09 Mar 3 Biotech Stocks in Focus Now!
Biotech Companies continue to show resurgence even in these challenging times, with more and more companies persevering with bringing their clinical candidates to fruition. While Vaccine development and therapeutics to combat the COVID-19 pandemic are at the forefront of development activities in the biotech sector, there are some companies that are making strides in oncology and other related fields that have a large unmet need for innovative therapeutics. A big pharma acquisition, an impending drug launch and a Biotech with a novel technology are our biotech picks. Here’s Why!
Market Cap: $97.01M; Current Share Price: 4.54 USD
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The Company is leveraging its proprietary NK cell engager (TriKE™) technology to develop immuno-oncology-based therapeutics for the treatment of cancers such as acute lymphocytic leukemia, non-Hodgkin’s lymphoma, acute myeloid leukemia and multiple solid tumors. Tri-specific NK cell Engagers (TriKEs) and Dual Targeting NK cell Engagers are capable of targeting natural killer or NK cells and tumor cells by forming an immune synapse that causes NK cell activation and results in mediating ADCC through the highly potent CD16 activating receptor.
GT Biopharma firmly believes that its novel technology can overcome the limitations of CAR-T therapy and other antibody therapies. Since TriKEs and TetraKEs are small single-chain fusion proteins that can bind with the CD16 receptor of NK cells directly, they have demonstrated increased potency and lasting response in preclinical studies. In addition, they have several advantages such as a greater biodistribution, non-immunogenicity, rapid clearance and can be quickly engineered, thereby making them a highly suitable platform for NK Cell-based immunotherapies.
The Company’s pipeline consists of GTB-3550, intended for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies; GTB-4550 for the treatment of PD-L1+ solid tumor cancers and GTB-5550 that is being developed for the treatment of B7H3+ solid tumor cancers. GTB-3550 is currently being evaluated in a Phase I/II clinical trial and its IND will primarily focus on acute myelogenous leukemia, or AML.
In December 2020, the Company entered into an agreement with Cytovance, a USA based CDMO for granting exclusive GMP manufacture for three of the Company’s TriKE™ therapeutic product candidates. The Company will be using Cytovance’s proprietary Keystone® bacterial or mammalian expression systems to manufacture TriKE™ and will make certain milestone-based payments with an option to pay up to $6 million for the license in cash or in the form of company stock.
Interim results from the GTB-3550 suggest that the therapy demonstrated preferential proliferation of NK cells, with no toxicity even at 10x doses and had significantly less effect on CD8+ T-cells. The Company intends to extend the pipeline to include GI and breast cancers and has filed US and international patent applications in the areas of HER2+, HER3+, and HER2+/HER3+ heterodimer complex breast and gastrointestinal cancers, thereby expanding the scope of its platform and broadening its addressable market.
Market Cap: $1.74B; Current Share Price: 37.76 USD
Data by YCharts
Five Prime Therapeutics is making waves, after the news of its acquisition by Amgen (NASDAQ: AMGN), in exchange for $38.00 per share in cash or approximately $1.9 billion in total equity value, became public. The Company will make a valuable addition to Amgen’s oncology pipeline and the acquisition is expected to be completed by the end of Q2,2021, subject to customary closing conditions.
The Company’s lead drug candidate Bemarituzumab, is a first-in-class, fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) antibody that can block tumor growth by binding specifically to FGFR2b and inhibiting tumor growth. It is capable of engineering antibody-dependent cell-mediated cytotoxicity through natural killer cells. The candidate is being evaluated for efficacy and safety in Gastric cancer and is currently undergoing phase 3 trials. Five prime announced Top-Line data from phase 2 gastric/gastroesophageal cancer study namely FIGHT, which demonstrated improvement in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR).
Furthermore, the pipeline also consists of FPT155, a soluble CD80 fusion protein that can stimulate anti-tumor immunity and co-stimulate potent anti-tumor activity and is being clinically evaluated for the treatment of Solid Tumors. The candidate is undergoing Phase 1a/1b clinical trials as a monotherapy as well as in combination with pembrolizumab in Australia and South Korea. FPA157, an anti- CCR8 antibody, is being developed as an immunomodulator that can remove Treg-mediated immune suppression in solid tumors and the Company intends to submit an IND application in H1,2022.
Five Prime has entered into a collaboration with Zai Lab, to develop and commercialize Bemarituzumab in China, Hong Kong, Macau, and Taiwan. The Company is also collaborating with Seagen to develop a novel antibody drug conjugate (ADC) program for an undisclosed target with a potential for up to $295M in milestones and mid-single digit loyalties. Five Prime has partnered with Bristol Myers Squibb (NYSE: BMY) for 3 antibody programs with potential for up to $300M in milestones per program with mid-single to low double-digit royalties. The programs are a result of its discovery collaboration with BMS and consist of a TIM-3 antibody in Phase 1/2.
Market Cap: $227.59M; Current Share Price: 7.90 USD
Data by YCharts
Tivozanib, the Company’s lead candidate is an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), intended for the treatment of renal cell carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers. The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for the tivozanib as a treatment for relapsed or refractory RCC in June 2020, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2021. The drug has already been approved by the European Commission for treatment of adult patients with advanced RCC in the E.U along with Norway, New Zealand and Iceland.
As the Prescription Drug User Fee Act (PDUFA) of March 31 is approaching, the Company has already set-in place the commercial infrastructure the U.S launch of tivozanib and is positive about addressing the challenges posed by third- and fourth-line of treatment, that witness high patient dropouts, by providing them with a more effective and better tolerated treatment option.
The Company’s pipeline consists of ficlatuzumab (HGF MAb) being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and metastatic pancreatic ductal cancer (PDAC). AV-203 (CAN017), an ErbB3 (HER3) inhibitory antibody candidate intended for the treatment of advanced solid tumors has completed a Phase 1, open-label, dose-escalation study. The Company has entered into a collaboration and licensing agreement with CANbridge Life Sciences for worldwide rights to AV-203, excluding the United States, Canada, and Mexico.
The Company is also evaluating AV-380, a first-in-class, potent, humanized inhibitory IgG1 antibody for treatment of cachexia and AV-353, a potent, selective, high affinity inhibitory antibody for treatment of cancer, cardiovascular diseases and neurodegenerative conditions.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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