olinvacimab (TTAC-0001) / PharmAbcine - LARVOL DELTA

A Phase lb/ll, Open Label, Single Arm Study With Olinvacimab and Capecitabine in mCRC Patients (OLCAP) (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Korean Cancer Study Group | N=90 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A multicenter, 3-arm, open-label, phase IIa clinical trial to evaluate the safety and efficacy of tanibirumab (VEGFR2 mAb), in patients with recurrent glioblastoma (GBM). (ASCO 2017) - P2; " Eligibility criteria included age ≥19 yrs at 1st or 2nd recurrence of GBM, measurable disease, KPS≥80, and no prior bevacizumab. Tanibirumab can be safely administered to patients with recurrent GBM, with CH being common. SD was seen in 2 patients up to 10+ months, with some indication that VEGFR2 expression may be a response biomarker."

Adverse events • Biomarker • Clinical • P2 data • Biosimilar • Cardiovascular • Oncology

Reassessing vascular endothelial growth factor (VEGF) in anti-angiogenic cancer therapy. (PubMed, Cancer Treat Res Commun) - "Today, anti-VEGF drugs such as Sunitinib, Sorafenib, Axitinib, Tanibirumab, and Ramucirumab have been approved for the treatment of advanced and metastatic cancers. The call for reassessment is based on two rationales: first, tumour blood vessels are abnormal, disorganized, and leaky; this not only prevents optimal drug delivery but it also promotes hypoxia and metastasis; secondly, tumour growth or regrowth might be blood vessel dependent and not angiogenesis dependent as tumour cells can acquire blood vessels via non-angiogenic mechanisms. Therefore, a critical assessment of VEGF, VEGFRs, and their inhibitors could glean newer options such as repurposing anti-VEGF drugs as vascular normalizing agents to enhance drug delivery of immune checkpoint inhibitors."

Journal • Review • Immune Modulation • Inflammation • Oncology

TTAC-0001 and Pembrolizumab Phase Ib Combination Trial in Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P1b | N=11 | Active, not recruiting | Sponsor: PharmAbcine | Trial completion date: Feb 2022 ➔ Oct 2022

Combination therapy • Trial completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab (clinicaltrials.gov) - P2 | N=19 | Terminated | Sponsor: PharmAbcine | N=36 ➔ 19 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2021 ➔ Jul 2022; Subject recruitment issues and follow-up study plans

Enrollment change • Trial primary completion date • Trial termination • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IDH1

PharmAbcine Inc. (BIO 2022) - "Our lead asset olinvacimab is a tumor angiogenesis inhibitor with a best-in-class potential, and is currently in three clinical studies. Our potentially first-in-class preclinical assets are being prepared for clinical studies in 2022: PMC-309 (anti-VISTA mAb) and PMC-403 (anti-TIE2 mAb)."

Oncology • Ophthalmology

PharmAbcine Announces Last Patient Last Visit in its Phase Ib mTNBC Combination Trial (PRNewswire) - "PharmAbcine...announced today the completion of last patient last visit in its Phase Ib combination trial for mTNBC (metastatic Triple-Negative Breast Cancer) patients in Australia. The clinical study, which had the first patient dosed in December 2018, evaluated the safety and clinical efficacy of olinvacimab, the Company's anti-VEGFR2 (Vascular Endothelial Growth Factor Receptors) antibody candidate, in combination with MSD's (Merck & Co., Inc., Kenilworth, NJ., USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). A total of 11 patients were recruited and divided into two cohorts."

Trial completion • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Olinvacimab With Pembrolizumab in Patients With mTNBC (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: PharmAbcine | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • ER • HER-2

PharmAbcine Announces First Patient Enrolled and Dosed in the Phase II Clinical Trial for the Treatment of mTNBC (PRNewswire) - "PharmAbcine Inc....announced it has dosed the first patient in its Phase II clinical trial evaluating the combination of olinvacimab, PharmAbcine's anti-VEGFR2 (Vascular Endothelial Growth Factor Receptors) antibody, and KEYTRUDA^® (pembrolizumab), MSD's anti-PD-1 molecule, for the treatment of mTNBC (metastatic Triple-Negative Breast Cancer) in Australia....The Phase II clinical trial is currently open and actively recruiting patients."

Trial status • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

[VIRTUAL] Phase Ib trial of olinvacimab and pembrolizumab in patients with metastatic triple-negative breast cancer (SABCS 2020) - "Combination therapy of O and P was well tolerated with evidence of efficacy in mTNBC pts who had all previously received anthracycline and taxanes, with 3 pts having previously received immunotherapy. These results support the combination entering into a phase 2 study."

Clinical • P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab (clinicaltrials.gov) - P2; N=36; Recruiting; Sponsor: PharmAbcine; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IDH1

PharmAbcine to Participate in ACCESS CHINA Biotech Forum (PRNewswire) - "PharmAbcine Inc...announced today that the Company will virtually participate in ACCESS CHINA Biotech Forum. The event will take place from September 23 – September 30, 2021...During the event, PharmAbcine's pre-recorded presentation video will be made available to Chinese pharmas or biotechs that are looking to enrich their pipeline through in-licensing deals. In the presentation video, the Company will introduce its core technology and update the R&D progress of the main pipelines such as olinvacimab, PMC-403, and PMC-309...PMC-309 is expected to enter a global clinical trial in 2022."

Clinical • New trial • Oncology

PharmAbcine Announces Joint Patent Application with MSD for the Treatment of Cancer (PRNewswire) - "PharmAbcine Inc...announced it submitted a Patent Cooperation Treaty (PCT) application for the combination therapy of olinvacimab, the Company's anti-VEGFR2 antibody, and KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 antibody, for the treatment of cancer...The application, which was submitted jointly with MSD, is based on the Phase Ib olinvacimab and pembrolizumab combo trial in metastatic Triple-Negative Breast Cancer (mTNBC)."

Patent • Breast Cancer • Oncology • Triple Negative Breast Cancer

PharmAbcine Receives HREC Clearance for Phase II Trial of Olinvacimab and Pembrolizumab in mTNBC (PRNewswire) - “PharmAbcine…announced today that the company has received Human Research Ethics Committee (HREC) clearance to commence the Phase II combination trial of olinvacimab, PharmAbcine's anti-VEGFR2 antibody, and KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 molecule, for the treatment of metastatic Triple-Negative Breast Cancer (mTNBC) in Australia…The study will evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after the administration of 16mg/kg of olinvacimab, and 200mg of pembrolizumab…‘We are excited to initiate this study and expect the first patient enrollment to take place in October 2021’.”

Trial status • Breast Cancer • Oncology • Triple Negative Breast Cancer

A Phase lb/ll, Open Label, Single Arm Study With Olinvacimab and Capecitabine in mCRC Patients (OLCAP) (clinicaltrials.gov) - P1/2; N=90; Not yet recruiting; Sponsor: Korean Cancer Study Group; Trial completion date: Dec 2023 ➔ Aug 2024; Initiation date: Mar 2021 ➔ Jan 2022; Trial primary completion date: Dec 2022 ➔ Oct 2023

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

PharmAbcine to Participate in H.C. Wainright 23rd Annual Global Investment Conference (PRNewswire) - "During the conference...CEO of PharmAbcine, will update PharmAbcine's R&D progress via a presentation video, highlighting the Company's core technology and pipelines such as olinvacimab, PMC-403, and PMC-309...The Company expects PMC-403 to enter global clinical trials for both ophthalmology and oncology in 2022...PMC-309 is expected to enter a global clinical trial in 2022."

Clinical • New trial • Oncology

PharmAbcine to Participate in Biotechgate Digital Partnering (PRNewswire) - "During the event, PharmAbcine's business development team will hold one-on-one virtual meetings with global pharmas, biotechs, and healthcare companies to discuss potential licensing deals or collaborations for the Company's main pipelines such as olinvacimab, PMC-403, and PMC-309."

Commercial • Oncology

Olinvacimab With Pembrolizumab in Patients With mTNBC (clinicaltrials.gov) - P2; N=36; Not yet recruiting; Sponsor: PharmAbcine

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • ER • HER-2

[VIRTUAL] PharmAbcine Inc. (BIO 2021) - "It is currently in three clinical trials: Phase 2a in rGBM patients who progressed on bevacizumab. Phase 1b combo trial with pembrolizumab in mTNBC patients. Olinvacimab received ODD to treat rGBM from Korean MFDS and US FDA."

Oncology • Triple Negative Breast Cancer

PharmAbcine to Present at the BIO Digital International Convention 2021 (PRNewswire) - “PharmAbcine Inc…announced today that the company will participate in BIO Digital International Convention. The company will participate in virtual one-on-one meetings with registered pharmaceutical companies to look for business and development partnerships. The event will be held virtually from June 10-11 and 14-18, 2021…The video will feature Dr. Jin-San Yoo, Chairman and Chief Executive Officer of PharmAbcine, delivering introduction on the company's core technology and pipelines. The company's pipeline introduction will include olinvacimab, PMC-403, and PMC-309…The company expects PMC-309 to enter a phase I clinical trial in 2022.”

Clinical • New P1 trial

PharmAbcine announces Clinical Trial Collaboration with MSD for the Phase II study in mTNBC (PRNewswire) - “PharmAbcine Inc…announced today that the company has entered into an agreement with MSD to initiate a Phase II combination trial of olinvacimab, an anti-VEGFR2 antibody, and KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, in metastatic Triple-Negative Breast Cancer(mTNBC)… Under the terms of the agreement, PharmAbcine will sponsor a phase II clinical trial that will take place in both Australia and South Korea, and MSD will supply KEYTRUDA…‘We will try our best so the multinational clinical study can begin in the first half of 2021.’”

Licensing / partnership • New P2 trial • Breast Cancer • Oncology • Triple Negative Breast Cancer

TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab (clinicaltrials.gov) - P2; N=36; Recruiting; Sponsor: PharmAbcine; Trial primary completion date: Jun 2020 ➔ Jun 2021

Clinical • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IDH1

TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab (clinicaltrials.gov) - P2; N=36; Recruiting; Sponsor: PharmAbcine; Not yet recruiting ➔ Recruiting; Trial completion date: Nov 2020 ➔ Dec 2021; Initiation date: May 2019 ➔ Nov 2019

Clinical • Enrollment open • Trial completion date • Trial initiation date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IDH1

TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab (clinicaltrials.gov) - P2; N=36; Not yet recruiting; Sponsor: PharmAbcine

Clinical • New P2 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IDH1

TTAC-0001 and Pembrolizumab Phase Ib Combination Trial in Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P1b; N=11; Active, not recruiting; Sponsor: PharmAbcine; Trial completion date: Apr 2020 ➔ Feb 2022

Clinical • Combination therapy • Trial completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR