SELLAS Life Sciences Announces Positive Readout for Leukemia Drug

SELLAS Life Sciences' (SLS) stock shot up as the company reported positive results from its Phase 1/2 study of its Galinpepimut-S treatment for patients with acute myeloid leukemia. The trial demonstrated that the patients treated with the drug candidate showed significant improvement in the survival rate. The median overall survival stood at 21 months while median follow-up remained at 30.8 month, in comparison to 5.4 months in patients treated with best standard care.

SELLAS had earlier reported initial data from the Phase 1/2 study of GPS. The median follow up in that read out was at 19.3 months, while median Overall Survival was 16.3 months, in comparison to 5.4 months in patients given best standard therapy. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS, said, Were extremely pleased with this follow-up data, which show that GPS may have potential as a longer-term therapy for AML patients in CR2, an aggressive disease where the majority of patients typically relapse and have a survival rate of approximately 5 months with best standard therapy.

SELLAS is currently working towards recruiting patients for the ongoing Phase 3 REGAL study. It is a 1:1 randomized, open label study which compares GPS monotherapy in the maintenance setting to investigators choice of best available treatment. The trial is aimed at AML patients with hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy. These patients have been found ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint of the study is related to Overall Survival from the time of study entry whereas the secondary endpoints are related to antigen-specific T-cell immune response dynamics, leukemia-free survival and measurable residual disease by multigene array among others.

In January, the company provided highlights of its clinical development progress and upcoming catalysts during 2020. SELLAS expects to release interim analysis of the Phase 1/2 basket study of GPS with pembrolizumab in multiple tumor types during the second half of 2020. It also anticipates receiving guidance from the FDA on the regulatory and development pathway for NPS in TNBC patients in the first quarter of 2020.

For its third quarter, the company had reported its research and development expenses at $1.8 million, up from $1.7 million it had spent during the third quarter of the previous year. Its general and administrative expenses for the quarter were reported at $2.4 million while the corresponding figure for the previous year quarter was at $1.3 million. SELLAS reported its cash and cash equivalent at $9.1 million as of September 30, 2019. The company announced that its net loss attributable to common stockholders was $11.5 million while its net loss for the third quarter of the previous year was at $9.4 million. The net loss for the nine months stood at $20.5 million, down from $27.9 million in net loss for the corresponding time period of the past year.

SELLAS had a turbulent past year when its stock tumbled more than 97 percent in the stock market. The latest positive news is expected to bring some respite; however, investors are still advised to remain cautious. One of the biggest concerns about the company is its lack of income stream. The company has yet to report any revenue. SELLAS has robust drug pipeline with several ongoing trials. It is testing GPS in combination with Keytruda as a basket study for 5 indications. It is also working on testing drug candidate for treating Malignant Pleural Mesothelioma and Multiple Myeloma. SELLAS has NPS clinical trials going on for breast cancer as well.

Endo International (ENDP) reported its fourth-quarter results where it surpassed revenue and net income estimates. The company announced its EPS at $0.74, beating consensus estimate of $0.57. Its revenue for the quarter stood at $764.8 million, surpassing the market estimate of $731.43 million. However, its revenue dropped 3 percent on a year-over-year basis as it had earned $786 million in revenue during the fourth quarter of the previous year.

Endo also provided segment wise update where its revenue from the Sterile Injectables segment increased by 10% to $285 million. The increase was mainly due to the continued robust growth of Vasostrict and Adrenalin. The companys Generic Pharmaceuticals revenues dipped 14% due to the competitive pressure on generic products.

Endo provided guidance for FY 2020 as it expects its total revenue to be in the range of $2.72 billion and 2.92 billion. Its adjusted EPS from continuing operations will likely be between $2.15 and $2.40. The consensus estimates for EPS stands at $2.25 while revenue is expected to be $2.90 billion. Paul Campanelli, Chairman, President and Chief Executive Officer at Endo, said, In 2019, Endo delivered stronger than expected performance during the fourth quarter and for the full year, driven by continued double-digit percentage revenue growth in our Sterile Injectables segment and in the Specialty Products Portfolio of our Branded Pharmaceuticals segment, and as a result of our dedication to operational execution.

Endo is engaged in the development and marketing of branded and generic pharmaceuticals in the United States. The company has strong pipeline and has multiple trials going on for treating different ailments. Some of its most prominent products are Testopel, Fortesta and Xiaflex.

Menlo Therapeutics (MNLO) announced that its Phase 2 clinical for treating chronic pruritus of unknown origin failed to meet its primary endpoint. The trial involved patients treated with one a day daily oral serlopitant. The data demonstrated that there was no meaningful difference between the placebo group and serlopitant group. The main purpose of the study was to demonstrate reduction in itching as measured by a rating scale.

The study showed that 37.9 percent of patients treated with serlopitant achieved a 4 point or greater improvement on the rating scale. However, the placebo group showed 39.3 percent of patients hitting that mark. The placebo group also showed 10 percent higher response than in any of the previous studies testing the once-daily pill. The company CEO Steve Basta said that there is no such indication that such a high rate would be replicated in future studies. He added, That would be putting undue weight on the [chronic pruritus of unknown origin] results. I think what youll see is this is an outlier. He also said that, The higher placebo response rate may be due to characteristics of the CPUO population, which is not well understood clinically.

The company expects the results from Phase 3 trials for the treatment of pruritus associated with prurigo nodularis to be out in the months of March or April this year.

However, this is not the first time the placebo effect has disrupted serlopitant tests. The company suffered two mid-stage failures, involving the testing of drugs for managing itching in atopic dermatitis and chronic cough. These research and development measures will now likely take place under the management of Foamix. Menlo and Foamix have agreed for an all-stock merger, which was approved by Menlo shareholders in January. It is expected that the agreement will close on or around March 9, 2020.

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SELLAS Positive Trial Data, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha