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LYMPHOMA PHASE I TRIAL (TACTAL) Group A: Active disease (15 patients) 7 complete responses (CR) Durable for 4 months -- >5 years No patient achieving a CR has subsequently relaps

Key Takeaway: 6 LYMPHOMA PHASE I TRIAL (TACTAL) Group A: Active disease (15 patients) 7 complete responses (CR) Durable for 4 months -- >5 years No patient achieving a CR has subsequently relapsed 8 stable disease (SD) Durable for 4 -- >12 months) 2 patients subsequently achieved CR with confo

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+35%
120-day peak, hindsight
Typical move
5.1%
average across 5 past catalysts
Cash runway
~9 mo
Medium dilution risk
Lead asset
Low dose FRα vaccine
Phase 2 · Breast Cancer

Full Press Release Details

6 LYMPHOMA PHASE I TRIAL (TACTAL) Group A: Active disease (15 patients) 7 complete responses (CR) Durable for 4 months -- >5 years No patient achieving a CR has subsequently relapsed 8 stable disease (SD) Durable for 4 -- >12 months) 2 patients subsequently achieved CR with confounding factors Group B: Adjuvant ( 17 patients*) 14/17 currently remain in remission Range 9 months -- >4 years Mean time in CCR is 29 months 3 relapses occurred between 8 - 33 months Presented at Society of Hematology Oncology (SOHO) Sept 2019 Autologous MultiTAA T cells for adult patients with lymphoma *1 patient treated twice after initial relapse Group A Monotherapy for patients with active disease Group B Maintenance therapy for patients in remission from prior therapy Dose escalation (n=11) Dose escalation (n=14) Antigen escalation (n=3) Antigen escalation (n=4)
9 AML & MDS PHASE I TRIAL (ADSPAM) Group B: Active Disease (All AML) (6 patients ) 1 CR: Duration 13 months Survived 2.5 years; died of heart attack 1 partial response (PR): Duration 4 months Significant reduction in circulating tumor blasts Tumor reduction from 50% to 15% and 70% to 40% 3 patients responded sufficiently to qualify for a subsequent therapy for which they were previously ineligible Overall survival ranged from 4 months to 30 months Group A: Adjuvant (11 AML, 2 MDS) (13 patients) 11/13 patients remain alive (range 6 weeks to 2.5 years post - infusion) 9 never relapsed and remain in CR (durable for 6 weeks to 2.5 years) 2 patients had relapse in CNS treated with local therapy, 1 patient had extramedullary relapse treated in Group B with CR for 13 months Presented at American Society of Blood and Marrow Transplantation (ASBMT) Annual Meeting Feb 2019 Dose Escalation DL1 5x10 6 cells/m 2 DL2 1x10 7 cells/m 2 DL3 2x10 7 cells/m 2 DL4* 5x10 7 cells/m 2 DL5* 1x10 8 cells/m 2 Allogeneic MultiTAA T cells 30 days post allo - HSCT Group A Maintenance therapy for AML/MDS patients who are disease - free after transplant Group B Monotherapy for patients with relapsed/refractory AML/MDS post - transplant *DL4 and DL5 added during amendment, currently ongoing 1 patient treated twice
15 PANCREATIC PHASE I/II TRIAL (TACTOPS ARM A) Tumor biopsies showed significant T cell infiltration within the tumor Significant T cell expansion and epitope spreading was observed in patients responding to therapy Limited or no significant T cell expansion and epitope spreading was seen amongst non - responders Presented at American Association for Cancer Research: Immune Cell Therapies for Cancer Meeting July 2019 Notable observations:
17 Primary objectives are to evaluate: Relapse - free survival (RFS) (Group 1) The best overall response rate (BOR), duration of response (DOR) (Group 2) Additional objectives include: The safety of multiple tumor associate antigen ( multiTAA ) - specific T cell therapy OS Graft - versus - host disease RFS (GRFS) PFS (Group 2) Study the expansion, persistence, and anti - tumor immune effects of the adoptively - transferred, donor - derived, multiTAA - specific T cells, as well as the presence of epitope spreading Main Entry Criteria: Patients with AML after allogeneic HSCT (HLA - matched related donor, matched unrelated donor, or haploidentical) Karnofsky /Lansky score of 60 Age 18 Life expectancy 8 weeks Adequate organ function Immune Monitoring Analyzed for immunological parameters at multiple timepoints PHASE 2 STUDY DESIGN FOR AML
Last updated: Sep 24, 2019