Dermatology Times’ Post

Congratulations to BioNTech SE and Duality Biologics! The companies announced that the U.S. Food and Drug Administration granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer who have progressed on or after standard systemic regimens. BNT324/DB-1311 is a next-generation antibody-drug conjugate candidate targeting the transmembrane glycoprotein B7-H3, an immune checkpoint protein which is overexpressed in a range of tumor types and has been associated with disease progression and poor prognosis for patients. BNT324/DB-1311 is currently being evaluated in an ongoing Phase 1/2 study (NCT05914116) in patients with advanced solid tumors. https://lnkd.in/dSbkbKnN

#News: BioNTech SE (22UAy.DE), and its partner Duality Biologics said on Monday they initiated a late-stage trial testing their #precisiondrug against a certain type of #breastcancer, taking on a rival partnership between AstraZeneca (AZN.L), and Daiichi Sankyo, Inc. Sankyo (4568.T). #COVID19 #vaccine maker #BioNTech, which is renewing its focus on its traditional roots in #oncology, said in a joint statement with China's Duality that their drug would be tested on women with a certain type of advanced breast cancer with low levels of a #cellsurfacereceptor known as #HER2. HER2 is a common mechanism of tumour growth that has been targeted by established drugs such as Roche's (ROG.S), #Herceptin. Partners Astra and Daiichi have taken the concept further with their leading drug #Enhertu, based on the #antibodydrugconjugate technology, a type of #highprecision #chemotherapy. That drug is expected by analysts to generate several billions of dollars in annual revenue, mainly because the drug has been approved to treat a larger population of HER2-type breast cancer patients to include women with low levels of the receptor. Read more from Reuters 👇🏼

Latest Updates: US FDA grants fast track designation to Theriva Biologics’ VCN-01 to treat metastatic pancreatic cancer: Theriva Biologics, a diversified clinical-stage company developing therapeutics designed to treat cancer and related #diseases in areas of high unmet need, announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in #patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the ongoing multinational phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC. https://lnkd.in/dzibtUAx

Hepatic Tumor Treatment Drugs, Clinical Trials, Pipeline Insights, and Companies 2024: DelveInsight’s, “Hepatic Tumor Pipeline Insight 2024”report provides comprehensive insights about 75+ companies and 75+ pipeline drugs in Hepatic Tumor pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, … Continue reading → #PharmaceuticalsBiotech

Congratulations to Mabwell (Shanghai) Bioscience Co., Ltd.! The company announced that its self-developed novel Nectin-4-targeting antibody-drug conjugate (ADC: R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic Nectin-4 positive triple negative breast cancer. 9MW2821 contains a humanized antibody and the cytotoxic moiety monomethyl auristatin E site-specifically conjugated via a linker designed to form site-specific disulfide bonds by cross-linking the reduced cysteines in the Fab and hinge regions of an antibody, thereby rendering a highly homogeneous drug-to-antibody ratio of 4. 9MW2821 has received multiple regulatory designations from the FDA, including FTD for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) and recurrent or metastatic cervical cancer (CC) progressed on or following prior treatment with a platinum-based chemotherapy regimen, and Orphan Drug Designation (ODD) for the treatment of esophageal cancer.  #mabs #adcs https://lnkd.in/eBZHaZkY

Congratulations to CytomX Therapeutics! The company announced the first patient has been dosed in a Phase 1 dose escalation study (NCT06265688) of CX-2051 in patients with advanced solid tumors. CX-2051 is a masked PROBODY® antibody drug conjugate (ADC) directed toward epithelial cell adhesion molecule (EpCAM), a cell-surface target that is highly expressed across many cancer types including colorectal, gastric, endometrial, and ovarian cancers. The cytotoxic payload utilized in CX-2051 is a derivative of camptothecin, a topoisomerase-1 inhibitor, a class of drug that has shown potent clinical anti-cancer activity and demonstrated significant clinical benefit as an approved ADC in multiple cancers. The CX-2051 Phase 1 dose escalation is designed to efficiently test the safety and preliminary anti-tumor activity of CX-2051, to provide initial clinical proof of concept to inform a potential decision to move into dose expansions in 2025. #mabs https://lnkd.in/eCzgRG7s

Immune checkpoint inhibitors (ICIs) have become pivotal in cancer treatment, with Chinese pharmaceutical firms advancing the development of PD-1 and PD-L1 inhibitors for various cancers. Now, several of these companies are eyeing or already making moves into the US and European markets. BeiGene, Hengrui Medicine, Shanghai Junshi Biosciences Co Ltd, and Innovent Biologics lead the charge in PD-1/PD-L1 research in China, boasting several approved and ongoing assets. In the fiercely competitive landscape of PD-1/PD-L1 therapeutics, success hinges on innovation. Companies must strive to carve out unique approaches and target areas where current treatments fall short. Pioneering novel measures or addressing unmet needs can set businesses apart in this intense arena. Noteworthy additions to the array of PD-1/PD-L1 inhibitors include spartalizumab (Novartis), sasanlimab (Pfizer), zimberelimab (Arcus Biosciences), INCB99280 (Incyte Corporation), balstilimab (Agenus), among others. To know more, visit: https://lnkd.in/gcK2Dksq #ImmuneCheckpointInhibitors #ICIs #cancertreatment #PD1inhibitors #PDL1inhibitors #ChinesePharma #USmarket #Europeanmarket #Beigene #HengruiMedicine #JunshiBiosciences #InnoventBiologics #innovation #competitiveness #noveltreatments #spartalizumab #sasanlimab #zimberelimab #INCB99280 #balstilimab

TIVDAK® for Cervical Cancer Treatment Accepted by FDA Pfizer and Genmab have submitted an application to the FDA to convert the accelerated approval of TIVDAK to full approval for the treatment of recurrent or metastatic cervical cancer. The FDA has granted the application Priority Review status. Data from the innovaTV 301 trial showed that TIVDAK demonstrated superior results compared to chemotherapy in terms of overall survival, progression-free survival, and confirmed objective response rate. The safety profile of TIVDAK aligns with existing guidelines. TIVDAK was initially approved in 2021 based on response and durability of response in a Phase 2 trial. The data from the innovaTV 301 trial are expected to support global regulatory submissions. For more details please click the link! https://lnkd.in/d-5XHDAP #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

In regulatory affairs news, AbbVie announced submission of a Biologics License Application to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression. The BLA submission is supported by data from Phase 2 LUMINOSITY trial, an ongoing study designed to characterize the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC populations. Data from the LUMINOSITY study were recently presented at the 2024 American Society of Clinical Oncology congress. Review of the BLA will be conducted under FDA's Oncology Center of Excellence Real-Time Oncology Review program.  #mabs https://lnkd.in/dXSHdfxd

A Leap with Bispecific Antibody Drug Conjugates in Solid Tumours Bispecific antibody‒drug conjugates (BsADCs) represent a novel therapeutic class combining the attributes of antibody‒drug conjugates (ADCs) and bispecific antibodies (BsAbs), aiming to address existing challenges in targeted cancer therapy. The review by Yilin Gu et al. meticulously examines BsADC design considerations, including target selection, antibody formats, and the linker‒payload complex, to enhance clinical efficacy and safety.   ✅ Enhanced selectivity and improved internalization of BsADCs are achieved through dual-epitope/target binding, offering a promising solution to overcome limitations such as off-target toxicity and drug resistance. ✅ Case studies on BsADCs targeting HER2, EGFR, and MET reveal potential superior internalization and therapeutic efficacy compared to traditional ADCs.   ❗ Despite promising early clinical trial outcomes, the current understanding and optimization of the intricate interplay among the BsAb, linker, and payload components is still a challenge.   ❓ How can the therapeutic window of BsADCs ensure efficacy across a wider range of tumor heterogeneity and expression profiles, given the variable expression of targeted antigens in solid tumours? Link: https://lnkd.in/dAzDJv7Z