omalizumab biosimilar (AVT23) / Alvotech, Advanz Pharma - LARVOL DELTA

Alvotech Enters Exclusive Global Licensing Agreement with BiosanaPharma for Co-Development of a Proposed Biosimilar (AVT23) to Xolair (Omalizumab) (Businesswire) - "Alvotech Holdings S.A...has entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23 (also called BP001), a proposed biosimilar to Xolair® (omalizumab)...Under terms of the agreement, Alvotech will receive exclusive global rights for AVT23, a proposed biosimilar to Xolair."

Licensing / partnership • Asthma • Immunology

[VIRTUAL] A phase II study of BP1001 (liposomal Grb2 antisense oligonucleotide) in patients with hematologic malignancies. (ASCO 2020) - P2a | "A Phase I/Ib single center study in patients with refractory/relapsed leukemias demonstrated the safety of BP1001 up to 90 mg/m2 dose and the efficacy of BP1001 in combination with low dose cytarabine (LDAC) in refractory/relapsed acute myeloid leukemia (AML) patients (Ohanian, Lancet Haematol 2018)...The secondary objectives of this study are to assess: Safety of BP1001 + decitabine; partial remissions and blast count reductions; overall survival, time to response and duration of response; minimal residual disease status in patients who achieve complete remission; and plasma PK profile of BP1001. The exploratory objective of this study is to evaluate the association of treatment response with cytogenetic and molecular characteristics. Research Funding: Bio-Path Holdings, Inc."

Clinical • P2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bio-Path Holdings, Inc.; Initiation date: Jul 2020 ➔ Oct 2020

Trial initiation date • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Prostate Cancer • Sarcoma • Solid Tumor

Clinical Trial of BP1001 (Liposomal Grb2 Antisense Oligonucleotide) in Combination With Dasatinib in Patients With Ph + CML Who Have Failed TKI, Ph+ AML, Ph+ MDS (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: Bio-Path Holdings, Inc.; N=46 ➔ 0; Trial completion date: Dec 2021 ➔ May 2020; Recruiting ➔ Withdrawn; Trial primary completion date: Dec 2020 ➔ May 2020

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Acute Myelogenous Leukemia • Chronic Kidney Disease • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Clinical Trial of BP1001 (L-Grb-2 Antisense Oligonucleotide) in CML, AML, ALL & MDS (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: Bio-Path Holdings, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bio-Path Holdings, Inc.; Initiation date: Feb 2020 ➔ Jul 2020

Clinical • Trial initiation date • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Prostate Cancer • Solid Tumor

BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bio-Path Holdings, Inc.

Clinical • New P1 trial