BPX-603 / Bellicum - LARVOL DELTA

Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=220 | Suspended | Sponsor: Bellicum Pharmaceuticals | Recruiting ➔ Suspended

CAR T-Cell Therapy • Metastases • Trial suspension • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Bellicum Discontinues Phase 1/2 Trials and Initiates Evaluation of Strategic Alternatives (GlobeNewswire) - "Bellicum Pharmaceuticals...announced its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. The trials for BPX-601 and BPX-603 are being discontinued following the Company’s assessment of the risk/benefit profile of BPX-601 in combination with rimiducid. The most recent patient treated in the Phase 1/2 trial of BPX-601 in metastatic castration-resistant prostate cancer (mCRPC) experienced serious immune-mediated adverse events including Grade 4 cytokine release syndrome (CRS), the second dose-limiting toxicity observed in this cohort of dose escalation....The Company is communicating with clinical trial sites and regulatory agencies regarding its decision to discontinue its trials, and an evaluation of the Company’s strategic alternatives is underway."

Trial termination • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=220 | Recruiting | Sponsor: Bellicum Pharmaceuticals | Trial completion date: Jan 2025 ➔ Jan 2027 | Trial primary completion date: Dec 2023 ➔ Dec 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Bellicum Reports Fourth Quarter 2021 Financial Results and Provides Operational Update (GlobeNewswire) - "Enrollment in the Phase 1/2 dose escalation clinical trial in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC) is ongoing....The company expects to present a data update on BPX-601 in the first quarter of 2023....Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers....The company expects to present a data update on BPX-603 in the first half of 2023."

Enrollment status • P1/2 data • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Urothelial Cancer • Uterine Cancer

Bellicum Announces Positive Interim Data from Phase 1/2 GoCAR-T Studies, Secures $35 Million Private Placement Equity Financing Priced at Market (GlobeNewswire) - P1, N=220; NCT04650451; Sponsor: Bellicum Pharmaceuticals; "Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers...No dose-limiting toxicities were observed; Serious adverse events reported were pleural effusion and pneumonia. Neither was determined to be related to study drug....Enrollment is ongoing at dose level 2 of 1x106 cells/kg alone or followed by weekly rimiducid, and results from these patients will be submitted for presentation at a medical meeting in 2022."

P1 data • Trial status • Breast Cancer • Gastric Cancer • Gynecologic Cancers • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

Bellicum Announces Positive Interim Data from Phase 1/2 GoCAR-T Studies, Secures $35 Million Private Placement Equity Financing Priced at Market (GlobeNewswire) - "Bellicum has also entered into an agreement for a $35 million private placement of equity securities with two biotechnology specialist investment funds. Proceeds from the financing will be used to support ongoing clinical development of BPX-601 and BPX-603."

Licensing / partnership • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Positive Breast Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Solid Tumor

Bellicum Reports Third Quarter 2021 Financial Results and Provides Operational Update (Bellicum Press Release) - "BPX-601 GoCAR-T: Enrollment in the Phase 1/2 dose escalation clinical trial in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC) is ongoing. Bellicum expects to announce the first interim data in mCRPC in the first quarter of 2022....BPX-603 GoCAR-T: The company expects to announce initial Phase 1 data from this trial in the fourth quarter of 2021."

Enrollment status • P1 data • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Bellicum Reports Second Quarter 2021 Financial Results and Provides Operational Update (GlobeNewswire) - "Bellicum expects to provide a Phase 1 data update on BPX-601 and rimiducid in patients with mCRPC in the first quarter of 2022...BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates Bellicum’s iMC activation and CaspaCIDe® safety switch technologies. The company expects to present initial Phase 1 data from this trial in the fourth quarter of 2021."

P1 data • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

Bellicum Reports First Quarter 2021 Financial Results and Provides Operational Update (GlobeNewswire) - "The company expects to present initial Phase 1 data from...Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers...in the fourth quarter of 2021."

P1 data • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer

Bellicum Reports Fourth Quarter 2020 Financial Results and Provides Operational Update (GlobeNewswire) - "Bellicum plans to present a Phase 1 data update on BPX-601 and rimiducid in patients with metastatic castration-resistant prostate cancer in the first quarter of 2022...The company expects to provide initial Phase 1 data from...Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers...in the second half of 2021."

P1 data • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

"Adam or Jacob any thoughts on $BLCM BPX601 PSCA dose escalated/ expansion to prostate CA PTs BPX603 HER2 pts enrolled could we see PR CR? MC 24m institutional ownership has gone up significantly in past qtr. Thanks" (@ChrisLaCoursie1)

Clinical • HER-2

"Institutional investors know @BellicumPharma exists Ikarian Capital Boxer Capital BakerBrothers and TBA hedgfunds own 80% of company in matter of 4 months smart money has been accumulating $BLCM anticipating merger & BPX603 HER2 data in coming months PT $50 on merger $120 on CR" (@ChrisLaCoursie1)

Clinical • HER-2

Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors (clinicaltrials.gov) - P1/2; N=220; Recruiting; Sponsor: Bellicum Pharmaceuticals

Clinical • New P1/2 trial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Bellicum Enrolls First Patient in Phase 1/2 Clinical Trial for BPX-603 (GlobeNewswire) - "Bellicum Pharmaceuticals, Inc…announced enrollment and apheresis of the first patient in the Phase 1/2 clinical trial for BPX-603 in patients with tumors that express human epidermal growth factor 2 (HER2). BPX-603 is Bellicum’s first dual switch GoCAR-T® product candidate that incorporates the company’s iMC activation and CaspaCIDe® safety switch technologies…. The trial will enroll patients with previously treated, locally advanced or metastatic solid tumors with HER2 amplification or overexpression."

Trial status • Oncology • Solid Tumor

Bellicum Reports Clinical Hold Placed on BPX-601 Phase 1/2 Clinical Trial (GlobeNewswire) - "Bellicum Pharmaceuticals, Inc...today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer. The FDA is taking this action due to the death of a pancreatic cancer patient in the trial reported to the agency by the company...The clinical hold does not affect the company’s plans to initiate enrollment in the Phase 1/2 clinical trial of BPX-603, a dual switch GoCAR-T®, in patients with HER2+ solid tumors by the end of the year."

Enrollment status • FDA event • New P1/2 trial • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Bellicum Reports Third Quarter 2020 Financial Results and Provides Operational Update (Bellicum Press Release) - "The company plans to initiate enrollment in a Phase 1/2 basket trial in solid tumors that express HER2 later this year."

Enrollment status • Oncology • Solid Tumor

Bellicum Reports Second Quarter 2020 Financial Results and Provides Operational Update (GlobeNewswire) - "BPX-603 GoCAR-T: BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates both the company’s iMC activation and CaspaCIDe^® safety switch technologies and the company plans to initiate a Phase 1/2 basket trial in solid tumors that express HER2 later this year...BCMA GoCAR-NK™ Program: Management expects to present additional preclinical data for this program by the end of 2020.:"

New P1 trial • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Bellicum receives FDA IND clearance to initiate a phase 1/2 clinical trial for BPX-603, a dual-switch GoCAR-T for HER2+ solid tumors (GlobeNewswire) - "Bellicum Pharmaceuticals, Inc…announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for BPX-603. BPX-603 is a GoCAR-T® product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2)….'We look forward to initiating our Phase 1/2 trial with BPX-603 targeting solid tumors that express HER2 later this year.'"

IND • New P1/2 trial • Oncology • Solid Tumor

Bellicum reports first quarter 2020 financial results and provides operational update (GlobeNewswire) - "Bellicum continues to conduct its investigational work in preparation of its response to the FDA’s request to further characterize this product candidate and support potential IND clearance. Management expects to provide an update on its progress for this program in the third quarter of 2020....BCMA GoCAR-NK™ Program: Management expects to present additional preclinical data for this program by the end of 2020."

IND • Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor