On November 17, 2023 BioMimetix JV, LLC, a clinical-stage biotechnology company developing metalloporphyrins, a novel drug class for the treatment of cancer patients, reported the presentation of encouraging data from its Phase 2 study of lead candidate, BMX-001, for the treatment of high-grade glioma (HGG) at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting (Press release, BioMimetix Pharmaceutical, NOV 17, 2023, View Source [SID1234637787]). In the Phase 2 study, BMX-001 in combination with radiotherapy (RT) and temozolomide (TMZ) demonstrated a 6.6 month increase in median survival, mitigation of radiation-induced cognitive issues, and improved white matter integrity with a tolerable safety profile, compared to current standard of care. The abstract will be published in SNO’s official journal, Neuro-Oncology.

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"Patients with high grade glioma are challenging to treat because the disease grows quickly, ultimately outcomes are very poor for these patients and often carries an unfavorable prognosis. Current treatments aim to remove the tumor through surgery or slow its growth using chemotherapy and radiation therapy, but they are not curative and are associated with significant toxicities, including radiation-induced cognitive dysfunction that is responsible for negatively impacting the quality of life for our patients. The diversity of cases makes finding a cure difficult, and seeing durable responses in these patients is encouraging," said Katy Peters, MD PhD FAAN (Lead Principal Investigator). "BMX-001 is a promising first-in-class molecule with clinically meaningful activity and the potential to become a new treatment option for patients diagnosed with high grade glioma."

"The exciting data presented today at SNO underscore what I have sought to achieve over the past several decades in our scientific research. The primary mechanism of action of a redox active metalloporphyrin is modulation of key pathways of cellular signaling in a pattern that augments radiation therapy in killing tumor cells while protecting normal tissues. This is demonstrated by the promising effects seen in this trial with BMX-001 on patients with high grade glioma receiving concurrent radiation and chemotherapies," said James Crapo, M.D., Chief Executive Officer at BioMimetix. "High grade glioma is an aggressive brain cancer with a low survival rate that affects 10,000-15,000 people in the US per year. A substantial increase in median survival over the standard of care coupled with improved quality of life represents a significant stride towards bringing patients a transformative treatment. We are motivated to continue developing BMX-001 for this area of high unmet need, while also continuing to explore the utility of BMX-001 in other cancer types."

Presentation Highlights:

The Phase 2 clinical trial included 160 subjects with newly diagnosed high grade glioma of which 145 completed protocol treatment.
Patients on concurrent RT/TMZ who also received BMX-001 were found to have an increased median survival of 6.6 months.
BMX-001 also mitigated radiation-induced cognitive issues – demonstrated by an increase in Hopkins Verbal Learning Test scores at 6-months post-baseline versus the control group, and an improvement in Brief Assessment of Cognition (BAC) scores.
BMX-001 was found to have an excellent safety profile.
Presentation Details:
Title: Results of BMX-HGG study: a multi-institutional, randomized phase 2 clinical trial of concurrent chemoradiation with or without BMX-001 in patients with newly diagnosed high-grade glioma
Abstract Number: LTBK-09
Date and Time: Friday, November 17, 2023, from 9:05 – 9:15 a.m. PT
Session: Plenary I, Exhibit Hall C
Presenter: Katherine Peters, M.D., Duke University Medical Center

About BMX-001

BMX-001 is a metalloporphyrin, a novel class of redox-active, small molecule. The active center is designed to mimic the center of superoxide dismutase. The primary mechanism of action is modulation of cellular signaling pathways. BMX-001 inhibits both NFkB and HIF-1a. By inhibiting these pro-survival and pro-angiogenic transcription factors, BMX-001 augments tumor killing by radiation therapy and inhibits tumor regrowth. The inhibition of NFkB blocks major components of the inflammatory cascade which simultaneously results in protection of normal tissue from radiation induced injury. BMX-001 is also being developed in head and neck cancer, anal cancer, and rectal cancer and has been previously granted Orphan, Fast Track and Breakthrough designations by the FDA.

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

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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.