On February 2, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the successful completion of the three-patient safety run-in for the pancreatic cancer cohort of the phase 1/2 GOBLET study following evaluation by the study’s Data Safety Monitoring Board (DSMB) (Press release, Oncolytics Biotech, FEB 2, 2022, View Source [SID1234607617]). The DSMB noted no safety concerns in these patients and recommended the study proceed as planned. The safety run-in for the trial’s third-line metastatic colorectal cancer cohort remains ongoing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.

"This positive safety evaluation adds to a robust body of evidence demonstrating the favorable safety profile of pelareorep-checkpoint inhibitor combinations across multiple indications," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "It also represents an important step in the development of these combinations for the treatment of pancreatic cancer and builds on prior clinical proof-of-concept data in this indication. These data highlight the potential of pelareorep to benefit patients with pancreatic and other gastrointestinal cancers by reversing immunosuppressive tumor microenvironments that limit the effectiveness of checkpoint inhibitors. We believe adding pelareorep to treatment regimens will improve clinical response rates in these patients, and we look forward to evaluating this hypothesis through successfully advancing the GOBLET study."

The GOBLET study’s pancreatic cancer cohort extends previously reported clinical data demonstrating the synergy and anti-cancer activity of pelareorep combined with checkpoint inhibition in pancreatic cancer patients who progressed after first-line treatment (link to PR, link to poster). It also builds on prior early clinical data that showed a greater than 80% increase in median progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression who received pelareorep in combination with chemotherapy (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, GOBLET also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may increase the likelihood of success of future registrational studies by allowing selection of the most appropriate patients.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:
1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Gastrointestinal Cancer
Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer expected to be diagnosed in the U.S. in 20211. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer2 and 9,090 new cases of anal cancer3 in the U.S.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.