On February 27, 2023 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company dedicated to developing life-changing immuno-oncology therapies for cancer patients worldwide, reported that the first patient has been dosed in a Phase 1 clinical trial of ES014, a first-in-class anti-CD39xTGF-β bispecific antibody (bsAb) (Press release, Elpiscience, FEB 27, 2023, View Source [SID1234627781]). The principal investigator of the study is Professor Lu Shun, Director of Oncology Department of Shanghai Chest Hospital.

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ES014 simultaneously targets the CD39-adenosine and TGF-β pathways, aiming to convert the immunosuppressive tumor microenvironment (TME) into an immune-friendly one. Adenosine and TGF-β are two key immunosuppressive pathways within the TME. TGF-β, frequently expressed on solid tumors, suppresses T cell activation and induces CD39 expression, the rate-limiting enzyme in the ATP-adenosine pathway. ES014 is designed to have the following functions: 1. It blocks suppressive adenosine generation through CD39 inhibition while maintaining high levels of immune-stimulatory extracellular ATP, the substrate of CD39; 2. ES014 simultaneously neutralizes TGF-β, leading to activation of T cells and blockade of Treg differentiation while avoiding or minimizing systemic immunotoxicity.

"We are excited to have initiated the trial of this novel drug candidate. I’m proud of our highly committed team for their exceptional execution of the project. ES014 has shown strong single-agent anti-tumor efficacy in PD-1 non-responsive animal model. We look forward to seeing positive impact in cancer patients, " said Dr. Steve Chin, Chief Medical Officer of Elpiscience.

"I’m glad to lead the clinical study of ES014 in China. We have observed significant immune-promoting and tumor killing effect by ES014 in our ex vivo model of pleural effusion and ascites samples from patients with cancer. I am excited to move ES014 now to clinical study to investigate its safety and preliminary clinical signal in human," shared Professor Lu.

On February 27, 2023 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported that its wholly owned subsidiary, Eucure (Beijing) Biopharma Co., Ltd. ("Eucure Biopharma"), has reached an exclusive licensing agreement with Chipscreen NewWay Biosciences ("Chipscreen NewWay"), a holding subsidiary of Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences", SSE: 688321) for the clinical development and commercialization of bispecific antibody YH008 in Greater China (including Mainland China, Hong Kong, Macau and Taiwan) (Press release, Biocytogen, FEB 27, 2023, View Source [SID1234627780]). Eucure Biopharma retains YH008’s global rights to develop and commercialize YH008 outside Greater China. Under the agreement, Chipscreen NewWay will pay Eucure Biopharma an upfront payment of 40 million RMB, a potential development milestone payment of up to 360 million RMB, a potential sales milestone payment of up to 196 million RMB, as well as tiered royalties on net sales.

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YH008 is Biocytogen’s independently developed proprietary bispecific antibody for tumor immunotherapy. The IND application for a phase I study of YH008 was cleared by the US FDA and accepted by the Chinese NMPA.

"Chipscreen Biosciences and Chipscreen NewWay have extensive experience in clinical drug development and commercialization," said Dr. Yuelei Shen, President and CEO of Biocytogen. "With this agreement in place, we will work together to accelerate YH008’s entry into the market to benefit patients."

"Biocytogen’s YH008 has unique mechanisms and outstanding preclinical results," said Dr. Xianping Lu, CEO and President of Chipscreen Biosciences. "This licensing agreement will expand Chipscreen NewWay’s pipeline in the field of antibody drugs and immuno-oncology. I look forward to these fruitful collaborations."

"The unique mechanism of action of YH008 bring together the synergies of immune activation and immunosuppressive blockade, and can reduce toxic side effects and increase safety," said Dr. Bin Liu, Head of the Center of Antibody Early R&D at Chipscreen NewWay. "The clinical potential of YH008 is worth looking forward to and it is a good addition to the products under development of Chipscreen NewWay. Chipscreen NewWay will rapidly advance the clinical stage research and development of YH008."

About YH008

YH008 is a bispecific antibody that exerts antagonistic and agonistic activities. In vitro and in vivo studies indicate that YH008 can conditionally activate the immune pathway in the tumor microenvironment where certain tumor specific T cells are enriched to avoid systemic non-specific activation. Additionally, YH008 was engineered with an Fc-silent IgG1 isotype to avoid Fc-receptor-mediated non-specific immune activation. YH008 demonstrated superior anti-tumor activity when compared to parental monoclonal antibodies (mAbs) or combination therapy in syngeneic models. In vivo pharmacodynamic studies indicate that YH008 can activate tumor-infiltrating DCs and T cells. In addition, both in vivo studies and GLP toxicology studies indicate improved safety of YH008 compared with benchmark mAbs.

On February 27, 2023 Neuboron Medical Group (NMG), a leading global Accelerator-based Boron Neutron Capture Therapy (AB-BNCT) total solution provider reported that the first AB-BNCT cancer research center in China, Xiamen Humanity Hospital (XHH) BNCT Center has successfully performed 14 irradiations on 12 patients for its first Investigator Initiated Trial (IIT) aimed to evaluate the safety and efficacy of BNCT in the treatment of advanced refractory malignant tumors (Press release, Neuboron Medtech, FEB 27, 2023, View Source [SID1234627779]). With this milestone, China has become the second country to master and utilize accelerator BNCT technology.

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The clinical protocol relied on a full suite of NeuPex AB-BNCT device system and NeuMANTA Treatment Planning system, boron-containing drug BPA and PET imaging drug F-BPA supplied from Neuboron. NeuPex is a highly integrated and sophisticated medical system that consists of a Beam Shaping Assembly, Accelerator, Patient Positioning System, Dose Monitoring System, QC/QA System, Medical User Control system and Interlocks, etc. Benefiting from Neuboron’s unique beam control technology, the NeuPex system under the proton condition of 18.4 kW/2.3 MeV/8 mA (the highest efficiency of AB-BNCT system in clinical use worldwide) has already met the clinical criteria. The accelerator for the NeuPex system is manufactured by Neuboron’s partner TAE Life Sciences.

This clinical research was launched on Oct. 9, 2022, after being validated by a large number of animal preclinical studies and approved by Xiamen Humanity Hospital’s Institutional Review Board (IRB). These twelve patients were diagnosed with recurrent head and neck, high-grade glioma, and melanoma cancers with traditional cancer therapies exhausted.

After a 3-month follow-up, the first 4 patients showed satisfactory safety and superior tumor control performance. All of them showed tumor regression. The 12 patients will have remained follow-up observation accordingly. The clinical study preliminarily not only verifies the safety of the combined treatment of neutron radiation and BPA drug, but also demonstrated good clinical treatment value.

"The completion of our first-in-human clinical study at this stage demonstrates great efficacy and safety using novel in-hospital accelerator-based BNCT," said Prof Yuan-Hao Liu, Ph.D., CEO and CSO of Neuboron Medical Group. "This milestone marks a great potential to treat recurrent, advanced, and refractory cancer." "We are very excited to have witnessed this binary radiotherapy expanding our patient’s lives and will continue to work tirelessly on our end to bring our one-stop BNCT total solution to the global market as quickly as possible," emphasized Prof. Dr. Liu.

About BNCT

Boron Neutron Capture Therapy (BNCT) is a targeted radiation oncology therapy in that neutron beams destroy only boron compound-bearing tumors without destroying neighboring healthy tissue. BNCT has significant advantages of delivering highly effective and very cell-centralized radiation therapy in treating patients with recurrent, invasive, and local-regional metastases refractory tumors with a relatively low impact on the patient’s quality of life. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On February 27, 2023 Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, reported that the U.S. Food and Drug Administration (FDA) reviewed Cantex’s Investigational New Drug application and issued a "Study May Proceed" letter for Cantex’s Phase 2 clinical trial to assess the safety and therapeutic effect of azeliragon in patients with newly diagnosed unmethylated glioblastoma treated with standard of care radiation therapy (Press release, Cantex, FEB 27, 2023, View Source [SID1234627778]). Azeliragon was recently granted FDA Orphan Drug Designation for the treatment of glioblastoma.

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"We are very pleased to have received this favorable response from the FDA enabling Cantex to initiate a Phase 2 clinical trial of azeliragon for the treatment of glioblastoma," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "Today’s news significantly advances Cantex’s azeliragon development program. We look forward to soon commencing enrollment in this trial given the urgent need for novel therapies that can better address this devastating disease."

Glioblastoma is the most common primary brain cancer, with approximately 13,000 cases diagnosed in the U.S. per year. It is a highly malignant brain tumor for which current therapeutic options provide a limited life extension benefit. The median survival after a glioblastoma diagnosis is 15-18 months and 5-year survival is less than 10%. Given this prognosis, new treatments of glioblastoma are urgently needed.

Azeliragon is an orally administered small molecule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the glioblastoma microenvironment. By preventing interaction of RAGE with these ligands, azeliragon may inhibit glioblastoma and overcome its resistance to effective treatment. Cantex is also developing azeliragon for the treatment of other major cancers not adequately addressed by current treatments where RAGE has been implicated in disease progression and in complications of cancer treatment.

Dr. Marcus continued: "The Phase 2 trial of azeliragon in glioblastoma is one of several promising clinical programs we continue to advance with azeliragon to treat cancer and other diseases where RAGE is implicated. Additional azeliragon indications include pancreatic cancer, breast cancer, and cancers such as lung cancer and breast cancer that have metastasized to the brain. These programs highlight the versatility of azeliragon and our commitment to develop new treatment options for these cancers. We expect significant progress on these clinical trials during 2023 and 2024."

About Azeliragon
Azeliragon, previously known as TTP488, is an orally active, small molecule, antagonist of the receptor for advanced glycation end products (RAGE) licensed by Cantex from vTv Therapeutics Inc. (NASDAQ:VTVT). vTv Therapeutics discovered azeliragon and carried out phase 3 clinical trials for Alzheimer’s disease. Although these trials did not demonstrate efficacy in Alzheimer’s disease, clinical safety data from these trials, involving over 2000 patients dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. A broad range of evidence suggests that RAGE—ligand interactions play a critical role in cancer and its complications as well as in a range of inflammatory diseases.

On February 27, 2023 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it plans to release unaudited financial results for the fourth quarter ended December 31, 2022 and provide an update on recent developments prior to the open of the U.S. financial markets on Monday, March 13, 2023 (Press release, Gracell Biotechnologies, FEB 27, 2023, View Source [SID1234627777]). The management team will host a live audio webcast and conference call at 8:00 am Eastern Time.

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Conference call and webcast details:

Monday, March 13, 2023 @ 8:00 a.m. ET
Investor domestic dial-in: (800) 715-9871
Investor international dial-in: (646) 307-1963
Conference ID: 5617240

Live webcast link: View Source

A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days.