K36 Therapeutics announces dosing of first patient in KTX-1001 Phase 1 Clinical Trial for relapsed or refractory multiple myeloma and addition of Mr. Michael Heffernan as Independent Board Director

• KTX-1001 is the first inhibitor of multiple myeloma SET domain (MMSET) to enter clinical development
• MMSET is the oncogenic driver of multiple myeloma in patients with genetic translocation t(4;14), reported to be undruggable

CAMBRIDGE, Mass., April 11, 2023 /PRNewswire/ -- K36 Therapeutics ("K36"), a privately held biotechnology company developing KTX-1001, an investigational small molecule methyltransferase inhibitor of multiple myeloma SET domain known as MMSET, announced today that the first patient has been dosed in its Phase 1 clinical trial earlier this year. KTX-1001 is an oral, first-in-class, selective and potent MMSET catalytic inhibitor that suppresses H3K36me2 in patients with relapsed and refractory multiple myeloma. The K36-MMSET-001 Phase 1 clinical trial is designed to assess the safety, tolerability, pharmacology, and initial clinical activity of KTX-1001 (NCT05651932).

"We are thrilled to have reached this clinical milestone and appreciate our ongoing partnership with Sarah Cannon Research Institute (SCRI) at Tennessee Oncology," said Terry Connolly, Ph.D., Chief Executive Officer of K36. "KTX-1001 has not only demonstrated encouraging preclinical activity and a favorable tolerability profile, but it also addresses unmet need for patients who have received other standard of care therapies available to patients suffering from multiple myeloma. We look forward to working with all our sites, investigators, and study teams to efficiently enroll our Phase 1 clinical trial."

The first patient has been dosed in Nashville, TN by the Lead Principal Investigator and Director of Myeloma Research for SCRI at Tennessee Oncology, Jesus Berdeja, MD, who stated, "There still remains a need for new personalized therapies to treat multiple myeloma and novel precision therapeutics like KTX-1001 offer a potential solution to address the challenges seen in high-risk subsets like translocation t(4;14). We are delighted to be the first institution to advance this first-in-class agent into the clinic with K36."

K36 has also appointed Michael Heffernan as an Independent to the company's Board of Directors. "We are pleased to welcome Michael Heffernan to the Board," said Dr. Connolly. "Michael's late-stage development and commercial experience will complement our exceptionally strong scientific board as we further our business and pursue our mission to expand therapeutic pursuits that serve patients."

Michael brings over 30 years of experience in building and leading development stage and commercial companies in the biopharmaceutical space. "It is an exciting time at K36. I am excited to work with the Board, Terry, and the talented K36 team to further the development and commercialization plan of KTX-1001," noted Mr. Heffernan.

Mr. Heffernan is an advisor, investor, and board member of numerous public and private biopharmaceutical companies. He began his career at Eli Lilly and Company, where he served in numerous sales and marketing roles. He then served a variety of roles, including President and CEO of Collegium since its inception, co-founder and CEO of Clinical Studies Ltd. (acquired by PhyMatrix Corp), Co-Founder and Chairman/CEO of Avenge Bio, Inc., Chairman/CEO of Onset Dermatologics, and Founder and Chairman of Collegium Pharmaceutical (COLL). He currently is a member of the Board of Directors of Biohaven (BHVN), Collegium (COLL), Trevi (TRVI), and Synlogic (SYBX).

Mr. Heffernan was named E&Y Entrepreneur of the Year, Northeast Regional Winner in 2016. He is a registered pharmacist and earned his B.S. Degree in Pharmacy from the University of Connecticut.

About KTX-1001

KTX-1001 is a novel, first-in-class, potent, and selective catalytic inhibitor of the H3K36 methyltransferase MMSET. It is an investigational and orally administered small molecule being developed initially for the treatment of relapsed and refractory multiple myeloma, with a focus on patients with the genetic translocation t(4;14).

About K36 Therapeutics, Inc.

Founded in February 2021, K36 is a privately held biotech company. Our mission is to translate epigenetic modulation of oncogenic pathways into first-in-class small molecule therapeutics for the benefit of cancer patients worldwide.

CLINICAL TRIAL INFORMATION

The Phase 1 clinical trial is a single-arm, open-label study in subjects with relapsed and refractory multiple myeloma. It is a multi-part clinical trial with dose escalation followed by an expansion cohort in patients with the genetic translocation t(4;14) to evaluate the safety, tolerability, and preliminary efficacy of different doses of KTX-1001.

For information about our clinical trials, visit www.clinicaltrials.gov (NCT05651932).

For more information visit:

www.k36tx.com

https://www.linkedin.com/company/k36-therapeutics

SOURCE K36 Therapeutics