On August 23, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported the treatment of the first patient in its Phase 1b expansion cohort C (NCT03686124) evaluating IMA203CD8, the company’s 2nd generation TCR-T monotherapy approach where a proprietary CD8αβ co-receptor is added to PRAME-specific IMA203 T cells (Press release, Immatics, AUG 23, 2022, View Source [SID1234618568]). The CD8 co-receptor plays an important role during T cell antigen recognition and T cell activation, enabling the effective engagement of CD8 and CD4 T cells in the anti-tumor response. The 2nd generation TCR-T IMA203CD8 aims to further enhance depth and durability of anti-tumor responses and clinical outcomes of TCR-T targeting PRAME in patients with solid cancers. PRAME is highly prevalent across several indications thereby supporting the program’s potential to reach a broad patient population.

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"IMA203CD8’s unique mode of action has been validated by preclinical data presented at SITC (Free SITC Whitepaper) last year, which demonstrated sustained suppression of tumor growth in serial killing experiments. With the initiation of the IMA203CD8 cohort, we can now test to what extent the interplay of engineered CD8 and CD4 T cells enhances anti-tumor activity in the clinical setting," said Dr. Cedrik Britten, M.D., Chief Medical Officer at Immatics. "Today’s milestone brings us closer to our goal of achieving long-lasting responses for a broad range of cancer patients having solid tumors that express PRAME."

The importance of CD4 T cells for the duration of responses has been demonstrated by Immatics in preclinical assays where IMA203CD8 showed enhanced potency and prolonged anti-tumor activity compared to IMA203 alone. These findings are in line with a growing body of literature from CD19 CAR-T cells in hematological cancers that suggest a relevant role of engineered CD4 T cells in maintaining durable anti-tumor responses over a long period. Immatics’ proprietary lentiviral vector enables CD4 and CD8 T cells to be engineered with the PRAME-specific IMA203 TCR and a CD8αβ construct. In the preclinical studies, this approach showed functional superiority over multiple other CD8 constructs in conjunction with the PRAME-specific IMA203 TCR. Immatics has successfully developed a proprietary 4-in-1 vector that includes both IMA203 TCRα and TCRβ as well as CD8α and CD8β chains while maintaining a high transduction rate, circumventing the challenges associated with increasing the lentiviral vector payload.

The IMA203CD8 Phase 1b dose expansion cohort is expected to enroll up to 24 patients with different types of solid tumors across several clinical trial sites in the U.S. and in Germany. Following personalized manufacturing and lymphodepletion, patients will receive a single dose of IMA203CD8. Initially, 3 patients will be treated at a dose level 3 (DL3, up to 0.48 billion total transduced T cells per m² body surface area) before patient treatment at the provisional recommended Phase 2 dose, DL4 (up to 1.2 billion total transduced cells per m² body surface area). The primary objective of this Phase 1b cohort is to evaluate the safety profile of IMA203CD8. Secondary objectives include evaluating initial anti-tumor and biological activity.

The 2nd generation TCR-T IMA203CD8 is part of Immatics’ strategy to realize the full clinical potential of IMA203 TCR-T targeting PRAME. This strategy includes three Phase 1b expansion cohorts, which have all been initiated during the first half of 2022 and build on the promising early clinical results during the company’s Phase 1a trial. Interim data showed a 50% objective response rate (8/16 patients) across several solid tumor indications including melanoma, head and neck cancer, uveal melanoma and synovial sarcoma.

Cohort A – IMA203 as monotherapy at the provisional, recommended Phase 2 dose (RP2D) plus exploration of a higher dose level DL5 (up to 4.7 billion transduced CD8 T cells per m² body surface area)
Cohort B – IMA203 in combination with an immune checkpoint inhibitor, Opdivo (nivolumab)
Cohort C – IMA203CD8, a 2nd generation monotherapy in which IMA203 is co-transduced with a CD8 co-receptor

Each Phase 1b expansion cohort is designed to evaluate the observed objective response rate, demonstrate durability of response and provide the basis for entering registration trials. The next data readout for the IMA203 monotherapy cohort at RP2D is expected during 2H 2022 and an initial data readout for Cohort B and Cohort C is planned for YE2022.

About IMA203CD8 and target PRAME
ACTengine IMA203CD8 T cells are directed against an HLA-A*02-presented peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers thereby supporting the programs’ potential to address a broad cancer patient population. Immatics’ PRAME peptide is present at a high copy number per tumor cell and is homogenously and specifically expressed in tumor tissue. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform XPRESIDENT. Through its proprietary TCR discovery and engineering platform XCEPTOR, Immatics has generated a highly specific T cell receptor (TCR) against this target which is engineered into CD8 and CD4 T cells alongside a proprietary CD8αβ co-receptor for its 2nd generation TCR-based cell therapy approach, ACTengine IMA203CD8. In preclinical studies, Immatics’ proprietary CD8αβ construct showed functional superiority over multiple other CD8 constructs in conjunction with the PRAME-specific IMA203 TCR.

About ACTengine
ACTengine is a personalized cell therapy approach for patients with advanced solid tumors. The patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor. The approach is also known as TCR-engineered cell therapy (TCR-T). All Immatics’ ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth.

On August 23, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that initial results of the multi-regional clinical trial ("MRCT") of fruquintinib, FRESCO-2, will be presented at the upcoming European Society for Medical Oncology ("ESMO") Congress 2022, taking place on September 9-13, 2022 (Press release, Hutchison China MediTech, AUG 23, 2022, View Source [SID1234618567]). The meeting will be held at the Paris Expo Porte de Versailles, in Paris, France.

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Further details of the presentation are as follows:

Title: FRESCO-2: A global Phase 3 multi-regional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer
Presenter: Arvind Dasari, MD, MS, Associate Professor, Department of Gastrointestinal (GI) Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Session: Proffered Paper session 2: GI, lower digestive
Abstract No.: LBA25
Date & Time: Monday, September 12, 2022, 10:55 – 11:15 am Paris time
Location: 7.2.F – Fécamp Auditorium

Investor audio webcast and conference call is scheduled on Monday, September 12 at 2:00 pm Paris Time (1:00 pm London time, 8:00 am New York time, and 8:00 pm Hong Kong time).

Participating on the webcast will be members of the HUTCHMED management team as well as co-Principal Investigators from the study: Dr. Arvind Dasari and Professor Cathy Eng, MD, FACP, FASCO, David H. Johnson Endowed Chair in Surgical and Medical Oncology and Co-Leader, Gastrointestinal Cancer Research Program, at the Vanderbilt-Ingram Cancer Center.

Details of the conference call dial-in and the webcast link will be provided on the company website at www.hutch-med.com/event/. The presentation will be available for downloading before the conference call begins. A replay will also be available on the website shortly after the event.

About FRESCO-2
The FRESCO-2 study was a MRCT conducted in the U.S., Europe, Japan and Australia that investigated fruquintinib plus best supportive care ("BSC") vs placebo plus BSC in patients with advanced, refractory metastatic colorectal cancer ("CRC"). As previously disclosed, the study met its primary endpoint of overall survival ("OS") in patients with metastatic CRC who had progressed on standard chemotherapy and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib. In addition to OS, a statistically significant improvement in progression-free survival ("PFS"), a key secondary endpoint, was observed. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported studies.

About CRC
CRC is a cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 915,000 deaths in 2020.[1] In the U.S., an estimated 151,000 people will have been diagnosed with CRC and 53,000 people will have died from CRC in 2022.[2] In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.1 In Japan, CRC is the most common cancer, with an estimated 147,000 new cases and 59,000 deaths in 2020.1

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China
Metastatic CRC in China: Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE. It has been included in the China National Reimbursement Drug List (NRDL) since January 2020. ELUNATE is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study[3], a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

About Fruquintinib Development Beyond CRC Monotherapy
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

Gastric Cancer ("GC") in China: The FRUTIGA study is a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for the treatment of patients with advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma who did not respond to first-line standard chemotherapy. Approximately 700 patients have received either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. The co-primary efficacy endpoints are OS and PFS (clinicaltrials.gov identifier: NCT03223376).

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT in China).

Metastatic breast, endometrial, and CRC in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in advanced, refractory triple negative breast cancer ("TNBC"), endometrial cancer, and CRC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib as a single agent were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the U.S. (NCT03251378).
Gastric, colorectal and non-small cell lung cancers ("NSCLC") in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or NSCLC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04716634.
Endometrial cancer and other solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced cervical cancer, endometrial cancer, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO). Following encouraging data in the advanced endometrial cancer cohort, it has been expanded into a single-arm registrational Phase II study of over 130 patients. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT03903705.

On August 23, 2022 Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular disorders, reported it has entered into a global licensing agreement with Lee’s Pharmaceutical (HK) Limited, (Lee’s) and its affiliate Zhaoke Pharmaceutical (Hefei) Co. Ltd., (Zhaoke) for the development and commercialization of Windtree’s acute pulmonary pipeline treatments KL4 surfactant and drug/device combination, AEROSURF, for the treatment of preterm infants with respiratory distress syndrome (RDS) and other potential applications (Press release, Lee’s Pharmaceutical, AUG 23, 2022, View Source [SID1234618566]). RDS often occurs in preterm infants when the lung is not fully developed with natural lung surfactant and may require surfactant therapy to sustain life.

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"We are excited to announce this global licensing transaction for our KL4 surfactant platform given the value it can provide to the Company, its shareholders and critically ill patients," said Craig Fraser, President and Chief Executive Officer of Windtree. "The out-licensing of the KL4 platform supports our portfolio prioritization and increases non-dilutive resources to progressing istaroxime on the significant opportunity in the major markets of cardiogenic shock and heart failure where recent positive data has created what we believe could be a relatively fast and less expensive developmental pathway in cardiogenic shock. Given the clinical potential of KL4 surfactant and AEROSURF to help preterm infants with RDS, we desired a partner who was capable of fully assuming execution of the platform and could build value. Over the past few years, we have worked with the Lee’s and Zhaoke’s teams as they invested significantly in building manufacturing, analytical and clinical capabilities to move the KL4 platform into late-stage development. This transaction strengthens Windtree’s resources for its core programs and delivers significant potential value to its shareholders on assets we were no longer progressing ourselves."

Under terms of the global license agreement, Lee’s and Zhaoke will receive a global license to develop and commercialize Surfaxin, lyophilized lucinactant and AEROSURF for any potential indications and applications. Lee’s and Zhaoke will be responsible for funding all development, intellectual property, manufacturing, and commercialization activities and provide developmental, regulatory and eventual commercial sales milestones for Windtree of up to $78.9 million plus potential double-digit royalties. Windtree had previously granted a regional license to Lee’s and Zhaoke for KL4 and AEROSURF for the territory of Greater China for which Windtree received an upfront payment, and this new agreement expands that territory globally. With the execution of this agreement, Windtree will no longer have ongoing maintenance and operating costs for the KL4 platform.

About Lyophilized Lucinactant and AEROSURF
Lyophilized lucinactant is an investigational synthetic peptide (KL4 surfactant) containing drug product that is being developed to improve the management of RDS in premature infants who may not have fully developed natural lung surfactant and may require surfactant therapy to sustain life. AEROSURF (lucinactant for inhalation) is a drug/device combination designed to deliver aerosolized KL4 surfactant noninvasively using our proprietary ADS technology and potentially may meaningfully reduce the use of invasive endotracheal intubation and mechanical ventilation. We believe that AEROSURF, if approved, may meaningfully reduce the number of premature infants who are subjected to invasive surfactant administration, and potentially provide transformative clinical and pharmacoeconomic benefits. The FDA has granted Fast Track designation for AEROSURF to treat RDS and the program has Orphan Drug designation.

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.