On October 14, 2021 Kojin Therapeutics Inc., a company developing new targeted therapeutics based on cell state and ferroptosis biology, reported the appointment of Luba Greenwood as Chief Executive Officer (Press release, Kojin Therapeutics, OCT 14, 2021, View Source [SID1234591248]). Greenwood, who has served on Kojin’s board of directors since June 2021, joins Kojin’s co-founder Vasanthi Viswanathan and Chief Scientific Officer Kay Ahn in leading the company’s vision and growing its women-led executive team.

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Greenwood is a leading figure in healthcare with vast experience as an executive, company builder, and investor in therapeutics, life sciences, and tech sectors. She has co-founded biotech and digital health companies in immunotherapy, women’s health, artificial intelligence and machine learning, and the microbiome space, and as a life sciences and biotech expert, lectures at Harvard University in the School of Engineering and Applied Sciences. Her leadership roles have spanned Roche, Google, and Pfizer and most recently Greenwood served as a Managing Partner at the Dana-Farber Cancer Institute’s venture fund, Binney Street Capital, a venture arm she founded to further Dana-Farber’s mission of developing treatments for incurable cancers.

"With a focus on oncology, immunology, and neurology, I’ve had the privilege to access and witness the latest breakthrough advancements," said Luba Greenwood, CEO of Kojin Therapeutics. "From the outset, Kojin’s differentiated platform and modality stood apart, and I knew I wanted to be a part of this revolutionary science and the impact it will have on drug discovery. As a board member I was able to get to know Kojin’s approach and the incredible team behind it, and I’m honored to serve as CEO as we move forward and create transformative medicines for patients."

In June 2021, Kojin launched with a $60 Million Series A to accelerate its drug discovery platform based on its groundbreaking approach to cell state and ferroptosis biology to develop novel, targeted therapeutics. Since then, the company has accelerated its platform and partnerships with a focus on hard-to-treat cancers, immunology, and fibrosis.

"Luba has been a driving force behind Kojin’s mission and growth trajectory. She brings a collaborative leadership style that is especially valuable for early stage biotech companies bringing interdisciplinary science and technology together," said Stuart Schreiber, co-founder of Kojin Therapeutics. "We now have a very clear indication of where we will prioritize our platform and we’re thrilled to have Luba implementing this vision as she leads our talented team."

Greenwood is committed to advancing women in biotechnology and has been a recipient of several awards and honors for her work in the community, including the Science Club for Girls Catalyst Award for her commitment to advocating for women in science and technology.

"We’re incredibly proud to add Luba to our executive team, especially in an industry where chief women executives remain rare," said Vasanthi Viswanathan, co-founder and Head of Discovery Biology of Kojin Therapeutics. "Luba is an inspirational leader who personifies a winning combination of values, experience and perspective that will allow her to fully develop Kojin’s platform and partnering potential while simultaneously steering our programs into the clinic. It is a privilege to have a partner at the helm who so deeply believes in the founding mission of Kojin — transforming the lives of patients by developing a completely new category of therapeutics that work by modulating ferroptosis biology."

Kojin is focused on building out exceptional in-house biology and computational capabilities to rapidly advance its science. Since its launch, the company has more than doubled in size and will be moving into its own headquarters located in Boston’s Seaport neighborhood in February 2022. The company is tripling its machine learning efforts and actively looking to hire computational biologists and chemists.

On Sunday, October 17 at 11:30 a.m. Eastern, Greenwood will be moderating a panel at HLTH 2021 to discuss investment trends in patient experience and engagement.

On October 14, 2021 MAIA Biotechnology, Inc., a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs ("MAIA"), reported that it has raised an additional $6.2 million in an equity offering at $8/share (Press release, MAIA Biotechnology, OCT 14, 2021, View Source [SID1234591249]). The proceeds of the financing will advance the company’s programs and will support the initiation of a Phase 2 clinical trial (THIO-101) evaluating the administration of THIO followed by cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC). The THIO-101 trial is expected to begin this year.

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"We are excited to have closed this latest financing round, which brings MAIA additional capital as we continue to advance our THIO program," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We appreciate the continued support of our high-quality investors who share our vision developing novel cancer therapies aimed at overcoming treatment resistant diseases."

About the Phase 2 Clinical Trial in Advanced Non-Small Cell Lung Cancer (NSCLC)

This trial (THIO-101) will be the first to test THIO’s immune system activation by administering THIO in advance of administration of the checkpoint inhibitor (co-developed by Regeneron and Sanofi), potentially allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to checkpoint inhibitor treatment will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or progressed after first-line treatment regimen containing a checkpoint inhibitor.

The THIO-101 trial will assess the safety, mechanistic activity and immune system activation of four THIO dose levels, each in separate arms. Each dosing arm will then be evaluated further for efficacy based on Overall Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS) and Overall Survival (OS). Additional patients may be recruited for further clinical evaluation in any of the THIO arms based on safety and clinical benefit. Each arm of the trial will enroll up to 41 evaluable patients.

About THIO

THIO (6-thio-dG, 6-thio-2’-deoxyguanosine) is a potentially first-in-class small molecule that, to our knowledge, is the only cancer telomere targeting agent currently in development. THIO is believed to selectively target telomerase-positive cancer cells, which account for more than 85% of human cancers. Data from pre-clinical studies showed that THIO’s activity was shown to be specific to tumor types with active telomerase, an enzyme that is silent in most healthy cells. Studies to date also showed that telomerase recognizes THIO and selectively incorporates it into the telomeres in tumor cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends, which results in rapid tumor cell death. Low doses of THIO, followed by anti-PD-L1 or anti-PD1 therapy, completely eliminated advanced tumors in pre-clinical models and produced cancer cell-specific immune memory, where the immune system continued to be active against the cancer cells after extended periods of time, with no additional treatment. These results support the hypothesis that demonstrate how the THIO-produced telomere stress increases innate sensing and adaptive anti-tumor immunity, and provides a strong rationale for sequentially combining telomere-targeted therapy with immunotherapy. THIO is investigational and has not been approved yet for any use by regulatory authorities.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death worldwide. It is estimated that, in 2020, more than 2.2 million new cases were diagnosed globally, including 228,000 new cases in the U.S. Approximately 85% of all lung cancers are NSCLC and an estimated 80% of these cases are telomerase positive. While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains a significant unmet need to optimize treatment of patients and offer additional clinical options.

On October 14, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported the publication of a comprehensive review article on arenaviral immunotherapies in the peer-reviewed online journal, Frontiers in Oncology (Link) (Press release, Hookipa Biotech, OCT 14, 2021, View Source [SID1234591234]). The article reinforces the potential of HOOKIPA’s versatile arenavirus platform as a promising strategy to elicit potent, tumor-specific T cell responses and help address critical unmet needs in the treatment of cancer.

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"We believe there is broad potential for our foundational arenavirus platform to deliver novel immunotherapies for a range of cancers. The publication in Frontiers in Oncology validates the strength of our science as an emerging strategy in cancer treatment and offers hope to patients and clinicians who need more tools in their fight," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We remain focused on advancing our promising HB-200 program, including progressing to Phase 2 in the coming months, as well as exploring other cancer targets, like prostate cancer, based on our selection of tumor antigens."

Taken together, the publication highlights several key advantages of HOOKIPA’s arenavirus platform, including the ability to:

Directly target and activate antigen-presenting cells (APCs) to induce robust, polyfunctional CD8+ T cell responses;
Target APCs without killing them (non-lytic), unlike other viral approaches which must infect tumor cells directly to be efficacious;
Administer intravenously, which is accessible for all patients and less invasive than some intratumoral approaches required by other viral therapies;
Further augment CD8+ T cell responses with administration of alternating vector therapy to levels previously not observed with other technologies;
Induce sustained cytotoxic T lymphocyte (CTLs) responses and durable anti-tumor activity, indicating immunologic memory;
Potentially work synergistically with PD-1 inhibitors, helping expand the number of people who may benefit from therapy and improve long-term outcomes.
The article also reviews clinical data from the ongoing HB-201/HB-202 trial in people with advanced HPV16+ cancers. The clinical data, as presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting, showed that HB-200 is highly immunogenic, inducing unprecedented levels of activated, tumor antigen-specific CD8+ T cells (up to 40 percent of the T cell pool). In addition, HB-201 monotherapy showed an 18 percent overall response rate and median progression-free survival of 3.45 months in heavily pre-treated head and neck cancer patients who progressed on standard of care, including checkpoint inhibitors. While the trial is ongoing, these initial data show results with monotherapy that are better than the current second-line standard of care in these advanced patients. The data offer clinical proof-of-concept for the arenavirus platform, which has the potential to target a range of cancers based on antigen selection.

About HB-201/HB-202
HB-201 and HB-202 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (Lymphocytic Choriomeningitis Virus for HB-201 and Pichinde Virus for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-201 and HB-202 showed a ten-fold increase in immune response and better disease control than either compound alone. Both compounds are being evaluated in an ongoing Phase 1/2 study (NCT04180215) in individuals with treatment-refractory HPV16+ cancers who have progressed on standard of care, including checkpoint inhibitors.

On October 14, 2021 Pillar Biosciences, an innovative, next-generation sequencing (NGS) solutions, in-vitro diagnostics company, reported that it has entered into an agreement with Labcorp (NYSE: LH), a leading global life sciences company, to provide genomic testing for people with cancer (Press release, Pillar Biosciences, OCT 14, 2021, View Source [SID1234591250]).

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Under the agreement, Pillar Biosciences will provide the oncoReveal Essential Myeloproliferative Neoplasm (MPN) panel. Using NGS, the test simultaneously measures for DNA mutations across multiple genes.

"Collaborating with Labcorp makes available a targeted NGS testing solution to accurately diagnose and monitor people with cancer who are suspected of having myeloproliferative neoplasms, which are diseases of the blood and bone marrow," said Laura Beggrow, Chief Business Officer at Pillar Biosciences. "This collaboration presents a broad market opportunity and bolsters our mission to make precision medicine accessible to all by providing high-quality, affordable specialty NGS testing capabilities."

"Our collaboration with Pillar Biosciences allows us to provide an accurate, efficient and scalable solution to patients with blood and bone marrow diseases through a multiplex targeted gene panel," said Dr. Marcia Eisenberg, Chief Scientific Officer at Labcorp and a Member of the Scientific Advisory Board of Pillar Biosciences. "Offering this specialty oncology assay will enable patients and health care providers to make the most-informed and best-possible treatment decisions."

On October 14, 2021 OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, reported the appointment of Jennifer R. Diamond, M.D., as Chief Medical Officer (Press release, OnKure, OCT 14, 2021, View Source [SID1234591216]). Dr. Diamond, a trained oncologist, brings over 10 years of extensive clinical expertise in early phase trials and translational oncology research.

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"We are very pleased to welcome Jennifer to our growing leadership team," said Tony Piscopio, Ph.D., Co-Founder, President and Chief Executive Officer of OnKure. "Her vast knowledge of conducting early-stage trials for novel oncology therapeutics, as well as her experience exploring novel combination strategies, will be vital as we continue to build and advance our broad pipeline of best-in-class precision medicines."

In addition to serving in her role at OnKure, Dr. Diamond works in the Division of Medical Oncology at the University of Colorado Anschutz Medical Campus as a breast cancer medical oncologist and Associate Professor of Medicine. She is also the Clinical Research Director of the Phase 1 and Expansion/Molecular Studies Program (POEMs) and the founding Co-Director of the Women’s Cancer Developmental Therapeutics Program at the CU Cancer Center. Dr. Diamond has been involved in clinical and translational research in the Phase 1 and Breast Cancer research programs at CU since 2007 and currently runs a research laboratory focused on the development of targeted agents in TNBC, including strategies to overcome treatment resistance. She received her B.A. from the University of Arizona and her M.D. from the University of Arizona College of Medicine. Dr. Diamond completed her fellowship in Medical Oncology at CU under Dr. Gail Eckhart.

"I am thrilled to be joining OnKure at such an important time in the Company’s growth," said Dr. Diamond. "OnKure’s proven structure-based drug design approach has the potential to create optimal, tumor-agnostic treatments for cancer patients with high unmet need. I look forward to leveraging my experiences to lead the Company’s clinical development efforts and advance its promising lead candidate, OKI-179, as well as future oncology programs in the clinic."