STAND UP TO CANCER® ANNOUNCES NEW RESEARCH AND EDUCATION EFFORT FOCUSED ON IMPROVING HEALTH EQUITY FOR UNDERSERVED LUNG CANCER PATIENTS

On July 16, 2020 Stand Up To Cancer reported a new $5 million grant from Bristol Myers Squibb to fund research and education efforts aimed at achieving health equity for underserved lung cancer patients, including Black people and people living in rural communities (Press release, SU2C, JUL 16, 2020, View Source [SID1234562023]). Despite recent progress in treating lung cancer, the disease remains the leading cause of cancer death in the U.S. with particularly high death rates in rural communities and among Black men.

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The research efforts funded by the three-year grant will consist of supplemental grants to current Stand Up To Cancer research teams. The supplemental grants will focus on identifying new and innovative diagnostic and treatment methods for lung cancer patients in need. These supplemental grants will be designed to jumpstart pilot projects at the intersection of lung cancers, health disparities and rural healthcare, for instance increasing clinical trial enrollment among historically under-represented groups.

In early 2021, a Stand Up To Cancer Innovation Summit will launch the project, bringing together lung cancer experts with researchers specializing in health equity and access. The competitive grant application and selection process for proposed projects will be overseen by Stand Up To Cancer’s Scientific Advisory Committee.

"Stand Up To Cancer’s portfolio already includes 17 team science projects in lung cancer, and 24 lung cancer clinical trials have been funded to date," said Nobel Laureate Phillip A. Sharp, PhD, chair of the SU2C Scientific Advisory Committee, and Institute professor, David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology. "With this comprehensive lung cancer network and the dedication to diversifying cancer clinical trials, Stand Up To Cancer will leverage the Bristol Myers Squibb grant to reach lung cancer patients who have historically been marginalized by our health care system."

"Despite the remarkable recent progress in the diagnosis and treatment of cancer, the disparities in care experienced by underserved patient populations are persistent and acute," said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb. "As a company focused on transforming patients’ lives through science, we are dedicated to improving health outcomes for all patients. Our support of Stand Up to Cancer’s work to address the burden of lung cancer among diverse and rural communities is another extension of our long-standing commitment to ensuring that every patient has access to quality care."

Since 2014, Bristol Myers Squibb has provided funding for important Stand Up To Cancer research initiatives. Bristol Myers Squibb was the inaugural donor for SU2C Catalyst, supporting research and clinical trials targeting a wide range of cancers, including non-small cell lung cancer, metastatic melanoma, smoldering multiple myeloma, pediatric hypermutant cancers, pediatric brain tumors and pediatric neuroblastoma. Funding has also supported Convergence Grants, which harness computational science to understand fundamental cancer biology, Innovative Research Grants focused on immuno-oncology, as well as Dream Teams focused on lung cancer.

Stand Up To Cancer’s Health Equity Initiative formalizes requirements that will apply to all future teams seeking Stand Up To Cancer funding. The requirements include addressing recruitment and retention of patients from different ethnic groups and underserved communities to improve diverse participation in cancer clinical trials. To improve cancer clinical trial education, outreach and recruitment in underserved communities, Stand Up To Cancer is collaborating with advocacy and community-based organizations such as the Black Women’s Health Imperative and Friends of Cancer Research.

Bristol Myers Squibb has long been committed to promoting heath equity and continues to forge collaborations and invest in programs to increase the reach of medical innovation to diverse and heavily burdened populations. An important example of the company’s commitment in this area is the work of the Bristol Myers Squibb Foundation, which for more than 20 years has launched initiatives around the world to improve the health outcomes of those disproportionately affected by serious diseases. This includes initiatives focused on underserved populations in the Southeast United States where the lung cancer burden is the highest, with a tailored focus on innovative models of prevention, detection, and education while helping people with lung cancer access and navigate cancer care and support services. From 2014-2019, the Bristol Myers Squibb Foundation committed $35 million to expand the scope of community-based resources and cancer survivorship support programs to underserved populations in the U.S.

IDEAYA Announces IDE196 Program Update and Clinical Protocol Criteria Met for Cohort Expansion in Skin Melanoma for Phase 2 GNAQ/11 Basket Trial

On July 16, 2020 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, repored that it has met the clinical protocol criteria for cohort expansion in the cutaneous (skin) melanoma cohort of its Phase 2 basket arm evaluating IDE196 monotherapy in solid tumors harboring GNAQ or GNA11 hotspot mutations (GNAQ/11) (Press release, Ideaya Biosciences, JUL 16, 2020, https://www.prnewswire.com/news-releases/ideaya-announces-ide196-program-update-and-clinical-protocol-criteria-met-for-cohort-expansion-in-skin-melanoma-for-phase-2-gnaq11-basket-trial-301094514.html [SID1234561989]).

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IDEAYA has enrolled 4 evaluable and 1 non-evaluable skin melanoma patients harboring GNAQ/11 mutations in an initial Stage 1 cohort of the study design. Pursuant to the protocol, if no RECIST (Response Evaluation Criteria in Solid Tumors) responses are observed in the targeted 9 patients of Stage 1 cohort, no additional expansion patients are to be enrolled in that cohort; otherwise, a second Stage 2 of enrollment comprising of 15 additional patients may be enrolled for a total of 24 patients. The 1 confirmed partial response in a GNAQ/11 mutation skin melanoma patient was determined by RECIST guidelines (version 1.1).

"I am pleased IDE196 has met the criteria for Stage 2 expansion in skin melanoma, as these patients with GNAQ/11 mutations may not have actionable BRAF driver mutations and may also have a low tumor mutational burden, and thus be less responsive to existing treatment options," said Marlana Orloff, M.D., Assistant Professor at Thomas Jefferson University Hospital in Philadelphia, who is a Principal Investigator on the IDEAYA clinical trial.

IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results. Covid-19 infection rates have increased over the last weeks in several states in which our enrollment sites are located.

Based on the increased target enrollment and potential impact of the Covid-19 pandemic, further IDE196 monotherapy interim data is anticipated to be in the first half of 2021.

"IDE196 expansion in skin melanoma enables IDEAYA to build a larger data set and to explore potential combinations in this tumor type, and further validates our GNAQ/11 tissue-agnostic approach," said Mick O’Quigley, Vice President, Head of Development Operations at IDEAYA Biosciences.

Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Malaysia for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer

On July 16, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX (neratinib) in Malaysia from the Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH) (Press release, Puma Biotechnology, JUL 16, 2020, View Source [SID1234561988]). NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.

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STA Chief Executive Officer Carlo Montagner said, "This approval in Malaysia represents the fifth STA approval of NERLYNX for commercialization, after approvals in Australia, New Zealand, Singapore and Brunei. These approvals, along with pending regulatory submissions in the Philippines and other Southeast Asian regions, will extend the reach of this medicine to patients who were previously underserved."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "The commercial strategy implemented by Specialized Therapeutics in Australia and the successful market entry into additional countries throughout Southeast Asia support our commitment to expanding access to NERLYNX to breast cancer patients around the world. Addressing recurrence in HER2-positive breast cancer patients remains paramount for Puma and our global partners."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

Illumina to Announce Second Quarter 2020 Financial Results on Thursday, August 6, 2020

On July 16, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for the second quarter 2020 following the close of market on Thursday, August 6, 2020 (Press release, Illumina, JUL 16, 2020, View Source [SID1234561987]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time), Francis deSouza, President and Chief Executive Officer, and Sam Samad, Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, August 6, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both with Conference ID 4194447. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

ImmunoGen Announces Conference Call to Discuss Its Second Quarter 2020 Operating Results

On July 16, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, July 31, 2020 to discuss its second quarter operating results (Press release, ImmunoGen, JUL 16, 2020, View Source [SID1234561986]). Management will also provide a brief update on the business.

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Conference Call Information

To access the live call by phone, dial (877) 621-5803; the conference ID is 4388395. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.