First Patient Enrolled in Phase I Program in STK11 Mutant Non-Small Cell Lung Cancer at Moffitt Cancer Center
Panbela Therapeutics (OTCQB: PBLA) has announced the enrollment of the first patient in a Phase I dose escalation study evaluating CPP-1X-S (eflornithine sachets) in STK11 mutant non-small cell lung cancer (NSCLC). The study aims to determine the maximum tolerated dose of eflornithine combined with Keytruda, an immune checkpoint inhibitor. Data from this trial is expected by mid-2025, with plans to initiate a Phase II efficacy trial in 2024.
The trial, titled 'Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC,' will be conducted at approximately one academic medical center in the United States. Dr. Jhanelle Gray, Principal Investigator and Chair of Moffitt's Department of Thoracic Oncology, emphasized the importance of combining new agents with immunotherapy to overcome reduced anti-tumor T cell levels in STK11 mutant tumors.
Panbela Therapeutics (OTCQB: PBLA) ha annunciato l'arruolamento del primo paziente in uno studio di fase I di escalation della dose che valuta CPP-1X-S (sacchetti di eflornitina) nel cancro polmonare non a piccole cellule (NSCLC) con mutazione STK11. Lo studio mira a determinare la dose massima tollerata di eflornitina combinata con Keytruda, un inibitore del checkpoint immunitario. I dati di questo studio sono attesi entro la metà del 2025, con piani per avviare uno studio di efficacia di fase II nel 2024.
Lo studio, intitolato 'Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC,' sarà condotto presso un centro medico accademico negli Stati Uniti. La Dr.ssa Jhanelle Gray, Investigatrice principale e Presidente del Dipartimento di Oncologia Toracica di Moffitt, ha sottolineato l'importanza di combinare nuovi agenti con l'immunoterapia per superare i livelli ridotti di cellule T anti-tumorali nei tumori con mutazione STK11.
Panbela Therapeutics (OTCQB: PBLA) ha anunciado la inclusión del primer paciente en un estudio de fase I de escalamiento de dosis que evalúa CPP-1X-S (sachets de eflornitina) en cáncer de pulmón no microcítico (NSCLC) mutante de STK11. El estudio tiene como objetivo determinar la dosis máxima tolerada de eflornitina combinada con Keytruda, un inhibidor del punto de control inmunitario. Se espera que los datos de este ensayo estén disponibles para mediados de 2025, con planes de iniciar un ensayo de eficacia de fase II en 2024.
El ensayo, titulado 'Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC,' se llevará a cabo en aproximadamente un centro médico académico en Estados Unidos. La Dra. Jhanelle Gray, Investigadora principal y Presidenta del Departamento de Oncología Torácica de Moffitt, enfatizó la importancia de combinar nuevos agentes con inmunoterapia para superar los niveles reducidos de células T antitumorales en tumores mutantes de STK11.
팬벨라 테라퓨틱스(OTCQB: PBLA)는 STK11 변이 비소세포 폐암(NSCLC)에서 CPP-1X-S(에플로르니틴 파우치)를 평가하는 1상 용량 증량 연구에 첫 번째 환자의 등록을 발표했습니다. 이 연구는 키트루다(면역 체크포인트 억제제)와 결합된 에플로르니틴의 최대 내약 용량을 결정하는 것을 목표로 합니다. 이 시험의 데이터는 2025년 중반에 발표될 예정이며, 2024년에는 2상 효능 시험을 시작할 계획입니다.
'STK11(LKB1) 경로 결핍 NSCLC에서 면역요법적 표적으로서 ODC 타겟팅'이라는 제목의 이 연구는 미국의 한 학술 의학 센터에서 진행될 예정입니다. Janelle Gray 박사, Moffitt 흉부 종양학과의 주요 연구자 겸 의장, 은 STK11 변이 종양에서 감소된 항종양 T세포 수준을 극복하기 위해 새로운 제제를 면역요법과 결합하는 것의 중요성을 강조했습니다.
Panbela Therapeutics (OTCQB: PBLA) a annoncé l'inscription du premier patient dans une étude de phase I d'escalade de dose évaluant CPP-1X-S (sachets d'éflornithine) dans le cancer du poumon non à petites cellules (NSCLC) mutant STK11. L'étude vise à déterminer la dose maximale tolérée d'éflornithine en combinaison avec Keytruda, un inhibiteur de point de contrôle immunitaire. Les données de cet essai sont attendues d'ici mi-2025, avec des plans de lancement d'un essai d'efficacité de phase II en 2024.
L'essai, intitulé 'Cibler l'ODC comme cible immunothérapeutique dans le NSCLC défectueux du chemin STK11 (LKB1),' sera mené dans environ un centre médical académique aux États-Unis. Dr. Jhanelle Gray, Investigatrice principale et Présidente du Département d'Oncologie Thoracique de Moffitt, a souligné l'importance de combiner de nouveaux agents avec une immunothérapie pour surmonter les niveaux réduits de cellules T anti-tumorales dans les tumeurs mutantes STK11.
Panbela Therapeutics (OTCQB: PBLA) hat die Einschreibung des ersten Patienten in eine Phase-I-Dosiseskalationsstudie bekannt gegeben, die CPP-1X-S (Eflornithin-Säckchen) bei STK11-mutiertem nicht-kleinzelligem Lungenkrebs (NSCLC) bewertet. Die Studie zielt darauf ab, die maximal tolerierte Dosis von Eflornithin in Kombination mit Keytruda, einem Immun-Checkpoint-Inhibitor, zu bestimmen. Daten aus dieser Studie werden bis Mitte 2025 erwartet, mit Plänen, 2024 eine Phase-II-Effektivitätstudie zu beginnen.
Die Studie mit dem Titel 'Zielgerichtete ODC als immuntherapeutisches Ziel in STK11 (LKB1)-defizientem NSCLC' wird an einem akademischen medizinischen Zentrum in den Vereinigten Staaten durchgeführt. Dr. Jhanelle Gray, Hauptprüferin und Leiterin der Abteilung für Thoraxonkologie von Moffitt, betonte die Bedeutung der Kombination neuer Wirkstoffe mit Immuntherapie, um die reduzierten Anti-Tumor-T-Zellniveaus in STK11-mutierten Tumoren zu überwinden.
- First patient enrolled in Phase I trial for CPP-1X-S in STK11 mutant NSCLC
- Recent approval of CPP-1X (DFMO) for neuroblastoma, the first oncology approval for a polyamine targeted therapy
- Potential to restimulate the immune system through polyamine modulation
- Planned Phase II trial to determine efficacy of combining polyamine targeted therapies with checkpoint inhibitors
- Data from Phase I trial not expected until mid-2025
- STK11 mutant NSCLC historically has poor response to checkpoint inhibitor therapy
MINNEAPOLIS, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced the first patient enrolled in a Phase I dose escalation study to evaluate CPP-1X-S (eflornithine sachets) in STK11 mutant non-small cell lung cancer (NSCLC). The initial goal of the Phase I trial will be to determine the maximum tolerated dose of eflornithine in combination with the immune checkpoint inhibitor Keytruda, while evaluating efficacy and then moving into a Phase II efficacy trial. Data from the Phase I trial is expected by mid-2025, with a look to start the Phase II trial in 2024.
The trial entitled “Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway- Deficient NSCLC” is a Phase I/II trial where Phase I is a dose escalation study establishing the safety, toxicity and recommended Phase II dose of CPP-1X-S in combination with Keytruda in patients with STK11 mutant NSCLC at approximately one academic medical center in the United States. Detailed information on the trial can be located at https://clinicaltrials.gov/study/NCT06219174?term=DFMO&rank=4.
“Options for combining new agents with standard of care immunotherapy is critical to overcoming the reduced levels of anti-tumor T cells and immune evasion that is observed in STK11 mutant tumors,” said Jhanelle Gray, M.D., Principal Investigator of the clinical trial, Chair of Moffitt’s Department of Thoracic Oncology and Co-Leader of Moffitt’s Molecular Medicine Program. “By working with Panbela, we are using CPP-1X-S to modulate polyamine levels and potentially restimulate the immune system, which may be a valuable therapeutic strategy to target these hard-to-treat tumors.”
“With the recent approval of CPP-1X (DFMO) for neuroblastoma, the first oncology approval for a polyamine targeted therapy, we’re really excited to have the first patient enrolled in the Phase I trial for CPP-1X-S led by Moffitt Cancer Center,” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. “Preclinical studies have shown that polyamine modulation has the potential to restimulate the immune system. This trial allows us to explore the potential of CPP-1X-S clinically in the STK11 mutant NSCLC population which historically have a poor response to checkpoint inhibitor therapy. Once the safety of CPP-1X-S in combination with Keytruda is established in this Phase I trial, the planned Phase II trial will determine the potential efficacy of combining polyamine targeted therapies with checkpoint inhibitors hopefully demonstrating the first clinical proof of concept of this unique approach. In addition to the possibility of providing a better treatment option for this patient population, we are excited to evaluate the role of eflornithine and ivospemin as modulators of the immune system in combination with other immunotherapies such as CAR-T therapy for tumors where response rates have been low with immunotherapy.”
About Panbela’s Pipeline
The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of anticipated catalysts with programs ranging from pre-clinical to registration studies.
Ivospemin (SBP-101)
Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of
Flynpovi ™
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase III clinical trial in patients with sporadic large bowel polyps, the combination prevented >
CPP-1X
CPP-1X (eflornithine) is being developed as a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.
About Panbela
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further information can be found at www.panbela.com. Panbela’s common stock is eligible for quotation on the OTCQB under the symbol “PBLA”.
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This press release contains “forward-looking statements,” including within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “believe,” “can,” “design,” “expect,” “focus,” “intend,” “looking forward,” “may,” “plan,” “positioned,” “potential,” and “will.” All statements other than statements of historical fact are statements that should be deemed forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially and adversely from the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) our ability to obtain additional capital, on acceptable terms or at all, required to implement our business plan; (ii) our lack of diversification and the corresponding risk of an investment in our Company and the corresponding risk of potential deterioration of our financial condition and results due to failure to diversify; (iii) our ability to obtain and maintain our listing on a national securities exchange; (iv) results, progress and success of our randomized Phase Ia/Ib and Phase II/III clinical trials; (v) our ability to demonstrate the safety and effectiveness of our product candidates: ivospemin ( SBP-101 ), Flynpovi, and eflornithine (CPP-1X); (vi) potential delays or risks to the success of our randomized Phase II/III clinical trial resulting from a termination in our relationship with our CRO; (vii) our ability to obtain regulatory approvals for our product candidates, SBP-101, Flynpovi and CPP-1X in the United States, the European Union or other international markets; (viii) the market acceptance and level of future sales of our product candidates, SBP-101, Flynpovi and CPP-1X ; (ix) the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates, SBP-101, Flynpovi and CPP-1X ; (x) the rate of progress in establishing reimbursement arrangements with third-party payors; (xi) the effect of competing technological and market developments; (xii) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xiii) such other factors as discussed in Part I, Item 1A under the caption “Risk Factors” in our most recent Annual Report on Form 10-K , any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Any forward-looking statement made by us in this press release is based on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement or reasons why actual results would differ from those anticipated in any such forward-looking statement, whether written or oral, whether as a result of new information, future developments or otherwise.
Contact Information:
Investors:
James Carbonara
Hayden IR
(646) 755-7412
james@haydenir.com
Media:
Tammy Groene
Panbela Therapeutics, Inc.
(952) 479-1196
IR@panbela.com
FAQ
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