On September 4, 2024 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) ("LIXTE" or the "Company") reported it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent application number 16/467,721, titled, "Oxabicycloheptanes for Modulation of Immune Response," for combining the Company’s LB-100 compound with various innovative cancer immunotherapies (Press release, Lixte Biotechnology, SEP 4, 2024, View Source [SID1234646372]).

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"The patent award further bolsters LIXTE’s existing intellectual property portfolio and underscores the Company’s commitment to pioneering research and delivering innovative solutions to patients battling cancer," said Bas van der Baan, LIXTE’s Chief Executive Officer.

LIXTE is developing its first-in-class lead clinical PP2A inhibitor, LB-100, as a potentiator of cancer immunotherapy. The Company is testing LB-100 in combination with immunotherapies in clinical trials at the Netherlands Cancer Institute (NKI) in Amsterdam and at The University of Texas MD Anderson Cancer Center in Houston.

At NKI, LIXTE is providing LB-100, and F. Hoffmann-La Roche Ltd. ("Roche") is providing atezolizumab (Tecentriq, a PD-L1 inhibitor) through the imCORE Network as part of a new clinical trial in immune therapy for unresponsive (MSI Low) metastatic colon cancer. The imCORE Network is an academic-industry collaboration that aims to accelerate cancer immunotherapy research through institution-sponsored studies

A second trial underway at MD Anderson is testing the combination of LB-100 and GSK’s dostarlimab-gxly for the treatment of ovarian clear cell carcinoma (OCCC).

The new patent award follows the signing of an exclusive patent license agreement earlier this year between LIXTE and the National Institute of Neurological Disorders and Stroke (NINDS) and National Cancer Institute (NCI), each a component of the National Institute of Health (NIH). The agreement provides LIXTE with an opportunity to explore and develop novel combination therapies that can potentially transform the landscape of cancer treatment.

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 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that Chairman and Chief Executive Officer Vlad Vitoc, M.D. will present at the H.C. Wainwright & Co. 26th Annual Global Investment Conference taking place September 9–11, 2024, in New York City (Press release, MAIA Biotechnology, SEP 4, 2024, View Source [SID1234646364]).

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Dr. Vitoc’s presentation will reveal the latest clinical data from MAIA’s Phase 2 THIO-101 clinical trial of lead candidate THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens.

Conference details:

MAIA live presentation:

Tuesday, September 10, 2024, at 08:00 am ET*

Live webcast:

Join here.

Conference location:

Lotte New York Palace, New York City

Conference registration:

Available on the conference website.

1-on-1 meetings:

Requests available upon registration.

Presentation slides:

ir.maiabiotech.com under Company Info: Presentations

*Please note that the presentation date and time are subject to change. Participants should refer to H.C. Wainwright’s final program agenda for up-to-date information.

THIO is a small molecule telomere-targeting anticancer agent that acts by producing direct telomeric DNA damage and inducing cancer-specific immune responses. THIO-101’s treatment results to date have demonstrated exceptional efficacy in NSCLC, the most prevalent tumor type by mortality. Long-term efficacy results are expected before year-end. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by Regeneron’s cemiplimab (Libtayo) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On September 4, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to enhancing survival of 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 [SID1234646363]). 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 HEPTA Medical ("HEPTA"), a private medical device company dedicated to providing an efficient, safe, and minimally-invasive thermal ablation therapy for early-stage lung cancer, reported it has successfully raised €5.7M in the first close of its Series A funding round (Press release, Hepta Medical, SEP 4, 2024, View Source [SID1234646362]). The investment was led by BPI France with the participation of M&L Healthcare and Clery IG.

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This financing round will enable HEPTA to initiate the US regulatory approval process for the first version of its microwave ablation platform and to commence its clinical trials. Lung cancer is the leading cause of cancer-related deaths worldwide. As lung cancer screening programs are being implemented, the management of early-stage lung cancer patients has become an increasingly urgent concern for healthcare organizations. HEPTA aims to address this need by offering a controlled, incision-less technology, that provides a minimally invasive approach to treat patients quickly, safely, and efficiently.

"We are grateful for our new investors, and excited to bring microwave ablation therapy to new heights. In August, we obtained our first proprietary patent, completing our three patent families under license. We have multiple upcoming milestones, including the release of early preclinical trial results conducted in collaboration with world-renowned centers, which we’ll publish at the CIRSE conference in September," says Dr. Thomas Bancel, CEO of HEPTA Medical.

The chairman of the board of directors, Gérard Hascoët, a Sofinnova Venture Partner, will be joined by Philippe Boucheron and Jocelyn Kum as representatives for BPI France and M&L Healthcare, respectively.

"We are thrilled to be part of HEPTA Medical’s journey as they push the boundaries of innovation in minimally invasive lung cancer treatment. This investment aligns with our commitment to support groundbreaking medical technologies that have the potential to significantly improve patient outcomes. HEPTA’s unique approach to thermal ablation therapy, combined with their dedicated team and cutting-edge technology, positions them at the forefront of transforming lung cancer care. We are confident that HEPTA Medical will achieve significant milestones in the near future and are excited to support their continued growth and success," comments Philippe Boucheron, Deputy Chief of Life Sciences Investments at BPI France.

HEPTA Medical was founded in 2019 by Sofinnova medtech acceleration team, MD Start. HEPTA develops a flexible microwave ablation probe compatible with any lung navigation system. It is equipped with a proprietary patented tissue temperature sensor that enables monitoring of the growth of the ablation zone in-situ and in real-time during endobronchial ablation procedures. The device also incorporates predictive software, powered by artificial intelligence, which combines procedural CT images and temperature measurements to display the ablation zone in real-time to the clinician during the procedure.