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ADCT announced initial data from Phase 2 of Zynlonta in marginal zone lymphoma

Sotio Biotech

11/7/2024 | 3 minutes to read

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ADCT announced that initial data from an investigator-initiated Phase 2 clinical trial evaluating Zynlonta demonstrated a high response rate in patients with relapsed or refractory (r/r) marginal zone lymphoma (MZL). The 50-patient single-arm, open-label Phase 2 multicenter study is currently being conducted at the Sylvester Comprehensive Cancer Center at University of Miami and City of Hope.

CLINICAL AND REGULATORY 

ADC Therapeutics announced initial data from Phase 2 trial of Zynlonta in marginal zone lymphoma 

This study is evaluating the safety and efficacy of six cycles of Zynlonta across 18 weeks in patients with r/r MZL previously treated with ≥1 line of systemic therapy. As of the data cutoff date of March 30, 2024, 15 patients were evaluable. Of these 15 patients evaluated, 13 achieved a CR and one patient achieved a PR. All patients who achieved responses had maintained them at the time of the data cutoff. In this study, Zynlonta was generally well-tolerated and safety was consistent with the known profile, with two patient discontinuations. 

Shares of MacroGenics dropped after announcing ADC study deaths 

MacroGenics disclosed Phase 2 results of its ADC candidate vobramitamab duocarmazine in pancreatic cancer, reporting five patient deaths in the TAMARACK study of the B7-H3-directed ADC. Two patients died of myocardial infection and the deaths were determined unrelated to the treatment, while two deaths due to pneumonitis and one due to pleural effusion are under investigation. The deaths under investigation occurred in the higher, 2.7 mg/kg dose cohort. The lower 2.0 mg/kg dose cohort had a better safety profile, though the efficacy results were mixed. The lower dose led to better PSA reductions, with 44% of the 82 evaluable patients achieving a reduction of at least 50% compared with 37% of the 71 patients in the higher dose group. The lower dose had a lower unconfirmed ORR (24% vs. 44%). 

Bolt restructuring to cease further development of trastuzumab imbotolimod 

Bolt Biotherapeutics reported financial results for the first quarter 2024 and announced a strategic prioritization as well as changes to its leadership team. The company will focus its pipeline on its first-in-class proprietary agonist antibody targeting Dectin-2 and its next-generation Boltbody ISAC programs, continue to support its collaborations with Genmab and Toray, and reduce its workforce by approximately 50%. This will extend cash runway into the second half of 2026. Following a strategic review, Bolt has determined that the program will not meet its pre-defined success criteria, and Bolt will therefore be focusing resources on its next-generation ISAC programs. 

DEALS AND FINANCING 

Pheon announced $120 million Series B financing to fund development of its ADC pipeline 

Pheon Therapeutics announced completion of a $120 million Series B financing to fund the development of its pipeline of differentiated ADCs. The financing was led by TCGX with participation from other new investors BVF Partners, Lightspeed and Perceptive Advisors, alongside existing investors Atlas Venture, Brandon Capital, Forbion, and Research Corporation Technologies. The new financing will be used to further advance Pheon’s differentiated ADC pipeline through clinical proof of concept. The first three assets are aimed at an undisclosed novel target which is highly overexpressed in a wide range of solid tumors. The first program has demonstrated an unprecedented preclinical therapeutic index while utilizing a DAR8 Topoisomerase-1 inhibitor linker-payload, whereas the next two ADCs utilize other linker-payload technologies to mine the broad potential of this target. The company expects to start its first Phase 1 clinical trial in 2024 and rapidly advance towards dose expansion cohorts. The capital will also enable the expansion of Pheon’s suite of in-house technology platforms to generate optimized ADC constructs. 

ADC Therapeutics announced $105 million underwritten offering of common shares 

ADC Therapeutics announced it has agreed to sell by underwritten offering 13,411,912 of its common shares at a price of $4.90 per share and pre-funded warrants to purchase 8,163,265 common shares at a price of $4.81 per pre-funded warrant. The gross proceeds from the offering are approximately $105 million. 

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