Bio-Path Holdings Reports Solid Tumor Patient Response Supporting BP1001-A’s Compelling Potential as Treatment for Advanced Solid Tumors
Bio-Path Holdings (NASDAQ:BPTH) reports positive outcomes from its ongoing clinical trials. In the Phase 1/1b trial of BP1001-A for solid tumors, the first patient treated with a higher dose (90 mg/m2) showed tumor regression and stable disease. This elderly female patient with gynecologic cancer experienced a 15% reduction in her primary tumor through six cycles of treatment, after failing multiple lines of chemotherapy and surgeries.
Additionally, two elderly patients in the Phase 2 triple combination study of prexigebersen for Acute Myeloid Leukemia (AML) demonstrated extended treatment durability. One patient has received 16 cycles over 21 months, while another has completed 12 cycles over 14 months, both remaining in complete remission.
These results support the potential of Bio-Path's DNAbilize® platform technology to treat vulnerable cancer patients with fewer side effects compared to standard therapies.
Bio-Path Holdings (NASDAQ:BPTH) riporta risultati positivi dai suoi studi clinici in corso. Nella sperimentazione di Fase 1/1b di BP1001-A per tumori solidi, la prima paziente trattata con una dose più alta (90 mg/m2) ha mostrato regressione tumorale e malattia stabile. Questa paziente anziana con carcinoma ginecologico ha sperimentato una riduzione del 15% nel suo tumore principale attraverso sei cicli di trattamento, dopo aver fallito diversi cicli di chemioterapia e interventi chirurgici.
Inoltre, due pazienti anziani nello studio combinato triplo di Fase 2 di prexigebersen per la Leucemia Mieloide Acuta (LMA) hanno dimostrato una durata del trattamento prolungata. Un paziente ha ricevuto 16 cicli in 21 mesi, mentre un altro ha completato 12 cicli in 14 mesi, entrambi rimanendo in completa remissione.
Questi risultati supportano il potenziale della tecnologia della piattaforma DNAbilize® di Bio-Path per trattare pazienti oncologici vulnerabili con effetti collaterali inferiori rispetto alle terapie standard.
Bio-Path Holdings (NASDAQ:BPTH) informa sobre resultados positivos de sus ensayos clínicos en curso. En el ensayo de Fase 1/1b de BP1001-A para tumores sólidos, el primer paciente tratado con una dosis más alta (90 mg/m2) mostró regresión tumoral y enfermedad estable. Esta paciente anciana con cáncer ginecológico experimentó una reducción del 15% en su tumor primario a través de seis ciclos de tratamiento, tras haber fallado en múltiples líneas de quimioterapia y cirugías.
Además, dos pacientes ancianos en el estudio de combinación triple de Fase 2 de prexigebersen para la Leucemia Mieloide Aguda (LMA) demostraron durabilidad prolongada del tratamiento. Un paciente ha recibido 16 ciclos en 21 meses, mientras que otro ha completado 12 ciclos en 14 meses, permaneciendo ambos en remisión completa.
Estos resultados respaldan el potencial de la tecnología de plataforma DNAbilize® de Bio-Path para tratar a pacientes con cáncer vulnerables con menos efectos secundarios en comparación con las terapias estándar.
바이오-패스 홀딩스 (NASDAQ:BPTH)는 진행 중인 임상시험에서 긍정적인 결과를 보고했습니다. 고형 종양을 위한 BP1001-A의 1/1b 상 시험에서 높은 용량(90 mg/m2)으로 치료받은 첫 번째 환자가 종양 축소와 안정된 병세를 보였습니다. 여러 차례의 화학요법과 수술에 실패한 이 고령 여성 환자는 여섯 차례의 치료 과정을 통해 주요 종양에서 15%의 감소를 경험했습니다.
또한, 급성 미세모구성 백혈병(AML)을 위한 프렉시제버센의 2상 삼중 조합 연구에서 두 명의 고령 환자가 연장된 치료 내구성을 나타냈습니다. 한 환자는 21개월 동안 16회의 치료를 받았고, 다른 한 환자는 14개월 동안 12회의 치료를 완료하여 두 사람 모두 완전 관해 상태를 유지하고 있습니다.
이러한 결과는 바이오-패스의 DNAbilize® 플랫폼 기술이 표준 요법에 비해 부작용이 적으면서도 취약한 암 환자를 치료할 가능성을 지지합니다.
Bio-Path Holdings (NASDAQ:BPTH) rapporte des résultats positifs de ses essais cliniques en cours. Dans l'essai de Phase 1/1b de BP1001-A pour les tumeurs solides, le premier patient traité avec une dose plus élevée (90 mg/m2) a montré une régression tumorale et une maladie stable. Cette patiente âgée souffrant d'un cancer gynécologique a connu une réduction de 15% de sa tumeur primaire après six cycles de traitement, après avoir échoué à plusieurs lignes de chimiothérapie et à des opérations.
De plus, deux patients âgés dans l'étude de combinaison triple de Phase 2 de prexigebersen pour la leucémie myéloïde aiguë (LMA) ont montré une durabilité prolongée du traitement. Un patient a reçu 16 cycles sur 21 mois, tandis qu'un autre a complété 12 cycles sur 14 mois, les deux restant en rémission complète.
Ces résultats soutiennent le potentiel de la technologie de plateforme DNAbilize® de Bio-Path pour traiter des patients atteints de cancer vulnérables avec moins d'effets secondaires par rapport aux thérapies standards.
Bio-Path Holdings (NASDAQ:BPTH) berichtet über positive Ergebnisse aus den laufenden klinischen Studien. In der Phase 1/1b Studie von BP1001-A zur Behandlung solider Tumoren zeigte der erste Patient, der mit einer höheren Dosis (90 mg/m2) behandelt wurde, eine Tumorreduktion und stabile Erkrankung. Diese ältere Frau mit gynäkologischem Krebs erlebte eine Reduktion von 15% in ihrem Primärtumor nach sechs Behandlungszyklen, nachdem sie mehrere Chemotherapie- und Operationslinien gescheitert war.
Darüber hinaus zeigten zwei ältere Patienten in der Phase 2 Tripel-Kombinationsstudie von Prexigebersen für akute myeloische Leukämie (AML) eine verlängerte Behandlungsdauer. Ein Patient erhielt 16 Zyklen über 21 Monate, während ein anderer 12 Zyklen über 14 Monate abgeschlossen hat, wobei beide in kompletter Remission bleiben.
Diese Ergebnisse unterstützen das Potenzial der DNAbilize® Plattformtechnologie von Bio-Path zur Behandlung von verletzlichen Krebspatienten mit weniger Nebenwirkungen im Vergleich zu Standardtherapien.
- First solid tumor patient treated with higher dose (90 mg/m2) of BP1001-A showed 15% tumor reduction and stable disease
- Two elderly AML patients demonstrated extended treatment durability with prexigebersen combination therapy
- Positive outcomes suggest potential of DNAbilize platform to produce multiple drug candidates for target-specific protein inhibition
- BP1001-A treatment shows fewer side effects compared to standard frontline therapies in advanced solid tumor patients
- None.
Insights
This news is encouraging for Bio-Path's DNAbilize platform. The tumor reduction and stable disease observed in a heavily pretreated solid tumor patient at a higher dose (90 mg/m2) of BP1001-A is promising. It's particularly noteworthy that this was achieved without severe side effects, which is often a limiting factor in cancer treatments. The
The extended treatment durability in two elderly AML patients (16 and 12 cycles over 21 and 14 months, respectively) with the triple combination therapy is also significant. AML typically progresses rapidly, especially in older patients, so these outcomes are noteworthy. However, we must be cautious as these are individual cases and not representative of the entire study population.
Bio-Path's DNAbilize platform shows promise in addressing two critical challenges in cancer treatment: targeted delivery and reduced toxicity. The P-ethoxy DNA backbone modification, combined with the neutral lipid bilayer, appears to enhance drug stability and cellular uptake while minimizing side effects. This could potentially lead to improved efficacy and tolerability across multiple cancer types.
The company's pipeline diversity, with four candidates targeting different proteins (Grb2, Bcl-2, STAT3), is strategically sound. However, investors should note that Bio-Path is still in early to mid-stage clinical trials. While the recent results are encouraging, the path to market is long and uncertain. The company's ability to advance multiple candidates simultaneously will be important for long-term success and risk mitigation.
While the clinical progress is promising, Bio-Path's financial position needs careful consideration. As a clinical-stage biotech, the company likely has significant ongoing R&D expenses without product revenues. The positive clinical data may improve Bio-Path's chances of securing partnerships or additional funding, which is important for advancing its pipeline.
Investors should monitor the company's cash burn rate and funding options. The stock (NASDAQ:BPTH) may experience volatility based on these clinical updates. However, it's important to note that the market often overreacts to early-stage clinical data. Long-term value will depend on continued clinical success, regulatory approvals and eventual commercialization. The diverse pipeline provides multiple shots on goal but also requires substantial resources to develop.
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)
Supportive Safety and Efficacy Data from Two Assets Validate Potential of DNAbilize® Platform Technology to Treat Most Vulnerable Cancer Patients
HOUSTON, Aug. 21, 2024 (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 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 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. “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 has shown tumor regression and stable disease. 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 frontline therapies,” continued Mr. Nielsen.
“In addition, we observed extended treatment durability in two elderly patients in our Phase 2 triple combination study of prexigebersen, venetoclax and decitabine in AML patients. 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 AML patients are typically unable to tolerate intensive chemotherapy and thus experience very poor clinical outcomes,” concluded Mr. Nielsen.
Bio-Path’s DNAbilize Technology Platform – Bio-Path’s DNAbilize platform is a novel technology that achieves systemic delivery for target-specific protein inhibition for any gene product that is over-expressed in disease. The Company’s drug delivery and antisense technology uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a lipid bilayer having neutral charge. Bio-Path believes this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, DNAbilize delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and dosing in clinical trials, the Company’s DNAbilize drug candidates have demonstrated a promising safety and efficacy profile. Bio-Path currently has four DNAbilize drug product candidates in development.
Solid Tumor Patient Response in Second, Higher Dose Cohort – Bio-Path’s first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experiencing a positive response 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
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 – During the Company’s recent pause for an interim analysis of results for Bio-Path’s Phase 2 clinical trial treating AML patients, attention focused on two elderly patients who demonstrated continued treatment durability. The first patient is an elderly female who has received 16 cycles of treatment over 21 months and continues in complete remission. The second patient is an elderly male who is completing his twelfth cycle of treatment over fourteen months and continues in complete remission. The clinical trial investigator treating these two patients indicated that they are both doing very well on treatment. 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. 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 lymphoma and 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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