To: erippetoe who wrote (1120 ) 8/13/2025 8:31:09 PM From: End2War 3 RecommendationsRecommended By
Read Replies (1) | Respond to My question to Chat-GPT5 and its response:Question : Review this PR from IBRX and let me know why the stock movement occurred for such early data on only 2 patients in Africa. How unusual was it to get the CRs that lasted 6 months? Has that ever happened in third line after prior treatments in this illness? Did they use a drug package that tends to support Anktiva, or is this completely different and some new drug? Response : IBRX reported the first 2 evaluable WM patients in its South Africa phase-1 QUILT-106 trial of CD19 CAR-NK (CD19 t-haNK) :CR with single-agent CAR-NK in a third-line patientCR with CAR-NK + rituximab in another patient, ongoing at 6 months Chemo-free, no lymphodepletion; outpatient infusions; no significant toxicities (infusions included CAR-NK cells and “cytokines,” not specified). ImmunityBio OncLive Why the stock jumped on “n=2” CRs are rare in WM , especially after multiple prior lines. Standard late-line options like venetoclax show high ORR but 0% CR in prospective data; most responses are PR/VGPR, not CR. So two CRs—one with monotherapy—screen as signal-rich despite tiny n. PMC+1 OncLive The regimen is chemo-free and outpatient with no lymphodepletion , which—if scalable—implies a safer, lower-burden cell therapy profile than CAR-T. The field has precedent that CAR-NK can be effective with milder toxicity (e.g., MD Anderson’s cord-blood CAR-NK), so investors extrapolate to a broader NHL platform opportunity. OncLive New England Journal of Medicine MD Anderson Cancer Center IBRX also framed this as the first trial to show potential for CRs in late-stage WM using a chemo-free immunotherapy , which adds “first-in-category” optics ahead of ASH. Sentiment + scarcity of WM innovations = outsized move. ImmunityBio How unusual is a 6-month CR in third-line WM? In WM, deep responses are hard ; across regimens (BR, BTKi, venetoclax), CRs are infrequent and many studies report no CRs in relapsed/refractory cohorts. Thus a continuing CR at 6 months is not unheard of but uncommon this late in the disease course. PMC+1 OncLive Has it ever happened? Yes—CD19 CAR-T case series have reported CRs (including MRD-negative) in heavily pretreated WM , but numbers are tiny. Today’s readout is the first reported CRs using chemo-free CAR-NK in late-stage WM. Waldenstrom's Foundation PMC What exactly was given—does this “support” Anktiva? The trial tested CD19 t-haNK alone , then with rituximab ; the press materials mention “cytokine” infusions but do not name them . Anktiva (N-803) is an IL-15 superagonist IBRX frequently pairs with NK products, and the company’s NHL materials state CD19 t-haNK will be tested with N-803 + rituximab in NHL programs. However, QUILT-106’s release does not confirm N-803 was used —so treat this result as new cell therapy (CAR-NK) data , not an Anktiva label-line result. ImmunityBio+2ImmunityBio+2 Context you can benchmark against BTK inhibitors (ibrutinib/zanubrutinib) : high ORR/MRR, but CRs uncommon ; depth often tops out at VGPR. PMC Nature Venetoclax (R/R WM, many post-BTKi): ORR ~84%, VGPR ~19%, CR 0% ; larger real-world series similarly show strong ORR but few/no CRs. PMC Nature CAR-T in WM : early reports (n˜3) include one prolonged CR ; transformed WM series also show high efficacy, supporting B-cell antigen targeting. Waldenstrom's Foundation ASH Publications CAR-NK safety : prior studies show lower CRS/neurotoxicity vs CAR-T and off-the-shelf logistics; today’s outpatient, no-lymphodepletion use is directionally consistent with that profile. New England Journal of Medicine MD Anderson Cancer Center What to watch next (to separate real signal from hype) N : WM enrollment is tiny (3 WM patients among 13 NHL so far); durability and consistency across additional WM patients are key. Cancer Network Protocol specifics : confirmation of the cytokine(s) used (is N-803 part of QUILT-106 dosing?) and any manufacturing/expansion data for persistence. ImmunityBio Independent presentation : the team says data were submitted to ASH ; look for a poster/oral with patient-level details (mutational status, prior BTKi/venetoclax, marrow clearance). OncLive Bottom line: The stock moved because IBRX showed two chemo-free, outpatient CRs —one with CAR-NK monotherapy —in a setting where CRs are rare after multiple prior lines. It’s platform-validating optics with a favorable safety narrative—but it’s still n=2 . Treat it as promising but preliminary until we see more patients and longer follow-up . ImmunityBio
