On August 23, 2022 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical stage biotechnology company pioneering a new class of medicines that modulate gene expression through selectively targeting the chromatin regulatory system, reported that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on the Phase 1 dose escalation study of FHD-286, an inhibitor of BRG1/BRM, in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) (Press release, Foghorn Therapeutics, AUG 23, 2022, View Source [SID1234618564]). The dose escalation Phase 1 study of FHD-286 in metastatic uveal melanoma (mUM) continues per protocol. The company plans to report data from the mUM study in the first half of 2023.

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The full clinical hold in the AML/MDS study is due to the observation, in the data submitted in response to the partial hold, of additional suspected cases of fatal differentiation syndrome believed to be associated with FHD-286. Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that has been seen with, and is believed to be on-target for, the proposed mechanism of action for FHD-286. The FDA has additional questions and requires further analyses before the clinical hold may be lifted.

"We are committed to patient safety and will work with the FDA to address the agency’s questions and provide further analyses to resolve the clinical hold as soon as possible," said Foghorn CEO Adrian Gottschalk.

About FHD-286

FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, two highly similar proteins that are the ATPases, or the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors. To learn more about these studies please visit ClinicalTrials.gov. (Link here for metastatic uveal melanoma and here for AML and MDS).

About AML

Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.

About Uveal Melanoma

Uveal (intraocular) melanoma (UM) is a rare eye cancer that forms from cells that make melanin in the iris, ciliary body, and choroid. It is the most common eye cancer in adults. It is diagnosed in about 2,000 adults every year in the United States and occurs most often in lightly pigmented individuals with a median age of 55 years. However, it can occur in all races and at any age. UM metastasizes in approximately 50% of cases, leading to very poor prognosis.

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.