Fri, Sep. 4, 7:18 AM
- The FDA designates Roche's (OTCQX:RHHBY) investigational factor VIIIa-mimetic bispecific antibody, ACE910, a Breakthrough Therapy for the treatment of hemophilia A, a rare inherited blood disorder caused by a deficiency in an essential clotting protein called factor VIII. People with severe hemophilia A are susceptible to uncontrolled or difficult-to-control bleeding, including internally and frequently in the joints, which can eventually lead to the need for joint replacements.
- ACE910 is a humanized bispecific monoclonal antibody designed to simultaneously bind to factors IXa and X, thereby mimicking the cofactor function of factor VIII. It promotes blood coagulation in patients with hemophilia A regardless of whether they have developed inhibitors to factor VIII.
- Roche has development and commercial rights to ACE910 worldwide with the exception of Japan, Taiwan and Korea via an agreement with Chugai Pharmaceutical (OTCPK:CHGCY). A Phase 3 study in patients with inhibitors will commence by the end of the year followed by a Phase 3 trial in patients without inhibitors in 2016. A pediatric study will commence in 2016 as well.
- Breakthrough Therapy provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the NDA.
Mon, Aug. 24, 1:33 PM
- Roche (OTCQX:RHHBY) has struck a deal with U.K. molecular diagnostics firm Lumora to buy "products associated with [Lumora's] unique, patent-protected Heat Elution technology for nucleic acid purification of multiple sample types including challenging formalin-fixed paraffin-embedded (FFPE) tumor samples." Terms are undisclosed.
- Roche: "Today, nucleic acid purification technology from specimens including formalin-fixed tissues can be cumbersome and inefficient. Lumora's highly differentiated proprietary methodology will enable simple and automated nucleic acid isolation in minutes instead of hours. In addition, the technology is environmentally friendly and can be applied to process a wide variety of sample types including whole blood, fecal matter, sputum, FFPE tissue and buccal swabs."
- The drug giant adds it plans to explore integrating Lumora's technology into its sequencing workflow solution.
Thu, Aug. 20, 7:10 AM
- The European Commission approves Novartis' (NYSE:NVS) Odomzo (sonidegib) for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
- BCC, accounting for more than 80% of non-melanoma skin cancers, consists of abnormal, uncontrolled lesions that arise from the basal cells of the skin. Advanced BCC accounts for as many as 10% of all BCC cases.
- Odomzo is a once-daily pill that inhibits the molecular pathway called Hedgehog. It will compete with Roche's (OTCQX:RHHBY) Erivedge (vismodigib), an antagonist of part of the hedgehog signaling pathway called smoothened receptor, approved in January 2012. It will generate ~$175M in sales this year. The FDA cleared Odomzo about a month ago.
- Previously: FDA clears Novartis' Odomzo for skin cancer (July 24)
Wed, Aug. 19, 7:25 AM
- Roche (OTCQX:RHHBY) acquires privately-held Wilmington, MA-based Kapa Biosystems, a provider of genomic tools that optimize enzymes for next-generation sequencing (NGS), polymerase chain reaction (PCR) and real-time PCR applications. Kapa's large portfolio of NGS reagents, including novel DNA polymerases, have the potential to improve the performance of the entire sequencing workflow.
- Financial terms of the transaction are not disclosed.
Mon, Aug. 17, 7:17 AM
- Results from a 667-subject Phase 2 clinical trial, BIRCH, show that Roche's (OTCQX:RHHBY) Breakthrough Therapy-tagged atezolizumab shrank tumors (objective response rate) in patients with PD-L1-positive, locally advanced or metastatic non-small cell lung cancer. The study also demonstrated that patients' responses were correlated with the amount of expressed PD-L1.
- Atezolizumab (MPDL3280A) is a monoclonal antibody that binds to PD-L1 (programmed death ligand 1), a transmembrane protein that plays a key role in suppressing the immune system.
- The company intends to discuss the results with the FDA. It has 11 Phase 3 trials either planned or in process evaluating atezolizumab in various cancers.
- Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
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)
Thu, Aug. 13, 6:57 AM
- Roche (OTCQX:RHHBY) acquires privately-held Los Gatos, CA-based GeneWEAVE for $190M upfront plus up to $235M in product-related milestones. Once closed, the company will be integrated into Roche Molecular Diagnostics.
- GeneWEAVE develops clinical microbiology diagnostic solutions to aid healthcare professionals in their fight against drug-resistant bacteria. Its technology, called Smarticles, measures antibiotic susceptibility in addition to the detection of bacterial nucleic acid. The company refers to it as "Sample-In/Susceptibility-Out." The approach provides healthcare providers access to quick and accurate diagnoses that enable them to make more rapid informed treatment decisions.
Wed, Aug. 12, 9:52 AM
- Immune Design (IMDZ +3.7%) enters into a clinical trial collaboration with Roche's (OTCQX:RHHBY -0.9%) Genentech to evaluate the combination of Immune's CMB305 and Genentech's atezolizumab (MPDL3280A) in patients with soft tissue sarcoma.
- CMB305 is a "prime boost" cancer immunotherapeutic designed to induce anti-tumor cytotoxic T lymphocytes (CD8 T cells) to target NY-ESO-1, a tumor antigen found in a variety of tumors.
- Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor.
- The randomized, open label Phase 2 study will enroll patients with locally advanced, relapsed or metastatic synovial sarcoma or myxoid/round cell liposarcoma, two types of sarcoma that tend to broadly express NY-ESO-1.
- Soft tissue sarcomas are cancers that arise from the soft tissues of the body. They strike about 12K Americans each year. The mortality rate is over 40%.
Wed, Aug. 12, 9:29 AM
- A Phase 2 clinical trial, M13-982, assessing AbbVie's (NYSE:ABBV) Breakthrough Therapy-tagged venetoclax for previously treated chronic lymphocytic leukemia (CLL) patients who have part of their chromosome 17 missing (17p deletion), successfully achieved its primary endpoint of a clinically meaningful reduction in the number of cancer cells (overall response rate).
- Venetoclax is a small molecule inhibitor of the BCL-2 protein, which plays a key role apoptosis (programmed cell death). Blocking BCL-2 is believed to restore the signaling system that tells cancer cells to self-destruct.
- The company intends to submit an NDA to the FDA and an MAA in Europe by the end of the year, although the estimated study completion date is May 2017. The data will be presented at a future medical conference.
- Up to 50% of CLL patients have the 17p deletion, a population that does not respond well to chemotherapy regimens. The median life expectancy is less than three years.
- Venetoclax is being developed in collaboration with Roche (OTCQX:RHHBY) and Genentech.
Fri, Aug. 7, 8:14 AM
- A new class of cancer therapeutics has been rekindled of late led by Pfizer (NYSE:PFE) and Bristol-Myers Squibb (NYSE:BMY). They are called immune system accelerators, antibodies that target a protein called 4-1BB, also known as CD137.
- When the immune system's T-cells and natural killer (NK) cells identify cancer cells, the 4-1BB protein appears on their surfaces which accelerates their attack. The protein was discovered over 20 years ago, but its development was abandoned in 2008 after early-stage studies done by Bristol showed signs of liver damage. Scientists eventually realized that lower doses of 4-1BB, given at the right time, could elicit the desired anti-cancer effect without the unwanted toxicity. Early results have been impressive. A 38-subject study done by Pfizer, 40% of patients with follicular lymphoma and a third of those with mantle cell lymphoma experienced a reduction in cancer with no serious side effects.
- Phase 1 studies are underway assessing combinations of immune checkpoint inhibitors, like Roche's (OTCQX:RHHBY) Rituxan (rituximab) and accelerators. Studies are planned for Pfizer's 4-1BB candidate in combination with Herceptin (trastuzumab) and the combination of Bristol's 4-1BB candidate, urelumab, with Eli Lilly's (NYSE:LLY) Erbitux (cetuximab). Bristol in currently enrolling patients in five Phase 1 studies in multiple myeloma, lymphomas and solid tumor cancers. Pfizer is planning trials with an immunotherapy from Kyowa Hakko Kirin and Merck's (NYSE:MRK) Keytruda (pembrolizumab).
- Johnson & Johnson (NYSE:JNJ) and AbbVie (NYSE:ABBV) are a step behind doing preclinical work on their accelerator candidates.
Fri, Jul. 31, 7:13 AM
- The European Commission (EC) approves Roche's (OTCQX:RHHBY) Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy, for the neoadjuvant (before surgery) treatment of adult patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer at high risk of recurrence.
- The regimen is the first neoadjuvant breast cancer treatment approved by the EC based on pathological complete response (pCR) data, which means that there is no tumor tissue detectable at the time of surgery in the affected breast or in the affected breast and local lymph nodes. This measure can be assessed more quickly that traditional endpoints in early breast cancer (eBC).
- Perjeta was previously cleared for the neoadjuvant treatment of HER2-positive eBC in the U.S. and 21 other countries.
Thu, Jul. 30, 7:57 AM
- Roche (OTCQX:RHHBY) submits its Premarket Approval (PMA) application to the FDA seeking clearance for its cobas EGFR Mutation v2, a companion diagnostic test for AstraZeneca's (NYSE:AZN) Orphan Drug-, Fast Track- and Breakthrough Therapy-tagged AZD9291.
- Patients with non-small cell lung cancer (NSCLC) who have adenocarcinoma with tumor containing an EGFR (epidermal growth factor receptor) sensitizing mutation respond initially to current EGFR TKI therapies. About 67% relapse and develop drug resistance due to, in large part, the acquisition of a mutation called T790M. Patients with this mutation will most likely benefit from treatment with AZD9291.
- Roche's second generation test is built upon its current FDA-cleared assay for EGFR mutations. It is designed to identify a broad spectrum of EGFR mutations in patients with NSCLC, including T790M.
Tue, Jul. 28, 12:57 PM
- Privately-held Boehringer Ingelheim (BI) enters into an exclusive license and collaboration agreement with Seoul, Korea-based Hanmi Pharmaceutical to develop and commercialize HM61713, a third generation epidermal growth factor receptor (EGFR)-targeted therapy for the treatment of EGFR mutation-positive lung cancer.
- Under the terms of the agreement, Hanmi will receive an upfront payment of $50M, milestones up to $680M and tiered double-digit royalties on net sales. BI will have exclusive global commercialization rights to HM61713 except South Korea, China and Hong Kong.
- HM61713 is an orally active, irreversible EGFR mutation-selective tyrosine kinase inhibitor (TKI). It is currently in Phase 2 development for the treatment of patients with non-small cell lung cancer with T790M mutations who have developed resistance to other EGFR-targeting agents. A Phase 3 study will commence next year.
- EGFR-related tickers: (AZN +0.3%)(OTCQX:RHHBY +1.3%)(OTCPK:ALPMY) (OTCPK:ALPMF) (BMY +0.1%)(LLY +1.4%)(GSK -0.1%)(AMGN +4.3%)
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Fri, Jul. 24, 12:26 PM
- The FDA approves Novartis' (NVS -0.5%) Odomzo (sonidegib) for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or who are not candidates for surgery or radiation therapy.
- Odomzo is a once-daily pill that inhibits the molecular pathway called Hedgehog. It will compete with Roche's (OTCQX:RHHBY -0.9%) Erivedge (vismodigib), an antagonist of part of the hedgehog signaling pathway called smoothened receptor (SMO), that was cleared in January 2012. It will generate ~$175M in sales this year.
Fri, Jul. 24, 8:10 AM
- Roche (OTCQX:RHHBY) launches its improved CARDIAC point-of-care (POC) Troponin T test for suspected acute myocardial infarction (heart attack). The new test can detect troponin concentrations as low as 40 ng/L compared to the previous version's detection limit of 100 ng/L. The hand-held diagnostic, which requires no sample preparation or lengthy setup, can generate a result in 12 minutes, making it ideal for a non-laboratory setting such as an emergency room, ambulance or physician office.
- The test is used as an aid to rule-in suspected heart attack patients and triage them appropriately. Patients with Troponin T levels <50 ng/L are at lower risk and can be sent to a local hospital for further evaluation. The pre-hospital triage can reduce the time to treatment and potentially save costs.
- In the U.S. and Europe, as many as 20M patients each year visit hospital emergency rooms complaining of chest pain and symptoms consistent with heart attack.
- Troponin T is a protein found in striated muscle. In a heart attack, it becomes elevated two to four hours after the onset of myocardial necrosis (tissue death due to lack of blood supply) and can remain elevated for up to 14 days.
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