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.

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.

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.

Be The Match BioTherapies® Announces Strategic Collaboration with Kiadis Pharma to Accelerate Patient Access to Haploidentical Stem Cell Therapies

On May 22, 2019 Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, and Kiadis Pharma N.V. ("Kiadis") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, reported a strategic collaboration to support clinical evaluation of an innovative cell therapy product with potential to make haploidentical hematopoietic stem cell transplantations (HSCT) safer and more effective for patients (Press release, Be The Match BioTherapies, MAY 22, 2019, View Source [SID1234536533]).

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Under the terms of the collaboration agreement, Be The Match BioTherapies will provide logistical and technological solutions to support Kiadis’ Phase III clinical trial for ATIR101, an adjunctive immunotherapeutic designed to address key risks and limitations of HSCT in the treatment of blood cancers.

Kiadis’ multinational Phase III clinical trial is evaluating the safety and efficacy of ATIR101 as an adjunctive treatment to HSCT from a half-matched (haploidentical) family donor compared to post-transplant cyclophosphamide (PTCy or "Baltimore" protocol) in adult patients with blood cancers. The Phase III study is currently enrolling patients in the EU, Canada, Israel and the U.S.

The collaboration will leverage Be The Match BioTherapies’ industry-leading expertise in cell delivery logistics and supply chain case management, including the company’s MatchSource end-to-end supply chain management software, to manage the transport and processing of cellular products for use at Kiadis’ clinical trial sites in the U.S. and Canada.

"Kiadis’ quest to provide better treatment outcomes for patients receiving stem cell transplants is one we deeply share, given the foundational role that our parent company, the National Marrow Donor Program/Be The Match, has played in improving stem cell transplantation for more than three decades," said Chris McClain, vice president of Sales and New Business Development, Be The Match BioTherapies. "We look forward to utilizing our cell therapy expertise to advance Kiadis’ important work."

"We’re pleased to partner with Be The Match BioTherapies to progress our clinical investigation of ATIR101 and to expedite its availability to patients," said Andrew Sandler, chief medical officer of Kiadis Pharma. "We believe this therapeutic approach could allow family members to serve as stem cell donors for those patients who would otherwise not find a matching donor in time, ultimately saving lives."

Merck Foundation Announces Grant to American Cancer Society to Improve Access to Cancer Care in Resource-Limited Settings

On May 22, 2019 The Merck Foundation (the Foundation) and the American Cancer Society (ACS) reported that the Foundation awarded a $1.99 million, five-year grant to ACS to improve support and access to care for people living with cancer in low-and-middle-income countries, particularly in sub-Saharan Africa (Press release, Merck & Co, MAY 22, 2019, View Source [SID1234536532]). This funding will help ACS further develop its capacity development approach to expanding patient navigation to countries with a growing burden of cancer.

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More than 70% of the 9 million cancer-related deaths worldwide are in resource-limited settings, where patients face many barriers in seeking a timely diagnosis and receiving high-quality cancer care. Patient navigators—whether nurses providing cancer education or lay health workers linking patients to transportation services in the community—play a vital role in supporting patients from the point of diagnosis at a health facility through their treatment journey.

With support from the Foundation, ACS will fortify its patient navigation program in Kenyatta National Hospital (KNH), a national referral hospital in Kenya, and adapt it for a high need facility in Uganda – The Uganda Cancer Institute (UCI), which serves about 200 patients daily.

"We are excited about the American Cancer Society’s program to bring patient navigation services to cancer patients in areas of the world where care coordination is especially challenging" says Dr. Julie Louise Gerberding, chief patient officer, Merck and vice chair, Merck Foundation Board of Trustees. "Cancer patients deserve quality care delivered with compassion, regardless of where they live."

This grant is a first step toward broad expansion of patient navigation programs to help more patients in resource-limited settings receive timely, high-quality cancer care. As part of this effort, ACS will develop a comprehensive guide and toolkit to develop and implement patient navigation programs, designed specifically for health facilities in low- and middle-income countries. Lessons learned from collaborating with hospitals in Kenya and Uganda will be incorporated into this guide, which ACS will pilot in health institutions in Asia and Latin America.

ACS hopes to demonstrate that resource-limited health care institutions can use patient navigation as an effective tool to improve cancer care. Looking ahead, ACS will help KNH and UCI integrate patient navigation services into the way they deliver cancer care, with the goal of transforming the patient experience so patients continue to receive the timely, high-quality cancer care they need.

"Over the last 30 years, patient navigation has become a standard of care across the U.S. to address the myriad hurdles that cancer patients – especially the most vulnerable – confront across the complicated continuum of cancer care," says Sally Cowal, senior vice president of Global Cancer Control, American Cancer Society. "We are eager to bring our expertise in this area to countries where health system challenges prevent patients from getting timely diagnoses and treatment."

"Uganda has a population of 43 million, but there are only 20 oncologists in the entire country. That’s one of the reasons why patient navigators are so important in helping patients manage the day-to-day challenges that prevent them from receiving care and empowering them to seek treatment and stay in care," says Dr. Jackson Orem, Executive Director of the Uganda Cancer Institute.

ACS will work with the Rollins School of Public Health at Emory University in Atlanta to evaluate the implementation of the patient navigation programs in Kenya and Uganda as well as the pilot of the program design guide and implementation toolkit. The evaluation team will disseminate its findings to the global cancer community and other interested stakeholders to advance the field’s knowledge of how to effectively support cancer patients in resource-limited settings.