11 Jan 5 Biotech Stocks To Watch Out for in 2021
While Industries across the globe are grappling with the pandemic and its impact on their operations, Biotech Industry has been focused on minimizing the impact and marching ahead with its innovations and breakthroughs.
We take a look at some Biotech’s that are impervious to the scare and offer a very attractive upside in the long run. These companies not only have an excellent potential for growth and returns but have major upcoming catalysts such as positive data from clinical trials, impending approvals to commercial launches lined up for 2021.
Market Cap: $1.36B; Current Share Price: 6.98 USD
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ImmunoGen is a leader in the antibody drug conjugates (ADC) field and is developing cutting-edge therapeutics for cancer. The Company is one of the only few to create CD37-targeting antibodies and has expertise in development of tumor-targeting antibodies, which it intends to leverage to target therapeutics indications such as Ovarian Cancer, Acute Myeloid Leukemia and Blastic plasmacytoid dendritic cell neoplasm (BPDCN).
The Company’s lead program, mirvetuximab soravtansine is a first-in-class ADC in Phase 3 development for platinum-resistant ovarian cancer. In addition, its pipeline consists of IMGN 632(monotherapy in BFDCN), which has received a Breakthrough Therapy designation from the FDA, IMGC936 (NSCLC, Gastric, Pancreatic, TNBC and other Solid Tumors) and IMGN151 (Ovarian, Endometrial, NSCLC and TNBC).
Furthermore, ImmunoGen has strategic cross-licensing agreement with CytomX Therapeutics (NASDAQ: CMTX) for ProbodyTM drug conjugate (PDC) therapies and a co-development and co-promotion collaboration with MacroGenics to develop a first-in-class ADAM9-targeting ADC. The Company is currently engaged in two clinical trials namely SORAYA, which is currently enrolling patients in the U.S and E.U and MIRASOL, which is enrolling patient globally.
The data from the SORAYA clinical trial is expected to be announced in Q3 2021, with potential filing of a BLA in H2 2021. MIRASOL’s topline data is expected to be released in n H1 2022, with a potential approval in 2023.
Market Cap: $319.91M; Current Share Price: 13.44 USD
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Alpine Immune Sciences forte is creating protein-based multispecific immunotherapies for treatment of cancer, autoimmune/inflammatory disorders. The company’s lead candidate ALPN-101 is a first-in-class dual inhibitor of the CD28 and ICOS T cell costimulatory pathways that aims to treat severe inflammatory diseases. Alpine believes that the candidate has the potential to improve healthcare outcomes in patients suffering from severe autoimmune/inflammatory disease.
The Company has signed an exclusive worldwide option and license agreement with AbbVie (NASDAQ: ABBV) in June 2020, to conduct a phase 2 study in systemic lupus erythematosus, where AbbVie will take over future clinical development, manufacturing and commercialization activities. Alpine will receive $60 million in upfront payment, in addition to being eligible to receive up to $805 million on achievement of certain development, regulatory and commercial milestones.
Furthermore its pipeline consists of ALPN-202 (Oncology) and ALPN-303(autoimmune/inflammatory diseases). The Company has a collaboration and licensing agreement with Adaptimmune Therapeutics (NASDAQ: ADAP) that leverages its secreted and transmembrane immunomodulatory protein (termed SIP™ and TIP™) technology to develop next-generation SPEAR™ T-cell products. Alpine will receive potential development and commercialization milestones of up to $288 million and additional low-single digit royalties on worldwide net sales.
These collaborations have not only led to the stock skyrocketing to nearly 205.2 percent over the last 12 months, but also bought in enough cash to fund its clinical pipeline through 2024.
Market Cap: $280.15M; Current Share Price: 5.72 USD
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Xeris Pharmaceuticals leverages its proprietary XeriSol and XeriJect formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drugs. The technology overcomes the limitations offered by aqueous formulations such as low stability and poor solubility. The Company’s non-aqueous injectable solutions or suspensions do not require reconstitution or refrigeration and can be administered through smaller volumes through subcutaneous (SC) or intramuscular (IM) administration.
The technology can be applied to peptides, small molecules, proteins, monoclonal antibodies, and vaccines. The Company’s lead candidate Gvoke Hypopen is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 2 years and above. In addition, the company has candidates under development for the treatment of severe hypoglycemia, post-bariatric hypoglycemia, Acute Repetitive Seizures (ARS) and T1D/T2D Blood Sugar Control.
The company has a robust intellectual property portfolio with 112 patents approved 92 patents pending worldwide. Xeris’s primary focus is on expanding its ready-to-use glucagon portfolio through developing additional Glucagon Rescue Products and pursuing out-licensing opportunities for its proprietary technology. The Company believes that the glucagon market is under-penetrated with innovation products constituting over 40 percent of the glucagon market. It wants to actively collaborate with drug development companies, both large and small, to formulate their drugs using its platform in exchange for milestone payments and royalty stream.
Xeris has recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Ogluo™ (glucagon), the EU trade name for Xeris’ RTU glucagon for injection. The Company is expecting a decision on the Marketing Authorization Application for Ogluo in the Q1, 2021, and intends to launch Ogluo in H2, 2021 in certain European Countries.
Market Cap: $446.73M; Current Share Price: 9.03 USD
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Gamida is a clinical-stage biotechnology company that develops advanced cell therapies for the treatment of blood cancers and rare, serious hematologic diseases. Its lead candidate Omidubicel, is based on its proprietary nicotinamide-based or NAM-based, cell expansion technology, and is intended for allogeneic hematopoietic stem cell transplant in patients with high-risk blood cancers and bone marrow failure disorders.
The Company announced positive topline results from a phase 3 study evaluating the safety and efficacy of omidubicel, the candidate achieved its primary and secondary endpoint and demonstrated shorter median time to neutrophil engraftment than the comparator group. In December 2020, the Company conducted a Type B Meeting with the FDA and received a positive feedback, however Gamida has been asked to generate additional manufacturing-related before the submission of its Biologics License Application (BLA). The Company has already undertaken Commercial manufacturing readiness activities to meet with the FDA requirements and intends to submit its BLA in H2, 2021 and is eyeing a commercial launch in the U.S in mid-2022.
Omidubicel has been granted a Breakthrough Therapy Designation, making it the first bone marrow transplant product to receive the status from the FDA, in addition to receiving an Orphan Drug Designation in the U.S. and EU.
In addition the Company is also developing GDA-201, aimed at using the body’s natural killer cells (NK) to treat refractory non-Hodgkin lymphoma or multiple myeloma. Its proprietary NAM-based cell expansion technology harnesses the properties of nicotinamide that has demonstrated the ability to preserve gene expression, and regulate cellular metabolism, while withstanding pressure during cell expansion. The Company intends to submit an IND for the candidate in 2021.
The Company is backed by Novartis, which owns 15 percent stake in Gamida and is its second-largest shareholder, and had previously decided not to exercise the option to buy the company for $165 million. However the potential approval of omidubicel, could prove to be a game-changer for the Company.
Market Cap: $118.49M; Current Share Price: 1.41 USD
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Corbus is engaged in creating innovative therapies for the treatment of Inflammatory and Fibrotic diseases by harnessing the potential of the endocannabinoid system. This clinical stage company is developing Lenabasum as its lead candidate for the treatment of Systemic Lupus Erythematosus, which is currently undergoing Phase III trials.
Lenabasum is a synthetic small molecule selective cannabinoid receptor type 2 (CB2) agonist that targets chronic inflammation and fibrotic processes. It has shown to promote the production of Specialized Pro-resolving lipid Mediators (“SPMs”) that activate the endogenous pathways which help treat inflammation and achieve bacterial clearance without the need for immunosuppression. It can also limit fibrogenic growth factors that can prevent tissue fibrosis (scarring).
RESOLVE-1, its phase 3 clinical trials in Systemic Sclerosis could not meet its primary endpoint; however the Company is analyzing the data to improve the design of its next phase 3 study. DETERMINE, its ongoingphase3 study in DERMATOMYOSITIS has completed subject enrolment and is expected to announce topline results in Q2,2021. The Company is also engaged in phase 2 studies of systemic lupus erythematosus that is being funded and run by National Institutes of Health.
It has built a preclinical library of an impressive 600 compounds, which it intends to translate into at least 2 phase I programs each year. Its proprietary technology is safe guarded by a robust Intellectual Property Rights (IPR) portfolio including 4 U.S patents covering composition of matter and broad use in inflammatory and fibrotic diseases that offer it protection through 2034.
In September 2018, the company entered into a licensing agreement with Jenrin Discovery, LLC for gaining the exclusive worldwide rights to more than 600 novel compounds targeting the endocannabinoid system. It has also entered into collaboration with Kaken Pharmaceutical Co. (OTCPINK: KKPCF), for the development and commercialization of Lenabasum in the Japanese market, in consideration for a $27 million upfront payment and over $173 million in milestone payments and double-digit royalties.
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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