On January 14, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported an investigator-initiated study led by David R. Wise, M.D., Ph.D. of the Perlmutter Cancer Center at NYU Langone Health to study DKN-01, as a monotherapy and in combination with docetaxel in patients with advanced prostate cancer (Press release, Leap Therapeutics, JAN 14, 2019, View Source [SID1234532649]). This clinical trial is specifically targeting a biomarker-selected patient population in metastatic castration-resistant prostate cancer (mCRPC) with elevated Dickkopf-1 (DKK1) levels.

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"DKK1 can promote prostate cancer growth through suppressing the anti-tumor immune response. We have discovered that DKK1 is upregulated in the substantial portion of advanced prostate cancers that lack expression of androgen receptor," commented Dr. Wise. "Patients with this type of prostate cancer have a very poor prognosis and may benefit from this new immunotherapy strategy targeting DKK1 therapy with DKN-01."

"An important part of our DKN-01 development strategy is to target biomarker-selected patient populations," said Cynthia Sirard, M.D., Vice President, Clinical Development of Leap Therapeutics. "In our esophagogastric cancer study, we have identified DKK1 levels measured by RNAScope as a potential predictor of response to DKN-01-based therapy. We are looking forward to treating mCRPC patients with elevated DKK1 levels in this study, building on our and Dr. Wise’s work."

The study is expected to begin enrolling patients in the first quarter of 2019. mCRPC patients who have progressed on one or more androgen receptor (AR) therapies (Xtandi or Zytiga) will be screened for DKK1 elevation in their plasma or in a tumor sample. Up to 97 patients will be enrolled in a dose-escalation and then dose expansion cohorts. DKK1+ mCRPC patients who have not received prior taxane chemotherapies will be treated with DKN-01 and docetaxel. DKN-01 will be given as a monotherapy to DKK1+ mCRPC patients who have progressed on or refused docetaxel treatment.

About Prostate Cancer

Prostate cancer is the leading type of non-skin cancer in the US, and the second leading cause of cancer worldwide. Approximately 1 in 9 men will be diagnosed with prostate cancer at some point in their lives. Androgen receptor (AR)-targeted therapy can be highly effective for the treatment of prostate cancer. Unfortunately, most patients will eventually develop resistance and progress to castration-resistant prostate cancer (CRPC), an incurable form of the disease.

Disclosure

Dr. Wise is compensated to serve as a consulant to Leap Therapeutics. Also, Dr. Wise’s involvement in this upcoming study does not constitute an institutional endorsement from NYU Langone Health or its Perlmutter Cancer Center of the drug DKN-01 being studied.

On January 14, 2019 Stemline Therapeutics, Inc. (Nasdaq:STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported that it intends to offer and sell, subject to market conditions, 6,600,000 shares of its common stock in an underwritten public offering (Press release, Stemline Therapeutics, JAN 14, 2019, View Source [SID1234532634]). All of the shares to be sold in the offering will be offered by Stemline. In addition, Stemline intends to grant the underwriters a 30-day option to purchase up to an additional 990,000 shares of its common stock offered in the public offering.

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J.P. Morgan Securities LLC is acting as book-running manager for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL‑401) including clinical trials for additional indications including CMML, MF and other diseases; (ii) clinical development of SL‑801, SL‑701 and potentially SL-901; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.

Stemline has filed a preliminary prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-219794) with the U.S. Securities and Exchange Commission ("SEC") for the proposed public offering of its common stock. The offering will be made only by means of a prospectus and a prospectus supplement, which will be available on the SEC’s web site at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204.

The offering of these securities is being made under an effective shelf registration statement on file with the SEC. 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 under the securities laws of any such state or jurisdiction.

On January 14, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that its Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, will be featured in a trial-in-progress poster at The ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, taking place February 28-March 2, 2019, in San Francisco, CA (Press release, Compugen, JAN 14, 2019, View Source [SID1234532648]).

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The poster titled "A Phase 1 Study Evaluating COM701 in Patients With Advanced Solid Tumors," will be presented by Drew W. Rasco, M.D, Associate Director of Clinical Research at the South Texas Accelerated Research Therapeutics (START), San Antonio, TX and a Principal Investigator in the Phase 1 COM701 study.

The poster abstract is expected to be published on the conference website on February 25, 2019, and will reflect enrolment information as of the date of the abstract submission. The poster presentation will take place on Thursday, February 28, 2019, and will include updated enrolment information.

The poster will be available on Compugen’s website at www.cgen.com following the conference presentation.

On January 14, 2019 Oncoceutics, Inc. reported that the United States Patent and Trademark Office (USPTO) has issued patent #10,172,862 for the use of ONC201 to treat midline gliomas having a histone 3 K27M (H3 K27M) mutation (Press release, Oncoceutics, JAN 14, 2019, View Source [SID1234558362]). This patent extends the ONC201 patent life through at least 2038.

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This patent is the eighth issued on ONC201 in the United States, and expands the IP protection the company has received covering the compound’s use in cancer. These patents, combined with issued patents around the compound’s formulation and use in combination with other therapies, as well as FDA regulatory designations, provide ONC201 with a robust suite of intellectual property.

ONC201, a member of the imipridone family, has demonstrated anti-cancer activity and safety in preclinical models and ongoing clinical trials, including multiple clinical trials in adult and pediatric patents harboring this mutation, funded by grants from the NCI. These trials are being carried out at Massachusetts General Hospital, Dana Farber Cancer Institute, NYU Langone, MD Anderson Cancer Center, Levine Cancer Institute, Miami Cancer Institute, UCSF, and the University of Michigan. Recently, the FDA granted Fast Track Designation to ONC201 for the Treatment of Adult Recurrent H3 K27M-mutant High-Grade Glioma.

"We are delighted that the USPTO has recognized these indications as novel uses of ONC201 and granted the appropriate patent protections," said Martin Stogniew, Ph.D., Chief Development Officer of Oncoceutics. "The company’s current patent portfolio provides Oncoceutics more than 19 years of patent protection for the vast majority of human cancers, including tumor types where ONC201 is currently in Phase II trials."

On January 14, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (Press release, BeiGene, JAN 14, 2019, View Source [SID1234532635]).

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"We are very excited to receive the Breakthrough Therapy designation from the FDA," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "Zanubrutinib has been designed to maximize BTK occupancy and minimize off-target effects. We believe that the Breakthrough Therapy designation underscores the potential of zanubrutinib as a meaningful treatment for patients with MCL who have received at least one prior therapy. More than 1,300 patients worldwide have been treated with zanubrutinib, and it’s being developed in a broad clinical program that currently includes seven Phase 3 or pivotal trials conducted globally or in China."

About Breakthrough Therapy Designation
The FDA’s Breakthrough Therapy designation program is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. According to the FDA’s guidelines, the features of the program include more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. The Food and Drug Administration Safety and Innovation Act (FDASIA) requires the following actions, as appropriate: holding meetings with the sponsor and the review team throughout the development of the drug, providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable; taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-disciplinary members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control, compliance) for coordinated internal interactions and communications with the sponsor through the review division’s regulatory health project manager; and involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review. The designation may be rescinded if the drug candidate does not continue to meet the criteria for Breakthrough Therapy designation.

About Mantle Cell Lymphoma
Lymphoma is a diverse group of malignancies that originates from B-, T- or NK- cells. Mantle cell lymphoma (MCL) is typically an aggressive form of non-Hodgkin lymphoma (NHL) that arises from B-cells originating in the "mantle zone." In the United States, about 70,800 new cases of NHL were expected in 2014, with MCL representing about six percent (about 4,200 cases) of all new cases of NHL in the United States. In 2013, the incidence of lymphoma was 4.2 per 100,000 and the mortality was 2.2 per 100,000 in mainland China, making it the eleventh most common cancer and the tenth leading cause of cancer death. MCL usually has a poor prognosis, with a median survival of three to four years, although occasionally patients may have an indolent course. Frequently, MCL is diagnosed at a later stage of disease.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, the currently only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.

Zanubrutinib has been granted Fast Track designation for the treatment of patients with WM and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy by the U.S. Food and Drug Administration (FDA). The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.