Clinical Outcomes Solutions’ Post

Onco-This-Week (OTW) is here with the oncology clinical development weekly updates. 📁Subscribe to get your OTW newsletter directly weekly to your inbox at: https://lnkd.in/e3WDGyVz  💊 DRUG APPROVALS 📌FDA: Bristol Myers Squibb Breyanzi CAR T Cell Therapy for R/R CLL or SLL; BeiGene TEVIMBRA for ESCC 🔬REGULATORY NEWS 📌 ODD granted: Terns Pharmaceuticals TERN-701 for CML; Poseida Therapeutics, Inc. P-BCMA-ALLO1 for MM; PureTech Health LYT-200 for AML 📌FDA Advisory Committee Votes in Favor of BMS Abecma for MM 📌NDA accepted Xcovery ensartinib for NSCLC 📌FTD for ImmVira MVR-T3011 IT for HNSCC 📌UroGen Pharma Rolling NDA submitted for UGN-102 ; ENVISION trial expected to support NDA 📌IND cleared CytomX Therapeutics CX-2051 ADC 📌NMPA: NDA approved CARsgen Therapeutics BCMA CAR-T Therapy Zevorcabtagene Autoleucel for R/R MM 📌EMA: TransThera | 药捷安康 Global Ph3 CT for CCA Authorized & ODD granted to Tinengotinib for BTC 📢TRIAL RESULTS 📌Merck KEYTRUDA + CRT Improved OS v/s CRT alone in Cervical Cancer 📌Pfizer Positive OS in Ph3 CT of ADCETRIS in R/R DLBCL 📌中外製薬 / Chugai Pharmaceutical Co., Ltd. Mosunetuzumab Achieved PE in Ph1 study for R/R FL   📊TRIAL/PROGRAM STATUSES 📌FDA Lifts Partial Clinical Hold on Nurix Therapeutics NX-2127 Ph1 Trial 📌MacroGenics, Inc. Ph1 study of MGC026 initiated   💼BUSINESS NEWS 📌IDEAYA Biosciences & Merck to Evaluate IDE161+KEYTRUDA in Endometrial Cancer 📌Tubulis GmbH Closes Upsized €128 M Series B2 to Accelerate Clinical Development of Solid Tumor-Focused ADC Pipeline 📌Collaborations: Biotheus Inc. & Hansoh Bio for EGFR/cMET Bispecific ADCs; Bayer & Aignostics on next gen precision oncology; Domain Therapeutics & Chime Biologics manufacturing agreement to advance anti-CCR8 antibody for Immunotherapy 📌Asgard Therapeutics announces €30 M Series A financing to advance its first-in-class in vivo cell reprogramming platform for immuno-oncology   ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD and Anusha Jayaraman, PhD, Managing Editors Himanshi Agarwal, PhD and Siftjit Kaur, PhD, Social Media Managers

Onco-This-Week (OTW) is here with bite-size updates on Oncology Clinical Development. 📁Subscribe to get the free newsletter directly in your inbox at: https://lnkd.in/e3WDGyVz   🔬REGULATORY NEWS 📌Bristol Myers Squibb FDA accepts BLA for s/c Nivolumab 📌Context Therapeutics FDA clears IND Application for Ph1 CT of CTIM-76 📌Ellipses Pharma Next-gen RET inhibitor EP0031/A400 cleared for Ph2 clinical development 📌Jacobio Pharma submits NDA for Glecirasib   📢TRIAL RESULTS 📌Merck Ph3 KEYNOTE-811 meets Dual Primary Endpoint of OS as 1L in HER2+ve Advanced Gastric or GEJ Adenocarcinoma 📌UroGen Pharma announces results from ATLAS with Robust UGN-102 Durability of Response in NMIBC 📌The Janssen Pharmaceutical Companies of Johnson & Johnson 100% Recurrence rate in Ph2 of ERLEADA + ADT following radical prostatectomy in high-risk localized prostate cancer 📌AstraZeneca Improved PFS with Calquence combination regimen in 1L MCL, ECHO Ph3 CT 📌SELLAS Life Sciences Group, Inc. 100% RR of SLS009 in R/R AML with ASXL1 Mutation 📌Allarity Therapeutics Ph2 CT of Stenoparib concludes early with Significant Milestone in Advanced Ovarian Cancer 📌Jacobio Pharma reports data from Ph2 registrational study of the KRAS G12C inhibitor glecirasib 📌The Janssen Pharmaceutical Companies of Johnson & Johnson 80% RR for TAR-200 monotherapy in high-risk NMIBC 📌CG Oncology 75.2% RR for Cretostimogene Monotherapy High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer 📊TRIAL/PROGRAM STATUSES 📌First Patient Dosed: HiberCell CT for HC-7366+WELIREG in advanced ccRCC; Remix Therapeutics Two Ph1 CTs for REM-422 for ACC & AML/MDS; Galecto, Inc. Investigator-Initiated Ph2 Trial of GB1211+Pembrolizumab combo; Repare Therapeutics Ph1/1b MYTHIC Trial for PKMYT1+WEE1 Inhibition; IN8bio Ph2 CT of INB-400 in Newly Diagnosed Glioblastoma 📌Guangzhou Bio-gene Technology Co., Ltd initiate Ph1 CT for BG1805 📌Sutro Biopharma, Inc. initiates REFRαME-O1 Trial of luvelta in PROC 📌ALX Oncology starts Ph2 Investigator-Sponsored Trial of Neoadjuvant Radiation & Evorpacept-Pembrolizumab combo in Untreated HPV-Mediated Oropharyngeal Cancer 💼BUSINESS NEWS 📌Acquisition: Novartis gets Mariana Oncology to Advance Precision Radiopharmaceuticals to Treat Cancer 📌BridgeBio launches BridgeBio Oncology Therapeutics (BBOT) with $200M of private external capital to accelerate the development of its novel precision oncology pipeline 📌Delphia Therapeutics Launches a New Field of Cancer Medicines based on Activation Lethality platform 📌Collaboration: G1 Therapeutics, Inc.-Pepper Bio announce Global (Excluding Asia-Pac) License Agreement for Lerociclib; Editas Medicine-Bristol Myers Squibb Extend Alpha-Beta T Cell Collaboration; Astellas Pharma-Poseida Therapeutics, Inc. to Develop Novel Allogeneic Cell Therapies in Oncology ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur & Himanshi Agarwal, PhD, Social Media Managers

Onco-This-Week (OTW) is here with comprehensive updates on Oncology Clinical Development. 📁Subscribe to get the free newsletter directly in your inbox at: https://lnkd.in/e3WDGyVz   💊DRUG APPROVALS 📌US: Amgen Imdelltra in SCLC; BMS CAR T Cell Therapy Breyanzi in R/R FL 📌Japan: ONO PHARMACEUTICAL CO., LTD. BRAFTOVI & MEKTOVI for Two New Indications 📌FDA withdraws accelerated approval to QED Therapeutics, Inc. infigratinib in mCCA   🔬REGULATORY NEWS 📌FDA Breakthrough Therapy Designation: Nuvalent, Inc. NVL-655; Merus N.V. Petosemtamab 📌FDA grants Type B End-of-Ph2 Meeting for Agenus BOT/BAL Therapy for R/R mCRC 📌FDA accepts Protocol for Ph2 Study for Nanobiotix NBTXR3 in Lung Cancer 📌Verismo Therapeutics SynKIR-310 gets FDA IND Clearance in R/R B-cell NHL 📌EMA grants PIP waiver to Lisata Therapeutics, Inc. Certepetide in Pancreatic Cancer 📌China CDE clears Ph3 Trial of Jacobio Pharma Glecirasib in CRC   📢TRIAL RESULTS 📌UroGen Pharma announces Long-Term Jelmyto Durability Data & Date for ENVISION Data 📌Arvinas & Pfizer announce Clinical Data from Ph1b Trial of IBRANCE 📊TRIAL/PROGRAM STATUSES 📌Bolt Biotherapeutics, Inc. ceases development of BDC-1001 📌Enrollment completed: Kura Oncology, Inc. Registration-Directed Trial of Ziftomenib in NPM1-Mutant AML 📌First Patient Dosed: Ph1 Trial of Senti Biosciences SENTI-202 in R/R Hematologic Malignancies Including AML; Phio Pharmaceuticals Corp. PH-762 Ph1b Dose-Escalation Study; Carisma Therapeutics Ph1 Trial of CT-0525; EVEREST-2 Ph1 Trial of a2bio2 Novel Mesothelin Logic-Gated CAR T; Flamingo Therapeutics IIT for Danvatirsen in Ph1 for AML/MDS 📌HUTCHMED & Hengrui Pharma Co.,Ltd initiate Ph2/3 Trial of Surufatinib & Camrelizumab in PDAC 📌HUTCHMED initiates RAPHAEL Registrational Ph3 Trial of HMPL-306 in IDH1- and/or IDH2-Mutated R/R AML in China 📌Bayer initiates PhI Trial of PSMA-Targeted Radionuclide Therapy 225Ac-PSMA-Trillium in Prostate Cancer 💼BUSINESS NEWS 📌AstraZeneca plans $1.5B manufacturing facility for ADCs in Singapore 📌Collaboration: Aulos Bioscience & Merck to Study Bavencio+AU-007 combination; FogPharma & ARTBIO to Co-Develop Multiple Helicon-Enabled Alpha-Particle Radioligand Therapies; Reneo Pharmaceuticals & OnKure Therapeutics Announce Proposed Merger; eFFECTOR Therapeutics, Inc. & Dana-Farber Cancer Institute for Ph2 Trial for Zotatifin in ER+ Endometrial Cancer & Serous Ovarian Cancer 📌Tavros Therapeutics gets Two Milestone Payments with Vividion Therapeutics, Inc. ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD and Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur and Himanshi Agarwal, PhD, Social Media Managers

Join Richa Tewari, PhD as she brings Onco-This-Week (OTW) with comprehensive updates on oncology clinical development. 🖐️Subscribe to join the free weekly newsletter directly in your inbox at: https://lnkd.in/e3WDGyVz   ♻️Share this with your network and get the conversation going!   💊DRUG APPROVALS 📌FDA: Citius Pharmaceuticals, Inc. LYMPHIR in R/R CTCL; Servier VORANIGO for IDH-mutant glioma 🔬REGULATORY NEWS 📌FDA Clears IND Application for Kura Oncology, Inc. Ziftomenib in GIST 📌FDA Fast Track Designation: Hinova Pharmaceuticals Inc. HP518 in AR+TNBC 📌FDA grants “Study May Proceed” letter for Ph1/2 study of Senhwa Biosciences, Inc. Silmitasertib+chemo in R/R solid tumors 📌FDA accepts sNDA for Exelixis Cabozantinib in Neuroendocrine Tumors 📌Salubris Biotherapeutics gets EMA Approval to Initiate Ph1 CT of JK06 📌FDA provides IND requirements for Arovella Therapeutics ASX: ALA ALA-101 for first-in human trials for lymphoma & leukaemia 📢TRIAL RESULTS 📌Sanofi Sarclisa induction treatment improves PFS in newly diagnosed MM 📌Elevation Oncology announces Initial Data from Ph1 Trial of EO-3021 in Solid Tumors 📌FAILED TRIAL: Ultimovacs ASA FOCUS Ph2 Trial of UV1 + Pembrolizumab didn’t improve PFS & OS in Metastatic or Recurrent Head & Neck Cancer 📊TRIAL/PROGRAM STATUSES 📌Merck Ph3 KeyVibe-008 Trial of Vibostolimab+Pembrolizumab in Extensive-Stage SCLC to be discontinued as per IDMC recommendations 📌Kiromic Biopharma, Inc. Part 1 of Deltacel-01 Ph 1 clinical trial completed; part 2 to be launched 📌First Patient Dosed in Ph 1 Clinical Trial of Angiex Inc. AGX101 📌Enrollment completed: Ph 2/3 COMPANION-002 trial of Compass Therapeutics Inc. CTX-009+paclitaxel in 2L BTC 💼BUSINESS NEWS 📌Collaboration: Daiichi Sankyo US & Merck for MK-6070; Seed Therapeutics & Eisai US for Molecular Glue Degraders for Oncology Indications; NEC Bio Therapeutics GmbH & AGC Biologics for Personalized Cancer Vaccines; WuXi Biologics & Medigene AG for Off-the-Shelf TCR-Guided T Cell Engagers 📌Acquisition: Merck to Acquire CN201 from Curon Biopharmaceutical 📌IDRx Announces $120M Series B Financing to Advance New Treatment for GIST 📌Genmab Takes Full Control of Acasunlimab Development Program ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur & Himanshi Agarwal, PhD, Social Media Managers

Join Richa Tewari, PhD for comprehensive updates on oncology clinical development at Onco-This-Week (OTW). 📁Subscribe to get the free weekly newsletter directly in your inbox at: https://lnkd.in/e3WDGyVz 🔬REGULATORY NEWS 📌FDA clears IND: Salarius Pharmaceuticals SP-3164, Ph1 to commence in R/R NHL; Rgenta Therapeutics Inc. RGT-61159 in CRC & ACC; IMMORNA Biotherapeutics conducts Ph1/2 of JCXH-211 IV as Monotherapy & with CPI in Solid Tumors 📌Senhwa Biosciences, Inc. submits IND for Ph1/2 study of Silmitasertib in R/R solid tumors 📌Can Fite BioPharma (CANFY) files FDA Orphan Drug Designation for Namodenoson in Pancreatic Cancer 📌FDA Fast Track Designation: Obsidian Therapeutics OBX-115 in Advanced Melanoma; Adicet Bio, Inc ADI-270 in Metastatic/Advanced Clear Cell RCC 📌Moleculin Biotech, Inc. completes End of Ph2 Meeting with FDA for Annamycin in AML 📌Elevar Therapeutics plans for Near-Term Resubmission of NDA as 1L Treatment for Unresectable HCC 📌EMA to re-evaluate PharmaMar Aplidin for MM 📌TGA grants HREC approval & CTN clearance to Interius BioTherapeutics for Ph1 Trial of INT2104 in B-Cell Malignancies 📌EMA Orphan Drug Designation for SELLAS Life Sciences Group, Inc. SLS009 in AML 📌Curium Pharma submits 505(b)(2) NDA for Lutetium Lu177 Dotatate Injection to FDA for somatostatin receptor-positive GEP-NETS 📢TRIAL RESULTS 📌IDEAYA Biosciences announce Positive Interim Ph2 Monotherapy Expansion Data for IDE397 in MTAP-Deletion Urothelial & Lung Cancer 📌Immutep Limited reports Positive Results in 1L HNSCC with Negative PD-L1 Expression 📌Soligenix, Inc. expands HyBryte treatment showing positive outcomes in CTCL 📌Ph2/3 Trial Results for Kazia Therapeutics Limited Paxalisib in GBM 📌Safety approval for First Dose Cohort in Ph1a/b Trial of PharmAbcine Inc. PMC-309 in Advanced or Metastatic Solid Tumors 📊TRIAL/PROGRAM STATUSES 📌Salarius Pharmaceuticals holds Ph1/2 dose-escalation study of SP-2577+azacitidine in MDS & CMML 📌Amgen discontinues development of AMG 794 for Solid Tumors 📌First Patient Dosed: Intensity Therapeutics, Inc. in INVINCIBLE-3 for Metastatic STS; iTeos Therapeutics in GALAXIES Lung-301 Ph3 Study 📌Lisata Therapeutics, Inc. announces Full Enrollment of Pancreatic Cancer Cohort of CENDIFOX Trial 💼BUSINESS NEWS 📌Ipsen & Foreseen Biotechnology announce exclusive global licensing agreement for ADC 📌ReEngage Therapeutics to accelerate development of ACSS2 Inhibitors as Cancer Therapies 📌Collaboration: Prelude Therapeutics & Merck to evaluate PRT3789 + KEYTRUDA in SMARCA4-Mutated Cancers; Nona Biosciences & Alaya.bio to Advance CAR-T Cell Therapy 📌Context Therapeutics acquires Ph1-ready T cell Engager CT-95 📌TuHURA Biosciences, Inc. Enters into Exclusivity & Right of First Offer Agreement for Kineta KVA12123 anti-VISTA Checkpoint Inhibitor ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur & Himanshi Agarwal, PhD, Social Media Managers

Join Richa Tewari, PhD as she highlights this week's oncology clinical development weekly updates with Onco-This-Week (OTW) 📁Subscribe to get your OTW newsletter directly weekly to your inbox at: https://lnkd.in/e3WDGyVz 💊 DRUG APPROVALS 📌EMA: Approves CStone Pharmaceuticals Sugemalimab as 1L for NSCLC 🔬REGULATORY NEWS 📌 FDA Advisory Committee reviewed AstraZeneca Imfinzi for resectable NSCLC based on AEGEAN Ph 3 trial 📌PDUFA Action Date Extension for Syndax Pharmaceuticals Revumenib NDA for R/R KMT2Ar Acute Leukemia Announced 📌Positive EU CHMP Opinion Merck KEYTRUDA + Padcev 1L Urothelial Carcinoma 📌Notable Ph 2 volasertib program receives “Clearance to Proceed” by FDA and agreement on the dosing plan for Ph 2 CT 📌GSK Blenrep combinations in MM application accepted for review by EMA 📌FDA Clears IND for Zymeworks Inc. ZW191, a Novel FR-⍺ Targeted Topo I Inhibitor ADC 📌Positive feedback received from FDA on the planned Immutep LimitedT ACTI-004 Ph3 trial of eftilagimod alfa + KEYTRUDA + chemo for 1L NSCLC 📌Regulatory path forward for GlycoMimetics uproleselan in R/R AML would require an additional clinical trial 📌FDA Grants ODD and RPDD Status to Cellectis UCART22 product candidate for ALL 📌FDA Approves Individual Patient IND for Anixa Biosciences, Inc. Ovarian Cancer CAR-T Therapy 📌FDA Accepts BLA Resubmission of Checkpoint Therapeutics Inc Cosibelimab for Advanced cSCC 📌Positive Opinion from CHMP For Shanghai Junshi Biosciences Co Ltd Toripalimab Announced 📌CHMP recommends Johnson & Johnson RYBREVANT + chemo for EGFR-mutated NSCLC after failure of prior therapy 📢TRIAL RESULTS 📌Fixed-duration Calquence + venetoclax, with or w/o obinutuzumab, significantly improved PFS in 1L CLL in AstraZeneca AMPLIFY Ph 3 trial 📌Positive treatment updates announced from MAIA Biotechnology, Inc. Ph 2, THIO-101, of THIO + cemiplimab in NSCLC 📊TRIAL STATUSES 📌Cohort 3 initiated in Ph 1 CT of NeOnc Technologies Holdings Inc NEO212 Against Malignant Brain Tumors 📌Enrollment of 80mg PK Run-In Cohort in Atossa Therapeutics, Inc. Ph 2 EVANGELINE Trial of (Z)-Endoxifen as a Neoadjuvant Treatment for ER+ / HER2- Breast Cancer Completed 📌6th Patient dosed in TC BioPharm ACHIEVE Study in AML 💼BUSINESS NEWS 📌Immunome, Inc. acquired worldwide, exclusive rights to a panel of antibodies from Nectin Therapeutics, Bluefin BioMedicine, & OncoResponse 📌NorthStar Medical Radioisotopes, LLC and BWXT Medical Sign Supply Agreement Supporting Actinium-225 Production ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD and Anusha Jayaraman, PhD, Managing Editors Himanshi Agarwal, PhD and Siftjit Kaur, PhD, Social Media Managers

Onco-This-Week (OTW) is here with the oncology clinical development weekly updates. 📁Subscribe to get your OTW newsletter directly weekly to your inbox at: https://lnkd.in/e3WDGyVz 💊 DRUG APPROVALS 📌USA: AbbVie EPKINLY for R/R FL; Efficacy Data Eisai US KEYNOTE-B61 Added To Lenvima, Indication for 1L in RCC 📌China & Japan: Astrazeneca Tagrisso + chemo 1L lung cancer 📌EU: MAA accepted for ExCellThera UM171 Cell Therapy heme malignancies 🔬REGULATORY NEWS 📌Merck Patritumab Deruxtecan BLA Submission Receives CRL from FDA 📌FDA clears IND GT Biopharma, Inc. GTB-3650 Leukemia; Adicetbio ADI-270 RCC 📌Positive CHMP Opinion for AbbVie Epcoritamab R/R FL 📌Regeneron Odronextamab Recommended for EU Approval in R/R FL & DLBCL 📌Medicenna Therapeutics Corp. MDNA11 CTA gets EMA Approval to Expand Ph1/2 ABILITY-1 to Europe 📌FDA FTD: Tubulis GmbH TUB-040 OC; Carisma Therapeutics CT-0525 HER2 high Solid Tumors 📌FDA Rare Pediatric Disease Designation to SELLAS Life Sciences Group, Inc. SLS009 in Pediatric ALL 📌FDA aligns on BLA resubmission strategy for Checkpoint Therapeutics Inc cosibelimab 📢TRIAL RESULTS 📌FAILED TRIAL: G1 Therapeutics, Inc. Ph3 PRESERVE 2 Trilaciclib TNBC; Astrazeneca ADJUVANT BR.31 Ph3 Imfinzi in NSCLC 📌Astrazeneca NIAGARA Ph3 Imfinzi statistically significant EFS & OS in MIBC 📌Dose-dependent Clinical Activity Reported Ph1 Lyell Immunopharma LYL797 📌Clinical benefit for Allarity Therapeutics Ph2 of Stenoparib in OC 📌Repare Therapeutics announce positive Ph1 MINOTAUR data for Lunresertib + FOLFIRI 📌Alligator Bioscience AB Bioscience announces OS Benefit & DoR for Mitazalimab OPTIMIZE-1 Ph2 1L Pancreatic Cancer 📌Updated Interim Ph1/1b Data reported for Bicara Therapeutics Ficerafusp Alfa in 1L HNSCC 📌Preliminary DFS analysis of Elicio Therapeutics AMPLIFY-7P Ph1a of ELI-002 7P 📌Positive Topline Results from Immutep Limited TACTI-003 Ph2b in 1L HNC 📌Initial Safety & Efficacy Data from Ph1 Werewolf Therapeutics WTX-330 in Solid Tumors or NHL 📊TRIAL STATUSES 📌Oncolytics Biotech Inc. concludes Type C meeting with FDA for potential registration-enabling trial for pelareorep in mBC 📌EMD Serono, Inc. group discontinues Ph3 TrilynX xevinapant+CRT in unresected LA SCCHN 📌Elevation Oncology announces Planned Combination Strategy for EO-3021 in Gastric or GEJ 📌Sixth Patient treated in Anixa Biosciences, Inc. biosciences OC CER-T CT 📌Database Lock announced for IMUNON Ph2 OVATION 2 IMNN-001 in OC 📌First Patient dosed: IDEAYA Biosciences Ph1 IDE397+Trodelvy Bladder Cancer 📌Third Independent Safety Review Panbela Therapeutics, Inc Ph 3 ASPIRE CT Announced; DSMB Recommended Continuation with no Modification 💼BUSINESS NEWS 📌OSE Immunotherapeutics Announces Commercial & RSA in CAR T-cell Therapy ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Himanshi Agarwal, PhD, & Siftjit Kaur, PhD, Social Media Managers

Here is the latest Onco-This-Week (OTW) issue brought by Richa Tewari, with comprehensive updates on oncology clinical development. 🖐️Subscribe to get the free weekly newsletter directly in your inbox at: https://lnkd.in/e3WDGyVz 💊DRUG APPROVALS 📌FDA: Roche SC Tecentriq Hybreza 🔬REGULATORY NEWS 📌Orphan drug designation: Actuate Therapeutics, Inc. Elraglusib for Soft Tissue Sarcomas; Agios Pharmaceuticals Tebapivat for MDS 📌IND Status: Positive Pre-IND FDA Meeting BriaCell Therapeutics Corp. Bria-PROS+ Prostate Cancer Announced 📌IND clearance: Biosplice Therapeutics cirtuvivint; Ph1/2 of Vironexis Biotherapeutics VNX-101 📌BLA Status: Successful pre-BLA meeting with FDA for Replimune RP1 in anti-PD1 failed melanoma 📌FDA RMAT Designation Poseida Therapeutics, Inc. therapeutics P-BCMA-ALLO1 R/R MM 📢TRIAL RESULTS 📌Data Readout: AstraZeneca TROPION-Lung01 Ph3 Datopotamab deruxtecan OS in NSCLC; MAIA Pharmaceuticals Ph2 THIO-101 THIO & Cemiplimab OS in NSCLC; Relay Therapeutics RLY-2608; BriaCell Therapeutics Corp. OS Ph2 Bria-IMT + CPI; Regeneron Libtayo NSCLC; Bayer Ph1/2 SOHO-01 BAY 2927088 NSCLC; Actuate Therapeutics, Inc. Elraglusib Anti-Tumor Activity in R/R Ewing & related Sarcomas; BioInvent International AB Ph2a BI-1808; Boehringer Ingelheim Zongertinib NSCLC 📌Failed trial: Ipsen CONTACT-02 Ph3 mCRC 📊TRIAL STATUSES 📌First patient dosed: Oryzon Genomics SA Ph1b iadademstat 1L AML; CytomX Therapeutics CX-801 Ph1 Solid Tumors; Incendia Therapeutics Ph1 PRTH-101 for solid tumors; BioInvent International AB of BI-1206, rituximab & Calquence for NHL 📌Global Launch of OSE Immunotherapeutics Artemia Ph3 for Tedopi in 2L NSCLC 📌Trial discontinuation: Oncternal Therapeutics ONCT-534 in mCRPC & ONCT-808 in BCL; Ultimovacs ASA LUNGVAC Trial UV1 + CPI in NSCLC; 📌FDA Lifts Partial Clinical Hold on Zentalis Pharmaceuticals Azenosertib Studies 💼BUSINESS NEWS 📌Collaboration: Nona Biosciences & Umoja Biopharma for in Vivo CAR-T; Sanofi, Radiomedix, Inc. & Orano Med for radioligand medicine for rare cancers 📌Licensing: ITM Isotope Technologies Munich SE from Debiopharm for CA IX-Targeted Programs for Solid Tumors; Vir Biotechnology, Inc. With Sanofi for Multiple Clinical-Stage T-Cell Engagers 🏥CONFERENCE COVERAGE 📌ESMO 2024: More than 70 highlights from ESMO - European Society for Medical Oncology meeting captured in the comment section ✍️ OTW TEAM Richa Tewari, PhD, Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Himanshi Agarwal, PhD & Siftjit Kaur, PhD, Social Media Managers ♻️Share this with your network and get the conversation going!

🎤 #Webinar alert! Limited #patient populations are a challenge for #raredisease studies, but can be mitigated with adaptive #clinicaltrial design strategies. Boaz Adler and Valeria Mazzanti delve into four: sample size optimization, sample size re-estimation, #phase2/#phase3 seamless designs, and Exact #Statistical methodologies. Click to learn more and to register for the March 6 webinar: 👉 https://bit.ly/49VackU #biotech #pharma #pharmaceutical #pharmaceuticalindustry #drugdevelopment #rarediseaseday #adaptivetrials

BioCity Biopharma has announced significant progress with #SC0062, its endothelin receptor type A (ETA) selective antagonist. In the phase 2 clinical trial (2-SUCCEED), designed for chronic kidney disease (CKD), SC0062 has achieved its primary goal of reducing proteinuria. The trial is currently ongoing with a focus on diabetic kidney disease (DKD) patients. SC0062 has shown both clinically meaningful and statistically significant reductions in proteinuria, demonstrating a clear dose-response relationship and maintaining a favorable safety profile with no observed fluid retention in treated patients. Notably, its combination with SGLT2 inhibitors in the trial has also shown promising safety outcomes. Trial data showcasing SC0062's novel approach as a highly selective ETA antagonist, enhancing renal blood flow, and addressing inflammatory and fibrotic processes in CKD, will be presented at upcoming scientific conferences. This milestone underscores BioCity Biopharma's dedication to advancing safer and more effective treatments for kidney diseases. #BioCityBiopharma #CKDResearch #KidneyDisease #ClinicalTrials #MedicalInnovation #HealthcareUpdates