AstraZeneca’s (AZN) checkpoint PD-L1 inhibitor Imfinzi and NewLink Genetics’ (NLNK) IDO inhibitor indoximod will be combined and tested in Phase 2 randomized, placebo-controlled clinical trials together with the standard of care chemotherapy treatment for metastatic pancreatic cancer. AstraZeneca and NewLink Genetics will jointly fund the phase 2 trial of the combination that  NewLink will be sponsoring  It is a Phase 2  trial that will be …

Exelixis (EXEL) announced that Daiichi Sankyo (“Daiichi Sankyo”) reported positive top-line results from a phase 3 pivotal trial of esaxerenone for essential hypertension in Japan. The product is the fruit of the collaboration agreement signed by both firms back in 2006. The Story More than ten years ago, in March 2006, Daiichi Sankyo and Exelixis signed a research collaboration agreement to discover, develop and commercialize …

The Week in Review #5 ALNYLAM (ALNY) and Sanofi Genzyme, the specialty care global business unit of Sanofi announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic for hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score (mNIS+7) at …

EXELIXIS Being called overvalued by one analyst does not mean that Exelixis (EXEL) is, indeed, overvalued. We believe it is not and that’s why we decided to accumulate the stock on any weaknesses in EXEL. We do not intend to sell this stock at this time for what we believe are the wrong reasons. Some bloggers tried to interpret the reasons that led to the …

Prohost Letter #413 FROM BIOTECH TO BIOPHARMA - New research, new findings, new discoveries of trustworthy and doubtful biomarkers more understanding of genomics and proteomics, in addition to more breakthrough diagnostic procedures, are all gifts of the life-science revolution. This revolution started with molecular biology, the discovery of the DNA and its functions, which was the prelude to genomic understanding, gene sequencing, and genetic engineering and …

The Week in Review #4 AMAZING STOCK REBOUNDING - We have already witnessed and wrote about the fierce rebounding of some of our selected stocks comprising: Exelixis (EXEL), Sangamo (SGMO), Array (ARRY), ImmunoGen (IMGN) and others . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Agenus (AGEN) announced that the U.S. Food and Drug Administration (FDA) Advisory Committee voted unanimously, recommending the approval of GlaxoSmithKline’s (GSK) shingles vaccine candidate, Shingrix, containing Agenus’ proprietary immune adjuvant, QS-21 Stimulon®. This is good news for Agenus. As Garo Armen, Ph.D., Agenus CEO and Chairman of the Board said, “The Advisory Committee’s recommendation for the approval of Shingrix marks the first for a product …

Mirati Therapeutics (MRTX) announced positive preliminary data from two ongoing clinical trials of its product sitravatinib in non-small cell lung cancer (NSCLC). Combination of sitravatinib and Bristol Myers Squibb (BMS) checkpoint inhibitor Obdivo (nivolumab) might have broken the resistance against the immunotherapy checkpoint inhibitor drug in NSCLC patients with documented progression following prior checkpoint therapy. The results of the combination sitravatinib/nivolumab demonstrated 3 confirmed Partial …

Following the announcement of two new licensing agreements for its ENHANZE® drug-delivery technology, Halozyme Therapeutics (HALO) raised financial guidance for 2017 as follows: - Net revenue of $245 million to $260 million, an increase of $130 million from the prior range of $115 million to $130 million, reflecting the portion of upfront payments from the new agreements expected to be recorded as revenue in 2017; - Operating expenses of $240 million …

Amicus (FOLD) announced the failure of its topical wound-healing product SD-101 for patients with epidermolysis bullosa (EB). The drug failure was revealed when top-line results from the randomized, double-blind, placebo-controlled Phase 3 clinical ESSENCE study SD-101 were announced. The results showed that the drug did not demonstrate a statistically significant difference from placebo in the intent to treat (ITT) population. The first primary endpoint results …

Positive Phase 2 Results for Tipifarnib in HRAS Mutant Head and Neck Cancer Four of the first six HRAS Mutant HNSCC Patients enrolled on study achieve confirmed RECIST Partial Responses and Durable Responses Greater than One Year   On September 7, 2017, i.e., five days ago, Kura Oncology (KURA) announced positive results from a Phase 2 trial from its lead product candidate, tipifarnib, in patients with …

Marinus Pharmaceuticals’ (MRNS) stock rallied following its announcement of top-line data from Phase 2 open-label study in patients with the severe epilepsy disorder known as CDKL5. The disease is a rare  severe genetic derived epilepsy that results in seizures, pervasive neuro-developmental delay and disabling behavioral issues. The disease has no approved treatments. The good news that boosted the stock price early today has come out …

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 …

In the news, the FDA has placed a clinical hold on two phase 1 trials of Cellectis’ (CLLS) off- the-shelf product UCART123 after the death of a 78-year old patient. Cellectis is working with the FDA towards finding ways that help mitigate the risks expected to have caused the fatality. We experienced deaths with other CAR T products with the cytokine release syndrome on the …

Portola Portola Pharmaceuticals (PTLA) announced that it will host a webcast and conference call to provide an update on its anticoagulant Factor Xa inhibitor Bevyxxa® (betrixaban) launch plans, the validation of the commercial manufacturing process and drug release timing. Conference Call Details: The live conference call will be held today, Tuesday, September 5, 2017, at 4:30 p.m. Eastern Time (1:30 p.m. PT). It can be accessed by …

Coming Soon... The Week in Review #3 Gilead Acquisition - Rallying by Association - Improving on Cancer Treatments...

The answer is, indeed, Gilead (GILD) and its CAR T drug approval will be for non-Hodgkin lymphoma (NHL). This is true, as in May, the FDA has accepted for priority review Kite Pharma’s Biologics License Application (BLA) for its genetically engineered Chimeric Antigen Receptor T Cell (CAR-T) product axicabtagene ciloleucel. The submission follows positive data demonstrated after a single infusion of axicabtagene ciloleucel in the …

Eli Lilly and Company (LLY) and Incyte (INCY) announced that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018. That was fast, we mean the re-submission. To remind you, the firms had submitted Baricitinib for review seeking marketing approval for rheumatoid arthritis in the U.S., the …

Earlier this month, on Aug. 24, 2017, Propeller Health announced the expansion of its 2015 collaboration with GlaxoSmithKline (GSK), enabling both companies to prepare for and undertake commercial activities using the Propeller clip-on sensor and software platform for use with  ELLIPTA Inhaler. The inhaler, which is marketed by GSK, is produced by Innoviva (INVA) and approved by the FDA in other countries around the world. …

CRISPR Therapeutics (CRSP) and Massachusetts General Hospital Cancer Center (MGHCC) have entered into a two-year research collaboration and license option agreement to develop Novel T cell therapies for cancer. As part of the collaboration, CRISPR/Cas9 gene editing technology will be utilized to improve upon current T cell therapies in development addressing unmet needs in both hematologic and solid tumors.  This improvement is expected to occur by combining the …