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 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 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 26, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the company has entered into a definitive licensing agreement for CHEMOSAT commercialization in Europe with medac Gesellschaft für klinische Spezialpräparate mbH (medac), a privately held, multi-national pharmaceutical company based in Hamburg area, Germany (Press release, Delcath Systems, DEC 26, 2018, View Source;p=RssLanding&cat=news&id=2381596 [SID1234532279]). Founded in 1970, medac specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases. The company has offices globally, worldwide partner agreements in over 90 countries, and approximately 1,200 employees.

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Under the terms of the seven-year agreement, Delcath’s European subsidiary, Delcath Systems, Ltd. exclusively licenses medac to sell and market CHEMOSAT in all member states of the European Union, Norway, Liechtenstein, Switzerland, and the United Kingdom. medac will pay Delcath €6,000,000 in a combination of upfront and success-based milestone payments. Additionally, Delcath will receive a fixed transfer price per unit of CHEMOSAT as well as royalties. The agreement has a projected value of up to $45 million over the first seven-year term and includes an optional five-year extension.

"With offices throughout Europe and a well-established network among oncology key opinion leaders, medac is a well-suited partner to help advance CHEMOSAT commercialization in the European Union and neighboring countries," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "medac provides the organizational scale, expertise and market reach necessary to help us strive to firmly establish CHEMOSAT in the European treatment landscape for cancers of the liver. Additionally, through this agreement, we obtain immediate resources to support our efforts to advance our clinical development program. This is a highly significant development for Delcath, and we are pleased to be working with a market leader like medac to help this therapy fully realize its potential."

Heiner Will, Chief Marketing Officer of medac, said, "We are excited to build upon the growing customer and revenue base that Delcath has built in Europe to provide patients with liver metastases a promising treatment modality. We are convinced by the assessment of European clinicians about the very meaningful impact CHEMOSAT has on the quality of life of these patients who, because of the safety profile of CHEMOSAT can receive multiple treatments." This substantial new business opportunity strengthens and expands medac’s expertise in the treatment of cancer. medac is currently working diligently with Delcath launching commercial efforts in Europe in January 2019.

On December 26, 2018 Immunomedics, Inc., (NASDAQ: IMMU) and Johnson Matthey (LSE: JMAT), reported the companies have expanded their long-term master supply agreement under which Johnson Matthey will continue to scale the manufacturing of CL2A-SN-38, the drug-linker that is a key component of sacituzumab govitecan, Immunomedics’ lead antibody-drug conjugate currently under priority review by the FDA for accelerated approval as a treatment for patients with metastatic triple-negative breast cancer (Press release, Immunomedics, DEC 26, 2018, View Source [SID1234532281]).

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"We are significantly scaling our ongoing partnership with Johnson Matthey," said Dr. Morris Rosenberg, Chief Technology Officer of Immunomedics. "This agreement signifies our continuing commitment to expand our supply-chain strategy as we look to broaden the applicability of sacituzumab govitecan to a multitude of solid cancer indications and expand it to other world markets."

"Immunomedics is one of our largest and most strategic relationships and we are proud to be able to contribute to their efforts in providing viable treatment options to improve cancer patients’ lives," said Jason Apter, Sector Chief Executive, Health at Johnson Matthey.

Financial terms of the agreement were not disclosed.

About Sacituzumab Govitecan

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate. It is currently under priority review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who have received two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first therapy approved for patients with metastatic triple-negative breast cancer.