Shares are currently up 5% in the premarket session but have traded flat since my first article.
New data for lead drug candidate IMP321 at SITC was encouraging.
Tumor reductions were observed in 7 of 12 advanced metastatic melanoma patients (58%) who received IMP321 in combination with pembrolizumab.
No treatment discontinuations due to adverse events or dose-limiting toxicities were observed. The high dose cohort (30 mg) is ongoing and I am looking forward to results here.
Readers who are interested in the story and have done their due diligence should initiate a pilot position. Wait for technical strength to serve as confirmation to add.
Shares of Prima Biomed (PBMD) are currently up 5% in the premarket session after revealing new data for lead drug candidate eftilagimod alpha (IMP321) to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. The stock has finished flat since my initial article at the beginning of October and was a slight loser for us in the ROTY model account.
Keys to the original bullish thesis included the following:
The stock was a former runner and appeared to be moving up "under the radar", with many traders and investors unfamiliar with the name. Their LAG-3 centered pipeline had several shots on goal involving both wholly-owned drug candidates and those partnered with the likes of Novartis and GlaxoSmithKline.
The company had already reported data earlier this year from a mid-stage study of IMP321 in metastatic breast cancer testing two doses (6mg and 30mg). The latter dose resulted in a stronger immune response and was chosen for the randomized portion of the trial in 226 patients. Safety run-in data showed they had an active drug, with the disease control rate of 87% for IMP321 in combination with paclitaxel and an increase in CD8 T-cell and killer cell numbers observed.
I believed that several catalysts could push shares higher, including safety run-in data for the fourth quarter and data from the first two cohorts of the TACTI-mel phase 1 Australian study in metastatic melanoma. The company had upcoming presentations at the World Immunotherapy Congress and at SITC.
I also pointed out that in June Bristol-Myers Squibb announced promising data for its anti-LAG-3 candidate BMS-986016 in combination with Opdivo in heavily pretreated advanced melanoma patients who were relapsed or refractory on anti-PD-1/PD-L1 therapy. Patients with LAG-3 expression (n=25) in at least 1 percent of tumor-associated immune cells within the tumor margin had three times more improvement in ORR as compared to those with less than 1% LAG-3 expression (20 percent versus 7.1 percent, respectively). Generally speaking, this could provide validation of the target in spite of differences in approach.
Moving on to the SITC presentation, the poster was titled, "Pushing the accelerator and releasing the brake: testing the soluble LAG-3 protein (IMP321), an antigen presenting cell activator, together with pembrolizumab in unresectable or metastatic melanoma". Tumor reductions were observed in 7 of 12 advanced metastatic melanoma patients (58%) who were treated with eftilagimod alpha (1 mg or 6 mg) in combination with pembrolizumab. Keep in mind that these were subjects whose disease had already progressed on pembrolizumab or experienced a less than optimal response to the approved treatment. Figure 2:Efficacy results (source: SITC poster)
As for the safety profile, I note that 25% of patients experienced a serious adverse event (SAE), but there were no treatment-related SAEs. There were two treatment-related adverse events (grade 3 or 4) in one patient. Importantly, there were no treatment discontinuations due to adverse events or dose-limiting toxicities in either cohort.
Chief Scientific and Medical Officer Dr. Frédéric Triebel had the following to say.
The data to be presented at the SITC meeting is very encouraging and demonstrates that antitumor activity was observed in patients following the administration of eftilagimod alpha in combination with pembrolizumab. Furthermore, it is important to note that prior to coming into this study, these patients were treated with pembrolizumab monotherapy and did not achieve a meaningful therapeutic benefit from this treatment. The data also supports the hypothesis that there is a therapeutic synergy when administering an APC activator, which enhances anti-tumor T cell production, in combination with a checkpoint inhibitor, which releases the brake on the T cells.
Figure 3:Confirmed complete response in 84 year old patient with stage IV visceral disease whose best response on pembrolizumab was irPD (source: SITC poster)
I want to point out that the high dose cohort (30 mg) is ongoing and I am looking forward to results here. I agree with management that evaluating IMP321 in combination with other PD-1/PDL1 checkpoint inhibitors in various tumor settings is warranted. Cash balance as of September 30th was A$17.0 million, which included R&D tax refunds, a milestone payment from Novartis and proceeds from the July A$6.5 million financing. Management continues to guide for an operational runway into the end of 2018. Prima Biomed is a Buy
Readers who are interested in the story and have done their due diligence should initiate a pilot position in the near term and adopt a "buy the dips" strategy. However, with further data coming in 2018 I believe there is no rush to accumulate shares and one can do so in a gradual manner, waiting for technical strength to serve as confirmation.
One key risk is dilution in the medium term- while management has guided for an operational runway until the end of 2018, I wouldn't be surprised to see a financing in the next six to nine months. Milestone payments from partners or accessing other non-dilutive options would negate the need for tapping capital markets. Disappointing data from the high dose cohort of the IMP321 pembrolizumab combination study would result in substantial downside, as investors are looking for improved responses over the first two cohorts. There is a lot of competition in indications being targeted, as many biotech concerns are seeking to combine various assets with checkpoint inhibitors to improve response rates. Disappointing data for the metastatic breast cancer and INSIGHT studies, as well as with partnered candidates, would also result in additional downside.
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PRR Price at posting:
2.9¢ Sentiment: Hold Disclosure: Held
Figure 2: Efficacy results (source: SITC poster)
Figure 3: Confirmed complete response in 84 year old patient with stage IV visceral disease whose best response on pembrolizumab was irPD (source: SITC poster)
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