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.
Fri, May 29, 5:24 PM
- Bristol-Myers Squibb (NYSE:BMY) stumbled 7% today on a 4.5x surge in volume in response to the presentation of an abstract (#109) at ASCO that underwhelmed many investors. The data were from Phase 3 study, called CheckMate-057, assessing the company's PD-1 inhibitor, Opdivo (nivolumab) compared to the standard-of-care chemotherapy agent docetaxel in treatment-experienced patients with advanced, non-squamous non-small cell lung cancer, the most common form of lung cancer. A drug used after another (treatment experienced) is called a second line setting.
- The study met its primary endpoint of a statistically significant 27% reduction in the risk of cancer progression or death compared to docetaxel (p=0.0015). The trial also evaluated the efficacy of Opdivo compared to docetaxel by the level of PD-L1 expression, 1%, 5% and 10%. As expected, the median overall survival (OS) in the Opdivo group was significantly longer than the chemo cohort for all three levels where PD-L1 was highly expressed (greater than or equal to 1, 5, 10%).
- What raised eyebrows was the absence of a treatment benefit compared to docetaxel in the three groups with low PD-L1 expression (<1%, <5%, <10%). Median OS was barely higher in the Opdivo group with <1% expression and lower than docetaxel in the other two. This potentially opens the door for eventual competitors such as Roche (OTCQX:RHHBY) and Merck (NYSE:MRK) whose offerings show strong efficacy in tumors that highly express PD-L1. Had Opdivo shown a significant OS advantage in low PD-L1 expression tumors, its dominance in the second line setting would have been virtually assured.
- CheckMate-057 was stopped early based on the successful achievement of its primary endpoint, per the recommendation of the independent Data Monitoring Committee.
- Previously: Phase 3 study stopped early after Bristol-Myers' Opdivo hits efficacy endpoint (April 17)
Thu, May 28, 7:19 AM
- Roche (OTCQX:RHHBY) enters into an exclusive license agreement with Bern, Switzerland-based Galenica for the commercialization of Mircera (methoxy polyethylene glycol-epoetin beta) in the U.S. and Puerto Rico. Mircera is a long-acting erythropoietin stimulating agent indicated for the treatment of anemia associated with chronic kidney disease in adult patients.
- Under the terms of the agreement, Roche will receive upfront and milestone payments, supply reimbursements and tiered royalties. Specific financial terms are not disclosed.
- Galenica has entered into a supply agreement with Fresenius Medical Care of North America under which Galenica will supply Mircera to its dialysis facilities.
- The FDA approved Mircera in November 2007 but the launch was delayed due to patent infringement issues with Amgen.
Tue, May 26, 1:14 PM
- Quintiles Transnational Holdings (Q +0.2%) upgraded to Buy from Neutral by SunTrust Robinson Humphrey.
- ReWalk Robotics (RWLK +1.6%) upgraded to Buy from Hold by Canaccord Genuity.
- Ilumina (ILMN) upgraded to Overweight from Equal-Weight by Morgan Stanley but price target lowered to $162 (21% downside risk) from $190. Current price: ~$205.
- Sarepta Therapeutics (SRPT +1.6%) upgraded to Buy from Hold with a $30 (12% upside) price target by Canaccord Genuity.
- Roche (OTCQX:RHHBY -1.4%) upgraded to Buy from Neutral with a CHF325 (18% upside) price target by UBS.
- Sarepta Therapeutics downgraded to Neutral from Buy by Bank of America; price target raised to $28 (5% upside) from $20.
- Bruker (BRKR -0.9%) downgraded to Neutral from Buy with a $22 (13% upside) price target by Mizuho Securities.
- Achillion Pharmaceuticals (ACHN -0.3%) downgraded to Market Perform from Outperform by JMP Securities; $24 price target removed.
- Intercept Pharmaceuticals (ICPT) downgraded to Neutral from Buy with a $315 (21% upside) price target by Bank of America.
- Healthways (HWAY -1%) downgraded to Hold from Buy by Stifel Nicolaus; $25 price target removed.
- AmerisourceBergen (ABC -0.4%) downgraded to Market Perform from Outperform with a $121 (7% upside) price target by Cowen & Co.
Tue, May 26, 9:21 AM
- The FDA approves privately-held Boehringer Ingelheim's once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not cleared for the treatment of asthma or acute deterioration of COPD.
- Tiotropium, a long-acting anticholinergic, is the active ingredient in Spiriva, the most prescribed COPD maintenance treatment worldwide. Olodaterol, a long-acting beta2-agonist that complements the efficacy of Spiriva, has a fast onset of action that improves airflow in five minutes after dosing.
- COPD-related tickers: (NASDAQ:TBPH) (NYSE:GSK) (NASDAQ:THRX) (NYSE:AZN) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY) (NASDAQ:AQXP)
Wed, May 20, 1:14 PM
- Thinly traded nano cap Lpath (LPTN -79.5%) craters on a massive 78x surge in volume in response to its announcement that its lead product candidate, iSONEP, failed to achieve its primary and key secondary efficacy endpoints in a Phase 2 trial in patients with wet age-related macular degeneration (wet AMD) who had not responded adequately to anti-vascular endothelial growth factor (VEGF) therapies such as Roche's (OTCQX:RHHBY -0.4%) Lucentis (ranibuzumab) or Avastin (bevacizumab) or Regeneron's (REGN +1.4%) Eylea (aflibercept).
- Patients treated with iSONEP, either alone or as an adjunct, did not show any statistically significant improvement in visual acuity.
- SVP and Chief Development Officer Dario Paggiarino, M.D., says, "This trial was designed to evaluate the activity of iSONEP in wet AMD patients that had previously received at least three prior injections of an anti-VEGF agent and had not responded well. While the primary endpoint of the trial was not met, we will be conducting a complete analysis of the data, including additional anatomical endpoints, to better understand the results from each arm of the trial."
- iSONEP is a monoclonal antibody that binds to a bioactive lipid called sphingosine-1-phosphate, a major regulator of vascular systems.
- Final results will be presented in November at the American Academy of Ophthalmology meeting in Las Vegas, NV.
- Related ticker: (PFE +0.4%)
Mon, May 18, 4:23 PM
- Ilumina (NASDAQ:ILMN) files a lawsuit in the U.S. District Court for the Northern District of California against Roche (OTCQX:RHHBY) subsidiary Ariosa Diagnostics accusing it of infringing on U.S. Patent No. 7,955,794 entitled "Multiplex Nucleic Acid Reactions." The action is focused on Ariosa's Microarray-based version of its Harmony Prenatal Test.
- Previously, Ilumina and its subsidiary Verinata Health filed suits in the same court accusing Ariosa of infringing the '794 patent as well as Patent Nos. 8,296,076 and 8,318,430 with the sequencing-based version of its Harmony Prenatal Test.
Thu, May 14, 10:17 AM
- Interim data from a Phase 2 trial, called POPLAR, evaluating Roche's (OTCQX:RHHBY +2.6%) investigational cancer immunotherapy, MPDL3280A, in treatment-experienced non-small cell lung cancer (NSCLC) patients showed a doubling of overall survival (OS) in those whose cancer expressed the highest levels of PD-L1 (programmed death ligand-1) compared to docetaxel chemotherapy. A less-profound improvement was observed in patients with medium/high PD-L1 expression.
- MPDL3280A is a monoclonal antibody that inhibits PD-L1, a protein on the surface of cancer cells that plays a key role in suppressing the immune system by hindering the proliferation of CD8+T cells, the body's front-line attackers of foreign antigens.
- Complete interim results from POPLAR (Abstract #8010) will be presented on the afternoon of May 31 at the American Society of Clinical Oncology meeting in Chicago, May 29 - June 2.
- Previously: Roche's MPDL3280A a Breakthrough Therapy for NSCLC (Feb. 2)
Thu, May 14, 10:00 AM
- In separate Phase 1/2 studies, patients treated with Roche's (OTCQX:RHHBY +2.1%) alectinib demonstrated response rates as high as 68.8%. Patients with ALK-positive non-small cell lung cancer whose disease had progressed following treatment with crizotinib (Pfizer's Xalkori) showed an overall response rate (ORR) of 50% in Study NP28673 and 47.8% in Study NP28761. In patients whose cancer has spread to the central nervous system, the ORRs were 57.1% and 68.8%, respectively.
- Alectinib is an anaplastic lymphoma kinase (ALK) inhibitor created at Chugai Kamakura Research Labs.
- Complete results will be presented at the American Society of Clinical Oncology meeting in Chicago, May 29 - June 2. Study NP28673 (Abstact #8008) will be presented on the morning of May 31 and Study NP28761 (Abstract #8019) will be presented on the morning of June 1.
Mon, May 11, 5:22 PM
- Ophthotech (NASDAQ:OPHT) completes enrollment in its first Phase 3 trial assessing Fovista (anti-PDGF BB pegylated aptamer) in combination with Roche's (OTCQX:RHHBY) Lucentis (ranibizumab) compared to Lucentis alone as monotherapy in patients with wet age-related macular degeneration (wet-AMD).
- Patient enrollment in a second Phase 3 study assessing Fovista + Lucentis compared to Lucentis alone should be completed by the end of Q3. Data readout from the first two studies should happen in 2016.
- A third Phase 3 study evaluating Fovista in combination with Regeneron's (NASDAQ:REGN) Eylea (aflibercept) or Roche's Avastin (bevacizumab) compared to Eylea or Avastin alone should reach its enrollment target in the same time frame as the other two studies, although the expected time from today is unclear.
- Total enrollment in the three trials will be ~1,866 across 225 sites worldwide.
- The company's objective with Fovista is to be agnostic relative to the choice of anti-VEGF agent co-administered with it.
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