On May 21, 2024 Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company based in Korea, reported to have entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to evaluate Qurient’s proprietary CDK7 inhibitor, Q901, in combination with an antibody drug conjugate (ADC) targeting tumor-associated calcium signal transducer 2 (TROP2) with topoisomerase 1 inhibitor payload for the treatment of small cell lung cancer (SCLC) and other relapsed solid tumors (Press release, Qurient Therapeutics, MAY 21, 2024, View Source [SID1234643511]).

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Q901 is a highly selective CDK7 inhibitor under Phase 1/2 clinical development in the United States and South Korea. Qurient demonstrated Q901’s main mechanism of action as transcriptional inhibition of essential genes for tumor progression, including genes involved in DNA damage repair response, which led to strong synergy with a topoisomerase 1 inhibitor (Ref: DOI: 10.1158/1538-7445.AM2024-5712). These results are consistent with prior findings from Dr. Anish Thomas’ team at NCI, which revealed a synergistic mechanism between CDK7 inhibition and topoisomerase 1 inhibition (Ref: DOI: 10.1158/1535-7163.MCT-21-0891).

Under this CRADA, NCI and Qurient will collaborate on an NCI-sponsored Phase 1/2 clinical study of Q901 in combination with the TROP2-ADC in SCLC and other relapsed solid tumors, starting from combination dose escalation and evaluating the safety, efficacy, and potential synergy of this novel combination. This collaboration is focused on development and evaluation of this innovative therapy for patients with extensive stage SCLC.

"The collaboration between the NCI and Qurient is based on the science discovered through independent research conducted by each institution," said Kiyean Nam, Ph.D., CEO of Qurient. "We hope the new combination therapy will help patients with small cell lung cancer, where current therapeutic options are limited."

About Q901

Q901 is a highly selective covalently binding small molecule CDK7 inhibitor under Phase 1/2 clinical development. Q901 demonstrated strong tumor growth inhibition in multiple cancer models including HR+ breast cancer, pancreatic cancer, prostate cancer, ovarian cancer, and small cell lung cancer as a single agent, as well as in combination with other therapies. Q901 in combination with fulvestrant is in a clinical trial for HR+ breast cancer patients who are refractory to CDK4/6 inhibitor and estrogen therapy combination.

On May 21, 2024 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported that it has entered into a clinical collaboration with Merck (known as MSD outside the US and Canada), to evaluate DF9001, Dragonfly’s EGFR immune engager, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced solid tumors expressing EGFR (Press release, Dragonfly Therapeutics, MAY 21, 2024, View Source [SID1234643510]).

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"Merck, a trusted leader in drug development, has been a wonderful collaborator with Dragonfly since we signed our first collaboration agreement in 2018," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "We are pleased to enter into this agreement with Merck for our ongoing, investigational Phase 1 trial of DF9001. In preclinical models, DF9001 engages multiple immune effector cells to drive anti-tumor activity and induces PD-L1 expression in tumor cells, sensitizing cold tumors to checkpoint inhibitors. We are hopeful that DF9001 in combination with KEYTRUDA will drive potent anti-tumor activity in a broad range of indications and are excited to further accelerate progress in the clinic to benefit patients in need."

Dragonfly is the study sponsor and first patients are expected to receive DF9001 in combination with pembrolizumab in Q4 2024. Clinical trial sites are currently open for monotherapy dosing in the U.S., with additional sites in North America and Europe expected to open in 2024. Additional information about the trial, including eligibility criteria, can be found at: View Source (ClinicalTrials.gov Identifier: NCT 05597839).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About DF9001
DF9001 is an investigational first-in-class multi-specific drug candidate that targets EGFR and potently redirects natural killer (NK) cells, gamma-delta T cells, and CD8 T cells by engaging activating receptors NKG2D and CD16. DF9001 was discovered and developed using Dragonfly’s TriNKET platform. DF9001 is being evaluated in adult patients for the treatment of advanced solid EGFR-positive tumors. DF9001 has the potential to stimulate anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF9001 is the second wholly owned drug candidate in a pipeline of TriNKETs that Dragonfly is developing to address high unmet needs for patients across a broad range of disease areas.

On May 21, 2024 Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, proudly reported that its flagship program, RAG-01, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) (Press release, Ractigen, MAY 21, 2024, View Source [SID1234643509]). This notable achievement marks a significant milestone in the advancement of saRNA technology and underscores Ractigen’s commitment to addressing critical unmet medical needs. The milestone establishes RAG-01 as the first saRNA drug worldwide to achieve FTD.

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RAG-01 is currently undergoing a Phase I clinical trial in Australia for the treatment of non-muscle invasive bladder cancer (NMIBC). The trial, initiated in December 2023, has successfully enrolled and dosed three patients, demonstrating the program’s progress in clinical development.

FDA’s recent approval of the Investigational New Drug (IND) application for RAG-01 further validates the therapeutic potential of this innovative saRNA therapy. This regulatory milestone not only paves the way for the expansion of clinical trials in the United States but also highlights the FDA’s recognition of RAG-01’s promise in addressing the urgent medical needs of NMIBC patients.

Fast Track Designation is granted to investigational drugs intended for the treatment of serious conditions with unmet medical needs, facilitating their expedited development and review process. With FTD, Ractigen gains enhanced opportunities for collaboration with the FDA, enabling closer communication and expedited guidance throughout the development and regulatory review process.

Dr. Long-Cheng Li, Founder and CEO of Ractigen Therapeutics, expressed his enthusiasm about the FDA’s decision: "We are thrilled to receive Fast Track Designation for RAG-01, marking a significant milestone not only for our program but also for the saRNA field as a whole. This designation underscores the urgency and importance of advancing innovative therapies like RAG-01 to address critical medical needs. We remain dedicated to accelerating the development of innovative saRNA therapies to address a wide range of diseases, including cancer, genetic disorders, and chronic conditions. Through strategic collaborations and pioneering research efforts, the company aims to deliver transformative treatments that improve patient outcomes and quality of life."

About RAG-01: RAG-01 is a pioneering saRNA candidate engineered to target and activate the tumor suppressor gene p21 via the mechanism of RNAa. Traditionally considered "undruggable," p21 presents a unique opportunity for saRNA-based targeted activation. The drug, delivered through intravesical instillation using Ractigen’s proprietary LiCO delivery technology, has shown significant tumor suppression in mouse orthotopic bladder cancer models. Currently, the Phase I clinical trial of RAG-01 in Australia has successfully enrolled and dosed the first three patients. Its development marks a significant stride in RNAa based therapies, addressing the unmet needs of NMIBC patients.

About NMIBC: NMIBC represents 50-80% of all bladder cancer cases. Despite standard treatments like transurethral resection of bladder tumor (TURBT) followed by intravesical BCG or chemotherapy, recurrence rates remain high, estimated at 50-70% within the first five years. RAG-01’s development is a significant step towards addressing this substantial unmet need in bladder cancer therapy.

About RNAa: Pioneered by Dr. Long-Cheng Li and his team, RNAa is a clinically validated platform technology. It employs saRNA to target gene regulatory domains, activating gene expression and restoring therapeutic protein levels. This technology has vast potential for developing therapeutic drugs across various diseases, especially where traditional methods fall short, including cancer, genetic disorders, chronic diseases, and metabolic and cerebrovascular disorders.

On May 21, 2024 Evergreen Theragnostics, Inc., a clinical-stage radiopharmaceutical company, reported that they have entered into a collaboration and licensing-agreement with the Medical University of Innsbruck (MUI), a leading European research institution to advance the development of novel radiopharmaceuticals (Press release, Evergreen Theragnostics, MAY 21, 2024, View Source [SID1234643508]). The agreement covers the clinical development of EVG321, a novel radioligand therapy (RLT) for small cell lung cancer (SCLC), targeting the cholecystokinin 2 receptor (CCK2R).

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RLTs have surged into the clinic and represent a rapidly expanding market. By combining the power of medical isotopes and the precision of targeted therapeutics, these types of medicines allow for cell-specific ablation of a tumor target, thereby localizing ionizing radiation to diseased tissues. CCK2R has been shown to be highly expressed in SCLC, and has the potential to facilitate robust, tumor-specific delivery.

"We are very pleased to announce this new collaboration with the Medical University of Innsbruck," commented James Cook, CEO of Evergreen Theragnostics. "For several years, the research groups of Univ. Prof. Dr. Irene Virgolini and Priv. Doz. Dr. Elisabeth von Guggenberg in Innsbruck have established themselves as key innovators in the RLT-field, and we are excited to be working with them on one of their lead programs – this was an easy choice to make." He added: "Especially in the realm of small cell lung cancer, novel therapies are urgently needed, and we are confident that EVG321 has the potential to significantly improve outcomes for cancer patients in this indication."

Univ. Prof. Dr. Irene Virgolini, Medical University of Innsbruck, said: "Evergreen Discovery is a pioneer in the field of radiopharmaceuticals, and their team is looking back on an impressive record in bringing novel medicines to patients. We are delighted to be collaborating with them. In conjunction with their subject matter expertise and proven ability to translate new radioligand therapies, it is their exceptional sense of urgency to bring novel drugs to patients in need, making them such valuable partners for us."

Over the next months, Evergreen intends to begin registration enabling therapeutic and diagnostic clinical trials for Lutetium-177 (177Lu) EVG321 and Gallium-68 (68Ga) EVG321. If successful, EVG321 could offer new hope to patients with small cell lung cancer.

On May 21, 2024 Aster Insights, the leading provider of scientific and clinical intelligence for oncology discovery, reported the company and members of the Oncology Research Information Exchange Network (ORIEN) will be presenting at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which will be held May 31 – June 4, in Chicago, IL (Press release, Aster Insights, MAY 21, 2024, View Source [SID1234643507]). Four abstracts examining melanoma, kidney, gastrointestinal, and uterine cancers highlight the work of collaborators across ORIEN, Aster Insights, and the National Institutes of Health (NIH) with several authors contributing to more than one of these studies, demonstrating the importance of cross-functional, multidisciplinary research.

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"The abstracts chosen for presentation at ASCO (Free ASCO Whitepaper) highlight the unique and diverse investigations that can be launched when premier cancer institutions are collaborating and harnessing deep multimodal data," said Dr. Anand Shah, CEO of Aster Insights. "Robust representation across cancer types and patient demographics enables us to launch research that yields critical insights to better care for patients."

Schedule of Aster Insights’ ASCO (Free ASCO Whitepaper) Poster Presentations:

Riya Patel. Genomic signature analysis and survival outcomes in cholangiocarcinoma (CCA) using oncology research information exchange network (ORIEN) database.
Abstract 4101; Poster 81

Ahmad Tarhini. A prognostic model based on selected cell state and cellular community scores in patients with advanced melanoma treated with immune checkpoint inhibitors (Ecotype-ICI score) as a predictor of ICI immunotherapeutic benefits.
Abstract 9568; Poster 352

Juan Antonio Raygoza Garay. Unraveling the gene expression signatures with associated clinical outcomes in papillary renal cell carcinoma.
Abstract 4558; Poster 253

Taylor Rives. Comparison of the clinical and genomic profiles of endometrial cancer in Appalachian and non-Appalachian patients.
Abstract 5591; Poster 462
"We look forward to sharing our important work to construct an immune cell state atlas through ecotype analyses to foster a deeper understanding of the correlations between immune cell states and responsiveness to immune checkpoint inhibitors," said Ahmad Tarhini, MD, PhD of Moffit Cancer Center and Chair of the ORIEN Scientific Committee and ORIEN Immuno-Oncology Research Interest Group. "This collaborative effort draws on multidisciplinary expertise and rich clinicogenomic data from across ORIEN and Aster Insights, as well as the NIH."

Aster Insights will be attending ASCO (Free ASCO Whitepaper). Please contact us to request a meeting.