which focuses on early stage high growth potential companies, this company can continue to develop its ambitious plans."

Cumulus is also announcing that Dr Russell Greig will be joining the board as Chairman. Greig, a GlobalScot, spent much of his career working on both the drug development and investment sides of the business at GlaxoSmithKline, where he held a number of positions including President, International Pharmaceuticals, and Senior Vice President, Worldwide Business Development. More recently, he has held board roles for a series of biotechs and has advised life science VCs and biotechnology companies in the USA, Europe, and Asia via his Philadelphia-based Greig Biotechnology Global Consulting business.

Dr Russell Greig, Chairman, Cumulus Oncology, said: "Cumulus has established a unique position in Europe, and is set to make an impact further afield in other regions including North America. I look forward to helping to guide Clare and her expert team around strategic focus over the months and years ahead."

GT Medical Technologies Announces 2021 GammaTile® Therapy ELITE Member Roster for Use of Its Innovative Brain Tumor Treatment

On February 22, 2022 GT Medical Technologies Inc., reported that creators of GammaTile Therapy, a Surgically Targeted Radiation Treatment for operable brain tumors, reported its 2021 roster of ELITE Distinguished Brain Tumor Specialists that have completed 10 or more GammaTile Therapy procedures in 2021 (Press release, GT Medical Technologies, FEB 22, 2022, View Source [SID1234608841]). This year’s introduction into the ELITE program includes Piedmont Atlanta Hospital, Vidant Medical Center, Emory Healthcare, and The University of Kansas Health System. These hospitals join the existing ELITE Distinguished Brain Tumor specialists awarded in 2020, including Memorial Sloan Kettering Cancer Center, M Health Fairview, HonorHealth Scottsdale Osborn Medical Center, NorthShore University HealthSystem, and Mayfield Brain & Spine.

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GammaTile ELITE institutions share GT Medical Technologies’ purpose of improving the lives of patients with brain tumors. These medical centers are each committed to excellence by putting quality of life for their patients first and embracing evidence-based innovation.

"GammaTile represents a major upgrade compared to standard radiotherapy options," said Roukoz Chamoun, MD, Neurosurgeon and Associate Professor, Department of Neurosurgery, The University of Kansas Health System in Kansas City, KS. "With GammaTile, radiation is delivered precisely where it is needed resulting in increased efficacy and minimal potential for side effects. In addition, because it is placed during surgery immediately after tumor resection, it eliminates unnecessary and potentially dangerous delay in radiation therapy."

"GammaTile allows us to treat previously untreatable patients and has allowed selected patients to achieve astonishing survival durations. At Piedmont we love having this tool in our toolbox," said Adam Nowlan, MD, MPH, Medical Director, Radiation Oncology, Piedmont Atlanta Hospital in Georgia.

GammaTile Therapy features a bioresorbable, conformable, 3D-collagen tile that is implanted in the last five minutes of brain tumor removal surgery. The sustained, controlled, and therapeutic dose of radiation immediately begins targeting tumor cells, sparing healthy tissue. Patients receive their radiation treatment while going about their daily life, without the necessity of daily trips to a medical center for external radiation. Over time, the tile naturally resorbs into the adjacent tissue with no need for additional surgery to remove it. GammaTile Therapy is shown to improve local tumor control, which can extend a patient’s life. GammaTile was FDA-cleared in 2018 for recurrent brain tumors, including recurrent high-grade gliomas, glioblastomas, meningiomas, and brain metastases. In 2020, the FDA expanded that indication to include newly diagnosed malignant brain tumors.

"We are pleased to see this technology become available to patients with brain tumors across the United States, with over 60 leading institutions now offering GammaTile," said Matthew Likens, President & CEO of GT Medical Technologies. "We take great pleasure in welcoming these prestigious institutions into the GammaTile ELITE program and commend them on their commitment to innovation and quality patient care."

GT Medical Technologies was founded by five Arizona brain tumor specialists in 2017 to overcome the limitations of the current standard of care for patients with brain tumors. The treatment has since helped hundreds of patients receive life-altering cancer treatment in top brain tumor centers across the U.S. Healthcare providers can learn more by visiting View Source