“Despite advances for the treatment of B-cell malignancies, substantial unmet need remains for effective treatments. Preclinical evidence has demonstrated a differentiated profile for CLN-978 as it binds with very high affinity to CD19-expressing cells even at barely detectable levels of CD19.” said
The study is a Phase 1, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and efficacy of CLN-978 in patients with relapsed/refractory B-NHL.
IND submission remains on track for CLN-617 (IL-2, IL-12 fusion protein) in 1H 2023.
ABOUT CLN-978
CLN-978 is a novel, highly potent, half-life extended CD19/CD3 bispecific T-cell engaging antibody construct. CLN-978 contains two single-chain variable fragments (scFv), one recognizing with high affinity CD19 on malignant cells and the other targeting CD3 on T-cells. While CLN-978 resembles the BiTE format, it also contains a single-domain antibody (VHH) binding to human serum albumin (HSA). CLN-978 redirects and activates T-cells to destroy cancer cells via T-cell mediated cytotoxicity.
CLN-978 potentially offers a convenient, off-the-shelf therapeutic option that may provide an alternative to CD19 CAR T-cell therapies. High-affinity binding of CLN-978 to CD19 allows for increased potency against tumor cells expressing very low levels of CD19. An HSA-binding domain increases the serum half-life of CLN-978 and, with subcutaneous delivery, permits more patient-friendly dosing and potentially reduced toxicity.
CLN-978 has the potential to become a highly effective treatment option for patients across a range of B-cell malignancies, including those who have relapsed on other CD19-directed therapies due to reduced CD19 target expression. CLN-978 is currently being evaluated as a novel treatment for B-NHL, but with potential applicability across the entire spectrum of B-cell mediated diseases.
About
Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer. Learn more about our Company at www.cullinanoncology.com, and follow us on LinkedIn and
Forward-looking statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan’s beliefs and expectations regarding our preclinical and clinical development plans and timelines, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to our expectations and beliefs around the safety and efficacy of CLN-978. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our product candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the
InvestorsChad Messer +1 203.464.8900 cmesser@cullinanoncology.com MediaRose Weldon +1 215.801.7644 rweldon@cullinanoncology.com
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