Indaptus Therapeutics Announces Clinical Supply Agreement with BeiGene to Evaluate Novel Cancer Treatment Combinations
Indaptus Therapeutics (Nasdaq: INDP) has announced a clinical supply agreement with BeiGene to evaluate novel cancer treatment combinations. The planned trial, expected to start in 2025, will combine BeiGene's checkpoint inhibitor tislelizumab with Indaptus' Decoy20, a broadly targeted, short-duration systemic immune stimulator.
Decoy20, when combined with a PD-1 inhibitor and an oral non-steroidal anti-inflammatory agent, demonstrated 80-100% tumor eradication rates in preclinical studies. The trial aims to improve outcomes in human patients with various cancers, including liver, colon, and pancreatic.
BeiGene will provide access to its PD-1 inhibitor and technical expertise to accelerate the clinical trial. Indaptus will seek FDA approval to initiate the combination trial. A conference call is scheduled for October 22, 2024, at 4:30 PM ET to discuss the agreement and future plans.
Indaptus Therapeutics (Nasdaq: INDP) ha annunciato un accordo di fornitura clinica con BeiGene per valutare nuove combinazioni di trattamento contro il cancro. Lo studio pianificato, previsto per iniziare nel 2025, combinerà l'inibitore del checkpoint di BeiGene, tislelizumab, con Decoy20 di Indaptus, un immunostimolatore sistemico a bersaglio ampio e a breve durata.
Decoy20, quando combinato con un inibitore PD-1 e un agente antinfiammatorio non steroideo orale, ha dimostrato tassi di eradazione tumorale dell'80-100% negli studi preclinici. L'obiettivo dello studio è migliorare gli esiti nei pazienti umani affetti da vari tipi di cancro, inclusi quelli al fegato, al colon e al pancreas.
BeiGene fornirà accesso al suo inibitore PD-1 e competenze tecniche per accelerare la sperimentazione clinica. Indaptus cercherà l'approvazione della FDA per avviare lo studio combinato. È prevista una chiamata conferenza per il 22 ottobre 2024, alle 16:30 ET, per discutere dell'accordo e dei progetti futuri.
Indaptus Therapeutics (Nasdaq: INDP) ha anunciado un acuerdo de suministro clínico con BeiGene para evaluar nuevas combinaciones de tratamiento contra el cáncer. El ensayo planeado, que se espera comience en 2025, combinará el inhibidor de checkpoint de BeiGene, tislelizumab, con Decoy20 de Indaptus, un estimulador inmune sistémico de amplio espectro y corta duración.
Decoy20, cuando se combina con un inhibidor de PD-1 y un agente antiinflamatorio no esteroide oral, demostró tasas de erradicación tumoral del 80-100% en estudios preclínicos. El ensayo tiene como objetivo mejorar los resultados en pacientes humanos con varios tipos de cáncer, incluidos los de hígado, colon y páncreas.
BeiGene proporcionará acceso a su inhibidor de PD-1 y experiencia técnica para acelerar el ensayo clínico. Indaptus buscará la aprobación de la FDA para iniciar el ensayo de combinación. Se programó una llamada de conferencia para el 22 de octubre de 2024, a las 4:30 PM ET, para discutir el acuerdo y los planes futuros.
Indaptus Therapeutics (Nasdaq: INDP)는 BeiGene과 새로운 암 치료 조합을 평가하기 위한 임상 공급 계약을 발표했습니다. 계획된 임상시험은 2025년에 시작될 것으로 예상되며, BeiGene의 체크포인트 억제제인 티슬리주맙과 Indaptus의 Decoy20, 광범위한 목표의 단기간 시스템 면역 자극제를 결합할 것입니다.
Decoy20는 PD-1 억제제와 경구 비스테로이드 항염증제를 결합했을 때, 전임상 연구에서 80-100%의 종양 제거율을 보였습니다. 이 시험은 간, 대장 및 췌장 등 다양한 암을 앓고 있는 환자들의 치료 결과를 개선하는 것을 목표로 하고 있습니다.
BeiGene은 임상 시험을 가속화하기 위해 PD-1 억제제와 기술적인 전문 지식을 제공할 예정입니다. Indaptus는 조합 시험 시작을 위한 FDA 승인을 요청할 것입니다. 협약 및 향후 계획에 대한 논의를 위해 2024년 10월 22일 오후 4시 30분 ET에 컨퍼런스 콜이 예정되어 있습니다.
Indaptus Therapeutics (Nasdaq: INDP) a annoncé un accord de fourniture clinique avec BeiGene pour évaluer de nouvelles combinaisons de traitements contre le cancer. L'essai prévu, qui devrait débuter en 2025, combinera l'inhibiteur de checkpoint de BeiGene, le tislelizumab, avec Decoy20 d'Indaptus, un stimulateur immunitaire systémique à large spectre et de courte durée.
Decoy20, lorsqu'il est combiné avec un inhibiteur de PD-1 et un agent anti-inflammatoire non stéroïdien oral, a montré des taux d'éradication tumorale de 80 à 100% dans des études précliniques. L'essai vise à améliorer les résultats chez des patients humains atteints de divers cancers, y compris ceux du foie, du côlon et du pancréas.
BeiGene fournira un accès à son inhibiteur de PD-1 et une expertise technique pour accélérer l'essai clinique. Indaptus cherchera à obtenir l'approbation de la FDA pour initier l'essai de combinaison. Une conférence téléphonique est prévue pour le 22 octobre 2024 à 16h30 ET pour discuter de l'accord et des futurs projets.
Indaptus Therapeutics (Nasdaq: INDP) hat eine klinische Liefervereinbarung mit BeiGene angekündigt, um neue Kombinationen von Krebsbehandlungen zu evaluieren. Die geplante Studie, die voraussichtlich im 2025 beginnen wird, wird den PD-1-Checkpoint-Inhibitor Tislelizumab von BeiGene mit Decoy20 von Indaptus kombinieren, einem breit angelegten, kurz wirkenden systemischen Immunstimulans.
Decoy20 zeigte in präklinischen Studien in Kombination mit einem PD-1-Inhibitor und einem oralen nichtsteroidalen entzündungshemmenden Mittel 80-100% Tumoreradikationsraten. Die Studie zielt darauf ab, die Ergebnisse bei menschlichen Patienten mit verschiedenen Krebsarten, einschließlich Leber-, Darm- und Bauchspeicheldrüsenkrebs, zu verbessern.
BeiGene wird Zugang zu seinem PD-1-Inhibitor und technische Expertise zur Beschleunigung der klinischen Studie bereitstellen. Indaptus wird die FDA-Zulassung anstreben, um die Kombinationstests zu starten. Eine Telefonkonferenz ist für den 22. Oktober 2024 um 16:30 Uhr ET geplant, um die Vereinbarung und zukünftige Pläne zu besprechen.
- Clinical supply agreement with BeiGene for novel cancer treatment combinations
- Preclinical studies showed 80-100% tumor eradication rates with Decoy20 combination
- Potential to improve outcomes for various cancer types, including liver, colon, and pancreatic
- BeiGene to provide access to PD-1 inhibitor and technical expertise
- Planned clinical trial expected to start in 2025
- None.
Insights
This clinical supply agreement between Indaptus and BeiGene represents a significant milestone in cancer immunotherapy. The planned combination of Decoy20 with tislelizumab could potentially enhance the efficacy of checkpoint inhibitors, addressing a critical need in oncology.
Key points to consider:
- Preclinical data showing
80-100% tumor eradication rates is promising, but human trials are crucial - The "Pulse-Prime" approach of Decoy20 offers a novel mechanism to boost immune response with manageable side effects
- Targeting multiple cancer types (liver, colon, pancreatic) broadens the potential market impact
- BeiGene's involvement provides valuable resources and expertise
While promising, investors should note that clinical trials are not expected to start until 2025, indicating a long runway before potential commercialization. The upcoming conference call may provide more insights into timelines and financial implications.
The proposed combination of Decoy20 and tislelizumab represents an innovative approach in cancer immunotherapy. Decoy20's broad immune stimulation could potentially synergize with PD-1 inhibition, addressing the limitations of current checkpoint therapies.
Critical aspects to consider:
- The "Pulse-Prime" approach may offer a better safety profile compared to continuous immune stimulation
- Targeting multiple cancer types suggests a platform technology with broad applications
- The combination with NSAIDs in preclinical studies is intriguing and warrants further investigation
However, the transition from animal models to human trials often reveals unexpected challenges. The 2025 start date for clinical trials indicates a long development timeline, typical for novel cancer therapies. This collaboration could accelerate development, but results will take years to materialize.
Planned industry first clinical trial combining BeiGene's checkpoint inhibitor tislelizumab with Indaptus’ broadly targeted, short duration systemic immune stimulator Decoy20 expected to start in 2025
Indaptus Therapeutics Management will hold a conference call on October 22, 2024 at 4:30PM ET to discuss the agreement and future plans
NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company pioneering innovative cancer and viral infection treatments, today announced a clinical supply agreement with BeiGene. Building on Indaptus’ preclinical observation that Decoy20, when combined with a PD-1 inhibitor, induced complete cancer regressions and immunological memory in animal models, Indaptus plans to advance human clinical evaluation of the combination of BeiGene's anti-PD-1 antibody, tislelizumab, with Indaptus’ Decoy20, a novel treatment designed to induce a broad immune response to fight cancer.
Indaptus’ Decoy20 is being studied for its potential to treat a variety of cancers, including liver, colon, and pancreatic. PD-1 inhibitors are considered key agents in modern immunotherapy and have produced impressive response rates in some patients. In preclinical studies, Decoy20, when used in combination with a PD-1 inhibitor and an oral non-steroidal anti-inflammatory agent, demonstrated tumor eradication rates of 80
“PD-1 inhibitors have proven to be meaningful in treating multiple types of cancer. We are optimistic that we can improve outcomes by broadly and safely stimulating the immune system in a way that could enhance overall effectiveness of currently approved cancer treatments,” said Jeffrey Meckler, CEO of Indaptus Therapeutics. “This agreement with BeiGene marks a significant step forward in the search for curative cancer treatments for some of the most challenging cancers. Additionally, we view this as a significant milestone for Indaptus.”
As part of the agreement, BeiGene will provide Indaptus with access to its PD-1 inhibitor as well as technical expertise in order to accelerate the first clinical trial combining the two investigational drugs. Decoy20 utilizes Indaptus’ unique “Pulse-Prime” approach, which induces a strong and broad boost to the immune system but clears rapidly with only transient and tolerable side effects.
“Decoy20’s ability to synergize with a variety of approved therapeutic modalities, including checkpoint therapy, makes it a promising partner for several novel combination approaches,” said Dr. Michael Newman, Founder and Chief Scientific Officer at Indaptus. “This trial could reshape the checkpoint therapy landscape, as it will be the first time a short but broadly acting agent such as Decoy20, utilizing our innovative Pulse-Prime approach, will be tested in combination with a PD-1 inhibitor."
Indaptus will seek approval from the FDA to initiate a combination trial, which is anticipated to begin in 2025.
Conference Call to be held October 22, 2024 at 4:30PM ET
Indaptus management will host a conference call today at 4:30 p.m. ET to discuss this development and outline the Company’s path forward. Following management’s formal remarks, there will be a question-and-answer session.
Participants can register for the conference by navigating here. Registered participants will receive their dial in number upon registration. Participants who have not preregistered within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Indaptus Therapeutics conference call.
The conference call will also be available through a live webcast that can be accessed here. A replay of this call will be available until January 22, 2025, and can be accessed at the link above.
A telephonic replay of the call will be available until November 22, 2024 by dialing 1-877-344-7529 (or 1-412-317-0088 for international callers) and using replay access code 8098162.
About PD-1 Inhibitors
PD-1 inhibitors are a class of immunotherapy drugs that block the PD-1 (programmed death-1) receptor on T cells, preventing cancer cells from evading immune detection. By inhibiting the interaction between PD-1 and its ligands (PD-L1/PD-L2) on tumor cells, these drugs restore the ability of the adaptive arm of the immune system to recognize and attack cancer cells.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product candidate, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product candidate. Indaptus’ Decoy product candidates have also produced meaningful single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things: our expectations and plans regarding our clinical supply agreement with BeiGene; our plans to advance clinical evaluation of the combination of BeiGene's anti-PD-1 antibody, tislelizumab, with Decoy20; our plans to seek FDA approval and to initiate a combination trial; the anticipated effects of our product candidates, including Decoy20; the plans and objectives of management for future operations; our research and development activities and costs; the sufficiency of our cash and cash equivalents to fund our ongoing activities and our cash management strategy; and our assessment of financing options to support our corporate strategy. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 filed with the SEC on August 12, 2024, our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2024, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.
Indaptus Contact: investors@indaptusrx.com
Investor Relations Contact (for Indaptus):
CORE IR
Louie Toma
louie@coreir.com
Media Contact (for Indaptus):
Cuttlefish Communications
Shira Derasmo
shira@cuttlefishpr.com
917-280-2497
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