On March 17, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Wednesday, March 24, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the fourth quarter ended December 31, 2020 (Press release, Navidea Biopharmaceuticals, MAR 17, 2021, View Source [SID1234576775]).

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!

Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On March 17, 2021 M2GEN reported a significant new investment by Clayton, Dubilier & Rice ("CD&R") funds, the Merck Global Health Innovation Fund ("Merck GHI"), and McKesson Ventures to recapitalize M2GEN, a leading oncology data and informatics platform focused on transforming cancer care, in partnership with its existing shareholders (Press release, M2Gen, MAR 17, 2021, View Source [SID1234576800]). The financial terms of the transaction, which closed today, were not disclosed.

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!

Merck GHI and McKesson Ventures invested alongside CD&R funds, collectively now the company’s largest shareholder. Existing shareholders Moffitt Cancer Center, Hearst Healthcare, and The Ohio State University Foundation continue to hold a significant minority interest M2GEN. Proceeds from the transaction are expected to accelerate growth of M2GEN’s consented, linked clinical and genomic data asset and advance the technology and informatics capabilities of the company. In conjunction with the recapitalization, Sandra E. Peterson, CD&R Operating Partner and former Group Worldwide Chairman of Johnson & Johnson, has assumed the role of Chair of the M2GEN board.

In conjunction with the transaction, M2GEN will bolster its existing senior management team led by President and CEO Helge Bastian, Ph.D., with two experienced executive hires: Todd Johnson, M.D., most recently Senior Vice President of Life Sciences Commercialization and Clinical Research Groups at Optum, as Chief Growth Officer, and Wilf Russell, a seasoned technology leader with experience from companies including Volvo, Nike, and Microsoft, as Chief Technology Officer.

M2GEN runs one the world’s largest observational research studies in cancer, which tracks patients throughout their lifetime, links longitudinal clinical data with molecular information, and enables a deeper understanding of a patient’s disease. M2GEN has established one of the largest and most comprehensive linked clinical and genomic databases in the country, empowering innovative, collaborative cancer research and supporting the development of novel oncology drugs by its biopharmaceutical partners.

M2GEN’s data platform includes more than 300,000 patients across its alliance of leading cancer research centers, known as the Oncology Research Information Exchange Network (ORIEN). ORIEN members benefit through collaborative research and shared data; M2GEN’s biopharmaceutical partners benefit through access to the network and a dataset that supports clinical trial design, patient recruiting and new therapy development; and the ultimate beneficiaries are patients, as this process informs new drug treatment options.

"M2GEN is purpose-driven and patient-centric, and we believe it will impact healthcare for the next generation by connecting patients, providers, researchers, and pharma R&D to fundamentally change the way cancer is studied and treated," said Sarah Kim, CD&R Partner. "CD&R has spent significant time evaluating the real-world data market within pharma services and sees a tremendous opportunity to join forces with an exceptional group of shareholders to support M2GEN’s next phase of growth, drive operational excellence, and further its mission to connect patients to a cure by accelerating the discovery, development and delivery of more personalized therapies."

"Merck GHI closely tracked M2GEN for many years through our research colleagues’ collaborations first with Moffitt Cancer Center and then with M2GEN’s spin-out from Moffitt," said David M. Rubin, Ph.D., Managing Director, Merck GHI. "This syndicated investment will support the build of scaled resources that have the potential to enable the development of new medicines and precision cancer care."

"McKesson Ventures is proud to support M2GEN’s leading and comprehensive linked clinical and genomic data platform. Our investment directly reflects McKesson’s broader commitment to advance and improve community oncology care through The US Oncology Network and Ontada, our innovative oncology technology and insights business," said Dave Schulte, Senior Vice President and Managing Director, McKesson Ventures.

Ropes & Gray LLP acted as legal advisor to CD&R in connection with the transaction. Perella Weinberg Partners LP served as exclusive financial advisor and Shumaker, Loop & Kendrick, LLP acted as legal advisor to M2GEN. Green Shoots Consulting, LLC served as advisor and McDermott Will & Emery LLP acted as legal advisor to Merck GHI.

On March 17, 2021 Future Planet Capital has invested in a $168m Series B financing reported by Vaccitech Ltd. Future Planet joins other leading investors including M&G Investment Management, Tencent, Gilead Sciences, Monaco Constitutional Reserve Fund and fellow existing investor, Oxford Sciences Innovation (Press release, Vaccitech, MAR 17, 2021, View Source [SID1234576817]). As part of the Series B financing, $43 million in convertible loan notes previously issued by Vaccitech will convert into Series B shares, resulting in total gross proceeds to Vaccitech of $168 million before expenses.

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!

Douglas Hansen-Luke, Executive Chairman of Future Planet Capital, explained: "Our decision to support Vaccitech last year, before the results of the COVID-19 Vaccine AstraZeneca trials were known, has been vindicated by the vaccine’s approval for emergency use by national and international regulators. The success of the COVID-19 Vaccine AstraZeneca has increased our confidence in Vaccitech’s immunotherapy platform and our continuing support is signalled by our investment today."

Bill Enright, CEO of Vaccitech, said: "We expect this financing to enable us to reach key value inflection points for our lead programs. We now look forward to advancing key programs towards generating proof-of-concept data in indications with significant need of effective new treatments."

Ed Phillips, Head of Origination at Future Planet, concluded: "This is a concrete example of our vision in action – financing the best minds to address global challenges. We look forward to working with other entrepreneurs and businesses dedicated to solving global challenges in the future."

Vaccitech is a clinical stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer; in 2020 it co-invented a COVID-19 vaccine candidate with the University of Oxford, AZD1222, which is known as the COVID-19 Vaccine AstraZeneca.

On March 17, 2021 M2GEN, a leading oncology-focused data and informatics company, reported a significant new five-year agreement with Merck, known as MSD outside the United States and Canada (Press release, M2Gen, MAR 17, 2021, View Source [SID1234576801]). Under the terms of the agreement, M2GEN will provide valuable patient-consented, de-identified, linked clinical and genomic data in support of Merck’s oncology efforts.

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!

This data will be accessed through M2GEN’s Oncology Research Information Exchange Network (ORIEN), a network of 18 leading cancer centers across the United States. ORIEN Avatar is a collaboration between this network, pharmaceutical companies and M2GEN, which manages the program. Patients donate clinical and molecular data through their consent to the Total Cancer Care research protocol; that data follows patients pre-and post-treatment and is then utilized by the ORIEN cancer center members and pharmaceutical partners to speed discoveries and match eligible patients to cutting-edge trials. The program represents an unprecedented, pre-competitive approach to fighting cancer, designed to accelerate the discovery and development of novel therapies for patients around the world.

Merck’s participation in the program builds on a history of collaboration dating back to the founding of M2GEN in 2006, when the companies operationalized a multi-year agreement based on the Total Cancer Care protocol. The collaboration with M2GEN has provided important utility in Merck’s oncology development programs including indications for KEYTRUDA (pembrolizumab).

"Merck has been a key strategic partner to M2GEN since helping to found the Total Cancer Care protocol 15 years ago, and we are very proud of what we have accomplished together," said M2GEN President and CEO Helge Bastian, PhD. "We greatly value Merck’s long-term partnership and see tremendous potential in it for the future."

"We see this new partnership as an important milestone in the fight against cancer," said Sandra E. Peterson, Chair of the M2GEN Board of Directors. "We are thrilled to expand our collaboration with Merck to enable the development of more effective medicines and patient care."

"Our work with M2GEN yielded valuable insights that have informed our oncology development strategy," said Dr. Eric Rubin, SVP Oncology Clinical Development, Merck Research Laboratories. "We look forward to continuing our collaboration and building on our shared commitment to improving cancer care."

On March 17, 2021 T-Cure Bioscience, Inc., a privately held company focused on developing T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the Company has entered into a clinical research agreement with Rutgers, The State University of New Jersey, to fund a Phase I clinical study testing a TCR-based product candidate for the treatment of tumors expressing Kita-Kyushu lung cancer antigen 1 (KK-LC-1), such as gastric, cervical, lung, and triple negative breast cancers (Press release, T-Cure Bioscience, MAR 17, 2021, View Source [SID1234576818]). T-Cure acquired the KK-LC-1 TCR therapy under an exclusive, worldwide license with the National Cancer Institute (NCI) in 2020. The Principal Investigator who will conduct the clinical research is Christian S. Hinrichs, M.D., Chief of the Section of Cancer Immunotherapy and Co-Director of the Cancer Immunology and Metabolism Center of Excellence at Rutgers Cancer Institute of New Jersey. Dr. Hinrichs is an expert in cancer immunology and immunotherapy and was recruited from the NCI where he served as Senior Investigator at the Genitourinary Malignancies Branch. T-Cure anticipates the KK-LC-1 TCR therapy will enter a multi-site Phase 1 clinical study in the second quarter of 2021 at the NCI, with the clinical study responsibilities to be transferred to Rutgers in the second half of 2021.

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!

"I joined the Cancer Immunology and Metabolism Center of Excellence because I believe that Rutgers Cancer Institute can be a global leader in cancer and tumor immunology research and development. In support of that mission, I am excited to partner with T-Cure to launch the first cell therapy clinical trial targeting the KK-LC-1 antigen," stated Dr. Hinrichs. "I began collaborating with the T-Cure team on this T cell receptor therapy while at the NCI, and I am pleased to continue working with them to advance this therapy at Rutgers."

"We look forward to our partnership with Dr. Hinrichs at Rutgers as a continuation of the work we undertook with him and his team at the NCI to advance this novel TCR product candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "The TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to a safely administered immunotherapy. Accordingly, we believe it holds great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without being harmful to healthy tissue."