On October 20, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data supporting the clinical utility of its DecisionDx-Melanoma and DecisionDx-SCC tests in guiding risk-aligned treatment decisions, including SLNB for patients with melanoma and surveillance imaging for those with SCC (Press release, Castle Biosciences, OCT 20, 2024, View Source [SID1234647276]). The data were shared in two video abstracts at the 2024 American Society for Dermatologic Surgery (ASDS) Annual Meeting, held Oct. 17-20, 2024, in Orlando, Florida.

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"While staging is an important part of skin cancer risk assessment, well-validated molecular tests like DecisionDx-Melanoma and DecisionDx-SCC are designed to look deeper into the biology of a patient’s tumor to provide additional insight into its likely behavior," said Etan Marks, D.O., board-certified pathologist, laboratory director and primary investigator at Advanced Dermatology and Cosmetic Surgery in Delray Beach, Florida. "As demonstrated in the studies at ASDS, these insights can enhance clinical decision-making and arm clinicians with more precise risk information to help route patients to the most appropriate modality aligned to their risk of metastasis and survival."

Details regarding Castle’s video abstracts presented at ASDS are included below:

DecisionDx-Melanoma

Title: The i31-GEP identifies patients with T1 cutaneous melanoma who can safely avoid sentinel lymph node biopsy: Results from a prospective, multicenter study
Lead Author: Etan Marks, D.O., Advanced Dermatology and Cosmetic Surgery, Delray Beach, Florida
Key take-aways:
National Comprehensive Cancer Network (NCCN) guidelines regarding SLNB are most ambiguous for patients with T1a tumors with high-risk features and T1b tumors, for whom SLNB may be considered due to an increased risk of metastasis. Data from this ongoing prospective, multicenter study (CONNECTION) confirm that DecisionDx-Melanoma can identify patients with T1 tumors with a low risk of sentinel lymph node positivity who can safely forgo SLNB (negative predictive value of 98.4%), while maintaining very high survival rates in low-risk patients who did not have an SLNB (three-year recurrence free survival rate of 99.5%).1 Additionally, the data indicate that using DecisionDx-Melanoma test results to guide SLNB decisions in patients with T1 tumors could have reduced the number of unnecessary biopsies by up to 64%, as well as procedure-related complications and health care costs.
View video abstract here.
DecisionDx-SCC

Title: The 40-gene expression profile (40-GEP) test enhances risk-aligned guidance for surveillance imaging in high-risk cutaneous squamous cell carcinoma (cSCC)
Lead Author: Emily S. Ruiz, M.D., MPH, Brigham and Women’s Hospital and Harvard Medical School, Boston
Key take-aways:
Radiologic surveillance imaging in patients with high-risk SCC can identify disease recurrence earlier, which may improve patient outcomes. This study evaluated the utility of the DecisionDx-SCC test in guiding these decisions in patients with higher stage disease (i.e., patients with BWH T2b SCC tumors), whom studies have shown are at a higher likelihood of nodal or distant metastasis relative to lower-staged patients. In the study, approximately 42% of the patients with T2b tumors who received radiologic surveillance imaging received a Class 1 (low risk) test result and had a metastasis rate of 5.9%, indicating that clinicians could have safely deferred surveillance imaging for these Class 1 patients due to the low metastatic rate. For patients who were not imaged, almost 50% received a Class 2A or 2B (higher or highest risk) test result and had an 18.8% metastasis rate, suggesting that these patients may have benefitted from imaging to promote early detection of disease progression and improved outcomes. Overall, these data demonstrate the utility of DecisionDx-SCC to help improve selection of BWH T2b patients for radiologic surveillance imaging based on their biological risk of metastasis, as provided by the test.
View video abstract here.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2024, DecisionDx-Melanoma has been ordered more than 173,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to stratify risk of metastasis in patients with cutaneous squamous cell carcinoma who have one or more NCCN high-risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management and guide decision-making regarding the use of adjuvant radiation therapy. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that the test can significantly improve risk-stratification when used with traditional staging systems and clinicopathologic risk factors to guide risk-aligned management and treatment decisions. Learn more at www.CastleBiosciences.com.

On October 19, 2024 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, reported the presentation of clinical data from its ongoing Phase 1a/1b clinical trial of NX-5948, an orally bioavailable, brain penetrant degrader of Burton’s tyrosine kinase (BTK), in patients with relapsed/refractory Waldenstrom’s macroglobulinemia (WM) at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-12) which is being held in Prague, Czech Republic October 17–19, 2024 (Press release, Nurix Therapeutics, OCT 19, 2024, View Source [SID1234649113]).

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"We are encouraged by the emerging positive data from NX-5948 in patients with Waldenstrom’s macroglobulinemia, which add to the previously disclosed robust clinical activity observed in patients with chronic lymphocytic leukemia," said Paula G. O’Connor, M.D., chief medical officer of Nurix. "These data support our decision to advance NX-5948 into the ongoing Phase 1b expansion cohort in patients who have previously received at least one prior line of therapy including a BTK inhibitor and patients presenting with Bing-Neel syndrome, a rare form of WM with central nervous system involvement where NX-5948’s ability to penetrate the brain may offer a distinct advantage."

The data presented at IWWM-12 included previously reported safety findings for all patients in the Phase 1a dose escalation study treated with NX-5948 at doses ranging from 50 mg to 600 mg once daily by oral administration regardless of diagnosis (n=79) based on an April 17, 2024 data cut. NX-5948 demonstrated a tolerable safety profile, and the safety profile for patients with WM was consistent with the safety profile for the overall population (WM patient safety data not shown separately).

New data from an October 10, 2024 data cut include the baseline characteristics of the first 13 patients with WM enrolled across both the Phase 1a and Phase 1b portions of the trial, clinical response assessments in 9 response-evaluable patients, and duration on study for all 13 patients. Among the 13 WM patients, the median age was 74 years and the median number of prior lines of therapy was 3. All 13 patients previously had been treated with both BTK inhibitors (BTKi) and chemotherapy/chemo-immunotherapy. Three patients (23.1%) had received prior treatment with the non-covalent BTKi pirtobrutinib, and one patient (7.7%) had received prior treatment with a BCL2 inhibitor. Baseline mutation status in MYD88 and CXCR4 was captured from patient records, and eight patients (61.5%) had mutations in MYD88, and two patients (15.4%) had mutations in CXCR4. Among the nine patients who were evaluable for response, seven patients (77.8%) had an objective response and two patients experienced stable disease (22.2%). All seven responses were observed at the first assessment at 8 weeks, and five remain on treatment with two patients on treatment for longer than one year. Responses were observed in patients regardless of their baseline mutations in MYD88 and CXCR4.

Two illustrative cases studies of patients treated with NX-5948 were presented. The first case study is a patient with baseline MYD88 and CXCR4 mutations and four prior lines of therapy, including autologous bone marrow transplantation and ibrutinib, who demonstrated a rapid response observed at the first assessment and remained on study at the time of the October 10, 2024 data cut with greater than one year of treatment (currently in cycle 16; 28 days per cycle). NX-5948 treatment resulted in deepening of response over time as measured by reduction in serum IgM levels, a key biomarker of clinical response in WM patients. The second case study is a patient with baseline MYD88 mutation and three prior lines of treatment, having most recently progressed while on zanubrutinib. This patient also experienced a rapid response at the first assessment with decreasing IgM through treatment which was ongoing in cycle 15 at the time of the October 10, 2024 data cut.

The IWWM-1 presentation is available in the Scientific Resources section of Nurix website in the Posters and Presentations section.

About NX-5948
NX-5948 is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. NX-5948 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Nurix has previously reported that NX-5948 is highly potent against a range of tumor cell lines that are resistant to current BTK inhibitor therapies, an important consideration in heavily pretreated CLL/SLL patient populations. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022).

About Waldenstrom’s Macroglobulinemia
WM is a rare, slow growing type of non-Hodgkin’s lymphoma that is characterized by the replacement of normal bone marrow cells by malignant lymphocytic cells that produce monoclonal IgM. This replacement leads to anemia, bleeding, and impaired immune function, while the elevated IgM levels may cause neurologic symptoms. In the United States the annual incidence rate is approximately 3 per million or between 1,000 to 1,500 newly diagnosed patients per year. Recommended first-line treatments including chemoimmunotherapy and BTK inhibitor therapy. There are no therapies approved to treat patients after BTKi. Additional therapeutic options are needed.

On ober 18, 2024 REGiMMUNE, the regulatory T cell targeting drugs for immunotherapy and Kiji Therapeutics, the specialist in Induced Pluripotent Stem Cells-Mesenchymal Stem Cells (IPSC-MSC) engineered cell therapies for inflammatory diseases, reported an intention to merge both companies (Press release, REGimmune, OCT 18, 2024, View Source [SID1234651585]). This merger will create the Treg specialist REGiMMUNE/Kiji TX. The merger will be subject to customary conditions and full final due diligence by both parties.

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The creation of the merged new company will combine the complimentary portfolio of platforms and therapies to create an international Treg biotech, and the leading company globally in modulating Treg function. Both companies have been focused on addressing unmet medical needs by the modulation of the Treg function. REGiMMUNE has been able to regulate the role of the Treg by using a molecule enhancer to increase Treg function, and monoclonal antibodies (depleter; inhibitor) to reduce the function of, or eliminate Tregs. Kiji can add an advanced, next generation multigene engineered stem cell therapy IL10 enhancer to increase Treg anti-autoimmune function.

The combination of these technologies will create an international specialist in Treg modulation and will focus on immune-oncology and autoimmunity. It will combine three diverse platforms, based on small molecules, monoclonal antibodies and cell and gene therapy. This will give REGiMMUNE/Kiji TX the ability to augment or reduce Treg function in vivo by downregulating Tregs in immune-oncology and upregulating Tregs in autoimmunity.

Commercially, REGiMMUNE/Kiji TX will prepare for an IPO with a listing in the Emerging Stock Market in Taiwan. Therapeutically, REGiMMUNE/Kiji TX will now initially focus its multiple target pipeline on 4 therapies. It will establish proof of concept with gene engineered mesenchymal stem cells (KJ01) in graft-versus-host disease (GvHD), and prepare for clinical entry in the second half of 2025, develop its iPSC platform (KJ02) for Inflammatory Bowel Disease (IBD), Psoriasis and CNS disorders, define clinical readiness with a Treg depleting/inhibiting monoclonal antibody (RGI6004) and advance clinical development with the launch of a phase III clinical trial with a clinical stage small molecule Treg enhancer targeting GvHD (RG2001). This will be developed for potential partnering activities.

The companies were brought together in discussions by the main REGiMMUNE shareholder, DCI Partner Co., Ltd. With high level executives based in Taiwan, Japan, Europe and the US, REGiMMUNE/Kiji TX will provide a global bridge for cell and gene therapy (CGT) development, and take advantage of the strong and growing interest in Southeast Asia, and specifically Taiwan for CGT.

The companies will be led by a highly experienced senior management team, with Miguel Forte as CEO and Kenzo Kosuda as co-CEO. Miguel Forte will contribute his extensive experience and network as the current President of leading global CGT association, the International Society for Cell & Gene Therapy (ISCT) and Alliance for Regenerative Medicine (ARM) board and executive committee member. Kenzo Kosuda brings extensive financial and management expertise together with East Asia experience. Tony Ting will be chief scientific officer, Ping Chung will be chief technology officer, TsungYen Wu will be chief business officer and Steve Yang will be chief operating officer.

"Tregs have proved themselves to be a leading promising modality in the cell and gene therapy field, both therapeutically and commercially. As a result of this potential, we have collectively created a global Treg specialist super-company to realize this potential," said Miguel Forte, CEO, Kiji TX. "We will also be able to combine several fields, including small molecule, CGT and monoclonal antibodies to use Tregs to their full potential. These approaches are off-the-shelf and allogeneic, with a competitive advantage over autologous or patient matched Treg approaches currently in development in the sector. The new company now has a variety of options, including an IPO by mid-2025 in the Taiwan Stock Exchange. This will enable REGiMMUNE/Kiji TX to develop our multiple therapeutic pipeline in–house, as well as partnering for co-development or out-licensing."

"Modulating Treg function in both directions has significant potential in a variety of conditions with major commercial benefits. Creating the new Treg specialist REGiMMUNE/Kiji TX will result in a company that will have the resources to achieve this potential. With a planned IPO in 2025, we will be able to combine leading modalities to develop therapies for conditions involving significant numbers of patients globally," said Kenzo Kosuda, CEO, REGiMMUNE. "The global reach of the company and experience of the senior management also enables us to explore development across the globe to match the therapeutic potential and size of the market that is open to us."

On October 18, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that members of the Company’s senior management team will participate in the following investor conferences in November and December 2024 (Press release, Zai Laboratory, OCT 18, 2024, View Source [SID1234647273]):

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Goldman Sachs APAC Healthcare Corporate Day 2024
Time: November 5-8, 2024
Location: Hong Kong, Hong Kong

Jefferies London Healthcare Conference
Fireside Chat: Tuesday, November 19, 2024,1:30 p.m. GT
Location: Aldwych, London

Citi’s 2024 Global Healthcare Conference
Time: December 3-5, 2024
Location: Miami, Florida

On October 18, 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 its financial results for the six months ending June 30, 2024, and provides business and clinical highlights and an outlook for the rest of the year (Press release, TME Pharma, OCT 18, 2024, View Source [SID1234647272]).

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Aram Mangasarian, CEO of TME Pharma commented: "2024 has been a highly productive year for TME Pharma marked by a series of important clinical, regulatory and financial achievements, that fully demonstrate our capabilities and potential to investors. The latest analysis of GLORIA clinical data showcased at this year’s ESMO (Free ESMO Whitepaper) Congress highlighted the statistically significant benefit of NOX-A12 combined with bevacizumab and radiotherapy in glioblastoma patients when compared not only to the standard of care, but also to NOX-A12 combined with radiotherapy alone. Our extensive preclinical and clinical data package for NOX-A12 led to the FDA clearance of our IND application for a Phase 2 study and granting of Fast Track designation, substantially clarifying NOX-A12’s path to market. Our Phase 2 preparations are underway, and we are in active discussions to secure the required funding. It is our firm belief that that further validation of NOX-A12’s survival benefit through additional data will catalyze significant interest from the pharmaceutical industry, offering licensing and partnering opportunities and increasing value creation for our shareholders. Furthermore, we have made great progress in developing the spin-out opportunity for NOX-E36. We believe that its anti-fibrotic properties make it potentially applicable to a large number of ophthalmologic conditions, including glaucoma surgery, diabetic retinopathy, and both wet and dry forms of age-related macular, which offer a much larger market."

Business and Clinical Highlights

Potential for Unprecedented Clinical Benefit in Glioblastoma

The GLORIA NOX-A12 clinical trial has achieved exceptional clinical results in newly diagnosed glioblastoma patients with extremely poor prognosis that have tumors resistant to standard chemotherapy plus incomplete surgical resection showing potential benefit as a therapy for glioblastoma.

The study achieved a remarkable 19.9-month median overall survival (mOS) rate for patients receiving NOX-A12 in combination with the VEGF inhibitor bevacizumab and radiotherapy. This doubles the 9.5-month mOS rate demonstrated in the standard of care matched reference cohort, as presented by Dr. Frank Giordano, the lead investigator of the clinical trial, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in September 2024. The ESMO (Free ESMO Whitepaper) presentation further revealed statistically significant improvement in survival for this triple combination (NOX-A12 + bevacizumab + radiotherapy) over standard of care reference cohort as well as NOX-A12 + radiotherapy alone.
Analysis of the competitive landscape has shown that the NOX-A12 survival results surpass those from what TME Pharma believes are all relevant therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy. NOX A12’s effectiveness is even more impressive considering the NOX-A12 GLORIA trial enrolled patients with a worse prognosis than those in the competitor trials. The NOX-A12 trial only enrolled patients with residual detectable tumor after surgery whereas competitor trials also included patients with no detectable tumor after surgery, i.e. patients that would be expected to have a better average survival outcome.
This progress highlights the immense potential of NOX-A12 to transform the treatment of glioblastoma patients, who face a devastating prognosis from this highly aggressive form of brain cancer.

Clear Path for Phase 2 Clinical Development with Open IND and Fast Track Designation Awarded by US FDA, and Protocol Approved in Germany

TME Pharma engaged in discussions with the US Food and Drug Administration (FDA) in late 2023 to establish a clear regulatory roadmap for the next stage of NOX-A12’s clinical development.

The FDA cleared in March 2024 TME Pharma’s Investigational New Drug (IND) application on the basis of the protocol for a randomized, controlled Phase 2 clinical trial in glioblastoma, allowing the company to expand clinical development in the US. Subsequently, the Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) has also approved the protocol, enabling the company to conduct Phase 2 study in Germany.
NOX-A12 was also granted Fast Track designation by the US FDA. This designation aims to facilitate the development and expedite the review of drugs addressing serious conditions like glioblastoma. Companies whose programs are granted Fast Track Designation can benefit from more frequent interactions with the FDA during the clinical development process, and thus potentially accelerated timelines.
TME Pharma perceives the achievement of these two key regulatory milestones as the FDA’s recognition not only of the urgent unmet medical need which glioblastoma represents, but also the potential of NOX-A12 to address it. This paves the way to accelerate NOX-A12’s route to market while providing investors and potential partners with a clear development pathway for NOX-A12.

Publication of Data from the GLORIA Study in Nature Communications

The research by Dr. Frank Giordano at the University Medical Center Mannheim and members of the five other centers in Germany led by a translational research team at the University of Bonn on a potential predictive biomarker, the "EG12 score", was published in the high-impact peer-reviewed journal, Nature Communications.

The article highlights that the presence of NOX-A12’s target in tumor tissue can be used as a biomarker to predict the success of treatment with NOX-A12 and radiotherapy in glioblastoma patients.
The EG12 biomarker’s predictive character provides robust evidence of NOX-A12’s mechanism of action.
Tumor tissue analysis revealed that patients with higher biomarker scores show superior clinical efficacy when treated with NOX-A12 + radiotherapy than patients with low biomarker scores.
The EG12 score is calculated by analyzing the frequency of positivity for NOX-A12’s target, CXCL12, on two key cell types in the glioblastoma tumor microenvironment: endothelial (E) and glioma (G) cells.
H1 2024 Financial Highlights

For the reporting period, the Group – TME Pharma N.V., TME Pharma AG and TME Pharma Inc. – has not generated any revenues. The Group, like most pre-commercial biotech companies, does not expect any revenues to be generated from any product candidates that it develops until the Group either signs a licensing or collaboration agreement or obtains regulatory approval and commercializes its compounds.

Research and development (R&D) expenses decreased by 16% in H1 2024 over the same period last year. This reduction is primarily due to the GLORIA trial of NOX-A12 in brain cancer nearing completion, which required lower costs while at the same time generating more mature data. As a result, TME Pharma was able to decrease drug manufacturing costs, service fees and other costs related to the clinical trials and preclinical testing, in addition to lower personnel expenses, patent costs and consulting services, partly offset by higher other research and administrative expenses.

General and administrative (G&A) expenses increased by 12% in H1 2024, mainly driven by higher legal, consulting and audit fees in connection with the financing transactions in the first six months of 2024. The net loss for H1 2024 decreased by 11% compared to the prior year period.

Capital Raised in H1 2024

The company raised €5 million (gross) through multiple financial transactions in the first half of 2024.

The successful €1.48 million (gross) private placement with a group of new investors closed in February 2024 was intended for buyback of outstanding convertible debt and allowed the company to redeem all of the outstanding convertible bonds held by Atlas Special Opportunities (ASO) at that time. The event marked the end of TME Pharma’s convertible bond financing program with ASO.
TME Pharma successfully completed a capital raise in June 2024 for a total consideration of €2.35 million (gross) through a private placement with professional investors and a public offering to retail investors in France via the PrimaryBid platform.
In addition, the company raised €1.2 million (gross) through Warrants Y and Z exercises during the first half-year 2024, resulting from the preferential rights issue launched in November 2023. Subsequent to the reporting period, the exercise of Warrants Z, settled in September 2024, resulted in the issuance of 1,940 new shares for gross proceeds of €0.4 thousand. Outstanding 2,811,080 Warrants Z have potential to raise an additional €0.7 million if exercised in full before the end of the final exercise period in June 2025.
TME Pharma has focused its financial resources on achieving its primary goal of generating mature overall survival data in the GLORIA trial of NOX-A12 in brain cancer and creating an attractive clinical and regulatory package to enable initiation of Phase 2 trial. With the trial now nearing completion, TME Pharma will assess how and where to deploy the Group’s available financial resources to maximize the chances of NOX-A12 reaching the market.

Considering cash and cash equivalents of €2.7 million as of June 30, 2024, TME Pharma has financial visibility into January 2025.

Outlook for the Remainder of 2024 and for 2025

NOX-A12 Clinical Development Plans in Glioblastoma

TME Pharma has achieved significant regulatory milestones in advancing the NOX-A12 glioblastoma program to the next phase of clinical development, having received approval for the Phase 2 study protocol from both the FDA in the US and BfArM in Germany. TME Pharma’s next milestones in the clinical development of the NOX-A12 program are financing and initiation of the randomized, controlled Phase 2 clinical trial. With clinical trial preparations underway and sufficient supply of NOX‑A12 available, the clinical trial can be launched rapidly upon closing of the funding gap. The company is actively engaged in discussions with potential strategic industrial partners and governmental institutions to out-license NOX-A12 and secure non-dilutive support for the upcoming clinical trial.

NCI’s Presentation of NOX-A12 Pre-Clinical Research at SNO

The Society for Neuro-Oncology (SNO) Annual Meeting in November 2024 will feature a poster presentation highlighting data from preclinical studies conducted at the U.S. National Cancer Institute (NCI) exploring the effects of inhibition of CXCL12 by NOX-A12 in combination with immune checkpoint inhibition in glioblastoma models. The research was conducted at the NCI 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.

Clinical development plans for NOX-E36

While TME Pharma has largely focused its available resources on NOX-A12 during recent years, TME Pharma also has a second clinical-stage asset, NOX-E36. While limited resources have been employed behind NOX-E36 over the last two years, it presents a very promising opportunity for development in eye diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The anti-fibrotic mode of action of NOX-E36 has already been demonstrated in a relevant animal model published by researchers at the Singapore Eye Research Institute (SERI), and TME Pharma believes that development in ophthalmological indications could be a promising opportunity to diversify its project portfolio. For these reasons, TME Pharma has engaged in discussions with multiple players and institutions specialized in ophthalmology to develop NOX-E36 in the clinic with minimal or no financial contribution from TME Pharma, yet leaving a potential commercial success as potential upside to TME Pharma’s investors.

The Group will carefully monitor its available cash and calibrate additional financings through available sources in order to ensure its ability to complete its ongoing trial and pursue financing of its future clinical development plans in brain cancer and, to the extent deemed appropriate, maintain a sufficient cash runway, yet minimize shareholder dilution whenever possible.