On December 3, 2020 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported five projects selected to receive funding for clinical and preclinical evaluation of abemaciclib (Press release, NCCN, DEC 3, 2020, View Source [SID1234572151]). Abemaciclib is a cyclin dependent kinase (CDK) 4 & 6 inhibitor used in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The proposals were reviewed and awarded by a scientific steering committee made up of experts from NCCN Member Institutions, and the NCCN ORP is handling project oversight. Research funding is being provided by a grant from Eli Lilly and Company.

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The selected projects are:

A Prospective, Multi-Center, Biomarker Driven Trial to Evaluate the Efficacy and Safety of Abemaciclib Monotherapy Beyond First Line CDK4/6 Inhibition in ER + Breast Cancer (AMBER)
Aditya Bardia, MD, MPH, Massachusetts General Hospital Cancer Center and Seth Wander, MD, PhD, Harvard Medical School
Refractory Hormone Receptor Positive Breast Cancer: A Role for Estrogen Receptor β
Mathew Cherian, MBBS, The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute
A Preclinical Study of Abemaciclib in Combination with Merestinib Against Breast Cancer Brain Metastasis *
Inan Olmez, MD, The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute
Inhibition of Aurora A Kinase Restores Sensitivity to CDK 4/6 Blockade of ER Positive Breast Cancers
Mateusz Opyrchal, MD, PhD, Washington University in St. Louis
PET Imaging of Cell Cycle Arrest for Predicting Response to Abemaciclib Alone or in Combination with Endocrine Therapy *
Chenbo Zeng, PhD, Abramson Cancer Center at the University of Pennsylvania
"Congratulations to all of these accomplished grantees," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "We are eager to learn more about which patients develop resistance to CDK 4 & 6 inhibitors, the potential underlying mechanisms, and ways in which such resistance can be overcome, in order to improve the application of this potentially life-prolonging therapy. This research is one of the many ways we work to improve longevity and quality-of-life for people with metastatic breast cancer."

"I have had a frontline view of how metastatic breast cancer can be unpredictable and complex," said Maura Dickler, MD, Vice President, Late Phase Development, Lilly Oncology. "Every day the lives of an estimated 115 women and men in the United States are lost as a result of this disease. Lilly is honored to support this research because it is critical in furthering our efforts to improve treatment options for people living with metastatic breast cancer."

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

* The preclinical studies by Drs. Olmez and Zeng have already begun. The remainder are expected to commence in mid-2021.

On December 3, 2020 enGene Inc., a biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to enGene for EG-70, the company’s lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, enGene, DEC 3, 2020, View Source [SID1234572150]).

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The Fast Track program is intended to facilitate the development and expedite the review of therapies that treat serious conditions and fill an unmet medical need. Therapeutic programs that receive Fast Track Designation can benefit from more frequent communication with the FDA, eligibility for Priority Review and Accelerated Approval, and potentially for Rolling Review of the marketing application.

"Fast Track Designation underscores the urgent need for new and effective treatments for BCG-unresponsive NMIBC patients," said Jason Hanson, Chief Executive Officer at enGene. "We are pleased with the FDA’s recognition of our EG-70 program with this designation and we look forward to working closely with the FDA throughout the clinical development process to bring this innovative treatment to patients as quickly as possible."

On December 3, 2020 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, reported that it will be participating in the Benzinga Global Small Cap Conference being held virtually on December 8 and 9, 2020 (Press release, Citius Pharmaceuticals, DEC 3, 2020, https://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-present-corporate-update-at-benzinga-global-small-cap-conference-on-december-8-301186114.html [SID1234572149]). Citius Chairman Leonard Mazur will present at 11:30 am ET on Tuesday, December 8, 2020, and will host one-on-one investor meetings.

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Advanced investor registration for the conference and virtual one-to-one meeting requests can be accessed here.

We are currently advancing four proprietary product candidates: Mino-Lok, CITI-002 (halobetasol-lidocaine formulation or Halo-Lido), CITI-101 (Mino-Wrap), and CITI-401 (iMSC). Mr. Mazur will discuss recent Company developments for these product candidates including:

Mino-Lok is advancing in its Phase 3 trial
A positive second interim analysis report from the independent Drug Monitoring Committee (DMC) for the Mino-Lok pivotal Phase 3 trial
The signing of an exclusive worldwide license agreement with Novellus Therapeutics, Limited for a cellular therapy to treat acute respiratory distress syndrome (ARDS), a leading complication of COVID-19; and the formation of our Novecite, Inc. subsidiary.
Submission of a pre-investigational new drug (PIND) consultation request for Mino-Wrap with written response and guidance is expected
Update on Halo-Lido which is anticipated to begin Phase 2b trial in the first quarter of 2021

On December 3, 2020 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community on Tuesday, Dec. 8, at 4:00 p.m. ET following the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Amgen, DEC 3, 2020, View Source [SID1234572148]). David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of the clinical development team, will participate to discuss our oncology and hematology programs with a focus on Amgen’s innovative BiTE platform including the first clinical data for AMG 701 and analyses from a BLINCYTO (blinatumomab) Phase 3 pediatric study.

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Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On December 3, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported a clinical update from the company’s ongoing dose-escalation Phase 1 study of STRO-002, a folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC), for patients with ovarian cancer (Press release, Sutro Biopharma, DEC 3, 2020, View Source [SID1234572147]).

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STRO-002-GM1 is a single-arm monotherapy dose-escalation study for patients with ovarian cancer not selected based on their FolRα-expression levels. The dose-escalation portion of the study was fully enrolled with 39 patients in August 2020. Patients were heavily pre-treated and had a median of 6 prior lines of therapy, including standard of care platinum-based regimens, bevacizumab, PARP inhibitors, and checkpoint inhibitors.

The dose-escalation study included 34 patients treated with clinically active dose levels, 2.9 mg/kg or higher, of which 31 patients had post-baseline scans and were evaluable for RECIST responses. At the data cutoff of October 30, 2020, median time on treatment was 19 weeks and 10 patients remained on treatment. Results out of 31 evaluable patients included:

10 patients met RECIST criteria for response. Of which, 1 patient achieved a complete response (CR) and 9 patients achieved a partial response (PR). Of the PRs, 3 were confirmed PRs (cPRs) and 6 unconfirmed PRs (uPRs)
23 patients (74%) achieved disease control at 12 weeks
18 patients (58%) achieved disease control at 16 weeks
4 patients (13%) were on treatment for 52 weeks. 3 patients remained on treatment beyond 64 weeks
STRO-002 continues to be well-tolerated and 86% of all treatment-emergent adverse events (AEs) were Grade 1 or 2. Of note, prophylactic corticosteroid eye drops have not been required and no ocular toxicity signals have been observed. The most common Grade 3 and 4 AEs were reversible neutropenia. Grade 3 arthralgia (15.4%) and neuropathy (7.7%) were observed and managed with standard medical treatment, including dose reductions or delays without evidence of compromised efficacy.

"We are encouraged to see meaningful clinical benefit from STRO-002 for patients with advanced platinum-resistant and refractory ovarian cancer. The women on the study are heavily pretreated and have limited treatment options as many have received experimental agents and participated in other clinical trials," said Dr. Lainie P. Martin, Leader of Gynecology/Oncology Program at Hospital of the University of Pennsylvania and an investigator on the STRO-002 study. "The deepening of responses in patients as well as disease control over time demonstrates STRO-002 to be an important potential treatment option for patients with ovarian cancer."

"We are seeing improved outcomes in disease control and RECIST responses as the data matures and will continue to follow the patients who remain on study for further deepening of responses or clinical benefit," said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. "The broad therapeutic index of STRO-002 should allow for long-term dosing and dose intensity. Although a maximum tolerated dose was not reached, we have identified dose levels of 4.3 and 5.2 mg/kg that we plan to randomize in the dose-expansion. We plan to dose the first patient January 2021 and will be treating less heavily pre-treated ovarian cancer patients. An expansion cohort for FolRα-selected endometrial cancer is planned for next year."

"We are rapidly moving forward with further development of STRO-002, the FolRα-targeted ADC program. Based on emerging IHC data from our dose-escalation, we have seen responses and stable disease at various FolRα-expression levels. For dose-expansion, we will be collecting required tissue samples at enrollment and using an established assay to determine if a FolRα-selection enrichment strategy is needed," said Bill Newell, Chief Executive Officer of Sutro Biopharma. "Additional data from the dose-expansion will inform regulatory discussions, accelerate registration strategy, and identify the broadest population that may benefit from STRO-002."

STRO-002 Virtual Event Information

The data will be presented and discussed by investigators from two STRO-002 clinical trial sites:

Lainie P. Martin, M.D. – Leader, Gynecology/Oncology Program and Associate Professor of Medicine at Hospital of the University of Pennsylvania; Dr. Martin is also a member of Sutro’s Clinical Advisory Board
R. Wendel Naumann, M.D. – Professor & Director of Gynecologic Oncology Research and Associate Medical Director of Clinical Trials at Levine Cancer Institute – Atrium Health in Charlotte, North Carolina; Dr. Naumann is also a member of Sutro’s Clinical Advisory Board
To access the live virtual event on Thursday, Dec. 3, at 2pm PT (5pm ET), please click here. An archived webcast of the event will be available on the Investor section of the company’s website at ir.sutrobio.com for approximately 30 days.

About the Phase 1 Trial of STRO-002 in Ovarian Cancer

STRO-002-GM1, the Phase 1 open-label, multicenter, dose escalation trial with dose expansion of STRO–002, has completed enrollment. Follow-up is ongoing and will continue to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian and primary peritoneal cancer. The trial is registered with clinicaltrials.gov identifier NCT03748186. Sutro discovered, developed and manufactures STRO-002 using its proprietary XpressCF cell-free protein synthesis and XpressCF+ site-specific conjugation technologies.