GT Biopharma (OTCMKTS: GTBP) is a stock that I’ve been watching for some time now, and with today’s news, I’m glad it’s on my radar. In a press release issued early this morning, the company announced it has begun treatment of the second patient in a Phase I/II clinical trial.
Here’s what’s going on:
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GTBP Stock Is One To Watch After Dosing Of Second Patient In A Phase I/II Trial For AML (Acute Myeloid Leukemia)
In the press release, GT Biopharma said that it had begun treatment of its second patient in its GTB-3550 TriKE Phase I/II AML clinical trial.
Importantly, this news follows the successful completion of the first patient who achieved stable disease, increased NK cell production, and no adverse side effects.
The trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota. Additional sites are being engaged in states that have now modified their COVID-19 shelter-in-place restrictions to allow for the conduct of other clinical trials.
In the phase 1 portion of the trial, GTBP is working to evaluate GTB-3550 in patients with CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550.
In the Phase 2 portion of the trial, the company will further evaluate the recommended dose of GTB-3550 in this patient population.
GT Biopharma shared great news from the first patient treated in the trial. Here are the key points:
- Founder Anthony Cataldo was also the Founder of one of the first cell therapy companies, Genisis Biopharma, Inc., now know as Iovance Biotherapeutic, Inc. (NASDAQ: IOVA – $41.00 per share) Market Cap $5 Billion dollars.
- Multiple strategies to redirect immunity have been developed in the past two decades, but they have technical hurdles, cause undesirable side-effects, or are very expensive as exemplified by the T cell therapy-based chimeric antigen receptor (CAR-T) therapies. GTB-3550 has the potential to avoid the significant cost and management challenges associated with approved CAR-T Therapies. As the TriKE™ is a targeted immuno-oncology protein therapeutic drug, the cost and patient delivery/administration of the TriKE is much more advantages compared to CAR-T cell therapies and unlike CAR-T therapies, is not limited to just liquid tumors (20% of the cancer market) as the TriKE also works on liquid and solid tumors (80% of the cancer market) as well.
- What makes the multi-targeting TriKE™ unique from all other single target NK cell therapies (Affimed NV [ NASDAQ: AFMD ], Innate Pharma SA [ NASDAQ: IPHA ] and Dragonfly Therapeutics (www.dragonflytx.com), is the proprietary incorporation of IL-15 (an NK cell stimulating cytokine) directly into the core multi-targeting TriKE™ construct. Thereby enhancing activation, proliferation and persistence of NK cells while minimizing the toxicities associated with the systematic administration of cytokine therapy to stimulate the patient’s immune system. Which also will make the TriKe drug much more cost effective and patient friendly.
- In the current FDA trial the first patient achieved stable disease with respect to the number of AML blasts observed in bone marrow before and after. The Trike elicited an encouraging initial efficacy marker response.
- No adverse side effects were experienced.
- An increase of the patient’s total NK cell population was achieved. This increase was attributed to the IL-15 component of the TriKE molecule.
- There was no appreciable increase of any hyper-active T-cell population which could result in cytokine storm or other T-cell associated toxicities.
- The second patient enrolled in the study has now begun the first cycle of GTB-3550 TriKE therapy. The data from this patient will be evaluated upon the completion of the third cycle of treatment.
Why This News Is So Important
The news issued by GT Biopharma is important for multiple reasons. First and foremost, myelodysplastic syndromes are very difficult to treat. Data from the first patient shows that the company is achieving success with their TriKE treatment option.
That being said, the myelodysplastic syndromes market is a massive one, generating more than $2 billion in revenue annually for those involved in the space. Considering the fact that GTBP trades with a market cap under $15 million. This is very similar to Mr. Cataldo’s founding of Iovance. Breaking into this space would be an incredible opportunity for the company.
Moreover, the company recently announced a collaboration agreement with Cytovance® Biologics, a USA-based contract development and manufacturing organization and a subsidiary of the Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (“Hepalink”) (002399:SZ) a publicly traded company with a market capitalization value of approximately $3 Billion USD, to provide development services for a TriKE™ therapeutic for the treatment of coronavirus infection. The TriKE technology is the same proprietary NK cell engager platform that will be applied for in the development of the COVID-19/TriKE™. We look forward to the COVID-19/TriKE™ developments that could quickly become a multi-indication drug and a huge opportunity in the face of COVID-19.
All in all, if you’re not paying attention to GTBP yet, now is the time to start.
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