On November 17, 2023 March Biosciences (March Bio), a clinical stage biotechnology company committed to combating challenging cancers unresponsive to existing immunotherapies, reported that it has received a notice of award for a major competitive grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to help support continued clinical development of its innovative chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed and refractory CD5 positive T-cell cancers (Press release, March Biosciences, NOV 17, 2023, View Source [SID1234637786]). The approximately $13.4 million product development award is intended to support March Bio’s upcoming Phase 2 clinical trial of MB-105 for the treatment of relapsed and refractory T-cell lymphomas.

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MB-105 is currently being assessed in a Phase 1 clinical trial in patients with relapsed and refractory T-cell malignancies at Baylor College of Medicine. This grant follows a $4.8 million investment from the Cancer Focus Fund announced earlier this month also to support the MB-105 Phase 2 trial.

"We are committed to advancing MB-105 and creating a best and first-in-class therapy for patients with these difficult cancers," commented Sarah Hein, cofounder and CEO of March Biosciences. "We expect that receipt of this substantial non-dilutive award from CPRIT will serve as a catalyst to our current financing activities and allow us to continue to move quickly to advance MB-105 as a novel treatment for patients seeking better options."

Patients with T-cell malignancies face a dismal prognosis once their disease becomes relapsed or refractory to first-line therapies and have extremely limited continuing treatment options, resulting in just 15% survival over about 3 years. The development of specific therapies for these indications is difficult due to the fact that many potential targets, including the CD5 receptor targeted by MB-105, are present on both normal and malignant T-cells, which means that therapies targeting malignant T-cells risk damaging the healthy T-cells needed for normal immunity.

Since CD5 is widely expressed by both normal and malignant T-cells, the MB-105 CD5 CAR-T cell therapy has been specifically engineered to preserve many healthy T-cells while maintaining potency against CD5 positive tumor T-cells. In an ongoing Phase 1 trial conducted at the Center for Cell and Gene Therapy at Baylor College of Medicine, Houston Methodist Hospital, and Texas Chidren’s Hospital, MB-105 has demonstrated a favorable safety profile and encouraging early efficacy results in patients with both relapsed and refractory T-cell lymphoma and T-cell acute lymphoblastic leukemia.

March Biosciences was cofounded with inventors Drs. Max Mamonkin and Malcolm Brenner, leading scientists from the Center for Cell and Gene Therapy who are both recipients of CPRIT research awards. Dr. Mamonkin is an Associate Professor at Baylor and serves as Chief Scientific Officer at March Biosciences. He was recently awarded the Outstanding New Innovator Award by the American Society for Cell and Gene Therapy. Dr. Brenner is a renowned leader in the field, with an extensive history of technology invention contributing to the launch of both private and public biotechnology companies. He serves as an advisor to cell therapy companies across the industry.

Dr. Mamonkin commented, "The treatment of T-cell lymphomas and leukemias has been particularly challenging, which led us to focus on the development of this new approach early on. We have been highly encouraged by the clinical results we have already seen, and I am pleased that CPRIT has recognized the potential importance of these efforts to patients and will support the continued development of the CD5 CAR-T approach."

March Bio is currently preparing for its Phase 2 trials of MB-105 with a development collaboration with recent CPRIT awardee, CTMC, a joint venture between MD Anderson Cancer Center and National Resilience.

On November 17, 2023 CytoMed Therapeutics Limited (NASDAQ: GDTC) ("CytoMed" or "Company"), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor-derived cell-based allogeneic immunotherapies for the treatment of various cancers, reported its first half of 2023 financial results and provided clinical and corporate updates (Press release, Cytomed Therapeutics, NOV 17, 2023, View Source [SID1234637784]).

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"We are committed to advancing our "off-the-shelf" allogeneic cellular immunotherapies for a broad spectrum of cancer," said Peter Choo, Chairman of CytoMed. "By committing ourselves to our stem cell research and cell therapy, we have made extraordinary progress thus far and look towards the future with overseas ambition especially China. We benefit from the low cost infrastructure in Southeast Asia."

Clinical Updates

In January 2023, the Company received formal approval from the Health Sciences Authority (HSA) in Singapore to conduct a Phase I clinical trial and has begun to recruit blood donors in July 2023. The clinical trial, in partnership with the National University Hospital (NUH), Singapore, will use the donor blood to manufacture allogeneic CAR-γδ T cells for the trial. The cells will be processed in CytoMed’s Good Manufacturing Practice (GMP) facility in Malaysia.

As of November 2023, the Company are translating two exclusively licensed technologies, namely donor blood cell-based CAR-γδ T cell technology and induced pluripotent stem cell-based γδ NKT cell technology. The former has been granted patents in the US and China, the latter in Japan and China.

Financial Results for the Six Months Ended June 30, 2023

Net Loss: For the six months ended June 30, 2023, the Company’s unaudited net loss amounted to S$1.16M ($860,695) excluding expenses related to its NASDAQ Initial Public Offering (IPO) in April 2023 and the costs associated with being a public listed company, compared to S$936,377 for the six months ended 2022.

Cash and Cash Equivalents: As of June 30, 2023, the Company had cash and cash equivalents of S$10.44M ($7.72M). Over the course of the last six months, the Company raised S$12.94M ($9.57M) gross proceeds from the IPO.

R&D Expenses: The Company’s research and development expenses were S$811,319 ($599,955) and S$604,043 for the six months ended June 30, 2023, and 2022, respectively. This was primarily due to the clinical progress achieved over the last six months.

G&A Expenses: The Company’s general and administrative expenses were S$1.50M ($1.11M) and S$306,457 for the six months ended June 30, 2023, and 2022, respectively. The increase was primarily driven by non-recurring IPO expenses and the costs associated with being a public listed company.

Conference Call Information

The investment community may participate in the conference call by tuning into the following webcast:

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On November 17, 2023 CG Pharmaceuticals reported the commencement of Phase 2 study for metastatic pancreatic ductal adenocarcinoma (PDAC) with the recommended Phase 2 dose (RP2D) of ivaltinostat (ClinicalTrials.gov ID NCT05249101) (Press release, CrystalGenomics, NOV 17, 2023, View Source [SID1234637783]).

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The RP2D of ivaltinostat (250 mg/m2) was determined by the Safety Review Committee (SRC) following a thorough safety data review from 3 cohorts of increasing dose levels of ivaltinostat in combination with a fixed dose of capecitabine. The SRC has unanimously recommended proceeding to Phase 2, marking a significant milestone, effective immediately, the study is open for the enrollment of patients.

In Phase 2, metastatic PDAC patients who show no evidence of disease progression after an initial treatment with FOLFIRINOX will receive either combination therapy or capecitabine monotherapy. The primary endpoint is progression free survival.

Dr. Gene Cho, Vice President of Global Strategic Planning at CG Pharmaceuticals, expressed his excitement, "I am thrilled and honored to share this important study milestone and witness the commencement of Phase 2, with an enrollment target of 52 patients. We extend our heartfelt gratitude to our investigators, partners, and, most importantly, our patients for their invaluable participation in this critical study."

The study abstract has been accepted by the ASCO (Free ASCO Whitepaper) GI and will be presented on January 19, 2024, San Francisco, California.

About Ivaltinostat:

Ivaltinostat, a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase, has been evaluated for solid tumors and hematologic malignancies.

On November 17, 2023 GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, reported an increase of clinical cases in the United States using its GammaTile Therapy in patients diagnosed with several brain tumor types (Press release, GT Medical Technologies, NOV 17, 2023, View Source [SID1234637781]). The data was presented at the Society for Neuro-Oncology (SNO) 28th Annual Meeting and Education Day taking place from November 15-19, 2023, at the Vancouver Convention Center in Vancouver, Canada.

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The results were presented by Chief Medical Officer Dr. Michael Garcia of GT Medical Technologies as a poster entitled, "Usage Trends of Collagen Tile Brachytherapy for the First 1,000 Orders," (Abstract INNV-05) on Friday, November 17. GammaTile has been used in over 1,000 patients with both newly diagnosed malignant brain tumors and recurrent brain tumors since 2019 and has been used in different tumor types, including glioblastoma, brain metastasis and meningioma. Within this poster, study authors reported that GammaTile usage is rising over time. They saw an increase of orders in every quarter over more than 4 years.

"It is encouraging to see an increase in adoption of GammaTile across the country as this demonstrates that more and more patients are having access to this treatment option, especially since treatment options can be limited in the recurrent brain tumor setting," said Dr. Garcia. "It was rewarding to present these results to the neuro-oncology community. I’m also proud of GammaTile’s commitment in investing in clinical trials and the fact that we are studying quality of life on these trials."

Currently, GammaTile is sponsoring 4 clinical trials including a multi-institute registry trial (NCT0442738) that includes quality of life as a study metric. Another poster presented by Dr. Garcia on November 17, titled, "Impact of Collagen Tile Brachytherapy as Treatment for Recurrent Glioblastoma on Functional Status and Quality of Life," (Abstract: NCOG-36) outlines how quality of life is being studied for patients who receive GammaTile for recurrent glioblastoma.

On November 17, Adam Turner, PhD, DABR, and Senior Director of Medical Physics of GT Medical Technologies, presented a poster presentation, entitled," A Biologically Effective Dose Comparison between Radiosurgery and Collagen Tile Brachytherapy for Post-operative Treatment of a Brain Metastasis Resection Cavity," (Abstract: RADT-13). The poster reported that GammaTile provided excellent biologically effective dose (BED) coverage to oncologically at-risk brain tissue adjacent to the resected tumor bed, while demonstrating a rapid radiation dose fall-off outside of the target volume. These dose characteristics might underlie the durable local control seen in the recurrent brain metastasis setting, though larger-scale analyses are being performed with clinical outcomes on the multi-institute registry trial (NCT0442738), and there is a Phase 3 trial evaluating GammaTile for newly diagnosed brain metastases needing resection (NCT04365374).

All posters were presented on November 17 from 7:30 pm to 9:30 pm in Exhibit Hall A/B of the convention center. The full poster abstracts can be access by the meeting mobile app.

GammaTile Therapy is a Surgically Targeted Radiation Therapy (STaRT) that delivers immediate radiation and eradicates brain tumor cells before they can replicate post-surgery while helping to protect healthy brain tissue. GammaTiles are bioresorbable collagen embedded with radioactive seeds, Cesium 131.

Since GammaTile Therapy received FDA clearance in 2018 for recurrent brain tumors and in 2020 for newly diagnosed malignant tumors, more than 1,000 patients have benefitted from its innovative design that targets remaining cancer cells after a tumor is surgically removed.

On November 17, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported the presentation of new Phase 2 clinical data for ST101 at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting 2023 (Press release, Sapience Therapeutics, NOV 17, 2023, View Source [SID1234637780]). The poster summarized results from an ongoing surgical window of opportunity sub-study in newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM) patients.

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Poster Presentation Details and Summary of Data:

Title: "Neoadjuvant treatment with monotherapy ST101, a C/EBPβ antagonist, results in pathological and clinical responses in glioblastoma patients. Tissue-based analysis and clinical outcomes from a surgical window of opportunity clinical trial."
Poster Number: CTNI-44
Date and Time: Friday, November 17, 2023, 7:30 pm – 9:30 pm PT
Presenter: Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center

The SNO poster summarized data from an ongoing surgical window of opportunity sub-study designed to assess the effect of neoadjuvant and adjuvant treatment with ST101 on tumor tissue and clinical outcomes, as well as assessment of biomarkers in tumors and blood.
In the sub-study, patients receive 2-4 doses of IV 500 mg ST101 QW neoadjuvant.
Following surgery, ndGBM patients continue ST101 QW + temozolomide (TMZ) + radiation; rGBM patients continue ST101 as monotherapy.
MRI assessment is conducted at screening, post ST101 neoadjuvant and before surgery, after surgery, and every 9 weeks thereafter.
As of November 7, 2023, 12 patients received 2-4 doses of ST101 before surgery and were evaluable (6 with ndGBM and 6 with rGBM).
Key Results as of November 7, 2023:

Newly diagnosed GBM:
83% Disease Control Rate (DCR), including 1 Complete Response (CR) and 4 patients with Stable Disease (SD), in 6 patients treated with neoadjuvant and adjuvant ST101 as part of their standard of care treatment.
5/6 patients remain on study, with a treatment duration of ~15-38 weeks.
Recurrent GBM:
67% DCR, including 2 Partial Responses (PRs) and 2 SD, in 6 patients treated with neoadjuvant and adjuvant ST101 monotherapy.
3/6 patients remain on study with disease control beyond 6 months (2 PR and 1 SD), resulting in a 6-month PFS of 50%.
Extensive treatment-related effects (geographical necrotic tissue) were observed in GBM patients treated with neoadjuvant ST101 monotherapy, including patients who were previously treatment-naïve.
"The results demonstrated with ST101 in this GBM study are very encouraging, given the poor prognosis associated with this devastating brain cancer. Based on the results thus far, administration of ST101, before and/or after brain surgery, has a direct impact on GBM cells and a favorable effect on the tumor microenvironment, which translates to longer disease control and potential partial or complete responses to therapy," said Dr. Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center. "I look forward to continuing to evaluate ST101 in the ongoing Phase 2 study and delivering hope to my GBM patients and their families."

More information can be found on the 2023 SNO website.

About ST101

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing Phase 2 dose expansion rGBM cohort (n=30), ST101 weekly administration resulted in a 30% Disease Control Rate (DCR) with 1 Partial Response (PR) and 8 patients with Stable Disease (SD), with a 6-month median duration of SD. In the ongoing surgical window of opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in newly diagnosed GBM (ndGBM).

ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and Orphan Drug designations for glioma from the U.S. FDA and the European Commission.