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Sandeep Singh Dhillon
NIH And 11 Pharmaceutical Companies Announce $215 Million Collaboration – Forbes
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By Ellie Kincaid , FORBES STAFF

The U.S. National Institutes of Health and 11 pharmaceutical companies today announced the launch of a five-year cancer immunotherapy research collaboration as part of the Cancer Moonshot. In total the partners will contribute $215 million to what they are calling the Partnership for Accelerating Cancer Therapies (PACT).

PACT’s fundamental question, NIH director Francis Collins told reporters in a press conference, is, “why doesn’t immunotherapy work for all patients in all types of cancer, and what can we do about that?”

Top priority in answering that question is testing immune- and cancer-related biomarkers in clinical trials to understand the mechanisms of how cancers respond to or resist immunotherapy. With standardized biomarkers to look at and harmonized assays to test them across many different trials, data from different studies will be more easily compared, Collins said.

Developing standardized biomarkers for immuno-oncology will be “extremely enabling,” like standardizing IP addresses in the early days of the web, Thomas Hudson, vice president for oncology discovery and early development at AbbVie, said at the press conference.

He expects having standard biomarkers and sharing data will help provide a scientific basis for deciding which cancer drugs to try in combination. Given the sheer number of potential combinations, that’s “one of the key reasons we got involved in PACT,” he said. “We don’t think random combinations are the way to go.”

The data for researching biomarkers will come from four National Cancer Institute-funded Cancer Immune Monitoring and Analysis Centers at Dana-Farber Cancer Institute, Stanford Cancer Institute, Precision Immunology Institute and the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai and University of Texas MD Anderson Cancer Center. The centers will support adult and pediatric immunotherapy trials with tumor and immune profiling.

Getting access to data from clinical trials NCI supports was “very attractive,” Hudson said.

Which biomarkers the collaboration will focus on first is still to be discussed at a meeting the companies will likely have next month, said Douglas Lowy, NCI’s acting director.

The 11 pharmaceutical companies participating are AbbVie, Amgen, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb, Celgene Corporation, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research and Pfizer. Each will contribute up to $1 million per year for the five-year partnership, totaling $55 million.

The NCI will make up the rest with $160 million in funding mostly from the Cancer Moonshot, with some coming from regular appropriations, Lowy said.

Read the full article at https://www.forbes.com/sites/elliekincaid/2017/10/12/nih-and-11-pharmaceutical-companies-announce-215-million-collaboration/#287c1aef7b54

Sandeep Singh Dhillon
Pfizer Acquires Medivation for $14 Billion (PFE, MDVN) – Investopedia.com
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American pharmaceutical corporation, Pfizer Inc.(PFE) has confirmed it will be acquiring San Francisco-based biopharmaceutical company, Medivation Inc (MDVN) for $81.50 a share and a total enterprise value of $14 billion in an all-cash deal. The deal is projected to expand Pfizer’s portfolio with the addition of the leading prostate cancer drug produced by Medivation.

“The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer,” said Ian Read, Chairman and Chief Executive Officer, Pfizer. “The addition of Medivation will strengthen Pfizer’s Innovative Health business and accelerate its pathway to a leadership position in oncology, one of our key focus areas, which we believe will drive greater growth and scale of that business over the long-term. This transaction is another example of how we are effectively deploying our capital to generate attractive returns and create shareholder value.” According to the released statement, the deal is “expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter.” (See also Who Is Driving Pfizer’s Management Team? )

The deal is worth a lot more than the $52.50 a share offer made by France’s Sanofi in April. Medivation shares closed at $67.16 on Friday, pegging its market value at $11.1 billion. The company produces prostate cancer drug, Xtandi, which has already been approved for sale in many countries and is forecasted to generate over $5.7 billion in annual sales by 2020. The firm is also in the process of developing a drug for breast cancer, Talazoparib, and another for called Pidilizumab for the treatment of lymphoma. The latter has the potential to be combined with IO therapies in Pfizer’s portfolio

Pfizer Motivation
Pfizer CEO, Ian Read said in May, that the company has been looking to acquire late-stage pharmaceutical assets as it already has exposure to early-stage drugs. The company’s oncology offerings include breast cancer drug, Ibrance, and other immune-oncology drugs. The $14 billion deal with Medivation will strengthen the CEO Read’s efforts to boost the company’s business. Xtandi is already approved for sales in U.S. and Pfizer will divide its sales with Medivation’s partnered company, Astellas Pharma Inc.

According to Evaluate Pharma, Xtandi, could be one of the top-selling cancer drugs by 2020. On the other hand, the equal prostate-cancer treatment against Xtandi is produced by Johnson & Johnson called as Zytiga. The analysts believe that J&J may pose a threat to Xtandi in the short-run.

After rejecting the French drug maker Sanofi’s offer in April, the firm reached out to more potential buyers such as Pfizer, Gilead Sciences Inc., Celgene Corp. and Amgen Inc. The deal was initially valued at $9 billion consisting of $58 per share in cash and $3 a share as a contingent value right

The current M&A between the drug and biotechnology industry illustrates the future demand for new cancer treatments adding up to patient’s lives and burgeoning revenues of the companies holding the business.

The Bottom Line
Following the takeover talks, Medivation’s share price have appreciated by two folds in the past six months. Medivation’s investors were upbeat with the news as its share price has increased significantly by around 20% in the pre-market trading on Monday.

The Big Oncology Launches of 2016
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Novartis and Pfizer join forces to upend oncology dogma
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For the past four years, the cancer research community has been acting on an accumulation of evidence suggesting that hard-to-treat tumors driven by mutations in a gene called KRAS have an Achilles’ heel. While KRAS itself seemed undruggable, these tumors appeared to be addicted to autophagy, a cellular recycling system that helps cells be thrifty in times of stress and starvation. The field had latched on to the idea that KRAS-mutant tumors could be shut down by inhibiting autophagy and researchers had begun acting on it, hoping to find new therapies for pancreatic cancer and other pernicious diseases.

The flurry of activity spurred by this idea, however, may be coming to a halt based on new findings from the Novartis Institutes for BioMedical Research (NIBR), and also, coincidentally, from Pfizer. Two independent industry labs found evidence that casts doubt on the hypothesis that autophagy inhibitors will shut down KRAS-driven tumors.

“The idea had become dogma in the field,” says Leon Murphy, a director in the Developmental and Molecular Pathways group at NIBR. “But in every case we probed, we found that the hypothesis was not valid.”

After a chance encounter at a conference led the industry researchers to learn of one another’s work, they joined forces to bring their data to light by publishing a paper (link is external) together in the Proceedings of the National Academy of Sciences. The paper is unusual because results that de-validate hypotheses often go unpublished.

“Jointly we have accumulated an enormous amount of negative validation data,” says Murphy. “We feel it’s important to release these data so that the community will not go off in the wrong direction and invest in areas that aren’t likely to lead to the development of a therapeutic.”

The need for new therapies for KRAS-driven tumors is strong. Approximately 90 percent of pancreatic cancer tumors involve KRAS mutations, and only 5 to 15 percent of patients survive the disease. 1So far, there are no approved drugs that inhibit mutant KRAS and there are no obvious ways to interfere with the mutant protein’s action.

“The idea of attacking KRAS-driven tumors by shutting down autophagy was super attractive,” says Beat Nyfeler, a NIBR investigator and autophagy expert who led the Novartis investigation. “An autophagy inhibitor would have met a huge unmet medical need.”

Gathering evidence
Acting on this potential, the team at NIBR screened a collection of 47 cell lines, including some with cancer-causing KRAS mutations and some with healthy (i.e., wildtype) KRAS. They used RNA interference to disable different components of autophagy. What they found was striking: Disabling autophagy had no effect on growth across all 47 cell lines.

In parallel, Christina Eng, a principal scientist at Pfizer and also an autophagy expert, had become interested in inhibiting autophagy to treat KRAS-driven tumors. “The first step is trying to validate the hypothesis,” she says. “But we couldn’t.”

Chance brought Eng and Nyfeler to the Keystone Autophagy Meeting in Austin, Texas in the spring of 2014. Eng sought out Nyfeler to say hello. She soon learned that they both would be presenting findings refuting the autophagy hypothesis.

“It was shocking,” says Eng. “But what was really beautiful was that it was a perfect complement of tests. He used one set of models, and I used another, but the data were identical.”

Nyfeler followed the screening experiment with another in which he used genome editing technology to delete autophagy in the cultured cell lines. Again he found no effects on cell growth. He ran the test again, this time growing the cancer cells in mice rather than in plastic dishes. The results remained the same.

At Pfizer, Eng had performed the same experiments, targeting the same genes contributing to autophagy. She, too, started in cultured cells and then moved to mouse models and consistently found no effects on growth.

A missing mechanism
The researchers also made an important discovery about the anti-malarial drug chloroquine. Recent research suggests that chloroquine might also work against cancer, ostensibly by inhibiting autophagy, and clinical trials are currently underway to test this hypothesis. But the Novartis-Pfizer team showed that chloroquine slows growth equally in cells whether autophagy is working or has been disabled. “Chloroquine does block autophagy, and it does inhibit cell proliferation, but these things have nothing to do with one another,” says Nyfeler.

The findings do not rule out chloroquine as a promising drug for use in combination with other therapies for cancer, says Eng. “But we need to focus on the mechanism by which it’s actually inhibiting the growth of those tumor cells, and it’s not through autophagy.”

Labs currently acting on the hypothesis that KRAS-mutant tumors are addicted to autophagy and vulnerable to its inhibition may need to re-evaluate this strategy given these findings. “That’s the point,” says Murphy. “Hopefully this will allow researchers to focus on finding different ways that autophagy is important in cancer.”

1S Eser, et. al. Oncogenic KRAS signaling in pancreatic cancer. British Journal of Cancer (2014) 111, 817-822.

Main image: HeLa cells by Paul Andrews/University of Dundee/Wellcome Images. Modified by PJ Kaszas.

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