Meningeal Carcinomatosis

The novel combination therapy with atezolizumab and bevacizumab added to chemotherapy as first-line treatment in the ATRACTIB trial demonstrates significant antitumor activity in in patients with advanced triple-negative breast cancer Cohort 5 of the DEBBRAH trial, reveals promising results, including a median overall survival of 13.3 months in patients with HER2[+] and HER2-low breast cancer with leptomeningeal carcinomatosis These results bring renewed optimism providing a beacon of hope to patients confronting pressing medical challenges in these difficult-to-treat diseases SAN ANTONIO, Dec. 8, 2023 /PRNewswire/ -- MEDSIR, a global leader in oncology research, today presented significant breakthroughs in the fight against aggressive breast cancer at the 46th San Antonio Breast Cancer Symposium (SABCS) that have the potential to transform the lives of breast cancer patients. The results from the ATRACTIB trial, focusing on advanced triple-negative breast cancer (TNBC), and DEBBRAH Cohort 5, centered on HER2[+] or HER2-Low advanced breast cancer with leptomeningeal carcinomatosis, offer new hope for patients with limited treatment alternatives. ATRACTIB: Transforming the Landscape for TNBC Patients This phase II clinical trial highlights the success of a combined therapy approach as a first-line treatment for advanced TNBC patients. Specifically, the combination of anti-PD-L1 atezolizumab and antiangiogenic bevacizumab with chemotherapy agent paclitaxel, demonstrated significant antitumor activity. This breakthrough holds particular significance since most of the patients included in this trial had PD-L1 negative tumors. Dr. María Gion, Medical Oncologist at Ramón y Cajal University Hospital and first author of the study, presented the study's outcomes, revealing a median progression-free survival of 11 months—a substantial delay in cancer progression compared to previous data on similar patient populations—. Impressively, 63% of patients responded positively to the treatment, achieving 13 complete responses and 50 partial responses, with a median duration of response reaching 10 months. Notably, the clinical benefit was observed in 79% of patients. In the trial, 100 adult patients with untreated advanced TNBC received intravenous atezolizumab, bevacizumab, and paclitaxel until disease progression, intolerable toxicity, death, or patient withdrawal. The safety considerations revealed that peripheral neuropathy (68%) and fatigue (62%) were the most common side effects. Grade 3/4 adverse events, occurred in 47% of patients, primarily peripheral neuropathy (13%) and neutropenia (12%). Importantly, there were no drug-related deaths. The combination of immunotherapy, antiangiogenic therapy, and chemotherapy demonstrated a manageable safety profile and merits further research for PD-L1-negative advanced TNBC patients. DEBBRAH Cohort 5: Shaping the future for HER2[+] and HER2-Low Advanced Breast Cancer with Leptomeningeal Carcinomatosis The DEBBRAH trial, focusing on HER2[+] or HER2-Low advanced breast cancer patients with brain metastases and/or leptomeningeal carcinomatosis, showcased promising results from Cohort 5, which specifically included patients with pathologically confirmed leptomeningeal carcinomatosis. This rare but serious complication occurs in approximately 10% of advanced breast cancer patients and is associated with poor outcomes and limited therapeutic options. Currently, there are no specific drugs approved for metastatic breast cancer patients with brain metastases and/or leptomeningeal carcinomatosis, and there is no consensus on how to manage these cases. This trial was designed to address this gap in knowledge, aiming to investigate whether an antibody-drug conjugate called trastuzumab deruxtecan, which has shown promise in treating breast cancer that has spread to the brain and elsewhere in the body, can help improve the treatment for this specific group of patients. The antibody-drug conjugate, under evaluation demonstrated notable activity with no new safety concerns. The results of the Cohort 5, which included 7 patients, were presented by Dr. Marta Vaz, Medical Oncologist at Hospital Professor Doutor Fernando Fonseca, showing a remarkable median overall survival of 13.3 months, meeting the primary endpoint. Five patients (71.4%) experienced prolonged disease stabilization for at least 24 weeks, and the median progression-free survival was 8.9 months. The safety profile was consistent with previous studies. The results of the DEBBRAH trial are extremely interesting and suggest that leptomeningeal carcinomatosis may become a more treatable condition with the introduction of new antibody-drug conjugates targeting HER2. These encouraging data warrant further investigation to address the unmet need in this difficult-to-treat disease. ABOUT ATRACTIB The ATRACTIB phase II study explored a combined treatment approach for advanced triple-negative breast cancer (a type of breast cancer characterized by the fact that the cancer cells don't have estrogen or progesterone receptors, and do not have any or much of a protein called Human Epidermal Growth Factor Receptor-2). The trial evaluated the first-line therapy atezolizumab (an immunotherapy drug), bevacizumab (an antiangiogenic drug), and paclitaxel (a chemotherapy agent) in a cohort of 100 patients, regardless of their PD-L1 tumor expression. Primarily, the study looked at progression-free survival, or how long the disease remained stable. Secondly, it also assessed overall survival, response to treatment, and safety. The results were encouraging, showing that this combination treatment had a positive impact on advanced TNBC patients, even when tumors didn't express PD-L1. Additionally, the safety profile of the treatment was consistent with what was known from previous studies. ABOUT DEBBRAH The DEBBRAH phase II trial was designed to evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2[+] and HER2-low advanced breast cancer (meaning that tumors were characterized by the presence of either high or low levels of HER2 protein) with a history of brain metastases and/or leptomeningeal carcinomatosis. Patients were enrolled into one of five cohorts based on the HER2 protein level and type of central nervous system involvement. At SABCS 2023, results of Cohort 5 were presented, which specifically included 7 patients with leptomeningeal carcinomatosis. The main objective for this cohort was to measure the overall survival, or amount of time from the start of the treatment until death from any cause. With a median follow-up of 12 months (range, 2.5-18.6), results showed that treatment with trastuzumab deruxtecan led to a remarkable median overall survival of 13.3 months, meeting the primary endpoint. Five (71.4%) patients experienced a prolonged stabilization of their disease for at least 24 weeks, and the median time before their disease worsened again (known as progression free survival), was 8.9 months. ABOUT MEDSIR Founded in 2012, MEDSIR works closely with its partners to drive innovation in oncology research. Based in Spain and the United States, the company manages all aspects of clinical trials, from study design to publication, utilizing a global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that helps research partners experience the best of both worlds from industry-based clinical research and investigator-driven trials. To promote independent cancer research worldwide, MEDSIR has a strategic alliance with Oncoclínicas, the leading oncology group in Brazil with the greatest research potential in South America. Learn how MEDSIR brings ideas to life: . ABOUT SABCS San Antonio Breast Cancer Symposium (SABCS), hosts about 10,000 clinicians and scientists from all over the world and is the largest and most prestigious scientific gathering on breast cancer research. SOURCE MEDSIR

SAN DIEGO--(BUSINESS WIRE)--Biocept, Inc. (Nasdaq: BIOC) (“Biocept” or the “Company”), a leading provider of molecular diagnostic assays, products and services, announces that its CNSide cerebrospinal fluid assay was featured in two oral presentations at the 2023 SNO/ASCO CNS Cancer Conference on Saturday, August 12. The abstracts were presented by Priya U. Kumthekar, MD, a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist at Northwestern University, and David Piccioni, MD, PhD, Director of Neuro-Oncology at University of California, San Diego. The conference, sponsored by the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO), was held August 10-12 in San Francisco. “While patients with leptomeningeal metastasis (LM) have limited treatment options, select patients may benefit from targeted therapies,” said Dr. Kumthekar. “Using CNSide in patients with solid tumors and LM to detect HER2 amplification could provide valuable information in treatment decision making.” Dr. Kumthekar is the principal investigator at Northwestern University of Biocept’s ongoing FORESEE clinical trial, which is evaluating the performance of CNSide in monitoring the response of LM to treatment and assessing the impact of CNSide on treatment decisions made by physicians. “Patients with leptomeningeal carcinomatosis (LMC) have limited survival and early detection by traditional CSF cytology is poor,” said Dr. Piccioni. “From this study, we concluded that using CNSide was superior in detecting LMC, and its ability for molecular profiling on captured CSF tumor cells (CSF-TCs) could improve earlier detection and treatment outcomes.” A summary of the abstracts is as follows: “The HER2 Flip: HER2 Amplification of Tumor Cells in the Cerebrospinal Fluid (CSF-TCs) of Patients with Leptomeningeal Metastasis having solid tumors; implications for treating the LM tumor with anti-HER2 therapy.” Results of this study indicated that HER2 amplification in the CSF can be detected in a substantial fraction of CSF-TCs from patients with LM having breast, upper GI and non-small cell lung cancer, and other solid tumors, and that an increased HER2 positivity in LM may imply HER2 as a driver for developing LM. The results suggest that prospective studies are needed to determine if evaluation of HER2 amplification in the CSF of patients with LM having solid tumors should be routinely considered, as it may offer viable treatment options otherwise not considered. “Circulating tumor cell analysis from the cerebrospinal fluid informs early diagnosis, treatment and prognosis in leptomeningeal carcinomatosis (LMC).” This study compared traditional CSF cytology and circulating tumor cell (CTC) analysis using CNSide to evaluate patients for presence of LMC. The results suggested that CTC provided superior sensitivity in detecting LMC compared with traditional cytology, and allowed for earlier detection and consequently earlier treatment. Molecular analysis of CTCs also allowed for identification of therapeutic targets specific to the CSF, which provides more information for treatment decision making and potentially improves survival versus historical controls. The abstracts from both presentations are available on the Biocept website here. About Biocept Biocept is a molecular diagnostics company with commercialized assays for patients with carcinomas or melanomas. Our experts have spent years working to change the way physicians look at cerebrospinal fluid in cancer patients. Biocept has developed a unique, patented methodology to isolate cancer material that is shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and cell-free DNA (cfDNA). As such, Biocept is a leading commercial provider of testing services designed to enable clinicians to rapidly detect and monitor cancer biomarkers from a cerebrospinal fluid sample. Forward-Looking Statements Disclaimer This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements regarding the potential benefits and capabilities of CNSide for use in patients with LM and LMC, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors, including that the results of the FORESEE clinical trial may not support the inclusion of CNSide in clinical care guidelines; risks related to our need for additional capital and the risk that our products and services may not perform as expected. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission (SEC), including under the “Risk Factors” heading of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at .

– JV continues to advance to its IPO- OT-101 immunotherapy expanding with at least 10 planned IIS clinical trials for 2023- OT-101 commercialization effort expanding on multiple fronts - Manufacturing and DAO capabilities being built with platform launched slated for 2023 AGOURA HILLS, Calif., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a clinical stage cancer and aging biotechnology company, today issued a letter to its shareholders from its Chief Executive Officer, Dr. Vuong Trieu. To our Shareholders, 2022 was a defining year for Oncotelic as we entered into a JV agreement with Dragon Overseas Limited (“Dragon”) to form GMP Biosciences Limited (“GMP Bio”) to advance the development of OT-101 along multiple oncology indications through various pivotal internal studies and external investigator-initiated studies (“ISS”). Additionally, we are building out new platform technologies for manufacturing, and expansion into DAO/animal health. We are strategically positioned to execute on anticipated 2023 milestones and beyond. The JV and our proprietary OT-101 platform has positioned us with two potential world firsts: a tumor environment modulator for treatment of cancer and a host targeted treatment for infectious diseases and aging. Throughout 2022, the lion’s share of our clinical efforts focused on the engagement of renowned investigators for OT-101 across multiple cancer types in combination with multiple marketed immunotherapies. At the same time, we are working together with multiple regulatory agencies, including the United States Food and Drug Administration (“FDA”), to initiate pivotal clinical trials in diffuse midline gliomas (“DMG”) and Pancreatic Cancer while building a solid IP wall around our assets. OT-101 Immunotherapy Program. 10 planned ISS clinical trials and possibly more coming for 2023. We have been actively engaging Key Opinion Leaders (KOLs) and Centers of Execellence. It is gratifying that responses been overwhelmingly positive resulting in at least 10 planned ISS clinical trials in 2023. M201- the MPM ISS trial with OT-101 combined with pembroluzimab is being pushed back with a possible FPI 2Q23 due to logistic and business reasons. At the same time, the lung and glioma programs are being prioritize and are moving rapidly beyond protocol stage. Upcoming Milestones: Initiation of IIS clinical trials for Non-Small Cell Lung Cancer (“NSCLC”), Pancreatic Cancer, Leptomeningeal Cancer, Melanoma, and Gliomas OT-101 Pancreatic Cancer Phase 2/3 Clinical Trial. FPI in 2023 The P001 trial was an open-label, multicenter dose-escalation study to evaluate the safety and tolerability of OT-101in adult patients with advanced tumors known to overproduce TGF- β2, which are not or no longer amenable to established therapies. We recently presented at this year JCA-AACR Special Joint Conference and SITC Conference data showing that OT-101 has favorable OT-101 PK, safety, and efficacy characteristics. More than half of the OT-101 treated PC patients went into long term disease control (21 of 37 pts, 55%) allowing them to enter into subsequent chemotherapy which has an unexpected benefit of more than doubling their median OS, 9.3 vs. 2.6 mos, p<0.0001. OT-101 single agent activity is at minimum on par with the recently approved Onivyde + 5FU/LV. Upcoming Milestones: Regulatory approval and FPI for the global phase 2/3 pancreatic cancer trial OT-101 Glioma Clinical Trials. FPI in 2023 The G004 trial was a multi-center, open label, active controlled, randomized trial for OT-101 in recurrent high-grade glioma. In G004, OT-101 exhibited remarkable single agent activity against recurrent/refractory high-grade glioma patients with more than a third of patients (26 of 77) receiving the intended 4-11 cycles of therapy achieving durable complete responses, partial responses, or prolonged stable disease and a median OS of 1280 days. We recently reported this year at the 12th AACR-JCA Joint Conference: Breakthroughs in Cancer Research— Translating Knowledge into Practice and SNO Conference data validating TGF-β2- the target of OT-101- against gliomas. Reduced TGF-β2 in Pediatric Brainstem Patients increased OS from 9 mos to 22 mos, N=95 pts, p<0.0001. Reduced TGF-β2 in Gliomas patients treated with TMZ increased OS from 25 mos to 94 mos, N=230 pts, p<0.0001. Reduced TGF-β2 in Gliomas patients treated with Radiation increased OS from 25 mos to 94 mos, N=293 pts, p<0.0001. Upcoming Milestones: Regulatory approval and FPI for G101: An Open-label Dose Escalation Study to Evaluate the Safety and Tolerability of Repeated Cycles of OT-101 in Pediatric Diffuse Midline Glioma ("DMG") Patients, Administered Intraventricularly.Regulatory approval and FPI for the global phase 2/3 glioma trial OT-101 COVID-19. Long COVID observational trial to start in 2023 In 2021, we completed clinical trial for OT-101 in COVID-19 in Peru and Argentina. The results of the trial suggest that OT-101 is effective against high risk COVID-19 patients. In October, we were awarded funding from the Biomedical Advanced Research and Development Authority (“BARDA”) for the development of OT-101 for long COVID. The award was under the EZ-BAA funding program. We were awarded the maximum award under the EZ-BAA program. Additionally with the pandemic raging in China, we feel that this is an opportunity for us to leverage our clinical experience against the pandemic. Upcoming Milestones: Enrollment started for long COVID in 2023 DAO Platform: Minting of Token for Animal Health in 2023 Our subsidiary, Pet2DAO, is a DAO technology company developing new animal health products, leveraging on the strong governance of traditional corporation combined with the innovative DAO architecture. We look to engage stakeholders to preserve and build value through the DAO while maintaining the rigor of traditional corporation including governance, compliance, and accountability through a team of veterans in public companies with innovators in AI, blockchain and Web3. Upcoming Milestones: Launch of PET2DAO and minting of PDAO token and distribution to shareholders/stakeholders of record Expanded Management Team and Strengthen Financial We added significant core competencies within our management team with the additions of both a Chief Medical Officer and Chief Regulatory Officer rounding out the already strong team. As reported in our latest 10Q, we have reduced R&D cost greater than 95% while continuing expansion of our OT-101 clinical programs. We also have reduced G&A cost by more than 50%. We enter 2023, inspired by all the opportunities and milestones ahead of us. On behalf of all of us at Oncotelic and GMP Bio, I want to thank our partners/investigators/KOLs and clinical trial volunteers for helping us advance our clinical and other efforts. We look forward to a year filled with health and safety for all and we will continue to keep all of our shareholders abreast of news and developments. Sincerely, Dr. Vuong TrieuChief Executive Officer Oncotelic's Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof, the progress, timing of clinical development, scope and success of future clinical trials, the reporting of clinical data for the company's product candidates and the potential use of the company's product candidates to treat various cancer indications as well as obtaining required regulatory approval to conduct clinical trials and upon granting of approval by the regulatory agencies, the successful marketing of the products; building and the success of our nanoparticle platform and the related success of launching the platform. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements or may not occur at all. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, taking the Company or its affiliates through initial public offerings. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's annual report on Form 10-K filed with the SEC on April 15, 2022 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information, future events, or otherwise. Contact Information:For Oncotelic Therapeutics, Inc.:Investor Relationsir@oncotelic.com