On December 8, 2020 H3 Biomedicine, Inc. (H3), a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported the presentation of three posters at the 2020 San Antonio Breast Cancer Symposium (SABCS) (Press release, H3 Biomedicine, DEC 8, 2020, View Source [SID1234572402]). The presentations include interim data from H3’s ongoing Phase 1/2 clinical development program, H3B-6545, a potential first-in-class, orally available Selective ERα Covalent Antagonist (SERCA), in women with ER-positive, HER2-negative breast cancer.
"Our ongoing evaluation of H3B-6545 underscores our mission to work to develop new oncology therapeutics by unlocking cancer genomics, real-world patient data and biomarkers," said Antonio Gualberto, MD, PhD, Chief Medical Officer of H3. "H3B-6545 is part of a new class of endocrine therapies that target normal or mutated versions of the ER-alpha protein and we look forward to showcasing its progress and potential at SABCS 2020."

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H3B-6545 PRESENTATIONS

Abstract Number: 1142
Title: Phase I/II Trial of H3B-6545, a Novel Selective Estrogen Receptor Covalent Antagonist (SERCA), in Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer
Session: PD8-06
Date and Time: Thursday, December 10, 2020, 2:15pm – 3:30pm CT
Presenter: Erika P. Hamilton, Sarah Cannon Research Institute, Tennessee Oncology

Abstract Number: 1268
Title: Pharmacokinetics of H3B-6545 in Patients with Locally Advanced or Metastatic Estrogen Receptor-Positive HER2 Negative Breast Cancer (ER+ and HER2- BC)
Session: PS12-15
Date and Time: Wednesday, December 9, 2020, 8:00am CT
Presenter: Oneeb Majid, Eisai Ltd.

Abstract Number: 918
Title: Development of H3B-6545, a First-in-Class Oral Selective ER Covalent Antagonist (SERCA), for the Treatment of ERWT and ERMUT Breast Cancer
Session: PS12-23
Date and Time: Wednesday, December 9, 2020, 8:00am CT
Presenter: Manav Korpal, H3 Biomedicine, Inc.

About H3B-6545
Estrogen receptor alpha (ERα) plays an important oncogenic role in the genesis and progression of luminal breast cancers and historically has been a target of endocrine therapies. However, recently, hotspot mutations in ERα have been detected in nearly 30% of endocrine-therapy resistant metastases. Functional studies have shown that these ERα mutations can confer ligand-independent activation of the ERα pathway and can promote partial resistance to existing classes of ER-directed therapies. H3B-6545, a first-in-class small molecule selective estrogen receptor covalent antagonist (SERCA) demonstrates activity in tumor models that harbor wild-type or mutant ERα. H3B-6545 activity against ERα mutants resistant to standard therapy provides an opportunity to target a currently unmet medical need both as a single agent and in combination with other breast cancer therapies.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

On December 8, 2020 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate Pharmaceuticals"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported it has entered into a clinical collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate the combination of Checkmate Pharmaceuticals’ CMP-001, a Toll-like receptor 9 (TLR9) agonist, and Bristol Myers Squibb’s Opdivo (nivolumab), a PD-1 blocking antibody (Press release, Checkmate Pharmaceuticals, DEC 8, 2020, View Source [SID1234572438]).

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The companies will collaborate on two trials: (a) a single arm Phase 2 study of CMP-001 in combination with nivolumab in subjects with unresectable or metastatic melanoma that is refractory to PD-1 blockade as monotherapy or in combination with other therapies, and (b) a randomized Phase 2 study of first-line CMP-001 in combination with nivolumab compared to nivolumab monotherapy in subjects with unresectable or metastatic melanoma. For both trials, under the terms of the agreement, Checkmate Pharmaceuticals will be the sponsor and Bristol Myers Squibb will supply nivolumab.

"This collaboration between Checkmate Pharmaceuticals and Bristol Myers Squibb underscores our mutual dedication to advancing the impact of immunotherapy for the benefit of patients living with melanoma and other types of cancer," said Barry Labinger, President and Chief Executive Officer of Checkmate Pharmaceuticals. "We believe that CMP-001 in combination with Opdivo offers promise for patients and we are pleased to be working together with Bristol Myers Squibb on this important pursuit."

Opdivo is a registered trademark of Bristol Myers Squibb.

On December 8, 2020 Candel Therapeutics ("Candel") reported that Paul-Peter Tak, M.D., Ph.D., was appointed president and chief executive officer of Candel Therapeutics in a planned transition to lead a new phase of growth as the Company advances its broad pipeline of oncolytic viral immunotherapies (Press release, Candel Therapeutics, DEC 8, 2020, View Source [SID1234572454]). Dr. Tak is a world-renowned immunologist, drug developer, entrepreneur and patient advocate who brings more than 25 years of demonstrated success to the role. The company has also appointed Nathan Caffo as chief business officer, John Canepa as chief financial officer and Susan Stewart as chief regulatory officer.

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"Candel has tremendous potential to change the cancer treatment paradigm for the many patients who aren’t well served by currently available treatment options," said Paul-Peter Tak, M.D., Ph.D., CEO of Candel Therapeutics. "Our approach, which is based on two differentiated oncolytic virus-based platforms, enables local destruction of tumor cells while eliciting a robust, systemic, long-lasting immune response. With our lead compound currently in a phase 3 clinical trial, our rQNestin 34.5 oncolytic HSV in phase 1, and our recently initiated discovery program, Candel is leveraging a unique platform to develop innovative immunotherapies for patients with an unmet need."

Candel is focused on developing immunotherapies that induce immunogenic cell death in cancer cells at the site of injection, unmasking tumor neo-antigens while activating immuno-inflammation in the tumor microenvironment. This process leads to a broad, systemic immune response against the cancer cells, with the potential to change disease outcomes across a variety of solid tumor indications. Candel currently has clinical programs in prostate cancer, glioblastoma, non-small cell lung cancer and pancreatic cancer.

Dr. Aguilar-Cordova commented, "Candel has made tremendous progress in advancing its viral immunotherapy platforms. Having now administered our investigational therapies to over 700 patients in multiple phase 1 to phase 3 clinical trials, we are at an important stage of the company’s growth. Building on this foundation, we are proud to have attracted such accomplished industry veterans as Paul-Peter, Nathan, John and Sue to join us and help realize Candel’s potential in this next stage of growth."

With a career spanning nearly three decades in the life science and biopharma industry, Dr. Tak was most recently president and chief executive officer of Kintai Therapeutics as well as venture partner at Flagship Pioneering. Previously, he was senior vice president and global head of R&D for immuno-inflammation, oncology and infectious disease, as well as chief immunology officer and global development leader at GlaxoSmithKline (GSK), while also serving as co-chair of GSK’s scientific review board. Prior to that, Dr. Tak was president and CEO of Tempero Pharmaceuticals, where he facilitated the company’s acquisition by GSK. He co-founded Sitryx Therapeutics and Arthrogen, and serves on the boards of Sitryx Therapeutics, Levicept, and Citryll. He previously served on the board of a variety of companies, including ViiV Healthcare, Galvani Bioelectronics, and Omega Therapeutics. Dr. Tak is board certified in internal medicine, was trained as an immunologist, earned a Ph.D., and later became a professor of medicine at various universities. He has been elected Fellow of the Academy of Medical Sciences (UK).

"With his strong leadership, broad drug development experience and unwavering patient advocacy, Paul-Peter embodies Candel’s mission, values and core strengths," said Paul Manning, chairman of Candel and chairman and CEO of PBM Capital. "We, alongside CandeI’s board, look forward to working with this outstanding team as the company moves through its next evolution, advances multiple late-stage clinical programs across various tumor types, and evaluates its next steps in the capital markets."

Nathan Caffo brings a depth of experience to Candel. His 26-year industry career has been focused on cancer therapeutics, personalized medicine and applications of genomic technology. He was most recently chief business officer at ALX Oncology, an immuno-oncology company where he played an instrumental role in multiple private and debt financings totaling $120 million, as well as the company’s $186M IPO in July 2020. Prior to ALX Oncology, he was president and CEO of Presage Biosciences, an oncology company that developed the first intratumoral microdosing platform for evaluation of multiple oncology agents. While at Presage, he also led the company’s partnering strategy, resulting in numerous biopharma partnerships, including strategic equity investments from Celgene and Takeda. He also held business development and management roles at Perlegen, Applied Biosystems and Celera.

John Canepa has over 40 years of experience in the life science industry as an audit partner with a large international public accounting firm, and as a financial executive with public and private life science companies. Prior to joining Candel, he served as CFO of Frequency Therapeutics. During his tenure, Frequency completed several public and private financings, including its initial public offering in October 2019. Prior to joining Frequency, he served as CFO of Agilis Pharmaceuticals, Inc. and was instrumental in its sale to PTC Therapeutics in August 2018. Prior to Agilis, he was COO and CFO of Asterand Bioscience and led its sale to a private equity group in 2017. Mr. Canepa began his career at Arthur Andersen & Co. and was with the firm for 23 years.

Susan Stewart, J.D. has worked for more than 28 years in biopharmaceutical regulatory affairs, with significant experience devising innovative strategies for novel therapeutics, overseeing regulatory submissions at various stages of product development and leading interactions with global health authorities. She served as the program lead on several products that received FDA approval including Renagel (sevelamercarbonate) and Thyrogen (thyrotropinalpha). As an independent consultant, she also serves as chief regulatory officer at Kaleido Biosciences, and had served as senior vice president of regulatory affairs and quality. She held previous regulatory and leadership positions at Abbott, Genzyme, Tokai, and Transmolecular.

On December 8, 2020 ImmunoGenesis, Inc., a clinical-stage biotechnology company developing therapeutics to catalyze effective immune responses in immunologically cold cancers such as prostate, colorectal and pancreatic cancer, reported that it has acquired the rights to the hypoxia-reducing agent evofosfamide. The company plans to initiate a Phase 2 clinical trial in 2021 investigating evofosfamide in combination with both CTLA-4 and PD-1 blockade in patients with castration-resistant prostate cancer (CRPC), pancreatic ductal adenocarcinoma (PDAC) and HPV-negative head and neck cancer (HNSCC) (Press release, ImmunoGenesis, DEC 8, 2020, View Source [SID1234651021]).

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Evofosfamide, a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard (Br-IPM), was originally developed as a hypoxia-activated prodrug. Dr. Michael A. Curran, founder of ImmunoGenesis, discovered that evofosfamide can reduce hypoxia in solid tumors. Dr. Curran demonstrated in pre-clinical models that evofosfamide could restore T cell function and synergize with checkpoint inhibition.

Based on Dr. Curran’s work as Associate Professor of Immunology at The University of Texas MD Anderson Cancer Center, ImmunoGenesis is developing evofosfamide as a hypoxia-reversal agent (HRA) which could synergize with checkpoint blockade to drive efficacy in tumor types where checkpoint blockade monotherapy is ineffective. Dr. Curran’s financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee.

The planned Phase 2 trial is supported by data from a Phase 1 trial, both led by David S. Hong, M.D., Professor of Investigational Cancer Therapeutics at MD Anderson. The Phase 1 study investigated evofosfamide in combination with the CTLA-4 inhibitor, ipilimumab, in four tumor types where hypoxia is believed to be a major source of immune resistance. The combination treatment drove an overall response rate of 17 percent and a disease control rate of 83 percent across four different dose levels in 21 heavily pre-treated patients.

"Overcoming resistance to immunotherapy in immunologically cold tumors will likely require a multi-faceted approach to address diverse mechanisms of host immune suppression," said Dr. Curran, "Evofosfamide is the first drug to demonstrate success in reversing hostile tumor metabolism through reduction of hypoxia. Restoration of tumor oxygen supply facilitates T cell infiltration and persistence allowing these otherwise poorly immune checkpoint sensitive cancers to become therapeutically sensitized."

In addition to the clinical efficacy demonstrated in the Phase 1 trial, a clear biomarker picture has emerged. Pre-existing immune gene signatures predicted response to therapy, while hypermetabolic tumors predicted progression. Responders also showed improved cellular signatures of anti-tumor immunity.

"Our vision at ImmunoGenesis is to develop a pipeline of drugs that synergize to address the critical ingredients necessary for effective immunity against the particularly difficult-to-treat cold tumors, including the generation of sufficient anti-tumor T cells, the protection and expansion of those cells in the tumor, and finally the reduction in hostile tumor metabolism" said James Barlow, ImmunoGenesis President and CEO. "Coupled with the PD-L1/PD-L2 dual specific antibody and STING agonist the company previously licensed from Dr. Curran’s lab, the addition of evofosfamide creates an integrated suite of molecules with extraordinary potential to address the unmet therapeutic need in cold cancers."

On December 8, 2020 TAE Life Sciences (TLS) reported a new joint venture (JV) agreement with Neuboron Medtech (Neuboron) for the widespread adoption of Accelerator-based Boron Neutron Capture Therapy (AB-BNCT) for the treatment of invasive, recurrent and difficult to treat cancers (Press release, TAE Life Sciences, DEC 8, 2020, View Source [SID1234572716]). Under the agreement, TLS becomes the second shareholder in Neuboron Therapy System (NTS), originally a wholly owned subsidiary of Neuboron.

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Each day, 50,000 people are diagnosed with cancer worldwide, and the ability to provide a unique approach to deliver targeted therapy with biological precision is critical. This agreement is expected to further expand NTS’s influence and speed up the deployment of Neuboron’s AB-BNCT system.

Established in 2017, NTS has obtained Neuboron’s IP and technology licenses in the field of AB-BNCT. Through TLS’s new capital contribution, NTS becomes an equity joint venture with international capital. The business scope of NTS covers research, development, manufacturing, system integration, clinical trials, market accesses and sales of AB-BNCT system.

AB-BNCT is a powerful alternative cancer treatment to traditional radiotherapy and other particle therapies because it delivers targeted radiation selectively to cancer cells and spares surrounding healthy tissue. BNCT has demonstrated compelling responses for some of the most difficult to treat cancers and has been successful in treating cancer patients for whom other treatment options have been exhausted. Typically, patients only need to undergo 1 or 2 treatments with BNCT vs. dozens with conventional therapies. This provides patients with greater flexibility in their treatment regimen as well as enhance efficiency of the cancer center.

"China is one of the largest market opportunities for BNCT. Our partnership with Neuboron Therapy System includes delivering our accelerator-based neutron system and has the potential to transform the cancer therapy landscape. BNCT provides a new treatment modality for patients diagnosed with the most aggressive and recurrent cancers like gliomas, head and neck tumors, and melanomas," said Bruce Bauer, Chief Executive Officer of TAE Life Sciences. "We have found a true partner in NTS as we both work toward the common goal to enable AB-BNCT to become a first-line treatment for patients globally."