NT219 was well tolerated
Antitumor activity at relevant high dose levels was observed with an objective response rate (ORR) of 29% and a disease control rate (DCR) of 71%.
Rehovot, Israel, February 27, 2024 (Globe Newswire) — Purple Biotech Co., Ltd. (“Purple Biotech” or the “Company”) (NASDAQ/TASE: PPBT) is developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance. is a clinical-stage company, and announced today. Clinical results of a phase 1/2 dose escalation study of the combination of cetuximab and NT219 in the treatment of patients with recurrent/metastatic head and neck cancer (R/M SCCHN).
This data was presented at the European Society of Medical Oncology Targeted Anticancer Therapies (ESMO TAT) 2024 Congress held in Paris on Monday, February 26, 2024, by Ali, the study's clinical investigator and assistant professor at the University of Chicago School of Medicine. Presented by Dr. Rosenberg. , a member of Purple Biotech's Head and Neck Cancer Scientific Advisory Committee, said, “Interim results from a phase 1/2 trial of NT219 in combination with cetuximab in patients with advanced/metastatic head and neck squamous cell carcinoma (SCCHN )”.
A Phase 1/2 dose-escalation study (NCT04474470) evaluated NT219 as monotherapy in various indications and in combination with cetuximab in the treatment of R/M SCCHN and colorectal cancer.
As of the closing date of January 25, 2024:
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17 R/M SCCHN patients were enrolled on NT219 + cetuximab combination therapy. The median number of prior treatment lines was 2, and 94% of patients had received prior immunotherapy.
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The safety profile was well tolerated and manageable, including at 100 mg/kg. The most frequent treatment-emergent adverse events (AEs) were infusion-related reactions and nausea, and no treatment-related grade 4/5 AEs were observed.
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Pharmacokinetic analysis demonstrated that NT219 plasma concentrations increased in a dose-dependent manner.
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Fifteen patients were evaluable for efficacy, seven of them at the highest relevant dose levels in which antitumor activity was observed, 50 and 100 mg/kg. Of these 7 patients, 2 had confirmed partial responses and 3 had stable disease (all patients with partial responses and stable disease had HPV-negative disease), 29 % ORR and 71% DCR. Median follow-up across all dose levels is 9.4 months (95% CI: 3.4-10.0, 8 of 15 patients remain in follow-up).
The company recently reported that the recommended Phase 2 dose for NT219 is 100 mg/kg.
“We are encouraged to see antitumor activity in HPV-negative patients,” said Dr. Michael Schickler, Purple Biotech's head of clinical and regulatory affairs. “Second- and third-line R/M SCCHN patients have unmet medical needs, most have HPV-negative disease, and have relatively short survival times of less than 9 months. Trials of NT219 must continue to establish good treatment options.”
“We plan to begin a Phase 2 study in combination with cetuximab in head and neck cancer in the first half of 2024, and we continue to build on these positive results,” said Gil Efron, CEO of Purple Biotech. “The data supports the progress of NT219.” “We would like to thank the study participants, their families, and clinical researchers for participating in this important study.”
About NT219
NT219 promotes the degradation of insulin receptor substrate 1/2 (IRS) and phosphorylates signal transducer and activator of transcription 3 (STAT3), two major complementary signaling pathways that play important roles in tumors. A first-in-class small molecule that inhibits oxidation. and its microenvironment. IRS1/2 acts as a scaffold to organize signaling complexes that mediate mitogenic, metastatic, angiogenic, and antiapoptotic signals from IGF1R and other oncogenes. These signals are important drivers in multiple cancers and are deeply involved in the induction of drug resistance. STAT3 is a transcription factor that is widely overactivated in many cancers and promotes proliferation, survival, angiogenesis, metastasis, and tumor immune evasion. Feedback activation of STAT3 plays an important role in mediating drug resistance to various anticancer therapies. As an inhibitor of both IRS1/2 and STAT3, NT219 may prevent the development of resistance to multiple approved treatments.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies to overcome tumor immune evasion and drug resistance. The company's oncology pipeline includes NT219, CM24, and IM1240. NT219 is a dual inhibitor, a novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study has been completed and a Phase 2 study of his NT219 at the recommended Phase 2 dose level in combination with cetuximab is planned for patients with recurrent and/or metastatic SCCHN . CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The company is developing CM24 as a combination therapy with an anti-PD-1 checkpoint inhibitor in a phase 2 trial for the treatment of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement with Bristol-Myers Squibb for a Phase 2 clinical trial evaluating the combination of CM24 and the PD-1 inhibitor nivolumab in addition to chemotherapy. The company is advancing a preclinical platform of conditionally activated trispecific antibodies that engage both T cells and NK cells to mount a strong local immune response within the tumor microenvironment. . Cleavable capping technology has the potential to confine the therapeutic activity of compounds to the local tumor microenvironment, thereby expanding the potential therapeutic window for patients. The third arm specifically targets tumor-associated antigens (TAAs). This technology presents a new mechanism of action by unleashing both the innate and adaptive immune systems to mount an optimal anti-tumor immune response. IM1240 is the first trispecific antibody in development targeting 5T4, which is expressed in a variety of solid tumors and is correlated with progressive disease, increased invasiveness, and poor clinical outcomes. Our headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/.
Forward-Looking Statements and Safe Harbor Statements
Certain statements in this press release are forward-looking statements that are not statements of historical fact and are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to: Limited to statements that are not statements of historical fact, such as “believe,” “expect,” “intend,” “plan,” “may,” “should,” “could,” May be identified by words such as “may”. “,'' “seek,'' “aim,'' “will,'' “plan,'' “anticipate,'' “continue,'' or “anticipate,'' or these words or other equivalent words. Negatives or variations of or are strictly related to historical matters by the fact that these statements are not. You should not place undue reliance on these forward-looking statements as they are not guarantees of future performance. Forward-looking statements reflect the Company's current beliefs, expectations, beliefs or intentions regarding future events and are subject to a number of assumptions and involve known and unknown risks, many of which are beyond the Company's control. and are subject to uncertainties and other factors. As a result, our actual results, performance or achievements may differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among other things, risks related to: management's plans, strategies and goals for future business operations; Product development of tribody platform with NT219, CM24 and its lead tribody IM1240. The process by which such early-stage therapeutic candidates can lead to approved medicines is lengthy and subject to very significant risks, especially when it comes to joint development collaborations. The fact that drug development and commercialization involves long and expensive processes with uncertain outcomes. our ability to successfully develop and commercialize our pharmaceutical products; the cost, duration, progress and results of clinical trials; the impact of changes in regulations and laws that may affect the pharmaceutical industry; difficulties in obtaining the necessary regulatory approvals to commercialize our products; the difficulty of predicting the actions of the U.S. Food and Drug Administration or other applicable drug regulatory authorities; changes in the regulatory environment and healthcare policies and systems of the countries in which we operate; uncertainty surrounding the actual market acceptance of our pharmaceutical products approved for sale in certain markets; Introduction of competitive products. Patents obtained by competitors. dependence on the effectiveness of our patent and other protection for our innovative products; our ability to obtain, maintain and defend issued patents; the initiation of patent interference or infringement proceedings against our patents and our ability to prevail, obtain favorable judgments or recover damages in such proceedings; exposure to litigation, including patent litigation and/or regulatory actions, and as discussed in the Company's Annual Report on Form 20-F for the year ended December 31, 2022 and other filings with U.S. securities exchanges; Other factors that may affect our performance include a careful discussion of risks and uncertainties in the “Risk Factors” section of our registration statement and annual report. These are factors that we believe could cause our actual results to differ materially from our expected results. Factors other than those listed by us may also adversely affect us. The forward-looking statements in this press release speak only as of the date on which they are made. We do not intend to publicly release forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. We have no intention or obligation to update or revise it periodically. However, we encourage you to review any additional disclosures we make in our filings with the SEC, which are available on the SEC's website. https://www.sec.gov.
contact address:
Company contact:
Riolu Fima
CFO
IR@purple-biotech.com