UNICEF and Lilly Collaborate to Help Improve Health Outcomes for 10 Million Children and Adolescents

On February 2, 2022 Eli Lilly and Company (NYSE: LLY) and UNICEF reported a new collaboration to help improve health outcomes for 10 million children and adolescents living with chronic, non-communicable diseases (NCDs) through 2025 (Press release, Eli Lilly, FEB 2, 2022, View Source [SID1234607616]).

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Lilly has committed $14.4 million in support of UNICEF’s lifesaving work to address NCD risk factors, strengthen health systems, and enhance the ability of health care workers to care for patients in Bangladesh, Malawi, Nepal, the Philippines and Zimbabwe1. The countries were selected based on the diversity of geography and the potential to strengthen country-level health systems and models that provide care and support for children and adolescents with chronic conditions.

Based on data from the Global Burden of Disease Study, every year nearly one million people under the age of 20 die from often treatable non-communicable diseases, including type 1 diabetes, cancer, congenital and rheumatic heart disease, sickle cell disease and asthma. These deaths account for 15 percent of overall mortality for this age group.

"No child should die from a treatable disease because of inadequate care or treatment. Non-communicable diseases undermine a child’s right to health, nutrition, education and play," said Karin Hulshof, Deputy Executive Director, UNICEF. "We are grateful to Lilly for this collaboration to help strengthen health care systems children rely on and ensure health care workers are well-equipped and confident in providing care and treatment to children living with chronic conditions."

This four-year commitment reflects the respective efforts of Lilly and UNICEF to work towards the UN Sustainable Development Goals (SDGs), specifically SDG3, which aims to ensure healthy lives and promote well-being for all at all ages.

"UNICEF’s relentless work to reach disadvantaged children, combined with Lilly’s experience and deep commitment to bettering people’s lives and society, serve as the foundation of this collaborative effort," said David A. Ricks, chair and CEO of Lilly. "This critical, lifesaving work by UNICEF is aligned to the Lilly 30×30 initiative to provide improved access to quality health care for 30 million people in resource-limited settings, annually, by 2030."

Interventions in the five countries will include strengthening data and health information systems for NCDs; establishing and strengthening prevention, care and treatment of NCDs within primary health care and referral facilities (e.g., capacity building of local health care providers including training, mentorship, remote patient monitoring, etc.); and capacity building of service providers for the screening and improved management and treatment of NCDs.

About Lilly 30×30
Through investments in people, medicines and health systems, we aim to improve access to quality health care for 30 million people living in limited resource settings annually by 2030. We call this global effort Lilly 30×30. To achieve our goal, we have structured Lilly 30×30 as a company-wide effort in strategic collaboration with valued external partners. Lilly 30×30 initiatives include activities across three areas of impact: pipeline, programs and partnerships. In each of these areas, we are leading cross-functional teams to develop high-impact, scalable projects and solutions.

ADC Therapeutics to Participate in Guggenheim Oncology Conference

On February 2, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that Chris Martin, PhD, Chief Executive Officer, will participate in a fireside chat at the virtual Guggenheim Oncology Conference on Wednesday, February 9th at 9:30 a.m. EST (Press release, ADC Therapeutics, FEB 2, 2022, View Source [SID1234607615]).

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A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

XBiotech Inks Clinical Manufacturing Deal

On February 2, 2022 XBiotech Inc. (NASDAQ: XBIT) reported that it executed Manufacturing Agreement with Janssen Research & Development, LLC to manufacture clinical product, including Bermekimab, a True Human monoclonal antibody sold to Janssen by XBiotech in December 2019 (Press release, XBiotech, FEB 2, 2022, View Source [SID1234607614]).

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XBiotech discovers and develops therapeutics based on antibodies it identifies from donors with natural human immunity against disease. XBiotech has also developed a unique manufacturing technology and has a state-of-the-art production facility at its headquarters in Austin, Texas.

The Company’s manufacturing technology and production facilities support commercialization of the Company’s internally discovered candidate drugs. Contract drug manufacturing services to third parties have not been an integral part of the Company’s business strategy. However, with the sale to Janssen of bermekimab in 2019, XBiotech committed to provide manufacturing services during a transitional period to Janssen and has been manufacturing bermekimab under contract since the sale. The new agreement will extend XBiotech’s manufacturing support until December, 2023.

John Simard, XBiotech’s Chairman and CEO, stated, "We are pleased to be able to continue to support Janssen in its development of bermekimab. While contract manufacturing is not a core business, manufacturing bermekimab fits well into our system and revenue generated extends our runway for the development of our up and coming therapeutics."

PDS Biotech Announces Preliminary Efficacy Achievement in VERSATILE-002 Phase 2 Trial of PDS0101 in Combination With KEYTRUDA® (pembrolizumab) in Advanced Head and Neck Cancer

On February 2, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus (HPV)-associated head and neck cancer achieved its preliminary objective response benchmarks (Press release, PDS Biotechnology, FEB 2, 2022, View Source [SID1234607612]). The trial, which studies PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), will now progress to full enrollment of 54 patients in this group of checkpoint inhibitor (CPI) naïve patients. As pre-specified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more) confirmed by two separate measurements among at least four or more of the first 17 patients in the CPI naïve arm allows that arm to progress to full enrollment. We anticipate these data will be presented in more detail at an upcoming medical conference.

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VERSATILE-002, being conducted in collaboration with Merck (known as MSD outside the US and Canada), is being studied in two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group have not been previously treated with a checkpoint inhibitor (CPI naïve). An initial assessment of the combination in a second group of 21 patients who have failed prior therapy with checkpoint inhibitors (CPI refractory) is ongoing.

"The achievement of this important milestone in the VERSATILE-002 Phase 2 clinical trial strengthens the evidence of our novel Versamune platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with KEYTRUDA has the potential to significantly improve clinical outcomes for patients with advanced HPV16-positive head and neck cancers."

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email [email protected] or visit the website at View Source to learn more.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

TRACON Pharmaceuticals Announces Initiation of Randomized Phase 2 Trial of TRC102 in Lung Cancer Sponsored by the National Cancer Institute

On February 2, 2022 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics reported that the National Cancer Institute (NCI) has initiated a randomized Phase 2 trial of TRC102 in combination with chemoradiation in patients with stage III non-squamous non-small cell lung cancer (NCT05198830: View Source;draw=2&rank=3) (Press release, Tracon Pharmaceuticals, FEB 2, 2022, View Source [SID1234607611]).

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The open-label two arm trial will enroll 78 patients and assess the benefit of adding TRC102 to current standard of care treatment of pemetrexed, cisplatin, and radiation therapy followed by consolidative durvalumab. The primary endpoint of the trial is progression free survival (PFS) and the trial is designed to detect an improvement in PFS at one year from 56% to 75%. Enrollment is expected to begin in June 2022 and results are expected in 2024.

"We are pleased by the continued support of the National Cancer Institute for the development of TRC102 through our Cooperative Research and Development Agreement (CRADA), including sponsorship of the initial randomized trial of TRC102," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "The initiation of a randomized clinical trial of TRC102 marks an important milestone for the program."

The randomized trial builds upon positive data from a Phase 1 trial of TRC102 in combination with chemoradiation presented at ASCO (Free ASCO Whitepaper) 2020 that demonstrated a 100% response rate in 15 patients with Stage IIIA or Stage IV non-squamous non-small cell lung cancer, including three patients who had a complete response to treatment. These data compared favorably to historical data of the same combination of chemoradiation without TRC102 in advanced lung cancer from the PROCLAIM and the PACIFIC clinical trials.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the U.S. FDA in malignant glioma, including glioblastoma.