Cancer is being cured- The aberancy of the Cytokine Cycle is abated

 Lifted from Fierce Publications

Novartis ($NVS) picked up an FDA breakthrough therapy designation for its in-development treatment for blood cancer, guaranteeing the company preferred access to top regulators as it prepares to file for approval.

The agency has added PKC412 to its breakthrough program, which is meant to accelerate the process for treatments that could change the standard of care in particularly underserved diseases.

Novartis' drug is an oral therapy designed to treat patients with a form of acute myeloid leukemia, or AML. PKC412, also known as midostaurin, works by blocking multiple enzymes key to cancer growth in the roughly one-third of AML patients who have mutations in their FLT3 genes. In Phase III data presented at the American Society of Hematology meeting last year, the drug charted a median overall survival of 74.7 months, beating out the 25.6 months seen on placebo alone.

Novartis said it's on track to submit PKC412 for global regulatory approvals in the first half of this year, working with Invivoscribe Technologies to develop a companion diagnostic that can screen AML patients for FLT3 mutations.

AML accounts for about 25% of all adult leukemias, according to Novartis, and has the lowest survival rate.

"For more than 25 years, medical developments have been limited for AML patients and the chemotherapy treatment strategy has essentially remained unchanged," Novartis oncology chief Alessandro Riva said in a statement. "We look forward to working closely with the FDA to bring PKC412 (midostaurin), the first potential AML targeted therapy, to patients as quickly as possible."

Novartis is also developing PKC412 in mast cell leukemia and myelodysplastic syndrome

JAK Inhibition

                             JAK inhibition

                                           Insight

 The complete Cytokine cycle must be illucidated  in order for in part results to make sense.

This was jacked from Fierce newsletter on stock info.

JAK inhibition for solid tumors flops, forcing Incyte to pull the plug on a slate of trials

Thursday, February 11, 2016 | By John Carroll

Incyte CEO Hervé Hoppenot

Jakafi has failed to help patients in a late-stage study for pancreatic cancer, and Incyte feels that it now has all the data it needs to prove that a JAK1 inhibitor is the wrong way to go in solid tumors.

Just ahead of its annual numbers release, Incyte reported today that it is slamming the brakes on a range of studies for Jakafi as well as the experimental INCB39110, another JAK1. Already halted on one colon cancer trial failure, Incyte is ending the Phase III pancreatic cancer study, a separate midstage trial in colorectal cancer, a Phase II for breast and lung cancers and a dose-ranging trial for INCB39110 in pancreatic cancer.

Shares of Wilmington, DE-based Incyte ($INCY) plunged 23% on the news of the setback.

Incyte, though, still believes that the drug's impact on the tumor microenvironment, a key target in oncology, is worth studying in combination studies using Merck's checkpoint inhibitor Keytruda, as well as its in-house IDO1 inhibitor and PI3k drug. INCB39110 plus osimertinib, AstraZeneca's next-generation EGFR inhibitor, will also stay in the pipeline.

Back in the summer of 2013, evidence of some success using Jakafi against pancreatic cancer spurred a 33% spike in the biotech's share price, encouraging CEO Hervé Hoppenot to tell reporters some months later that the company's shares were undervalued. At the time the company's shares had risen to about $64 a share. The company's shares were on their way to $130 in the fall of 2015. Today, the price is just north of $57 as a bear market mauls industry shares.

Jakafi is approved to treat myelofibrosis, and Incyte expects the drug will reap more than $800 million in revenue from the treatment this year. 

"The hypothesis to evaluate the therapeutic utility of JAK inhibition in patients with solid tumors and high levels of systemic inflammation was initially supported by a subgroup analysis of the randomized, double-blind Phase 2 RECAP study, which suggested a survival benefit in patients with high levels of CRP. As a result, we and the broader scientific community believed further study in pancreatic cancer and other solid tumors with evidence of systemic inflammation was warranted. Unfortunately, the larger studies did not confirm this hypothesis," said Rich Levy, Incyte's chief drug development officer.

Cancer and its elimination- $57 M.We do have believers

Indubidibly there is a connection with the proposed Cytokine Cycle and its Pathophysiologic Consequence and what Pat is funding here. I will repost it soon 

Billionaire entrepreneur Patrick Soon-Shiong's NantCell raised $57.3 million in equity to fund its work on treatments that use the immune system to fight cancer, becoming one of the most well-funded companies in its founder's constellation of biotech endeavors.

The round, which sold shares to 125 investors, follows a $100 million fundraise disclosed in September and a $75 million equity sale over the summer. Like most of Soon-Shiong's many biotech ventures, NantCell has provided little detail on its specific goals, and the company didn't respond to a request for comment Monday.

Launched early last year, NantCell is an arm of Soon-Shiong's NantWorks umbrella that is developing immuno-oncology therapies. The company's first move was paying an undisclosed sum for the rights to Amgen's ($AMGN) ganitumab, a once-failed antibody that NantCell believes can be repurposed against cancer. In March, the company widened its pipeline by trading $110 million in cash and equity for the rights to some immunotherapies from Sorrento Therapeutics ($SRNE), a frequent Soon-Shiong collaborator. And it has remained quiet ever since.

NantCell, one of about a dozen under the NantWorks name, does business alongside NantiBody, a joint venture with Sorrento; NantPharma, at work on a next-generation version of Celgene's ($CELG) Abraxane; NantBioScience, developing nanoparticle cancer treatments; NantKwest ($NK), an immuno-oncology company that raised more than $200 million in a July IPO; and NantHealth, a tech firm offering what Soon-Shiong calls "the Google of genome mapping."

                               JAK Inhibition

Jakafi has failed to help patients in a late-stage study for pancreatic cancer, and Incyte feels that it now has all the data it needs to prove that a JAK1 inhibitor is the wrong way to go in solid tumors.

Just ahead of its annual numbers release, Incyte reported today that it is slamming the brakes on a range of studies for Jakafi as well as the experimental INCB39110, another JAK1. Already halted on one colon cancer trial failure, Incyte is ending the Phase III pancreatic cancer study, a separate midstage trial in colorectal cancer, a Phase II for breast and lung cancers and a dose-ranging trial for INCB39110 in pancreatic cancer.

Shares of Wilmington, DE-based Incyte ($INCY) plunged 23% on the news of the setback.

Incyte, though, still believes that the drug's impact on the tumor microenvironment, a key target in oncology, is worth studying in combination studies using Merck's checkpoint inhibitor Keytruda, as well as its in-house IDO1 inhibitor and PI3k drug. INCB39110 plus osimertinib, AstraZeneca's next-generation EGFR inhibitor, will also stay in the pipeline.

Back in the summer of 2013, evidence of some success using Jakafi against pancreatic cancer spurred a 33% spike in the biotech's share price, encouraging CEO Hervé Hoppenot to tell reporters some months later that the company's shares were undervalued. At the time the company's shares had risen to about $64 a share. The company's shares were on their way to $130 in the fall of 2015. Today, the price is just north of $57 as a bear market mauls industry shares.

Jakafi is approved to treat myelofibrosis, and Incyte expects the drug will reap more than $800 million in revenue from the treatment this year. 

"The hypothesis to evaluate the therapeutic utility of JAK inhibition in patients with solid tumors and high levels of systemic inflammation was initially supported by a subgroup analysis of the randomized, double-blind Phase 2 RECAP study, which suggested a survival benefit in patients with high levels of CRP. As a result, we and the broader scientific community believed further study in pancreatic cancer and other solid tumors with evidence of systemic inflammation was warranted. Unfortunately, the larger studies did not confirm this hypothesis," said Rich Levy, Incyte's chief drug development officer.