On January 6, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that company management will participate in a pre-recorded fireside chat at the H.C. Wainwright Bioconnect Virtual Conference (Press release, Xencor, JAN 6, 2022, View Source [SID1234598398]).

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The on-demand recording will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com beginning Monday, January 10, 2022 at 4:00 a.m. PT and will be available on the website for at least 30 days.

On January 6, 2022 The Global Liver Institute (GLI), the only patient-led liver health nonprofit operating internationally, in partnership with TriSalus Life Sciences, an immunotherapy company on a mission to extend and improve the lives of patients living with liver and pancreatic tumors, reported the launch of Liver Central, a comprehensive online guide for all things related to liver cancer (Press release, TriSalus Life Sciences, JAN 6, 2022, View Source [SID1234598397]).

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Liver Central provides a central location for those seeking educational materials about the liver and liver cancers, including treatment options and ongoing clinical trials. With founding support from TriSalus Life Sciences, GLI developed this new resource to fill a significant gap in the availability of educational resources and tools. Liver Central will be regularly updated with the latest information on the central role the liver plays in overall health, immunological pathways that impact liver tumor progression and resistance to therapies, as well as treatment approaches and guidelines for various types of liver cancer.

"The growing burden of liver cancer is deeply concerning as more patients hear the words ‘you have liver cancer’ and are left with few treatment options. LiverCentral.org is designed to raise awareness of this vital organ and provide answers for patients and clinicians looking for information and new approaches to treat this devastating disease," said Donna Cryer, founder and CEO of the Global Liver Institute, and a 27-year liver transplant recipient.

"Our hope is that Liver Central will serve as an enduring educational resource to support patients, clinicians and researchers along the cancer care continuum," said Steven C. Katz, MD, FACS, chief medical officer at TriSalus. "We want to raise awareness as to how unique the liver is in general, and with respect to how liver immune function creates therapeutic challenges for cancer patients. As we work to bring multi-modality approaches to better address these challenges and ensure more patients can benefit from the promise of immunotherapy, we are grateful for the opportunity to partner with GLI to develop this resource and advance care for patients living with liver tumors."

In a recent discussion on GLI LIVE, GLI’s weekly educational program that provides tailored information for patients living with liver diseases on a variety of timely topics, Dr. Katz and Ms. Cryer highlighted Liver Central’s functionality for experienced and new patients alike. During their discussion, they spoke at length about the critical need to reinvent liver cancer education, tailor therapeutic approaches based on the unique biology of the liver, and how a central hub of information can bring about positive change in a patient’s experience with liver cancer.

Over the last several decades the percentage of Americans who develop liver cancer has grown.[1] Liver cancer is among the leading causes of cancer death worldwide with more than 800,000 people diagnosed annually.1 Additionally, the liver is one of the most common sites of metastatic cancer. Liver metastases – not the primary cancer – are often the cause of mortality. In fact, for colorectal cancer patients whose cancer has metastasized to the liver, the 5-year survival rate is only 11%.[2]

Today, patients urgently need new treatment options that are designed to address the unique challenges specific to liver tumors. Despite progress made in cancer treatment, patients with primary or metastatic liver tumors still experience poor outcomes, as these tumors remain stubbornly difficult to treat. Two of the most significant barriers that prevent optimal delivery and performance of therapeutics for liver and pancreatic tumors include immune response suppression and ineffective drug delivery due to high intratumoral pressure. The high intratumoral pressure prevents medicine from entering the tumor, meaning patients often receive little benefit from new immunotherapy drugs such as checkpoint inhibitors and CAR T-cell therapies. While these treatments may help reduce symptoms, there is no cure for liver metastases.

On January 6, 2022 SHINE Technologies LLC (SHINE), a next-generation nuclear technology company, and the Department of Energy’s National Nuclear Security Administration (NNSA) and Office of Environmental Management (DOE-EM) reported that signing of the first-ever contracts as part of the Department’s Uranium Lease and Take-back Program (Press release, Shine Medical Technologies, JAN 6, 2022, View Source [SID1234598396]). The shared milestone for SHINE and the Department’s efforts will help increase domestic production of molybdenum-99 (Mo-99), a crucial medical radioisotope used in over 40,000 daily medical diagnostic procedures across the United States to assist in diagnosing life-threatening diseases, including heart disease and cancer.

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The NNSA’s lease contract will provide SHINE with the low-enriched uranium necessary to produce Mo-99, while SHINE’s contract with DOE-EM details requirements surrounding the return of any resulting radioactive waste without a commercial disposition path once Mo-99 production is complete.

"Signing these contracts with SHINE is a crucial step toward medical isotope autonomy for the United States," said Corey Hinderstein, NNSA Deputy Administrator for Defense Nuclear Nonproliferation. "Once SHINE begins production, our country will be that much closer to creating a reliable and sufficient supply of these life-saving materials right here at home, while also increasing nuclear security by reducing the use of highly enriched uranium."

The American Medical Isotopes Production Act of 2012 directed DOE/NNSA to establish a program to make uranium available to medical isotope producers in the United States. Although the Act also requires DOE to establish take-back contracts for spent nuclear fuel and radioactive waste resulting from medical isotope production without a disposal path, there is no spent fuel or radioactive waste involved in these contracts.

SHINE is steadily progressing toward Mo-99 production capability at its plant located in Janesville, Wis.

"We are incredibly proud to partner with the NNSA and DOE to be deploying an integrated irradiation and processing facility to manufacture U.S.-based, high-specific-activity (HSA) Mo-99 that millions of patients rely on every year throughout the U.S.," said SHINE CEO Greg Piefer. "We consider the ability to produce HSA Mo-99 without the need for highly enriched uranium to be a huge win for both patient access to essential medical diagnostic procedures, and for nuclear security."

SHINE is also one of the DOE/NNSA’s cooperative agreement partners. As announced in October 2021, NNSA awarded SHINE an additional $35 million to support their efforts to produce Mo-99 commercially by the end of 2023. This award is part of the DOE/NNSA financial assistance efforts to establish a reliable, U.S.-produced supply of Mo-99, without using highly enriched uranium. NNSA has implemented this effort by competitively awarding cost-shared cooperative agreements to commercial entities, as well as providing funds to DOE’s National Laboratories to support development of non-highly enriched uranium Mo-99 production technologies.

On January 6, 2022 Paula and Rodger Riney of St. Louis, MO, through the Paula and Rodger Riney Foundation, reported a $40 million grant to support multiple myeloma research at Dana-Farber Cancer Institute (Press release, Dana-Farber Cancer Institute, JAN 6, 2022, View Source [SID1234598389]). The grant represents the largest single award supporting multiple myeloma research in Dana-Farber’s history. The Paula and Rodger Riney Foundation has been a strong supporter of Dana-Farber and with this grant has cumulatively donated nearly $60 million to the Institute.

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Multiple myeloma is a challenging cancer that forms in a type of white blood cell called a plasma cell. Dana-Farber has been at the forefront of multiple myeloma therapies over the past two decades, helping to convert myeloma from a fatal disease to a chronic condition for many patients. However, therapeutic resistance and drug-related toxicities continue to take a toll on many patients, underscoring the need for innovative treatments.

"The path to developing new treatments for multiple myeloma is through rigorous research. The most effective way to spur that research is in supporting the scientists doing the complex work. The Riney Family are generous and stalwart supporters, and through this grant and their previous support they continue to make a profound impact on scientific discovery and clinical care. Their leadership will help patients at Dana-Farber and around the world," said Laurie H. Glimcher, MD, President and CEO of Dana-Farber and the Richard and Susan Smith Professor of Medicine at Harvard Medical School.

"My own journey as a myeloma patient—and knowing how many others are also living with this disease—has led us to seek out the individuals, teams, and organizations that are on the leading edge of research," said Rodger Riney. "There is no time to waste in the pursuit of better understanding, treatment, and cures. My family and I feel grateful to be able to support Ken, Paul, and Nikhil and their teams at Dana-Farber who are making incredible inroads. We are humbled by the lifelong dedication that Ken, Paul, and Nikhil bring to myeloma patients suffering from this terrible disease. We hope this gift will inspire others to also support the tremendous work happening every day in Dana-Farber’s labs and clinics."

This new $40 million grant builds upon ongoing work and will deepen and expand approaches for addressing the most complex challenges in myeloma research and improving patient care. Specifically, this grant will:

Renew support for preclinical experiments to identify novel targets and develop new medicines and immune-based therapies for patients;
Fund clinical research designed to test novel myeloma therapies, alone and in combination with standard and experimental treatments, to improve patient outcomes; and,
Support to co-locate myeloma labs at Dana-Farber to facilitate greater cohesion and collaboration among members of the research team.
"I extend my heartfelt thanks to Paula and Rodger Riney for their unprecedented support of our research to develop novel treatments for multiple myeloma. This very generous grant will fast-forward our translation of basic discoveries to clinical trials, ultimately providing innovative treatments for patients and their families," said Ken Anderson, MD, program director at Dana-Farber’s Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics and Kraft Family Professor of Medicine at Harvard Medical School. Anderson will lead the research efforts supported by this grant in close partnership with Nikhil Munshi, MD, director of Basic and Correlative Science at the Jerome Lipper Multiple Myeloma Center and Kraft Family Chair at Dana-Farber. The grant will also provide support for clinical work led by Paul Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center and RJ Corman Professor of Medicine at Harvard Medical School.

The Rineys have a strong legacy of supporting multiple myeloma research at Dana-Farber and in 2019 gave a $16.5 million gift to establish the Riney Family Multiple Myeloma Initiative, which has driven groundbreaking research in record time. Examples of recent discoveries by Dana-Farber investigators include:

Bringing therapeutic antibodies, which help immune cells find and attack tumors, to patients with multiple myeloma.
Leading clinical studies demonstrating the remarkable therapeutic effects of CAR T-cells that have been engineered to target multiple myeloma.
Setting the stage for the development of innovative therapies that exploit the unique vulnerabilities of multiple myeloma cells.
Over the past two years, the Paula and Rodger Riney Foundation also made gifts totaling $2.6 million to establish the Riney Family Fund for COVID-19 and Multiple Myeloma Research at Dana-Farber, under Richardson’s direction.

These commitments provide powerful momentum for The Dana-Farber Campaign, an ambitious multi-year $2 billion fundraising effort to prevent, treat, and defy cancer by accelerating revolutionary science, extraordinary care, exceptional expertise, and essential opportunities.

On January 6, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into an exclusive license agreement with Gaelan Medical Trade LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), for Talicia (omeprazole magnesium, amoxicillin and rifabutin)1, an H. pylori therapy, in the United Arab Emirates (UAE) (Press release, RedHill Biopharma, JAN 6, 2022, View Source [SID1234598388]).

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Under the terms of the agreement, RedHill will receive an upfront payment of $2 million and is eligible for additional milestone payments as well as tiered royalties up to mid-teens on net sales of Talicia in the UAE. Gaelan Medical will receive the exclusive rights to commercialize Talicia in the UAE, as well as a right of first refusal to commercialize Talicia in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain and Oman) for a pre-determined period.

"We are delighted to partner with Gaelen Medical to help bring Talicia to H. pylori patients in the UAE and potentially other territories in the region," said Dror Ben-Asher, RedHill’s CEO. "This partnership is particularly important given that H. pylori, a major public health concern, impacts up to 84% of the population in the region2 and is one of the strongest risk factors for gastric cancer, leading to a recent regional clinical consensus meeting calling for eradication therapy to be offered to all individuals infected with H. pylori3. We are seeing rapid growth of Talicia in the U.S. in light of the alarming failure rates of clarithromycin-based therapies and growing physician awareness of the need for highly effective first-line H. pylori therapy. We continue to explore with potential partners the expansion of Talicia’s reach into additional ex-U.S. territories."

"H. pylori can cause extensive damage if not properly eradicated first-time and there is considerable need for a therapy like Talicia in the UAE, where 41% of the population4 is affected and have limited options for treatment," said Ghassan Aboud, Chairman of GAG. "Talicia would become the first approved combination product in the UAE specifically designed to treat H. pylori, and we are excited to be partnering with RedHill and at the prospect of realizing Talicia’s potential to help patients with H. pylori infection in the UAE and potentially other territories in the region."

About Talicia
Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill’s pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent5 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm6.

Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.

About H. pylori
H. pylori is a bacterial infection that affects approximately 35%7 of the U.S. population, with an estimated two million patients treated annually8. Worldwide, more than 50% of the population has
H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer9 and a major risk factor for peptic ulcer disease10 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma11. More than 27,000 Americans are diagnosed with gastric cancer annually12. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies13.