Mon, Jul. 13, 8:42 AM
- Results from a 20-subject Phase 2 trial assessing Ohr Pharmaceutical's (NASDAQ:OHRP) OHR-102 (squalamine lactate ophthalmic solution 0.2%) in patients with macular edema secondary to branch and central retinal vein occlusion show that treatment with a combination of OHR-102 and Roche's (OTCQX:RHHBY) Lucentis (ranibizumab injection) produced greater gains in visual acuity compared to Lucentis alone. At week 38, the mean gain in visual acuity from baseline in the combination arm was +27.8 letters compared to +23.3 letters for Lucentis. The difference was clinically meaningful but unclear as to statistical significance. The data were presented at the 2015 Annual Meeting of the American Society of Retina Specialists in Vienna, Austria.
- Shares are up 23% premarket on robust volume.
Mon, Jul. 13, 6:44 AM
- A Phase 2 trial, called IMvigor 210, evaluating Roche's (OTCQX:RHHBY) Breakthrough Therapy-tagged atezolizumab (MPDL3280A) in patients with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed on initial treatment met its primary endpoint of objective response rate (ORR). In addition, patients with high amounts of PD-L1 (Programmed Death Ligand-1) correlated with increased response to atezolizumab.
- The results will be presented at an upcoming medical conference and will be reviewed with regulators as soon as possible to clarify an approval path.
- A Phase 3 study, IMvigor 211, assessing atezolizumab with standard-of-care chemo in patients with relapsed UBC is ongoing. Another Phase 3, IMvigor 010, in patients with early stage muscle-invasive bladder cancer who are PD-L1 positive and at risk of recurrence is expected to start shortly.
- Bladder cancer is the ninth most common cancer globally, with 430K new cases each year resulting in 145K deaths.
Thu, Jul. 2, 4:07 PM
- The FDA issues 510(k) clearance for privately-held Theranos' diagnostic testing system and its test for herpes simplex 1 IgG, the 153rd test that the company provides for less than $10 in its service offering. The automated system the company has developed utilizes microfluidics to perform a wide array of tests on small volume blood samples, including those from a finger stick. Some observers believe Theranos will upend the clinical diagnostics industry with its modest costs. The herpes test, for example, will sell for only $9.07 compared to ~$175 from leading reference labs.
- Theranos founder and CEO Elizabeth Holmes is one the newest celebrity entrepreneurs. Based on the company's current valuation, she is the youngest self-made female billionaire in U.S. history.
- Some diagnostics-related tickers: (NYSE:ABT) (OTCQX:RHHBY) (NASDAQ:QDEL) (NYSE:BIO) (NASDAQ:QGEN) (NASDAQ:CPHD) (NASDAQ:CEMI) (NASDAQ:TRIB) (NASDAQ:AXDX) (NASDAQ:CBMX) (NYSE:TMO)
Wed, Jul. 1, 11:08 AM
- Exelixis (EXEL -7.7%) slumps on average volume in response to the FDA's decision to extend its action date for its review of Genentech's (OTCQX:RHHBY) New Drug Application (NDA) for cobimetinib to November 11 from August 11. The agency feels that the extension is necessary in order for it to review additional data from coBRIM, the Phase 3 trial of cobimetinib and vemurafenib (Zelboraf) in patients with BRAF V600 mutation-positive advanced melanoma. The additional data were requested by the regulator.
- Cobimetinib was discovered by Exelixis. Its collaboration with Genentech began in late 2006.The companies will co-promote the product in the U.S. while Genentech will promote it ex-U.S.
- Previously: Roche's melanoma combo NDA gets Priority Review (Feb. 19)
- Previously: Roche submits NDA for skin cancer med (Dec. 15, 2014)
Fri, Jun. 26, 10:48 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Roche's (OTCQX:RHHBY +0.1%) Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy, for the neoadjuvant treatment (before surgery) of adult patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer at high risk of recurrence. A final decision by the European Commission usually takes ~60 days.
- This is the first CHMP recommendation in the neoadjuvant setting based on pathological complete response (pCR), which means that there was no evidence of tumor tissue detectable at the time of surgery in the affected breast and local lymph nodes. In a mid-stage trial, called NeoSphere, almost 40% of patients receiving Perjeta + Herceptin + taxane chemo showed a pCR compared to 21.5% of patients who received Herceptin and taxane alone.
- There are ~100K cases of HER2-positive breast cancer diagnosed in Europe each year. Breast cancers that are positive for HER2 (human epidermal growth factor receptor 2) are more aggressive than those negative for the oncogene.
- The FDA approved Perjeta for this indication in September 2013. The agency approved it in 2012 for advanced late-stage HER2-positive breast cancer.
Tue, Jun. 23, 7:46 AM
- Data from a Phase 1 extension study show that patients with severe hemophilia A who received a once-weekly subcutaneous injection of Roche's (OTCQX:RHHBY) humanized bispecific antibody ACE910 experienced significant reductions in bleeding events for up to 18.5 months. The data were presented yesterday at the International Society on Thrombosis and Haemostasis annual meeting in Toronto, Canada.
- Patients were divided into three ACE910 dose-related cohorts: 0.3 mg/kg, 1 mg/kg and 3 mg/kg. Maximum reductions in annualized bleeding rates for the three arms in patients not receiving factor VIII inhibitors were 82.7%, 100% and 100%, respectively. The maximum reduction for patients receiving factor VIII inhibitors was 100% in all three arms. The follow up periods were 5.6 - 18.5 months. A total of 18 patients were involved.
- The company intends to start a Phase 3 study in patients with Factor VIII inhibitors by the end of the year and another Phase 3 study in patients without Factor VIII inhibitors in 2016.
- ACE910 is an investigational humanized FVIIIa-mimetic bispecific monoclonal antibody engineered to simultaneously bind factors IXa and X, thereby mimicking the cofactor function of factor VIII. Roche obtained the rights from Chugai Pharmaceutical in 2014.
Mon, Jun. 22, 2:09 PM
- In an effort to simplify the complex statistics behind cancer drugs, a group of U.S. oncologists has devised a 0 to 100 rating scale that aims to assess a drug's overall benefit (extend life or delay cancer progression) versus its potential side effects. The scale to rate drugs used for advanced cancers goes up to 130. The ultimate goal is to put the data in a user-friendly mobile software app that doctors can use at the bedside. The scale was published today in the Journal of Clinical Oncology.
- How did some leading drugs fare? Well, not so good. A regimen including Eli Lilly's (LLY +0.5%) Alimta (pemetrexed), which costs ~$9,200/month, rated a big fat zero. Roche's (OTCQX:RHHBY +1.8%) Herceptin (trastuzumab) scored the highest at 48, but Avastin (bevacizumab), which costs almost $12,000/month, only managed a score of 16, as did Sanofi's (SNY +4.7%) Jevtana (cabazitaxel).
- Scores cannot be compared against each other since the ratings are based on older drugs that the newer ones were tested against in clinical studies. Also, drug costs are not directly included.
- ASCO is now soliciting comments on the proposed system. Representatives from the drugs and insurance industries provided input into the design of the scale.
Wed, Jun. 17, 8:15 AM
- Results from a Phase 1 single ascending dose study in 40 healthy volunteers of Prothena's (NASDAQ:PRTA) monoclonal antibody for the potential treatment of Parkinson's disease (PD), PRX002, demonstrated mean reductions of free serum alpha-synuclein of up to 96%. The results were highly statistically significant (p<0.00001). No serious adverse events or hypersensitivity reactions were reported. The highest dose administered was 30 mg/kg.
- Alpha-synuclein is a protein found in the blood, cerebrospinal fluid (CSF) and the brain. PD patients have decreased levels of the protein in the CSF, believed to be due to the accumulation of pathogenic alpha-synuclein in the brain which plays a role in neurodegeneration.
- A Phase 1 multiple ascending dose trial in PD patients is ongoing.
- Prothena established a global collaboration with Roche (OTCQX:RHHBY) in December 2013 to develop and commercialize alpha-synuclein-targeting antibodies, including PRX002. To date, Prothena has received $45M of the potential $600M in milestones specified in the agreement. Prothena has the option to co-promote PRX002 in the U.S. where the companies will share the development and commercial costs and profits on a 30/70 basis (PRTA: 30%; Roche: 70%). Roche as exclusive rights ex-U.S. and will pay Prothena up to double-digit royalties on commercial sales.
Mon, Jun. 15, 6:52 PM
- Relatively recent IPO Avalanche Biotechnologies (NASDAQ:AAVL) craters 40% after hours on robust volume in response to its announcement of top-line results from a Phase 2a study assessing its lead product candidate, AVA-101, in patients with wet age-related macular degeneration (wet AMD). The primary endpoint of the trial was safety, but secondary efficacy measures have apparently disappointed investors despite the study not being powered to show statistical significance.
- The trial enrolled 32 wet AMD patients at least 55 years old. They were randomized to receive AVA-101 (n=21) or control (n=11). Both arms received two ranibizumab injections [Roche's (OTCQX:RHHBY) Lucentis] at day 0 and week 4. Almost all (n=29/32) had received prior anti-VEGF therapy with a median of 10 prior injections.
- The mean change in best corrected visual acuity (BCVA) from baseline in the AVA-101 cohort was +2.2 letters compared to -9.3 letters for control. In addition, 42.9% of patients (n=9/21) receiving AVA-101 improved or maintained stable vision with two or fewer rescue injections compared to 9.1% (n=1/11) for control. BCVA improvement of at least 10 letters with no more than two rescue injections occurred in 23.8% of the AVA-101 arm versus 0% in control.
- The modest average letter gain for the AVA-101 arm is substantially less than published studies of Eylea and Lucentis, which have demonstrated mean improvements in BCVA scores of 18.9 letters and 14.2 letters, respectively. If the difference persists in subsequent studies, then Regeneron will be less likely to take advantage of its right of first negotiation for the rights to AVA-101.
- The value proposition of AVA-101, a gene therapy that contains a gene that encodes a naturally occurring anti-VEGF protein, is a single subretinal injection compared intravitreal (inside the eye) injections as frequent as once per month for Regeneron's (NASDAQ:REGN) Eylea and Roche's Lucentis.
Wed, Jun. 10, 7:31 AM
- The FDA designates Roche's (OTCQX:RHHBY) ACTEMRA/RoACTEMRA a Breakthrough Therapy for the treatment of systemic sclerosis, a rare degenerative connective tissue disease caused by the overproduction of collagen and characterized by scarring in the skin, joints and internal organs. A Phase 3 study has been initiated (NCT02453256) for the indication.
- ACTEMRA/RoACTEMRA is a humanized anti-interleukin 6 (IL-6) receptor antagonist monoclonal antibody that is currently approved for the treatment of adult patients with rheumatoid arthritis who have not responded to DMARD (Disease-Modifying Anti-Rheumatic Drugs) therapy and pediatric patients with polyarticular or systemic juvenile idiopathic arthritis. IL-6 is a pro-inflammatory cytokine that is secreted by T cells to stimulate an immune response.
- Breakthrough Therapy status provides for more intensive guidance from the FDA on a development path, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
Fri, Jun. 5, 8:15 AM
- The FDA approves Roche's (OTCQX:RHHBY) cobas HSV 1 and 2 test for the direct detection and differentiation of herpes simplex virus DNA in anogenital specimens.
- The agency also clears the cobas direct Cdiff test to detect Clostridium difficile (C. difficile) in stool specimens.
- The cobas system is an automated laboratory analyzer that performs a wide array of diagnostic tests.
Tue, Jun. 2, 1:09 PM
- Thinly traded micro cap Cerulean Pharma (CERU -12.3%) moves south on 50% higher volume, albeit on turnover of only 430K shares, in response to the presentation of data (abstract #4543) at ASCO from a Phase 1b/2 trial assessing its lead product candidate, CRLX101, in combination with Roche's (OTCQX:RHHBY -0.4%) Avastin (bevacizumab), for the treatment of patients with metastatic renal cell carcinoma (mRCC).
- The study met its primary endpoint of at least half of the patients achieving progression-free survival (PFS) of four months or greater (n=12/22). Median PFS was 9.9 months. Overall response rate (ORR) was 23%. Average durability of response was 3.5 months from partial response to time off the study.
- The source of investors' lack of enthusiasm over the data may its comparison with Roche's AVOREN study that assessed bevacizumab in combination with interferon alfa (IFN) in mRCC. Median PFS was 10.2 months for Avastin + IFN compared to 5.4 months for placebo + AFN while ORR was 30% for Avastin + IFN versus 12% for placebo + IFN.
- CRLX101 is nanoparticle-drug conjugate (NDC) that delivers highly toxic camptothecin directly to cancer cells.
Tue, Jun. 2, 11:56 AM
- Puma Biotechnology (PBYI -13.3%) drops again on 3x normal volume as investors continue to head for exits in response to less-than-expected results from a Phase 3 study, called ExteNET, that assessed its lead product candidate, PB272 (neratinib) versus placebo after adjuvant treatment with Roche's (OTCQX:RHHBY -0.6%) Herceptin (trastuzumab) in women with early stage HER2-positive breast cancer. The data were presented yesterday (abstract #508) at ASCO. Shares have slumped 26% since then.
- The ExteNET trial randomized 2,840 patients in 41 countries with HER2+ breast cancer who had undergone surgery and adjuvant (following) treatment with Herceptin. The two treatment arms were neratinib and placebo.
- The primary endpoint was invasive disease-free survival (DFS). Patients treated with neratinib showed a 33% lower risk of invasive disease recurrence or death compared to placebo (p=0.009), but there was only a modest separation in the two-year DFS rates: 93.9% for neratinib versus 91.6% for placebo.
- The secondary endpoint was disease-free survival including ductal carcinoma in situ (DFS-DCIS). Patients receiving neratinib showed a 37% reduction in risk of disease recurrence including DCIS or death versus placebo (p=0.002) but the difference in 2-year DFS-DCIS rates was, again, slight: 93.9% for neratinib versus 91.0% for placebo.
- Subgroups of patients whose tumors were assessed in a single reference location and those positive for hormone receptor (HR) showed higher reductions in risk of recurrence and greater differences in DFS compared to placebo.
Tue, Jun. 2, 7:31 AM
- Amgen (NASDAQ:AMGN) and Roche (OTCQX:RHHBY) collaborate on a Phase 1b study to assess the former's talimogene laherparepvec (T-Vec) in combination with the latter's MPDL3280A (atezolizumab) in patients with triple-negative breast cancer and colorectal cancer with liver metastases. The partnership is another example of the rationale that combining immunotherapies with different mechanisms of action may be more effective in treating certain cancers.
- T-Vec is an investigational oncolytic immunotherapy that works in two ways. First, it is injected into tumors where it replicates inside tumor cells causing them to rupture and die in a process called lysis. The ruptured cells then release tumor-derived antigens, along with a white blood cell growth factor called GM-CSF (granulocyte-macrophage colony-stimulating factor) that can stimulate a system-wide immune response.
- Atezolizumab is an investigational monoclonal antibody that binds to PD-L1 (programmed death-ligand 1), a protein found on the surface of cancer cells that enable them to avoid detection by the immune system.. Binding to the protein enables T cells to recognize and kill cancer cells.
Mon, Jun. 1, 8:56 AM
- Micro cap Vascular Biogenics (NASDAQ:VBLT) is up 11% premarket on robust volume in response to its announcement of positive interim results from a Phase 2 study assessing its lead product candidate, VB-111, in patients with recurrent glioblastoma (rGBM), one of the most aggressive primary brain tumors. The data showed a statistically significant benefit in overall survival (OS) in patients treated with VB-111 followed by VB-111 in combination with Roche's (OTCQX:RHHBY) Avastin (bevacizumab) upon disease progression compared to patients treated with VB-111 followed by bevacizumab alone (p=0.05). The full results were presented earlier this morning at a meeting for investors in conjunction with ASCO.
- 46 patients with rGBM were treated with VB-111. Upon disease progression, 23 were treated with VB-111 + bevacizumab and 22 received bevacizumab alone (one patient was stable on VB-111 alone after 18 months). Median OS in the combination arm was 16 months compared to eight months in the bevacizumab alone arm (p=0.05).
- VB-111 is an anti-angiogenic agent which is designed to restrict tumor growth by inhibiting the proliferation of new blood vessels that form to support rapidly growing cells.
- The company intends to initiate a Phase 3 trial later this year.
Mon, Jun. 1, 8:09 AM
- TheStreet's Adam Feuerstein reports from ASCO in Chicago. On the plus side, he says Oncothyreon (NASDAQ:ONTY), Roche (OTCQX:RHHBY), Merck (NYSE:MRK), ImmonoGen (NASDAQ:IMGN), Celldex Therapeutics (NASDAQ:CLDX) and CTIBiopharma (NASDAQ:CTIC) all presented impressive data.
- On the negative side, Clovis Oncology (NASDAQ:CLVS) and Puma Biotech (NYSE:PBYI) fell short of wowing the crowd while Bristol-Myers Squibb (NYSE:BMY) was a bit of a mixed bag.
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