On December 27, 2018 Xynomic Pharma, a clinical stage US-China oncology drug development company, reported that its Trials-in-Progress poster discussing the ongoing, potentially pivotal, phase 3 trial of abexinostat plus pazopanib as first- or second-line therapy in patients with locally advanced or metastatic renal cell carcinoma (RCC) will be presented by Dr. Rahul Aggarwal of University of California San Francisco, a lead investigator, at the ASCO (Free ASCO Whitepaper)-Genitourinary Cancers Symposium on February 16, 2019 in San Francisco, California, USA (Press release, Xynomic Pharmaceuticals, DEC 27, 2018, View Source [SID1234532296]).

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Xynomic Pharma has also filed 3 China Investigational New Drug (IND) applications with China National Medical Products Administration (NMPA) to test abexinostat, Xynomic’s lead drug candidate and a China Category 1 drug, against RCC and lymphoma. All 3 clinical trials are potentially pivotal and will test (1) abexinostat in combination with pazopanib as a first- or second-line therapy against RCC, (2) abexinostat as a third-line mono therapy against diffuse large B-cell lymphoma, the most common aggressive non-Hodgkin’s lymphoma (NHL) subtype according to the Leukemia & Lymphoma Society (LLS), and (3) abexinostat as a third-line mono therapy against follicular lymphoma, the most common indolent NHL subtype according to LLS. The first clinical trial will also be a part of an on-going multinational, multi-center trial. Furthermore, Xynomic Pharma has filed an IND with the NMPA for a fourth trial, not intended for registration purpose in China, to test abexinostat as a fourth-line mono therapy against follicular lymphoma. This fourth trial will be a part of an on-going multinational, multi-center trial.

In addition, Xynomic Pharma has officially commissioned its dedicated R&D Innovation Center in Shanghai, China with a ribbon cutting ceremony. This center is staffed with a team of multinational scientists from China and India and focuses on leveraging kinase inhibition, immuno-oncology and epigenetic modification to discover and develop innovative small molecule oncology drugs. The center is designed to have research capabilities from lead identification to pre-clinical drug candidate selection and development capabilities in early phase clinical trials.

On December 27, 2018 JHL Biotech reported that the first patient at Beijing Cancer Hospital has been successfully randomized in the Phase III study of JHL1101 to treat diffuse large B-cell lymphoma (DLBCL) (Press release, JHL Biotech, DEC 27, 2018, View Source [SID1234532295]).

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The Phase III study is a multinational, randomized, double-blind, positive-controlled, parallel group clinical study. It compares the efficacy and safety of JHL1101 in combination with CHOP (J-CHOP) versus rituximab in combination with CHOP (R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. CHOP is the standard chemotherapy treatment for diffuse large B-cell lymphoma. The study is being conducted in Europe, China, and other parts of Asia.

JHL1101, a biosimilar product to rituximab which is a monoclonal antibody targeting CD20, is being developed by JHL Biotech for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA).

After completion of similarity assessment in quality attributes and preclinical, a pharmacokinetic (PK) study is being conducted in RA patients in Europe. Earlier this year, the Chinese regulatory authority approved the clinical trial application of the Phase III study.

"Rituximab is an important biologic for the treatment of lymphoma and rheumatoid arthritis. Unfortunately, it is very expensive for patients and healthcare payers. JHL1101 would provide an affordable treatment for these patients," said Mr. Racho Jordanov, CEO, JHL Biotech. "This is a significant milestone for JHL, and a step forward in our goal to become a global leader in developing, manufacturing, and commercializing biologics."

In addition to JHL1101, JHL has several other biosimilars currently in or expected to be in clinical trials. These include:

Bevacizumab biosimilar, JHL1149, used for the treatment of several cancers, the most common of which are metastatic colorectal cancer, non-small cell lung cancer, and ovarian cancer, as well as cervical cancer, renal cell carcinoma, and glioblastoma. Pharmacokinetics study in Europe has been conducted. Received clinical trial approval for Phase III in China in 2018.
Dornase alfa biosimilar, JHL1922, to manage symptoms of cystic fibrosis. Pharmacokinetics study in Europe has been conducted. Expected Phase III trial in Europe in 2019.
Trastuzumab biosimilar, JHL1188, to treat breast cancer. Expected pharmacokinetics study in Australia in 2019.
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On December 27, 2018 Harpoon Therapeutics, Inc. ("Harpoon"), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering of its common stock (Press release, Harpoon Therapeutics, DEC 27, 2018, View Source [SID1234532294]). All shares of common stock to be sold in the proposed offering will be offered by Harpoon. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Harpoon has applied to list its stock for trading on the Nasdaq Stock Market under the symbol "HARP."

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Citigroup and Leerink Partners are acting as joint book-running managers for the proposed offering. Canaccord Genuity and Wedbush PacGrow are acting as co-managers for the proposed offering.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the proposed offering may be obtained, when available, from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected].

On December 27, 2018 Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported the company has filed an Investigational New Drug Application (IND) with the China National Medical Products Administration (NMPA) for the Company’s anti-Trop2 Antibody-Drug Conjugate (ADC), BAT8003, as a therapeutic agent for the treatment of Trop2 positive cancers (Press release, BioThera Solutions, DEC 27, 2018, View Source [SID1234532293]). Subject to NMPA acceptance, Bio-Thera Solutions plans to initiate the Phase I clinical trial early in 2019.

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The planned Phase I trial will evaluate the safety, tolerability and pharmacokinetics of BAT8003 as a single agent in subjects with Trop2 positive cancers. The first cohort of patients in the planned clinical trial will be enrolled in a standard [3+3] dose escalation regimen to assess safety and pharmacokinetics and to determine maximum tolerated dose of BAT8003. Multiple dose expansion cohorts are planned with patients with Trop2 positive cancers, such as triple negative breast cancer and gastric cancer. The primary objective of the dose expansion cohort is to confirm the safety and clinical activity of BAT8003 in patients with Trop2 positive cancers.

"The filing of this IND for our novel Trop2-ADC is a significant achievement for Bio-Thera Solutions," said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "Pending NMPA acceptance of the IND, we will begin the dose escalation portion of this Phase I trial early in 2019 and anticipate reporting on the early safety assessment and determination of a maximum tolerated dose in mid-year 2019."

About BAT8003

BAT8003 is an investigational Trop2-ADC being evaluated in multiple tumor types. BAT8003 utilizes Bio-Thera Solutions’ proprietary linker-payload combination, Batansine. The antibody component of the BAT8003 is engineered for site-specific conjugation to allow for better control of the ADC DAR providing a more homogenous product. The linker is non-cleavable ensuring superior delivery of the payload to the cancer cells and improving the safety profile of the ADC. BAT8003 is being developed for use as a single agent and in combination with other agents for the treatment of Trop2 positive cancers.

About the Trop2 Receptor

Trop2, also known as tumor-associated calcium signal transducer 2 and trophoblast cell surface antigen 2, is a transmembrane glycoprotein that functions as an intracellular calcium signal transducer. It signals cells for self-renewal, proliferation and invasion. While Trop2 is expressed in some normal tissues at low levels, Trop2 is overexpressed in many types of cancers and the overexpression of Trop2 is of prognostic significance.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker. An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells. By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.

On December 27, 2018 MannKind Corporation (NASDAQ: MNKD) reported that it will host a conference call on Friday, January 4, 2019 to discuss Company developments at 9:00 AM (Eastern Time) (Press release, Mannkind, DEC 27, 2018, View Source [SID1234532292]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna.

To participate in the live call by telephone, please dial (800) 263-0877 or (646) 828-8143 and use the participant passcode: 1338434. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 1338434#. A replay will also be available on MannKind’s website for 14 days.