On August 23, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for tislelizumab in combination with chemotherapy as first-line treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, BeiGene, AUG 23, 2022, View Source [SID1234618563]).

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Esophageal cancers are classified based on the type of cells involved and ESCC is the most common subtype, accounting for more than 85% of esophageal cancers worldwidei,ii. In China, esophageal cancer is the fourth leading cause of death due to malignancy and remains a significant threat to public health with 246,000 new diagnoses reported in 2015iii.

"Our global clinical development program for tislelizumab encompasses more than 20 registration-enabling trials and we are pleased that our robust clinical data for tislelizumab are contributing to advancing the treatment landscape for solid tumors in China," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "We look forward to working with NMPA on this submission and to progressing global regulatory submissions based on the clinically meaningful overall survival benefit seen in the RATIONALE 306 trial."

The sBLA is supported by data from an interim analysis of the RATIONALE 306 (NCT03783442) global clinical trial that enrolled 649 patients from research centers across Asia-Pacific, Europe, and North America. RATIONALE 306 results were presented as a late-breaking oral presentation at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in June.

Tislelizumab is approved by the China NMPA as a treatment for nine indications, including approval for use in patients with locally advanced or metastatic ESCC who have disease progression or are intolerant to first-line standard chemotherapy. Tislelizumab is not approved for use outside of China.

About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first investigational medicine from BeiGene’s immuno-oncology biologics program and is being evaluated in solid tumor and hematologic malignancies, as monotherapy and in combination.

The global tislelizumab clinical development program includes more than 11,000 subjects enrolled to-date in 30 countries and regions. More information on the tislelizumab development program, including clinical trials and regulatory submissions, can be found on the Tislelizumab Fact Sheet in our corporate press kit.

About RATIONALE 306
RATIONALE 306 (NCT03783442) is a randomized, placebo-controlled, double-blind, global Phase 3 study to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a first-line treatment in patients with advanced or metastatic ESCC. The primary endpoint of the trial is overall survival (OS). Secondary endpoints include progression free survival, overall response rate, duration of response per RECIST v1.1, and OS in patients with PD-L1 score ≥ 10%, as well as health-related quality of life measures and safety.

BeiGene Oncology
BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 3,300 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody, tislelizumab, as well as the PARP inhibitor, pamiparib, in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North America, Europe, and Japan. Building upon this productive collaboration, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor, ociperlimab, that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On August 23, 2022 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s interim report for January–June 2022 is now available on the company’s website, www.isofolmedical.com (Press release, Isofol Medical, AUG 23, 2022, View Source [SID1234618562]).

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The information in the press release is intended for investors.

Second quarter, April–June 2022
Net revenue amounted to TSEK 4,027 (7,333) and other revenue to TSEK 0 (0)
The result for the period amounted to TSEK -54,033 (-45,394)
Earnings per share amounted to SEK -0.33 (-0.48)
Cash and cash equivalents at June 30 amounted to TSEK 277,727 (530,682)
First half of the year, January-June 2022
Net revenue amounted to TSEK 8,033 (12,548) and other revenue to TSEK 1 (0)
The result for the period amounted to TSEK -101,907 (-88,055)
Earnings per share amounted to SEK -0.63 (-0.99)
Significant events during the second quarter 2022
On April 22, it was announced that the analysis process of study data from the AGENT study had begun.
Jan Törnell was elected as new Chairman of the Board of the company in conjunction with the Annual General Meeting on May 19.
Significant events after the event of the period
On August 3, Isofol presented the topline results of the global pivotal AGENT study in advanced colorectal cancer. The data revealed that the study did not achieve the primary endpoint of objective response rate (ORR) or the key secondary endpoint of progression-free survival (PFS).
In July, Isofol received approval of a biomarker analysis patent.
CEO´s comment:
" It is incredibly disappointing that the results from the top-line analysis did not demonstrate the advantages we had hoped for. Final data and sub-group analyses will be decisive for the final assessment of our application options. I would like to point out that Isofol has a strong financial position, which will enable us to complete the AGENT study and analyze the final data in an efficient and reliable manner. This is very important in the situation we now find ourselves in.", says CEO Ulf Jungnelius.

Audiocast, August 23, at 12:30 p.m. CEST
In conjunction with the publication of the interim report for the second quarter of 2022, Isofol invites investors, analysts, and media to an audiocast on August 23, 2022 at 12:30 p.m. CEST. The presentation will be held by Isofol´s CEO Ulf Jungnelius and CFO Gustaf Albèrt, who will present and comment the report, followed by a Q&A-session. The presentation will be held in English.

This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CEST, on August 23, 2022.

On August 23, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its senior management team are scheduled to participate in the following upcoming investor conferences (Press release, Innate Pharma, AUG 23, 2022, View Source [SID1234618561]):

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Citi’s 17th Annual BioPharma Conference
Event Date: September 7-8, 2022 (in-person event)
H.C. Wainwright 24th Annual Global Investment Conference
Event Date: September 12-14, 2022

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 [SID1234618560]). 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.

On August 23, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported it has completed cohort 2 and advanced to cohort 3 in the theranostic 64Cu/67Cu SARTATE neuroblastoma trial (CL04 trial) (Press release, Clarity Pharmaceuticals, AUG 23, 2022, View Source [SID1234618559]).

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The independent Safety Review Committee (SRC) assessed the safety data from cohort 2 in all three participants, confirming no Dose Limiting Toxicities (DLTs) occurred following the administration of a single therapy cycle of 67Cu-SARTATE. The SRC has recommended the trial progress to cohort 3, without modification, increasing the 67Cu SARTATE dose from 175MBq/kg body weight in cohort 2 to 275MBq/kg body weight in cohort 3. Additional therapy cycles of 67Cu SARTATE have been requested by clinical sites and are being administered to participants in cohorts 1 and 2. Subsequent therapy cycles are contingent on the Investigators assessment that the participant is demonstrating therapeutic benefit.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Our team of colleagues and collaborators are very excited to advance the SARTATE product in neuroblastoma, an aggressive childhood cancer. With cohort 2 of this theranostic trial now completed, we look forward to exploring the therapeutic benefits of using an increased dose of 67Cu SARTATE in these children, where no other options are available. The further increase in dose between cohorts 2 and 3 is significant, and we look forward to analysing the safety and efficacy data in these higher-level cohorts in neuroblastoma, a radiation sensitive disease.

"We are also pleased with the speed of recruitment in cohort 2 and have been able to close this cohort in 6 months. The increased pace of recruitment is due to the subsided effects of the global pandemic. We continue to progress the trial at some of the leading cancer centres in the US and will aim to open additional clinical sites in the US over the coming months to further accelerate the speed of recruitment in this trial.

"Improving treatment outcomes of children with cancer is at the heart of our mission and something we are very passionate about. As such, we hope that Clarity will be able to continue building upon the mounting diagnostic and therapeutic benefits of the SARTATE products and improve the treatment paradigm for children with this insidious disease," said Dr Taylor.

About CL04
The CL04 trial is a Phase I/IIa theranostic (diagnosis and therapy) trial in paediatric patients with high-risk neuroblastoma using 64Cu/67Cu SARTATE in the US (NCT04023331)1. It is a multi-centre, dose-escalation, open label, non-randomised clinical trial with up to 34 patients currently conducted at five clinical sites in the US, with additional US clinical sites opening for recruitment in the coming months.

About SARTATE
SARTATE is a next generation, highly targeted theranostic radiopharmaceutical. It is being developed for diagnosing, staging and subsequently treating cancers that express somatostatin receptor 2 (SSTR2), including neuroblastoma and neuroendocrine tumours (NETs). Like all Clarity products, the SARTATE product can be used with copper-64 (64Cu) for imaging (64Cu SARTATE) or copper-67 (67Cu) for therapy (67Cu SARTATE).

About Neuroblastoma
Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

In 2020, the US Food and Drug Administration (FDA) awarded Clarity two Orphan Drug Designations (ODDs), one for 64Cu SARTATE as a diagnostic agent for the clinical management of neuroblastoma and one for 67Cu SARTATE as a therapy of neuroblastoma, as well as two Rare Paediatric Disease Designations (RPDDs) for these products. Should Clarity be successful in achieving marketing approval from US FDA for these two products, RPDDs may allow the Company to access a total of two tradeable Priority Review Vouchers (PRVs) which most recently traded at USD110M per voucher.4