Grail validation data show highly accurate detection of cancers, tissues of origin

Grail validation data show highly accurate detection of cancers, tissues of origin

Photo: harmpeti, Getty Images

A test in development for early detection of cancers was able to pick up a dozen of the deadliest cancer types at stages I-IV with a high degree of accuracy while also determining where the tumor was located, according to validation data announced Monday.

Menlo Park, California-based Grail said an analysis from its Circulating Cell-Free Genome Atlas, or CCGA study, showed that its early detection test could pick up more than 20 total cancer types with a low false-positive rate. Data from the analysis will be presented at the American Society of Clinical Oncology Breakthrough conference, which takes place in Bangkok from Friday through Sunday.

“Today, cancer remains the second leading cause of death worldwide, and we believe an effective multi-cancer early detection technology has the potential to transform the cancer care landscape,” Grail CEO Hans Bishop said in a statement.

The data set included 927 participants from the CCGA, including 654 who had cancer and 273 who did not, as well as 337 participants without cancer from the STRIVE study. The data showed a high degree of specificity, 99.3 percent, meaning there was a low false-positive rate. When looking at 12 deadly cancer types – anal, bladder, colorectal, esophageal, head and neck, liver/bile duct, lung, lymphoma, ovarian, pancreatic, plasma cell neoplasm and gastric – the detection rate was 76 percent, with a 99.3 percent specificity. Detection rates between stages I and IV were 39-92 percent. For those cancers, the tissue of origin – which helps to accurately identify where in the body a cancer originates – was provided for 97 percent and correctly identified in 93 percent of cases.

Among the more than 20 cancer types, the detection rate was 55 percent, ranging from 18-93 percent depending on stage and with the tissue of origin correctly identified in 93 percent of cases.

Minimizing false positive rates is a crucial aspect of the kind of early cancer detection system Grail is developing, with even seemingly small false positive rates making a significant difference for patients. When it reported data on 2,508 participants in its study at the ASCO annual meeting in June, Grail reported a 99 percent sensitivity rate – corresponding with a 1 percent false positive rate that the company had forecast was likely to go down.

While a false positive rate of 1 percent in a 5,000-patient population is manageable, an interviewed expert at ASCO said, it could become more problematic when the population reaches hundreds of thousands or millions. The danger of a high rate is that it could create problems for the cost effectiveness of early detection, as patients who got false positive results would have to be subjected to several tests afterward.

Source: Grail validation data show highly accurate detection of cancers, tissues of origin

Kite Pharma founder’s venture capital firm closes new $600M fund

Kite Pharma founder’s venture capital firm closes new $600M fund

Photo: Feodora Chiosea, Getty Images

A venture capital firm formed by a founder of one of the first companies to win Food and Drug Administration approval for a cell therapy for cancer closed a new fund worth more than half of $1 billion.

Boston-based Vida Ventures said Thursday that it had closed its Vida Ventures II, or Vida II fund, raising $600 million. The close brings the total amount the firm has raised to about $1 billion since the firm’s founding in late 2017 by Arie Belldegrun, founder of Kite Pharma. Kite won FDA approval for Yescarta (axicabtagene ciloleucel) in diffuse large B-cell lymphoma in October 2017. In August of that year, Gilead Sciences announced it would acquire Kite for $11.9 billion.

A Form D filed with the Securities and Exchange Commission on July 15 states that the firm had sought to raise $600 million. Another Form D, filed Dec. 6, 2017, states that Vida had raised $254.8 million.

“Vida maintains a unique advantage by combining a best-in-class investment team with firsthand business and scientific expertise that directly applies to our portfolio investments,” Belldegrun said in a statement. “With the added expertise from our newest team members, we are positioned better than ever before to add value by identifying and investing in meaningful science that ultimately has the potential to help patients in need.”

In its most recent publicly announced investment, Vida co-led a $105 million Series A funding round for Kronos Bio, along with Omega Funds. The San Mateo, California-headquartered company is developing small-molecule drugs to target historically undruggable targets.

Last year, Belldegrun and fellow Kite alumnus David Chang founded Allogene, a South San Francisco, California-based company developing “off-the-shelf” allogeneic CAR-T therapies, which use T cells from donors rather than requiring the harvesting of patients’ own T cells. The company raised a $120 million private financing in September of last year before filing to go public the same month.

Source: Kite Pharma founder’s venture capital firm closes new $600M fund

Nanotech injection nabs cancer cells on the run

Nanotech injection nabs cancer cells on the run

Cellular soldiers created using the body’s own defenses can track down and kill cancer cells that escape during surgeries, researchers report.

This could prevent metastasis and save lives, particularly in cases of triple-negative breast cancer.

Researchers attached two proteins to the surface of lipid nanoparticles: TNF-related apoptosis-inducing ligand—or TRAIL—and the adhesion receptor E-selectin. The injected nanoparticles then adhere to white blood cells, and the introduction of these TRAIL-coated leukocytes into the bloodstream before, during, and after tumor removal kills all cancer cells loosed as a result.

“Collisions between the TRAIL-coated leukocytes and cancer cells in the bloodstream are happening constantly,” says Michael King, a professor of engineering and chair of the biomedical engineering department at Vanderbilt University.

“We’ve tested this both in the bloodstream and in hundreds of blood samples from cancer patients being treated in clinics across the country. In all cases, within two hours, the viable cancer cells are cleared out. This has worked with breast, prostate, ovarian, colorectal, and lung cancer cells.”

Not only can the method work during surgeries, King says, but also potentially with patients who already suffer metastatic cancer in multiple sites and who have no worthwhile treatment options. Because all the components of the TRAIL-coated leukocytes occur naturally in the body, it increases the potential for a quicker path from the bloodstreams of mouse models to human trials.

Surgical intervention in breast cancer is a known cause of metastatic growth and accelerated tumor relapse, either because of cancer cells shed during the process, inflammation at the wound site, or a combination of the two factors. Chemotherapy is the most widely used treatment for the resulting metastasis, but still, the five-year survival rate for triple negative breast cancer sits well below 30%.

The group’s past experiments with TRAIL-coated leukocytes were effective in blocking metastasis, but required multiple repeated injections to sustain their beneficial effect. King says this new breakthrough overcomes those issues by designing three simple doses to coincide with the surgical procedure.

The paper appears in Science Advances. Support for the work came from the National Institute of Health and the NCI/NIH Cancer Center.

Source: Vanderbilt University

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Source: Nanotech injection nabs cancer cells on the run

Biotech M&A takes off as Sanofi and Celgene spend $20 billion

Biotech M&A takes off as Sanofi and Celgene spend $20 billion

(Reuters) – Biotech deal activity exploded on Monday with French drugmaker Sanofi and U.S.-based Celgene spending a combined total of more than $20 billion to add new products for hemophilia and cancer to their medicine cabinets.

The acquisitions will fuel expectations for a busy year of mergers and acquisitions (M&A) as large drugmakers snap up promising assets from smaller rivals to help revive growth.

Sanofi agreed to buy U.S. hemophilia expert Bioverativ for $11.6 billion, its biggest deal for seven years, while Celgene is paying about $9 billion for the 90 percent of cancer specialist Juno Therapeutics it does not already own.

The two cash deals were agreed at a prices of $105 and $87 per share respectively. Shares in Bioverativ leaped 63 percent in early U.S. trading and Juno jumped 27 percent, reflecting the offers, while Sanofi fell 4 percent. Celgene was little changed.

Other biotech stocks were driven higher by the takeover news, with rivals to Juno including Bluebird Bio , Sangamo Therapeutics and Cellectis each gaining around 10 percent.

“The signs are good for biotech deal activity in 2018,” said Chris Stirling, head of KPMG’s global life sciences practice.

Big companies are under pressure from declining sales of older treatments and many are struggling to find sufficient high-value replacements from within their own laboratories, making buying in products and know-how an attractive option.

“It takes a long time to introduce technology that makes a significant difference, and in the interim CEOs are looking at any way to get their hands on product where they believe they can make a decent return,” Stirling said. “They’ve got to be seen to be doing things, otherwise they really struggle to convince investors.”

Both Sanofi and Celgene had been seen as likely multibillion-dollar acquirers.


FILE PHOTO: A scientist prepares protein samples for analysis in a lab at the Institute of Cancer Research in Sutton, Britain, July 15, 2013. REUTERS/Stefan Wermuth/File Photo

The French group, which faces mounting competition in its key diabetes unit, lost out on buying U.S. cancer firm Medivation to Pfizer in 2016, and also missed acquiring Swiss-based Actelion, which was bought by Johnson & Johnson last year.

Celgene, meanwhile, needs to dilute its reliance on cancer drug Revlimid. It had been widely tipped as a buyer for Juno, whose technology is at the cutting edge of cancer treatment.

Juno is one of several pioneers of a system to modify immune cells to fight tumors and its JCAR017 product is likely to reach the market in 2019, behind rival approval treatments from Novartis and Gilead.

FILE PHOTO:A scientist prepares protein samples for analysis in a lab at the Institute of Cancer Research in Sutton, July 15, 2013. REUTERS/Stefan Wermuth/File Photo.

Gilead only recently jumped into the space after acquiring Kite Pharma last year for $12 billion in one of the few standout deals during a relatively subdued year for biotech M&A.

Despite the late start, Celgene believes JCAR017 could have peak annual sales of $3 billion and it sees the acquisition being “incrementally additive” to net product sales in 2020. Following setbacks at Juno, Celgene is paying less than the $93 a share it stumped up for just under 10 percent of the company in 2015.

Sanofi expects Bioverativ, which was spun off from Biogen last year, can deliver commercial success despite rapid changes in the $10 billion hemophilia market posed by a novel drug from Roche and the potential of gene therapy to provide a one-time cure.

Those changes have spooked some investors but Sanofi is betting that the factor replacement therapies made by Bioverativ will remain the standard of care for many years and it expects the deal to boost earnings immediately.

Monday’s two big acquisitions build on an already busy start for 2018 biotech M&A, with Celgene earlier agreeing to acquire privately-held Impact Biomedicines for as much as $7 billion, including $1.1 billion upfront, and Novo Nordisk bidding $3.1 billion for Belgium’s Ablynx.

Separate reports this month by consultancy EY and law firm Baker McKenzie both predicted a significant rise in life sciences M&A in 2018, helped by U.S. tax changes that may lift big companies’ appetite for deals.

Lazard advised Sanofi on its deal, while Guggenheim Securities and J.P. Morgan worked for Bioverativ. J.P. Morgan also worked for Celgene and Morgan Stanley for Juno.

Additional reporting by Tamara Mathias, Matthias Blamont and Shubham Kalia; Editing by Edmund Blair and Alexander Smith

Source: Biotech M&A takes off as Sanofi and Celgene spend $20 billion