On April 14, 2021 Wugen Inc., a clinical stage biotechnology company developing a pipeline of allogeneic, off-the-shelf cell therapies, reported the appointment of Daniel M. Kemp Ph.D., as the company’s Chief Executive Officer (Press release, Wugen, APR 14, 2021, View Source [SID1234578030]). Dr. Kemp is an accomplished researcher with over 30 publications and built his career at Novartis, Merck and Takeda over 20 years leading pipeline initiatives from early discovery through to the clinic. More recently, he was responsible for transacting Takeda’s key strategic partnerships in the CAR-NK and CAR-T cell therapy space.

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As CEO of Wugen, Kemp will initially focus on propelling the company’s allogeneic memory NK and CAR-T cell therapy platforms through mid-stage clinical development and continue to build on Wugen’s current strategic partnerships. Dr. John McKearn, the founding Chief Executive Officer of Wugen and a managing director at RiverVest Venture Partners, will remain as Chairman of the Board of Directors.

"We welcome Dan as an experienced strategist with invaluable knowledge of cell therapy development and strong research background. We look forward to him leading the company’s rapid growth and innovative pipeline of cell therapies to treat both hematologic and solid organ malignancies," said John McKearn. "His leadership experience and ability to make good strategic business decisions will be critical to Wugen’s path forward."

Dr. Kemp added, "I am thrilled to be joining such an exceptional team at Wugen. I’m incredibly impressed with how rapidly the company has leveraged its foundational partnerships with Washington University, HCW Biologics and Alpha Biopharma to advance its lead Memory NK cell therapy through clinical proof of concept for relapsed/refractory AML, in addition to advancing its "off-the-shelf" fratricide-resistant CAR-T cell therapy for clinical testing later this year to treat T-cell cancers. I thank John for his trust in me and in the strong foundation that he has created for Wugen."

During his tenure at Takeda, Dr. Kemp was a formative member of the company’s oncology cell therapy leadership team where he transacted a series of cornerstone collaborations that established a pipeline of CAR-NK, CAR-T and gdT cell programs. Notably, Dan spearheaded the in-licensing of Takeda’s flagship allogeneic NK cell program from MD Anderson Cancer Center in late 2019, which consolidated the emergence of NK cell therapies as an important therapeutic platform in the immuno-oncology space. He served on the Boards of GammaDelta Therapeutics and Adaptate Biotherapeutics, both companies that he was instrumental in creating in 2017 and 2019, respectively. Previously, Dr. Kemp was Senior Vice President at Beryllium (acquired by UCB) where he was responsible for directing drug discovery partnerships, and prior to that he directed drug discovery programs at Merck Research Labs ranging from target validation to clinical proof of concept. At Novartis Institutes for BioMedical Research, he led an early discovery team in diabetes and metabolic diseases.

Dr. Kemp received his BSc and Ph.D. in molecular pharmacology from the University of Kent at Canterbury, UK. He was awarded an HHMI Fellowship at Harvard Medical School and carried out his postdoc research on pancreatic beta-cell biology at Massachusetts General Hospital.

On April 14, 2021 Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center reported the extension and expansion of their joint Virtual Research and Development Center (VRDC) to explore new molecules from Boehringer Ingelheim’s KRAS (Kirsten rat sarcoma) and TRAILR2 (TNF-related apoptosis-inducing ligand receptor 2) portfolios for the potential treatment of lung cancer, particularly non-small cell lung cancer (Press release, Boehringer Ingelheim, APR 14, 2021, View Source [SID1234578023]).

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The collaboration, launched in 2019, has successfully combined MD Anderson’s innovative clinical research infrastructure and the patient-driven drug development capabilities of the Therapeutics Discovery division with Boehringer Ingelheim’s pipeline of innovative cancer medicines and expertise in advancing breakthrough therapies. Under the new agreement, joint research will continue for five additional years.

"Our collaboration with MD Anderson strengthens our determination to find solutions for the most difficult-to-treat cancers, and this latest commitment marks an important step forward, especially in our holistic KRAS program," said Norbert Kraut, Ph.D., Head of Global Cancer Research at Boehringer Ingelheim. "We are delighted to extend our collaboration with MD Anderson. With our shared dedication to patients and like-minded approach to innovation, we have the potential to bring the medicines to lung and gastrointestinal cancer patients that they so much need."

The flexible nature of the VRDC agreement allows the teams to expand their lung cancer indication programs targeting KRAS and TRAILR2, including Boehringer Ingelheim’s first-in-class SOS1::pan-KRAS inhibitor (BI 1701963), inhibitors of KRAS G12C (BI 1823911) and MEK (BI 3011441), as well as a novel undisclosed bi-specific TRAILR2 agonist.

The collaboration already has resulted in a number of joint publications1, conference presentations (including at the 2021 AACR (Free AACR Whitepaper) Annual Meeting2) and clinical trial activities. Boehringer Ingelheim is pursuing a comprehensive mutant KRAS-directed effort with multiple programs expected to enter the VRDC with MD Anderson.

"We are proud to expand our work with Boehringer Ingelheim in a very exciting drug-development space – advancing novel targeted therapies against KRAS and TRAILR2," said Timothy Heffernan, Ph.D., Head of Oncology Research in Therapeutics Discovery at MD Anderson. "Our collaboration is built upon a strong working relationship and complementary expertise, highlighting how an academic center and a pharmaceutical company can strategically work together to advance innovative therapies for patients with cancer."
MD Anderson’s Therapeutics Discovery division is anchored by an experienced team of drug development experts working to advance the next generation of cancer therapies. The Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platform, led by Heffernan, performs cutting-edge translational research to rapidly advance new therapies to the patients most likely to benefit.

KRAS is the most frequently mutated cancer-causing oncogene. One in seven of all human metastatic cancers expresses KRAS mutations, with mutation rates of more than 30 percent in lung adenocarcinomas, more than 40 percent in colorectal cancers and more than 90 percent in pancreatic cancers. No approved treatments for KRAS-driven cancers exist currently, further underscoring the need for continued investment in research and development. Tumor cell-selective activation of TRAILR2 can trigger cancer cell death in indications of high medical need, including lung and gastrointestinal malignancies.

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This press release is issued from our corporate headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Disclosures
MD Anderson has an institutional financial conflict of interest with Boehringer Ingelheim related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan.

On April 14, 2021 Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the online publication of data in the peer-reviewed medical journal Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), that supports the broad application of the Company’s proprietary VDC technology platform for treating cancer (Press release, Aura Biosciences, APR 14, 2021, View Source [SID1234578022]). The manuscript, titled, "Virus-like Particle-drug Conjugates Induce Protective, Long-lasting Adaptive Anti-Tumor Immunity in the Absence of Specifically Targeted Tumor Antigens," describes promising long term anti-tumor activity of AU-011, the Company’s lead VDC candidate, as a monotherapy and in combination with checkpoint inhibitor antibodies in preclinical studies conducted in collaboration with the Center for Cancer Research at the National Cancer Institute of the National Institutes of Health.

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"Collectively, these promising results confirm treatment of AU-011 resulted in targeted tumor cytotoxicity with hallmarks of immunogenic cell death that may promote a durable anti-tumor immune response," said Cadmus C. Rich, MD, MBA, Chief Medical Officer and Head of R&D for Aura. "Additionally, the additive activity of AU-011 in combination with checkpoint inhibitors has shown a high level of durable complete responses and prevention of tumor recurrence, warranting continued research into its potential clinical utility to effectively treat multiple types of tumors like non-muscle invasive bladder cancer as a primary treatment and further prevent metastatic disease."

Key findings from the manuscript include:

In vitro and in vivo studies in immunocompetent murine tumor models demonstrated a dose-dependent cytotoxic response of AU-011 with an upregulation of the markers of immunogenic cell death like caspase-1 and calreticulin surface expression demonstrating that AU-011 mediated cell death was able to generate potent immune stimulatory conditions within the tumor microenvironment.

A single in vivo dose administration of AU-011 caused rapid cell death leading to long term complete responses in 50% of all animals. Combination with immune checkpoint inhibitor antibodies improved therapeutic efficacy resulting in 70-100% complete response rate that was durable 100 days post-treatment with 50-80% of those animals displaying protection from secondary tumor re-challenge.

Depletion studies of CD4+ or CD8+ T-cells at the time of AU-011 treatment or tumor re-challenge confirmed the involvement of both cell populations in the mechanism of action of AU-011 and the promotion of long-lasting anti-tumor protection.

"These promising findings further reinforce the therapeutic advantages of VDCs in treating cancer compared to other available treatments, which include the broad tumor selectivity and multivalent binding of the virus-like particles compared to antibodies, the ability to deliver hundreds of cytotoxic molecules and the generation of long-lasting anti-tumor immunity," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "While our initial clinical focus has been in ocular oncology, our VDC approach has wide application as a single agent and as a combination therapy in a variety of solid tumors, including non-muscle invasive bladder cancer, which is expected to enter the clinic in 2022 We remain focused on advancing our novel VDC approach to transform the treatment of tumors and improve outcomes for patients with cancer."

About AU-011 (belzupacap sarotalocan)

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparan sulphate proteoglycans (HSPGs) that are modified and overexpressed on the tumor cell surface of choroidal melanoma (and other tumor types) and delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant melanoma cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. The possibility of early treatment intervention and the activation of the immune system could lead to a reduction in the metastases rate for patients with this life-threatening disease. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and is currently in Phase 2 clinical development.

On April 14, 2021 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported that three projects have been selected to study oral decitabine (35 mg) and cedazuridine (100 mg) (Press release, Astex Pharmaceuticals, APR 14, 2021, View Source [SID1234578021]). The NCCN ORP convened a Scientific Review Committee to review, evaluate, and select awardees and will provide oversight for the two-year studies—which will commence later in 2021. Research funding will be provided by a grant from Taiho Oncology, who will also supply the decitabine and cedazuridine tablet.

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The selected projects are:

• Michael Byrne, DO, Vanderbilt-Ingram Cancer Center, Moffitt Cancer Center
o Phase 2 Study of Decitabine and Cedazuridine in Combination with Venetoclax for AML Relapse after Allogeneic Hematopoietic Cell Transplantation

• Gurkamal Chatta, MD, Roswell Park Comprehensive Cancer Center
o A Phase 1b Clinical Trial: Improving Outcomes with Androgen Pathway inhibitors by Targeting DNA Methyltransferase Activity

• Martin McCarter, MD, University of Colorado Cancer Center
o Oral Decitabine/Cedazuridine in Combination with Nivolumab as a Strategy to Enhance the Efficacy of Immune Checkpoint Blockade in Unresectable or Metastatic Mucosal Melanoma

"Congratulations to all of the selected investigators," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "We look forward to their work advancing our understanding of this medication combination. The potential for oral medication in place of intravenous delivery is particularly worthy of exploration, as this may provide better options for outpatient therapy with reduced office visits, which in turn improves access to care and helps underserved patient populations.

"Taiho Oncology is pleased to continue our collaboration with the National Comprehensive Cancer Network to help broaden the understanding of oral decitabine and cedazuridine for patients with solid tumors and hematologic malignancies," said Terri L. Washington, DNP, RN, Vice President, Scientific Partnerships and Medical Affairs Operations, Taiho Oncology, Inc. "These grants will help advance critical research and represent a step forward in exploring the full potential of oral decitabine and cedazuridine for patients to help improve outcomes."

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

On April 14, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate and host 1:1 meetings at the virtual Kempen Life Science Conference, taking place April 21, 2021 (Press release, Hookipa Pharma, APR 14, 2021, View Source [SID1234578019]).

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Additional information will be available within the Investors & Media section of HOOKIPA’s website at View Source