On September 5, 2024 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 2024, which is taking place virtually and in-person in Barcelona, Spain from September 13 to 17 (Press release, Eisai, SEP 4, 2024, View Source [SID1234646370]).

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First presentation of results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC) will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium (NCT04246177(New Window); Presentation: #LBA3).

"The late-breaking data from the Phase 3 LEAP-012 trial add to a growing body of research that we have undertaken in hepatocellular carcinoma, reinforcing Eisai’s longstanding commitment to people living with this devastating disease," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "We are eager to share these findings at ESMO (Free ESMO Whitepaper), alongside our other research on lenvatinib monotherapy and in combination with pembrolizumab, and pipeline developments, as this crucial scientific exchange fuels our mission to accelerate progress in oncology and help improve the lives of patients and families affected by cancer."

Additionally, a Mini Oral presentation will feature real-world evidence for patients with radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) treated with lenvatinib monotherapy in Europe and Canada (Presentation: #1926MO). Research into the use of lenvatinib monotherapy in patients with HCC from the Phase 4 STELLAR study (Presentation: #964P) and from a real-world study utilizing the LINK (Liver cancer IN Korea) research network (Presentation: #972P) will be shared in poster presentations. An exploratory analysis from the Phase 3 LEAP-001 trial evaluating tumor response with lenvatinib plus pembrolizumab for patients with advanced or recurrent endometrial carcinoma will also be presented (NCT03884101(New Window); Presentation: #737P).

Research from Eisai’s pipeline includes a quality-of-life analysis from the Phase 3 EMERALD study in Japan evaluating either Eisai’s eribulin (HALAVEN) or a taxane in combination with trastuzumab and pertuzumab in patients with HER2-positive, locally advanced or metastatic breast cancer (NCT03264547(New Window); Presentation: #373P); findings from a Phase 1b dose-expansion cohort evaluating E7386 (a CBP/β-catenin interaction inhibitor) in combination with lenvatinib in patients with advanced endometrial carcinoma with progression following prior anti-PD-(L)1 immunotherapy and platinum-based chemotherapy (NCT04008797(New Window); Presentation: #738P); as well as presentations for BB-1701, an antibody drug conjugate which combines an anti-HER2 antibody with Eisai’s approved anticancer drug eribulin via its linker, in previously-treated patients with HER2-positive or HER2-low unresectable or metastatic breast cancer (NCT06188559(New Window); Presentation: #437TiP) and non-small cell lung cancer patients with HER2 mutation/amplification (Presentation: #1296P; presented by Bliss Biopharmaceutical Co., Ltd), respectively.

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 Eisai presentations is included below. Regular abstracts will be made available via the ESMO (Free ESMO Whitepaper) website on Monday, September 9, at 12:05 AM Central European Summer Time (CEST). Late-breaking abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) as a Proffered Paper or Mini Oral will be published on the ESMO (Free ESMO Whitepaper) website at 12:05 AM CEST on the day of the presentation. Posters will be on display from 9:00 AM – 5:00 PM CEST on the day of their poster session.

Cancer Type Study/
Compound Abstract Title Abstract Type & Details
Lenvatinib Plus Pembrolizumab
Genitourinary Cancer LEAP-012 Transarterial chemoembolization (TACE) with or without lenvatinib (len) plus pembrolizumab (pembro) for intermediate stage hepatocellular carcinoma (HCC): phase 3 LEAP-012 study
Presidential Symposium
(Proffered Paper Session)
Presentation #LBA3
September 14, 2024
5:36-5:48 PM CEST

Endometrial Carcinoma
LEAP-001

Characterization of tumor response with lenvatinib plus pembrolizumab (LEN + Pembro) in the ENGOT-en9/LEAP-001 study
Poster Session
Presentation #737P
September 14, 2024

Lenvatinib
Differentiated
Thyroid Cancer Real-World Evidence
Radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) patients treated with lenvatinib monotherapy: real-world treatment patterns and clinical outcomes in Europe and Canada

Mini Oral Presentation
Presentation #1926MO
September 13, 2024
4:05-4:10 PM CEST

Gastrointestinal Cancer

Real-World Evidence

Efficacy and safety of lenvatinib vs. sorafenib in hepatocellular carcinoma: a multi-center real-world study from the LINK research network
Poster Session
Presentation #972P
September 16, 2024

STELLAR

Lenvatinib (L) and sorafenib (S) in patients (pts) with advanced or unresectable hepatocellular carcinoma (uHCC): an international, multicenter, phase 4 study (STELLAR)
Poster Session
Presentation #964P
September 16, 2024

Eribulin
Breast Cancer JBCRG-M06/ EMERALD
Quality-of-life outcomes in patients with HER2-positive, locally advanced or metastatic breast cancer treated with eribulin mesylate in combination with trastuzumab and pertuzumab in the phase 3 JBCRG-M06/EMERALD study

Poster Session
Presentation #373P
September 16, 2024

Pipeline
Endometrial Carcinoma E7386 Global, phase 1b dose-expansion cohort of E7386 + lenvatinib (LEN) in patients (pts) with advanced (a) endometrial cancer (EC) that progressed on platinum-based chemotherapy (CTx) and an anti-PD-(L)1 immunotherapy (IO)
Poster Session
Presentation #738P
September 14, 2024

Breast Cancer BB-1701 An open-label, multicenter, phase 2 study to evaluate the safety and efficacy of BB-1701, a novel antibody drug conjugate (ADC) targeting HER2, in previously treated patients (pts) with HER2+ or HER2-low unresectable or metastatic (M) breast cancer (BC)
Poster Session
Presentation #437TiP
September 16, 2024

Non-Small Cell Lung Cancer BB-1701 A phase 2 study to evaluate the efficacy and safety of BB-1701 in advanced or metastatic NSCLC patients with HER2 mutation/amplification (Presented by Bliss Biopharmaceutical Co., Ltd.)
Poster Session
Presentation #1296P
September 14, 2024　

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of 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 anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, pembrolizumab. Eisai and Merck & Co., Inc., Rahway, 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 May 2023, Eisai entered into a joint clinical trial collaboration agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd. (Headquarters: Zhejiang Province, China, "BlissBio"), for BB-1701, a HER2-targeting antibody drug conjugate (ADC), with option rights for a strategic collaboration. Eisai is currently investigating BB-1701 in a Phase 2 clinical trial in Japan and the United States for breast cancer, and BlissBio is investigating a Phase 1/2 clinical trial in the United States and China for HER2-expressing solid tumors.

On September 4, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that management will participate in the following investor conferences in September (Press release, CytomX Therapeutics, SEP 4, 2024, View Source [SID1234646339]).

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H.C. Wainwright 26th Annual Global Investment Conference
Date: Wednesday, September 11, 2024
Formal Presentation: 12:30 p.m. ET
Location: New York, NY

2024 Cantor Global Healthcare Conference
Date: Thursday, September 19, 2024
Fireside Chat: 9:45 a.m. ET
Location: New York, NY

Live webcasts of the H.C. Wainwright presentation and Cantor fireside chat will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

On September 4, 2024 TippingPoint Biosciences, a therapeutic company focused on innovative drug discovery targeting the aberrant DNA in cancer cells, reported pre-seed investment from the Pediatric Brain Tumor Foundation, Sontag Foundation, Yuvaan Tiwari Foundation, and BrightEdge, the impact investment and venture capital arm of the American Cancer Society (Press release, TippingPoint Biosciences, SEP 4, 2024, View Source [SID1234646355]).

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The investments will support TippingPoint’s breakthrough work to target Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric brainstem tumor that is untreatable and terminal, usually within months of diagnosis. TippingPoint’s novel drug discovery platform is the first to target disease-specific interfaces in DNA packaging networks in cancer cells, also known as chromatin states, without affecting healthy states. Current approaches to address DNA packaging dysfunction target single chromatin factors that have broad functions across both disease and healthy cells, which leads to unwanted toxicities. Because TippingPoint’s platform is able to specifically target the unique chromatin interactions in disease, they have successfully applied their technology to target DIPG cancer cells in the laboratory, which cancer researchers regard as a significant breakthrough.

"We are committed to accelerating breakthrough treatments for DIPG and other fatal pediatric brain tumors," said Parvati Tiwari, President and Co-Founder of the Yuvaan Tiwari Foundation. "TippingPoint’s innovative approach to targeting complex chromatin interactions offers real hope for new therapies. We’re proud to back their efforts to transform the future of DIPG treatment."

"We are proud to support the work being done by Tipping Point to further the American Cancer Society’s mission to end cancer as we know it for everyone, said Alice Pomponio, VP, Innovation & Impact Investing / Managing Director, BrightEdge. It has been a privilege to support their journey from the beginning to where they are today, and we look forward to seeing a DIPG treatment benefit people with cancer in the future."

"There will be no cure for DIPG without collaboration, and we’re proud to come alongside other investors to back TippingPoint’s novel search for new treatment pathways," said Pediatric Brain Tumor Foundation President and CEO Courtney Davies. "We believe their research focus promises to be transformative."

The Sontag Innovation Fund, building on the reputation of the Sontag Foundation as one of the largest private funders of brain tumor research in North America, is thrilled with being part of TippingPoint’s efforts. "We are excited to help support TippingPoint and their effort to use an innovative screening platform to identify new potential therapeutic options for DIPG and other diseases" said Scott Davis, Managing Director of the Sontag Innovation Fund.

TippingPoint Bioscience’s founder, Dr. Laura Hsieh, formerly a post-doctoral researcher in Dr. Geeta Narlikar’s lab at the University of California San Francisco (UCSF), left the university to launch TippingPoint and accelerate the development of cancer therapeutics. TippingPoint raised its first investments in 2023, from early stage ventures like Mission BioCapital, ACS BrightEdge and SOSV’s IndieBio, and won four golden or platinum ticket awards in pitch competitions sponsored by major pharmaceutical companies including ONO Pharma, Astellas, and Abbvie.

Dr. Hsieh and the TippingPoint Biosciences team are currently conducting hit-to-lead studies to develop a new class of molecules for DIPG that are highly specific to the disease. They are diligently working to increase the potency and selectivity of their molecules so they can test them in mouse models in the near term with an eye on reaching first-in-human studies for DIPG patients in 4 years.

"We are honored to receive these investments to further our drug development efforts for such a devastating disease like DIPG. In order to make significant breakthroughs in complex diseases like DIPG and really make a difference in patient lives, big bets need to be made on paradigm-shifting technologies like ours. The support in capital, expertise and networks with patient advocates and world-class researchers goes a long way for TippingPoint to continue development of much-needed therapeutics for DIPG and other complex diseases," said Dr. Laura Hsieh, CEO and Founder of TippingPoint Biosciences.

On September 4, 2024 MaaT Pharma, a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported that it will present two posters at the Society of Hematologic Oncology Annual Meeting taking place September 4-7, 2024, in Houston, Texas, USA (Press release, MaaT Pharma, SEP 4, 2024, View Source [SID1234646307]):. In addition, MaaT Pharma announced that Company management will participate in three investor conferences in September. Details are as follows:

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Society of Hematologic Oncology Annual Meeting – Presentation

Presentation Title – Poster MaaT013: Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from Early Access Program in Europe – Poster Number: CT-198
Presentation Title – Poster MaaT033: A Multicentre, Randomized, Double-Blinded, Phase 2b Study Evaluating The Efficacy And Safety Of Maat033, an Oral, Pooled Microbiome Ecosystem Therapy In Patients Undergoing Allogenic Hematopoietic Cell Transplantation to Improve Overall Survival: the PHOEBUS Study – Poster Number: CT-200
Session Date & Time: Wednesday, September 4, 2024, 6:15-7:30 PM CDT (7:15-8:30 PM EST)
Location: George R. Brown Convention Center, Houston, Texas, United States
Data included in both posters have been already presented at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in April 2024. The posters will be available on the Posters section of the MaaT Pharma website following the Congress.

Investor conferences

H.C. Wainwright 26th Annual Global Investment Conference – Presentation

Date: September 9-11, 2024
Location: New York, NY United States
The presentation will be available on-demand through the H.C. Wainwright conference portal, starting Monday, September 9, 2024.
Lyon Pole Bourse Forum – Participation

Date: September 24, 2024
Location: Lyon, France
KBC Securities’ Life Sciences Conference – Participation

Date: September 26, 2024
Location: Brussels, Belgium

On September 4, 2024 Pharma Two B Ltd. ("Pharma Two B"), a late-clinical stage company that is developing P2B001, an innovative combination product candidate for the treatment of Parkinson’s Disease ("PD") and Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) ("Hepion"), a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, reported the filing of a registration statement of Pharma Two B on Form F-4 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") (Press release, Hepion Pharmaceuticals, SEP 4, 2024, View Source [SID1234646340]).

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The Registration Statement contains a proxy statement/prospectus in connection with the proposed merger transaction pursuant to the definitive agreement entered into between Pharma Two B and Hepion (the "Merger Agreement", and the proposed transactions contemplated thereby, the "Proposed Transaction"). While the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Pharma Two B and Hepion and the Proposed Transaction.

As announced on July 22, 2024, Pharma Two B intends to become a publicly traded company on Nasdaq through a merger transaction with Hepion.

The Proposed Transaction, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol "PHTB" and other customary closing conditions. Upon the anticipated closing of the Proposed Transaction, the combined company will operate under the "Pharma Two B" name.

A.G.P./Alliance Global Partners is serving as financial advisor to Hepion and Sheppard, Mullin, Richter & Hampton LLP is acting as U.S. legal advisor to Hepion and Lipa Meir & Co.is acting as Israeli legal advisor to Hepion. Sullivan & Worcester LLP is serving as legal advisor to A.G.P.

Laidlaw & Company (UK) Ltd. is acting as financial advisor to Pharma Two B. and Meitar Law Offices and Goodwin Procter LLP are acting as legal advisors to Pharma Two B.