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cullinan ONCOLOGY Cullinan Oncology Provides Corporate Update and Reports Second Quarter 2021 Financial Results August 10 , 2021 Follow - up Cullinan Pearl data from Phase 1 portion of ongoing trial showed increased disease control rate ( DCR ) of 92 % in the 100mg dose cohort IND clearance of two immuno - oncology pipeline programs , Cullinan MICA and Cullinan Florentine , with clinical trial starts for each program expected in 2H 2021 Strong balance sheet with cash and investments of $ 456.3 million as of June 30 , 2021 CAMBRIDGE , Mass . , Aug. 10 , 2021 ( GLOBE NEWSWIRE ) -- Cullinan Oncology , Inc. ( Nasdaq : CGEM ) , an oncology company seeking to drive shareholder returns by focusing on the patient , today announced its financial results for the second quarter ended June 30 , 2021 and reported on recent business highlights . " Solid execution led to the advancement of our clinical pipeline this quarter , " stated Owen Hughes , Chief Executive Officer of Cullinan Oncology . " We are pleased with the encouraging results of Cullinan Pearl ( EGFR exon 20 ) showcased at ASCO as well as the recent IND clearance for the first two programs in our immuno - oncology pipeline , Cullinan MICA ( MICA / B antibody ) and Cullinan Florentine ( FLT3 bispecific ) . With over $ 456 million of cash and investments on hand , we remain well capitalized to advance our broad pipeline through multiple clinical readouts . In the near term , we expect to provide updated preclinical data on Cullinan Amber at the Next - Gen Cytokine Therapeutics Summit in September as well as a Cullinan Pearl clinical and regulatory update in the fourth quarter . " Q2 2021 Portfolio Highlights • Cullinan Pearl : Presented interim data at ASCO 2021 from ongoing Phase 1 / 2a trial evaluating CLN - 081 in non - small cell lung cancer ( NSCLC ) patients with epidermal growth factor receptor ( EGFR ) exon 20 mutations ( press release ) . • Safety : CLN - 081 continues to demonstrate promising overall safety and tolerability , with an encouraging Gl toxicity profile . • Efficacy : As of the ASCO data cutoff , there were 5 pending partial responses ( PR ) , 4 of which subsequently confirmed . In addition , follow - up data from patients in the 100mg Phase 1 cohort showed the DCR , defined as best response of PR + stable disease ≥6 months , increased to 92 % ( 12/13 patients ) . • Phase 1 / 2a trial status : Cullinan recently completed enrollment of the Phase 2a 100mg expansion cohort ( total n = 36 ) and initiated expansion at 150mg ( from 7 patients treated to date to 13 total ) . Cullinan intends to provide a clinical and regulatory update in Q4 2021 . • Cullinan MICA : Received U.S. Food and Drug Administration ( FDA ) clearance of Investigational New Drug application ( IND ) for CLN - 619 , a novel MICA / B - targeted antibody for the treatment of solid tumors ( press release ) . CLN - 619 is a first- in - class monoclonal antibody designed to promote an antitumor response by engaging both natural killer ( NK ) and T cells through the MICA / B - NKG2D axis , with therapeutic potential for both solid and liquid tumor indications . Cullinan intends to initiate a first - in - human ( FIH ) trial of CLN - 619 in 2H 2021 , including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy . • Cullinan Florentine : Received FDA clearance of IND for CLN - 049 , a FLT3 x CD3 bispecific antibody for the treatment of relapsed / refractory acute myeloid leukemia ( AML ) ( press release ) . CLN - 049 is designed to simultaneously bind to FLT3 on target leukemic cells and to CD3 on T cells , triggering the T cells to kill the targeted cancer cells via their intrinsic cytolytic mechanisms . Studies have shown that FLT3 is expressed on AML blasts in over 75 % of AML patients , regardless of FLT3 mutational status . Cullinan intends to initiate a FIH trial of CLN - 049 in 2H 2021 . • Cullinan Amber : Continued progress towards final candidate selection for CLN - 617 , a fusion protein combining two potent antitumor cytokines , IL - 2 and IL - 12 , in a single molecule with a collagen - binding tumor retention domain for the treatment of solid tumors . IND - enabling studies are planned to commence in the 2H 2021 . • Cullinan NexGem : Continued to progress CLN - 978 , an internally developed half - life extended T cell engager designed to simultaneously engage CD19 and CD3 , through IND - enabling development . Q2 2021 Financial Results • Cash Position : Cash , cash equivalents and investments were $ 456.3 million as of June 30 , 2021 , compared to $ 473.0