On June 2, 2022 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported that the clinical strategy for enhancing the efficacy of its Merkel cell polyomavirus (MCPyV)-specific T cell receptor (TCR) program for the treatment of PD-1 refractory Merkel cell carcinoma (MCC), from its strategic collaboration with Fred Hutchinson Cancer Center, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2022 (Press release, Affini-T Therapeutics, JUN 2, 2022, View Source [SID1234615468]). The poster presentation will be delivered by Joshua Veatch, M.D., Ph.D., from Fred Hutch.

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"We recognize that MCC patients are in desperate need of new treatments, in particular due to having no curative therapeutic options and a five-year survival rate of less than ten percent in those who have developed widespread disease," said Loïc Vincent, Ph.D., Chief Scientific Officer of Affini-T. "The clinical strategy to be presented at ASCO (Free ASCO Whitepaper) is the result of tumor biopsy analyses generated from treating MCC patients and reflects the recent addition of an MHC-I boosting molecule to the MCPyV-specific T cell Phase I/II study protocol. By enhancing MHC-I expression on MCC tumors, we hope to minimize immune system evasion and maximize the clinical efficacy of MCPyV-specific T cells to treat MCC patients."

Poster presentation details are as follows:

Title: ATTAC-MCC: Phase I/II study of Autologous CD8+ and CD4+ Transgenic T cells expressing a high-affinity MCPyV-specific TCR combined with checkpoint inhibitors and Class I MHC-upregulation in patients with metastatic MCC refractory to PD-1 axis blockade
Presenting Author: Joshua Veatch, M.D., Ph.D., Fred Hutchinson Cancer Center
Abstract Number: TPS9596
Poster Number: 186b
Poster Session Title: Melanoma/Skin Cancers
Date & Time: June 6, 2022, 2:15 PM EDT

About Merkel Cell Carcinoma and Merkel Cell Polyomavirus
Merkel cell carcinoma (MCC) is a highly aggressive skin cancer, with an incidence that has doubled in the last 20 years to approximately 3,000 cases per year in the U.S. Over one-third of patients will develop widespread disease and outcomes for these patients have been historically poor with a five-year survival rate of less than ten percent. Cancer-causing Merkel cell polyomavirus (MCPyV) is expressed in most MCC tumors and can be leveraged to target these tumors. Although immune checkpoint inhibitors (ICIs) targeting relevant biochemical pathways show promise, most MCC patients will eventually relapse. There is no standard of care for patients whose cancer has become resistant to ICIs. We believe that cellular immune therapies targeting MCPyV may provide additional clinical benefit to these patients.

On June 2, 2022 Arsenal Biosciences, Inc., a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, reported that the company’s Chief Executive Officer, Ken Drazan, MD, will present in person at the 2022 Jefferies Healthcare Conference on Thursday, June 9 at 4:00 p.m. Eastern time (Press release, Arsenal Bio, JUN 2, 2022, View Source [SID1234615467]).

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2022 Jefferies Healthcare Conference
Format: Live Presentation
Date: June 9, 2022
Time: 4:00 p.m. Eastern time

The Arsenal Bio management team will also participate in one-on-one investor meetings during the conference.

On June 2, 2022 Massive Bio, Inc., a leader in precision medicine and artificial intelligence (AI) enabled patient centric clinical trial enrollment, reported that it raised $9 million co-led by Revo Capital and Kenan Turnacioğlu, Chair of Board of Directors PaigeAI, with additional participation from DEG – Deutsche Investitions- und Entwicklungsgesellschaft mbH, the German Development Finance Institution (Press release, Massive Bio, JUN 2, 2022, View Source [SID1234615466]).

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This investment will enable the company to further scale its operations globally, invest in marketing, and launch additional non-status quo products in oncology clinical trial enrollment with its data-rich platform. The company’s clinical research business launched in late 2019, and the financing round builds on another exponential growth year for Massive Bio, with 60,000 cancer patients and 26 enterprise customers. 88% of those customers are large pharmaceutical companies and CROs. Massive Bio has expanded to 12 countries with a global workforce of 70 employees in the past 12 months.

Massive Bio Co-founder and CEO Selin Kurnaz stated, "We are building a category-defining company in the oncology ecosystem by engineering patient enrollment value chain, and we are excited by the unwavering support from our new and existing investors, who have seen our exponential organic growth, strong ROI to our clients and unique value proposition to patients and oncology eco-system." Dr. Kurnaz added, "We are significantly different than the companies at our stage, cost-efficient and generating consistent revenue and client growth despite the economic downturn, relying mostly on customer demand to fuel our growth. Our passion, dedication, perseverance, and smart work has led to the company’s success and expansion in 12 markets without a sales force or marketing. Having the financial support, healthcare expertise and global coverage of investors such as DEG and Kenan, along with heavy technology expertise of our existing investors like Revo Capital will help us execute our goals globally and at accelerated scale."

With tens of thousands active cancer clinical trials globally, and dozens of biomarkers and precision oncology molecules, Massive Bio aims to use AI and patient-centric concierge services at scale to reach cancer patients across the world and accelerate the oncology research and development infrastructure. Massive Bio had recently announced the launch of its NASA-style Oncology Clinical Trial Command Center (OCTCC) to disrupt and accelerate trial enrollment, the launch of its 100K Cancer Clinical Trial Singularity Program aimed at matching 100,000 cancer patients in real-time to cutting-edge clinical trials using its AI-based technology, website, and apps across iOS and Android platforms, and was included in the 2022 NYC Digital Health 100 which showcases the most exciting health start-ups in the New York region.

"Massive Bio has an impressive track record of landing and expanding on pharmaceutical customers while being relentless on execution. We were impressed with highly motivated and mutually complementary founders’ team that has the courage to solve large and complex problems with minimal capital and resources and we felt that we can bring their dream into action together in an accelerated fashion with our capital, domain expertise and highly qualified network. They have the potential to transform the oncology research industry and become a world-changing company," said Kenan Turnacioğlu, who is the co-lead of the round and new board member of Massive Bio.

"Our AI-enabled clinical trial and precision oncology therapy-finding technology along with our real-time patient-empowering approaches are key to solve the problem in clinical trial enrollment in cancer pharmaceutical biotech pipeline, and we have successfully proven the necessary market fit, product deliverables, ongoing demand and expansive network effects to meet our clients’ and investors’ confidence in our platform’s success," said Arturo Loaiza-Bonilla, M.D., Co-Founder of Massive Bio. "This vote of trust from investors is the product of our relentless efforts for constant growth, best use of technology and data to deliver to each client, and to optimize systems to automate processes efficiently, while expanding our innovation stack, network development and portfolio verticals, with a keystone strategy of being a hub to allow the sustainability of the digital networks we keep and thrive upon," added Loaiza-Bonilla.

"After working with Massive Bio for the past two years and seeing how its AI-powered end-to-end platform streamlined clinical trial recruitment while providing important insights to its pharma customers, we are proud to lead the round for the company’s next phase," said Cenk Bayrakdar, Founding Partner and Managing Director at Revo Capital.

DEG’s Dr. Tilman Kruse, Global Head of Early Growth & Venture Capital, and Anna Winter, Investment Manager Private Equity & Venture Capital and deal team leader, commented, "At DEG, we are impressed how Massive Bio has created a successful technology-driven business which has an enormous impact on people: As a global investor with a mandate to improve health and living conditions as part of the UN-Sustainable Development Goals (SDG), we are particularly proud to support Massive Bio’s further international expansion to improve access to new cancer treatments and clinical trials around the world, helping cancer patients globally. We are grateful to the founders and the entire cap table for smooth, trustful, and efficient cooperation on this round which enables Massive Bio to scale up and address its global Total Addressable Market (TAM)."

On June 2, 2022 Sarah Cannon Research Institute reported that it will highlight its latest cancer research insights through more than 140 abstracts and presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago and online from June 3-7, 2022 (Press release, Sarah Cannon Research Institute, JUN 2, 2022, View Source [SID1234615465]). Experts from across Sarah Cannon Research Institute’s network will join oncology leaders from around the globe to discuss the latest research findings that are accelerating progress in the fight against cancer. As a leader in drug development, Sarah Cannon Research Institute is presenting data from 75 early-phase studies.

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"Collaboration is essential to how we accelerate progress in the fight against cancer, and we look forward to coming together with our colleagues in Chicago to discuss the latest advances in oncology research," said Howard A. "Skip" Burris III, MD, FACP, FACSO, President, Clinical Operations & Chief Medical Officer, Sarah Cannon Research Institute. "With the variety of novel molecularly-targeted agents, immunotherapies, and cellular therapies in development, we are seeing a remarkable number of possibilities to truly transform care and personalize treatments for patients."

Presentations will cover a wide range of topics including how targeted agents and immunotherapies are performing in an array of disease settings, how molecular profiling is expanding access to clinical trials, and how researchers are advancing clinical research despite pressures in a post-pandemic environment.

Below are several highlighted presentations that Sarah Cannon principal investigators will lead during the Annual Meeting:

Gerald Falchook, MD, MS, Director, Drug Development, Sarah Cannon Research Institute at HealthONE, will deliver "Phase 1 Trial of TIM-3 Inhibitor Cobolimab Monotherapy and in Combination with PD-1 Inhibitors Nivolumab or Dostarlimab (AMBER)" in an oral presentation on June 4 from 1:15-4:15 p.m. CDT (2:27 p.m. CDT) in Hall B1.
Erika Hamilton, MD, Director, Breast Cancer and Gynecologic Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, will give two oral presentations – "Trastuzumab Deruxtecan (T-DXd) vs Trastuzumab Emtansine (T-DM1) in Patients (pts) with HER2-Positive (HER2+) Unresectable and/or Metastatic Breast Cancer (mBC): Safety Follow-Up of the Randomized, Phase 3 Study DESTINY-Breast03" on June 4 from 1:15-4:15 p.m. CDT (1:15 p.m. CDT) in Hall D1 and "Phase I, Two-Part, Multicenter, First-In-Human (FIH) Study of DS-6000a in Subjects with Advanced Renal Cell Carcinoma (RCC) and Ovarian Tumors (OVC)" on June 7 from 9:45 a.m. – 12:45 p.m. CDT (10:09 a.m. CDT) in S406.
Melissa Johnson, MD, Director, Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, will present "Resistance to KRAS Inhibition and Future Combinations" in the Education Session, Development of Novel Inhibitors of the RAS Pathway, on June 7 from 8-9:15 a.m. CDT in S406. Dr. Johnson will also present "Dose Escalation of a Phase 1b/2 Study of Modakafusp Alfa, an Immune-Targeting Attenuated Cytokine, in Patients (pts) with Metastatic Solid Tumors" in an oral presentation on June 4 from 1:15-4:15 p.m. CDT (1:51 p.m. CDT) in Hall B1.
Andrew McKenzie, PhD, Vice President, Personalized Medicine, Sarah Cannon Research Institute; Scientific Director, Genospace, will present "Expanding Access to Clinical Trials Through Molecular Profiling Review and Telehealth Consultations" during the Education Session, Rethinking Cancer Clinical Trial Conduct With Telemedicine, on June 6 from 4:45-6 p.m. CDT in S504.
Jeremy Pantin, MD, Senior Investigator, Sarah Cannon Transplant and Cellular Therapy Program at TriStar Centennial, will chair the Clinical Science Symposium, Beating Bad Blood: The Power of Immunotherapy in Hematologic Malignancies, as well as discuss "Refining the CAR-T’s Engine: How to Improve CD19-Directed CAR-T Performance" on June 6 from 8-9:30 a.m. CDT in S100bc.
David Spigel, MD, Chief Scientific Officer, Sarah Cannon Research Institute, is a speaker and panelist on the Education Session, The Business of Clinical Trials: The Impact of Funds Flow and the Shrinking Workforce on Trial Development, on June 5 from 8-9:15 a.m. CDT in S102.
Abstracts and presentations with Sarah Cannon experts as first authors will be presented by:

Dr. Howard Burris
Dr. Gerald Falchook
Lucio Gordan, MD, Chief Medical Officer, Sarah Cannon Research Institute at Florida Cancer Specialists
Dr. Erika Hamilton
Marilyn (Holt) Hammer, PhD, Program Specialist, Personalized Medicine, Sarah Cannon Research Institute
Lowell Hart, MD, FACP, Scientific Director, Clinical Research, Sarah Cannon Research Institute at Florida Cancer Specialists
Shekeab Jauhari, MD, Associate Director, Drug Development, Sarah Cannon Research Institute at Florida Cancer Specialists – Lake Mary
Dr. Melissa Johnson
William Kevin Kelly, DO, Senior Investigator, Drug Development, Sarah Cannon Research Institute at Sidney Kimmel Cancer Center
Meredith McKean, MD, MPH, Director, Melanoma & Skin Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology
Dr. Andrew McKenzie (Chair)
Kathleen Moore, MD, Director, Drug Development, Sarah Cannon Research Institute at the Stephenson Cancer Center
Manish Patel, MD, Director, Drug Development, Sarah Cannon Research Institute at Florida Cancer Specialists – Sarasota
Meredith Pelster, MD, MSCI, Assistant Director, Gastrointestinal Research, Sarah Cannon Research Institute at Tennessee Oncology
Cesar Augusto Perez, MD, Director, Drug Development, Sarah Cannon Research Institute at Florida Cancer Specialists – Lake Nona
Russell Schilder, MD, Director, Drug Development, Sarah Cannon Research Institute at Sidney Kimmel Cancer Center
Emma Sturgill, PhD, Senior Program Specialist, Personalized Medicine, Sarah Cannon Research Institute
Susanna Ulahannan, MD, MMed, Associate Director, Phase 1 Program, Sarah Cannon Research Institute at The Stephenson Cancer Center (Co-Chair)

On June 2, 2022 National Resilience, Inc. (Resilience) and The University of Texas MD Anderson Cancer Center reported the launch of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of innovative cell therapies for patients with cancer (Press release, National Resilience, JUN 2, 2022, View Source [SID1234615464]). Uniting the strengths of Resilience and MD Anderson, the joint venture will advance its work within a culture of academic innovation alongside industrial expertise.

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The Cell Therapy Manufacturing Center will be based in a state-of-the art 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage Good Manufacturing Practices (GMP).

The joint venture combines MD Anderson’s expertise in immunotherapy and cell therapies as well as a leading clinical trials infrastructure, with Resilience’s innovative biomanufacturing technologies, advanced analytics and a national network for developing and producing cell therapies. Together, the parties aim to accelerate the path of cell therapies to the clinic, while enabling scalability and a smooth transition to late-phase clinical and commercial activities.

"Cell therapies have had a dramatic impact for patients with certain cancers, but progress has been hampered by structural challenges," said Jason Bock, Ph.D., Chief Executive Officer of the Cell Therapy Manufacturing Center. "This novel joint venture was conceived to address those challenges by harnessing the complementary capabilities of two world-class organizations, allowing us to advance innovative programs to deliver impactful therapies to patients."

The joint venture will engage with MD Anderson researchers and external industry collaborators to advance new therapies through preclinical and clinical development, ensuring consistent and safe products that can be evaluated rapidly in clinical trials led by MD Anderson physicians. Resilience customers will be able to leverage this offering as part of the company’s growing network of biomanufacturing facilities that are flexible enough to scale projects from small-batch pre-clinical to large-scale commercial production. Resilience has 10 facilities across North America, with more than 1 million square feet of manufacturing space.

"The promise of cell therapies to help patients in need has been limited by a lack of innovation in biomanufacturing," said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. "This collaboration aims to overcome those hurdles by extending our network with this unique partnership, creating opportunities to incubate innovative ideas and provide cutting-edge biomanufacturing technologies and processes to researchers, with a goal of bringing more cell therapies to patients."

The joint venture will advance the most promising cell therapy modalities to answer unmet clinical needs, including engineered tumor infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified T cells, endogenous T cells (ETCs), engineered natural killer (NK) cells and other emerging technologies, for patients with hematological and solid tumors. MD Anderson researchers are leaders in the field of cancer cell therapy, responsible for advancing the translational and clinical development of many of the currently approved and experimental cell therapies.

The joint venture is built upon MD Anderson’s Biologics Development platform, formerly part of the institution’s Therapeutics Discovery division. Current strategic collaborations with MD Anderson’s Biologics Development platform will continue; collaborative relationships with MD Anderson’s Therapeutics Discovery division, as well as physicians and scientists across the institution, also will be maintained.

"We believe in the tremendous potential of cell therapies to deliver solutions that offer cures, not merely prolonged survival. Resilience offers unique capabilities that make it an ideal choice for unlocking that potential and accelerating impactful cell therapies," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. "Our mission at MD Anderson is to end cancer, and this joint venture is a strategic step toward realizing that goal."