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.

On September 4, 2024 Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company") reported that the Company will be sharing information on its proprietary AI/ML-powered SaMD, eyonis LCS, including recently announced data from the pivotal REALITY study, at Booth #2601 during the 2024 World Conference on Lung Cancer (WCLC), being held in San Diego, CA, USA, from September 7-10, 2024 (Press release, MEDIAN Technologies, SEP 4, 2024, View Source [SID1234646356]). The WCLC, the premier world conference on lung cancer, is organized by the International Association for the Study of Lung Cancer (IASLC), a global multidisciplinary association dedicated to eradication of all forms of lung cancers.

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eyonis LCS is designed to improving the detection and diagnostic accuracy of LDCT in lung cancer screening procedures. LDCT imaging is the standard of diagnostic care globally and is currently the only approved lung cancer screening modality in U.S. and Europe. The average five-year survival rate for all lung cancer patients is 18.6 percent because only 16 percent of lung cancers are diagnosed at an early stage2. Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%.

The Company released in August the definitive results from the first of the two pivotal eyonis LCS clinical studies, REALITY (Clinicaltrials.gov identifier: NCT0657623) evaluating the standalone performance of the medical device in characterizing cancerous vs non-cancerous patients (i.e. "performance at patient level"), and in detecting and characterizing suspicious versus malignant nodules. Despite the inclusion of many challenging LDCT images, the eyonis LCS SaMD achieved exceptional results and met all study primary and secondary endpoints with statistical significance and achieved an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as the primary endpoint for REALITY.

REALITY analyses were conducted on data from a cohort of 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose.

The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case (MRMC) study that will offer clinical validation of eyonis LCS to complement the analytical validation already achieved with REALITY. RELIVE is ongoing and scheduled for completion in the coming months, with an anticipated data read-out in Q1 2025. Median Technologies expects eyonis LCS regulatory filings in the US for FDA 510(k) clearance and in Europe for CE marking in H1 2025.

With eyonis LCS, Median Technologies is working to provide the U.S. and European lung cancer medical communities with a unique breakthrough software as medical device to help medical professionals expedite lung cancer screening programs. Increased accuracy with eyonis LCS can help save lives and reduce the distress and costs associated with unnecessary procedures.

About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic device that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to diagnose lung cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis LCS has been classified by regulators as "Software as Medical Device", or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in 2025. Separately, Median’s AI technology is being sold and deployed across cancer indications, via Median’s iCRO business unit, to companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.

About IASLC 2024 World Conference on Lung Cancer: The International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) is an immersive scientific meeting where over 5,000 leading experts, researchers, and oncologists gather to showcase cutting-edge advancements in lung cancer research, treatment modalities, and personalized therapies, fostering collaboration towards a world free from the burden of lung cancer. For more information about 2024 WCLC, visit View Source

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 4, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer, reported a plan to optimize its resource allocation through a pipeline prioritization and a workforce reduction of approximately 49% (Press release, In8bio, SEP 4, 2024, View Source [SID1234646341]). The Company will focus on generating robust clinical data from INB-100, the ongoing investigator-sponsored Phase 1 clinical trial of acute myeloid leukemia (AML), to further de-risk the registrational pathway and affirm the 100% one-year progression-free survival observed to date in this patient population.

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The Company will suspend its glioblastoma (GBM) development program while continuing to monitor patients in the Phase 1 INB-200 clinical trial and those enrolled in the Phase 2 INB-400 clinical trial. INB-200 has completed patient treatment with up to six repeat doses and further patient enrollment in the INB-400 trial is on hold while the Company explores potential partnership opportunities for the solid tumor program.

"The data across both of our INB-100 and INB-200 clinical programs remain positive and robust. We are committed to building upon the data for INB-100 in AML, and we are making the difficult decision to advance fewer pipeline programs, reduce our spend and focus on key milestones that can help to generate near-term interest and value creation," said William Ho, Chief Executive Officer and co-founder. "These are hard but necessary steps to enable us to continue developing these novel cellular immunotherapies that are demonstrating signs of clinical activity in difficult cancer patients. We are excited to focus on INB-100 as IN8bio and its investigators believe patient outcomes in its trial to date are surpassing that of similar leukemia patients, including those with AML undergoing haploidentical transplantation without receiving INB-100. I want to express my gratitude to all our employees, including those departing IN8bio today, for their contributions towards our mission of Cancer Zero."

Portfolio prioritization

INB-100 for AML

With additional funding, the INB-100 trial will continue to enroll patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results anticipated in late 2025 and in 2026.

IN8bio had a Type B meeting with the FDA earlier this summer where the Company received regulatory guidance on advancing INB-100 for the treatment of AML as a post-transplant maintenance therapy, with relapse-free survival as the primary endpoint. To affirm the improvements in relapse free and overall survival observed to date and to further de-risk a future registrational randomized control trial, IN8bio will also seek to add a control cohort to prospectively assess leukemia patients and enable comparison between patients receiving INB-100 to those who only receive standard haplotransplantation.

As of August 30, 2024, 100% of AML patients remain relapse-free after receiving their dose of INB-100 after a median follow-up of 18.7 months. The previously reported patients with other leukemic diagnoses (ALL and MDS/MPN overlap with concurrent TP53 mutations) who relapsed have since died of progression. There have been no new relapses reported since the last update.

INB-200 and INB-400

The Company has suspended patient enrollment in the INB-400 Phase 2 clinical trial for newly diagnosed GBM while it explores partnership opportunities for the program. IN8bio will continue to monitor patients previously treated in the fully enrolled INB-200 clinical trial as well as any patients that have been enrolled and are undergoing treatment in the INB-400 Phase 2 clinical trial.

Workforce Reduction

In conjunction with its pipeline prioritization, IN8bio is implementing a workforce reduction of approximately 49% of its current workforce, across all functional areas and at both its New York City and Birmingham, Alabama sites, along with cash compensation reductions implemented across the executive management team and the Company’s board of directors. IN8bio expects to incur one-time costs of approximately $0.3 million in connection with the workforce reduction, of which nearly all are cash expenditures related to severance. Such costs are expected to be incurred in the third quarter of 2024.