CAMBRIDGE, Mass., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Cullinan Management, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies, today announces the following business updates:
Portfolio Overview and Updates:
- Cullinan Pearl
Based on pre-specified efficacy criteria, Cullinan recently initiated Phase 2a Dose Expansion at the 100 mg BID dosing level in the ongoing Phase 1/2a study evaluating CLN-081 in adult NSCLC patients with EGFRex20ins mutations. This expansion will enable enrollment of up to 36 patients, inclusive of 13 previously enrolled patients, at this dosing level. Cullinan is contemplating additional expansion cohorts and intends to provide updated safety and efficacy data in mid-2021.
- Cullinan Florentine
In January 2021, Cullinan submitted an IND to the U.S. Food and Drug Administration (FDA) for a Phase 1/2a clinical trial evaluating CLN-049, a bispecific antibody targeting FLT3 and CD3, in relapsed or refractory AML patients. The FDA subsequently provided feedback, including a request to consider alternative trial designs that would enable the collection of exploratory pharmacokinetic and pharmacodynamic data before dose escalation. Based on this information, Cullinan elected to withdraw the IND to determine the most efficient path forward.
- Cullinan MICA
Cullinan is completing the production of GMP drug product to support an IND submission and subsequent clinical trial for its investigational product CLN-619, a monoclonal antibody designed to stimulate natural killer (NK) and T cell responses by engaging a unique target, MICA/B. Consistent with prior guidance, Cullinan intends to submit an IND in the second quarter of 2021.
SVB Leerink Global Healthcare Conference Event Details:
Chief Executive Officer, Owen Hughes, will provide a company overview and update at the 10th Annual SVB Leerink Global Healthcare Conference.
- Event: 10th Annual SVB Leerink Global Healthcare Conference
- Location: Virtual
- Date: Friday, February 26, 2021
- Time: 4:20 PM ET/1:20PM PT
Members of the Cullinan management team will also host investor meetings during the SVB Leerink Global Healthcare Conference.
A webcast of the SVB Leerink presentation will be available in the Investors section of the Cullinan website at https://www.cullinanoncology.com/.
About CLN-081
CLN-081 is an orally available, irreversible EGFR inhibitor that is designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertion mutations, with relative sparing of cells expressing wild type EGFR. CLN-081 is currently in a Phase 1/2a dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with NSCLC harboring EGFRex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy. CLN-081 is being developed in Cullinan Pearl, a Cullinan subsidiary.
About CLN-049
CLN-049 is a humanized bispecific antibody targeting FLT3 on target leukemic cells and CD3 on T cells, triggering cancer cell lysis via T cell cytolytic mechanisms. FLT3 is expressed frequently on AML cells and leukemic blasts but minimally on healthy blood cells, unlike other tumor surface antigens such as CD33 and CD123. CLN-049 is being developed in Cullinan Florentine, a Cullinan subsidiary.
About CLN-619
CLN-619 is MICA/B-targeted, humanized IgG1 monoclonal antibody that Cullinan intends to develop in patients with advanced solid tumors. MICA/B are stress-induced ligands that innate and adaptive immune cell populations recognize via the NKG2D receptor. To evade potential cytotoxic destruction by NK cells and T cells, tumors shed MICA/B from the cell surface. CLN-619 is designed to promote an antitumor response through multiple mechanisms of action, including shielding the proteolytic cleavage sites of MICA/B on cancer cells. CLN-619 is being developed in Cullinan MICA, a Cullinan subsidiary.
About Cullinan Management
Cullinan Management is a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies. The Company’s strategy is to build a pipeline of therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes.
