On February 27, 2023 Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will present at the Cowen 43rd Annual Health Care Conference on Tuesday, March 7, 2023, at 12:50 p.m. ET (Press release, Scholar Rock, FEB 27, 2023, View Source [SID1234627783]).

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A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

On February 27, 2023 Median Technologies (ALMDT) (Paris:ALMDT) reported that the Company has received feedback from the United States Food and Drug Administration (FDA) regarding the Q-submission phase initiated on May 2, 2022 for its iBiopsy Lung Cancer Screening (LCS) AI/ML tech-based CADe/CADx1 Software as Medical Device (SaMD) and reported completion of this phase (Press release, MEDIAN Technologies, FEB 27, 2023, View Source [SID1234627782]).

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The Q-submission phase is a major regulatory step which allows regular and in-depth discussions with the FDA on key topics such as pivotal study protocols. Further to this Q-submission phase, Median’s SaMD is better tailored to fit the FDA’s expectations and market needs.

As next steps, Median Technologies, having finalized its pivotal study protocols, is now getting ready for pivotal study execution by the end of Q2 2023, as planned, once all imaging and clinical data collection and preparation as well as reader training are completed. Likewise, Median still targets obtaining the FDA 510(k) clearance for its iBiopsy LCS CADe/CADx SaMD in the first half of 2024, subject to FDA review requirements.

"The Q-submission phase allowed us to have frequent and fruitful interactions with the Agency in order to better tailor our medical device software to the US market", Fredrik Brag, CEO and Founder of Median Technologies said. "But more than that, we had the opportunity to present to the FDA the vision we have for our product, the cutting edge performance we aim for, and our ambition to change the paradigm in the early diagnosis of lung cancer patients", Brag added.

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of AI/ML tech-based Software of Medical Devices (SaMD), to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on Lung Cancer, Liver Cancer (HCC) and Liver Disease (NAFLD/NASH).

Forward-looking statements: This press release contains express or implied information and statements that may be considered forward-looking information and statements about Median Technologies. They are not historical facts. Such information and statements include financial projections that are based on certain assumptions and assessments made by Median Technologies’ management in light of its experience and perception of historical trends, current economic and industry conditions, expected future developments and other factors it deems relevant. These forward-looking statements include statements that generally use conditional verbs and contain words such as "expects", "anticipates", "believes", "intends", "plans" or "estimates" and variations and conjugations thereof and words of similar import. Although Median Technologies’ management believes that the forward-looking statements and information are reasonable, Median Technologies’ shareholders and other investors are cautioned that the realization of these expectations is inherently subject to various known and unknown risks and uncertainties that are difficult to predict and generally beyond the control of Median Technologies. These risks could cause actual results and developments to differ materially from those expressed, implied or projected in the forward-looking statements. This press release contains only summary information and should be read in conjunction with the public information filed by Median Technologies with the AMF and that are available on Median Technologies’ website. Other than as required by applicable law, Median Technologies is issuing this press release as of the date hereof and does not undertake to update or revise any forward-looking information or statements.

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.