A Window of Opportunity Trial Evaluating the Oral TGF-beta Receptor I Inhibitor Vactosertib in Patients Undergoing Standard of Care Chemoradiotherapy for Locally Advanced Esophageal Adenocarcinoma

This interventional clinical trial aims to find ways of improving treatments for individuals with esophageal cancer. Laboratory-based studies show that using medicines that affect a protein called TGF-beta (TGFβ) can kill esophageal cancer cells in individuals who have localized esophageal adenocarcinoma and are being considered for standard-of-care chemoradiation prior to surgery. Participants of this study will take a pill called vactosertib for two weeks before starting standard of care chemoradiation. At the end of the two weeks of taking vactosertib, participants will have a Positron Emission Tomography Computer Assisted Tomography (PET CT) scan and undergo an endoscopy with a biopsy to determine if the vactosertib is working. After chemoradiation, participants will take vactosertib again for four weeks and then be considered for surgery.

Start Date30 Sep 2024

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT05588648

/ RecruitingPhase 1/2

A Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib As a Single Agent in Adolescents and Adults with Recurrent, Refractory or Progressive Osteosarcoma

MP-VAC-209 is a Phase I/II, open label, single arm, multi-center study to assess safety, tolerability, and antitumor activity of vactosertib as a single agent in adolescents and adults with recurrent, refractory, or progressive osteosarcoma. Vactosertib is given orally, twice a day, to people 12 years of age and older who meet the criteria for study enrollment.

Start Date01 May 2023

Sponsor / Collaborator

MedPacto, Inc.

KCT0007745

/ Not yet recruitingPhase 2IIT

A phase II multicenter study to assess the antitumor activity of vactosertib in combination with pembrolizumab in acral and mucosal melanoma patients progressed from prior immune check point inhibitor)

Start Date03 Oct 2022

Sponsor / Collaborator

Yonsei University Severance Hospital

100 Clinical Results associated with Vactosertib

100 Translational Medicine associated with Vactosertib

100 Patents (Medical) associated with Vactosertib

Literatures (Medical) associated with Vactosertib

01 Jan 2025·Small

Harnessing the Engineered Probiotic‐Nanosystem to Remodulate Tumor Extracellular Matrix and Regulate Tumor‐Colonizing Bacteria for Improving Pancreatic Cancer Chemo‐Immunotherapy

Article

Author: Wang, Jia‐Wei ; Meng, Ran ; Song, Wen‐Fang ; Chen, Wei‐Hai ; Lin, Yan‐Tong ; Zhang, Xian‐Zheng ; Deng, Xin‐Chen ; Yao, Wei‐Qin

Abstract:

Poor chemotherapy efficacy in pancreatic cancer is attributed to limited drug permeation caused by the dense extracellular matrix (ECM) and drug degradation induced by tumor‐colonizing bacteria. Here, a tumor‐targeting probiotic‐nanosystem is elaborately designed to remodulate ECM and selectively regulate tumor‐colonizing bacteria for improving chemo‐immunotherapy against pancreatic cancer. Specifically, drug‐loaded liposomes are conjugated with Clostridium Butyricum (CB) via matrix metalloproteinase‐2 (MMP‐2)‐responsive peptide to construct a probiotic‐nanosystem. Particularly, vactosertib (VAC, a transforming growth factor‐β1 receptor inhibitor) is delivered by probiotic‐nanosystem to silence the active pancreatic stellate cells (PSCs) for inhibiting the development of ECM, resulting in a loosened ECM and providing a golden opportunity for the deep penetration of chemotherapy drugs and immune cells. Subsequently, gemcitabine (GEM) is efficiently delivered into the core of tumors via probiotic‐nanosystem, achieving an enhanced chemotherapy efficacy. Noteworthily, CB can alleviate γ‐proteobacteria‐mediated GEM degradation through competitively reducing the contents of γ‐proteobacteria and promoting the amounts of tumor‐inhibiting bacteria, thereby significantly potentiating the therapeutic effect of GEM. The engineered probiotic‐nanosystem can not only enhance the GEM‐induced immunogenic cell death (ICD) of a pancreatic tumor to activate antitumor immune responses but also markedly increase the tumor‐infiltration of effector immune cells to heighten tumoricidal immunity, offering a promising strategy for chemo‐immunotherapy of pancreatic cancer.

01 Jan 2025·Neurology Research International

Inhibition of the Transforming Growth Factor‐β Signaling Pathway Confers Neuroprotective Effects on Beta‐Amyloid‐Induced Direct Neurotoxicity and Microglia‐Mediated Neuroinflammation

Article

Author: Thang, Zi Qing ; Tiong, Shao Qin ; Liew, Jennifer Yue Suan ; Mohgan, Raxshanaa N ; Chan, Zhi Ling ; Quek, Jia Yee ; Wong, Grace Yee Seen ; Gan, Sook Yee ; Chan, Elaine Wan Ling

Background: Abnormal elevation of transforming growth factor‐beta (TGF‐β) has been observed among Alzheimer’s disease (AD) patients. This may be due to microglia‐mediated release of proinflammatory cytokines, which promote neuroinflammation and neuronal apoptosis. Silencing of TGFBR1, a gene encoding TGF‐β receptor type I (TGF‐βR1), has resulted in neuronal survival from amyloid‐beta (Aβ)‐induced neurotoxicity. Therefore, the present study investigated the neuroprotective effect of TGF‐βR1 inhibitors (RepSox, Galunisertib, and Vactosertib) against Aβ‐induced direct neurotoxicity and microglia‐mediated neuroinflammation.Methods: The neuroprotective effect of TGF‐βR1 inhibitors against Aβ‐induced direct neurotoxicity and microglia‐mediated neuroinflammation were investigated using the RealTime‐Glo™ MT Cell Viability Assay. The inhibitory effect of TGF‐βR1 inhibitors on Aβ‐induced microglia‐mediated production of proinflammatory cytokines (TNF‐α and IL‐1β) was determined using enzyme‐linked immunosorbent assay (ELISA).Results: TGF‐βR1 inhibitors (RepSox, Galunisertib, and Vactosertib) at the tested concentrations (6.25–150 nM) showed no significant cytotoxicity effects on SH‐SY5Y and BV‐2 cells. Moreover, treatments with these inhibitors exhibited neuroprotection on SH‐SY5Y cells against Aβ‐induced direct neurotoxicity. The trend of cell viability after 24 h treatment also supports the microscopic images of the cells’ morphology. Furthermore, pretreatment with these inhibitors conferred indirect neuroprotective effect against Aβ‐induced microglia‐mediated neuroinflammation by attenuating the production of proinflammatory cytokines (TNF‐α and IL‐1β).Conclusion: The inhibition of the TGF‐β signaling pathway in neuronal and microglia cells by TGF‐βR1 inhibitors resulted in neuroprotection against Aβ‐induced direct neurotoxicity and microglia‐mediated neuroinflammation. Hence, targeting the TGF‐β signaling pathway in both neuronal and microglia cells could provide a promising therapeutic strategy in AD.

01 Jan 2025·BIOMEDICAL CHROMATOGRAPHY

Quantification of Vactosertib an Inhibitor of TGFBR1 by LC–MS/MS in Rat Plasma and Its Pharmacokinetic Profiling

Article

Author: Konidala, Sathish Kumar ; Boggavarapu, Rajesh Kumar ; Chimakurthy, Jithendra

ABSTRACT:

Vactosertib, an inhibitor of transforming growth factor β‐receptor type‐1 (TGFBR1) effective in preventing tumor cell proliferation, is approved for treating various cancers by FDA. The literature revealed that no LC–MS/MS method was reported for the quantification of vactosertib. To develop a validated LC–MS/MS method for the quantification of vactosertib in rat plasma, vactosertib and cabozantinib (internal standard [IS]) were detected using Waters LC–MS/MS system in MRM positive ionization mode, with a mixture of 0.2% formic acid and acetonitrile (70:30, v/v) on an Agilent XDB C18 (50 × 2.1 mm, 5 μm) column at a flow rate of 0.8 mL/min. The method was validated in accordance with M10 bioanalytical method validation USFDA guidelines and applied for the determination of pharmacokinetic parameters in rat plasma. The analytes were detected at m/z 400.23 → 289.19 and m/z 502.13 → 323.07 for vactosertib, and IS, respectively. The method demonstrated a sensitivity of 1.0 ng/mL, linearity ranging from 1.0 to 1000.0 ng/mL, an r2 of 0.999, accuracy ranged between 91.60% and 100.70%, and the drug was found to be stable across all freeze–thaw cycles. The results indicated that the method was selective, accurate, and validated for quantification of vactosertib in biological fluids and pharmacokinetic profiling of vactosertib.

News (Medical) associated with Vactosertib

10 Mar 2025

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BAVENCIO Continues to Strengthen Its Position in the Immuno-Oncology Landscape | DelveInsight

With the rising adoption of checkpoint inhibitors and combination therapies, BAVENCIO's market growth is driven by expanding indications and strategic partnerships. However, competition from KEYTRUDA and TECENTRIQ poses challenges, making differentiation through combination strategies key to its success. LAS VEGAS, March 10, 2025 /PRNewswire/ -- DelveInsight's " BAVENCIO Market Size, Forecast, and Market Insight Report" highlights the details around BAVENCIO, a human IgG1 lambda monoclonal antibody that targets programmed death-ligand 1 (PD-L1). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of BAVENCIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer/Merck/EMD Sereno's BAVENCIO (avelumab) Overview BAVENCIO is a human antibody targeting programmed death ligand-1 (PD-L1). Preclinical studies have demonstrated its ability to activate both adaptive and innate immune responses. By inhibiting the interaction between PD-L1 and PD-1 receptors, BAVENCIO helps restore T cell-mediated antitumor immunity in preclinical models. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and commercialize BAVENCIO. In the U.S., BAVENCIO is approved for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-based chemotherapy. It is also indicated for patients with locally advanced or metastatic UC who experience disease progression during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-based treatment. Additionally, BAVENCIO in combination with axitinib is approved in the U.S. for the first-line treatment of patients with advanced renal cell carcinoma. The FDA has also granted accelerated approval for BAVENCIO in the treatment of adults and pediatric patients (12 years and older) with metastatic Merkel cell carcinoma, based on tumor response rate and duration of response. Continued approval may depend on further clinical trials confirming its benefits. Currently, BAVENCIO is approved in 50 countries for at least one indication. Learn more about BAVENCIO projected market size for merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma @ BAVENCIO Market Potential Urothelial carcinoma is the most common cancer of the urinary system, arising from urothelial cells and primarily affecting individuals over the age of 50. It is more prevalent in males, with an incidence rate two to three times higher than in females. According to DelveInsight's analysis, approximately 41 million new cases of urothelial carcinoma were reported across the 7MM in 2023. The standard treatment primarily involves chemotherapy, particularly cisplatin-based regimens. For patients who do not respond to initial systemic therapy, immunotherapy—using agents such as atezolizumab and pembrolizumab—serves as a secondary option. In some cases, surgical interventions like nephroureterectomy are also performed. Approved treatment options for urothelial carcinoma include OPDIVO (nivolumab), PADCEV (enfortumab vedotin-ejfv), KEYTRUDA (pembrolizumab), and BAVENCIO (avelumab), among others. The urothelial carcinoma treatment market is projected to experience substantial growth, rising from USD 900 million in 2023 at a notable CAGR through 2034, driven by the introduction of innovative therapies currently in clinical trials. However, challenges such as treatment complications in elderly patients and dependence on blood transfusions may pose barriers to market expansion. Dive deep into an in-depth assessment of the Urothelial Carcinoma Market Merkel cell carcinoma is a rare and aggressive neuroendocrine skin cancer that originates from Merkel cells—specialized mechanoreceptors located at the dermo-epidermal junction responsible for touch sensation. According to DelveInsight's estimates, approximately 9,000 new cases of MCC were reported in the 7MM in 2023, with the United States accounting for 37% of these cases. Several approved treatments for MCC are currently available, primarily focusing on immune modulation. Notable therapies include BAVENCIO, a monoclonal antibody developed by Merck KGaA; KEYTRUDA (pembrolizumab), a PD-1 inhibitor from Merck; and ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor co-developed by Incyte Corporation and MacroGenics. DelveInsight's analysis estimates that the MCC treatment market in the 7MM was valued at approximately USD 411 million in 2023. Over the forecast period from 2024 to 2034, this market is expected to grow at a CAGR of 8.7%, driven by the introduction of innovative therapies. Discover more about the Merkel cell carcinoma market in detail @ Merkel Cell Carcinoma Market Report Renal cell carcinoma is the most prevalent form of kidney cancer, comprising approximately 90% of all cases. It ranks among the ten most common cancers worldwide. The prognosis for advanced RCC remains poor, with a five-year survival rate of around 11-12%. Research indicates that RCC accounts for the vast majority of kidney cancer cases. Over the past decade, the treatment landscape for advanced RCC has evolved significantly, driven by the introduction of novel therapies and advancements in surgical and ablative techniques. Treatment approaches have become increasingly personalized, with prognostic groups established to tailor interventions based on disease severity. For patients in good health with isolated metastases, surgical excision, radiotherapy, or ablative therapy may be recommended to postpone systemic treatment. Meanwhile, those ineligible for surgical removal may benefit from alternatives such as cryoablation, thermal ablation, or stereotactic ablative body radiation therapy. Additionally, targeted treatments like tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies have become essential in both first- and second-line therapy, offering effective management options for advanced RCC. The market outlook for advanced RCC appears promising, driven by ongoing innovations and the expansion of therapeutic options. As investigational treatments advance through clinical trials, they have the potential to significantly improve patient outcomes and address existing gaps in care. The competitive landscape is rapidly evolving, with developments in targeted therapies, immunotherapies, and combination treatments aiming to enhance survival rates and quality of life for patients with advanced RCC. For more insights on the evolving landscape of renal cell carcinoma, visit @ Advanced Renal Cell Carcinoma Market Emerging Competitors of BAVENCIO The urothelial carcinoma pipeline is highly dynamic, with promising new therapies in development, including IMFINZI + IMJUDO + SoC (AstraZeneca), Disitamab vedotin (Pfizer), Vactosertib + IMFINZI (MedPacto), TYRA-300 (Tyra Biosciences), LYTGOBI + KEYTRUDA (Taiho Oncology), UGN-104 (UroGen Pharma), and others. In the Merkel cell carcinoma space, the potential emerging competitors of BAVENCIO include IFx-2.0 (TuHURA Biosciences), NIDLEGY (L19-IL2/L19-TNF) (Philogen), ITI 3000 (Immunomic Therapeutics), PH 762 (Phio Pharmaceuticals/AgonOx), KT 253 (Kymera Therapeutics), MCLA 145 (Merus N.V.), and others. Key companies such as Exelixis/Bristol-Myers Squibb (Zanzalintinib (XL092) + Nivolumab), AstraZeneca/ HUTCHMED (Savolitinib + Durvalumab), Corvus Pharmaceuticals (Ciforadenant (CPI-444)), Xynomic Pharmaceuticals (Abexinostat), NiKang Therapeutics (NKT2152), and others are involved in developing drugs for advanced RCC. To know more about the number of competing drugs in development, visit @ BAVENCIO Market Positioning Compared to Other Drugs Key Milestones of BAVENCIO In January 2021, EMD Serono and Pfizer Inc. announced that the European Commission (EC) approved BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In December 2020, EMD Serono and Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In June 2020, EMD Serono and Pfizer Inc. announced that the FDA has approved the supplemental Biologics License Application (sBLA) for BAVENCIO as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed following first-line platinum-based chemotherapy. In June 2020, Merck KGaA and Pfizer Inc. announced that the European Medicines Agency (EMA) had accepted for review the Type II variation application for BAVENCIO as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. In April 2020, EMD Serono and Pfizer Inc. finalized the submission of a supplemental Biologics License Application (sBLA) to the FDA for BAVENCIO as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma. In October 2019, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has granted approval for BAVENCIO in combination with axitinib as a first-line treatment for adults with advanced renal cell carcinoma (RCC). In May 2019, Merck KGaA and Pfizer Inc. announced that the FDA granted approval for BAVENCIO in combination with INLYTA as a first-line treatment for patients with advanced renal cell carcinoma (RCC). In December 2017, Merck KGaA and Pfizer Inc. announced that the FDA had awarded Breakthrough Therapy Designation to avelumab in combination with INLYTA (axitinib) for newly diagnosed patients with advanced renal cell carcinoma (RCC). In September 2017, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has approved BAVENCIO as a standalone treatment for adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive form of skin cancer. In September 2017, Merck KGaA and Pfizer Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO as the first and only treatment for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan. In May 2017, EMD Serono and Pfizer Inc. announced that the FDA approved BAVENCIO Injection to treat patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after platinum-based chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-based treatment. In March 2017, EMD Serono and Pfizer Inc. announced that the FDA has approved BAVENCIO Injection 20 mg/mL, an intravenous treatment for adults and pediatric patients aged 12 and older with metastatic Merkel cell carcinoma (mMCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and market BAVENCIO. Discover how BAVENCIO is shaping the merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma treatment landscape @ BAVENCIO Injection BAVENCIO Market Dynamics BAVENCIO, co-developed by Merck KGaA and Pfizer, is an anti-PD-L1 checkpoint inhibitor primarily approved for urothelial carcinoma and Merkel cell carcinoma. Its key differentiation lies in its first-in-class approval for maintenance therapy in locally advanced or metastatic urothelial carcinoma, setting it apart from competitors like KEYTRUDA (pembrolizumab) and TECENTRIQ (atezolizumab). However, in the broader immuno-oncology (IO) landscape, BAVENCIO faces stiff competition from other PD-1/PD-L1 inhibitors that dominate indications in lung, renal, and other cancers. BAVENCIO's market uptake has been driven by its unique approval in the urothelial carcinoma maintenance setting, where it demonstrated a significant survival benefit. The drug has gained traction in major markets like the U.S., Europe, and Japan, benefiting from increased awareness and inclusion in treatment guidelines. However, its adoption has been tempered by physician familiarity with established IO therapies and payer considerations around cost-effectiveness, especially in competitive oncology segments. One of BAVENCIO's primary challenges is its limited label expansion compared to blockbuster PD-1 inhibitors like OPDIVO (nivolumab) and KEYTRUDA. While its urothelial carcinoma approval has a strong foothold, its lack of widespread use in high-incidence cancers like NSCLC constrains its market potential. Nonetheless, ongoing clinical trials exploring novel combination strategies with other immunotherapies and targeted agents could enhance its market positioning. Additionally, emerging markets and label expansions offer opportunities for future growth. The future of BAVENCIO will largely depend on its ability to secure new indications and differentiate itself in the crowded IO space. With increasing competition and biosimilar threats on the horizon, strategic partnerships, real-world evidence generation, and market access strategies will be crucial in sustaining its commercial success. Dive deeper to get more insight into BAVENCIO's strengths & weaknesses relative to competitors @ BAVENCIO Market Drug Report Table of Contents Related Reports Urothelial Carcinoma Market Urothelial Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key urothelial carcinoma companies including Pfizer, Merck, Eisai Inc, AstraZeneca, Seagen Inc, Bayer, Incyte Corporation, Acerta Pharma BV, among others. Urothelial Carcinoma Pipeline Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key urothelial carcinoma companies, including MedPacto, AstraZeneca, Helsinn, QED Therapeutics, Inovio Pharmaceuticals, Abbisko Therapeutics, Bayer, 4D pharma plc, RemeGen, Infinity Pharmaceuticals, Kyowa Kirin, Inc., Ikena Oncology, Vyriad, Seagen, RemeGen, Pfizer, Incyte Corporation, Prestige BioPharma, TARIS Biomedical, Janssen Research and Development, among others. Merkel Cell Carcinoma Market Merkel Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key merkel cell carcinoma companies including TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., among others. Renal Cell Carcinoma Market Renal Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key renal cell carcinoma companies including AstraZeneca, Ipsen, Novartis, Pfizer, Amgen, 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] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyBreakthrough Therapy

28 Nov 2023

·www.prnewswire.com

Navigating the Evolving Market Dynamics of Bone Sarcoma: A Comprehensive Analysis of Osteosarcoma, Ewing Sarcoma, and Chondrosarcoma | DelveInsight

Each individual's risk of being diagnosed with primary bone sarcoma and their chances of recovery following diagnosis are influenced by a range of unique factors. In 2023, it is anticipated that 4K individuals of all ages in the United States will be diagnosed with primary bone sarcoma, including 2K males and 1.8K females. In 2020, approximately 400 cases were reported among those aged 15 to 19. LAS VEGAS, Nov. 28, 2023 /PRNewswire/ -- Bone sarcoma is a rare and aggressive form of cancer that originates in the bone tissue. It poses significant challenges during its treatment due to several factors. Firstly, its rarity often leads to delayed diagnosis, as symptoms can mimic other common conditions. Additionally, bone sarcoma typically affects children and young adults, making the emotional toll of the disease particularly challenging. Treatment often involves a combination of surgery, chemotherapy, and radiation therapy, which can be physically demanding and cause severe side effects. Moreover, because bone sarcoma tends to occur in the extremities, treatment may require complex and lengthy surgical procedures, potentially affecting mobility and quality of life. Furthermore, the risk of recurrence remains a constant concern, necessitating long-term monitoring and follow-up care. Despite these challenges, ongoing research and advancements in medical technology offer hope for improved outcomes and a better quality of life for those battling bone sarcoma. DelveInsight has recently released a series of epidemiology-based market reports focusing on benign bone sarcoma including Osteosarcoma Market Report, Ewing Sarcoma Market Report, and Chondrosarcoma Market Report. These reports include a comprehensive understanding of current treatment practices, historical and forecasted patient pool, emerging drugs, market share of individual therapies, and historical and forecasted market size from 2019 to 2032 segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Additionally, the reports feature exhaustive analysis of prominent companies working with their emerging candidates in different stages of clinical development. Let's deep dive into the assessment of these bone sarcoma markets individually. Osteosarcoma Market Osteosarcoma is a rare bone tumor affecting having an annual incidence of 3.4 cases per million. It is the most prevalent form of bone cancer, primarily developed in the osteoblast cells of bones, with a predilection for long bones near the knee joint. However, it can also manifest in other locations, including the upper leg, lower leg, upper arm, and virtually any bone in the body, including those in the pelvis, shoulder, and skull. It has the potential to invade adjacent tissues, such as tendons and muscles, and can metastasize to distant organs or other bones via the bloodstream. As per DelveInsight analysts, the total incident population of osteosarcoma in the 7MM was ~2K in 2022. The estimates show the highest incident cases of osteosarcoma in the United States with ~1K cases in 2022, and it is expected to increase by 2032. Osteosarcoma is commonly treated through a combination of chemotherapy, surgery, and radiation therapy. Despite some recent developments, limited progress has been achieved since the late 1980s when chemotherapy was added to surgical treatment, leading to improved survival rates. Radiation therapy impacts both normal and cancerous cells, causing various effects. Chemotherapeutic drugs like cisplatin, doxorubicin, ifosfamide, and high-dose methotrexate with leucovorin calcium rescue (HDMTX) are widely used. Additionally, a few FDA-approved products, such as FUSILEV and KHAPZORY, are available for osteosarcoma treatment. As per DelveInsight analysis, the osteosarcoma market size is expected to increase at a significant CAGR by 2032. This growth would be fuelled by the increase in the patient pool and the expected entry of emerging therapies. Osteosarcoma Pipeline Therapies and Companies Lenvatinib: Eisai Naxitamab: Y-mAbs Therapeutics BAY80-6946: Bayer Vactosertib: MedPacto For a comprehensive view of the osteosarcoma market, check out the Osteosarcoma Market Assessment Ewing Sarcoma Market Ewing Sarcoma, a malignant tumor, typically initiates its growth within the bones, with a higher incidence among children and young adults, often manifesting during adolescence. Although it can originate in any bone, it predominantly affects the long bones, such as the thigh bone, shin bone, and upper arm bone. The pelvis bones are also frequently involved. In some cases, the tumor may originate in muscle and soft tissues. Common symptoms include bone stiffness, pain, swelling, or tenderness, along with tissue surrounding the affected bone. As per the assessment done by DelveInsight, the total incident cases of Ewing sarcoma in the 7MM comprised approximately 1.2K cases in 2022 and are projected to increase during the forecasted period. The management of Ewing sarcoma typically adopts a comprehensive approach, which may encompass surgery, chemotherapy, and radiation therapy. The National Comprehensive Cancer Network (NCCN) offers specific chemotherapy regimens for localized and metastatic Ewing sarcoma. For first-line treatment, NCCN suggests VDC/IE (vincristine, doxorubicin, and cyclophosphamide alternating with ifosfamide and etoposide), VAIA (vincristine, doxorubicin, ifosfamide, and dactinomycin), and VIDE (vincristine, ifosfamide, doxorubicin, and etoposide) for both initial presentations and as primary therapy for metastatic disease. In the second-line setting, NCCN recommends options like Cyclophosphamide and topotecan, Irinotecan + temozolomide ± Vincristine, Ifosfamide, carboplatin, etoposide, and Lurbinectedin. As per the latest Ewing Sarcoma Market Report, the total Ewing sarcoma market size in the 7MM is approximately USD 26 million in 2022 and is projected to increase during the forecast period (2023–2032). The expected introduction of upcoming therapies and the deepened integration of early patient screening, medication management in secondary care, and diverse clinical setups, ongoing research into optimal implementation approaches, and a surge in public awareness will ultimately pave the way for the advancement of efficient treatment choices. Ewing Sarcoma Pipeline Therapies and Companies SECLIDEMSTAT (SP-2577): Salarius Pharmaceuticals ZEPZELCA (LURBINECTEDIN): Jazz Pharmaceuticals and PharmaMar VERZENIO (ABEMACICLIB): Eli Lilly IBRANCE (PALBOCICLIB): Pfizer MECBOTAMAB VEDOTIN (BA3011): Bioatla IOPOFOSINE I 131 (CLR 131): Cellectar Biosciences TP-1287: Sumitomo Pharma Oncology NBRX-109: Inhibrx Explore in-depth for a comprehensive understanding of the Ewing Sarcoma Clinical Trials Chondrosarcoma Market Chondrosarcoma comprises a group of bone tumors originating from cells that overproduce cartilage. Among these tumors, conventional chondrosarcoma is the most frequent type and is generally associated with slow growth. Conversely, rarer subtypes like dedifferentiated chondrosarcoma, myxoid chondrosarcoma, clear cell chondrosarcoma, and mesenchymal chondrosarcoma tend to exhibit a more aggressive growth pattern and have the potential to spread to distant body parts. DelveInsight estimated that the total incident cases of chondrosarcoma in the 7MM comprised approximately 2K cases in 2022 and are projected to increase during the forecasted period. The management approach for chondrosarcoma is contingent upon factors like tumor type, grade, and location, with the grading system serving as the most reliable indicator of clinical prognosis. It is firmly established that surgical intervention remains the gold standard and sole effective treatment for chondrosarcoma, as alternative modalities such as radiotherapy and chemotherapy exhibit limited responsiveness and resistance. Surgical options encompass curettage, radical resection, and amputation, each necessitating comprehensive clinical judgment and contingent upon variables such as lesion size, location, and malignant characteristics. Anticipated advancements in upcoming therapies and increased integration of early patient screening and medication within secondary care and other clinical settings, along with ongoing research to determine the best implementation methods, are expected to contribute to the development of more effective treatment options. However, chondrosarcoma, being an orphan disease, presents challenges in conducting clinical trials. Limited outcome data for locally advanced or metastatic patients underscore the need for new treatment approaches. Phase I trials, due to their small number of chondrosarcoma patients at varying dose levels, make it difficult to draw definitive conclusions. Nevertheless, some Phase II trials have yielded promising results, warranting further investigation. Encouraging retrospective studies could help augment the currently limited data. Urgent efforts to boost research studies on this orphan disease are imperative. As per DelveInsight analysis, the total market size of chondrosarcoma in the 7MM is approximately USD 9 million in 2022 and is projected to increase at a massive CAGR of 24.8% due to increasing awareness of the disease and the launch of the emerging therapy. Chondrosarcoma Pipeline Therapies and Companies INBRX-109: Inhibrx To access a complete analysis of the chondrosarcoma market, visit Chondrosarcoma Market Assessment Trending Oncology Reports Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NHL companies, including GAbbVie, Genmab, Novartis, Angiocrine Bioscience, Autolus, Zentera Therapeutics, Jiangsu Hengrui Medicine, among others. Oncolytic Virus Cancer Therapies Market Oncolytic Virus Cancer Therapies Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key oncolytic virus cancer therapies companies, including Targovax, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichi Sankyo, among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda, among others. Oncology Conference Coverage Services DelveInsight's Oncology Conference Coverage Services deliver a comprehensive examination of conference outcomes from a range of prominent events, such as ASCO, ESMO, ASH, AACR, ASTRO, SOHO, SITC, European CAR T-cell Meeting, and IASLC 2023. This in-depth analysis equips businesses with the insights they need for effective competitive intelligence and forecasting market trends, aiding in the development of future strategies. About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. 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

Phase 2Clinical ResultRadiation TherapyASCO

31 Oct 2023

·www.prnewswire.com

CHIMERIC THERAPEUTICS ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR CHM 2101, A NOVEL CDH17 CAR T CELL THERAPY FOR ADVANCED GASTROINTESTINAL CANCERS

FDA IND Clearance for CHM 2101, a novel 3rd generation CDH17 CAR T cell therapy Anticipated to be the first CDH17 CAR T cell therapy to enter the clinic Phase 1A clinical trial to initiate patient enrolment in 2024 Phase 1A clinical trial will enroll patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours SYDNEY, Oct. 31, 2023 /PRNewswire/ -- Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), an Australian leader in cell therapy, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of CHM 2101, Chimeric's first in class CDH17 CAR T cell therapy for gastrointestinal cancers. The company plans to investigate CHM 2101 in a multi center, open label Phase 1A/B clinical trial for patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours. CHM 2101 is a 3rd generation, novel CDH17 CAR T cell therapy that targets CDH17, a cancer target associated with poor prognosis and metastasis in the most common gastrointestinal tumors including Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours. The clinical program for CHM 2101 builds upon the preclinical studies published in the preeminent scientific journal, Nature Cancer in March 2022 by leading immunotherapy scientist Xianxin Hua, MD, PhD, and his team at the Abramson Family Cancer Research Institute at the University of Pennsylvania. These experiments demonstrated that CHM 2101 was able to eradicate established tumours in seven cancer models with no toxicity to normal tissues. "It is exciting to see the advancement from discovery of the CDH17 target and CAR T therapy in preclinical studies to the initiation of clinical trials in patients with GI-cancers and neuroendocrine tumors," said Xianxin Hua, MD, PhD, Professor of Cancer Biology in Penn's Perelman School of Medicine, an investigator at the Abramson Family Cancer Research Institute and a Harrington Scholar Innovator. "This is a critical step forward in developing an entirely new CAR T therapy for GI-cancers and neuroendocrine tumors, providing new hopes for the cancer patients who are refractory to the existing therapies." With the FDA IND clearance Chimeric will now begin the initiation of a phase 1 /2 multi-site clinical trial in patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours. The study is planned to begin patient enrollment in 2024. (ClinicalTrials.gov ID: NCT06055439) "I am really excited about the planned Phase 1 clinical trial of CHM 2101 and the opportunity to bring a potentially transformative new investigational agent to cancer patients who need them most," said Michael R. Bishop, MD, Professor of Medicine and Director, The David and Etta Jonas Center for Cellular Therapy, University of Chicago. ABOUT CHIMERIC THERAPEUTICS Chimeric Therapeutics, a clinical stage cell therapy company and an Australian leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular therapies have the promise to cure cancer, not just delay disease progression. To bring that promise to life for more patients, Chimeric's world class team of cell therapy pioneers and experts is focused on the discovery, development, and commercialization of the most innovative and promising cell therapies. Chimeric currently has a diversified portfolio that includes first in class autologous CAR T cell therapies and best in class allogeneic NK cell therapies. Chimeric assets are being developed across multiple different disease areas in oncology with 3 current clinical programs and plans to open additional clinical programs in 2023. CHM 1101 (CLTX CAR T) is a novel and promising CAR T therapy developed for the treatment of patients with solid tumours. CHM 1101 is currently being studied in a phase 1B clinical trial in recurrent / progressive glioblastoma. Initial positive data from the investigator-initiated phase 1A trial has been presented on patients treated in the first two dose levels of the trial. CHM 2101 (CDH17 CAR T) is a first-in-class, 3rd generation CDH17 CAR T invented at the world-renowned cell therapy centre, the University of Pennsylvania. Preclinical evidence for CHM 2101 was published in March 2022 in Nature Cancer demonstrating complete eradication of tumors in 7 types of cancer. CHM 2101 (CDH17 CAR T) is currently in preclinical development with a planned phase 1A clinical trial in gastrointestinal and neuroendocrine tumours. CHM 0201 (CORE-NK platform) is a potentially best-in-class, clinically validated NK cell platform. Data from the complete phase 1A clinical trial was published in March 2022, demonstrating safety and efficacy in blood cancers and solid tumours. Based on the promising activity signal demonstrated in that trial, an additional Phase1B clinical trial investigating CHM 0201 in combination with IL2 and Vactosertib is now underway. From the CHM 0201 platform, Chimeric has initiated development of new next generation NK and CAR NK assets. Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper. CONTACT Investors Jennifer Chow Chief Executive Officer and Managing Director Chimeric Therapeutics T: + 1 9087238387 E: [email protected] Paul Hopper Executive Chairman Chimeric Therapeutics T: + 61 406 671 515 E: [email protected] W: Media Matthew Wright NWR Communications P: +61 451 896 420 E: [email protected] SOURCE Chimeric Therapeutics

Phase 1Cell TherapyINDImmunotherapy

100 Deals associated with Vactosertib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of Esophagus	Phase 2	United States	The Case Comprehensive Cancer Center	30 Sep 2024
Locally Advanced Gastric Adenocarcinoma	Phase 2	United States	The Case Comprehensive Cancer Center	30 Sep 2024
Osteosarcoma, Recurrent	Phase 2	United States	MedPacto, Inc.	01 May 2023
Melanoma	Phase 2	South Korea	MSD Korea Co. Ltd.	03 Oct 2022
Multiple Myeloma	Phase 2	United States	MedPacto, Inc.	30 Jan 2022
Non-Small Cell Lung Cancer	Phase 2	South Korea	Merck & Co., Inc.	30 Jan 2022
Non-Small Cell Lung Cancer	Phase 2	South Korea	AstraZeneca PLC	30 Jan 2022
Aggressive Fibromatosis	Phase 2	South Korea	MedPacto, Inc.	01 Jun 2021
PD-L1 positive Non-Small Cell Lung Cancer	Phase 2	South Korea	MedPacto, Inc.	17 Dec 2020
Metastatic Pancreatic Cancer	Phase 2	South Korea	Samsung Medical Center	17 Jun 2019

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


605 (SITC2024)	Phase 1/2	PD-L1 positive Non-Small Cell Lung Cancer Second line PD-L1-positive	60	Vactosertib 200 mg	wkbpexykyd(vbrpbdaqfx) = 6.7% ntzkouzbpu (ymnaawbemq ) View more	Positive	05 Nov 2024
605 (SITC2024)	Phase 1/2		60	Durvalumab 1500 mg		Positive	05 Nov 2024
ASH2023	Phase 1	Relapse multiple myeloma	-	Vactosertib	pqkrztllhk(hokiuxhmnx) = toguloxdmw tlzosgcavj (dnrwqrrzjv )	-	11 Dec 2023
NCT03724851 (ESMO2023) Manual	Phase 1/2	Metastatic Microsatellite Stable Colorectal Carcinoma Microsatellite Stable (MSS)	105	Vactosertib+pembrolizumab	votbbvtcwz(ujnncygqwm) = fdaeyithxo nxqofxrvxd (iegmoeicrn, 7.5 - 21.4) View more	Positive	22 Oct 2023
SOHO2023	Not Applicable	Multiple Myeloma	-	Vactosertib	mdsbbyvajj(ylniysgoaa) = Vactosertib + POM was well tolerated at all doses and had a manageable adverse event profile zucvmaocko (aajywrghap )	-	01 Sep 2023
NCT03666832 (ASCO2022) Manual	Phase 1	Metastatic Pancreatic Cancer Second line	16	FOLFOX+vactosertib	pazotkxojh(mcjxeajlwr) = afzpjgiqjc oaozisujmb (sxycipjtir ) View more	Positive	02 Jun 2022
NCT03724851 (MP-VAC-204, SITC2021)	Phase 1/2	Metastatic Colorectal Carcinoma TIL \| TGF-Î² \| PD-L1-positive ... View more	-	Vactosertib in combination with pembrolizumab	fnzstecgjq(cbjgammxsg) = vowdzurcjn owvgalmama (wpiuadatwk ) View more	Positive	10 Nov 2021
NCT03143985 (ASCO 12021 \| ASCO 22021) Manual	Phase 1	Relapse multiple myeloma Third line	15	pomalidomide+vactosertib	nquddvsbgo(eldynikimd) = grade II fatigue and pain in one pt, one episode of grade III renal failure that ~ ok less than 7 days ~ get back ~ baseline on another patient, sinus bradycardia that reversed ~ sinus rythem and an Afib that was rate controlled with beta blocerk bxjrknkiaa (fufkiouclv )	Positive	28 May 2021
NCT03724851 (ASCO 12021 \| ASCO 22021) Manual	Phase 1/2	Metastatic Microsatellite Stable Colorectal Carcinoma Microsatellite Stable (MSS)	33	vactosertib+pembrolizumab	lnwiqtxxao(attysmtpod) = sslbnufrin bsqoyphjyn (ggjvidojjn ) View more	Positive	28 May 2021
NCT03732274 (phase 1b/2a study, SITC2020)	Phase 1/2	PD-L1 positive Non-Small Cell Lung Cancer PD-L1 positive	26	Vactosertib 200 mg	jhdxlsvhps(xbtoeqmetu) = Grade 4 TRAE kivgeqwwjs (yprgpcwsjx ) View more	Positive	09 Nov 2020
NCT03732274 (phase 1b/2a study, SITC2020)	Phase 1/2	PD-L1 positive Non-Small Cell Lung Cancer PD-L1 positive	26	Durvalumab 1500 mg		Positive	09 Nov 2020
NCT03698825 (ESMO2020) Manual	Phase 1	Metastatic gastric adenocarcinoma Second line	12	paclitaxel+vactosertib	jzupzqbvmk(fhucszuupu) = vactosertib 300mg BID and weekly paclitaxel jbcfcqirlo (gndepwpxmu ) View more	Positive	17 Sep 2020
NCT03698825 (ESMO2020) Manual	Phase 1	Metastatic gastric adenocarcinoma Second line	12	paclitaxel+vactosertib		Positive	17 Sep 2020

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