Ascentage Pharma to Present New Data at 2019 ASCO Annual Meeting from Clinical Trials of MDM2-p53 Antagonist and IAP Inhibitor in Cancers

On May 22, 2019 Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, reported the presentation of new clinical data for its investigational apoptosis-targeted drug candidates at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago from May 31-June 4 (Press release, Ascentage Pharma, MAY 22, 2019, View Source [SID1234536534]).

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"We are excited to present the progress of our three clinical studies," said Yifan Zhai, M.D., Ph.D., Chief Medical Officer of Ascentage Pharma, "These presentations demonstrate Ascentage’s capabilities of moving multiple new drug candidates into clinical development across multiple cancer patient populations. Through breakthrough science and agile development, we are striving to deliver novel medicines of differentiated profiles to benefit patients. "

Three abstracts will be presented at 2019 ASCO (Free ASCO Whitepaper) including:

A Phase I Study of a Novel MDM2-P53 Antagonist APG-115 in Chinese Patients with Advanced Soft Tissue Sarcomas
Session Date and Time: Saturday, June 1 at 8:00am – 11:00am CDT
Poster Board: #116

Preliminary data suggested that APG-115 had promising anti-tumor activity in treatment of patients with MDM2-amplification and TP53-WT liposarcoma. Safety profile and PD effect were consistent with other MDM2 inhibitors. Dosing regimen optimization are ongoing.

A Phase I Study of a Novel MDM2 Antagonist APG-115 in Patients with Advanced Solid Tumors
Session Date and Time: Saturday, June 1 at 8:00am – 11:00am CDT
Poster Board: #118

APG-115 was well tolerated and had manageable adverse events. The MTD / RP2D of APG-115 monotherapy with oral administration, QOD for 21 days of a 28-day cycle for treatment of patients with advanced solid tumors was determined as 100 mg. Further evaluation of APG-115 in combination with pembrolizumab in patients with advanced solid tumors is ongoing.

A Phase I Study of a Novel IAP Inhibitor APG-1387 as a Monotherapy or in Combination with Pembrolizumab in Treatments of Patients with Advanced Solid Tumors
Session Date and Time: Saturday, June 1 at 8:00am – 11:00am CDT
Poster Board: #117

APG-1387 was well tolerated and had manageable adverse events. The potential effects of APG-1387 alone or in combination with pembrolizumab deserve further exploration in patients with advanced solid tumors, especially in the mPC (metastatic pancreatic cancer) patients.

About APG-115

APG-115 is an orally administered, selective, small molecule inhibitor of the MDM2-p53 PPI. APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. APG-115 is currently in Phase I clinical trials in China and the United States in patients with ACC (Adenoid cystic carcinoma ) and other sarcomas. APG-115 is in Phase Ib/II combination study with pembrolizumab in the U.S.

About APG-1387
APG-1387 is a novel small molecule IAP inhibitor (Inhibitor of Apoptosis Protein). Ascentage is developing APG-1387 globally, and has completed dose escalation Phase I clinical trials in advanced solid tumors in China and Australia, and a Phase I clinical trial of APG-1387 and pembrolizumab combination is currently ongoing in the U.S. APG-1387 is also being investigated for the treatment of patients with chronic hepatitis B virus in China.

DiaMedica Therapeutics to Present at the 16th Annual Craig-Hallum Institutional Investor Conference on May 29, 2019

On May 22, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that it will be participating in the 16th Annual Craig-Hallum Institutional Investor Conference on Wednesday, May 29, 2019, at the Depot Renaissance Minneapolis Hotel in Minneapolis, MN (Press release, DiaMedica, MAY 22, 2019, View Source [SID1234536518]). Management will be available to participate in one-on-one meetings with investors and attendees can contact their Craig-Hallum representative to arrange a meeting.

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Medicure Q1 2019 Results and Conference Call Dates

On May 22, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, reported that it will release financial results for the quarter ended March 31, 2019 on Monday, May 27, 2019 (Press release, Medicure, MAY 22, 2019, View Source [SID1234536535]). The first quarter financial statements will be made available on the Company’s website at www.medicure.com. Medicure will hold a conference call and webcast regarding the results on Tuesday, May 28, 2019 at 7:30 AM Central Time (8:30 AM Eastern Time).

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Conference Call Info:

Topic: Medicure’s Q1 2019 Results

Call date: Tuesday, May 28, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 6562291#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

GamaMabs Pharma to present updated results at 2019 ASCO Annual Meeting from the First-In-Human clinical study of murlentamab in advanced gynecological cancers

On May 22, 2019 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported the upcoming presentation of clinical data from the First-In-Human C101 phase Ia/Ib study of murlentamab (GM102), during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, on June 1, in Chicago, USA (Press release, GamaMabs Pharma, MAY 22, 2019, View Source [SID1234536519]).

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In this study, 68 heavily pre-treated patients with advanced or recurrent AMHRII-positive epithelial ovarian (EOC), granulosa cell tumor (GCT), cervical and endometrial cancers, received murlentamab as a single agent (n=59) or in combination with carboplatin and paclitaxel (n=9).

No dose limiting toxicity was reported at all doses and schedules tested, as a single agent and in combination with chemotherapy. One partial response with murlentamab single agent (RECIST 1.1) was observed in a patient with GCT. In combination with chemotherapy, 4 of 9 patients (44%) responded to treatment (1 complete and 3 partial responses). Among patients treated ≥ 6 months, 6 of 9 (67%) GCT patients with murlentamab single agent and 4 of 5 (80%) patients in combination (2 cervical and 2 endometrial cancers) had a longer Progression-Free Survival than under their previous systemic treatment (mean improvement of 3.9 and 2.1 months respectively). Blood samples from 25 patients treated with murlentamab single agent showed an increase in classical monocytes, as well as T cell and neutrophil activation.

"These updated data for these heavily pre-treated patients are really encouraging," said Pr. Alexandra Leary, Gustave Roussy Institute (France), principal investigator of the study. "We are very satisfied, especially regarding the combination with chemotherapy that supports the development of murlentamab in all gynecological cancers. This is crucial for patients with cervical cancers who have so few options. The excellent safety of the drug will allow testing combinations of murlentamab with all standard and experimental treatments."

"Murlentamab seems to rewire the tumor microenvironment and reinitiate the immunological antitumoral cascade from macrophage to cytotoxic T lymphocyte activation. It opens the field to a number of indications and combinations for murlentamab, given the AMHRII re-expression found in many solid tumors," said Dr. Isabelle Tabah-Fisch, Chief Medical Officer at GamaMabs Pharma. "In addition to these gynecological data, the first results of murlentamab in advanced colorectal cancers will be presented at the upcoming 21st ESMO (Free ESMO Whitepaper) World Congress on GI Cancers."

Murlentamab is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor involved in the regression of the Müllerian ducts in the male embryo, is constitutively expressed in ovarian granulosa cell tumors (GCT) and is re-expressed in a majority of gynecological cancers and a variety of non-gynecological cancers. Murlentamab is currently being evaluated in two clinical trials, phase 1b in gynecological cancers and phase 2 in advanced or metastatic colorectal cancers. Murlentamab exerts its anti-tumor activity through tumor-associated macrophages reprogramming, resulting in enhanced tumor phagocytosis and subsequent cytotoxic T cell reactivation.

Results will be presented at the 2019 ASCO (Free ASCO Whitepaper) Annual meeting in Chicago, during the Developmental Immunotherapy and Tumor Immunobiology session to be held on Saturday June 1, 8:00 AM-11:00 AM (Hall A) and during the poster discussion session at 1:15 PM – 2:45 PM (Hall D).

Abstract # 2521; ‘First-in-human phase I trial of murlentamab, an anti-Mullerian-hormone receptor II (AMHRII) monoclonal antibody acting through tumor-associated macrophage (TAM) engagement, as single agent and in combination with carboplatin (C) and paclitaxel’ by A Leary and co-authors.

IDEAYA Announces Pricing of Initial Public Offering

On May 22, 2019 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported the pricing of its initial public offering of 5,000,000 shares of common stock at a public offering price of $10.00 per share, before underwriting discounts and commissions (Press release, Ideaya Biosciences, MAY 22, 2019, View Source [SID1234536536]). All of the shares of common stock are being offered by IDEAYA. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. IDEAYA’s common stock is expected to begin trading on the Nasdaq Global Market on May 23, 2019, under the ticker symbol "IDYA". The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be $50.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on May 28, 2019, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Citigroup and Jefferies acted as joint book-running managers for the offering.

A registration statement relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on May 22, 2019. The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected].

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