#1AD #FDA #CarT #Cancer #CompleteResponse #BIOTECH 🔥AdAlta engages sector-leading advisors to support US FDA engagement for BZDS1901 CAR-T therapy 📢BZDS1901 has delivered multiple tumour responses (shrinkage) in patients with advanced and refractory mesothelioma, including two patients who have achieved complete tumour clearance (COMPLETE RESPONSE) that remain ongoing at 6 and 22 months after treatment respectively BZDS1901 targets an estimated US$4.2 billion segment of the advanced mesothelioma market ⚡️AdAlta has engaged Dark Horse Consulting Group, Inc (“DHC”), a leading specialist in cell and gene therapy development, to support regulatory engagement with US Food and Drug Administration (“FDA”) for its BZDS1901 CAR-T therapy ⚡️focus on preparing for a near-term pre-IND meeting with the FDA ⚡️potential advanced regulatory designations and accelerated pathways

Ongoing discussion around $NWBO and $IBRX, especially after @maveric92283613 post, warrants clarity on what Dr. Makary actually said and what he was pointing to: “I’d like to see more cancer therapies that apply to stage 4 metastatic disease, and cancer therapies that result in what we call, in medicine, a complete pathologic response. That is, the cancer melts away… eliminated without chemo, surgery, or radiation therapy.” Makary wasn’t speculating. He referenced therapies already in the pipeline. And his language, “eliminated without chemo, surgery, or radiation,” didn’t just describe efficacy. It implied safety: tumor clearance without exposing patients to the toxicity of conventional treatment. Let’s examine what’s on record: 🧬 Anktiva in GBM (QUILT 3.078 / NCT06061809) Combination therapy •Anktiva (N 803) •PD L1 t haNK •Bevacizumab (Avastin) Context •No chemo or radiation, but Avastin is not low risk •Carries FDA black box warnings: •GI perforation •Arterial thromboembolism •Wound healing failure •CNS hemorrhage avastin.com/hcp/safety.html •In GBM specifically, Avastin failed to improve overall survival in randomized trials and is used for symptom control only cancer.gov/about-cancer/trea… There is no published monotherapy data showing tumor elimination or systemic regression in stage 4 solid tumors with Anktiva. Trial registry: clinicaltrials.gov/study/NCT… 🧬 DCVax Direct (NCT01882946) Patient population •Stage 4, metastatic, inoperable •All had failed standard therapies Protocol •No chemo •No radiation •No surgery •Only one lesion injected •Uninjected tumors regressed Outcomes •Most common side effect: mild fever under 48 hours •Covered 13 advanced solid tumor types •Trial data published in Frontiers in Oncology (2018): frontiersin.org/articles/10.… •Updated and presented by Dr. Marnix Bosch at NYAS 2025 NYAS Slide Source: nwbio.com/wp-content/uploads… ClinicalTrials.gov: clinicaltrials.gov/study/NCT… Mechanistic evidence “TILs sharing sequences with peripheral T cells increased, indicating a systemic response.” Dr. Marnix Bosch Clarification: These were naturally activated TILs, induced in vivo by dendritic cell injection alone, not adoptively transferred or lab expanded. Importantly, no booster agents, immune modulators, lymphodepletion, or preconditioning were used. The systemic response was uncalibrated and unassisted. Systemic immune activation, without chemo, radiation, or adjuncts like Avastin. Clinical outcomes observed, not theorized. 🧠 Makary described exactly this: Stage 4. Tumor melt. No chemo. No radiation. No surgery. Low toxicity. That’s DCVax Direct. It is the only known published match. 🔍 What About Other Therapies? We searched ClinicalTrials.gov, Nature, NCBI, GSK pipelines, Mass General reports, and FDA archives for any therapy with equivalent results. ❌ CAR T in GBM (Mass General, INCIPIENT trial) •Regression in 3 patients •Not durable; tumors recurred •No systemic clearance confirmed Trial: clinicaltrials.gov/study/NCT… Press release: massgeneral.org/news/press-r… ❌ TIL Therapy in Melanoma •Durable responses in some patients •Requires toxic lymphodepletion plus IL 2 •Limited to immunogenic tumors (melanoma) FDA approval of lifileucel: fda.gov/drugs/news-events-hu… ❌ Dostarlimab (GSK) in Rectal Cancer •100 percent complete response in dMMR patients •But in non metastatic, locally advanced disease •Not applicable to Makary’s “stage 4” standard GSK trial data: nature.com/articles/s41591-0… None of these meet the full clinical profile Makary outlined. 🧩 The Clinical Bar Has Been Set Makary described a real immunologic phenomenon: •In stage 4 disease •Without chemo, surgery, or radiation •With confirmed systemic tumor regression •And without toxicity Only DCVax Direct demonstrates this, across tumor types, in human subjects, with published survival benefit and immune data. If anyone knows of a therapy that meets this standard more precisely, with public data, you are invited to present it. At this point, the case is not just made, it remains unchallenged. #DCVax #Murcidencel #Stage4 #TumorMelt #CompleteResponse #NoChemo #NoRadiation #NoSurgery #NoToxicity #SystemicImmunity #ImmuneActivation #PublishedData #Immunotherapy #GBM #ClinicalTrials #OpenChallenge @DrMakaryFDA

FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’! #healthcare #CompleteResponse #FDA hubs.li/Q03wJ9180

Pre-transplant CR in HR-MDS: insights from @MaxStahlMD @VJHemOnc #iwMDS25 #iwMPN25 #BMT #CompleteResponse

KEYNOTE-671 trial had previously achieved the other primary endpoint of event-free survival (EFS) during its first interim analysis, and pathological #completeresponse (pCR) and major #pathologicalresponse (mPR) ipharmacenter.com/post/europ… #news #media #ESMO23 #ESMO2023 #Science

So happy to work with the excellent @DrTakemura & @DrDanielHeng about the contemporary implications of #completeresponse in #kidneycancer Thanks to @IMDConline collaborators @montypal @tompowles1 @neerajaiims

Cellectar Biosciences Reports Complete Response in a Relapsed/Refractory CNS Lymphoma Patient bit.ly/CNSLCR #clinicaltrials #clinicalresearch #Lyphoma #CompleteResponse #bloodcancer #RareDiseaseDay2023 $CLRB

🚨@oncoalert @NEJM #dostarlimab 👏ALL 12 pts (100%) w/MMRD stage II or III #rectaladeno treated w/neoadj #dostarlimab had clinical #completeresponse ✅No evidence of tumor on MRI, 18F-FDG–PET, endoscopic, digital rectal examination, or biopsy Check👇 nejm.org/doi/full/10.1056/NE…

Incredible opportunity to hear @AndreaCercek speak about #PD1 #blockade in #mismatch #repairdeficient locally advanced #rectalcancer at #SocietyofPelvicSurgeons @MSKCancerCenter 100% #completeresponse 👏 🎉 @NEJM @ASCO nejm.org/doi/full/10.1056/NE…

DestinyBreast03: T-DXd vs TDM-1 #SABCS21 Subgroup analysis shows all groups benefit. No surprises given the magnitude of benefit in the treatment group overall. 🧠Notably, intracranial completeresponse 27% T-Dxd vs 2% TDM-1 #bcsm @OncoAlert

Dr. Makker #IGCS2021 practice-changing trial Lenvatinib Pembrolizumab for advanced #EndometrialCancer dMMR population. Improved PFS, OS& ORR compared to physicians choice. 14%CompleteResponse🌟 #GynCancer @OncoAlert #gyncsm #GynOnc @EndometrialCanc @cancer_womb @TeamEndo_MSK

All set for Nivo #5 treatment, still a complete responder, dietitian just popped in to say she wants a chat, better avoid the digestive biscuit #ipinivo #nivo #cancer #KidneyCancer #KidneyCancerAwareness #completeresponse

First of several indications for narsoplimab,MASP-2 inhibitor. update including final data to be included in BLA filing was an improvement over previous data,showing a completeresponse rate in overall patient population of (p<0.0001), well above FDA specified criteria of 15%.

I am going to present a case in MiniOral session in upcoming #ESMOAsia2020 in #Singapore (virtually). We will present how we successfully used #immunotherapy plus #radiation to treat a refractory metastatic #ProstateCancer and achieve almost #CompleteResponse

Fab keynote on #completeresponse to wrap up #DukesVirtualWeek . Fascinating

#teamwork #Eysac #collaboration #colorectalcancer #colorectalsurgery #completeresponse

The last day of #colorectalsurgery #handson course by @ESSOnews we start with an excellent presentation 🇳🇱 experience by #hillingdenise @UniLeiden #completeresponse #cCR #pCR #colorectalcancer

The real meat here is the CR rate. Even if the responses are equal the ability to get to CR on this % is amazing. #CR #completeresponse is the holy grail. #SITC2019 @SITC @angelesclinic

Intrigued by @EmbolxInc Sniper. Trying to exploit changes in downstream flow physiology after balloon occlusion. @JVIRmedia @SIRspecialists @SIRRFS @UHRadiology #completeresponse

Childs Pugh A cirrhotic with 5 cm infiltrative hcc with enhancing tumor thrombus in right portal vein. Y90 segmentectomy dose —> nothing but dead tumor at 3 months. #completeresponse #justnukeit #radialfirst #irad @JVIRmedia @BTGIO