Revolution Medicines to Participate in 3rd Annual RAS-Targeted Drug Development Summit

On September 15, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted drugs to inhibit frontier targets that drive and sustain RAS-addicted cancers, reported that the company will participate in the upcoming 3rd Annual RAS-Targeted Drug Development Summit being held September 21-23, 2021 (Press release, Revolution Medicines, SEP 15, 2021, View Source [SID1234587745]). Steve Kelsey, M.D., president, research and development, will serve as chairperson for one of the conference’s scientific tracks and moderate a panel discussion during the virtual event. In addition, Jan Smith, Ph.D., senior vice president, biology and Bob Nichols, Ph.D., project lead for RMC-6291, the company’s development-stage KRASG12C(ON) inhibitor, will each deliver a scientific presentation as part of the conference.

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Details of Revolution Medicines’ participation in the 3rd Annual RAS-Targeted Drug Development Summit are as follows:

Presentations:

Title: Targeting KRASG12C(ON) & Potential Application to Overcoming Drug Resistance in RAS-Addicted Tumors
Presenter: Bob Nichols, Ph.D., project lead for RMC-6291
Date: Wednesday, September 22, 2021
Time: 11:55 a.m. Eastern

Title: Combination Strategies to Defeat RAS-Addicted Cancers
Presenter: Jan Smith, Ph.D., senior vice president, biology
Date: Wednesday, September 22, 2021
Time: 2:00 p.m. Eastern

Panel Discussion:

Title: On the Horizon – Discussing the Post-Approval Landscape for Successful RAS Drugs Beyond AMG510
Moderator: Steve Kelsey, M.D., president, research and development
Date: Thursday, September 23, 2021
Time: 4:15 p.m. Eastern

Scientific Track:

Title: Validating Robust Combination Strategies
Chairperson: Steve Kelsey, M.D., president, research and development
Date/Time: Wednesday, September 22, 2021; 11:30 a.m. – 5:00 p.m. Eastern
Thursday, September 23, 2021; 11:00 a.m. – 12:30 p.m. Eastern

Additional information on the Digital RAS-Targeted Drug Discovery Summit is available through the conference website at https://ras-drugdevelopment.com/

NuCana Announces Enrollment of Required Number of Patients to Conduct First Interim Analysis in the Phase III Biliary Tract Cancer Study

On September 15, 2021 NuCana plc (NASDAQ: NCNA) reported it has completed enrollment of the number of patients in the ongoing Phase III NuTide:121 study required to conduct the first interim analysis (Press release, Nucana BioPharmaceuticals, SEP 15, 2021, View Source [SID1234587744]). The study, which is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer, has enrolled 418 patients with measurable disease. The first interim analysis will be conducted after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022. NuCana believes that a statistically significant improvement in the Objective Response Rate (ORR) at the first interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. Recruitment in the NuTide:121 study, which is intended to enroll up to 828 patients, is ongoing and NuCana believes subsequent analyses could provide the confirmatory data to support full (regular) approval.

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"We are very pleased to achieve this important enrollment milestone which brings us closer to our goal of developing more effective and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Biliary tract cancer is a devastating disease and there is a significant need for more effective medicines. We are especially grateful to all of the patients, their families, the investigators and other health care professionals involved in the NuTide:121 study."

Mr. Griffith continued: "The primary objective of the first interim analysis is to demonstrate at least a 14% improvement in the ORR in the Acelarin plus cisplatin arm compared to the gemcitabine plus cisplatin arm. In the ABC-08 study of Acelarin plus cisplatin as a first-line treatment for patients with biliary tract cancer, an ORR of 44% was achieved among the evaluable population. This compared favorably to the ORR of 26% achieved among evaluable patients treated with gemcitabine plus cisplatin in the ABC-02 study, which established this regimen as the global standard of care. We look forward to announcing the outcome of this first interim analysis in the first half of 2022."

About NuTide:121

NuTide:121 is a global, multi-center, 1:1 randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. The primary endpoints of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR) and the FDA-approved protocol includes three interim analyses. Based on the statistical analysis plan, and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, accompanied by positive trends in other endpoints, has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in the United States. Under this scenario, the NuTide:121 study would continue and the Company believes it could use the data from subsequent analyses as the confirmatory data required to support full (regular) approval. There are currently no agents approved for the first-line treatment of patients with biliary tract cancer.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, are a group of cancers originating in the biliary tract. The biliary tract is comprised of the gallbladder and interconnecting ducts responsible for the transport of bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the first-line treatment of patients with advanced biliary tract cancer; however, the worldwide standard of care in these patients is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.

NeuBase to Present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

On September 15, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology platform company Drugging the Genome to address disease at the base level using a new class of precision genetic medicines, reported that Dietrich A. Stephan, Ph.D., Chief Executive Officer of NeuBase, will present a corporate overview at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit being held September 20 – 23 (Press release, NeuBase Therapeutics, SEP 15, 2021, View Source [SID1234587743]).

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

Date: Tuesday, September 21st
Time: 3:45 p.m. ET
Location: Webcast Link – or at the company’s website (click here)

Mannkind Corporation Participating at Upcoming Conferences

On September 15, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that it will be participating at upcoming conferences (Press release, Mannkind, SEP 15, 2021, View Source [SID1234587742]). Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD.

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit – Wednesday, September 22, 2021 at 2:55 pm – 3:35 pm (ET)
2021 Cantor Global Virtual Healthcare Conference – Monday, September 27, 2021 at 11:20 am – 11:50 am (ET)
Interested parties can access a link to the live webcast of the presentations from the Events & Presentations section of the Company’s website at View Source The webcast replay may be accessed at the same location for 14 days following the live presentation.

Lexicon Pharmaceuticals to Present at the Oppenheimer Fall Healthcare Life Sciences & Medtech Summit

On September 15, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported that Lonnel Coats, Lexicon’s president and chief executive officer, will present virtually at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Tuesday, September 21, 2021 at 10:45 a.m. ET (Press release, Lexicon Pharmaceuticals, SEP 15, 2021, View Source [SID1234587741]).

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A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.