From Outperform; target to $10 from $35.
Monday, June 3, 2019
Natera Test Detects Immunotherapy Response in Metastatic Cancer: ASCO
A new study demonstrates the ability of Natera’s Signatera™ test to assess patient response to immunotherapy in the metastatic setting across multiple cancer types by detecting molecular traces of circulating tumor DNA (ctDNA) in the blood. The study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 1, 2019.
The study, conducted by Princess Margaret Cancer Centre in Toronto, enrolled 70 patients with advanced cancer, including head and neck, triple-negative breast, melanoma, and ovarian cancers. Patients were treated with the single-agent immune checkpoint inhibitor pembrolizumab as part of the phase II INSPIRE trial (NCT02644396). The study used Signatera to assess ctDNA at baseline and again at the start of the third treatment cycle.
Results showed a strong correlation between changes in ctDNA and overall survival (adjusted HR=0.38, p=0.004), progression-free survival (adjusted HR=0.47, p=0.006), and overall clinical response rate, illustrating that ctDNA may be a valuable predictive biomarker for patients with mixed solid tumors treated with checkpoint inhibitors. Signatera, a personalized, tumor-informed blood test, detected ctDNA in 68 out of 70 patients at baseline (97 percent sensitivity).1
The study (abstract 2542), titled “Bespoke Circulating Tumor DNA (ctDNA) Analysis as a Predictive Biomarker in Solid Tumor Patients (pts) Treated With Single Agent Pembrolizumab (P),” can be accessed here.
Forty Seven at ASCO with snapshot of promising CD47 data — and $115M IPO
Here’s a neat trick for up-and-coming oncology biotechs to consider.
Execs for Forty Seven, the CD47 star founded by Stanford’s legendary Irv Weissman, filed for a $115 million IPO on Friday and then — instead of hunkering down for the quiet period — promptly flew out to Chicago to tout a promising set of proof-of-concept data for their lead drug at ASCO.
Execs for Forty Seven, the CD47 star founded by Stanford’s legendary Irv Weissman, filed for a $115 million IPO on Friday and then — instead of hunkering down for the quiet period — promptly flew out to Chicago to tout a promising set of proof-of-concept data for their lead drug at ASCO.
Forty Seven has preliminary data on 22 patients taking 5F9, with an impressive initial snapshot of early data for the small group. Fifteen of the patients suffer from treatment resistant diffuse large B-cell lymphoma (DLBCL) and the other 7 have follicular lymphoma. In DLBCL investigators tracked an objective response rate of 40% with a third achieving a complete response; in follicular lymphoma the ORR was 71% with 43% achieving a CR.
It’s still too early to set a median rate on the duration of response, but the researchers say that just 1 of the 22 saw their cancer progress after 6 months.
5F9 is an antibody that targets the popular CD47 receptor targets, which has inspired a slate of development efforts. Hitting that target is intended to scramble the “don’t-eat-me” signal that cancer cells rely on to avoid being chewed up by macrophages. And the Menlo Park, CA-based biotech has 6 studies underway in solid tumors, acute myeloid leukemia, non-Hodgkin’s lymphoma and colorectal carcinoma.
It’s still too early to set a median rate on the duration of response, but the researchers say that just 1 of the 22 saw their cancer progress after 6 months.
5F9 is an antibody that targets the popular CD47 receptor targets, which has inspired a slate of development efforts. Hitting that target is intended to scramble the “don’t-eat-me” signal that cancer cells rely on to avoid being chewed up by macrophages. And the Menlo Park, CA-based biotech has 6 studies underway in solid tumors, acute myeloid leukemia, non-Hodgkin’s lymphoma and colorectal carcinoma.
The biotech plans to push its studies ahead as a mono therapy as well as in combinations with PD-1/PD-L1 and CTLA-4 checkpoint inhibitors, starting with Genentech’s Tecentriq.
Forty Seven has an interesting past. The 78-year-old Weissman was able to wrangle substantial support for his early research work on CD47 from the California Institute for Regenerative Medicine, even launching early human studies — a rare feat in academic circles. Weissman and former CIRM chief Alan Trounson enjoyed a tight relationship, which extended to Trounson’s appointment to the board of another startup that Weissman had helped found — StemCells —shortly after his departure from the agency. And Forty Seven is still getting money from CIRM under its latest $19 million grant.
Forty Seven has an interesting past. The 78-year-old Weissman was able to wrangle substantial support for his early research work on CD47 from the California Institute for Regenerative Medicine, even launching early human studies — a rare feat in academic circles. Weissman and former CIRM chief Alan Trounson enjoyed a tight relationship, which extended to Trounson’s appointment to the board of another startup that Weissman had helped found — StemCells —shortly after his departure from the agency. And Forty Seven is still getting money from CIRM under its latest $19 million grant.
So far the company has raised $149 million and spent $84 million of that, according to the S-1.
Mark McCamish, a Novartis vet who enjoyed a $3.7 million pay package last year, is the CEO. He also has 3.6% of the stock. Lightspeed Ventures Partners and Sutter Hill Partners each control 16.8% of the stock, followed by Clarus at 15.8%. And Weissman has retained a hefty 9.5% of the equity, which could soon be worth a small fortune.
Forty Seven includes the following companies on its list of rivals in the field: Celgene Corporation, Trillium Therapeutics, Alexo Therapeutics, Arch Therapeutics, Surface Oncology, Novimmune, OSE Immunotherapeutics and Aurigene Discovery Technologies.
Ironwood, Allergan Start Phase 2 for Non-opioid IBS Pain Med
Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD), a GI-focused healthcare company, today announced the initiation of patient dosing in a Phase II clinical trial evaluating MD-7246 in patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). Data from the Phase II trial are expected in the second half of 2020.
Ironwood and Allergan are evaluating MD-7246, an investigational new product, as an oral, intestinal, non-opioid, pain-relieving agent for patients suffering from abdominal pain associated with certain GI diseases. MD-7246 is a delayed-release formulation of linaclotide designed to provide targeted delivery of linaclotide to the colon, where the majority of the abdominal pain associated with IBS-D is believed to originate, and to limit fluid secretion in the small intestine resulting in minimal impact on bowel function.
“Abdominal pain is a dominant symptom experienced by approximately 16 million people in the U.S. living with IBS-D, and there are a limited number of treatment options for patients seeking effective pain relief,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of drug development at Ironwood. “Through its delayed release and differentiated mechanism of action, we believe that MD-7246 has the potential to target abdominal pain in patients with IBS-D and look forward to advancing it as a potential abdominal pain-relieving agent for this population. If successful, we hope to explore the broader potential of MD-7246 for the more than 50 million patients estimated to suffer from recurring abdominal pain across a broader range of GI disorders.”
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