On August 23, 2022 K36 Therapeutics, Inc. ("K36"), a privately held biotechnology company developing novel targeted therapies for the unmet medical needs of cancer patients, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for the Company’s lead program KTX-1001. KTX-1001 is an investigational small molecule methyltransferase inhibitor of multiple myeloma SET domain known as MMSET, a major regulator of chromatin structure and transcription in multiple myeloma (Press release, K36 Therapeutics, AUG 23, 2022, View Source [SID1234618585]). K36 plans to initiate a Phase 1 clinical trial in the second half of 2022 to establish the safety, tolerability and preliminary efficacy of KTX-1001 in patients with relapsed and refractory multiple myeloma, enriching for patients who have the genetic translocation t(4;14).

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K36 also announced the formation of its Clinical Advisory Board comprised of Drs. Jesus Berdeja, Shaji Kumar, Thomas Martin, María-Victoria Mateos, Noopur Raje, David Siegel and Suzanne Trudel.

"We are proud to announce the clearance of our first IND following the initial 30-day FDA review, officially marking our transition to a clinical-stage company in only 16 months since company inception. This achievement demonstrates our team’s efficiency and focus toward our goal of advancing KTX-1001 and positively impacting the lives of patients and families suffering from multiple myeloma," said Terry Connolly, Ph.D., President and Chief Executive Officer of K36. "Along with this significant milestone, I am delighted to announce the establishment of our Clinical Advisory Board, bringing together a group of leading experts with deep expertise in developing breakthrough therapies for the treatment of multiple myeloma. This Board will complement the exceptional experience of our internal team and Dr. Lori Kunkel, our Independent Director."

K36’s Clinical Advisory Board includes:

Jesus Berdeja, M.D., Director of Myeloma Research, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN

Shaji Kumar, M.D., Consultant, Division of Hematology, Professor of Medicine, Mayo Clinic, Rochester, MN

Thomas Martin, M.D., Clinical Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program, and Associate Director, Myeloma Program, University of San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA

María-Victoria Mateos, M.D. Ph.D., Consultant Physician in the Haematology Department and Associate Professor of Medicine at the University of Salamanca, Spain

Noopur Raje, M.D., Director, Center for Multiple Myeloma, Professor of Medicine, Harvard, Medical School, Massachusetts General Hospital Cancer Center, Boston, MA

David Siegel, M.D., Ph.D., Chief of the Multiple Myeloma Division, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ

Suzanne Trudel, M.D., M.Sc., Associate Professor of Medicine, University of Toronto, Clinician Scientist, Princess Margaret Hospital Cancer Centre, Toronto, Canada

"There remains a significant unmet need for new and more effective therapies that can benefit high-risk myeloma patients such as those with translocation t(4;14)," said Noopur Raje, M.D. "As we use expanded combinations in early lines, there is a need for new classes of agents like KTX-1001."

"BCMA T cell redirecting therapies and the use of quadruplet therapy in myeloma are incredible advances but still have not leveled the playing field for high-risk multiple myeloma patients," added Jesus Berdeja, M.D. "There is still a need for novel precision therapeutics such as KTX-1001, and we are excited to be a part of bringing this first-in-class agent into Phase 1 testing."

K36 expects to enroll approximately 50 patients in the Phase 1 study, including an expansion cohort that will recruit patients with the genetic translocation t(4;14).

About KTX-1001
KTX-1001 is a novel, first-in-class, potent, and selective methyltransferase inhibitor of the catalytic activity of lysine H3K36. 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 t(4;14) translocation.

About the KTX-1001 Phase 1 Clinical Trial
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.

On August 23, 2022 Nanostics Inc., a precision health diagnostics company, reported that it has received the CE-IVD Mark for its ClarityDX Prostate test (Press release, Clarity Pharmaceuticals, AUG 23, 2022, View Source [SID1234618584]). This regulatory milestone allows Nanostics to market and sell ClarityDX Prostate in Europe, as well as other countries that require the CE Mark for market access.

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The ClarityDX Prostate test uses a proprietary machine-learning algorithm that combines data from biological and clinical biomarkers to generate a risk score for clinically significant prostate cancer, defined as Gleason grade group 2 or higher, on prostate biopsy. The ClarityDX Prostate test is intended to be used as a reflex test for men with elevated levels of PSA and is designed to help physicians and patients make a more informed decision on whether to proceed with a biopsy or not.

"We’re excited to reach this regulatory milestone for our ClarityDX Prostate test built on our robust biomarker and machine learning platform," said John Lewis, CEO of Nanostics. "Using ClarityDX Prostate as a reflex test for men with elevated PSA levels will help physicians, patients, and their families make more-informed decisions on how best to proceed with prostate cancer screening and result in better health outcomes for men with prostate cancer."

Recently, Nanostics announced positive results from its 1,500-patient clinical validation study of its ClarityDX Prostate test, showing 94% sensitivity, 37% specificity, 49% positive predictive value, and 90% negative predictive value for predicting clinically significant (grade group ≥2) prostate cancer. Implementation could eliminate up to 37% of unnecessary biopsies and significantly reduce the number of unnecessary treatments for prostate cancer.

Compliance with the relevant EU legislation and attainment of the CE-IVD mark represents Nanostics’ commitment to developing and marketing in vitro diagnostic medical devices that meet stringent regulatory requirements. Nanostics is committed to expanding its regulatory portfolio to allow for market access in different jurisdictions.

On August 23, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that the first patient dosing in Australia for its proprietary PD-1/IL-2 bispecific antibody fusion protein (R&D code: IBI363) in Phase I clinical trial for the treatment of patients with advanced solid tumors or lymphomas (Press release, Innovent Biologics, AUG 23, 2022, View Source [SID1234618582]). It is first candidate drug to conduct clinical trial in Australia in Innovent’s pipeline.

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The study (NCT05290597) is an open-label, multi-center Phase I study evaluating the safety, tolerability, and preliminary efficacy of IBI363 in subjects with advanced solid tumors or lymphoma, and to determine the recommended Phase 2 dose (RP2D).

Interleukin 2 (IL-2), a cytokine secreted mainly by antigen-activated CD4 + T cells , is vital for maintaining CD4 + regulatory T cell (Treg) level, CD4 + T cell differentiation, and maintaining CD8 + T cell and natural killer cell activity. IL-2 was the first cytokine to be discovered and identified as playing a pivotal role in T-cell growth and expansion. Aldesleukin (IL-2) was approved by U.S. Food and Drug Administration for metastatic renal cell carcinoma and metastatic melanoma in the early 1990s, but it has not been widely used in clinic due to poor selectivity, narrow therapeutic window, and side effects.

IBI363, potential First-in-Class candidate drug, was independently developed by Innovent. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein. The IL-2 arm of IBI363 has been engineered to maximize efficacy and reduce toxicity, whereas the PD-1 binding arm achieves PD-1 blockade and selective IL-2 delivery. Therefore, IBI363 has both functions of simultaneously blocking PD-1/PD-L1 pathway and activating IL-2 pathway, allowing more precise and efficient targeting and activation of tumor specific T cells. IBI363 not only showed promising anti-tumor activity in a variety of tumor-bearing pharmacological models, but also exhibited prominent antitumor efficacy in PD-1 resistant and metastatic models; meanwhile, IBI363 demonstrated a good safety profile in preclinical in vivo models.

Dr. Morteza Aghmesheh, Southern Medical Day Care Centre Located in New South Wales, Australia, stated： "Wild type IL-2 is clinically validated as monotherapy, but limited by toxicity and low response rate due to poor selectivity. IBI363, a novel PD-1/IL-2 bispecific molecule, designed to selectively activates PD-1 positive T cells by cis-activating IL-2, but not PD-1 negative bystanders or naïve T cells, with the potential to significantly decrease toxicity related to IL-2 and potentially overcome immunotherapy resistance. We look forward to the positive results in the safety/tolerability and efficacy of IBI363 in the clinic."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Most patients will develop primary or secondary resistance after treatments of immune checkpoint inhibitors. At present, treatment options are limited upon progression after immunotherapy, and there is a huge unmet clinical needs. IBI363, developed by scientists at Innovent Academy, can enhance anti-tumor immune response by reversing T cell exhaustion, improving the efficacy of immune checkpoint inhibitors especially for patients with resistance to immunotherapy or "cold tumors", while minimizing IL -2 related side effects. We are pleased that the first patient dose of IBI363 has been completed in Australia. In parallel, the IND for IBI363 has been approved by NMPA in China. We are looking forward to the positive results of IBI363 in patients with advanced solid tumors or lymphoma. IBI363 is our first molecule to initiate clinical study in Australia, which marks a solid step of Innovent’s global innovation strategy. The company will also accelerate the development of more innovative molecules with high global potential, taking advantage of cross-regional R & D and clinical resources, adhering to the long-term development strategy of "driven by innovation, developed through globalization" with an aim to benefit cancer patients worldwide."

About IBI363

IBI363, potential First-in-Class candidate drug, was self-developed by Innovent. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein, which simultaneously blocks PD-1/PD-L1 pathway and activates IL-2 pathway to stimulate T cell activation and proliferation, thus killing tumor cells and inhibiting tumor growth. Currently, Phase 1 studies of IBI363 are conducted in China and Australia (NCT05460767, NCT05290597) to assess the safety, tolerability, and preliminary efficacy of IBI363 in subjects with advanced solid tumors or lymphoma, and to determine the recommended Phase 2 dose (RP2D).

On August 23, 2022 Whiterabbit.ai, an AI-technology company dedicated to making late-stage diseases a rarity, reported it signed a national distribution agreement with Arterys, a San Francisco-based AI-powered software company and developer of the world’s first internet platform for medical imaging, to expand the reach of Whiterabbit’s AI-driven software program ACT, nationwide (Press release, Whiterabbit, AUG 23, 2022, View Source [SID1234618581]). The program is designed to increase mammography screening compliance and volume.

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Arterys’ broad customer base of healthcare systems, some of which use its Breast AI software to detect breast cancer, measure breast density and deliver personalized risk assessments, will be able to purchase and integrate ACT into their compliance screening programs. Increasing the number of women who schedule their annual mammograms is essential to detecting cancer earlier. The partnership has the potential to significantly reduce the backlog of preventive screenings that were missed and remain overdue as a result of the COVID-19 pandemic.

"Our strategic partnership with Arterys further anchors Whiterabbit’s mission to make late-stage diseases a rarity through increased accessibility, supported by innovative AI-powered software," said Whiterabbit.ai CEO Alexander Sardiña, MD. "We believe AI has the power to transform healthcare through compliance, accurate disease detection and a patient-centric approach at cost reduction."

"Arterys is extremely pleased to add Whiterabbit’s AI ACT solution to our current suite of breast AI applications," said Dan Arnoff, senior VP of commercialization at Arterys. "ACT drives the compliance of screening mammograms, which in turn potentially reduces interval cancers. ACT combined with our current Breast AI solution for tomosynthesis provides the end user a very unique platform in the fight against breast cancer. Arterys is committed to developing the best of class AI solutions, deployed from a single cloud interface to maximize the power of AI to breast centers across the globe."

According to leading organizations dedicated to breast cancer research and education, it is estimated more than 287,800 women will be diagnosed with invasive breast cancer and more than 43,000 will die from breast cancer in 2022 in the U.S. Whiterabbit and Arterys are dedicated to transforming healthcare through the intersection of human intelligence and artificial intelligence to improve clinical outcomes for patients.

Trained on millions of data points, Whiterabbit’s ACT is designed to facilitate compliance among women with mammography recommendations using a personalized notification system that does not require intensive one-on-one follow ups. Additionally, ACT evenly distributes a clinic’s increase in patient volume throughout the year. Tested in more than 300 breast cancer screening centers across the U.S., ACT has a proven track record of more than 20 percent growth year over year in breast cancer screening volume.

On August 23, 2022 InnoCare Pharma (HKEX: 09969) and Keymed Biosciences (HKEX: 02162) reported that the Investigational New Drug (IND) of CM369, an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody, developed by a joint venture between the two companies called Tiannuojiancheng Pharma, has been approved by the China’s National Medical Products Administration (NMPA) (Press release, InnoCare Pharma, AUG 23, 2022, View Source [SID1234618579]).

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CM369 is a potential first-in-class drug co-developed by InnoCare and Keymed as a monotherapy or in combination with other therapies for the treatment of various cancers.

CCR8 is a highly promising immuno-oncology target. CM369 binds to CCR8 on Tregs and eradicates immunosuppressive Tregs through ADCC to augment the anti-tumor immunity in TME while preserving peripheral homeostasis. CM369 has the potential to deliver optimal tumor targeted Treg depletion and be more specific in anti-tumor activity than other immunotherapies.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: "CM369 is our third large molecule drug entering the clinical stage, and it is also the 12th innovative drug approved for clinical trial. CM369 selectively depletes Tregs in the tumor microenvironment, which is more specific than other immunotherapies. We will work with Keymed to accelerate clinical development, so that this potential first-in-class drug can benefit patients with advanced solid tumors earlier."

Dr. Bo Chen, Co-founder, Chairman and CEO of Keymed Biosciences, said: "CCR8 is a specific target for Treg cells in tumors. CM369 has demonstrated durable efficacy and excellent safety in preclinical studies, and has a potential for combination with other therapies to kill tumor cells by synergistic effects. We look forward to working with InnoCare to accelerate the clinical development of CM369 at full speed, so that patients can benefit from our innovation as soon as possible."