CNS Pharmaceuticals Expands Pipeline with In-License of Late Stage, Novel Potential Blood Brain Barrier Permeable Abeotaxane for Treatment of Brain Malignancies
CNS Pharmaceuticals (NASDAQ:CNSP) has expanded its pipeline by in-licensing TPI 287, a late-stage, potential blood-brain barrier permeable abeotaxane for treating brain malignancies. The company obtained exclusive rights from Cortice Biosciences in exchange for 616,698 shares and potential future milestone payments. TPI 287 has shown promising results in over 350 patients, including a 60% objective response rate and 96% disease control rate in a Phase 1 study for recurrent glioblastoma (GBM). CNS plans to engage with the FDA to design a registration study for TPI 287 in recurrent GBM, aiming to start in 2025. This complements their ongoing Berubicin program, with topline results expected in H1 2025. The company also launched a new corporate brand and website to align with its focus on GBM treatment.
CNS Pharmaceuticals (NASDAQ:CNSP) ha ampliato il suo portafoglio mediante l'in-licensing di TPI 287, un abeotaxano in fase avanzata, potenzialmente in grado di attraversare la barriera emato-encefalica per il trattamento delle neoplasie cerebrali. L'azienda ha ottenuto diritti esclusivi da Cortice Biosciences in cambio di 616.698 azioni e potenziali pagamenti per traguardi futuri. TPI 287 ha mostrato risultati promettenti in oltre 350 pazienti, inclusa una percentuale di risposta obiettiva del 60% e una percentuale di controllo della malattia del 96% in uno studio di Fase 1 per il glioblastoma ricorrente (GBM). CNS prevede di confrontarsi con la FDA per progettare uno studio di registrazione per TPI 287 nel GBM ricorrente, con l'obiettivo di iniziare nel 2025. Questo si aggiunge al loro programma Berubicin in corso, con risultati top-line attesi nel primo semestre del 2025. L'azienda ha anche lanciato un nuovo marchio aziendale e un sito web per allinearsi con il suo focus sul trattamento del GBM.
CNS Pharmaceuticals (NASDAQ:CNSP) ha ampliado su cartera al licenciar TPI 287, un abeotaxano en etapa tardía, potencialmente permeable a la barrera hematoencefálica para tratar malignidades cerebrales. La empresa obtuvo derechos exclusivos de Cortice Biosciences a cambio de 616,698 acciones y posibles pagos por hitos futuros. TPI 287 ha mostrado resultados prometedores en más de 350 pacientes, incluyendo una tasa de respuesta objetiva del 60% y una tasa de control de la enfermedad del 96% en un estudio de Fase 1 para glioblastoma recurrente (GBM). CNS planea comunicarse con la FDA para diseñar un estudio de registro para TPI 287 en GBM recurrente, comenzando en 2025. Esto complementa su programa Berubicin en curso, con resultados principales esperados para el primer semestre de 2025. La empresa también lanzó una nueva marca corporativa y un sitio web para alinearse con su enfoque en el tratamiento del GBM.
CNS Pharmaceuticals (NASDAQ:CNSP)는 뇌 악성 종양 치료를 위한 혈액-뇌 장벽을 통과할 수 있는 잠재적 아베오탁산인 TPI 287의 파이프라인을 확장했습니다. 이 회사는 Cortice Biosciences로부터 616,698주와 향후 이정표 지급을 대가로 독점 권리를 확보했습니다. TPI 287은 재발성 교모세포종(GBM)에 대한 1상 연구에서 350명 이상의 환자에서 유망한 결과를 보여주었으며, 객관적인 반응률이 60%이고 질병 조절률이 96%입니다. CNS는 2025년 재발성 GBM에 대한 TPI 287의 등록 연구를 설계하기 위해 FDA와 협력할 계획입니다. 이는 현재 진행 중인 Berubicin 프로그램을 보완하며, 상반기 2025년 중 최종 결과가 예상됩니다. 이 회사는 또한 GBM 치료에 중점을 두기 위해 새로운 기업 브랜드와 웹사이트를 출시했습니다.
CNS Pharmaceuticals (NASDAQ:CNSP) a élargi son pipeline en licenciant TPI 287, un abeotaxane en phase avancée, potentiellement perméable à la barrière hémato-encéphalique pour le traitement des tumeurs cérébrales. L'entreprise a obtenu des droits exclusifs de Cortice Biosciences en échange de 616 698 actions et de paiements pour des étapes futures éventuelles. TPI 287 a montré des résultats prometteurs chez plus de 350 patients, y compris un taux de réponse objective de 60 % et un taux de contrôle de la maladie de 96 % dans une étude de phase 1 pour le glioblastome récurrent (GBM). CNS prévoit de collaborer avec la FDA pour concevoir une étude d'enregistrement pour TPI 287 dans le GBM récurrent, avec l'objectif de commencer en 2025. Cela complète leur programme Berubicin en cours, avec des résultats principaux attendus au premier semestre 2025. L'entreprise a également lancé une nouvelle marque et un site Web pour s'aligner sur son objectif de traitement du GBM.
CNS Pharmaceuticals (NASDAQ:CNSP) hat sein Pipeline erweitert, indem es TPI 287 lizenziert hat, ein potenzieller abeotaxan in der späten Entwicklungsphase, der die Blut-Hirn-Schranke durchdringen kann, um Gehirntumoren zu behandeln. Das Unternehmen erwarb exklusive Rechte von Cortice Biosciences im Austausch für 616.698 Aktien und potenzielle zukünftige Meilensteinzahlungen. TPI 287 hat in über 350 Patienten vielversprechende Ergebnisse gezeigt, einschließlich einer objektiven Ansprechrate von 60 % und einer Krankheitskontrollrate von 96 % in einer Phase-1-Studie bei rezidivierendem Glioblastom (GBM). CNS plant, sich mit der FDA abzustimmen, um eine Zulassungsstudie für TPI 287 bei rezidivierendem GBM zu entwerfen, mit dem Ziel, im Jahr 2025 zu beginnen. Dies ergänzt ihr laufendes Berubicin-Programm, dessen Ergebnisse im ersten Halbjahr 2025 erwartet werden. Das Unternehmen hat auch eine neue Unternehmensmarke und Website gelauncht, um sich auf die Behandlung von GBM zu konzentrieren.
- Expansion of pipeline with late-stage drug candidate TPI 287
- TPI 287 showed 60% objective response rate and 96% disease control rate in Phase 1 GBM study
- Potential synergy between TPI 287 and Berubicin for GBM treatment
- Leveraging existing clinical infrastructure and relationships for expedited development
- Completed enrollment in potentially pivotal Berubicin study with topline results expected H1 2025
- Upfront payment of 616,698 shares of common stock for TPI 287 license
- Potential future milestone payments in cash or stock, which could lead to dilution
- Additional capital requirements for TPI 287 development
Insights
The in-licensing of TPI 287 by CNS Pharmaceuticals marks a significant expansion of their pipeline in the treatment of glioblastoma multiforme (GBM). This strategic move complements their ongoing Berubicin program, potentially positioning CNS as a leader in GBM treatment development.
Key points to consider:
- TPI 287 has shown promise in crossing the blood-brain barrier, a important factor for CNS treatments.
- Previous clinical trials demonstrated an impressive 60% objective response rate and 96% disease control rate in combination with bevacizumab.
- The progression-free survival of
5.5 months and overall survival of13.4 months are notably better than current standards. - CNS plans to leverage its existing clinical infrastructure to expedite TPI 287's development, potentially reducing costs and time to market.
However, investors should note that while promising, TPI 287 still requires further clinical validation and regulatory approval. The company's focus on GBM, a notoriously difficult-to-treat cancer, carries both high risk and potential high reward.
Financially, the deal structure - using stock for the upfront payment and potential future milestones - helps conserve cash but may lead to dilution for current shareholders. The true value of this acquisition will likely become clearer after the Berubicin trial results in 2025.
The acquisition of TPI 287 by CNS Pharmaceuticals represents a potentially significant advancement in GBM treatment. As an oncologist, I'm particularly intrigued by several aspects:
- TPI 287's mechanism as an abeotaxane that can potentially cross the blood-brain barrier addresses a major challenge in treating brain tumors.
- The combination of TPI 287 with bevacizumab showed promising results, suggesting a potential synergistic effect that could improve outcomes for GBM patients.
- The reported progression-free survival and overall survival data are encouraging compared to current standards, though we must await larger, confirmatory studies.
However, it's important to temper enthusiasm with caution. GBM remains an extremely challenging cancer to treat and many promising agents have failed in later-stage trials. The true test for TPI 287 will be in a larger, potentially registrational study.
The potential for combining TPI 287 with Berubicin is intriguing from a clinical perspective. If both drugs can effectively cross the blood-brain barrier, they could offer a novel combination approach that might be more effective than current treatments. However, this combination would require extensive safety and efficacy testing.
Overall, while TPI 287 shows promise, it's important for investors to understand that significant hurdles remain before it could become an approved treatment for GBM.
From a financial perspective, CNS Pharmaceuticals' acquisition of TPI 287 presents both opportunities and challenges:
- The upfront payment of 616,698 shares represents a non-cash transaction, preserving the company's cash reserves. However, it does result in immediate dilution for existing shareholders.
- Future milestone payments, which can be in cash or stock, provide flexibility in managing the company's capital structure but could lead to further dilution if paid in stock.
- The expanded pipeline could potentially increase the company's market value if TPI 287 proves successful, but also increases R&D expenses in the near term.
- Leveraging existing clinical infrastructure for TPI 287's development could lead to cost synergies, potentially improving the company's burn rate.
Investors should note that CNS Pharmaceuticals, with a market cap of approximately
The company's cash position and burn rate will be critical metrics to watch. As of their last filing, CNS had approximately
In conclusion, while the acquisition of TPI 287 enhances CNS Pharmaceuticals' potential, it also increases the company's risk profile. Investors should closely monitor clinical progress and the company's financial position in the coming quarters.
Strategic in-license from Cortice Bioscience is highly synergistic with the ongoing potentially pivotal Berubicin program and demonstrates further commitment to changing the treatment paradigm in GBM
Drug candidate, TPI 287, awarded Orphan designation and studied in over 350 patients to date, including clinical trials as monotherapy and in combination with bevacizumab demonstrating encouraging clinical efficacy and safety profile at target therapeutic doses
Company plans to engage the U.S. FDA to seek guidance on advancing TPI 287 into a potential registration study for recurrent GBM
Leveraging the significant clinical infrastructure and deep relationships established with the Neuro-Oncology community to expedite development of TPI 287
Company launches new corporate brand and website to more closely align with its unwavering commitment to addressing the most aggressive type of brain cancer, GBM, with an average survival of only 14 to 16 months after diagnosis and no cure
Company to host live video webcast to discuss the transaction today, July 30 th at 8:30 AM ET
HOUSTON, TX / ACCESSWIRE / July 30, 2024 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that it has entered into an exclusive license agreement with Cortice Biosciences, Inc. ("Cortice"). The Company will host a live webcast presentation to discuss the transaction on Tuesday, July 30, 2024 at 8:30 AM ET (details below). Additionally, CNS announced the launch of its new corporate branding and website, cnspharma.com.
Under the terms of the Agreement, CNS Pharmaceuticals has obtained an exclusive license and the intellectual property rights to TPI 287, a potentially blood brain barrier permeable microtubule inhibitor, currently in development for the treatment of GBM, in exchange for an upfront payment of 616,698 shares of the Company's common stock, as well as the possibility of future success-dependent milestone payments of cash or the Company's common stock to Cortice. CNS Pharmaceuticals intends to advance the development of TPI 287 for an oncology indication in the United States, Canada, Mexico, and Japan, which is the territory covered by the Agreement (the "Territory"). Such development efforts will include, but may not be limited to, the prosecution and maintenance of existing and new intellectual property; preclinical and clinical development of TPI 287 including research, manufacturing, laboratory and clinical testing, regulatory filing, and marketing of TPI 287 in the Territory.
John Climaco, CEO of CNS Pharmaceuticals, stated, "For years, our team has searched for another drug candidate with the same high level of human data-supported therapeutic potential in GBM as Berubicin. The in-licensing of TPI 287 is a transformational step forward and we are prepared for the next stage to execute our vision of CNS Pharmaceuticals being the leading biopharma company developing drugs for this devastating and currently inescapably fatal disease."
"Our vision is anchored by our confidence in and commitment to our trial of Berubicin in patients with recurrent GBM. The 252 patients enrolled in its potentially pivotal trial will provide significant data about overall survival compared with Lomustine, the outcome of which will be made public in the first half of next year. Our highly experienced team that created and is executing this trial - currently one of the largest GBM studies being conducted anywhere in the world - makes us uniquely positioned to meet the challenge presented by this disease. The clinical network we have established is unparalleled by any other company's GBM development program, and as a consequence, the TPI 287 program will require only limited capital resources prior to the release of Berubicin topline data. This will allow us to drive TPI 287 into potential registration studies in the most cost-effective manner possible. After negotiations spanning several years and following extensive scientific and clinical due diligence, we believe the highly compelling safety and efficacy data demonstrated by TPI 287 in over 350 patients to date makes it both the ideal complementary asset to Berubicin and the perfect next step in our Company's strategic plan. Our work on bringing TPI 287 to patients begins immediately," added Mr. Climaco.
TPI 287 Key Highlights
TPI 287 is an abeotaxane and has the same mechanism of action as other taxanes, e.g. paclitaxel (Taxol®) and docetaxel, in which it stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. While most taxanes are substrates for multi-drug resistant transporters, which maintain the blood brain barrier (BBB), similarly to Berubicin, TPI 287 has shown the potential to cross the BBB and treat CNS tumors.
TPI 287 has been well tolerated in over 350 patients to date, including in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of recurrent neuroblastoma and medulloblastoma, as well as refractory prostate cancer and melanoma, and in tauopathy disease, which can result in dementia.
In a multicenter Phase 1 study evaluating TPI 287 in combination with bevacizumab in patients with recurrent GBM, results demonstrated an objective response rate of
60% and disease control rate of96% in 23 subjects. Progression-free survival (PFS) of 5.5 months and overall survival (OS) of 13.4 months compare favorably to bevacizumab either as monotherapy or in combination with chemotherapy in similar patients yielding PFS of 2-4 months and OS of 6-9 months. The data from this study were recently published in a manuscript titled, " Phase 1 trial of TPI 287, a microtubule stabilizing agent, in combination with bevacizumab in adults with recurrent glioblastoma [1] ," in Neuro-Oncology Advances .CNS Pharmaceuticals plans to engage the U.S. FDA and obtain feedback on the design of a study focused on the registration of TPI 287 in recurrent GBM, with the goal of initiating the study in 2025.
Samuel A. Goldlust, MD, Medical Director of Neuro-Oncology at Saint Luke's Cancer Institute, a former investigator in the Company's global study of Berubicin, as well as the principal investigator of studies of TPI 287 in GBM added, "The data seen to date with TPI 287 have been highly encouraging. There remains a tremendous unmet need for the GBM patient population, which I believe will require the development of a variety of effective therapeutic approaches. With the promising data demonstrated with both Berubicin and the synergies that TPI 287 has shown, I am excited for the Company to further explore and unlock the potential of TPI 287."
As previously announced in April 2024, the Company completed enrollment in its global potentially pivotal study evaluating Berubicin for the treatment of GBM. In December 2023 the Company announced the successful completion of its pre-planned interim futility analysis and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification. CNS Pharmaceuticals expects to report topline results from its potentially pivotal study of Berubicin in the first half of 2025.
"We also fully understand that the complexity and severity of GBM challenges scientists and clinicians to create novel treatment approaches for brain malignancies. As we have grown our expertise in the development of blood brain barrier permeable chemotherapeutics, we understand that multiple therapeutics may be required to effectively treat these diseases. Combinations of anthracyclines and taxanes that have shown activity for systemic disease may be more powerful as combination agents for the treatment of diseases metastatic to the brain. There is tremendous potential therapeutic synergy between Berubicin and TPI 287, and we are excited to expand our pipeline of drug candidates to offer patients with recurrent GBM an additional brain-penetrative chemotherapeutic option," added, Sandra Silberman, MD, PhD, Chief Medical Officer of CNS. "Having successfully completed enrollment in our Berubicin study, we have gained extensive experience and expertise in conducting late-stage registrational studies for recurrent GBM. That experience will now inform our clinical strategy for TPI 287 as we engage with key investigators at our active clinical sites. Our investigator network, which took years to build, can now be repurposed to save valuable time and resources, allowing us to expeditiously move forward with a similar potentially registrational study of TPI 287 in 2025."
Webcast Details
CNS Pharmaceuticals will host a live video webcast presentation with members of management and neuro-oncologist and Key Opinion Leader, Dr. Samuel Goldlust for investors, analysts, and other interested parties today, June 30, 2024 at 8:30 a.m. ET to discuss the transaction. Interested participants may register for the event here. The live webcast will be accessible on the Events page of the Investors section of the CNS website, cnspharma.com, and will be archived for 90 days.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn.
Forward-Looking Statements
Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements include, without limitation, the Company's ability to move forward with a potentially registrational study of TPI 287 in 2025, the Company's timing of release of final data from the Berubicin trial expected to occur in the first half of 2025, the ability to continue to fund the Berubicin trial to completion and release of final data, and the ability to obtain FDA marketing approval for Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law.
CONTACTS:
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
CNSP@jtcir.com
[1] Neuro-Oncology Advances , Volume 6, Issue 1, January-December 2024, vdae009, https://doi.org/10.1093/noajnl/vdae009
SOURCE: CNS Pharmaceuticals, Inc.
View the original press release on accesswire.com
FAQ
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