Fri, Aug. 14, 7:16 AM
- Based on additional analyses of the data from a Phase 2a clinical trial in wet age-related macular degeneration, Avalanche Biotechnologies (NASDAQ:AAVL) decides not to proceed to Phase 2b with its lead product candidate AVA-101. Instead, it will conduct further preclinical studies to clarify the optimal dose and delivery of AVA-101 and AVA-201 compared to standard-of-care anti-VEGF protein therapy before advancing the best candidate back into the clinic. The process should be completed by the end of the year.
- The company's decision shouldn't be a surprise. The stock plummeted 40% in June after the company reported less-than-expected results from the Phase 2a study.
- 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 (OTCQX:RHHBY) Lucentis.
- Shares are down 14% premarket on light volume.
- Previously: Avalanche Bio plummets 40% after hours on less-than-expected AVA-101 data; chances dim for pick up by Regeneron (June 15)
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.
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)
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.
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.
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.
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)
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, Mar. 2, 8:48 AM
- Micro cap Athersys (NASDAQ:ATHX) jumps 20% premarket on robust volume in response to its announcement of an exclusive partnership and license agreement with Chugai Pharmaceutical Co. (OTCQX:RHHBY) to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan.
- Under the terms of the agreement, Chugai is responsible for the development and commercialization of MultiStem for the indication in Japan. Athersys will receive an upfront cash payment of $10M, development and regulatory milestones of up to $45M, sales milestones of up to $150M and tiered double-digit royalties on net sales.
- MultiStem is currently in Phase 2 development for ischemic stroke in the U.S. and Europe.
Tue, Feb. 10, 10:05 AM
- Pfenex (PFNX +25.9%) and Hospira (HSP +0.1%) team up to develop and commercialize PF582, Pfenex's lead biosimilar candidate to Genentech's (OTCQX:RHHBY +0.8%) Lucentis (ranibizumab), which logged ~$4B in sales last year.
- Under the terms of the collaboration, Pfenex will receive an upfront payment of $51M, once the agreement clears antitrust review, and up to $291M in development and sales milestones plus tiered double-digit royalties on commercial sales.
- The companies will share the Phase 3 equivalence clinical trial costs. Hospira will be responsible for manufacturing and commercializing PF582 worldwide.
Fri, Jan. 16, 6:14 AM
- Looking to gain access to an experimental drug to treat spinal muscular atrophy, Roche (OTCQX:RHHBY) has agreed to buy privately-held Trophos.
- The acquisition is the latest in a spate of deals by Roche, following its purchase of a $1B stake in Foundation Medicine and licensing agreement with Genome pioneer J. Craig Venter.
- Under the terms of the agreement with Trophos, the French firm's shareholders will receive an upfront payment of €120M ($140M), plus further payments based on predetermined milestones worth up to €350M.
- OTCQX:RHHBY -2.2% premarket
Thu, Jan. 15, 8:40 AM
- "Words fail me," says Swatch (OTCPK:SWGAY) CEO Nick Hayek. "Today's SNB action is a tsunami; for the export industry and for tourism, and finally for the entire country." Swatch is lower by 15.75% in European action.
- Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
- A sampling of others: Cement maker Holcim (OTCPK:HCMLY) is down 11.2%, Novartis (NYSE:NVS) is down 9%, Roche (OTCQX:RHHBY) is down 7.9%, Credit Suisse (NYSE:CS) is down 11.7%, and UBS (NYSE:OUBS) is down 10.8%.
- The good news for ADR players is that's all action in Switzerland. Thanks to the franc's now 13.5% gain, the ADRs trading in the U.S. are likely all to be higher.
Wed, Jan. 7, 10:41 AM
- Arena Pharmaceuticals (ARNA +33.4%) jumps on higher volume in early trading in response to its report of a dose-dependent effect on lymphocyte count lowering for APD334 in a Phase 1b trial.
- Mean decreases in lymphocyte count in blood from baseline were as high as 69%. Counts recovered from baseline, on average, within one week of cessation of dosing. Lymphocyte lowering has been shown to correlate with clinical efficacy in Phase 2 and 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis.
- APD334 is an oral drug that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases. The company plans to proceed to Phase 2 development.
- Related tickers: (OTCPK:ALIOF) (OTC:ALIOY) (NYSE:GSK) (OTCQX:RHHBY)
Dec. 19, 2014, 8:44 AM
- ImmunoGen (NASDAQ:IMGN) plummets 40% premarket on robust volume in response to Roche's (OTCQX:RHHBY) announcement that its Phase 3 trial evaluating Kadcyla (trastuzumab emtansine) failed to significantly improve progression-free survival as a first-line therapy in breast cancer patients.
- Kadcyla was developed based on ImmunoGen's ADC technology which uses tumor-targeting antibodies to deliver an ImmonGen cell-killing agent to cancer cells.
- Previously: Roche cancer drug fails label expansion trial (Dec. 19, 2014)
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
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