Oncosec (ONCS) reported data from PICES combination trial with Keytruda this morning and came below expectations. ONCS stock is down more than 50% on the data, which we believe is an overreaction. We are holding ONCS for the second shot on goal in December with their triple negative breast cancer data.
Data Set Has Small Sample Size & Immature
Oncosec reported results for only 9 patients with metastatic melanoma at 12 weeks. As of September 1, 2018, 21 patients had been enrolled in the study. However, 12/21 had not yet reached the first tumor evaluation at 12 weeks. So the company decided to just put out data on 9 patients, which we believe is premature- especially when it’s not homerun data.
2/9 patients (22%) experienced a partial response and 1 patient had stable disease (22% ORR and 33% DCR). We expected the company to report mid-20% response to be clinically significant and competitive with other therapies in development (read here). With only 9 patients, and only a 12 week observation, we believe it is early to draw any conclusions. The study is 24 weeks in duration.
Since this 12 week data is from September 1, the full 24 week dataset on the first 9 evaluable patients should be collected by year end. We expect ONCS to report data on 21 patients in Q1 2019. Expectations here remain the same: at least mid-20% response rate (6/21 patients).
Looking Ahead to Triple Negative Breast Cancer (TNBC)
OMS-140: Tavo monotherapy biomarket study in TNBC
Data Expected: Dec 4 – Dec 8 @ San Antonio Breast Symposium
Oncosec’s tavo monotherapy is a small study with 10 advanced or metastatic TNBC patients receiving one cycle of tavo. The main purpose of the study was to test immunology, however the clinician (Dr. Melinda Telli) gave nivolumab as an immediate next therapy to to 2/5 patients and saw “clinically meaningful objective responses” in these 2 patients. As a result of being a clinical observation, this “combo” piece of the study was not part of the protocol and no measurements were taken.
ONCS will present top line data in all 10 patients in December. Since the combination treatment was anecdotal, it is unclear if the remaining patients will receive combination with nivolumab.
What to Expect with OMS-140: ONCS has reported that 2 patients (out of first 5) experienced clinically meaningful objective responses. If Oncosec can report that 3/10 (30%) show a response in December, we believe the company will be well positioned to become a player in TNBC.
Keep in mind that Phase 1 OMS-140 data is extremely early and was anecdotal (clinical observation outside study scope). It is not clear whether the second group of 5 patients will also receive nivolumab as an immediate therapy following tavo. If patients do receive combo and responses are again shown, that would be an achievement for ONCS.
At $0.80/share, Oncosec is currently trading at a market cap of ~$60 million. The company has about $35M in cash. With early TNBC data in December and updated melanoma data sometime in Q1 2019, we think selling at a panic point is foolish.
PropThink contributors are LONG ONCS
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