Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian Cancer
Theratechnologies announced preliminary data from Part 3 of its Phase 1b trial of sudocetaxel zendusortide in advanced ovarian cancer patients. The trial, involving 13 heavily pre-treated patients, tested two weekly doses: 1.75-mg/kg/week (Arm A, 7 patients) and 2.5-mg/kg/week (Arm B, 6 patients).
Key findings include no dose-limiting toxicities in either arm and encouraging activity in Arm B, where three patients showed significant tumor shrinkage, including one with complete liver lesion resolution. Arm B patients received longer treatment duration (mean 10.25 weeks) compared to Arm A (mean 7.6 weeks).
The Medical Review Committee unanimously recommended continued evaluation at higher doses. The company plans to accelerate its search for a partner to advance its oncology program.
Theratechnologies ha annunciato dati preliminari dalla Parte 3 del suo studio di Fase 1b riguardante sudocetaxel zendusortide in pazienti con cancro ovarico avanzato. Lo studio, che ha coinvolto 13 pazienti gravemente pre-trattati, ha testato due dosi settimanali: 1,75 mg/kg/settimana (Braccio A, 7 pazienti) e 2,5 mg/kg/settimana (Braccio B, 6 pazienti).
I risultati chiave includono l'assenza di tossicità limitanti della dose in entrambi i bracci e un'attività incoraggiante nel Braccio B, dove tre pazienti hanno mostrato una significativa riduzione del tumore, incluso uno con risoluzione completa delle lesioni epatiche. I pazienti del Braccio B hanno ricevuto una durata di trattamento più lunga (media di 10,25 settimane) rispetto al Braccio A (media di 7,6 settimane).
Il Comitato di Revisione Medica ha raccomandato all'unanimità di proseguire la valutazione a dosi più elevate. L'azienda prevede di accelerare la ricerca di un partner per far avanzare il suo programma oncologico.
Theratechnologies anunció datos preliminares de la Parte 3 de su ensayo de Fase 1b sobre sudocetaxel zendusortide en pacientes con cáncer de ovario avanzado. El ensayo, que involucró a 13 pacientes con múltiples tratamientos previos, probó dos dosis semanales: 1,75 mg/kg/semana (Brazo A, 7 pacientes) y 2,5 mg/kg/semana (Brazo B, 6 pacientes).
Los hallazgos clave incluyen la ausencia de toxicidades limitantes de dosis en ambos brazos y una actividad alentadora en el Brazo B, donde tres pacientes mostraron una reducción significativa del tumor, incluido uno con resolución completa de lesiones hepáticas. Los pacientes del Brazo B recibieron una duración de tratamiento más larga (media de 10,25 semanas) en comparación con el Brazo A (media de 7,6 semanas).
El Comité de Revisión Médica recomendó unánimemente continuar la evaluación a dosis más altas. La empresa planea acelerar su búsqueda de un socio para avanzar en su programa de oncología.
Theratechnologies는 진행성 난소암 환자를 대상으로 한 sudocetaxel zendusortide의 1b상 Phase 1b 시험의 3부에서 preliminary data를 발표했습니다. 이 시험은 13명의 중증 환자를 대상으로 하였으며, 주 2회의 용량을 시험하였습니다: 1.75 mg/kg/주 (A군, 7명) 및 2.5 mg/kg/주 (B군, 6명).
주요 발견으로는 두 군에서 모두 용량 제한성 독성이 없었으며, B군에서 세 명의 환자가 유의미한 종양 크기 감소를 보여주었고, 한 명은 간 병변이 완전히 해소되었습니다. B군 환자들은 A군에 비해 치료 기간이 더 길었습니다(평균 10.25주) A군의 평균은 7.6주였습니다.
의료 검토 위원회는 높은 용량에서의 지속적 평가를 unanimously recommend했습니다. 이 회사는 암 치료 프로그램을 발전시키기 위한 파트너 찾기를 가속화할 계획입니다.
Theratechnologies a annoncé des données préliminaires de la Partie 3 de son essai de Phase 1b concernant sudocetaxel zendusortide chez des patients atteints d'un cancer ovarien avancé. L'essai, qui a impliqué 13 patients ayant subi de nombreux traitements, a testé deux doses hebdomadaires : 1,75 mg/kg/semaine (Bras A, 7 patients) et 2,5 mg/kg/semaine (Bras B, 6 patients).
Les résultats clés incluent l'absence de toxicités limitantes de dose dans les deux bras et une activité encourageante dans le Bras B, où trois patients ont montré une réduction significative de la tumeur, y compris un cas avec résolution complète des lésions hépatiques. Les patients du Bras B ont reçu une durée de traitement plus longue (moyenne de 10,25 semaines) par rapport au Bras A (moyenne de 7,6 semaines).
Le Comité de Révision Médicale a recommandé à l'unanimité de poursuivre l'évaluation à des doses plus élevées. L'entreprise prévoit d'accélérer sa recherche d'un partenaire pour faire avancer son programme d'oncologie.
Theratechnologies hat vorläufige Daten aus Teil 3 seiner Phase 1b-Studie zu sudocetaxel zendusortide bei Patienten mit fortgeschrittenem Eierstockkrebs bekannt gegeben. Die Studie umfasste 13 stark vorbehandelte Patienten und testete zwei wöchentliche Dosen: 1,75 mg/kg/Woche (Arm A, 7 Patienten) und 2,5 mg/kg/Woche (Arm B, 6 Patienten).
Zu den wichtigsten Ergebnissen gehört, dass in beiden Armen keine dosierungsbeschränkenden Toxizitäten auftraten und dass im Arm B ermutigende Aktivitäten zu verzeichnen waren, bei denen drei Patienten eine signifikante Tumorrückbildung zeigten, darunter einer mit vollständiger Auflösung der Leberläsionen. Die Patienten in Arm B erhielten eine längere Behandlungsdauer (im Durchschnitt 10,25 Wochen) im Vergleich zu Arm A (im Durchschnitt 7,6 Wochen).
Der Medizinische Bewertungsausschuss empfahl einstimmig, die Bewertung bei höheren Dosen fortzusetzen. Das Unternehmen plant, die Suche nach einem Partner zur Weiterentwicklung seines Onkologieprogramms zu beschleunigen.
- No dose-limiting toxicities reported in both dosing arms
- Three patients in Arm B showed significant tumor shrinkage (>25% reduction)
- One patient achieved complete resolution of liver lesion
- Longer treatment duration in higher dose Arm B (10.25 weeks vs 7.6 weeks)
- Medical Review Committee unanimously supports higher dose exploration
- No responses observed in Arm A patients
- Company seeking partnership indicates potential funding/development constraints
- Small patient sample size (13 patients total)
Insights
The Phase 1b trial data for sudocetaxel zendusortide shows promising results in advanced ovarian cancer patients. Key findings include no dose-limiting toxicities and encouraging efficacy signals, particularly in the higher-dose Arm B (2.5-mg/kg/week). Three out of six patients in Arm B demonstrated significant clinical benefits, including complete resolution of a liver lesion and >25% tumor size reduction in two patients.
The trial's weekly dosing schedule (three-weeks-on/one-week-off) appears better tolerated than the previous every-3-week dosing, with Arm B patients receiving longer treatment duration (mean 10.25 weeks vs 7.6 weeks in Arm A). The favorable safety profile and preliminary efficacy in heavily pre-treated patients suggest potential for higher doses, which could enhance therapeutic outcomes.
This data release represents a significant milestone for Theratechnologies' oncology program. The company's announcement of seeking partnership opportunities signals a strategic pivot that could unlock value for shareholders. The SORT1+ Technology™ platform's demonstrated flexibility with different payloads enhances its licensing potential.
For a small-cap biotech (
No dose-limiting toxicities reported in two different weekly doses in heavily pre-treated patients
Preliminary evidence of dose response includes significant tumor shrinkage and one patient with complete resolution of a liver lesion
MONTREAL, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Thera technologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced data from Part 3 (dose optimization, weekly dosing schedule) of its ongoing Phase 1b trial of sudocetaxel zendusortide (TH1902) – the company’s lead investigational peptide drug conjugate (PDC) – in patients with advanced ovarian cancer. Based on results demonstrating favorable tolerability and signals of efficacy, the Medical Review Committee, which includes study investigators and external experts, has unanimously recommended continued evaluation and exploration of higher doses.
“We are encouraged by the tolerability and preliminary efficacy data for sudocetaxel zendusortide seen thus far in this part of the Phase 1 study, which was designed to explore dose optimization utilizing a weekly dosing schedule in a population of heavily pre-treated ovarian cancer patients,” commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. “These latest results add to the growing body of evidence that our novel PDC technology can deliver a toxic payload into cancer cells with little impact on non-cancerous tissues and we believe there could be further clinical implications at a higher dose.”
A total of 13 patients with advanced ovarian cancer who progressed despite prior platinum-based and taxane chemotherapy were enrolled in two Arms in Part 3 of the Phase 1b trial. Seven patients were enrolled in Arm A and received a 1.75-mg/kg/week dose of sudocetaxel zendusortide on a weekly infusion, three-weeks-on/one-week-off schedule every 28 days. The six patients enrolled in Arm B received a 2.5-mg/kg/week dose on the same schedule.
Investigators observed no dose-limiting toxicities in either arm. Although there were no responses observed in the five Arm A participants that comprised the per-protocol (PP) set, there was encouraging evidence of activity observed in three of the six patients enrolled in the Arm B PP set, including one patient with a complete resolution of a liver lesion. Those three Arm B patients also experienced significant reductions in the CA-125 ovarian tumor marker as well as significant tumor shrinkage, including two patients with more than a
The Company received permission from the U.S. Food and Drug Administration (FDA) in 2023 to amend the initial Phase 1b clinical trial protocol based on results from Parts 1 and 2, which utilized every-3-week dosing. For Part 3, the protocol was amended to explore dosing weekly for three weeks, followed by a one-week break and shifted the focus to patients with ovarian cancer. At the 2024 American Society of Clinical Oncology (ASCO) annual meeting earlier this year, Theratechnologies presented an updated analysis from Parts 1 and 2 of the study, in which sudocetaxel zendusortide induced durable disease stabilization (up to 45 weeks) lasting beyond treatment completion in several patients with a variety of solid tumors. The ASCO presentation also highlighted early signals of efficacy observed in female cancers (ovarian cancer, endometrial cancer, triple-negative breast cancer [TNBC]), as well as a manageable safety profile when sudocetaxel zendusortide was dosed at 300mg/m2 given once every 3 weeks with few Grade 3 adverse events (AEs).
“The latest data from Part 3 of the Phase 1 trial build on a compelling body of preclinical and translational evidence of antitumor activity with sudocetaxel zendusortide,” said Ira Winer, M.D., Ph.D., FACOG, a member of the Gynecologic Oncology and Phase 1 Clinical Trials Multidisciplinary Teams at Karmanos Cancer Center and Professor of Oncology at Wayne State University School of Medicine in Detroit, MI. “While this is a small sample of patients, it is not often that we see promising signs of efficacy, combined with favorable safety and tolerability data, in this patient population with advanced disease. We therefore recommend and encourage continued investigation with further dose escalation for this agent.”
In addition to the Phase 1b clinical trial results, there is also an extensive body of preclinical data demonstrating the flexibility of the Company’s SORT1+ Technology™ platform when conjugated with different toxic payloads. With a significant portion of the clinical trial data to date now available, Theratechnologies will accelerate its search for a partner to advance its oncology program.
About Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology™
Sudocetaxel zendusortide is a first-of-its-kind sortilin receptor (SORT1)-targeting PDC, and the first compound to emerge from the Company’s broader licensed oncology platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy.
Theratechnologies has established the SORT1+ Technology™ platform as an engine for the development of PDCs that target SORT1, which is expressed in multiple tumor types. SORT1 is a “scavenger” receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival. It is estimated that SORT1 is expressed in
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on LinkedIn and X (formerly Twitter).
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: (i) the conjugation of different toxic payloads to be directed into cancer cells; (ii) signs of efficacy, combined with safety and tolerability data of sudocetaxel zendusortide; (iii) the further development of the Company’s lead PDC, sudocetaxel zendusortide; and (iv) the search for a partner to advance the oncology program. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. These assumptions include, without limitation, that: (i) the technology stemming from the oncology platform will allow for the development and conjugation of various PDC and payloads to treat cancer; and (ii) the Company will be able to find a partner to pursue the development of the oncology platform. Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to, (i) the lack of observation of signs of efficacy and safety results as sudocetaxel zendusortide may be further studied; (ii) difficulties in developing and conjugating payloads to peptides derived from the oncology platform; and (iii) the inability of the Company to find a partner to pursue the development of the oncology platform. We refer current and potential investors to the “Risk Factors” section of our annual information form filed under a Form 20-F dated February 21, 2024, available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date.
We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
Contacts:
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
Investor Inquiries:
Joanne Choi
Senior Director, Investor Relations
jchoi@theratech.com
551-261-0401
FAQ
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