User:Sookyoung/sandbox
 | |
| Company type | Public |
|---|---|
| KRX: 208340 | |
| Industry | Biotechnology |
| Founded | 2008 |
| Headquarters | , |
Key people | Jin-San Yoo, CEO Weon-Sub Lee, Head-Research & Founding Member Hyun-Seon Park, CBO/COO Chul-Bum Kim, CFO |
Number of employees | 57 (2021) |
| Website | www |
PharmAbcine is a clinical-stage biotech company focusing on development of next generation therapeutics to treat cancer, ophthalmologic diseases, and other medically unmet diseases. The company's mission is to develop a first-in class and best-in-class therapeutics for cancer and vascular-related diseases that improve patients’ lives.
History
[edit]In 2008, PharmAbcine was founded in Daejeon, South Korea as a spin-off of Korea Research Institute of Bioscience and Biotechnology (KRIBB). Two of the founding members, Dr. Jin-San Yoo, CEO, and Dr. Weon sup Lee, head of R&D center, are still with the company as Chief Executive Officer (CEO) and Head of Research & Development (R&D), respectively. The Company went public in 2018 and the shares are traded on KOSDAQ.
Some of the key events are listed as follows:
In 2009, the company received $6 million USD in a Series A financing from OrbiMed's Caduceus Asia Partners and Novartis Korea Venture Fund.[1]
In 2011, Olinvacimab (TTAC-0001, formerly known as tanibirumab) phase ⅠIND approved
In 2016, Olinvacimab (TTAC-0001, formerly known as tanibirumab) phase Ⅱa clinical trial[2]
In 2018, Clinical Research Collaboration for Combo Trials with MSD(Merck & Co.)
In 2018, the company went public on the KOSDAQ.
Research and development
[edit]PharmAbcine is advancing its lead antibody candidate olinvacimab through the clinic, alone and in combination, whilst developing a portfolio of clinical candidates that target key molecules implicated in oncology, angiogenesis and immune surveillance. Besides olinvacimab, developing other preclinical candidates, such as Anti-VISTA(V-type immunoglobulin domain-containing suppressor of T cell activation), TIE2(acts as an active vessel stabilizer)-activating monoclonal antibody.
Olinvacimab (TTAC-0001)
[edit]Olinvacimab(formerly Tanibirumab) is an anti-angiogenic antibody that neutralizes the pathway between VEGF and VEGFR2, suppresses the formation of tumor angiogenesis, and inhibits tumor growth and metastasis.[3],[4]
Preclinical research revealed potential anti-tumor activity of TTAC-0001 in colorectal, non-small-cell lung, triple-negative breast cancer and glioblastoma tumor models.[5] and further studies demonstrated that it could positively synergize with other chemotherapy agents (CPT-11 or 5-FU) to inhibit tumor growth.[6]
It has multiple ongoing global clinical trials. TTAC-0001 has no drug limiting toxicity (DLT) up to 24 mg/kg, based on the fact that it was tolerable up to 24 mg/kg per week in a phase-I clinical study.[7],[8] Common adverse events such as internal bleeding, hypertensive crises, and gastrointestinal perforation were not observed, which normally occur with anti-angiogenic drugs including Avastin.[9] [10] TTAC-0001 has displayed a shorter half-life in vivo (1.5–3.0 days) and less severe toxicity compared to Bevacizumab(Avastin).[11]
There are two Phase Ib studies taking place in combination with MSD’s pembrolizumab for the treatment of mTNBC (metastatic Triple Negative Breast Cancer) and rGBM (recurrent Glioblastoma) in Australia. Also, a Phase II mono study in bevacizumab non-responding rGBM was approved by FDA in October 2018 and is ongoing in both Australia and the U.S. In September 2021, PharmAbcine received a clearance to initiate a Phase II olinvacimab-pembrolizumab combo trial for mTNBC patients in Australia.[12]
PMC-403
[edit]PMC-403 is a novel TIE2-activating fully human antibody designed to stabilize and repair damaged blood vessels in a variety of diseases. PMC-403 is currently in development for treating AMD(Age-related Macular Degeneration), DME(Diabetic Macular Edema), and DR(Diabetic Retinopathy) which are common abnormal vascular-related eye diseases.[13]
In August 2020, the company signed MCRADA (Materials Cooperative Research and Development Agreement) with the NIAID (National Institute of Allergy and Infectious Diseases), a part of the NIH (National Institutes of Health), to assess the efficacy of PMC-403 in SCLS(Systemic Capillary Leak Syndrome, Clarkson Disease)[14]
In September 2020, PharmAbcine entered into a strategic partnership with Samsung Biologics for the development and manufacturing of PMC-403 pipeline. Samsung will provide the full scope of its CDMO services from cell line development, process development, cGMP clinical manufacturing to IND filing support.[15]
PMC-309
[edit]PMC-309, one of the company's first immunooncology drug candidates, is a monoclonal antibody that targets human VISTA (V-domain Ig Suppressor of T cell Activation) found overexpressed on immunosuppressive MDSC (Myeloid-Derived Suppressor Cells). VISTA blockade could enhance antitumor immunity in TME(tumor microenvironment). PMC-309 binding to VISTA expressing cells is highly selective and the selectivity is maintained even in the low pH conditions that mimic TME.
In in vivo study, PMC-309 suppressed tumor growth, which was further attenuated with an anti-PD1 antibody. PMC-309 as a next generation immuno-oncology(IO) agent, which can convert immunologically cold into hot tumors as a mono- or combo- therapy with other IO agent.[16]
In June 2020, PharmAbcine entered into a strategic partnership with Thermo Fisher Scientific for the development and manufacturing of PMC-309.[17]
PMC-402
[edit]PMC-402 is active vessels stabilizer targeting Tie2, having an effect of vessel stabilization in a ligand independent way. It inhibited VEGF-induced vascular leakage through decrease of p-VEGFR and VE-cadherin. This active vessel stabilizer could help deliver drug and lymphocyte into the TME. The therapeutic efficacy of immune checkpoint inhibitors can be increased when it combined with this active vessel stabilizer. Thus, this active vessel stabilizer can change cold tumor into hot tumor.[18]
In April 2020, PharmAbcine entered into a partnership with Samsung Biologics the development and manufacturing of PMC-402.[19]
US Subsidiary
[edit]PharmAbcine set up Wincal Biopharm, a U.S subsidiary in South San Franciso, California, and entered into a license agreement in June 2020. Through this agreement, Wincal Biopharm will use PharmAbcine’s assets to develop novel therapeutic drugs for non-oncology indications in nephrology, ophthalmology, and pulmonology, etc.
External links
[edit]· Business data for PharmAbcine: Google Finance Yahoo! Finance
Reference
[edit]- ^ "VentureFund Report 2010" (PDF). Novartis Venture Funds.
- ^ "Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma". clinicaltrials.
- ^ Dong Geon, Kim; Do-Hyun, Nam (2015). "Anticancer activity of TTAC-0001, a fully human anti-vascular endothelial growth factor receptor 2 (VEGFR-2/KDR) monoclonal antibody, is associated with inhibition of tumor angiogenesis". MAbs. 7 (6): 1195–1204. doi:10.1080/19420862.2015.1086854. PMID 26325365.
- ^ M, Tampellini; G V, Scagliotti (2016). "Novel anti-angiogenic therapeutic strategies in colorectal cancer". Expert Opinion on Investigational Drugs. 25 (5): 507–520. doi:10.1517/13543784.2016.1161754. PMID 26938715.
- ^ Jinil, Kim; Yoonseok, Choi (2018). "Evaluation of drug mechanism and efficacy of a novel anti-angiogenic agent, TTAC-0001, using multi-modality bioimaging in a mouse breast cancer orthotopic model". PLoS ONE. 13 (1): e0187063. doi:10.1371/journal.pone.0187063. PMID 29370209.
{{cite journal}}: CS1 maint: unflagged free DOI (link) - ^ SH, Lee (2011). "Tanibirumab (TTAC-0001): a fully human monoclonal antibody targets vascular endothelial growth factor receptor 2 (VEGFR-2)". Arch Pharm Res. 34 (8): 1223–1226. doi:10.1007/s12272-011-0821-9. PMID 21910042.
- ^ Su Jin, Lee; Young Suk, Park (2017). "Phase I trial and pharmacokinetic study of tanibirumab, a fully human monoclonal antibody to vascular endothelial growth factor receptor 2, in patients with refractory solid tumors". Invest New Drugs. 35 (6): 782–790. doi:10.1007/s10637-017-0463-y. PMID 28391576.
- ^ WS, Lee; SK, Cho (2018). "Preclinical pharmacokinetics, interspecies scaling, and pharmacokinetics of a Phase I clinical trial of TTAC-0001, a fully human monoclonal antibody against vascular endothelial growth factor 2". Drug Des Devel Ther. 12: 495–504. doi:10.2147/DDDT.S150241. PMID 29563774.
{{cite journal}}: CS1 maint: unflagged free DOI (link) - ^ F, Elice; F, Rodeghiero (2012). "Side effects of anti-angiogenic drugs". Thromb Res. 129 (Suppl 1): S50-3. doi:10.1016/S0049-3848(12)70016-6. PMID 22682133.
- ^ Weon Sup, Lee; Jin-San, Yoo (2015). "TTAC-0001, a human monoclonal antibody targeting VEGFR-2/KDR, blocks tumor angiogenesis". MAbs. 7 (5): 957–68. doi:10.1080/19420862.2015.1045168. PMID 25942475.
- ^ Soyoung, Cha; Kyoung‑Seok, Ryu (2020). "NMR mapping of the highly flexible regions of 13C/15N‑labeled antibody TTAC‑0001‑Fab". Journal of Biomolecular NMR. 74 (6–7): 311–319. doi:10.1007/s10858-020-00313-1. PMID 32415582.
- ^ "PHARMABCINE COLLABORATES WITH MSD ON CLINICAL EVAL."Worldwide Biotech. Feb2018, Vol. 30 Issue 2, p6-N.PAG. 3p.
- ^ "PharmAbcine to Participate in BIO-Europe 2021 (Press release)". AP NEWS. September 20, 2021.
- ^ "PharmAbcine announces the execution of a Material Cooperative Research and Development Agreement (MCRADA) with the NIH to evaluate the efficacy of PMC-403 to treat SCLS". Press release. bloomberg. August 18, 2020. Retrieved 20 October 2021.
- ^ "PharmAbcine Expands Partnership with Samsung Biologics for PMC-403". Press release. biospace. Sep 21, 2020. Retrieved 20 October 2021.
- ^ Cheon Ho, Park; Weon Sup, Lee (2021). "PMC309, a highly selective anti-VISTA antibody enhances T cell activation through blocking the interaction of T cells and myeloid derived suppressor cells (MDSC)". Cancer Res. 81 (13 Sup): 1626. doi:10.1158/1538-7445.AM2021-1626.
- ^ "PharmAbcine execute an agreement with Thermo Fisher for the development and manufacturing of its next-generation immune checkpoint blockade, PMC-309 for Phase I". Press release. AP NEWS. June 11, 2020. Retrieved 20 October 2021.
- ^ Eun-Ah, Lee; Joo Hyoung, Lee (2020). "A novel anti-Tie2 antibody stabilizes vessel and increases tumor infiltrated lymphocytes". Cancer Res. 80 (16 Supp): 1483. doi:10.1158/1538-7445.AM2020-1483.
- ^ Jeong-yeo, Lim (April 6, 2020). "Samsung Biologics strikes deal with PharmAbcine". koreaherald. Retrieved 20 October 2021.