05 Oct 4 Biotech Stocks That Warrant Your Attention!
Clinical-Stage companies offer an exciting investment opportunity with massive upside potential. Most of these companies bring new and highly differentiated approaches, advanced scientific knowledge and a zeal for innovation to the table.
Our biotech picks this week are making strides in fields such as immune-oncology, hematologic disorders and dermatology and rare immune diseases. Some of these companies have entered into strategic collaborations with some major pharmaceutical companies and have upcoming catalysts in the form of data readouts, initiation of clinical trials and IND submission to look forward to.
However, a word of caution is in order as clinical trials are fraught with risk and uncertainty. Even the slightest setback can prove detrimental to the existence of these companies. Failure to meet clinical endpoints, lack of funding or rejection from regulatory authorities are risks that these companies have to bear in pursuit of excellence.
We take a look at some of them below:
Molecular Templates, Inc. (NASDAQ: MTEM)
Market Cap: $370.54M; Current Share Price: 6.28 USD
Data by YCharts
The Company is developing the next generation of immunotoxins called engineered toxin bodies (ETBs) that are targeted and have a differentiated mechanism of action. These ETB’s offer numerous advantages such as force internalization of non-internalized target receptors, are capable of delivering payloads that include antigen seeding technology and have a de-humanized toxin scaffold.
Image Source: Company
The pipeline of the Company consists of MT-5111 targeting Multiple – solid tumors (HER2), TAK-169, intended for the treatment of Multiple Myeloma (CD38) and MT-6402 (PD-L1) being evaluated for the for the treatment of multiple solid tumors, which has completed preclinical evaluation and is in preparation for phase 1 clinical trial. The Company is also conducting preclinical studies for CTLA-4 for treatment of Multiple – solid tumors (CTLA-4) and SLAMF-7 targeting Multiple Myeloma (SLAMF-7) and CD45.
Molecular Templates has entered into multiple strategic partnerships and collaboration with industry leaders such as Bristol Myers Squibb, Takeda and Vertex Pharmaceuticals. These partnerships extend to multiple targets in oncology in case of BMS and Takeda and myeloablation with Vertex. In February 2021, the Company received an upfront payment of $70 million from BMS, and is eligible to receive up to $1.3 billion in development, regulatory, and sales milestone payments.
Meanwhile, in April 2021, the Company announced that it was resuming full rights of TAK-169 from Takeda after the company decided to “reprioritize its pipeline.” Furthermore, MT-3724., an experimental ETB, which was put on hold by the FDA in March 2021, after a treatment-related patient death. The Company will move forward with the development of TAK-169, after the completion of rights transition, which is expected to be completed within 90 days.
The Company has upcoming catalysts in the fourth quarter of 2021 in the form of interim dose experience data from MT-5111 (HER2), interim dose escalation data from TAK-169 (CD38), Potential interim dose escalation data from MT-6402 (PD-L1 + AST) and Preclinical data presentations and potential IND filing for CTLA-4 ETB.
Sutro Biopharma, Inc. (NASDAQ: STRO)
Market Cap: $891.57M; Current Share Price: 19.21 USD
Data by YCharts
Sutro is leveraging a proprietary cell-free protein synthesis platform XpressCF® and site-specific conjugation platform XpressCF+™ to develop a pipeline of next-generation oncology therapeutics. The Company’s STRO-002, a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC,) intended for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior lines of systemic therapy, was recently granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
The candidate is currently being evaluated in a Phase 1 trial namely STRO-001-GM1 to study its efficacy, safety and tolerability. The study is being conducted in sites in the U.S and Spain.
The Company’s pipeline consists of STRO-001, a CD74-targeting ADC intended for the treatment of multiple myeloma, which has been granted an Orphan Drug Designation by the FDA and is currently undergoing a Phase 1 clinical trial in advanced B-cell malignancies. In addition, the Company is also developing CC-99712, a BCMA-targeting ADC, in collaboration with Bristol Myers Squibb, which has been granted an orphan drug designation by the FDA and is currently enrolling patients in a phase 1 clinical trial in multiple myeloma.
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The Company has entered into a collaboration with EMD Serono (Merck KGaA) and is developing M1231, a MUC1-EGFR, intended for the treatment of metastatic solid tumors, non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma. BMS and EMD Serono have worldwide development and commercialization rights for the candidates, while the Company is eligible to receive milestone or contingent payments and tiered royalties.
Most recently, the Company announced that the research term for its first cytokine derivative program under a 2018 agreement with Merck, has been extended for another two years.
Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX)
Market Cap: $925.38M; Current Share Price: 19.03 USD
Data by YCharts
In September 2021, the Company announced a collaboration and licensing agreement deal with Incyte Corp, for a monoclonal antibody program involving axatilimab, an anti-CSF-1R monoclonal antibody, which is currently being evaluated in a phase 2 AGAVE -201 clinical trial for the treatment of chronic graft-versus-host disease. Axatilimab has been awarded an Orphan drug designation by the U.S FDA and is being developed under a 2016 exclusive worldwide licensing agreement between Syndax and UCB. The companies intend to initiate additional patient trials in 2022, including testing the drug in combination with a JAK inhibitor. The deal involves a payment of $117 million in upfront payment and a $35 million equity investment by Incyte, in addition to up to $450 million in potential milestone payments.
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Syndax’s pipeline also consists of SNDX-5613, intended for the treatment of patients with MLLr and NPM1 acute leukemias and entinostat, a class I HDAC inhibitor. SNDX-5613 is an orally available Menin-MLL1 inhibitor, which is currently enrolling patients in a phase 1 / 2 clinical trial named AUGMENT-101. The candidate has demonstrated positive results such as significant activity as a single agent, and good tolerance, along with promising anti-leukemic activity. The Company plans to submit an NDA in 2023.
The Company intends to extend its developmental pipeline by pursuing in-licensing opportunities and has a proven track-record of business development and building strategic relationships.
Krystal Biotech, Inc. (NASDAQ: KRYS)
Market Cap: $1.2B; Current Share Price: 54.03 USD
Data by YCharts
Krystal is leveraging its proprietary Skin TARgeted Delivery (STAR-D) platform to create novel topical and intradermal “off-the-shelf” therapies for dermatological indications with large unmet needs. The Company is developing a viral gene therapy platform by using the properties of type 1 herpes simplex virus (HSV-1), and creating a non-invasive therapeutic option for treating skin conditions.
The Company’s initial focus is on addressing orphan and rare diseases including monogenic and congenital skin diseases such as epidermolysis bullosa (DEB) and autosomal recessive congenital ichthyosis (ARCI). Krystal’s lead product candidate is Beremagene geperpavec (B-VEC), which has the potential to deliver wild-type human type VII collagen genes for molecular correction of a patient’s fragile skin in dystrophic epidermolysis bullosa (DEB). The candidate is currently being evaluated in a phase III clinical trial. The Company is expected to announce the topline results from the Phase 3 trial in the fourth quarter of 2021.
Image Source: Company
Krystal is also developing KB105 for the treatment of autosomal recessive congenital ichthyosis (ARCI), which is a part of an ongoing phase I/II clinical trial. The Company has built a 4,500 square foot state-of-the-art Good Manufacturing Practice (GMP) facility, near its headquarters in Pittsburgh, for meeting the manufacturing requirements of B-VEC. In addition, the Company is also building a commercial gene therapy facility, named ASTRA, that seeks to integrate all components of the supply chain and act as a commercial back-up facility for B-VEC.
The Company’s pipeline also consists of KB-301, a type III collagen that is currently being evaluated in a Phase 1 / 2 and the results from a Phase 1 efficacy are expected to be announced in the second half of 2021. Krystal also has multiple candidates under preclinical evaluation that target chronic skin conditions, Cystic Fibrosis, Netherton Syndrome and other Aesthetic Skin Conditions.
Most recently, the Company received an approval from the Human Research Ethics Committee in Australia for initiating a phase 1 trial of KB407 in Cystic Fibrosis.
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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References
https://www.sutrobio.com/pipeline/
https://delawarebusinesstimes.com/news/incyte-syndax-collab/
https://ir.syndax.com/static-files/ec1ddcca-2728-4880-ae53-9900a088c844
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