On December 1, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet technology (Press release, Zetagen Therapeutics, DEC 1, 2021, View Source [SID1234596376]). Previously known as ZetaFuse, ZetaMet is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

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"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

ZetaMet works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.1

ZetaMet has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

On December 1, 2021 Labcorp (NYSE: LH), a leading global life sciences company, and ConcertAI, LLC (ConcertAI), a leader in enterprise artificial intelligence (AI) and real-world data (RWD) solutions for life science companies and health care providers, reported a collaboration to optimize precision oncology research (Press release, LabCorp, DEC 1, 2021, View Source [SID1234596375]). The companies will work together to launch clinical studies in ways that minimize the burden on physician practices, drive faster patient recruitment, maximize patient retention and ensure equitable access to research as a care option.

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Through this collaboration, Labcorp will leverage ConcertAI’s suite of software-as-a-service (SaaS) offerings for clinical trial design, protocol optimization, site selection and study execution. These solutions, when paired with Labcorp’s expertise in clinical development services and diagnostic testing, will optimize oncology clinical trial design and execution using RWD and AI.

"With Labcorp, we are building an advanced network, AI technologies and SaaS solutions to further advance the industry’s goals for diversity and digital enablement in clinical development services, especially in oncology," said Jeff Elton, Ph.D., CEO of ConcertAI. "As a leading RWD and SaaS AI solutions company for evidence generation, ConcertAI is committed to advancing precision oncology in partnership with industry leaders."

ConcertAI’s offerings will allow Labcorp Drug Development to access data to make more informed decisions about oncology clinical trials. This analytical toolset drives actionable insights that will lead to a better understanding of patient profiles and treatment pathways, ultimately yielding quicker and more effective clinical trials.

Clinical trials also increasingly require analysis of potential trial sites to identify and select locations containing patients with specific characteristics. Using data to help understand the availability of patients across a sampling of oncology cancer centers helps bring health care within reach for all and ensures that the design of a trial contains a diverse set of participants to measure drug safety and effectiveness in broadly representative populations. ConcertAI and Labcorp have structured a long-term collaboration to leverage data and analytics to find solutions to these difficult problems.

"Oncology is highly complex, with hundreds of molecular targets and factors across solid tumors and hematological malignancies, so the need is great for diversity in cancer trials," said Prasanth Reddy, M.D., MPH, FACP, senior vice president and head of oncology at Labcorp. "Labcorp Drug Development, which supports more than 50% of all oncology clinical trials globally, combined with ConcertAI’s high-depth data and AI technologies, is a powerful combination to optimize trial design, improve patient access, and increase efficiency of oncology trials to bring new therapeutic options to patients who need them most."

Improved screening, along with new diagnostics and treatments in cancer have been significant contributors to recent reductions in deaths and other adverse outcomes. Health care providers and pharmaceutical companies require support to bring additional, innovative treatment options to market. Pairing ConcertAI’s RWD and AI expertise with Labcorp Drug Development’s established site relationships and patient-centric approach will provide customers with a differentiated offering, generating actionable insights and improved trial execution—ultimately yielding trials that are more cost effective, more inclusive and more likely to succeed.

On December 1, 2021 ITabMed reported it has completed the spin-off iTAb (immunotherapy antibody) platform and closed $20M Series A-round financing (Press release, ITabMed, DEC 1, 2021, View Source [SID1234596374]). Earlier in this year, Evive Biotech (formerly Generon BioMed Ltd) and Dr. Xiaoqiang Yan formed a joint venture and established ITabMed Ltd. with the full support from Evive and its shareholders . The JV company will focus on continued development of products derived from iTAb platform.

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The iTAb platform has been optimized over the last 10 years aiming to improve the clinical safety windows and to overcome the manufacturing-related challenges. The patented iTAb platform will allow the company to generate bi- or tri-specific T cell engagers. Two leading products, A-319 and A-337 are already in phase I clinical development. Multiple iTAb drug candidates are at different stages of preclinical development.

ITabMed recently closed series A-round financing, co-led by 3E Bioventures Capital and Yonjin Capital, and joined by Binhai Venture Capital. 3E Bioventures and Yonjin Capital are both active biotech investors, with a focus on innovation, with a track-record of success and good reputation.

ITabMed founder and CEO, Dr. Yan said: "We sincerely thank series A-round investors for supporting our continued efforts to bring safe and efficacious products to patients. We share the same mission ‘innovating for life’ and wish to grow together. We also thank the shareholders of Evive Biotech for their help and support."

Dr. Karen Liu, partner of 3E Bioventures commented: "Dr. Yan is a successful serial entrepreneur and a veteran drug developer. He is also a great scientist with a passion for innovation. T-cell engager is an important therapeutic approach in developing immune therapies. There are many drug candidates under development globally, but very few are approved because of issues relating to safety. We see the unique safety advantages of iTAb products and hope they will translate into real human drugs soon." Mr. Wen Chen said: "We are confident in the ITabMed team led by Dr. Yan. They experienced a 20-year path in new drug R&D in China with an outstanding track-record. We are committed to support the company and to bring new immunotherapy drugs to cancer patients."

On December 1, 2021 Shenzhen Chipscreen Biosciences’ licensing partner, HUYABIO International (HUYABIO), reported the regulatory approval for Chidamide (Tucidinostat, also known as Epidaza , Hiyasta, HBI-8000) monotherapy for the treatment of relapsed or refractory (R/R) PTCL by the Ministry of Health, Labour and Welfare in Japan (Press release, Shenzhen Chipscreen Biosciences, DEC 1, 2021, View Source;huyabio-international-receives-regulatory-approval-for-chidamide-monotherapy-of-peripheral-t-cell-lymphomaptcl-in-japan-301435093.html [SID1234596369]).

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"Relapsed and/or refractory PTCL carries a grim prognosis with limited treatment options. Data from the registration study of Chidamide has demonstrated meaningful disease response despite the advanced stage of disease, and acceptable safety profile, to address an important unmet medical need in this patient population", said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of Chidamide Phase 2 study.

The drug was approved based on data from a Phase 2b study that involved 55 patients with aggressive PTCL in Japan and Korea. These patients, having few effective treatment options, all had advanced disease either refractory to or relapsed to prior therapies. Chidamide 40mg orally administered twice weekly resulted in a 46% Objective Response Rate, median Progression-Free Survival of 5.6 months and a median Overall Survival of 22.8 months.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This second regulatory approval for our lead oncology drug, Tucidinostat(also known as Hiyasta), in Japan expands our drugs’ indications for patients with severe hematologic malignancies. We are looking forward to additional future indications for Tucidinostat that will benefit even more patients."

Dr. Lu Xianping, CEO & President of Chipscreen said, "Tucidinostat, an original new drug independently discovered and developed by Chipscreen, its ex-China rights were licensed out to Huya in 2006. Today, the Japanese approval on Tucidinostat for the treatment to peripheral T-cell lymphoma is another important milestone for the product’s expansion in overseas markets. We sincerely thank our partner Huya International. This new approval enables us to provide Tucidinostat for Japanese patients who are suffering from PTCL. It is also a remarkable step of Chipscreen in the way of providing affordable antitumor drugs for global patients. Via conducting further clinical research of Tucidinostat monotherapy and relevant combination therapies with other antitumor drugs, we are expecting to continuously make new progress to benefit patients all over the world who are suffering from other types of cancers."

About Chidamide (also known as Epidaza, Hiyasta, HBI-8000)

Chidamide is a first-in-class/best-in-class innovative drug which was discovered and developed originally by Shenzhen Chipscreen Biosciences in China. It is an Epigenetic Immunomodulator approved and launched in Chinese market for the treatment of lymphoma and metastatic breast cancer. It also has demonstrated immunomodulatory impact and is being tested in a global pivotal trial in melanoma combined with the checkpoint inhibitor Nivolumab. The product’s ex-China rights were licensed out from Chipscreen to HUYABIO. Later on, HUYABIO partnered with Meiji Seika for Japanese market.

On December 1, 2021 IFM Therapeutics (IFM), a privately-held biopharmaceutical company focused on developing therapies that modulate novel targets in the innate immune system, reported that IFM Due, an IFM subsidiary company, has extended its collaboration and exclusive option agreement with Novartis to develop immunotherapies that inhibit the cGAS-STING pathway to treat a range of serious inflammatory and autoimmune diseases (Press release, IFM Therapeutics, DEC 1, 2021, View Source [SID1234596368]).

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Under the terms of the agreement that began in September 2019, Novartis will continue to make fixed payments sufficient to fully finance IFM Due’s research and development costs for the cGAS-STING program in exchange for the option to acquire the IFM Due subsidiary. Upon option exercise, IFM Due’s shareholders will be entitled to consideration in aggregate value of up to $840 million, including an upfront payment upon option closing and other contingent consideration.

"At IFM, we believe innate immune biology offers a multitude of genetically-validated, clinically-relevant targets and pathways across several therapeutic areas," said H. Martin Seidel, Ph.D., CEO of IFM Therapeutics. "The continuation of our collaboration with Novartis underscores the value and relevance of this approach. By advancing novel therapies that selectively target the cGAS-STING pathway, we have the potential to deliver powerful therapeutic options for patients with serious chronic illnesses that, to-date, have not been adequately served by existing treatments."

The cGAS-STING (cyclic GMP-AMP Synthase, Stimulator of Interferon Genes) pathway functions within the innate immune system to sense cytosolic DNA, which is a signal of cellular danger, and then triggers a STING-dependent inflammatory response. Mutations that activate this pathway can cause a variety of serious autoinflammatory and autoimmune diseases in humans that are characterized by excessive interferon/cytokine signaling, including rare diseases such as Aicardi-Goutières syndrome (AGS), STING-associated vasculopathy with onset in infancy (SAVI) and a subset of systemic lupus erythematosus (SLE). Aberrant cGAS-STING activation, such as in the setting of mitochondrial dysfunction, also underlies more common diseases such as nonalcoholic steatohepatitis (NASH), chronic obstructive pulmonary disease (COPD), age-related macular degeneration (AMD) and Parkinson’s disease.

About IFM Due

IFM Due (pronounced du-eh), a subsidiary of IFM Therapeutics, is a biopharmaceutical company developing a suite of small-molecule antagonists and inhibitors targeting aberrant inflammatory responses of the innate immune system triggered by the cGAS-STING pathway, which is believed to underlie a variety of serious diseases. The Company is developing small-molecule, orally available drug candidates to address a breadth of potential therapeutic indications, including rare, autoimmune, fibrotic, and neurodegenerative diseases.