Mirati Therapeutics price target raised to $64 from $37 at Citi. Citi analyst Yigal Nochomovitz raised his price target for Mirati Therapeutics to $64 from $37 to reflect increased conviction on sitravatinib plus nivolumab in IO refractory non-small-cell lung cancer patients. The analyst updated his model to reflect the positive interim Phase 2 data reported in April and increased his peak share estimates for sitravatinib in IO refractory NSCLC patients to 24% from 12%. Further, Nochomovitz’s sensitivity analysis for preclinical KRAS G12C inhibitor, MRTX849, points to “significant upside.” While still preclinical, MRTX849 has garnered “substantial interested” from pharma and investors given the significant untapped market opportunity and the apparent superior preclinical profile versus competitor drugs, the analyst told investors in a research note dated Tuesday. He keeps a Buy rating on Mirati Therapeutics
Thursday, July 5, 2018
Valeritas started at buy by Oppco
Valeritas initiated with an Outperform at Oppenheimer. Oppenheimer analyst Steven Lichtman started Valeritas with an Outperform rating and $3.50 price target, citing its unique insulin delivery system, large market opportunity and drivers ahead.
Canopy Growth announces supply agreement with Alberta commission
Canopy Growth announces the completion of a supply agreement with the Alberta Gaming, Liquor & Cannabis Commission, or “AGLC,” to supply the province with premium cannabis products in a variety of forms including whole-flower, oil, and Softgel capsules. “Under the terms of the agreement, the largest of its kind in Canada, Canopy Growth will supply Alberta with over 15,000 kilograms of cannabis products to support the first six months of the province’s adult use recreational cannabis market set to open on October 17, 2018. Inventory will be replenished by the company as requested and the AGLC reserves the right to extend the agreement for up to two additional years in 12-month increments. Should the need arise, Canopy Growth is prepared to go beyond the minimum supply commitment to ensure the AGLC has sufficient product to meet market demand,” the company stated
Pharmaceuticals attempt to fight new U.S. insurer tactic
Major pharmaceutical companies are attempting to limit the economic damage from a new U.S. insurer tactic that helps patients avoid expensive drugs, according to Reuters. The maneuver by insurers is forcing drug makers to assist patients with their copays causing a decline in U.S. drug prices. Pharmaceutical companies are trying to battle the insurers by including new payment options to evade detection from copay accumulators and taking tougher stances in pricing negotiations. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY), AbbVie (ABBV), Amgen (AMGN) and Sanofi (SNY).
Wednesday, July 4, 2018
I-Mab closes one of China’s biggest-ever biotech fundraisings
China’s I-Mab Biopharma just raised a massive $220 million in a third-round fundraising that once again reveals the growing strength of the country’s emerging biotech sector.
The Shanghai-based company—which grew out of the merger between Third Venture Biopharma and Tasgen Biotech last year—says it plans to plow the cash back into its pipeline of preclinical and clinical-stage antibody drugs for cancer and autoimmune disorders. It’s had no difficulty raising cash to fund its endeavors, having completed a $150 million series B round in March 2017.
I-Mab will need plenty of cash if it to pursue its strategy of taking multiple programs through the clinic simultaneously. It has already filed for approval to start trials of several drug candidates in China and the U.S., including multiple phase 2 and phase 3 studies, with more on the way.
Last year, I-Mab boosted its pipeline by licensing MorphoSys’ anti-CD38 antibody MOR202—a potential rival to Johnson & Johnson’s multiple myeloma drug Darzalex—in China and neighboring territories for $120 million. It also licensed Chinese rights to interlukin-7 candidate HyLeukin from South Korean biotech Genexine in a deal reported to be worth $548 million, including $12 million upfront.
The company has a two-pronged approach to R&D, with one portion of its pipeline directed at the domestic Chinese market and a second focusing on therapies for the U.S. and other international markets.
“This round of financing will facilitate further development of our innovative assets in China and internationally,” said Jingwu Zang M.D., Ph.D., the founder and CEO of I-Mab.
The scale of the fundraising is a measure of just how far China’s biotech industry has come in recent years. The country is reported to be already conducting more clinical trials than the U.S. and is pushing hard to develop advanced new therapies including CAR-T. Last year, a CAR-T candidate for multiple myeloma from Legend Biopharma was a surprise hit at ASCO.
There are already warnings that the China’s biotech sector could be getting overheated. In a recent ChinaBio Group article, Jonathan Wang of OrbiMed Asia suggested there is “a big bubble forming right now [and] a few companies have raised financings or are planning IPOs at overly high valuations, compared to their counterparts in other markets, such as the U.S.”
On the other hand, Wang sees “a very real, unprecedented boom in China’s biopharma industry, triggered by the CFDA reform, the influx of returnees to China, the high interest of investors and the establishment of new exit channels.”
I-Mab’s series C was led by Hony Capital, with Hillhouse Capital, HOPU Investments, CDH Investment, Ally Bridge Group, Singapore-based EDBI, and existing investors C-Bridge Capital and Tasly Capital also participating.
Invion technology efficiently destroys ovarian cancer cells in vitro
- Invion and Hudson Institute of Medical Research are collaborating on R&D projects for the PhotosoftTM technology as a treatment of a range of cancers
- PhotosoftTM characterisation studies have been completed in multiple ovarian cancer cell lines
- PhotosoftTM caused efficient and highly effective cancer cell destruction in vitro
Invion Limited (ASX: IVX, ‘Invion’ or ‘Company’) is pleased to announce that initial characterisation of the novel chlorophyll based photodynamic therapy, PhotosoftTM in ovarian cancer has been completed under its Research & Development Alliance Agreement with leading Australian medical research institute, Hudson Institute of Medical Research (‘Hudson Institute’).
Spectral characteristics, cellular uptake and clearance, intracellular localisation, dark and photo-toxicity were investigated in multiple ovarian cancer cell lines (human and murine) in both 2D and 3D organoid culture in vitro. PhotosoftTM caused efficient and highly effective cancer cell destruction in vitro, with 100% cell death achieved in a matter of minutes following light activation.
In the absence of light activation, PhotosoftTM was completely non-toxic to cells – highlighting its potential for clinical application without inducing non-specific phototoxicity, a major impediment experienced in the clinical application of other photosensitiser compounds.
Photodynamic Therapy (PDT), combining a photo-sensitising compound and light to generate destructive reactive oxygen species, is an effective strategy for tumour tissue ablation. The efficiency of a photosensitiser is one of the main factors for determining its feasibility as a Photodynamic Therapy. Whilst several photosensitisers are clinically approved, some have undesirable properties including extreme photosensitivity, poor water solubility and inadequate selectivity, limiting their clinical application.
Dr Andrew Stephens, Group Head of the Ovarian Cancer Biomarkers Research Group at Hudson Institute said, ‘The Photosoft characterisation studies demonstrate that PhotosoftTM efficiently produces reactive oxygen species to destroy tumour cells in vitro, and that modulation of light energy can be used to control the mechanism of induced cell death.’
Managing Director and Chief Executive Officer, Dr Greg Collier, said ‘Ovarian cancers have a greater than 70% 5-year mortality rate, and patients almost universally develop recurrent, chemo-resistant disease. New therapies are urgently needed and we are very pleased with this early progress under our R&D Alliance Agreement with Hudson Institute. This data lays the groundwork for ongoing preclinical trials of the PhotosoftTMtechnology as an indication for chemo-resistant, solid ovarian tumours.’
Further results of these studies will be presented in September 2018 at a major international conference.
Rare Cancer Challenge: Genomic Screening and Clinical Trials
Although different countries define them differently, in the U.S., a rare cancer is defined as six or less out of 100,000 people having that cancer. European regulatory agencies tend to classify a rare cancer as prevalence of fewer than five cases out of 10,000. The International Rare Cancers Initiative (IRCI) defines a rare cancer as a cancer with an incidence of three or fewer newly diagnosed people out of a population of 100,000 pear years.
One of the problems, though, is that biopharmaceutical companies are focusing their drugs for smaller and smaller and more clearly delineated patient populations. An example is in April, the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations, which will be detected by an FDA-approved test.
That’s the trend. And both “rare cancers” and “sub-populations of cancers” present a challenge to companies conducting clinical trials—finding enough patients for those trials. And getting insurers to pay for those tests before approval and after. As Bloomberg noted, “The new medicines aim to shrink tumors by targeting a rare genetic anomaly—appearing in 1,500 to 5,000 patients’ tumors in the U.S. annually—that can spur cancer’s growth. Bayer AG is out in front with a drug that could go on sale by the end of the year. Roche Holding AG is pursuing the same target.”
Here’s a look.
On June 19, Roche agreed to pay $2.4 billion to acquire the rest of Foundation Medicine (FMI), which focuses on genomic profiling. FMI specializes in testing for cancer, offering comprehensive genomic profiling tests.
In terms of the tests for the Roche drug, physicians would need to test about 100 patients to identify a single candidate for the drug. And the tests aren’t cheap, they run thousands of dollars per person.
Fabrice Andre, with the department of medical oncology at Institute Gustave Roussy near Paris, told Bloomberg, “The question of access is really a question of whether a doctor will decide to do the test. What is going to be the uptake of doctors to prescribe a test that detects one percent of the population?”
This is an aspect of personalized medicine, the much-publicized but slow-to-gain traction movement toward using broad genomic testing to identify the best medications and treatments for patients. For years drug companies worked to develop drugs that worked on the broadest population possible, somewhat out of necessity, because they didn’t have the genetic tools and insight to narrow them down. Now they do, and the trend is toward developing drugs for smaller and smaller patient populations.
Even though it answers the conundrum of why some patients respond to drugs and others don’t, it still costs millions of dollars to develop a drug, often for a smaller group of patients, which justifies higher price tags, along with, in many cases, expensive genomic testing.
Bayer, on its part, licensed larotrectinib from Loxo Oncology in November 2017 for $1.55 billion. Loxo filed with the FDA and expects to get an answer by November 2018.
About a month after that deal, Roche acquired Ignyta for $1.7 billion. Ignyta has a compound similar to Loxo’s, but aren’t as advanced in the development process. Roche is still evaluating the drug to determine how well it works.
Bloomberg writes, “Both target a genetic anomaly called TRK fusion, in which two genes join together to spur the production of proteins that make cancers grow. The challenge of finding patients is one of the reasons Loxo elected to partner with Bayer for larotectinib, said Jacob Van Naarden, the U.S. biotech’s (Loxo) chief business officer. Oncologists usually focus on tumors in one specific area, few have training in molecular testing, and many have never heard of TRK fusion, Van Naarden said.”
The genetic sequencing tests generally run from $1,000 to $3,000 per patient. Some institutions will only order the test if the insurance company will pay. Memorial Sloan Kettering, however, offers its version of those tests to everyone with advanced cancer, whether they can pay or not. David Hyman, chief of early drug development at Kettering told Bloomberg that when the cancer drug’s monthly price tag can be dramatically higher than the test price, determining who benefits the most “seems to me to be the best value in medicine right now.”
Identifying the mutations and patients’ appropriateness for these drugs, which can have price tags in the five- and sometimes six-figure range, is of value to payers, and helps justify the outlay.
Obviously, there are multiple problems. Finding the patients needed for clinical trials can be difficult, because there are few of them and the companies need to convince physicians to run screens for them. Once the drugs are regulated, the companies still need to convince physicians to run the tests to further narrow down the patient’s disease and treatment paradigm.
In March, Medicare and Medicaid agreed to pay Foundation Medicine for its test, which includes the TRK fusion genes. And Bayer’s partner Loxo is working with Illumina on a test that will evaluate 170 different genes.
Sandra Horning, Roche’s chief medical officer, told Bloomberg, “The overall goal indeed is to make such broad testing available to more patients and to make the results more actionable.”
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