10 May Is Brooklyn ImmunoTherapeutics the Next GameStop in the making?
Brooklyn ImmunoTherapeutics, Inc. (NYSE: BTX) has been having a fantastic run at the stock market this year, with its shares rising by almost 1800 percent since the stock began trading in March 2021. The stock has caught the attention of reddit traders as a low float high short interest short squeeze candidate.
GameStop (NYSE: GME), a stock that was struggling after hitting historic lows of under $4 per unit since the past two years, has witnessed an almost miraculous resurgence, aided by the users of a Reddit forum named “r/WallStreetBets”. The stock went on a roller coaster ride and has given rise to a new phenomenon namely Meme Stocks. However, Meme stocks are raising concerns about issues such as the stock bubble, overzealous trading, investor protection and market manipulation.
These stocks do not necessarily have a fundamental reason underlying their popularity, besides the buzz generated on social media platforms, which is why they are risky and unpredictable.
In the case of Brooklyn, the Company was formed through a reverse merger with NTN Buzztime in March 2021, which holds approximately 96.25% of the outstanding common stock of Brooklyn and the stockholders of NTN Buzztime prior to the merger own the remaining 3.75% of Brooklyn’s outstanding common stock. Brooklyn is a clinical stage company and has one candidate in a phase 2b trial is IRX-2, which is currently being evaluated in head and neck cancer.
In April 2021, the Company acquired an exclusive license for mRNA gene editing and cell therapies technology from Factor Bioscience Limited and Novellus Therapeutics Limited, which it believes will make it a key player in the gene editing landscape.
Howard J. Federoff, M.D., Ph.D., Chief Executive Officer and President of Brooklyn commented,
“Our licensing of this technology represents a significant advancement in our approach to treating cancers, blood and other disorders, and transforms us from a single therapeutic company with multiple potential indications to a platform company with multiple products in a pipeline of next-generation engineered cellular medicines.”
The Company intends to pursue clinical development of programs in sickle cell anemia, inherited monogenic disorders and solid and liquid tumors, with an eye on filing an Investigational New Drug (IND) application for at least one indication by 2024.
Brooklyn ImmunoTherapeutics, Inc. (NYSE: BTX)
Market Cap: $ 1.60B; Current Share Price: 38.45 USD
Data by YCharts
Brooklyn ImmunoTherapeutics acquired its IRX-2 through IRX Therapeutics, Inc in November 2018.
Industry
Squamous cell carcinoma or cancer of the head and neck originates in the squamous cells, which are primarily found in the surface of the skin, eye and other internal organs to name a few. The cancer effects the mucosal surfaces of the head and neck such as the nasal cavity, sinuses, throat, mouth and larynx. Alcohol consumption, smoking, diabetes, radiation exposure and genetic predisposition are some of the risk factors for the disease, with human papilloma virus (HPV) emerging as a major cause of the disease in the last 10 years. This form of cancer accounts for nearly 90 percent of all head and neck cancers.
The disease manifests in the form of chronic sore throat, difficulty in swallowing, change in voice, lump formation in the throat or neck among others. SCCHND is often detected through a biopsy, blood tests, nasopharyngolaryngoscopy and imaging tests such as CT scan or MRI. The improvement in diagnostic facilities and advancement in medical procedures has led to better treatment options which include, TransOral Robotic Surgery (TORS), chemotherapy, radiation therapy and Thyroidectomy to name a few.
According to an estimate by Cancer.net, these cancers contribute to over 4% of all cancers in the United States and are twice as likely to affect men than women. In 2021, more than 66,630 people (48,740 men and 17,890 women) will develop head and neck cancer, while 14,620 (10,640 men and 3,980 women) will eventually succumb to the disease. A report by Transparency Market Research (TMR) estimates that the market for head and neck cancer will grow at a CAGR of 9.2% from 2018 to 2026, from US$ 933.3 Mn in 2017.
Company
Brooklyn ImmunoTherapeutics is a clinical stage biopharmaceutical company that is developing single agent and combination therapeutics that leverage the power of the human immune system to treat cancer and immunologic diseases. The Company’s lead candidate is IRX-2, which is currently undergoing a Phase 2b IRX-2 Neoadjuvant Therapy in Head and Neck SCC to Provide Immune Response Enhancement (INSPIRE) trial in head and neck cancer. IRX-2 is a human cell-derived (hd) IL-2 therapeutic that has demonstrated tolerability and overall survival benefits in prior trials. The Company is planning further single agent and combination studies and is keen on exploring its potential in various solid tumor cancer indications.
Image Source: Company
The Company’s approach is based on Interleukin-2 (IL-2), a type of cytokine that is made by a type of T lymphocyte, that increases the T lymphocytes and B lymphocytes, and bears a major impact on the immune system. However, its clinical application is limited by the challenges posed by high-dose rIL-2 toxicity, which is caused by overactive stimulation of the immune system and the activation of the alpha subunit leading to pulmonary edema. Brooklyn’s approach delivers human blood cell-derived IL-2 through a unique formulation at physiologic levels in order to restore immune function in the tumor microenvironment.
Using human blood cells (hd-IL-2) offers several advantages over recombinant IL-2 drug candidates such as higher immune activation due to additional active cytokines, greater functionality and physiological dosing. IRX-2 has demonstrated the ability to activate the immune system by targeting the lymph nodes with cytokines, which in turn leads to the tumor environment turning active and making the tumor hot. This leads to mounting of a response by antibodies, which travel to the primary and metastatic sites. Data suggests IRX-2 reduces immune suppression and is capable of restoring and activating multiple immune cell types including T cells, dendritic cells, and natural killer cells.
Image Source: Company
The Company has completed the enrollment of patients and expects to announce the results from the Phase 2b clinical trial (the INSPIRE study) of IRX-2 in 1H 2022. The trial is a randomized, multicenter, multinational clinical trial that has enrolled 105 patients with stage II, III, or IVA untreated squamous cell cancer (SCC) of the oral cavity who were candidates for resection with curative intent.
In addition, the Candidate is also being evaluated for the treatment of head and neck cancer in combination with other therapies including checkpoint inhibitors, which will evaluate parameters such as optimal dosing, safety and efficacy.
Key Takeaways
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Click here to please visit our detailed disclosure
References
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487309/
https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet
https://www.brooklynitx.com/science-of-irx-2/
https://www.brooklynitx.com/brooklyn-immunotherapeutics-acquires-irx-therapeutics/
No Comments