On October 15, 2024 Circle Pharma, Inc., a clinical-stage biopharmaceutical company dedicated to discovering and developing a new generation of macrocycle therapies, reported that the first patient cohort has been dosed in the phase 1 trial of CID-078, the company’s first-in-class oral cyclin A/B RxL inhibitor (Press release, Circle Pharma, OCT 15, 2024, View Source;utm_medium=rss&utm_campaign=circle-pharma-announces-first-patients-dosed-in-phase-1-clinical-trial-of-first-in-class-oral-cyclin-a-b-rxl-inhibitor-brcid-078-for-advanced-solid-tumors [SID1234647199]). The trial will evaluate CID-078 in patients with advanced solid tumors, including tumors with elevated E2F transcription factor activity, such as small cell lung cancer, triple negative breast cancer and ER+ HER-2- breast cancer following CDK 4/6-inhibitor therapy.

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"We are thrilled that the IND for CID-078 was cleared at the end of the 30-day regulatory review period and that CID-078 has now moved into human dosing at a consortium of world class cancer centers. This will allow our investigators to generate clinical proof-of-concept data which will inform CID-078’s potential impact in settings of high unmet medical need as well as validate Circle Pharma’s proprietary MXMO macrocycle platform for difficult-to-drug targets in cancer and other serious diseases," said David J. Earp, JD, Ph.D., CEO of Circle Pharma.

CID-078 is designed to selectively inhibit key protein-to-protein interactions involving cyclins A and B, both of which have been implicated in the proliferation and survival of cancer cells. The research program builds on work performed in the laboratory of Nobel Laureate and Circle Pharma’s Scientific Advisory Board Chair, William G. Kaelin Jr., MD, who demonstrated synthetic lethality through the disruption of these cyclins in settings of dysregulated cell cycle control and elevated E2F activity.

Geoffrey Shapiro, MD, Ph.D., senior vice president, Development Therapeutics at Dana-Farber Cancer Institute and professor of medicine at Harvard University, stated, "Disrupting the ability of E2F-driven cancer cells to turn off E2F at the appropriate time in the cell cycle has been shown to selectively induce apoptosis. Until now there hasn’t been a selective therapeutic agent to exploit this observation and so I am extremely excited to see Circle Pharma’s cyclin A/B RxL inhibitor move into the clinic."

All patients in the cohort are enrolled at The START Center for Cancer Research, Midwest, Grand Rapids, MI. Other clinical sites currently open include The START Center for Cancer Research, West Valley City, UT, and NEXT Oncology in San Antonio, TX. Additional clinical sites are planned to open soon.

Circle Pharma’s Phase 1 clinical trial (NCT06577987) is an open label, multi-center dose escalation and expansion study that is expected to enroll up to 100 patients. The study will evaluate the safety, pharmacokinetics and pharmacodynamics of CID-078 as well as preliminary anti-tumor activity in solid tumors. Circle Pharma anticipates reporting preliminary safety and anti-tumor data from the Phase 1 study in 2025.

About CID-078, Circle Pharma’s Cyclin A/B RxL Inhibitor Program

CID-078 is an investigational orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma’s investigational cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple xenograft models. Based on these findings CID-078 has progressed to a Phase 1 clinical study (NCT06577987).

On October 15, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported the appointment of Paige Mahaney, Ph.D. as the company’s chief scientific officer (CSO), effective October 28, 2024, following the decision of Stewart (Stew) Fisher, Ph.D. to retire and pursue personal interests (Press release, C4 Therapeutics, OCT 15, 2024, View Source [SID1234647198]). Dr. Fisher will serve as senior scientific advisor through the end of 2024 and as a consultant to C4T through the end of 2025.

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"We are excited to welcome Paige and look forward to utilizing her deep experience in expanding clinical portfolios at some of the world’s most prominent pharmaceutical organizations. Her expertise in leading innovation and pushing the boundaries of what’s possible with existing modalities, including degraders, will be instrumental as we look to further investigate the promise of targeted protein degradation," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "I would like to express profound gratitude to Stew for his contributions to both C4 Therapeutics and the entire targeted protein degradation field where he catalyzed research that is helping advance new therapies toward patients. Stew’s leadership over the past eight years has helped C4T build an exceptional platform that positions us to continue our evolution toward becoming a fully integrated biopharmaceutical company."
"As I closely followed the targeted protein degradation field and its exciting advances in recent years, I was drawn to C4T because of the demonstrated ability of the TORPEDO platform to consistently deliver highly catalytic, orally bioavailable degrader candidates across a wide range of target classes that have the potential to transform how medicine is practiced," said Dr. Mahaney. "I am thrilled to join C4 Therapeutics at this exciting time as we focus on opportunities to leverage our innovative science and further extend our leadership in targeted protein degradation science."

Dr. Mahaney’s experience in pharmaceutical executive leadership spans more than 25 years, with multidisciplinary expertise in discovery research and development along with successfully building clinical portfolios across a wide range of disease indications and treatment modalities. Most recently, she served as senior vice president and corporate head of drug discovery at Exelixis, Inc., where she was responsible for the strategy and execution of the company’s drug discovery portfolio as well as advancing the early clinical pipeline. In just over three years at Exelixis, she built the discovery team and a state-of-the-art discovery platform while advancing multiple candidates toward investigational new drug applications and clinical trials, including a USP-1 inhibitor, XL309, and XL495, a PKMYT1 inhibitor. Prior to Exelixis, she spent over 10 years at Boehringer Ingelheim Pharmaceuticals, Inc. focused on pipeline expansion and discovery in positions including senior vice president, global head of biotherapeutics discovery and discovery research site head; senior vice president, head of small molecule discovery and discovery research site head; and vice president, head of small molecule discovery. While at Boehringer Ingelheim, Dr. Mahaney’s teams were responsible for delivering drug candidates to the company’s global clinical portfolio, including several investigational assets in oncology, immunology, cardiometabolic, inflammation and respiratory and orphan diseases, many of which have received FDA regulatory pathways including accelerated approval or breakthrough therapy designation. These include important contributions to the advancement of Spevigo, a first-in-class IL36R blocking antibody for generalized pustular psoriasis; BI 764532, a first-in-class bi-specific T-Cell engager for neuroendocrine carcinomas and small cell lung carcinoma; and avenciguat, a small molecule activator of soluble guanyl cyclase for systemic sclerosis. Earlier in her career, she held scientist roles in medicinal chemistry at Hoffman-La Roche, Inc. and Wyeth Pharmaceuticals. She received her B.S. in chemistry from Guilford College and her Ph.D. in organic chemistry from the Massachusetts Institute of Technology (MIT).

Throughout his distinguished career, Dr. Fisher has dedicated himself, in academic and industry capacities, to identifying and discovering compounds to help advance treatments for patients. He joined C4T in 2016 and has served as the company’s CSO since 2018. While at C4T, he supported the development and evolution of the company’s TORPEDO platform and led the development of a library of over 10,000 Cereblon ligands constructed from over 200 unique scaffolds. Dr. Fisher has spearheaded the identification, characterization and optimization of novel, selective, orally bioavailable BiDAC and MonoDAC degraders that have resulted in a total of six development candidates across a wide range of target classes delivered to C4T’s clinical pipeline or a collaboration partner. Under his leadership, C4T has advanced three novel degraders into the clinic and partnered with global pharmaceutical companies to further extend the reach of targeted protein degradation.

"It has been my honor to work alongside talented professionals at C4 Therapeutics to quickly advance the field of targeted protein degradation and bring several degraders into the clinic," said Stew Fisher, Ph.D. "As I look forward to this exciting chapter of my personal life, I am also excited about the future of C4 Therapeutics with Paige’s leadership and innovation in place to help ensure our science will continue to push the boundaries of scientific discovery to positively impact patients."

On October 15, 2024 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA"), a leader in PCR-based DNA technologies, reported that Dr. James A. Hayward, president and chief executive officer, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit (Press release, Applied DNA Sciences, OCT 15, 2024, View Source [SID1234647197]). Maxim Group LLC is presenting the virtual summit from October 15th to 17th.

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Jason McCarthy, Ph.D., Maxim’s senior managing director and head of Biotechnology Research, will interview Dr. Hayward. Applied DNA’s fireside chat will be available for viewing by registered conference attendees on Wednesday, October 16, 2024.

Details for the fireside chat are as follows:
Date: Wednesday, October 16, 2024
Time: 12:50 p.m. EDT
Presenter: James A. Hayward, president and chief executive officer of Applied DNA
Registration: link

On October 14, 2024 TriSalus Life Sciences Inc. ("TriSalus" or the "Company") (Nasdaq: TLSI), an oncology company dedicated to enhancing outcomes for patients with liver and pancreatic cancer through its advanced delivery technology and novel immunotherapy, nelitolimod, reported that Mary Szela, Chief Executive Officer and President of TriSalus, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Thursday, October 17, 2024 (Press release, TriSalus Life Sciences, OCT 14, 2024, View Source [SID1234647190]).

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Details for the fireside chat are as follows:

Date: Thursday, October 17, 2024
Time: 12:30 p.m. EDT / 11:30 a.m. CDT
Presenter: Mary Szela, Chief Executive Officer and President of TriSalus

To attend the event, please register by clicking here.

On October 14, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the first patient has been dosed in the Company’s Phase 1 (POLAR) clinical trial evaluating RP-3467, a Polθ ATPase inhibitor, alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. RP-3467 is Repare’s fourth clinical program (Press release, Repare Therapeutics, OCT 14, 2024, View Source [SID1234647189]).

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"RP-3467, our potential best-in-class Polθ ATPase inhibitor, has demonstrated highly compelling preclinical results, including complete and durable tumor regressions in combination with olaparib, the leading PARP inhibitor, with no additive toxicities. This combination is designed to meaningfully improve patient outcomes by mitigating PARP inhibitor resistance, a significant area of high unmet medical need," said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. "In addition, Repare’s previously reported data established the potential for RP-3467 to improve efficacy and limit toxicity in combination with radioligand therapy and chemotherapy-bearing antibody drug conjugates (ADCs), and we look forward to exploring those areas."

The POLAR clinical trial (NCT06560632) is a multicenter, open-label, dose-escalation Phase 1 clinical trial to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467 alone or in combination with the PARP inhibitor, olaparib, in adults with molecularly selected advanced solid tumors. The study is expected to enroll approximately 52 patients with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. The primary objectives of the study are to assess the safety and tolerability of RP-3467 alone and in combination with olaparib, and to define a preliminary recommended Phase 2 dose of RP-3467 in combination with olaparib.