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EISAI DELIVERS NEW DATA AND HIGHLIGHTS CONTINUED PROGRESS OF ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2023

On May 23, 2023 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that the presentation of research across various types of cancer from its oncology portfolio and pipeline during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (#ASCO23), which is taking place virtually and in-person in Chicago, Illinois from June 2 to 6 (Press release, Eisai, MAY 23, 2023, View Source [SID1234631960]).

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Notable research includes an oral presentation of results from the final pre-specified overall survival analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA) versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (Abstract #4502). A post hoc analysis from the REFLECT trial evaluating lenvatinib monotherapy versus sorafenib in the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) will also be shared in a poster presentation (Abstract #4078).

"The outlook for advanced renal cell carcinoma has evolved in recent years, and the final analysis from the pivotal CLEAR trial to be presented at ASCO (Free ASCO Whitepaper) represents another step forward for patients and an opportunity to provide their physicians with long-term data," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "New data for lenvatinib and from our oncology pipeline showcase Eisai’s continued commitment to driving innovation and exploring novel therapeutic modalities in our ambition to live out our human health care concept, our corporate mission to meet the needs of more people who face a cancer diagnosis."

Additional data from Eisai’s pipeline include a poster presentation of findings from a phase 1b study of E7386, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced HCC (Abstract #4075), and the small cell lung cancer cohort of a phase 1b/2 trial evaluating E7389-LF, a new liposomal formulation of eribulin, in combination with nivolumab (Abstract #8593). Insights from preclinical testing of farletuzumab ecteribulin (FZEC), formerly known as MORAb-202, and MORAb-109, antibody drug conjugates (ADC), in rare gynecologic cancers will also be published online (Abstract # e17634).

Furthermore, Bliss Biopharmaceutical Co., Ltd. (BlissBio) will present a poster at the conference with results from the first-in-human study of BB-1701, a HER2-targeting ADC (Abstract #3029). Eisai entered into a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaboration in April 2023. A Phase 1/2 clinical study of BB-1701 in the U.S. and China for HER2-expressing solid tumors is currently underway.

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 on Thursday, May

25, 2023 at 4:00 PM Central Daylight Time (CDT).

Cancer Type Study/Compound Abstract Title Abstract Type & Details
Lenvatinib Plus Pembrolizumab
Gynecologic Cancer CLEAR Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC)
Oral Abstract Session
Abstract #4502
June 5, 2023
11:54 AM CDT

Lenvatinib

Gastrointestinal Cancer REFLECT Efficacy of lenvatinib (LEN) vs sorafenib (SOR) in the first-line (1L) treatment of patients (pts) with unresectable hepatocellular carcinoma (uHCC): A post hoc analysis of patients with nonviral etiology from REFLECT
Poster Session
Abstract #4078
June 5, 2023
8:00 AM CDT

Pipeline
Lung Cancer E7389-LF Phase 2 small cell lung cancer (SCLC) cohort of a phase 1b/2 trial of a liposomal formulation of eribulin in combination with nivolumab
Poster Session
Abstract #8593
June 4, 2023
8:00 AM CDT

Gastrointestinal Cancers E7386 (plus lenvatinib) A phase 1b study of E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced hepatocellular carcinoma
Poster Session
Abstract #4075
June 5, 2023
8:00 AM CDT

Gynecologic Cancer Farletuzumab Ecteribulin
(FZEC) Preclinical testing of farletuzumab ecteribulin (FZEC [MORAb-202]) and MORAb-109, folate receptor α and mesothelin targeting antibody-drug conjugates (ADCs), in rare gynecologic cancers
Online Publication
Abstract #e17634
May 25, 2023
4:00 PM CDT

Solid tumors BB-1701
(Presented by BlissBio) A first-in-human, open label, multiple dose, dose escalation, and cohort expansion phase 1 study to investigate the safety, tolerability, pharmacokinetics and antitumor activity of BB-1701 in patients with locally advanced/metastatic HER2-expressing solid tumors
Poster Session
Abstract #3029
June 3, 2023
8:00 AM CDT

Additional Research
Pan-tumor Systematic review Anti-drug antibodies related to CTLA-4, PD-1 or PD-L1 inhibitors across tumour types: A systematic review
Online Publication
Abstract #e14600
May 25, 2023
4:00 PM CDT

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 Merck’s anti-PD-1 therapy pembrolizumab. Eisai and Merck are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across more than 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 farletuzumab ecteribulin (FZEC, formerly known as MORAb-202), a folate receptor alpha (FRα)-targeting ADC. Eisai and Bristol Myers Squibb are currently investigating FZEC in multiple studies including: a Phase 1/2 clinical study in the United States and Europe for solid tumors including endometrial cancer, a Phase 2 clinical study in the United States and Europe for non-small cell lung cancer, and a Phase 2 clinical study in Japan, the United States and Europe for ovarian cancer, peritoneal cancer and fallopian tube cancer.

Deciphera Pharmaceuticals to Participate in Upcoming Investor Conferences

On May 23, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that members of the management team will participate in fireside chats at the following investor conferences (Press release, Deciphera Pharmaceuticals, MAY 23, 2023, View Source [SID1234631959]):

TD Cowen 4th Annual Oncology Innovation Summit on Tuesday, May 30, 2023 at 8:30 AM ET (virtual)

Jefferies Healthcare Conference on Thursday, June 8, 2023 at 2:30 PM ET in New York, NY

A live webcast of both events will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

Curium announces last patient enrolled in their Phase 1/2 SOLAR clinical trial imaging men with histologically-proven metastatic prostate cancer using copper Cu 64 PSMA I&T

On May 23, 2023 Curium, a world leader in nuclear medicine, reported that it has completed enrollment in its USA-led SOLAR Phase 1/2 study evaluating the safety, biodistribution, and image quality of Copper Cu64 PSMA I&T injection to detect metastatic prostate cancer in PET imaging (Press release, Curium, MAY 23, 2023, View Source [SID1234631958]).

Michael Patterson, CEO – North America at Curium commented, "We are pleased to complete the Phase 1/2 SOLAR study enrollment ahead of schedule. We are excited to use Curium’s centralized Copper-64 production capabilities and our industry leading distribution network in upcoming Phase 3 trials. As we work globally to redefine the experience of cancer through our trusted legacy in nuclear medicine, we remain focused on driving innovation to improve the lives of more than 14 million patients each year."

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, "Completing the enrollment of patients for the SOLAR study is not only an important milestone for the study itself, but also a testament to the hard work and dedication of our investigators. We are very pleased with the clinical development progress of Cu-64-PSMA-I&T. After the completion of our analysis, we look forward to collaborating with our future investigators to start our Phase 3 program looking into the use of Cu-64-PSMA-I&T in patients with prostate cancer for initial staging and also for biochemical recurrence."

Prostate cancer is the most common cancer and the second leading cause of cancer death among men in the United States. There will be an estimated 288,000 new cases of prostate cancer in 2023.

For more information about the SOLAR trial: View Source

Cogent Biosciences to Host Investor Webcast to Discuss Lead-In Data Being Presented at ASCO from the Ongoing Phase 3 PEAK Trial in Patients with Gastrointestinal Stromal Tumors (GIST)

On May 23, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the details of its investor webcast being held Monday, June 5, 2023 at 8:00 a.m. ET (7:00 a.m. CT) to discuss lead-in data from its ongoing Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) (Press release, Cogent Biosciences, MAY 23, 2023, View Source [SID1234631955]). The data are being presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3, 2023 at 2:15 p.m. ET (1:15 p.m. CT).

The webcast event will be led by Andrew Robbins, Cogent’s President and Chief Executive Office and will include a presentation by Andrew J. Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School.

The live webcast can be accessed on the Investors and Media page of Cogent’s website at investors.cogentbio.com/events. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

Checkpoint Therapeutics Announces $10 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On May 23, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,256,269 shares of its common stock (or pre-funded warrants in lieu thereof), Series A warrants to purchase up to 3,256,269 shares of common stock and Series B warrants to purchase up to 3,256,269 shares of common stock, at a purchase price of $3.071 per share of common stock (or pre-funded warrant in lieu thereof) and associated warrants, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Checkpoint Therapeutics, MAY 23, 2023, View Source [SID1234631953]).

The Series A warrants will be exercisable immediately upon issuance and will expire five years following the issuance date and have an exercise price of $2.821 per share and the Series B warrants will be exercisable immediately upon issuance and will expire eighteen months following the issuance date and have an exercise price of $2.821 per share.

H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.

The closing of the offering is expected to occur on or about May 25, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10 million. Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes, including the manufacturing of cosibelimab and certain pre-commercial activities in anticipation of potential approval and commercial launch.

The securities described above are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333-270843) that was previously filed with the Securities and Exchange Commission ("SEC") on March 24, 2023, and subsequently declared effective on May 5, 2023. The securities offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.