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.

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"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."

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.

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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 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its Chief Executive Officer Saiid Zarrabian will participate in the Benzinga Biotech Small Cap Conference to be held March 24-25, 2021 (Press release, Kintara Therapeutics, MAR 17, 2021, View Source [SID1234576816]). Mr. Zarrabian will present on March 24, 2021 at 9:45 am ET.

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Investors can view Mr. Zarrabian’s general corporate presentation once they register for the conference here and can also request a 1×1 meeting with Mr. Zarrabian.

On March 17, 2021 Amplia Therapeutics Ltd (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported that it has successfully completed the dosing of subjects in the Single Ascending Dose (SAD) component of the Phase 1 clinical trial of its proprietary focal adhesion kinase (FAK) inhibitor AMP945 (Press release, Amplia Therapeutics, MAR 17, 2021, View Source;[email protected] [SID1234576815]).

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The Single Ascending Dose study involved four cohorts of healthy volunteers. The last cohort of volunteers received the highest single dose of AMP945 administered to date and achieved drug exposures corresponding to the maximum allowable level specified in the trial design. As noted for prior cohorts, the highest single dose AMP945 was found to be well tolerated and no safety concerns were identified.

Last month, Amplia announced that it had started dosing subjects for the Multiple Ascending Dose (MAD) component of its Phase 1 trial. The Company remains on track to complete dosing and report top-line data from this trial in the June quarter. Dr John Lambert, CEO of Amplia commented: "We are very encouraged by the data that is coming in from this Phase 1 clinical study. Our focus is now on completing the trial in a timely manner, fully analysing the data and preparing for future clinical studies in patients with cancer and fibrosis."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On March 17, 2021 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported its financial results for the fourth quarter and full year 2020, and provided a corporate update (Press release, Xenetic Biosciences, MAR 17, 2021, View Source [SID1234576810]).

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"Notwithstanding the challenges presented by the COVID-19 pandemic, 2020 was a year of significant progress for the Company, including the establishment of partnerships and academic collaborations and advancement in our development efforts, in particular with respect to CAR design and model cell line development, as well as the strengthening of our financial position. Our focus remains on advancing the XCART platform, and we look forward to further evaluation of our XCART process in a clinical setting during our upcoming exploratory study in Eastern Europe," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Our goal remains to complete our preclinical development phase and advance into a Phase 1 study as quickly as possible."

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T therapy targeting tumor specific antigens that are independent of CD19 or other antigens common to all B-Cells. Lead program for Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to address an initial global market opportunity of over $5 billion annually.[1]

Program Highlights:

Collaboration with Pharmsynthez and multiple academic institutions in Eastern Europe to optimize the overall XCART workflow, including clinical manufacturing processes, and ultimately to conduct a first in-human study in B-cell Non-Hodgkin lymphoma (NHL) patients.
Research and development collaboration with Scripps Research covering design and implementation of the preclinical development program, as well as method development activities supporting process development for clinical manufacturing.
Upcoming Potential Milestones

Initiation of exploratory patient biopsy study in Eastern Europe.
Seeking U.S. FDA INTERACT meeting.
Initiating process development for clinical CAR T manufacturing.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlights:

Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of blood coagulation disorders.
Takeda currently has one active development program underway.
Royalty payments of approximately $0.4 million received in 2020 as Takeda’s sublicensee has now launched the relevant product in multiple global markets.
Company’s partner, PJSC Pharmsynthez, announced positive Phase 3 trial results and filed a registration dossier in Russia to obtain approval of Epolong, a polysialylated form of human erythropoietin as a treatment for anemia in patients with chronic kidney disease.
Summary of Financial Results for Fiscal Year 2020

Net loss for the year ended December 31, 2020, was approximately $10.9 million. R&D expenses for the year ended December 31, 2020, were $1.7 million compared to $4.9 million for the year ended December 31, 2019. The decrease was primarily due to IPR&D expense of $3.0 million incurred during the year ended December 31, 2019. General and administrative expenses decreased by approximately $1.3 million, or 28.1% for the year ended December 31, 2020, to $3.4 million from $4.7 million in the comparable period in 2019, primarily due to approximately $1.1 million of transaction costs associated with the XCART acquisition incurred during the year ended December 31, 2019. At December 31, 2020, the Company reported working capital was approximately $11.4 million compared to $9.7 million at December 31, 2019. During the year ended December 31, 2020, working capital increased by $1.8 million due to the Company’s December 2020 registered direct common stock offering resulting in approximately $5.4 million in net proceeds. This increase in working capital was substantially offset by the Company’s net loss for the year ended December 31, 2020. The Company ended the year with approximately $11.5 million of cash.