The Briefing Room, September 5: Today in Microcap Biotech Stocks

OneMedPlace introduces a new series, “The Briefing Room”, capturing the most important developments in microcap life sciences indexes. We’ve combed the net searching for the most interesting tidbits of information, tracking strategic partnerships, mergers and acquisition activity and clinical milestones of promising public emerging growth companies. Don’t forget to check out Your Biotech Calendar, a listing of upcoming dates and market influencers on the horizon.

This week, we focus on three interesting developments in oncology.

OncoSec Medical Inc. [OTC BB: ONCS] announced the issuance of a new Method of Use and Device patent in China for the company’s electroporation device platform. The patent covers claims regarding the electroporation device itself as well as method of use, said OncoSec President and CEO Punit Dhillon in a statement.

OncoSec uses electrooncology therapies for the treatment of solid tumor and metastatic cancers. OncoSec is developing minimally invasive and affordable therapies as an alternative to harsher treatments such as surgery, radiology and chemotherapy through the development of Oncosec Medical System (OMS), a device which applies controlled electrical pulses across a localized injection site where a drug is administered.

OncoSec’s drug delivery technology vastly increases the uptake of therapeutics at treatment sites, using a combination of enhanced immunotherapy (ImmunoPulse) and chemotherapy  (NeoPulse) delivered through electroporation. ImmunoPulse utilizes electroporation to up-regulate cytokine IL-12, and is currently in clinical trials for metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. NeoPulse utilizes electroporation to increase the efficacy of bleomycin in tumors, and is currently in clinical trials for head and neck cancers.

OncoSec has been featured as a company to watch on a number of financial blogs, as two Phase II clinical trials are set to report interim data in Q4, and after the presentation of positive data from a Phase III trial for NeoPulse (which had been licensed in Phase III from Inovio Pharmaceuticals in March 2011). Further, the company announced in July the initiation of a third Phase II trial for cutaneous T-cell lymphoma.

Read the OneMedResearch Initiation Report of OncoSec.


TG Therapeutics [OTC BB: TGTX] has announced the initiation of a Phase I/II clinical trial for ublituximab, the company’s third-generation anti-CD20 monoclonal antibody for patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma previously treated with rituximab. This is the first study of ublituximab in non-Hodgkin’s lymphoma, and the first trial conducted in America: in December 2011, the company presented data from a Phase I study in Chronic Lymphocytic Leukemia, in which a response rate of 45% was reported.

The dose escalation trial will enroll up to 36 patients for the Phase I component, and up to 77 patients total for Phase II.

This trial commencement caps a busy summer for the company formerly known as Manhattan Pharmaceuticals, which announced a name change and reverse stock split in April 2012. In May, the company announced investigational new drug (IND) status and clearance to commence clinical trials for ublituximab, named TGTX-1101.

In August the company announced an exclusive collaboration with Rhizen Pharmaceuticals SA to develop Rhizen’s lead candidate, a novel PI3K delta inhibitor. TG will make upfront licensing payments and milestones as well as bear the cost of clinical development through Phase II. The company will focus on development in hematologic malignancies and autoimmune disease. TG anticipates filing for IND for the novel PI3K delta inhibitor, known as TGR-1202, in 4Q2012.

Ublituximab has been granted Orphan Drug status in Europe and in the US for B-cell Lymphocytic Leukemia.

Anti-CD20 antibodies target and aid in the depletion of B-lymphocytes, and have also been shown to be effective in treating autoimmune diseases, including rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis.


Coronado Biosciences [Nasdaq: CNDO] announced the granting of a key patent for CNDO-109, a biologic that activates the immune system’s special lymphocytes to seek and destroy cancer cells. The patent claims cover methods of activating these cells as well as activated cell compositions. Preclinical studies of CNDO-109 have demonstrated in activity in multiple myeloma, breast cancer, prostate cancer and ovarian cancer, according to the company release. The company plans to initiate a phase I/II dose escalation trial in acute myeloid leukemia this year.

In June 2012, CNDO-109 was granted Orphan Drug Designation from the FDA for the treatment of AML. The company also plans to further patent claims in Europe and Asia.

CNDO-109 is a proprietary membrane lysate that activates special immune cells, dubbed Natural Killer (NK) cells. When activated, these cells can differentiate between normal cells and cancer cells by granzyme mediated lysis. This membrane works similarly to IL-2 administration, which also activates NK cells, however may not trigger the side effects associated with IL-2. Further, CNDO-109-activated cells retain their activated state after cryopreservation and thawing, while IL-2-infused cells do not. It is thus possible that cells activated with CNDO-109 can be prepared off-site yet delivered as a cryopreserved, patient-specific dose ready for infusion.

And, a bonus, non-Cancer development that caught our eye.

Pluristem Therapeutics [Nasdaq: PSTI] announced that the company’s PLacental eXpanded (PLX) cells had been successfully administered to a third patient at the Hadassah Medical Center in Haifa, Israel. This is the third life-saving compassionate use treatment completed since May 2012, and the company believes the success of these treatments suggests these PLX cells may have potential to treat various indications in bone marrow disease.

Last week, the company announced the filing of a request for orphan drug status for PLX cells in the United States for the treatment of aplastic anemia.

The latest patient is a 45-year-old male diagnosed with Acute Myeloid Leukemia, a form of blood cancer. The patient underwent chemotherapy, which removed cancerous cells as well as non-cancerous bone marrow cells. The patient received an allogeneic bone marrow transplant and hematopoietic stem cell transplants, however developed complications from the procedure. PLX cells were injected intramuscularly in two administrations over two weeks – the patient showed no local or systemic side effects, and doctors reported the patient’s wellbeing and general clinical condition had significantly improved.

This announcement comes during a series of milestones in summer 2012. In early August, Pluristem reported PLX cells had been used to save the life of a 54-year-old woman after unsuccessful bone marrow transplants following chemotherapy to treat lymphoma cancer. The woman’s clinical condition and blood counts improved after nine days of the second treatment to the point where the patient was subsequently discharged from the hospital.

**In July, OneMedRadio spoke with Jason Napodano of Zacks Investment Research about promising companies in regenerative medicine**

In May, Pluristem reported PLX cells had saved the life of a seven-year-old girl suffering from aplastic bone marrow.

During the summer, the Israeli company also announced the commencement of Phase II US clinical trial for intermittent claudication; approval for commencement of Phase II India clinical trial for Buerger’s Disease; approval for commencement of Phase I/II Germany study for muscle regeneration.

In June, OneMedRadio spoke with Senior Vice President William Prather about the incredible story of saving a little girl’s life.

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