NewLink Genetics: A Rally is Recuperating NLNK’s Unwarranted Stock Losses

Indeed, updated data from the ongoing Phase 2 NLG2103 study of NewLink Genetics (NLNK) IDO inhibitor immunotherapy product indoximod in combination with the PD-1 pathway inhibitor, KEYTRUDA (pembrolizumab) demonstrate positive results in advanced melanoma. The news rallied the stock that has been cremated following news that the same drug Indoximoll has failed to meet the endpoint in mid-phase trials on breast cancer in combination with Roche’s checkpoint inhibitor drug.

The new data will be presented tomorrow, Saturday September 9, 2017 at the Third International Cancer Immunotherapy Conference in Frankfurt/Mainz, Germany.

Prohost has kept the devastated stock in its Portfolio based on expected good news to be announced from other trials.

The Positive News

The presentation entitled, “Combined Inhibition of the IDO and PD-1 Pathways Improves the Response Rate for Patients with Advanced Melanoma”, demonstrates that combining indoximod with Keytruda (pembrolizumab) – a PD-1 inhibitor immunotherapy can improve outcomes for advanced melanoma patients.

Indeed, the press release from NewLink stated that the combination has improved over previously reported results presented at the AACR Annual Meeting 2017 for both the Complete Response rate (CR) and the Overall Response Rate (ORR) for patients1 who received the indoximod plus pembrolizumab combination.

The updated data demonstrate the following:

– Improvement in Complete Response (CR) to 20% compared to CR of 12%

– The Progression-Free Survival (PFS) by RECIST criteria was 56% at one year with median PFS (mPFS) of 12.9 months

The Update includes only those patients with cutaneous, mucosal and melanoma of unknown primary origin.
Data as presented at Third International Cancer Immunotherapy Conference

According to Charles J. Link, Jr., M.D., Mew Link Chairman, Chief Executive Officer, and Chief Scientific Officer, the updated data further support the firm decision to initiate a pivotal trial for patients with advanced melanoma.

Safety: Indoximod in combination with pembrolizumab was well-tolerated. The most common all-grade adverse events were fatigue, headache, and nausea. Three patients experienced grade 3 serious adverse events (SAE) possibly attributed to indoximod. Three patients experienced SAEs that led to discontinuation of treatment. No treatment related deaths were announced anywhere.

Prohost Observations

Prohost seems to have made the right decision taking advantage of the stock’s plummeting to keep it in its portfolio. The reasoning was based on the fact that the IDO inhibitors have already demonstrated they might be working well in combination with the checkpoint inhibitors’ such as
Keytruda and Opdivo. That’s what we hope to confirm now also about Incyte’s (INCY) IDO inhibitors in combination with the same immunotherapy products.

NewLink Genetics’ aims at conducting phase 3 pivotal trial in combination with both Merck’s (MRK) checkpoint inhibitor immunotherapy product keytruda and with Bristol-Myers’ (BMY) checkpoint inhibitor Obdivo.

The pivotal trial will be a large-scale (600 patients) trial in Stage 3 unresectable and metastatic stage IV melanoma. The trial will have a one to one randomization between indoximod plus Keytruda (pembrolizumab) or Opdivo (nivolumab) compared to single agent PD-1 inhibitor. The co-primary endpoints of the study are PFS by RECIST criteria and Overall Survival (OS).

Also, NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, acute myeloid leukemia, pancreatic cancer and prostate cancer.

NLNK is still rallying towards recuperating its losses the previous hysterical sell-off has caused. It is trading at this moment at $18.26 UP $4.65

Thanks for listening.

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