Miragen Therapeutics announced data from its Phase 1 clinical trial evaluating the safety, tolerability and efficacy of cobomarsen, an inhibitor of microRNA-155, in cutaneous T-cell lymphoma, or CTCL, and in adult T-cell leukemia/lymphoma, or ATLL. The company will also discuss initial clinical experience in treating diffuse large B-cell lymphoma, or DLBCL, patients with cobomarsen. The data will be presented at the 11th Annual T-Cell Lymphoma Forum. Updated durability data for the 300mg IV infusion cohort of the Phase 1 cobomarsen clinical trial, which is the dose and route of administration being used in the ongoing SOLAR Phase 2 clinical trial, showed that four of eight patients achieved an objective response with greater than four months of durability. The Phase 2 SOLAR trial will evaluate the safety and efficacy of cobomarsen given by intravenous infusion in an active control comparison trial versus Zolinza in patients with CTCL. ORR4 is the primary endpoint that will be used in the SOLAR trial. Based on discussions with the FDA, Miragen believes the results from the SOLAR trial could allow the company to apply for accelerated approval in the United States. Data from the ongoing Phase 1 clinical trial in ATLL has shown that cobomarsen had a favorable safety and tolerability profile with no serious adverse events attributed to the drug candidate in the clinical trial and no documented opportunistic infections, which are common in patients with the disease. Four patients who demonstrated a partial response after chemotherapy have maintained their responses while on cobomarsen monotherapy. Two of these patients have been stable for more than a year. There is evidence of disease stabilization in five patients on cobomarsen, as shown in both peripheral blood and lymph nodes, without negatively impacting the number of normal immune cells. One of these lymphomatous patients with significant adenopathy prior to enrollment has remained stable on cobomarsen, as measured by CT scans, for six months. This includes an objective improvement in three out of four measurable abnormal nodes since initiating cobomarsen therapy.
Thursday, January 10, 2019
Corvus Pharmaceuticals announces preclinical data from CPI-818 study
Corvus Pharmaceuticals announced data from a preclinical study of CPI-818, its investigational small molecule T-cell signaling pathway inhibitor. Study results indicated that orally-administered CPI-818 produced tumor regression in three of three companion dogs with spontaneous, naturally occurring T-cell lymphomas, without significant toxicity. These preclinical data are being presented in a poster at the T-cell Lymphoma Forum. Based on these data, Corvus plans to submit an investigational new drug, or IND, application with the FDA in early 2019. The company plans to evaluate CPI-818 in a Phase 1/1b study in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma, cutaneous T-cell lymphoma and others. Data demonstrated cytotoxicity against several types of human and mouse T-cell lymphomas at concentrations that do not harm normal T-cells. Also, data showed evidence of Th1 skewing in human and mouse lymphocytes, indicating that CPI-818 induced the differentiation of T-cells to cytotoxic T-cells, which is thought to be an important component of the immune system’s destruction of cancer cells.
BioMarin shares well positioned for upside, says Jefferies
After meeting with management, Jefferies analyst Eun Yang keeps a Buy rating on BioMarin with a $125 price target. With multiple clinical/regulatory catalysts in 2019, BioMarin is well positioned for upside, Yang tells investors in a research note. She believes the third-year durability data for valox in mid-2019 could potentially move the shares 20%.
Herbalife Nutrition move off lows attributed to LBO potential speculation
Shares of Herbalife Nutrition have moved off their earlier lows and turned positive following a Deal.com report speculating on whether the departure of the company’s CEO could open the door for a leverage buyout, according to contacts.
Ligand Pharma gets negative Grant’s mention
“Our contention is that Ligand’s (LGND -6.2%) shots are not so sure of the net as the Street would have it,” says Grant’s Interest Rate Observer in its latest issue.
Declining revenues could be in play after 2021 as the company’s top treatments will face tougher competition, and the majority of new products under development are a decade away from commercialization.
Providence St. Joseph Health announces new $150M healthcare fund
Seattle-based Providence Ventures, the venture capital arm of Providence St. Joseph Health, raised a $150 million healthcare venture capital and growth equity fund to invest in healthcare and technology partnerships aimed at changing how care is delivered to consumers.
The funding was announced at the 37th Annual JP Morgan Healthcare Conference underway in San Francisco. It is their second such fund and will target early and growth-stage health care companies that specialize in healthcare information technology, technology-enabled services, medical devices, and healthcare services.
Providence Ventures II will invest $5 to $15 million per portfolio company with flexibility to lead investment rounds or participate as a partner.
Providence St. Joseph a not-for-profit Catholic healthcare system operating multiple hospitals across five states. It is headquartered in Washington.
“Providence Ventures’ investment model is to find and invest in companies that create needle-moving opportunities that address top priorities for PSJH,” said Aaron Martin, Providence Ventures’ managing general partner, in a statement. Martin also serves as Providence St. Joseph executive vice president and chief digital innovation officer. “We partner closely with teams at PSJH and our portfolio companies to iterate, test, and scale their solutions at PSJH and other partner health systems.
Started in 2014, the venture arm managers an aggregate $300 million and has invested in fifteen portfolio companies and has commercial agreements with all of them. Providence Ventures has also invested in more than 25 healthcare venture capital firms.
The Providence Ventures team, which also has an office in SIlicon Valley, recently hired David Kereiakes, formerly of River Cities Capital Funds, and Rich Proscia, who formerly worked on venture initiatives at CVS and Athenahealth.
“In health care, it’s easy to say you want to be innovative. But, innovation will fall to the backburner if you don’t find the best opportunities and fund them,” said Rod Hochman, M.D., president and CEO of Providence St. Joseph Health, in a statement. “Through Providence Ventures, we have made a commitment to innovation by investing in and partnering with new companies that can help us find solutions to everyday challenges in health care.”
Anthem’s former CEO starts healthcare investment firm
After retiring from Anthem Health, Joseph Swedish has started his next act.
The former CEO and current senior advisor to the insurance giant co-founded Concord Health Partners, a health-focused private equity firm focused on investing in expansion-stage companies that have the potential to enhance the value of healthcare through technology and solutions that lower costs, improve quality or expand access to care.
The move was first reported by Axios’ Bob Herman, who ran into Swedish among the crowds at the annual J.P. Morgan Healthcare Conference in San Francisco this week.
Swedish co-founded the firm with managing partner James Olsen, who is a former managing director and head of not-for-profit healthcare at Jefferies and a former managing director of M&A at Bank of America Merrill Lynch. The firm’s chief operating officer and chief operating officer is Benson Jose.
Swedish notably presided over Anthem in challenging times, including the implementation of the Affordable Care Act exchanges as well as the insurer’s failed attempt to acquire Cigna.
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