Goal response charge of 39% with manageable security profile in sufferers with non-small cell lung most cancers (NSCLC) harboring EGFR Exon 20 insertion mutations handled with zipalertinib who had progressed after prior amivantamab remedy

CAMBRIDGE, Mass., June 01, 2024 (GLOBE NEWSWIRE) — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical firm targeted on growing modality-agnostic focused therapies, in the present day introduced optimistic preliminary knowledge in sufferers receiving zipalertinib after prior remedy with amivantamab enrolled in its pivotal Part 2b REZILIENT1 scientific trial.

As of a January 12, 2024 knowledge cut-off, 31 sufferers had been enrolled. Sufferers had acquired a median of three prior systemic anti-cancer regimens, together with prior platinum-based chemotherapy, prior anti-PD1/L1 remedy, and prior epidermal progress issue receptor (EGFR) tyrosine kinase inhibitor (TKI) remedy.

At knowledge cut-off, 18 sufferers have been evaluable for response and confirmed related anti-tumor exercise in contrast with these publish prior chemotherapy within the beforehand reported Part 1/2a a part of the research.

NE: Not but estimable
ORR: Goal response charge; DCR: Illness management charge; DOR: Period of response; PFS: Development-free survival
¹ Piotrowska Z, et al. JCO 2023
² DCR= (PR+SD) / response-evaluable sufferers
PR: Partial response; SD: Steady illness

Zipalertinib demonstrated a manageable security profile, just like what has been beforehand reported. There have been no grade 4 or grade 5 treatment-related hostile occasions‹.

In an evolving remedy panorama, that is the primary ever scientific knowledge to systematically characterize the potential of an irreversible and selective EGFR exon20 insertion mutation TKI akin to zipalertinib in sufferers who have been closely pre-treated and had acquired amivantamab. Given the current approval of amivantamab as a primary line remedy together with chemotherapy, we’re inspired by the preliminary outcomes of the Part 2b portion of the REZILIENT1 scientific trial, which present that in a post-amivantamab setting, zipalertinib demonstrated promising efficacy, just like that in sufferers who progressed after platinum-based chemotherapy alone, and had a manageable security profile, stated Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. With a complete growth plan for zipalertinib, this knowledge additional strengthens our confidence in its potential to deal with a major unmet want for sufferers with NSCLC harboring EGFR exon20 insertion mutations. We stay on observe to finish enrollment within the pivotal Part 1/2b REZILIENT1 trial by the tip of this 12 months.

Zipalertinib has a novel chemical construction that’s distinct from different exon20 insertion directed brokers, which makes it extremely selective for mutant exon 20 versus wild-type EGFR. Cullinan entered right into a partnership with Taiho in 2022, with an upfront money fee of $275M and extra funds totaling $130M to be made for US regulatory approvals in 1L and 2L+ NSCLC. Cullinan additionally retains a 50/50 revenue share within the U.S.

Cullinan and Taiho have a broad growth program for zipalertinib by means of a collection of REZILIENT research, together with two ongoing pivotal research in 1L and 2L+ exon20 insertion NSCLC in addition to research in different affected person populations akin to sufferers with lively mind metastases and people with unusual EGFR mutations. Each Module B2 (publish chemo solely) and Module C (publish accredited ex20ins remedies) of the pivotal REZILIENT1 trial stay on observe to finish enrollment by  finish of 2024, per prior projections.

Digital and Reside Investor Occasion
Cullinan Therapeutics will host an Investor Occasion on Saturday, June 1, 2024, at 6:30 PM Central Time, throughout which Dr. Jeff Jones, Chief Medical Officer at Cullinan Therapeutics, will current an outline of this zipalertinib knowledge together with CLN-619 knowledge shared on the 2024 American Society of Scientific Oncology Annual Assembly. Alexander Spira, MD, PhD, FACP, FASCO, Director, Virginia Most cancers Specialists Analysis Institute and Director, NEXT Oncology Virginia, will share an outline of the present remedy panorama for EGFR-mutated NSCLC. Buyers and analysts are invited to register to attend in individual by emailing Chad Messer, VP Investor Relations (cmesser@cullinantx.com). A stay webcast shall be obtainable through the occasions web page of the Firm’s investor relations web site at  https://cullinantherapeutics.com/events-and-presentations/, and a replay  shall be obtainable shortly after the conclusion of the stay occasion.

About Zipalertinib
Zipalertinib (CLN-081/TAS6417) is an orally obtainable small molecule designed to focus on activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, whereas sparing wild-type EGFR. Zipalertinib is designed as a subsequent era, irreversible EGFR inhibitor for the remedy of a genetically outlined subset of sufferers with non-small cell lung most cancers. Zipalertinib has acquired Breakthrough Remedy Designation from the FDA.

Zipalertinib is being developed by Taiho Oncology, Inc., its dad or mum firm, Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. Cullinan Pearl Corp., which Taiho Pharmaceutical Co., Ltd., acquired from Cullinan Therapeutics, Inc. in 2022, beforehand licensed the rights to zipalertinib in Better China to Zai Lab (NASDAQ:) Restricted in 2020.

About Cullinan Therapeutics
Cullinan Therapeutics, Inc.  (Nasdaq: CGEM) is a biopharmaceutical firm devoted to creating new requirements of look after sufferers. We’ve got strategically constructed a diversified portfolio of clinical-stage property that inhibit key drivers of illness or harness the immune system to eradicate diseased cells in each oncology and autoimmune ailments. Our portfolio encompasses a variety of modalities, every with the potential to be finest and/or first in school. Anchored in a deep understanding of oncology, immunology, and translational medication, we create differentiated concepts, determine essentially the most acceptable targets, and choose the optimum modality to develop transformative therapeutics throughout all kinds of most cancers and autoimmune indications. We push typical boundaries from candidate choice to differentiated therapeutic, making use of rigorous go/no go standards at every stage of growth to fast-track solely essentially the most promising molecules to the clinic and, in the end, commercialization. With deep scientific experience, our groups train creativity and urgency to ship on our promise to convey new therapeutic options to sufferers. Be taught extra about our Firm at  https://cullinantherapeutics.com/, and observe us on  LinkedIn  and  X.

Ahead-Wanting Statements
This press release incorporates forward-looking statements inside the which means of The Personal Securities Litigation Reform Act of 1995. These forward-looking statements embody, however usually are not restricted to, categorical or implied statements relating to Cullinan’s beliefs and expectations relating to the potential advantages and therapeutic potential of zipalertinib; our scientific growth plans and timelines; our plans relating to future knowledge displays and different statements that aren’t historic information. The phrases anticipate, imagine, proceed, might, estimate, count on, hope, intend, could, plan, potential, predict, undertaking, goal, ought to, would, and related expressions are supposed to determine forward-looking statements, though not all forward-looking statements include these figuring out phrases.

Any forward-looking statements on this press release are primarily based on administration’s present expectations and beliefs of future occasions and are topic to identified and unknown dangers and uncertainties which will trigger our precise outcomes, efficiency or achievements to be materially completely different from any expressed or implied by the forward-looking statements. These dangers embody, however usually are not restricted to, the next: uncertainty relating to the timing and outcomes of regulatory submissions; success of our scientific trials and preclinical research; dangers associated to our capability to guard and preserve our mental property place; dangers associated to manufacturing, provide, and distribution of our product candidates; the danger that anybody or extra of our product candidates, together with these which can be co-developed, is not going to be efficiently developed and commercialized; the danger that the outcomes of preclinical research or scientific research is not going to be predictive of future ends in reference to future research; and success of any collaboration, partnership, license or related agreements. These and different necessary dangers and uncertainties mentioned in our filings with the Securities and Alternate Fee, together with beneath the caption Danger Components in our most up-to-date Annual Report on Kind 10-Ok and subsequent filings with the SEC, might trigger precise outcomes to vary materially from these indicated by the forward-looking statements made on this press release. Whereas we could elect to replace such forward-looking statements sooner or later sooner or later, we disclaim any obligation to take action, even when subsequent occasions trigger our views to vary, besides to the extent required by legislation. These forward-looking statements shouldn’t be relied upon as representing our views as of any date subsequent to the date of this press release. Furthermore, besides as required by legislation, neither the corporate nor another individual assumes accountability for the accuracy and completeness of the forward-looking statements included on this press release. Any forward-looking assertion included on this press release speaks solely as of the date on which it was made.

Contacts:
Investor Relations
Chad Messer
+1 203.464.8900
cmesser@cullinantx.com

Media
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com