On May 5, 2021 Tiziana Life Sciences plc (Nasdaq: TLSA / LSE: TILS) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, reported that it has executed an agreement with Takanawa Japan K.K, Pharma Team, (Takanawa) for a strategic business development plan to Identify a clinical partner in Japan and other Asian countries for further clinical development of Milciclib for treatment in advanced hepatocellular carcinoma (HCC) patients (Press release, Tiziana Life Sciences, MAY 5, 2021, View Source [SID1234579295]). HCC is the most common type of liver cancer and affects approximately 200,000 people per year.

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Previously, Tiziana successfully completed a Phase 2 clinical trial with orally administered Milciclib in sorafenib-resistant or intolerant HCC patients. The clinical data, presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)1, demonstrated that the treatment was well-tolerated and produced clinical activity. Recently, a patent covering the use of Milciclib in combination with a tyrosine kinase inhibitor (TKI) or other drugs was granted2. The granted claims provide complete freedom to further develop a combination of Milciclib with an approved TKI for treatment of patients with advanced HCC or other cancers. Because the prevalence of HCC in Asian countries is large and there are no satisfactory therapeutic options for treatment of advanced HCC in Asian countries, the strategic initiative with Takanawa is particularly important to further develop Milciclib for the treatment of advanced HCC patients.

"We are pleased and excited to work with Takanawa, a firm with a distinguished history of business development activities in the Japanese pharmaceutical industry, to identify an appropriate partner in Japan for further clinical development of Milciclib. We believe the positive clinical activity in advanced HCC and other cancers warrant immediate further development in Japan and other Asian countries where the prevalence of this cancer is relatively high, and the current available therapies are not entirely satisfactory" said Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences.

"We are honored to get the opportunity to identify a strategic partner for Milciclib for the treatment of advanced hepatocellular carcinoma (HCC) patients. Tiziana has managed to develop a product that will really have an impact and save lives since HCC affects about 200,000 people in the world and 40,000 people in Japan every year. Therefore, we hope to receive a lot of interest from leading pharmaceutical companies " said Dr. Kaoru Nozu, Executive Representative of the Takanawa Pharma Team.

The person who arranged for the release of this announcement on behalf of the Company was
Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

Cited References:

1.Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.
First Author: Erica Villa, MD., et al.
2.US Patent (10,758,541 B2 (Inventor: Shailubhai) Issue Date: September 1, 2020

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (THE "EUWA")) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma.

On May 5, 2021 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, reported that it has completed the sale of approximately $10 million of its common shares pursuant to the Company’s ATM program established on March 9, 2020 through Jefferies LLC ("Jefferies"), acting as sales agent (Press release, Corvus Pharmaceuticals, MAY 5, 2021, View Source [SID1234579175]).

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An aggregate of 3,564,228 new shares were sold to EcoR1 Capital, a fundamental biotechnology-focused investment advisory firm, and 35,714 new shares were sold to Richard A. Miller, the Company’s co-founder, president and chief executive officer, at an at-the-market price of $2.80 per share. It is anticipated that the settlement and delivery of the new shares will take place on May 6, 2021.

A shelf registration statement on Form S-3 relating to Corvus’ securities being sold was declared effective by the Securities and Exchange Commission on March 19, 2020. Before purchasing shares, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

On May 5, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the first quarter ended March 31, 2021 (Press release, Tracon Pharmaceuticals, MAY 5, 2021, View Source [SID1234579391]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We continue to be pleased with the pace of enrollment in the pivotal ENVASARC trial and remain on track to deliver interim data in the 2nd half of this year and final data in 2022," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We have now initiated 22 sites and have enrolled more than 20 patients which has triggered the initial Data Monitoring Committee review of safety data from each cohort, which we expect later this quarter."

Recent Corporate Highlights

Envafolimab

In April, we resubmitted our Orphan Drug Designation application to the FDA in response to a request for preclinical or clinical evidence of activity for envafolimab in sarcoma. We expect correspondence from the FDA this quarter based on the amended application.

As of May 5, we have initiated 22 U.S. clinical sites and enrolled more than 20 patients in the pivotal ENVASARC trial of single agent envafolimab and envafolimab combined with Yervoy, which has triggered the initial Data Monitoring Committee review of safety data from each cohort.
Expected Key Upcoming Milestones

Orphan Drug Designation for envafolimab in soft tissue sarcoma from FDA in 1H 2021.

Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021.

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) presentation of ENVASARC pivotal trial design in 1H 2021.

ASCO presentation of TJ004309 Phase 1 data in 1H 2021.

Interim ENVASARC efficacy and safety data in 2H 2021.

Request FDA breakthrough therapy designation or Fast Track designation for envafolimab in 2H 2021.

Decision on the envafolimab New Drug Application (NDA) in MSI-H/dMMR cancer that is under priority review by the Chinese National Medical Products Administration (NMPA).
First Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments were $30.4 million at March 31, 2021, compared to $36.1 million at December 31, 2020. The Company expects that its current cash, cash equivalents and short-term investments will fund operations into the second half of 2022.

Research and development expenses for the first quarter of 2021 were $2.3 million, compared to $2.0 million for the first quarter of 2020.

General and administrative expenses for the first quarter of 2021 were $2.7 million, compared to $1.9 million for the first quarter of 2020.

Net loss for the first quarter of 2021 was $5.1 million, compared to $4.0 million for the first quarter of 2020.
Conference Call Details

Wednesday, May 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 8852857
A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by 3D Medicines. TRACON’s partners Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of the KEYNOTE-164 clinical trial.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

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.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

Merck & Co has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 5, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in a fireside chat at the 2021 Bank of America Securities Virtual Health Care Conference, which will be webcast on Tuesday, May 11, 2021 (Press release, Bristol-Myers Squibb, MAY 5, 2021, View Source [SID1234579211]). Chris Boerner, Ph.D., Executive Vice President, Chief Commercialization Officer will answer questions about the company at 5 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.