On December 28, 2018 CTI BioPharma Corp. (NASDAQ: CTIC) reported the completion of full enrollment of 150 patients in the PAC203 Phase 2 study of pacritinib (Press release, CTI BioPharma, DEC 28, 2018, View Source [SID1234532309]). The Company expects to report the determination of the optimal dose of pacritinib in mid-2019 following a meeting with the U.S. Food and Drug Administration (FDA). Topline efficacy and safety data are expected in the third quarter of 2019, with the new Phase 3 study targeted to commence enrollment in the third quarter of 2019.

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As previously announced, the Company has received input from the FDA on key elements of the design of a new randomized Phase 3 study of pacritinib in adult patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) and who have severe thrombocytopenia (as defined by patients with platelet counts of less than 50,000 per microliter), an indication that has been recognized by the medical community as an important unmet medical need. A planned interim safety review by an Independent Data Monitoring Committee (IDMC) is scheduled to occur in the first quarter of 2019.

The PAC203 study is evaluating the safety and efficacy of three dosing schedules (100 mg once daily, 100 mg twice daily and 200 mg twice daily) over 24 weeks in patients with myelofibrosis previously treated with ruxolitinib. More information on the PAC203 trial can be found at ClinicalTrials.gov at View Source

On December 28, 2019 Helix BioPharma Corp. (TSX, FSE: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a final tranche of a private placement financing for gross proceeds of CAD348,000 (Press release, Helix BioPharma, DEC 28, 2018, View Source [SID1234533055]).

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The terms of the placement are for the purchase of units at $1.20 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $1.50 and have an expiry of five years from the date of issuance. Helix intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

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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