On November 23, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported the presentation of a poster featuring NOX-A12 data from preclinical studies performed at the U.S. National Cancer Institute (NCI) at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting, taking place in Houston, Texas, USA, November 21-24, 2024 (Press release, TME Pharma, NOV 23, 2024, View Source [SID1234648583]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation showed that combining CXCL12 inhibition with anti-PD-1/CTLA4 immune checkpoint inhibition increases the presence of anti-cancer immune cells in tumor tissues both inside and outside the brain, including activated cytotoxic ("killer") T cells. Importantly, improved long-term survival and immunological protection from tumor recurrence were seen in models of tumors growing outside but not inside the brain. This suggests that while the combination with anti-PD-1/CTLA4 immune checkpoint inhibitors is a promising therapy for tumors outside the brain, it may not be an optimal approach for treating brain tumors.

These results support the different combination strategies pursued by TME Pharma in both brain and pancreas cancer. In pancreas cancer, a tumor originating outside the brain, NOX-A12 is combined with an anti-PD-1 immune checkpoint inhibitor and chemotherapy. In brain cancer (glioblastoma), TME Pharma pursues a different strategy combining NOX-A12 with anti-VEGF therapy and radiotherapy, which has already shown exceptional efficacy in animal models (100% complete response1) and in the GLORIA clinical trial where a statistically significant survival benefit over a matched standard of care cohort was shown with a doubling of median overall survival from 9.5 to 19.9 months2.

"The presented results confirm the activity of NOX-A12 on the tumor microenvironment and support TME Pharma’s strategy to focus on combination with the VEGF inhibitor bevacizumab in brain cancer that has yielded excellent results in newly diagnosed chemotherapy-resistant patients with residual tumor remaining after surgery," said Aram Mangasarian, CEO of TME Pharma. "The survival benefit shown at the SNO conference for the NOX-A12 combination with anti-PD1/CTLA4 immune checkpoint inhibitors suggests potential to treat multiple tumor types outside the central nervous system and supports our plans to combine NOX-A12 with the anti-PD-1 immune checkpoint inhibitor pembrolizumab and chemotherapy in the OPTIMUS pancreatic cancer study."

The research was conducted at the NCI, part of the National Institutes of Health, under the material transfer agreement established with TME Pharma in June 2022 to explore the effects of TME Pharma’s CXCL12 inhibitor NOX-A12 in brain tumors.3

Details of the poster presentation at the 2024 SNO Annual Meeting are as follows:

Title: Potentiating the efficacy of immune check-point inhibitors in glioblastoma by inhibition of CXCL12
Presenter: Dr. Chen Cam-El Makranz, Neuro-Oncology Research Fellow, National Cancer Institute, National Institutes of Health
Session: Poster Session, Poster number EXTH12
Time and Date: 7.30-9.30 p.m. CST, Friday, November 22, 2024

The abstract and poster presentation are available on the TME Pharma website.

On November 22, 2024, BioXcel Therapeutics, Inc. (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with Canaccord Genuity LLC, as underwriter (the "Underwriter"), in connection with the issuance and sale by the Company in a public offering of (i) 5,600,000 shares of the Company’s common stock, par value $0.001 per share ("Common Stock"), and accompanying warrants to purchase 5,600,000 shares of Common Stock, at a combined public offering price of $0.48 per share, and, in lieu thereof to certain investors, (ii) pre-funded warrants to purchase 9,000,000 shares of Common Stock, and accompanying warrants to purchase 9,000,000 shares of Common Stock, at a combined public offering price of $0.479 per pre-funded warrant, which equals the public offering price per share of Common Stock and accompanying warrant less the $0.001 exercise price per share of the pre-funded warrants, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3 (Registration No. 333-275261) and a related prospectus supplement filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, BioXcel Therapeutics, NOV 22, 2024, View Source [SID1234648604]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Each of the warrants in the offering is subject to customary beneficial ownership limitations on exercisability, is exercisable at any time after the date of issuance of such warrant and, in the case of the accompanying warrants, will expire on the fifth anniversary of the date of issuance. Each of the accompanying warrants will have an exercise price of $0.48 per underlying share of Common Stock.

The Company received net proceeds from the offering of approximately $6.2 million, after deducting underwriting discounts and commissions and estimated offering expenses, excluding the proceeds, if any, from exercise of any of the warrants. The Company intends to use the net proceeds of the offering to fund the SERENITY At-Home trial, prepare for the initiation of the TRANQUILITY In-Care trial, working capital and general corporate purposes. The Company expects the net proceeds from this offering combined with existing cash and cash equivalents will be sufficient to fund operations and service debt obligations into the first quarter of 2025. Our expectations regarding our anticipated cash runway into the first quarter of 2025 will be affected by many factors, our ability to execute our current business plan, the progress of our clinical trials and regulatory interactions. These expectations are based on estimates and the judgment of management. The Company’s cash runway may not extend as far as forecasted and anticipated cash needs could be greater than expected.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

The foregoing description of the Underwriting Agreement, the pre-funded warrants and the accompanying warrants are not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, the Form of Pre-funded Warrant and the Form of Warrant, copies of which are filed as Exhibit 1.1, 4.1 and 4.2, respectively, to this Current Report on Form 8-K and is incorporated by reference herein. An opinion of Honigman LLP regarding the validity of the shares to be issued and sold in the offering by the Company is filed as Exhibits 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.

On November 21, 2024, the exercise price of warrants to purchase 8,545,398 shares of common stock previously issued in March 2024 was reduced to $0.571 per share.

On November 22, 2024 CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), reported data from the FORESEE trial showcasing the CNSide CSF Assay Platform’s utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM (Press release, Plus Therapeutics, NOV 22, 2024, View Source [SID1234648586]). The data will be presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Current gold standard CSF cytology lacks the sensitivity needed to reliably diagnose LM in most clinical situations and lacks utility for disease monitoring," said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. "The FORESEE trial shows that CNSide may be a useful tool in accurately identifying all patients with LM, ruling out patients at risk, and enhancing the disease management and monitoring of LM."

Key highlights:

The FORESEE trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases evaluated, surpassing the predetermined 20% primary endpoint target
CNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM
CNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisions
CNSide exhibited high specificity, with no tumor cells detected in patients without LM
CNSide demonstrated improved Negative Predictive Value in ruling out LM (25%) vs. CSF cytology (10%)
CNSide revealed HER2 positivity in LM tumors in 60% of breast cancer patients with HER2-negative primary tumors, informing physician treatment strategies
The data will be presented on Sunday, November 24, at 10:15 a.m. CST in a session titled, "CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (FORESEE Study, NCT-5414123)," by Priya Kumthekar, M.D., Associate Professor of Neurology and Hematology/Oncology, and Director of Brain Metastases Program at Northwestern, University, Chicago, Illinois.

About CNSide Test
The CNSide Cerebrospinal Fluid (CSF) Assay Platform consists of four laboratory developed tests (LDTs) used for diagnosis, treatment selection, and treatment monitoring of patients with Leptomeningeal Metastases (LM) from carcinomas or melanoma. The CNSide platform facilitates tumor cell detection / enumeration and biomarker identification using cellular assays (immunocytochemistry (ICC) and fluorescence in situ hybridization (FISH)) and molecular assays (next generation sequencing (NGS)). The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial as an exploratory endpoint, and is anticipated to become commercially available in 2025.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells; yet, there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About FORESEE Clinical Trial

The FORESEE Study is a multi-center, prospective clinical trial enrolled patients with Breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). Standard of Care methods to diagnose or assess the treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. The goal of the FORESEE Study was to evaluate the performance of CNSide in monitoring the LM’s response to treatment and to assess the impact of CNSide on treatment decisions made by physicians.

On November 22, 2024 OverT Bio, an NYC-based cell therapy company, reported that it has been awarded a $120,000 G-Rex Grant from ScaleReadyTM, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH), and CellReadyTM (Press release, OverT Bio, NOV 22, 2024, View Source [SID1234648585]). This grant will support OverT Bio’s ongoing development efforts that will lead to next generation cell therapies for solid tumors, based on innovative data-driven discovery platforms OverTargetTM and OverTCRTM.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This grant, including its access to newly developed GMP closed system products and ScaleReady’s expertise, will help us accelerate the development of our products in a way that will ensure future scalability and cost-effectiveness of these potential medicines."

The G-Rex Grant is part of ScaleReady’s $20 million grant program aimed at advancing Cell and Gene Therapy (CGT) development and manufacturing. The G-Rex Grant Program offers recipients significant no-cost support allowing for expeditious optimization of cell manufacturing processes.

"We are pleased to receive ScaleReady’s support and their recognition of the potentially high impact our technology has to advance our shared mission of bringing new life-saving therapeutics to cancer patients," stated Mat Legut, PhD, CEO of OverT Bio. "This grant, including its access to newly developed GMP closed system products and ScaleReady’s expertise, will help us accelerate the development of our products in a way that will ensure future scalability and cost-effectiveness of these potential medicines."

"Our support of OverT Bio is yet another example of how our G-Rex Grant Program is being used to facilitate advancement of the field of cell and gene-modified cell therapy," said Josh Ludwig, Commercial Director of ScaleReady. "The G-Rex Grant Program augments ScaleReady’s primary purpose of providing every CGT company with the ability to save time and money while building a strong value proposition for continued investment on favorable terms."

On November 22, 2024 The Children’s Inn at the National Institutes of Health (NIH) reported that Gilead Sciences Inc. has awarded The Inn a $1 million grant to support its renovation and expansion (Press release, Gilead Sciences, NOV 22, 2024, View Source [SID1234648584]). The grant will fund a welcome center in the new wing of The Inn of Tomorrow, a $50-plus million project for which The Inn recently held a groundbreaking ceremony. As the first point of contact, The Gilead Sciences Welcome Center is designed to ensure young patients from around the world participating in groundbreaking clinical trials at NIH feel welcomed immediately upon their arrival at The Inn.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Gilead is a valued partner whose therapeutic interests have intersected with The Inn’s since our beginning. With this grant, we look forward to transforming our space with new capabilities to support young patients, their families, and NIH researchers at every step along the journey from hopes to cures."

"We are grateful for Gilead’s continuing partnership with The Inn," said Jennie Lucca, The Inn’s CEO. "Gilead is a valued partner whose therapeutic interests have intersected with The Inn’s since our beginning. With this grant, we look forward to transforming our space with new capabilities to support young patients, their families, and NIH researchers at every step along the journey from hopes to cures."

A commitment to health equity and equitable access to NIH pediatric clinical trials are driving forces behind The Inn of Tomorrow. The Inn seeks to remove barriers to potentially lifesaving clinical research studies for diverse families, ensure all families find a "place like home" at The Inn by designing culturally inclusive programs, and use the health equity lens to determine how environment helps patients in their journey to optimal health.

"Gilead is proud to work with The Children’s Inn on their ongoing efforts to provide essential support services to these young patients and their families," said Carmen Villar, Vice President, ESG and Corporate Citizenship, Gilead Sciences. "Our contribution demonstrates our continued commitment to supporting communities and advancing health equity."

Construction on the project is scheduled to start in early 2025. In addition to the new welcome center in the 15,000-square-foot addition, The Inn of Tomorrow will incorporate improved accessibility features throughout, resulting in a state-of-the-art residential facility that reflects best practices in healthcare and hospitality. When completed in 2027, the project will expand The Inn’s capacity to serve more and younger patients – increasing annual capacity by 25% from 2,400 to 3,000 families.