Clear Cell Sarcoma

The prevalence of soft tissue sarcoma has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of soft tissue sarcoma and the growing research and development activities to develop novel therapies to treat soft tissue sarcoma to drive the market. The companies developing the potential therapies in the last stage of development include Advenchen Laboratories, Philogen, Nanobiotix, and several others. LAS VEGAS, May 10, 2023 /PRNewswire/ -- DelveInsight's ' Soft Tissue Sarcoma Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline soft tissue sarcoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the soft tissue sarcoma pipeline domain. Key Takeaways from the Soft Tissue Sarcoma Pipeline Report DelveInsight's soft tissue sarcoma pipeline report depicts a robust space with 125+ active players working to develop 130+ pipeline therapies for soft tissue sarcoma treatment. Key soft tissue sarcoma companies such as Advenchen Laboratories, Philogen, Gradalis, Epizyme, Chugai Pharma France, CytRx, Taiho Pharmaceuticals, KaryoPharm Therapeutics, Nanobiotix, Apexigen, Lytix Biopharma, Incyte Corporation, Iovance Biotherapeutics, Aadi Bioscience, Inc., AVEO Pharmaceuticals, Bayer, VasGene Therapeutics, Mirati Therapeutics, Novartis Pharmaceuticals, Incyte Corporation, Tracon Pharmaceuticals, Jiangsu Hengrui Medicine, Exelixis, Qbiotics, AstraZeneca, Loxo Oncology, ImmunityBio, Monopar Therapeutics, Chipscreen Biosciences, Ltd., Agenus, C4 Therapeutics, Inc., Noxopharm Limited, Moleculin Biotech, Inc., Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., Tracon Pharmaceuticals Inc., Guangdong Xiangxue Precision Medical Technology Co., Ltd., Cornerstone Pharmaceuticals, Takara Bio Inc., Jazz Pharmaceuticals, Lyell Immunopharma, Telix Pharmaceuticals, and others are evaluating new soft tissue sarcoma drugs to improve the treatment landscape. Promising soft tissue sarcoma pipeline therapies in various stages of development include AL-3818, Onfekafusp alfa, Vigil, Tazemetostat, Aldoxorubicin, TAS-116, Selinexor, NBTXR3, APX005M, GPX-150, LTX-315, Lenvatinib, Chiauranib, Zalifrelimab, INCB081776, LN-145-S1, ABI-009, Tivozanib, LOXO-101, sEphB4-HSA, Sitravatinib, Envafolimab, Camrelizumab, Tigilanol Tiglate, Durvalumab, Tremelimumab, CFT8634, NOX66, Liposomal Annamycin, 609A, YH001, TAEST16001, CPI-613+Hydroxychloroquine, TBI-1301, Lurbinectedin, LYL132, and others. In October 2022, LIXTE Biotechnology Holdings, Inc. announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company's lead clinical compound, plus doxorubicin versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS). In September 2022, Immutep Limited was pleased to announce it has signed a Material Transfer Agreement ("Agreement") with the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, to enable an investigator-initiated open-label Phase II clinical trial. The trial will evaluate Immutep's lead product candidate, efti in combination with pembrolizumab and radiotherapy in the neoadjuvant setting (prior to surgery) in up to 40 patients with select soft tissue sarcoma (STS). In September 2022, TRACON Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted fast-track designation for the development of envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. In September 2022, Avacta Group plc announced that the US Food and Drug Administration (FDA) had granted Orphan Drug Designation (ODD) to the company's lead pre|CISION drug candidate, AVA6000, for treatment of soft tissue sarcoma.AVA6000 is a form of the generic chemotherapy doxorubicin that has been modified using the pre|CISION technology so that it is activated predominantly in the tumor with the aim of sparing healthy tissue from exposure and improving the safety, tolerability, and efficacy of the drug. In May 2022, Immix Biopharma, Inc., announced positive interim study data showing that after one cycle of treatment, ImmixBio's lead candidate IMX-110 produced 75% survival vs. 0% survival for Trabectedin (sold as YONDELIS ® by Janssen, a Johnson & Johnson Company, a U.S. FDA approved drug) in a connective tissue cancer Soft Tissue Sarcoma (STS) mice study. In this study, IMX-110 was compared against approved drugs used to treat STS. Trabectedin was dosed according to Meco et al., 2003 (trabectedin monotherapy treatment arm), and IMX-110 was administered at 2.0 mg/kg. In April 2022, Telix Pharmaceuticals Limited announced that it has entered into a license agreement with Eli Lilly and Company ("Lilly") under which Telix is granted exclusive worldwide rights to develop and commercialize radiolabelled forms of Lilly's olaratumab antibody for the diagnosis and treatment of human cancers. Telix's initial development focus will be on a rare type of cancer known as soft tissue sarcoma (STS). Request a sample and discover the recent advances in soft tissue sarcoma drug treatment @ Soft Tissue Sarcoma Pipeline Report The soft tissue sarcoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage soft tissue sarcoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the soft tissue sarcoma clinical trial landscape. Soft Tissue Sarcoma Overview Soft-tissue sarcomas (STS) are rare neoplasms that can develop in supporting or connective tissue, such as muscle, nerves, tendons, blood vessels, and fatty and fibrous tissues. They commonly affect the arms, legs, and trunk. They can also be found in the stomach and intestines (GIST), behind the abdomen (retroperitoneal sarcomas), and in the female reproductive system (gynecological sarcomas). Soft tissue sarcomas are classified based on the cell type involved, the nature of the malignancy, and the clinical course of the disease. The signs and soft tissue sarcoma symptoms differ greatly between patients depending on the type of soft tissue sarcoma. It is not associated with any obvious symptoms early in the course of the disease, but affected individuals may notice a slow-growing, painless mass in the affected area. Find out more about drugs for soft tissue sarcoma @ New Soft Tissue Sarcoma Drugs A snapshot of the Soft Tissue Sarcoma Pipeline Drugs mentioned in the report: Learn more about the emerging soft tissue sarcoma pipeline therapies @ Soft Tissue Sarcoma Clinical Trials Soft Tissue Sarcoma Therapeutics Assessment The soft tissue sarcoma pipeline report proffers an integral view of soft tissue sarcoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Soft Tissue Sarcoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Infusion, Intra-arterial, Intradermal, Intralesional, Intratumoral, Intravenous, Oral, Parenteral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Antibody-drug conjugate, Cell therapy, Gene therapy, Immunotherapy, Nanoparticle, Peptide, Recombinant fusion protein, Small molecule Therapeutics Assessment By Mechanism of Action: Fibroblast growth factor receptor antagonists, Platelet-derived growth factor beta receptor antagonists, Proto oncogene protein c-kit inhibitors, Vascular endothelial growth factor receptor 3 antagonists, Vascular endothelial growth factor receptor-1 antagonists, Vascular endothelial growth factor receptor-2 antagonists, Immunostimulants, Free radical stimulants, DNA intercalators, Type II DNA topoisomerase inhibitors, Cell membrane structure modulators, Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants, Type 1 fibroblast growth factor receptor antagonists, Type 3 fibroblast growth factor receptor antagonists, Type 4 fibroblast growth factor receptor antagonists, Type-2 fibroblast growth factor receptor antagonists, Fms-like tyrosine kinase 3 inhibitors, Lymphocyte specific protein tyrosine kinase p56(lck) inhibitors; Lyn protein-tyrosine kinase inhibitors, Src-Family kinase inhibitors Key Soft Tissue Sarcoma Companies: Advenchen Laboratories, Philogen, Gradalis, Epizyme, Chugai Pharma France, CytRx, Taiho Pharmaceuticals, KaryoPharm Therapeutics, Nanobiotix, Apexigen, Lytix Biopharma, Incyte Corporation, Iovance Biotherapeutics, Aadi Bioscience, Inc., AVEO Pharmaceuticals, Bayer, VasGene Therapeutics, Mirati Therapeutics, Novartis Pharmaceuticals, Incyte Corporation, Tracon Pharmaceuticals, Jiangsu Hengrui Medicine, Exelixis, Qbiotics, AstraZeneca, Loxo Oncology, ImmunityBio, Monopar Therapeutics, Chipscreen Biosciences, Ltd., Agenus, C4 Therapeutics, Inc., Noxopharm Limited, Moleculin Biotech, Inc., Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., Tracon Pharmaceuticals Inc., Guangdong Xiangxue Precision Medical Technology Co., Ltd., Cornerstone Pharmaceuticals, Takara Bio Inc., Jazz Pharmaceuticals, Lyell Immunopharma, Telix Pharmaceuticals, and others. Key Soft Tissue Sarcoma Pipeline Therapies: AL-3818, Onfekafusp alfa, Vigil, Tazemetostat, Aldoxorubicin, TAS-116, Selinexor, NBTXR3, APX005M, GPX-150, LTX-315, Lenvatinib, Chiauranib, Zalifrelimab, INCB081776, LN-145-S1, ABI-009, Tivozanib, LOXO-101, sEphB4-HSA, Sitravatinib, Envafolimab, Camrelizumab, Tigilanol Tiglate, Durvalumab, Tremelimumab, CFT8634, NOX66, Liposomal Annamycin, 609A, YH001, TAEST16001, CPI-613+Hydroxychloroquine, TBI-1301, Lurbinectedin, LYL132, and others. Dive deep into rich insights for new drugs for soft tissue sarcoma treatment; visit @ Soft Tissue Sarcoma Medications Table of Contents For further information on the soft tissue sarcoma pipeline therapeutics, reach out @ Soft Tissue Sarcoma Drug Treatment Related Reports Soft Tissue Sarcoma Market Soft Tissue Sarcoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key soft tissue sarcoma companies, including Gem Pharmaceuticals, Lytix Biopharma, Incyte Corporation, Daiichi Sankyo, NantPharma, Iovance Biotherapeutics, Agenus, Eli Lilly and Company, Adaptimmune, Aadi, AVEO Pharmaceuticals, Amgen, among others. Soft Tissue Sarcoma Epidemiology Forecast Soft Tissue Sarcoma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the soft tissue sarcoma epidemiology trends. Clear Cell Sarcoma Pipeline Clear Cell Sarcoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key clear cell sarcoma companies, including Tesaro, NantPharma, Rafael Pharmaceuticals, Pfizer, among others. Ewing Sarcoma Pipeline Ewing Sarcoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key Ewing sarcoma companies, including Gradalis, Inc., Shanghai Pharmaceuticals Holding Co., Ltd, Tyme, Inc, Pfizer, Hutchison Medipharma Limited, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Cranbury, NJ, June 01, 2022 (GLOBE NEWSWIRE) -- Cornerstone Pharmaceuticals, Inc. (“Cornerstone” or the “Company”), a company focused on rare cancer therapeutics and formerly known as Rafael Pharmaceuticals, today announced that the Company and its partners will present three abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3 – June 7, 2022 in Chicago. The three abstracts from Cornerstone’s partners and principal investigators, Mark Agulnik, Vaibhav Sahai and Philip Philip, highlight its ongoing trials studying CPI-613® (devimistat) in clear cell sarcoma and biliary tract cancer, with a special discussion on pancreatic cancer. “We are incredibly proud to have promising research findings to share in the three rare cancer areas that we’re focused on at ASCO’s Annual Meeting,” said Sanjeev Luther, President and CEO of Cornerstone Pharmaceuticals. “Our research provides hope for the future as we continue to put patients with rare cancer diagnoses at the forefront and move the needle towards progress for potentially life-saving therapy.” Poster Session Details:Title: Phase 1b results of a multicenter, randomized phase 1b/2 study of gemcitabine and cisplatin +/- CPI-613 as first-line therapy for patients with advanced biliary tract cancer (BilT-04)Presenter: Vaibhav Sahai, MBBS, MS, Associate Professor, University of Michigan HealthDate: Saturday, June 4, 2022Time: 8:00 a.m. CDT Location: Hall A | In-Person & On Demand Poster Presentation and Poster Discussion Session Details:Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and HepatobiliaryTitle: Phase 3, multicenter, randomized study of CPI-613 with modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) as first-line therapy for patients with metastatic adenocarcinoma of the pancreas (AVENGER500)Presenter: Philip Philip, M.D., PhD, FRCP, Professor, GI & Neuroendocrine Oncology, Henry Ford Cancer Institute, Wayne State University School of MedicineDate: Saturday, June 4, 2022Time: Poster Presentation – 8 a.m. CDT, Poster Discussion Session – 1:15 p.m. CDTLocation: Poster Presentation – Hall A, Poster Discussion Session – McCormick Place: Hall D2 | In-Person & Live Stream Poster Session Details:Title: Phase 1/2 study of devimistat in combination with hydroxychloroquine (HCQ) in patients with relapsed or refractory (R/R) clear cell sarcoma (CCS)Presenter: Mark Agulnik, M.D., City of Hope's section chief of sarcoma medical oncologyDate: Sunday, June 5, 2022Time: 8:00 a.m. CDT Location: Hall A | In-Person & On Demand “As biliary tract cancer cases continue to rise globally, I am pleased to partner with Cornerstone Pharmaceuticals and study the use of devimistat as a potential therapy option for the disease,” said Dr. Sahai. “I look forward to discussing my findings at ASCO with fellow industry professionals as we envision a future that could offer relief to patients who suffer from this aggressive cancer.” “It’s an honor to discuss our research in pancreatic cancer with some of the brightest minds in clinical oncology at ASCO,” said Dr. Philip. “Although pancreatic cancer remains a challenge for both patients and clinicians, devimistat’s promise as a potential treatment option gives us great hope for the future of care.” “Currently, patients who live with relapsed or refractory clear cell sarcoma (CCS) have limited treatment options,” said Dr. Agulnik. “In partnership with Cornerstone Pharmaceuticals, I am energized by the opportunity to share my research at ASCO on the promising Phase I and Phase II data using devimistat.” About Cornerstone Pharmaceuticals, Inc.Cornerstone Pharmaceuticals (“Cornerstone”) is committed to the development of therapies for rare cancers that have few to no treatment options available. Cornerstone’s lead compound, CPI-613® (devimistat), is designed to target the mitochondria of cancer cells in order to disrupt their energy production, cutting off the fuel for disease growth. Devimistat is undergoing multiple clinical trials and has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the following indications: Burkitt’s lymphoma, biliary tract cancer, soft tissue sarcoma, myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma. In addition, the European Medicines Agency (EMA) has granted orphan drug designation to devimistat for Burkitt’s lymphoma. With science stemming from the world’s most renowned institutions and compassion that runs deep, Cornerstone strives to improve the lives of people with rare cancers, inaugurating a new era of hope. For more information, please visit www.cornerstonepharma.com. Safe Harbor StatementThis press release contains forward-looking statements. These statements relate to future events or the company’s future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential" or "continue", the negative of such terms, or other comparable terminology. These statements are only predictions. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the company, or any other person, that such forward-looking statements will be achieved. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements.

It was another busy week for clinical trial news. Here’s a look. COVID-19-Related Boehringer Ingelheim enrolled the first patient in a new clinical trial in COVID-19 patients with respiratory failure. Weill Cornell Medicine and New York-Presbyterian Hospital are leading the study in whether these patients are more susceptible to developing progressive Interstitial Lung Disease (scarring of the lungs). Synairgen reported it had hit its recruitment target of 610 participants for its global Phase III SPRINTER trial of SNG001 for hospitalized COVID-19 patients. The study is being run in 17 countries. The drug is an inhaled formulation of interferon beta, a broad-spectrum antiviral protein. A topline readout is expected in early 2022, and if successful, the company plans to an Emergency Use Authorization (EUA) in the U.S. GlaxoSmithKline and Vir Biotechnology announced headline data from the COMET-TAIL Phase III trial of IM sotrovimab for mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents. It was non-inferior to IV administration. Sotrovimab is a SARS-CoV-2 neutralizing monoclonal antibody. Non-COVID-19-Related Bristol Myers Squibb’s Phase III CheckMate -816 trial hit the primary endpoint in an interim analysis. The study was evaluating the company’s checkpoint inhibitor Opdivo (nivolumab) and chemotherapy in patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC), which is a neoadjuvant setting—a first step to shrink a tumor before the main treatment, typically surgery. The combination demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) compared to chemotherapy alone when dosed before surgery. GlaxoSmithKline announced positive results in its Phase III trials of daprodustat. The drug, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor met the primary and secondary endpoints in the ASCEND-ND and ASCEND-D trials for anemia due to chronic kidney disease. Novartis announced results from a pooled post-hoc analysis of Phase III ORION-9, -10, and -11 trials. The studies were looking at the impact of body mass index (BMI) levels on the safety and efficacy of twice-yearly Leqvio (inclisiran). The drug was well-tolerated and demonstrated effective and sustained reduction of about 50% in low-density lipoprotein cholesterol (LDL-C) when used with other lipid-lowering therapies. The company also presented positive Phase III results from the JUNIPERA study in support of Cosentyx (secukinmab) in pediatric patients with juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA). The drug significantly delayed time to flare versus placebo. The company also published data from HER-MES, a Phase IV study that compares Aimovig (erenumab) with an oral prophylactic migraine treatment (topiramate). Aimovig has a superior efficacy versus topiramate with patients having a significantly higher probability of having a clinically meaning improvement in migraine frequency. Prelude Therapeutics reported the FDA had accepted its Investigational New Drug (IND) application for PRT2527. The company hopes to start a Phase I trial of the drug by the end of the year. PRT2527 is a potent and selective CDK9 inhibitor being developed for patients with selected solid tumors, including sarcoma, prostate cancer, breast cancer, and other cancers with genomic alterations that lead to MYC dependence. TFF Pharmaceuticals completed dosing in the Phase Ib study of Voriconazole Inhalation Powder for treatment and prevention of Invasive Pulmonary Aspergillosis. The drug is a next-generation, direct-to-lung, inhaled dry powder version of voriconazole. Selecta Biosciences announced topline results from a joint Selecta and AskBio Phase I trial of its ImmTOR platform to mitigate the formation of neutralizing antibodies against an adeno-associated viral serotype 8 serotype capsid used in gene therapies. At day 30, in patients receiving a single 0.3 mg/kg dose of ImmTOR, the company observed a median anti-AAV8 neutralizing antibody titer of 1:5, a 250-fold lower level than in subjects dosed with AAV8 capsid alone. AstraZeneca presented three new sub-analyses from the DAPA-CKD Phase III trial of Farxiga (dapagliflozin). The drug is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The data supports the consistency of the drug’s cardiorenal and mortality benefits in treating chronic kidney disease with and without type 2 diabetes. Crinetics Pharmaceuticals presented new data from ACROBAT Advance, the ongoing open label extension (OLE) trial of paltusotine in patients with acromegaly. ACROBAT Edge and Evolve are two separate Phase II studies. Treatment with paltusotine resulted in median serum insulin-like growth factor-1 (IGF-1) levels that were lower than those observed in the untreated period in the parent studies and were stably maintained at levels achieved on prior SRL therapy for up to 51 weeks. Affimed and NKGen Biotech initiated patient recruitment in the Phase I/IIa trial of the innate cell engager (ICE) AFM2 (Affimed’s tetravalent, bispecific EGFR and CD16A-binding ICE) in combination with SNK01, NKGen’s ex vivo expanded and activated autologous NK cell therapy. iOnctura fully enrolled the metastatic uveal melanoma expansion cohort of the DIONE-01 trial of IOA-244. IOA-244 is a selective PI3Kδ inhibitor. AbbVie presented integrated data from two Phase II trials, KEEPsAKE 1 and 2, of Skyrizi (risankizumab) in adults with active psoriatic arthritis. The data demonstrated that 24-weeks of treatment with the drug caused greater improvements in PsA signs and symptoms compared to placebo. Eli Lilly reported sub-analysis of the EMPEROR-Preserved Phase III trial of Jardiance (empagliflozin) for adults with heart failure with left ventricular ejection fraction (LVEF) over 40%. The drug decreased the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline regardless of chronic kidney disease status at baseline. Rain Therapeutics plans to initiate a Phase II MANTRA-3 trial of milademetan as a monotherapy for Merckel cell carcinoma patients refractory to immune checkpoint inhibition. The drug is an oral mouse double minute 2 (MDM2) inhibitor. The trial is expected to start mid-2022. SCYNEXIS completed its Phase I trial of a liposomal IV formulation of ibrexafungerp. The data support the safety of the liposomal IV formulation. Ibrexafungerp is an antifungal agent, a novel class of structurally distinct glucan synthase inhibitors, triterpenoids. Neuroplast announced positive Phase I results in patients suffering from Traumatic Spinal Cord Injury (TSCI). The company’s Neuro-Cells appeared safe and well tolerated. The treatment uses the patient’s own stem cells to prevent further loss of function after sustaining TSCI. Noxopharm initiated patient enrollment in its DARRT-2 Phase II trial. DARTT is an experimental immunotherapy based on Veyonda combining with a well-tolerated, low dosage of external beam radiotherapy to trigger an immune response. Jasper Therapeutics and AVROBIO are collaborating on using Jasper’s JSP191, an anti-CD117 monoclonal antibody as a targeted conditioning agent for patients with Fabry disease and/or Gaucher disease type 1 who are receiving one of AvroBio’s ex vivo lentiviral gene therapies. JSP191 blocks stem cell factor receptor signaling. Immutep announced final OS data from its Phase IIb AIPAC trial. The study evaluated eftilagimod alpha in combination with paclitaxel in metastatic breast cancer. The data supported Phase III development, with an OS benefit trend with median survival benefit of +2.9 months. Oncorus presented Phase I data on ONCR-177 in advanced injectable tumors. ONCR-177 is an oncolytic herpes-simplex virus-1 expressing five immunomodulatory transgenes. OncoC4 presented preliminary clinical data from the ongoing Phase Ia PRESERVE-001 trial of ONC-392 in cancer patients. ONC-392 is a nextgen anti-CTLA-4 monoclonal antibody. Aravive announced positive new data from the Phase Ib portion of its open-label Phase Ib/II trial of batiraxcept (AVB-500) in combination with cabozantinib in clear cell renal cell carcinoma. Batiraxcept is a therapeutic recombinant fusion protein that neutralizes GAS6 activity by binding to GAS6, selectively inhibiting the GAS6-AXL signaling pathway, which is upregulated in multiple cancers including ovarian, renal and pancreatic. CureVac announced promising data from the completed dose-escalation portion of the Phase I trial of CV8102. CV8102 is a single-stranded non-coding RNA optimized to maximize activation of cellular receptors that normally detect viral pathogens entering cells but is designed to recruit and activate antigen-presenting cells at the site of injection to present tumor antigens released from tumor cells to T cells in the draining lymph node. 89bio presented a sub-analysis of its Phase Ib/IIa proof-of-concept study of BIO89-100 in non-alcoholic steatohepatitis (NASH), looking at the correlation of liver fat and spleen volume. BIO89-100 is a potential best-in-class fibroblast growth factor 21 (FGF21) analog. Athira Pharma presented an overview and updates from two ongoing Phase III trials, ACT-AD and LIFT-AD of ATH-1017 in mild-to-moderate Alzheimer’s disease. ATH-1017 is a small molecular designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET. AC Immune announced that Genentech presented the full topline data from the Phase III LAURIET trial of semorinemab in mild-to-moderate Alzheimer’s disease. The drug is an investigational anti-Tau monoclonal antibody. As previously announced, the trial hit one of two co-primary endpoints, demonstrating statistically significant 43.6% reduction in rate of cognitive decline, but missed the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) or the secondary efficacy endpoints. Yumanity Therapeutics announced that YTX-7739 hit the primary endpoints in its Phase Ib trial in Parkinson’s disease. The drug is a potential first-in-class disease-modifying mechanism of action that inhibits stearoyl-CoA desaturase (SCD). It was generally well tolerated and demonstrated favorable PK/PD and safety pro Apellis Pharmaceuticals presented data from the Phase III DERBY and OAKS trials of pegcetacoplan in geographic atrophy (GA) secondary to age-related macular degeneration. The drug is a targeted C3 therapy. It hit the primary endpoint in the OAKS study of significantly reducing GA lesion growth compared to pooled sham at 12 months. The DERBY study narrowly missed the primary endpoint, demonstrating a decrease in GA lesions growth with monthly and every-other-month treatment compared to pooled sham at 12 months. Lindis Blood Care published results from the clinical pilot study of Catuvab for the removal of tumor cells from surgical blood. The results in 16 cancer patients undergoing abdominal tumor resection demonstrated efficacy and feasibility with no residual malignant cells detected in the final erythrocyte concentrates after the procedure. Catuvab is a medical device used to remove EpCAM-positive tumor cells from surgical blood and is designed to enable the use of machine autotransfusion technology (MAT). Nouscom announced promising interim safety, immunogenicity, PK/PD and clinical activity data from the Phase I trial of NOUS-209. The drug is an off-the-shelf cancer vaccine based on shared neoantigens, administered in combination with Merck’s Keytruda (pembrolizumab) for Microsatellite Instable High (MSI-H) gastric, colorectal and gastro-esophageal junction solid tumors. Finch Therapeutics reported positive topline data from PRISM-EXT, an open-label extension of its PRISM3 Phase II trial of CP101 for prevention of recurrent C. difficile infection. There were no treatment-related serious adverse events, and the drug showed an overall safety pro with what was seen in PRISM3. Freeline Therapeutics announced new data from its ongoing Phase I/II MARVEL-1 dose-finding trial of FLT190 for Fabry disease. The data of the trial has seen expression of alpha-galactosidase A reaching near-normal levels. HOOKIPA Pharma advanced HB-201 to Phase II. The drug is being evaluated in combination with Merck’s Keytruda (pembrolizumab) as a first or second-line treatment for HPV16+ squamous cell head and neck cancers (NHSCC). HB-201 is a single-vector compound with an arenavirus backbone that expresses an E7E6 fusion protein derived from HPV16. Rafael Pharmaceuticals enrolled the first patient in the APOLLO 613 Phase I/II trial of CPI-613 (devimistat) in combination with hydroxychloroquine in patients with clear cell sarcoma at City of Hope in Duarte, Calif. Two other sites, Cleveland Clinic Children’s and University of Michigan’s Rogel Cancer Center have also been opened. Adaptimmune Therapeutics reported updated clinical and translational data from its SPEARHEAD-1 Phase III trial of afamitresgene autoleucel in advanced synovial sarcoma or myxoid/round cell liposarcoma. Based on the reported overall response rate, it is expected to meet its primary endpoint in the final analysis planned later this year. Merck initiated the VICTOR Phase III trial of Verquvo (vericiguat) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event. The drug is already approved in the U.S. to reduce the risk of CV death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. Eisai and Biogen presented results of sensitivity analyses evaluating the consistency of lecanemab efficacy across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and mild AD. Lecanemab is an anti-amyloid beta protofibril antibody. Biogen also reported that its Aduhelm (aducanumab) significantly lowered plasma p-tau181, a biomarker of tau in Alzheimer’s disease. This was from two Phase III trials. They say change in plasma p-tau181 was significantly correlated with change in amyloid beta plaque, and it reduced cognitive and functional decline on all primary and secondary Alzheimer’s measurements. Horizon Therapeutics enrolled the first patient in a Phase IIb trial of hZN-825 for diffuse cutaneous systemic sclerosis, a subset of systemic sclerosis (scleroderma). The drug is a lysophosphatidic acid receptor 1 (LPAR1) antagonist. Ikena Oncology presented data from their IK-175 AHR antagonist program. The ongoing trial is recruiting patients in both monotherapy and combination cohorts with nivolumab. It is being evaluated in multiple tumor types, including urothelial carcinoma, a type of bladder cancer. Vaccitech reported results from ongoing Phase I and Phase Ib/IIa trials of VTP-300 for chronic hepatitis B infection. The drug is a heterologous prime-boost vector combination of ChAdOx1-HBV + MVA-HBV. It induced robust T cells against targeted HBV antigens. Cue Biopharma presented updated interim data from its ongoing trial of CUE-101 as a monotherapy for recurrent/metastatic HPV+ head and neck cancer. The drug is a Fc-fusion biologic that incorporates peptide-major histocompatibility complex molecules with engineered IL2.