On October 10, 2023 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, which is taking place virtually and in-person in Madrid, Spain from October 20 to 24 (Press release, Eisai, OCT 10, 2023, View Source [SID1234635806]).

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Notable presentations include a post-hoc analysis of tumor response by baseline characteristics of the metastases from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA), anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (NCT02811861(New Window); Presentation: #1903P). An exploratory analysis from the pivotal Phase 3 Study 309/KEYNOTE-775 trial of outcomes for patients with advanced endometrial cancer who completed treatment with pembrolizumab and continued with lenvatinib will also be presented (NCT03517449(New Window); Presentation: #748P).

"As a research and development-focused company driven by our hhc (human health care) concept, we strive to make a difference in the lives of patients and their families by advancing the science of cancer medicine with our robust portfolio and pipeline," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "At this year’s ESMO (Free ESMO Whitepaper) meeting, analyses from the pivotal Phase 3 CLEAR and Study 309/KEYNOTE-775 trials may provide greater insights into the treatment of patients with advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. We also look forward to sharing data for lenvatinib and from our pipeline, as well as engaging in critical scientific exchange with the community in service of moving oncology research forward."

Additional data from the LEAP (LEnvatinib And Pembrolizumab) clinical program to be presented include safety-run-in results from the Phase 3 LEAP-014 trial evaluating lenvatinib plus pembrolizumab and chemotherapy as a treatment option for patients with metastatic esophageal squamous cell carcinoma (NCT04949256(New Window); Presentation: #1534P). A network meta-analysis of lenvatinib versus key comparators as first-line treatment for patients with unresectable hepatocellular carcinoma will also be presented during a poster session (Presentation: #1007P).

Research from Eisai’s pipeline will be featured in a poster presentation of findings from the dose-expansion portion of a Phase 1 study evaluating E7389-LF, a liposomal formulation of eribulin, as a potential first-line chemotherapy treatment option for patients with metastatic/advanced HER2-negative breast cancer (Presentation: #405P). Additionally, insights from preclinical research on farletuzumab ecteribulin (FZEC, formerly known as MORAb-202), a folate receptor alpha (FRα)-targeting antibody drug conjugate (ADC), in endometrial cancer will be presented (Presentation: #786P).

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of presentations is included below. These abstracts will be made available via the ESMO (Free ESMO Whitepaper) website on Monday, October 16, 2023, at 12:05 AM CEST.

Cancer Type Study/
Compound Abstract Title Abstract Type & Details
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer CLEAR Tumor response by baseline metastases in patients with renal cell carcinoma treated with lenvatinib plus pembrolizumab vs sunitinib: post hoc analysis of the CLEAR trial
Poster Session
Presentation #1903P
October 23, 2023
9:00 AM-5:00 PM CEST

Gynecologic Cancer
Study 309/

KEYNOTE-775 Outcomes for patients with advanced endometrial cancer who completed pembrolizumab and continued lenvatinib in the phase 3 Study 309/KEYNOTE-775
Poster Session
Presentation #748P
October 22, 2023
9:00 AM-5:00 PM CEST

Gastrointestinal Cancer LEAP-014 First-line lenvatinib plus pembrolizumab and chemotherapy for metastatic esophageal squamous cell carcinoma: safety run-in results from the phase 3 LEAP-014 study
Poster Session
Presentation #1534P
October 23, 2023

9:00 AM-5:00 PM CEST
Lenvatinib
Gastrointestinal Cancer Network Meta-Analysis
Network meta-analysis of lenvatinib vs key comparators in first-line unresectable hepatocellular carcinoma

Poster Session
Presentation #1007P
October 23, 2023
9:00 AM-5:00 PM CEST

Real-World Evidence_

Liver Cancer Safety and efficacy of lenvatinib in patients with unresectable hepatocellular carcinoma in real-world practice in Korea
Poster Session
Presentation #987P
October 23, 2023
9:00 AM-5:00 PM CEST

Eribulin
Breast Cancer Eribulin
Health outcomes of treatment sequences with eribulin or other single agents’ chemotherapy for treating relapsed metastatic HER2-negative breast cance

Poster Session
Presentation #462P
October 21, 2023
9:00 AM-5:00 PM CEST

Pipeline
Breast Cancer E7389-LF E7389-LF as a first-line chemotherapy for patients with metastatic/advanced HER2-negative breast cancer: Results from a phase 1 study dose-expansion part
Poster Session
Presentation #405P
October 21, 2023
9:00 AM-5:00 PM CEST

Gynecologic Cancer
Farletuzumab Ecteribulin

(FZEC) Antitumor activity of farletuzumab ecteribulin in a panel of endometrial cancer patient-derived xenografts with four different molecular subtypes
Poster Session
Presentation #786P
October 22, 2023
9:00 AM-5:00 PM CEST

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the pembrolizumab, anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, NJ, USA. Eisai and Merck & Co., Inc., Kenilworth, NJ, USA are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across multiple clinical trials.

In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of FZEC. Eisai and Bristol Myers Squibb are currently investigating FZEC in multiple studies including: a Phase 1/2 clinical study for select solid tumors including endometrial cancer, a Phase 2 clinical study for non-small cell lung cancer, and a Phase 2 clinical study for ovarian cancer, peritoneal cancer and fallopian tube cancer.

On October 10, 2023 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that it will be participating in the Lytham Partners Fall 2023 Investor Conference taking place virtually on Tuesday, October 17, 2023 (Press release, Delcath Systems, OCT 10, 2023, View Source [SID1234635804]).

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Company Webcast

Gerard Michel, CEO, will be participating in a fireside chat. The Company’s webcast presentation will be available for viewing at 7:00am ET on Tuesday, October 17, 2023, on the Company’s website at View Source or View Source The webcast will also be archived and available for replay.

1×1 Meetings

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected] or register at View Source

On October 10, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that  the Compensation Committee of Crinetics’ Board of Directors granted non-qualified stock option awards to purchase an aggregate of 619,100 shares of its common stock to eleven new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") (Press release, Crinetics Pharmaceuticals, OCT 10, 2023, View Source [SID1234635803]). The stock options were granted as inducements material to the employees entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

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The 2021 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Crinetics, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Crinetics, pursuant to Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $26.97 per share, which is equal to the closing price of Crinetics’ common stock on The Nasdaq Global Select Market on October 10, 2023. The shares subject to the stock options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to each employee’s continued employment with Crinetics on such vesting dates. The options are subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of a stock option agreement covering the grant.

On October 10, 2023 Circio and Neoregen Biotech reported the start of a research collaboration on novel circular RNA (circRNA) therapeutics based on Circio´s proprietary circVec technology (Press release, Circio, OCT 10, 2023, View Source [SID1234635802]). The parties will test the ability of Neoregen´s NICT (Neoregen Intra-Cellular delivery Technology) delivery system to enhance cellular uptake and nuclear transfer of circVec vectors compared to commercially available delivery technologies.

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circRNA is an emerging class of novel RNA-therapeutics that offers improved durability and enhanced protein expression compared to mRNA. Due to these potentially significant advantages, circRNA has attracted significant funding and partnering transactions in the last two years. Circio is the leader in vector-delivery of circRNA based on its proprietary circVec technology, a DNA-based vector platform that enables high-yield intra-cellular expression of circRNAs for therapeutic applications. Intra-cellular expression of circRNA increases durability and protein expression compared to both synthetic LNP-delivered circRNA or mRNA, thereby offering potentially significant advantages in gene therapy, vaccines and cancer. The circVec technology is based on over ten years of research and is composed of a modular genetic cassette design for efficient biogenesis of multifunctional circRNAs that can be adapted and applied to multiple purposes.

Neoregen’s NICT platform technology is a novel peptide-based chemistry suitable for delivery of nucleic acid therapeutics. This technology enables the development of drugs for targets that were previously inaccessible using conventional methods and can also significantly improve the efficacy and safety of existing treatments. While many previously developed cell-penetrating peptides failed to achieve Endosome Escape, a crucial step for drug delivery, Neoregen’s technology has demonstrated superior results in animal experiments compared to competitors. Currently, discussions are underway for various forms of collaboration in this regard.

Dr. Jeong-Min, Seo CEO of Neoregen Biotech, stated, "Through this collaboration, we believe our peptide-based next-generation drug delivery system can overcome the limitations of existing mRNA-based therapeutic technologies and provide better delivery of innovative novel RNA therapeutics, bringing innovation to the biopharma industry."

Dr. Erik Digman Wiklund, CEO of Circio Holding ASA, added: "Synthetic DNA vectors hold major promise as durable protein replacement therapies for genetic diseases. However, efficient delivery to target tissues, and uptake into the cell nucleus, remain a technical challenge. Neoregen offers a unique solution to tackle this problem, and we are very excited to collaborate and develop novel NICT-delivered circVec therapeutic candidates."

On October 10, 2023 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, reported positive overall survival (OS) data from its Phase 2 trial of BXCL701, the Company’s investigational oral innate immune activator, in combination with KEYTRUDA (pembrolizumab) in patients with small cell neuroendocrine prostate cancer (SCNC) (Press release, BioXcel Therapeutics, OCT 10, 2023, View Source [SID1234635801]). As of a data cutoff of September 6, 2023, evaluable patients with SCNC (n=28) showed a median OS of 13.6 months (95% CI 10.9–NR), and a 12-month survival rate of 56.5%.

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"OS is the most meaningful measure by which the effectiveness of an oncology treatment is evaluated. Though these results are based on a non-randomized cohort of patients, observing a median OS of this duration including patients with long-term survival at 12 months and beyond shows exceptional promise, bearing in mind historic data with checkpoint inhibitor monotherapy in this high-risk subset of prostate cancer," said Rahul Aggarwal, M.D., Principal Investigator, Associate Director for Clinical Sciences, Helen Diller Family Comprehensive Cancer Center, and Professor of Medicine at the University of California San Francisco (UCSF). "SCNC represents a major unmet medical need, with the majority of patients unfortunately succumbing to their disease in less than one year following chemotherapy. The results of this trial suggest that BXCL701 has the potential to extend the lives of patients, and I look forward to its continued clinical development."

SCNC, classified as a "cold" tumor, represents an underserved, growing patient population, with cases increasing due to earlier and more widespread use of androgen receptor inhibitors. In 2023, there will be an estimated 288,3002 new patients with prostate cancer in the United States, with approximately 11,532 patients progressing to SCNC.

"We believe our trial results are highly encouraging for patients with this disease and have potential implications for our evaluation of BXCL701 for the treatment of other high-grade neuroendocrine tumors, such as small cell lung cancer, where effective therapies are lacking," said Vincent J. O’Neill, M.D., Chief R&D Officer, OnkosXcel Therapeutics, a wholly owned subsidiary of BioXcel Therapeutics. "We intend to discuss these data with the FDA to help determine our next steps with clinical development."

The Phase 2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab in men with SCNC. Twenty-eight (28) evaluable SCNC patients received 0.3 mg of BXCL701 twice daily (BID) on days 1 through 14 of a 21-day cycle (0.2 mg BID the first week of cycle 1) plus 200 mg of pembrolizumab administered intravenously on day 1 and every subsequent 21 days. The primary objective of the trial is a composite response rate defined as either objective response by RECIST 1.1 criteria and/or PSA50 and/or CTC count conversion. Secondary objectives include duration of response, progression-free survival, overall survival, and biomarker evaluation as measured by changes in circulating cytokines and correlation of outcome with baseline tumor characteristics.

The Company is continuing to actively evaluate strategic options for OnkosXcel Therapeutics, including potential financing, strategic partnership, or M&A.

Conference Call

BioXcel Therapeutics will host a conference call and webcast on October 10, 2023 at 8:00 a.m. ET to discuss the data results from the Phase 2 trial of BXCL701. To access the call, please dial 877-407-5795 (domestic) or 201-689-8722 (international). A live webcast and presentation materials will be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a webcast replay will be available through January 10, 2024.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may sign up to automatically receive email alerts and other information about the Company by visiting the "Email Alerts" option under the News/Events section of the Investors & Media website section and submitting your email address.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer (SCNC)

mCRPC is a form of advanced prostate cancer that is no longer responding to testosterone-lowering hormone treatments and has spread to other areas of the body such as the lymph nodes, bones, bladder, rectum, liver, or lungs. Treatment-emergent SCNC is a particularly difficult-to-treat histologic subtype of mCRPC that emerges in approximately 20% of mCRPC patients, though this number is increasing due to earlier and more widespread use of androgen blockers.