10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

BeiGene has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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National Comprehensive Cancer Network Announces Collaboration with Blood Cancer Experts in Poland

On February 27, 2023 The National Comprehensive Cancer Network (NCCN)—a not-for-profit alliance of leading United States cancer centers—reported a new collaboration with the Institute of Hematology and Transfusion Medicine in Poland (IHIT), and the Alliance For Innovation—Polish-American Foundation (AFI) (Press release, NCCN, FEB 27, 2023, View Source [SID1234627788]). The three organizations have signed an agreement enabling clinicians to share their established expertise and international experience in order to improve quality of care and outcomes for patients with hematologic malignancies in Poland and around the world.

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"This new agreement highlights our commitment to continue advancing our ongoing collaboration with Polish colleagues to standardize and improve how cancers are managed," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "The Institute of Hematology and Transfusion Medicine in Poland is the leading medical and research hospital in Poland for hematology; it serves as a national clinical and diagnostic reference center. Together, we can make sure more people with blood cancers receive region-appropriate treatment based on the latest evidence and expert consensus."

This new agreement builds on a multi-year collaboration between NCCN, the Marie Curie-Sklodowska National Research Institute of Oncology, Republic of Poland Ministry of Health, and AFI to improve country-specific guidelines for solid tumor diagnostic and therapeutic procedures in Poland, based on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) —as called for in Poland’s National Cancer Strategy. NCCN Guidelines are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. They have been translated, adapted, and harmonized in collaboration with local and regional experts, advocates, and policymakers across Sub-Saharan Africa, the Middle East and North Africa (MENA), the Caribbean, Asia, South America, and Europe, in order to make them more relevant and accessible to patients and care providers worldwide. The initial work with Poland launched in 2021; to date, the groups have co-developed Polish NCCN Guidelines Adaptations for:

Central Nervous System Cancers,
Cervical Cancer,
Colon Cancer,
Head and Neck Cancers, and
Ovarian Cancer
"Our main goal is to improve the quality of care and outcomes for hematologic patients in Poland," said Prof. Ewa Lech-Marańda, Director of the IHIT. "The cooperation between our institutions will include the development of adapted clinical guidelines based on NCCN’s knowledge, experience, and expertise, as well as longstanding procedures for continuous updates."

"The signing of an agreement between such important cancer control institutions is of great importance for patients and the oncological community, as well as for the further development of Polish-American cooperation," said Marcin Hańczaruk, Co-Chairman of AFI.

NCCN’s resources for cancer patients and providers are widely accessed and utilized free-of-charge around the world. Nearly half of the 1.7 million registered users who view NCCN Guidelines at NCCN.org or via the Virtual Library of NCCN Guidelines app are located outside of the U.S. Learn more about NCCN’s collaborative work to define and advance high-quality, high-value, patient-centered cancer care globally at NCCN.org/global.

Priothera cleared to begin Japanese arm of pivotal Phase 3 study with mocravimod in patients with Acute Myeloid Leukemia undergoing allogeneic Hematopoietic Cell Transplant

On February 27, 2023 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod, reported that it has received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for the pivotal global MO-TRANS Phase 3 study evaluating mocravimod in Acute Myeloid Leukemia (AML) patients undergoing allogeneic hematopoietic cell transplant (HCT) (Press release, Priothera, FEB 27, 2023, View Source [SID1234627787]).

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Elisabeth Kueenburg, M.D., Chief Medical Officer at Priothera, said: "We are grateful for the clearance from the PMDA to start our MO-TRANS Phase 3 study in Japan as we believe mocravimod has the potential to address a significant unmet need for Japanese patients with AML undergoing allogeneic HCT. We look forward to enrolling the first patients in several sites across Japan in the coming months."

Priothera is conducting the pivotal MO-TRANS study – now classified as a global Phase 3 trial following acceptance by regulatory authorities – in 15 countries, including the US, Japan, Israel, France, and in additional European, Asian and Latin American countries, to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in AML patients undergoing allogeneic HCT. The double-blind, placebo-controlled study assesses relapse-free and overall survival of two dose levels of mocravimod in comparison to placebo. Topline data from this study are expected in 2025.

Dr. Takanori Teshima, M.D., is the Principal Investigator in Japan for the MO-TRANS global Phase 3 trial. Dr. Teshima is Professor of Medicine in the Division of Hematology and Deputy-director of Hokkaido University Hospital. He serves as a president of the Japanese Society of Hematopoietic Cell Transplantation (JSHCT), an executive director of Japanese Society of Hematology (JSH) and Japan Society of Transfusion Medicine and Cell Therapy (JSTMCT).

Dr. Teshima, M.D., commented: "AML is the most common acute leukemia in Japan accounting for approximately 70% of all myeloid leukemias. Despite advances in the use of HCT in Japan, patients are still at risk of relapse with resulting poor prognosis. Any new treatment that can enhance the curative potential of this approach would offer a significant benefit to patients. I am therefore delighted that Japan will be part of the MO-TRANS global Phase 3 study investigating mocravimod as an innovative potential new adjunctive and maintenance therapy for patients with AML undergoing allogeneic Hematopoietic Cell Transplant."

Mocravimod, a sphingosine 1 phosphate (S1P) receptor modulator which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of allogeneic HCT. Mocravimod has shown a clinically relevant benefit in an early clinical study in patients with hematologic malignancies undergoing allogeneic HCT.

Florent Gros, Co-Founder and CEO of Priothera, added: "Japan represents an important potential market for us and one we see as a priority as we advance the development of mocravimod in AML patients undergoing allogeneic HCT globally. With this clearance we anticipate a further uptake in patient enrollment in our MO-TRANS trial. We look forward to seeing topline results from MO-TRANS in 2025."

Scholar Rock to Present at the Cowen 43rd Annual Health Care Conference

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.

Median Technologies Announces Completion of the Q-Submission Phase with the FDA for its iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device

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.