Bio-Path Holdings Provides Key Clinical Updates
Bio-Path Holdings (NASDAQ:BPTH) has reported positive updates from two ongoing clinical trials. In the Phase 1/1b BP1001-A solid tumor trial, the first patient treated with the higher dose (90 mg/m2) showed a 15% tumor reduction and maintained stable disease through ten treatment cycles. This elderly female patient with gynecologic cancer had previously failed multiple chemotherapy treatments and surgeries.
In the Phase 2 trial of prexigebersen triple combination therapy for Acute Myeloid Leukemia (AML), two elderly patients have maintained complete remission. The first patient has received 20 cycles over 26 months, while the second has completed 16 cycles over 20 months. The therapy combines prexigebersen with decitabine and venetoclax.
The company's DNAbilize® platform technology demonstrates potential for developing multiple drug candidates for target-specific protein inhibition. The Phase 1b portion will assess BP1001-A's safety and efficacy in combination with paclitaxel for ovarian or endometrial tumors, with additional studies planned for pancreatic cancer treatment.
Bio-Path Holdings (NASDAQ:BPTH) ha riportato aggiornamenti positivi da due studi clinici in corso. Nella sperimentazione di fase 1/1b BP1001-A per tumori solidi, il primo paziente trattato con la dose più alta (90 mg/m2) ha mostrato una riduzione del tumore del 15% e ha mantenuto una malattia stabile attraverso dieci cicli di trattamento. Questa paziente anziana con cancro ginecologico aveva precedentemente fallito diversi trattamenti chemioterapici e interventi chirurgici.
Nella sperimentazione di fase 2 della terapia combinata tripla con prexigebersen per Leucemia Mieloide Acuta (AML), due pazienti anziani hanno mantenuto una remissione completa. Il primo paziente ha ricevuto 20 cicli in 26 mesi, mentre il secondo ha completato 16 cicli in 20 mesi. La terapia combina prexigebersen con decitabina e venetoclax.
La tecnologia della piattaforma DNAbilize® dell'azienda dimostra potenziale per lo sviluppo di diversi candidati farmaceutici per l'inibizione specifica delle proteine. La parte di fase 1b valuterà la sicurezza e l'efficacia di BP1001-A in combinazione con il paclitaxel per tumori ovarici o endometriali, con ulteriori studi previsti per il trattamento del cancro pancreatico.
Bio-Path Holdings (NASDAQ:BPTH) ha informado actualizaciones positivas de dos ensayos clínicos en curso. En el ensayo de fase 1/1b BP1001-A para tumores sólidos, el primer paciente tratado con la dosis más alta (90 mg/m2) mostró una reducción del tumor del 15% y mantuvo una enfermedad estable durante diez ciclos de tratamiento. Esta paciente anciana con cáncer ginecológico había fracasado previamente en múltiples tratamientos de quimioterapia y cirugías.
En el ensayo de fase 2 de la terapia combinada triple con prexigebersen para Leucemia Mieloide Aguda (AML), dos pacientes ancianos han mantenido una remisión completa. El primer paciente ha recibido 20 ciclos durante 26 meses, mientras que el segundo ha completado 16 ciclos en 20 meses. La terapia combina prexigebersen con decitabina y venetoclax.
La tecnología de la plataforma DNAbilize® de la empresa demuestra potencial para desarrollar múltiples candidatos a fármacos para la inhibición específica de proteínas. La parte de fase 1b evaluará la seguridad y eficacia de BP1001-A en combinación con paclitaxel para tumores ováricos o endometriales, con estudios adicionales planificados para el tratamiento del cáncer pancreático.
Bio-Path Holdings (NASDAQ:BPTH)는 두 가지 진행 중인 임상 시험에서 긍정적인 업데이트를 보고했습니다. 1/1b 단계 BP1001-A 고형종양 시험에서, 고용량(90 mg/m2)으로 치료받은 첫 번째 환자는 종양이 15% 감소했으며 10회의 치료 주기 동안 안정적인 상태를 유지했습니다. 이 고령의 여성 환자는 이전에 여러 차례의 항암 치료와 수술에 실패한 바 있습니다.
프렉시제버센의 2상 시험에서는 급성 골수성 백혈병 (AML)에 대한 삼중 복합 요법에서 두 명의 고령 환자가 완전 관해를 유지하고 있습니다. 첫 번째 환자는 26개월 동안 20회의 치료를 받았고, 두 번째 환자는 20개월 동안 16회의 치료를 완료했습니다. 이 요법은 프렉시제버센과 데시타빈, 베네토클락스를 결합합니다.
회사의 DNAbilize® 플랫폼 기술은 표적 단백질 억제를 위한 여러 약물 후보 개발의 가능성을 보여줍니다. 1b 단계는 난소 또는 자궁내막 종양에 대해 paclitaxel과 함께 BP1001-A의 안전성과 효능을 평가할 예정이며, 췌장암 치료를 위한 추가 연구도 계획되어 있습니다.
Bio-Path Holdings (NASDAQ:BPTH) a rapporté des mises à jour positives de deux essais cliniques en cours. Dans l'essai de phase 1/1b BP1001-A pour les tumeurs solides, le premier patient traité avec la dose la plus élevée (90 mg/m2) a montré une réduction de 15 % de la tumeur et a maintenu une maladie stable pendant dix cycles de traitement. Cette patiente âgée atteinte d'un cancer gynécologique avait précédemment échoué à plusieurs traitements de chimiothérapie et à des interventions chirurgicales.
Dans l'essai de phase 2 de la thérapie combinée triple avec prexigebersen pour Leucémie Myéloïde Aiguë (LMA), deux patients âgés ont maintenu une rémission complète. Le premier patient a reçu 20 cycles sur 26 mois, tandis que le second a terminé 16 cycles sur 20 mois. La thérapie combine prexigebersen avec décitabine et venetoclax.
La technologie de la plateforme DNAbilize® de l'entreprise démontre un potentiel pour le développement de plusieurs candidats médicaments pour l'inhibition spécifique des protéines. La partie de phase 1b évaluera la sécurité et l'efficacité de BP1001-A en combinaison avec le paclitaxel pour les tumeurs ovariennes ou endométriales, avec d'autres études prévues pour le traitement du cancer du pancréas.
Bio-Path Holdings (NASDAQ:BPTH) hat positive Updates aus zwei laufenden klinischen Studien berichtet. In der Phase 1/1b-Studie BP1001-A für solide Tumoren zeigte der erste Patient, der mit der höheren Dosis (90 mg/m2) behandelt wurde, eine Tumorverkleinerung um 15% und hielt die Krankheit über zehn Behandlungszyklen stabil. Diese ältere Patientin mit gynäkologischem Krebs war zuvor in mehreren Chemotherapie-Behandlungen und Operationen gescheitert.
In der Phase-2-Studie der dreifachen Kombinationstherapie mit Prexigebersen für Akute Myeloische Leukämie (AML) haben zwei ältere Patienten eine vollständige Remission aufrechterhalten. Der erste Patient erhielt 20 Zyklen über 26 Monate, während der zweite 16 Zyklen über 20 Monate abgeschlossen hat. Die Therapie kombiniert Prexigebersen mit Decitabin und Venetoclax.
Die DNAbilize®-Plattformtechnologie des Unternehmens zeigt Potenzial zur Entwicklung mehrerer Arzneikandidaten zur gezielten Hemmung von Proteinen. Der Teil der Phase 1b wird die Sicherheit und Wirksamkeit von BP1001-A in Kombination mit Paclitaxel bei Eierstock- oder Endometriumtumoren bewerten, mit weiteren Studien zur Behandlung von Bauchspeicheldrüsenkrebs, die geplant sind.
- First patient in higher dose cohort (90 mg/m2) showed 15% tumor reduction
- Two AML patients maintained complete remission for over 20 months
- Treatment shows effectiveness in elderly patients who typically can't tolerate intensive chemotherapy
- No severe side effects reported in solid tumor treatment
- Early-stage trials with patient population
- Additional capital may be needed to continue operations
Insights
The latest clinical updates from Bio-Path Holdings demonstrate encouraging efficacy signals across both solid tumor and hematological malignancy programs, with notably favorable safety profiles. In the BP1001-A solid tumor trial, achieving 15% tumor reduction and maintained stable disease through ten cycles in a heavily pretreated gynecologic cancer patient is particularly significant. This response, observed at the 90 mg/m2 dose level without traditional chemotherapy-related side effects, suggests a potentially differentiated therapeutic approach.
The durability of complete remission in two elderly AML patients (extending 26 months and 20 months) in the Phase 2 triple combination study is remarkably promising. For context, elderly AML patients typically face dismal prognoses with standard treatments, with median survival often measured in months rather than years. The ability to maintain complete remission for over two years while preserving quality of life represents a potentially meaningful advance in this difficult-to-treat population.
These results validate Bio-Path's DNAbilize® platform technology in two critical aspects: First, the demonstration of clinical activity across both solid and hematological cancers suggests broad therapeutic potential. Second, the favorable safety profile, particularly important in elderly and heavily pretreated patients, could position these treatments as attractive options where current therapies are poorly tolerated.
The planned expansion into pancreatic cancer and the combination studies with established agents like paclitaxel and gemcitabine indicate a thoughtful development strategy that could accelerate the path to potential regulatory approval. However, it's important to note that these are still early-stage results with small patient numbers, and larger studies will be needed to confirm these promising signals.
First Solid Tumor Patient Treated with Second, Higher Dose in Phase 1/1b BP1001-A Clinical Trial Experienced Tumor Reduction and Continued Stable Disease
Reports Continued Patient Progress from Phase 2 Triple Combination Study of Prexigebersen in Acute Myeloid Leukemia (AML)
HOUSTON, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today provides an update from the Company’s ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the Company’s ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML).
“These continued positive responses mark a significant milestone for Bio-Path as they suggest our DNAbilize® platform technology has the potential to produce multiple drug candidates capable of target-specific protein inhibition for over-expressed, disease-causing gene products,” said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. “As previously reported in August 2024, we were thrilled to see that our first patient treated with the higher dose (90 mg/m2) in our Phase 1/1b study of BP1001-A who has shown tumor regression and stable disease continued successful treatment through a tenth treatment cycle. We believe this is significant, particularly considering the heavily pretreated and fragile patient population involved.”
“This elderly female patient with gynecologic cancer had previously been treated with multiple lines of chemotherapy along with multiple surgeries for her disease, and only now is showing positive clinical results with BP1001-A treatment. Importantly, we are not seeing the onerous side effects typically seen in patients with advanced solid tumors being treated with standard chemotherapies,” continued Mr. Nielsen.
“In addition, we previously noted extended treatment durability in two elderly patients in our Phase 2 triple combination study of prexigebersen, venetoclax and decitabine in AML patients. We are pleased to report that each of these patients remain in complete remission after two years of treatment. These ongoing positive outcomes underscore the potential for prexigebersen to treat fragile AML patients for extended periods. We are particularly pleased with these results, as elderly AML patients are typically unable to tolerate intensive chemotherapy and thus experience very poor clinical outcomes,” concluded Mr. Nielsen.
Solid Tumor Patient Response in Second, Higher Dose Cohort – Previously, Bio-Path reported its first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experienced a positive response that may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient appears to be doing well on study after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a
As of January 2025, this patient continues doing well on treatment, recently completing nine cycles and is now in her tenth treatment cycle.
The dose finding portion of the Phase 1/1b trial is comprised of BP1001-A monotherapy with no accompanying chemotherapy. This clinical trial of BP1001-A in patients with advanced or recurrent solid tumors has successfully completed the initial prescribed dose in the first cohort of 60 mg/m2 and began enrollment in the higher dose cohort of 90 mg/m2. The Phase 1b portion of the study is expected to commence after completion of three planned BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late-stage pancreatic cancer.
AML Patients Demonstrate Extended Treatment Durability – Previously, Bio-Path reported two patients were identified in the Phase 2 clinical trial treating AML patients who demonstrated continued treatment durability. As of January 2025, both these patients are receiving treatment and are continuing to do well. The first patient is an elderly female who had received 16 cycles of treatment over 21 months when first reported on. She continues on study having received 20 cycles over 26 months and she remains in complete remission. The second patient is an elderly male who had received 12 cycles of treatment over 14 months when first reported on. He continues on study having received 16 cycles over 20 months and remains in complete remission. Both patients are being treated with the triple combination of prexigebersen, decitabine and venetoclax.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and BP1001-A, a drug product modification of prexigebersen, is in a Phase 1/1b study for solid tumors and as a treatment for obesity and related metabolic diseases is being assessed preclinically. The Company’s second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including acute myeloid leukemia. In addition, an IND application is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3.
For more information, please visit the Company's website at http://www.biopathholdings.com.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10-K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information:
Investors
Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
will@sternir.com
Doug Morris
Investor Relations
Bio-Path Holdings, Inc.
832-742-1369
FAQ
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