Innovent Announces First Patient Dosing in Australia in Phase 1 Study of IBI363 (PD-1/IL-2 Bispecific Antibody Fusion Protein) in Patients with Advanced Malignancies

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).

Whiterabbit.ai Signs National Distribution Agreement with Arterys to Expand Reach of its AI-Powered Early Cancer Detection Technology Nationwide

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.

InnoCare and Keymed Jointly Announce Approval of Clinical Trial of CCR8 Monoclonal Antibody CM369

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."

AdvanCell Closes A$18M Series B Funding Led by Morningside

On August 23, 2022 AdvanCell, an Australian radiopharmaceutical company with a platform technology for a revolutionary cancer treatment called Targeted Alpha Therapy, reported the closing of an A$18 million Series B financing round led by Morningside (Press release, Advancell, AUG 23, 2022, View Source [SID1234618578]).

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Andrew Adamovich, CEO and Founder of AdvanCell noted, "We are very pleased with our progress to date and delighted that we will continue our rapid growth with the support of our shareholders. We have had a long-term relationship with our lead investor, Morningside, and are excited to come closer still to our goal to ‘Change the Course of Cancer Treatment.’"

Targeted Alpha Therapies represent the most exciting opportunity to treat currently untreatable cancers. The technology harnesses the natural decay and radiochemical properties of certain elements, in combination with specific targeting molecules, to selectively deliver cell-killing radiation to the tumour cell. AdvanCell believes this precise and powerful treatment will rapidly become a leading pillar of cancer treatment, providing treatments for diseases for which there are currently no effective options. Targeted Alpha Therapies demonstrate incredible efficacy, however widespread adoption and large commercial product launches require a scalable and reliable global isotope supply. AdvanCell was established to solve this problem.

AdvanCell’s ability to produce isotope on-demand and at scale, and its in-house radiopharmaceutical manufacturing expertise positions AdvanCell to play a leading role in this rapidly growing market. With additional support from NSW Health Medical Devices Fund and the Federal government’s Research & Development Tax Incentive, AdvanCell has developed a world-first scalable manufacturing platform to produce alpha-emitting isotopes for research, pre-clinical and clinical use and to advance its own and its partners’ radiopharmaceutical products.

Anthony Aiudi from Morningside commented, "AdvanCell is leveraging its ability to make alpha isotopes at scale and in clinically useful amounts along with its radiochemistry expertise, to develop an exciting portfolio of Targeted Alpha Therapies. Targeted Alpha Therapies hold incredible promise however their development has been hamstrung by a lack of radioisotope supply. Together with the team at AdvanCell, we look forward to writing a new chapter in oncology, to target large patient populations with significant unmet needs."

Mr Aiudi has been appointed to the Board of AdvanCell, joining Mr Adamovich, Bill Ferris AC, co-founder of CPE Capital, Adrian "Adi" Patterson, former Australian Nuclear Science and Technology Organisation (ANSTO) CEO and Kevin Cameron, CEO of Ionetix.

Bill Ferris AC, Chair remarked, "Our executive team has articulated a credible pre-clinical and clinical pathway for the delivery of the Company’s novel Targeted Alpha Therapies. Having successfully developed the manufacturing platform essential for the reliable and scalable supply of isotopes, the Company is on schedule with its pre-clinical work and is now moving into first-in-human trials. AdvanCell is on track to become a leading radiopharmaceutical company with a platform technology enabling novel cancer treatments."

GeneCentric Publishes New Data Comparing Predictive Immune Response Profiles in Patients Treated with Checkpoint Inhibition or IL-2

On August 23, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported its new publication in Cancer Research Communications that compares the immunogenomic response profiles to anti-PD-(L)1 or IL-2 therapy and the development of a novel response classifier to IL-2 treatment1 (Press release, GeneCentric Therapeutics, AUG 23, 2022, View Source [SID1234618577]). Cancer Research Communications is an open access peer-reviewed journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The study was conducted as a collaboration between Atrium Health Levine Cancer Institute, Sanofi, and GeneCentric and evaluated real-world data from patients diagnosed with renal cell carcinoma (RCC) who were treated with immune-oncology agents. Results suggest that common and distinct immune-related response markers for IL-2 and anti-PD-(L)1 therapy may help guide their use, either alone or in combination.

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"It is exciting to share the initial findings from this important collaboration where we attempted to identify the immunogenomic differences between IL-2 and anti-PD-1 responders in renal cell carcinoma," said Dr. Asim Amin, medical oncologist, Atrium Health Levine Cancer Institute, and study co-principal investigator. "Using RNA expression analysis, we were able to identify key characteristics that are unique to each treatment modality, as well as those that are shared between the two. With this work we were able to develop a novel IL-2 response signature that may have prognostic potential."

A primary focus of the study was to obtain a deeper understanding of the tumor microenvironment similarities and/or differences that may lead to IL-2 or anti-PD-(L)1 therapy response. Retrospective tumor samples and corresponding clinical response data were collected from patients with a primary diagnosis of RCC who were treated with high-dose IL-2 (HD-IL-2; aldesleukin) and compared to existing data from a similar cohort of RCC patients treated with the anti-PD-1 nivolumab2. Tumor samples from HD-IL-2 treated patients underwent RNA sequencing (RNAseq) prior to immunogenomic analysis. As a result, a novel RNA-based IL-2 treatment response signature was discovered that could ultimately assist in further developing diagnostics for next-generation IL-2 agents, several of which are in clinical development.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney and renal pelvis cancer in adults. In the United States, it is estimated that there will be approximately 79,000 new cases of kidney and renal pelvis cancer in 2022 and almost 14,000 deaths. Kidney and renal pelvis cancer, which includes RCC, is considered the 8th most common type of cancer. Standard treatment options for RCC are surgery, radiation, chemotherapy, targeted therapy or immunotherapy.