On October 20, 2020 Ankarys Therapeutics Inc. (Ankarys), Applied StemCell, Inc. (ASC), and HebeCell Corp. (HebeCell) reported that they have entered into a strategic collaboration to co-develop allogeneic induced pluripotent stem cell (iPSC)-derived chimeric antigen receptor (CAR) NK cell therapeutics targeting hematological malignancies (Press release, HebeCell, OCT 20, 2020, View Source [SID1234571033]).

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The collaboration will leverage Ankarys’ cGMP iPSC lines, proprietary CAR constructs, and FailSafe cell engineering technology. Ankarys will lead the Canadian CTA/US IND-enabling studies and launch a Phase I clinical trial in Canada and US.

ASC will use its proprietary TARGATT gene editing technology to insert the proprietary CAR constructs into Ankarys’ iPSC lines.

HebeCell will differentiate the CAR expressing iPSCs into NK cells using its proprietary 3D bioreactor platform and will be the manufacturing partner for the collaboration throughout the preclinical, clinical, and commercialization phases of the product.

"Our unique TARGATT gene insertion technology has multiple applications in immunotherapy and regenerative Medicine" said Dr. Ruby Yanru Tsai, Chief Executive Officer and Co-Founder of ASC. "I am very excited to see TARGATT technology being used in generating iPSC-derived CAR-NK therapeutic products."

Dr. Allen Feng, the Founder and Chief Scientific Officer of HebeCell added "We are thrilled to start this collaboration with Ankarys and ASC as all three companies have a shared goal of achieving the unmet needs in the immuno-oncology field,"

"This collaborative partnership builds on the unique complementary strengths and resources to rapidly deploy off-the-shelf CAR-NK products for all patients." Dr. Armand Keating, Founder of Ankarys said. "We are excited to be working with ASC and HebeCell, and believe our platform technologies will alter the NK cell therapy field by delivering cost effective allogeneic therapies worldwide."

On October 20, 2020 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that the Phase 2 clinical trial of PDS0101 in combination with standard of care chemoradiotherapy (CRT) for treatment of locally advanced cervical cancer is now open (Press release, PDS Biotechnology, OCT 20, 2020, View Source [SID1234570260]).

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This Phase 2 trial is being led by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D., Resident in Radiation Oncology at The University of Texas MD Anderson Cancer Center. The trial will investigate the anti-tumor efficacy and safety of the PDS0101-CRT combination, and their correlation with critical biomarkers of immune response, in approximately 35 patients.

"We are excited to have initiated this Phase 2 human study of PDS0101 administered with the current standard of care. We believe that the demonstrated potential of PDS0101 to activate the immune system to induce tumor-targeting T-cells provides strong potential to present improved treatments to patients with cervical cancer," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.

Dr. Lauren Wood, PDS Biotech’s Chief Medical Officer, will serve as PDS Biotech’s intermediary. The study is being performed pursuant to an Investigator Initiated Study Agreement between PDS Biotech and MD Anderson.

On October 20, 2020 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the third quarter ended September 30, 2020 before the US financial markets open on October 29, 2020 (Press release, Alexion, OCT 20, 2020, View Source [SID1234569967]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast from 8:00-9:00 a.m. Eastern Time (ET).

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To participate in this conference call, dial (866) 762-3111 (USA) or (210) 874-7712 (International), conference ID 6582445 shortly before 8:00 a.m. ET. The audio webcast can be accessed on the Investor page of View Source and an archived version will be available for a limited time following the presentation.

On October 20, 2020 Vaccitech Ltd, a clinical-stage biopharmaceutical company developing T cell vaccines and immunotherapies designed to treat and prevent infectious disease and cancer, reported the appointment of three new senior leaders across its clinical, financial and manufacturing operations during a period of significant growth for the company (Press release, Vaccitech, OCT 20, 2020, View Source [SID1234568968]).

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Margaret (Meg) Marshall, M.D. becomes Vaccitech’s full-time Chief Medical Officer, having worked as a consultant for the company since June 2020. Dr. Marshall has over 25 years of experience in the preclinical and clinical development of cell and antibody-based immunotherapy for infectious disease and cancer. Prior to joining Vaccitech, she held directorship positions in the clinical research departments of Kyowa Kirin, Kite Pharma and Pfizer. Dr. Marshall will lead the clinical development planning and execution of the company’s programs.

"It has been a great experience working for Bill and the team, and I’m thrilled to officially be on board to lead the clinical development of our exciting immunotherapy and vaccine programs. Our T cell-inducing platform has great potential to be transformative, and to deliver patient benefits in chronic infectious diseases such as HBV and HPV as well as in oncology indications such as prostate cancer and non-small cell lung cancer (NSCLC)," said CMO Dr. Meg Marshall.

Georgy Egorov joins Vaccitech as Chief Financial Officer. Mr. Egorov brings more than 20 years of senior finance, strategy, investment banking and capital markets experience as well as extensive knowledge of investor relations and corporate development to the company. Mr. Egorov joins Vaccitech from Exscientia, a global leader in AI drug discovery, where he was CFO and Board member. Mr. Egorov also worked in investment banking at Goldman Sachs and UBS, where he was involved in numerous M&A transactions and equity and debt financings.

CFO Georgy Egorov comments, "Despite the pandemic, 2020 has been an incredible year for investing in life sciences, with unprecedented amounts of capital raised. I look forward to ensuring Vaccitech stays on a firm financial footing as we expand our operations and seek to develop our T cell immunotherapy and vaccine product candidates from the clinic through to market, if approved."

In addition, Simon Alvis, Ph.D., joins Vaccitech as Vice President Manufacturing. Since 1999, Dr. Alvis has cultivated a broad expertise across process, analytical and formulation development of viral and recombinant protein biological drug products. He has great experience and strategic vision for the regulatory and manufacturing requirements necessary to move biologic product candidates forward towards commercialization. He joins Vaccitech after leading viral manufacturing programs at PsiOxus Therapeutics.

VP of Manufacturing, Simon Alvis adds, "We are planning for success and scale up at Vaccitech, and I am delighted to bring my manufacturing expertise to the company as we expand our clinical pipeline. I believe we can really make a difference to patients’ lives by treating and preventing infectious diseases and cancer."

Bill Enright, CEO of Vaccitech, said, "I am delighted to welcome aboard Meg, Georgy and Simon; their wealth of experiences driving product candidate development, financial management and manufacturing will be key to helping Vaccitech move its important immunotherapies forward."

On October 20, 2020 The Focus Fund GP, LLC, in partnership with The University of Texas MD Anderson Cancer Center, reported that it has launched Cancer Focus Fund, LP, an oncology-focused investment fund designed to support the advancement of compelling investigational cancer therapies from late preclinical development through Phase I and Phase Ib/II clinical trials (Press release, MD Anderson, OCT 20, 2020, View Source [SID1234568958]).

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Small to midsize biopharmaceutical companies often face challenges in conducting effective early-stage clinical studies as a result of a lack of funding, as well as access to oncologists, clinical facilities and eligible patients seeking to participate in cancer trials. Cancer Focus Fund aims to address this unmet need by providing investments for promising cancer therapeutics together with the clinical trials expertise and infrastructure of MD Anderson. The goal is to accelerate the progress of these promising therapies through Investigational New Drug (IND) approval and Phase I and Phase Ib/II studies.

Cancer Focus Fund has held its initial closing with over $50 million of capital commitments. In addition to MD Anderson, Limited Partners include the Baton Rouge Area Foundation, Rice University Endowment, LSU Health Shreveport Foundation, Ochsner Health and other private investors.

"The Cancer Focus Fund is a unique investment fund that aligns the scientific and clinical expertise of MD Anderson with business experts, public financing entities and private venture capital to propel promising cancer therapies toward pivotal trials," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "We are delighted to work with MD Anderson in this effort and are optimistic that our approach will help companies successfully conduct clinical trials and bring more novel treatments to patients. We also believe our unique approach has the potential to reward our investors and thereby provide incentives for further investments in innovative cancer therapies."

Cancer Focus Fund is jointly administered by a scientific advisory committee, made up of MD Anderson researchers and physicians, and an investment committee, composed of experienced biotechnology investment professionals. The scientific committee will consider candidates from worldwide sources for potential investment based on scientific merit, and the investment committee will make final decisions on funding based on those recommendations.

"We are committed to bringing forward the most impactful new therapies that will improve the lives of our patients," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. "Without appropriate support, we know that some therapies with great potential may be delayed, may not be developed properly in the clinical setting or may never make it into clinical studies. Through investment from the Cancer Focus Fund and the support of MD Anderson, we hope to advance worthwhile new treatments past the traditional hurdles in the drug development process to the patients who need them."

As part of the partnership, MD Anderson will design and host clinical studies for therapies that receive IND approval, utilizing the extensive expertise of MD Anderson physicians in conducting early stage clinical trials. In addition, Ochsner Health and LSU Health Shreveport, which serve large numbers of cancer patients, will work with Cancer Focus Fund portfolio companies to provide additional clinical trial sites so that patients can join clinical studies as appropriate.

"Through the Gayle and Tom Benson Cancer Center at Ochsner, the Precision Cancer Therapies Program offers the only program in our region dedicated to offering early phase clinical trials for cancer patients," said Leonardo Seoane M.D. Chief Academic Officer and Senior Vice-President Ochsner Health. "We are very excited to partner with the Cancer Focus Fund to help develop new therapies to treat cancer and provide these clinical trials closer to our communities."

"The Feist-Weiller Cancer Center at LSU Health Shreveport is excited to be a part of the Cancer Focus Fund to bring the latest new cancer clinical trials to our community," said Dr. Chris Kevil, Vice-Chancellor for Research at LSU Health Shreveport. "We are confident our clinical trial facilities, coupled with expanded patient access to clinical trials across north and central Louisiana in partnership with Ochsner Health, will yield promising results for all citizens of Louisiana."