On October 10, 2023 Helsinn Group ("Helsinn"), a fully integrated, global biopharma company with a track record of over forty years of commercial execution and a strong focus in supportive care, oncology, and rare diseases, reported the signing of a new financing agreement with BancaStato, effective from September 2023 (Press release, Helsinn, OCT 10, 2023, View Source [SID1234635808]).
This financing agreement with BancaStato replaces Helsinn’s prior credit facility agreement signed by Helsinn with a non-bank lender in December 2022. This new funding agreement offers convenient terms and conditions which will help drive the Company’s business objectives.

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Helsinn has recently undergone a strategic review to redefine its business model, activities, and investments to remain competitive in global markets. Proceeds from the recently concluded financing agreement will contribute to the implementation of the Company’s plans and will help to ensure sustainable and profitable performance in alignment with the current product portfolio as well as commercial and manufacturing capabilities – the company’s main pillars of success in the past.

Riccardo Braglia, Executive Chairman of Helsinn, commented: "Guided by our core values of respect, integrity, and quality, Helsinn’s strategy focuses on being the partner of choice as a commercial-stage enterprise with a strong focus in supportive care, oncology and rare diseases, able to reach patients worldwide through integrated CMC/manufacturing/supply and a commercial platform complemented by scientific and technological expertise.
We are very grateful to BancaStato for placing their trust in our business model and our solid commercial track record."

Dr. Melanie Rolli, Chief Executive Officer at Helsinn, said: "This new financial strength from BancaStato is a great step forward which will allow us to reach our business objectives as well as strengthen our portfolio of late- and commercial-stage supportive care, oncology and rare disease drugs and, more importantly, to continue to serve our customers around the world by identifying and collaborating with partners who share our passion and motivation: to extend and improve the lives of patients globally who use our products every day."

On October 10, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted three employees nonqualified stock options to purchase an aggregate of 47,000 shares of its common stock with an exercise price of $2.41, which is equal to the closing price of Gritstone’s common stock on October 5, 2023, the date of the grant (Press release, Gritstone Bio, OCT 10, 2023, View Source [SID1234635807]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

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.