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Monday, June 11, 2018

Soon-Shiong To Take New Cancer Company Public


Billionaire biotech entrepreneur Patrick Soon-Shiong has his eyes set on taking his newly formed oncology-focused Nant public this year. The former surgeon has hired bankers and financial advisors, including Credit Suisse, to help with the endeavor, Reuters reported.
Nant will focus on developing experimental cancer treatments. In an interview with Reuters Soon-Shiong said the fledgling company will use the proceeds from the initial public offering to develop the company’s pipeline. The new company’s pipeline will include Ganitumab, a drug licensed from Amgen several years ago after that company shelved the drug in 2012 following poor results in their own research.
Ganitumab was initially licensed by another of Soon-Shiong’s companies, NantCell. Reutersnoted that Ganitumab, formerly known as AMG-479, is currently in late-stage development. Ganitumab is a fully human monoclonal antibody that targets Type 1 insulin-like growth factor receptor (IGF-1R), a potential target for cancer therapy.
Nant also has a second late-stage drug, N-803. Reuters reported that N-803 targets a protein that activates immune system cells. N-803 is being developed for bladder cancer.
In his interview with Reuters, Soon-Shiong noted that a multi-drug regimen is the key to achieving long-term remission in cancer patients. He told the wire services that the tumor is “too smart” and only attacking a small piece of it will not achieve the necessary results. He said the “entire tumor system” needs to be attacked by physicians. That’s something the entrepreneur has said before. Several years ago Soon-Shiong, dubbed the world’s richest doctor, said the future of cancer care will involve “combination therapy with low dose, metronomic use of multiple chemotherapeutic agents, but combined also with immuno-oncology molecules, or with engineered killer cells targeted at the proteomic profile of the specific tumor, regardless of the anatomical type.”
While Soon-Shiong is looking to launch another company in his NantWorks network, the company has faced a number of scandals over the past year. In October the iconic singer Cher sued Soon-Shiong alleging that he “duped” her into selling shares of Florida-based Altor BioScience at a below-market cost. In June Soon-Shiong’s NantCell, Inc., a member of his NantWorks family, acquired Altor for $290 million, about $2 per share. In her lawsuit, Cher contends that the company did not tell her, along with other investors, that some of the company’s drugs were showing clinical promise in treating AIDS and HIV. Soon-Shiong’s acquisition of Altor came a month after Altor announced it received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational interleukin-15 agonist complex, ALT-803, in combination with bacillus Calmette-GuĂ©rin for the treatment of patients with non-muscle invasive bladder cancer.
The acquisition of Altor is not the only criticism that Soon-Shiong faced last year. The billionaire doctor has faced allegations a charitable donation he provided the University of Utah was self-dealing in order to benefit one of his companies.  According to reports, Soon-Shiong’s $12 million donation to the university was written so that his company, NantHealth Inc., received $10 million in order to conduct the research, as well as “reams of patient data” that allowed the company to inflate numbers provided to investors regarding its GPS Cancer product. Soon-Shiong has decried that report.

Incyte upped to buy by Evercore


Incyte upgraded to Outperform from In Line at Evercore ISI

Lilly animal health introduces new porcine vaccine


Elanco Animal Health, a division of Eli Lilly and Company, announces licensing of Prevacent PRRS by the USDA, a modified-live respiratory vaccine that has been shown to be effective in the reduction of porcine reproductive and respiratory syndrome, respiratory form, in piglets two weeks or older.

Adaptimmune cell therapy shows ‘persistent anti-tumor effects’


Adaptimmune Therapeutics (ADAP) announced that data from the pilot study of NY-ESO SPEAR T-cells in synovial sarcoma will be published in Cancer Discovery. GlaxoSmithKline (GSK) exercised its option to exclusively license the right to research, develop, and commercialize NY-ESO SPEAR T-cell therapy program in September 2017. Transition of this program to GSK is ongoing. Median duration of response of 30.9 weeks, overall response rate of 50%, and 60% among the ten patients who received the target dose of at least one billion transduced cells, there was one confirmed complete response and five confirmed partial responses, median time to initial response of 6.2 weeks. Median progression-free survival was 15 weeks, the current estimate of the median overall survival is approximately 120 weeks among the twelve patients in Cohort 1. Maximal effects of chemotherapy are typically observed within four weeks of treatment; however, seven patients experienced continued decreases in tumor burden following the four week evaluation point, and maximal antitumor responses occurred in four patients more than three months post-infusion, there was also demonstration of transient increases in the size of metastatic lesions consistent with lymphocyte-induced inflammation followed by regression as well as trafficking of SPEAR T-cells into the tumor bed, indicating that, unlike currently available immune therapies, these cells can kill cancer cells in previously non-inflamed tumors. The majority of adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies, there were no fatal serious adverse events in this treatment cohort, the most common adverse events greater than or equal to grade 3 were lymphopenia, leukopenia, neutropenia, anemia, hypophosphatemia, and thrombocytopenia, five patients experienced cytokine release syndrome of grades 1, 2, and 3, CRS occurred within a median of four days post-infusion and the median duration of CRS was ten days. Another safety assessment was monitoring for lentivirus that is used for gene transfer during manufacturing. Polymerase chain reaction was performed and all patients were found to be negative for replication-competent lentivirus. Clonality assessment was carried out to exclude insertional oncogenesis as a mechanism for persistence, and all analyzed samples showed high levels of SPEAR T-cell polyclonality with the absence of dominant clones indicating that oncogenesis is not a mechanism of persistence. SPEAR T-cells were detectable in all patients following infusion, with peak levels measured within the first ten days. Peak NY-ESO vector copy levels were statistically significantly higher in responders compared to non-responders. Among seven patients for whom monitoring continued beyond 200 days, circulating SPEAR T-cells were readily detectable. Persisting pools comprised largely central memory and stem cell memory subsets that remained virtually negative for exhaustion markers such as PD-1 and LAG-3 for the duration of the analysis period. CD8+ SPEAR T-cells were isolated from the pre-infusion product and at post-infusion time points, and analyzed for cytokine production in an in vitro assay with NY-ESO expressing target cells; cytokine staining showed production of various cytokines by SPEAR T-cells in vitro indicating that SPEAR T-cells are polyfunctional both pre- and post-infusion SPEAR T-cells from patient 202 were isolated and placed in an in vitro killing assay 28 months after infusion and found to kill NY-ESO expressing target cells without addition of exogenous cytokines.

Planet Fitness target upped by Cowen


Planet Fitness price target raised to $50 from $45 at Cowen. Cowen analyst Oliver Chen raised his price target on Planet Fitness to $50 from $45 following meetings with management. The analyst believes its model will sustain growth given its appealing low-price membership, structural demand for health and wellness, high millennial interest, and unit and comp growth. Chen reiterated his Outperform rating on Planet Fitness shares.

Tesaro target cut by Oppco


Tesaro price target lowered to $83 from $122 at Oppenheimer. Oppenheimer analyst Leah Rush Cann lowered her price target for Tesaro to $83 from $122 saying that she believes the current status of the PARP inhibitor market is resulting in less predictable physician adoption than is typical in oncology settings. The analyst is adjusting her 2018-2022 outlook for Tesaro to account for lower estimated Zejula sales.Cann reiterates an Outperform rating on the shares.

Advaxis doses 1st patients with personalized cancer immunotherapy


Advaxis announced it has commenced a Phase 1 trial with the dosing of the first patient with ADXS-NEO, an investigational personalized immunotherapy approach targeting personal neoantigens found by sequencing a patient’s own cancer cells. ADXS-NEO is being evaluated in an open-label, dose-escalation, multicenter Phase 1 clinical trial in the United States. The study is open to patients with metastatic non-small cell lung cancer, or NSCLC, metastatic microsatellite stable colon cancer and metastatic squamous head and neck cancer. The first patient dosed is being treated for non-small cell lung cancer. ADXS-NEO is being developed in collaboration with Amgen. Advaxis is leading clinical development through proof-of-concept. Pre-clinical findings for ADXS-NEO were presented at the 2018 American Association for Cancer Research, or AACR. The company presented data in mouse models showing that ADXS-NEO generates T cell responses against neoantigen peptides that control tumor growth, even when they were identified as “non-immunogenic” using a conventional peptide-adjuvant immunization. Additionally, data were presented highlighting the capacity of the Advaxis Lm vector and its ability to target frameshift mutations of greater than 90 amino acids, and to generate T cells to multiple neoantigens per frameshift in tumor mouse models. Enrolled patients will undergo a biopsy, and Advaxis will then manufacture an investigational personalized treatment for each patient based on an analysis of their tumor neoantigen mutations, which will be ready to dose within 8 weeks of the initial biopsy.