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Rain Therapeutics Announces Exclusive License to the Clinical-Stage MDM2 Inhibitor, DS-3032 (Milademetan) from Daiichi Sankyo

On September 2, 2020 Rain Therapeutics Inc. ("Rain"), a privately-held, clinical stage biotechnology company focused on targeted therapies for patients with cancer, reported it has licensed worldwide rights to a clinical stage, small molecule, oral MDM2 inhibitor, DS-3032 (milademetan) from Daiichi Sankyo Company, Limited (Press release, Rain Therapeutics, SEP 2, 2020, https://www.rainthera.com/rain-therapeutics-announces-exclusive-license-to-the-clinical-stage-mdm2-inhibitor-ds-3032-milademetan-from-daiichi-sankyo/ [SID1234564281]). Rain will re-designate the program as RAIN-32 .

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RAIN-32 is a potent and selective MDM2 inhibitor that has been evaluated in clinical trials for solid tumors and hematologic malignancies. The profile and dosing schedule of RAIN-32 may lend a differentiated tolerability profile, enabling longer-term therapy as compared to other MDM2 programs in development.

"We’re excited to add RAIN-32, a clinical program with the potential to significantly impact cancers characterized by MDM2 amplification or overexpression, to Rain’s pipeline of targeted cancer therapies," said Avanish Vellanki, cofounder and chief executive officer of Rain Therapeutics. "Daiichi Sankyo has done extensive work that we intend to build upon as we implement a biomarker-driven strategy to complete RAIN-32’s development."

MDM2 has emerged as a potentially valuable target for cancer therapies due to its inhibitory effects on p53, a critical tumor suppressor. Rain intends to evaluate RAIN-32 in multiple indications where patients demonstrate MDM2 gene amplification or overexpression, with an initial focus on liposarcoma, where two-thirds of patients display MDM2 amplification.

Robert Doebele, MD, PhD, cofounder of Rain Therapeutics, added, "We hope to pursue a rapid registrational path for RAIN-32 in a challenging tumor type that lacks effective therapies, and look forward to rationally developing RAIN-32 for additional oncology indications where MDM2 activity plays a central role."

Rain anticipates the presentation of clinical data from the ongoing Daiichi Sankyo clinical trial in patients with advanced solid tumors at an upcoming medical conference.

Rain has licensed global rights for all indications of RAIN-32. Deal terms from the license agreement were not disclosed.

About RAIN-32
RAIN-32 has been evaluated in patients with various solid tumors, acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). RAIN-32 also has been evaluated in continuous and intermittent dose schedules that may offer a differentiated tolerability profile as compared to other MDM2 programs.

Two clinical studies for RAIN-32 are ongoing, including a study evaluating the safety and efficacy of RAIN-32 in patients with liposarcoma and in patients with FLT3-ITD AML treated with RAIN-32 and the FLT3 inhibitor, quizartinib. In addition, multiple investigator sponsored studies are being conducted by MD Anderson Cancer Center (MDACC) as well as National Cancer Center Hospital (NCCH) in Tokyo, Japan.

Intellia Therapeutics to Present at Baird’s 2020 Virtual Global Healthcare Conference

On September 2, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo,reported that it will present at Baird’s 2020 Virtual Global Healthcare Conference on Wednesday, September 9, 2020 at 10:50 a.m. ET (Press release, Intellia Therapeutics, SEP 2, 2020, View Source [SID1234564280]).

A live webcast of Intellia’s presentation will be accessible through the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com. To access the webcast, please log on approximately 15 minutes prior to the start time, to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Intellia’s website for approximately 14 days following the live event.

MEI Pharma to Release 2020 Fiscal Year End Financial Results and Provide Corporate Update on September 9, 2020

On September 2, 2020 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that the Company will release its 2020 fiscal year end financial results after the close of the U.S. financial markets on September 9, 2020 (Press release, MEI Pharma, SEP 2, 2020, View Source [SID1234564279]). The Company will host a conference call and live webcast with the investment community to provide a corporate overview and update the same day at 5:00 p.m. ET.

Conference Call & Webcast Information
When: September 9, 2020, 5:00 p.m. ET
Dial-in: (866) 939-3921 (United States) or (678) 302-3550 (International)
Conference ID: 49919899

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived under for at least 30 days after the call.

CytomX Therapeutics to Participate in Upcoming Healthcare Conferences

On September 2, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that Sean McCarthy, D.Phil., president, chief executive officer, and chairman, will participate in the following virtual healthcare conferences in September (Press release, CytomX Therapeutics, SEP 2, 2020, View Source [SID1234564278]).

Citi’s 15th Annual BioPharma Virtual Conference

Date: Thursday, September 10, 2020

H.C. Wainwright 22nd Annual Global Investment Conference

Date: Tuesday, September 15, 2020

Time: 12:00 p.m. ET

A live audio webcast of the H.C. Wainwright presentation will be available through the Events and Presentations page of CytomX’s website at www.CytomX.com. An archived replay will be available for 90 days following the event.

Final analysis of the observational GioTag study: Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer

On September 2, 2020 Boehringer Ingelheim reported the final analysis from GioTag, a real-world retrospective, observational study (Press release, Boehringer Ingelheim, SEP 2, 2020, View Source [SID1234564277]). The study assessed the impact of first-line treatment with afatinib followed by osimertinib in Del19/L858R epidermal growth factor receptor mutation positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations, the most common mechanism of resistance to first-and second-generation EGFR tyrosine kinase inhibitors (TKIs). Results showed that across the 203 patients included in the analysis, sequential treatment of afatinib followed by osimertinib provided a median overall survival (OS) of 37.6 months (90% confidence interval (CI): 35.5–41.3) and median Time to Treatment Failure (TTF, combined treatment duration on sequential TKIs) of 27.7 months (90% CI: 26.7–29.9).i

Results showed that Asian and Del19-positive patients saw a median OS of 44.8 months (90% CI: 37.0–57.8) and 41.6 months (90% CI: 36.9–45.0) respectively. Median TTF was 37.1 months (90% CI: 28.1–40.3) and 30.0 months (90% CI: 27.6–31.9) for these groups, respectively.i In the 31 Asian patients with Del19-positive disease, median OS was 45.7 months (90% CI: 38.2–57.8) and TTF was 40.0 months (90% CI: 36.4–45.0).i The TTF observed here suggests that the GioTag treatment strategy could potentially allow these particular patient sub-groups to receive additional long-term, chemotherapy-free treatment.

Clinical effectiveness was also consistent across patient subgroups which are sometimes excluded from or under-represented in randomized clinical trials. For these subgroups, median OS was 31 months (90% CI: 19.5–45.0) in patients with stable brain metastases, 36.9 months (90% CI: 33.0–44.8) in patients aged ≥65 years, and 32 months (90% CI: 24.5–34.5) in those with ECOG PS ≥2.i TTF for these groups was 22.2 months (90% CI: 16.8–29.9), 27.3 months (90% CI: 20.4-31.3) and 22.2 months (90% CI: 16.0–26.5), respectively.i

Dr. Maximilian J. Hochmair, Medical Oncologist, Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute and coordinating investigator of the GioTag study said, "The real-world data reported here represent the most mature analysis of OS with sequential afatinib and osimertinib to date. The final GioTag results support the results of our previous analyses, that sequential afatinib and osimertinib treatment could be a feasible and effective therapeutic strategy in a broad, real-world population of patients with EGFR M+ NSCLC who acquire T790M."

Dr. Victoria Zazulina, Corporate Vice President and Global Head of Oncology, Medicine, at Boehringer Ingelheim said, "Treatment options beyond progression on the first-line targeted therapy are a key consideration towards extending a chemotherapy-free time for patients with EGFR mutation positive NSCLC. With this aim, the final GioTag data supports the use of sequential treatment with afatinib followed by osimertinib, particularly for Asian group and patients with DEL19 subtype of EGFR mutation."

About GioTag
GioTag was a real-world retrospective, observational study which assessed the impact of first-line treatment with afatinib followed by osimertinib in Del19/L858R EGFR M+ non-small cell lung cancer patients with acquired T790M mutations, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs). The study was conducted across ten countries: Austria, Canada, Israel, Italy, Japan, Singapore, Slovenia, Spain, Taiwan and USA; NCT03370770. Data were collected between December 2017 and December 2019. Inclusion was restricted to patients who initiated osimertinib treatment ≥10 months prior to enrolment to avoid early censoring and ensure mature data. A maximum of 15 patients were enrolled per site. Data were sourced either from sites directly approached by Boehringer Ingelheim (n = 77; 38%) or from electronic health records (n = 126; 62%) supplied by Cardinal Health (OH, USA). For quality assurance of the documented patient observations, source data verification was performed on approximately 30% of included patients. Main limitations of this study were its retrospective nature and potential for selection bias. The other main limitation of the study was a lack of a comparator arm, which limits interpretation of the results.

Boehringer Ingelheim in Oncology
Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope, by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.