Shares of Genocea Biosciences Inc. GNCA, +59.00% surged 101% in premarket trade Monday after the biotech announced promising data from an early-stage clinical trial of its lead drug candidate, a personalized cancer vaccine. Genocea’s vaccine, called GEN-009, uses neoantigens — antigens corresponding to tumor mutations that a patient’s immune system sees as foreign to the body — to prime the immune system to find and kill tumors. The company is currently running a Phase 1/2 clinical trial to evaluate the vaccine’s safety and efficacy. So far, immune-response data is available for five patients, and the therapy induced T-cell responses to 91% of the vaccine neoantigens given to the patients, according to the company. Also, 47% of the neoantigens were able to elicit ex vivo CD8+ T-cell responses, the company said. Shares of Genocea have gained 144% in the year to date through Friday. The S&P 500 SPX, -0.19% has gained 9.8%.
Monday, June 3, 2019
Blueprint Med Shows Anti-Tumor Activity in Updated Trial Data Presented at ASCO
— 60% ORR in post-platinum RET-fusion NSCLC and 63% ORR in RET-mutant MTC patients previously treated with multi-kinase inhibitors; median durations of response not reached —
— Responses observed across treatment-naïve and previously treated patients, and regardless of RET alteration or tumor type —
— Strong activity against brain metastases in NSCLC patients —
— Plan to submit initial NDA to FDA for BLU-667 in RET-fusion NSCLC in first quarter of 2020 —
— Blueprint Medicines to host investor event and webcast on Monday, June 3, 2019 at 6:30 p.m. CT —
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced updated data from the ongoing registration-enabling ARROW trial of BLU-667 in patients with RET-altered cancers. The data presented at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting show durable clinical activity in patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other cancers. Designed by Blueprint Medicines, BLU-667 is a potent and highly selective oral inhibitor of RET fusions and mutations, including predicted resistance mutations.
Blueprint Medicines will host an investor event on Monday, June 3, 2019 beginning at 6:00 p.m. CT (7:00 p.m. ET) in Chicago to provide a portfolio update, including a review of updated clinical data from the ongoing ARROW trial of BLU-667 in patients with RET-altered cancers and the ongoing registration-enabling NAVIGATOR trial in patients with PDGFRA Exon 18 mutant and fourth-line gastrointestinal stromal tumors (GIST). Formal presentations and the live webcast will begin at 6:30 p.m. CT (7:30 p.m. ET). The event will be webcast live and can be accessed under the “Investors & Media—Events & Presentations” section of Blueprint Medicines’ website at www.BlueprintMedicines.com. A replay of the webcast will be available approximately two hours after the event and will be available for 30 days following the event.
Constellation myelofibrosis Phase 2 show positive signs at interim: ASCO
CPI-0610 showed signals of clinical activity, both as a monotherapy and in combination with ruxolitinib, in refractory myelofibrosis (MF) patients — Patients treated with CPI-0610 exhibited improvement in spleen volume, constitutional symptoms, anemia, bone marrow fibrosis, and transfusion dependence — CPI-0610 was generally well-tolerated as a monotherapy and in combination with ruxolitinib — Company to host analyst/investor event and webcast June 4, 2019 at 7:00 AM CDT
Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, today announced the presentation of updated interim data from MANIFEST, the Company’s Phase 2 clinical trial of CPI-0610 in MF. The interim data, which highlight the tolerability and potentially disease-modifying activity of CPI-0610, were presented in a poster at the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.
Constellation will host an analyst/investor meeting, with an accompanying conference call and webcast, to discuss this interim update in the Jackson Park D room at Hyatt Regency McCormick Place in Chicago at 8:00 AM EDT/7:00 AM CDT on June 4, 2019. The agenda of the meeting will include:
— An overview of myelofibrosis (MF) and the potential impact of Constellation’s BET inhibitor CPI-0610 in treating MF — A review of the interim data from the MANIFEST clinical trial presented in a poster at ASCO on June 3 — A panel discussion with two key opinion leaders in MF: o Dr. Srdan Verstovsek, a medical oncologist at the University of Texas MD Anderson Cancer Center and an investigator in the MANIFEST trial; and o Dr. Raajit Rampal, a hematologic oncologist at Memorial Sloan Kettering Cancer Center
The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at http://ir.constellationpharma.com/events–and–presentations/events. Participants may also access the event and participate in the live question-and-answer session by dialing (877) 473-2077 (domestic) or (661) 378-9662 (international) and referring to conference ID 1295319.
Walmart joins MediLedger blockchain consortium to track pharma supply chain
Retail giant Walmart announced that it has joined the MediLedger consortium, CoinDesk writes. The consortium is developing a blockchain designed for tracking the provenance of medicine. The network is built on the enterprise version of the ethereum blockchain and uses the Parity client and proof of authority.
MediLedger’s members already include pharmaceutical manufacturer Pfizer as well as large U.S. pharmaceutical wholesalers, such as McKesson, AmerisourceBergen, and Cardinal Health.
This is Walmart’s second high-profile blockchain initiative. The retail behemoth is also part of IBM’s Food Trust, the supply chain for food built on IBM’s Hyperledger Fabric blockchain. Now, Walmart is also planning to put medicine on the blockchain. According to Walmart’s annual report, “Health and wellness”—which includes the sale of pharmaceuticals and over-the-counter meds—constitutes a tenth of the company’s sales, amounting to $35 billion.
MediLedger is also planning to launch a pilot project with the U.S. Food and Drug Administration (FDA) this month. By 2023, the agency needs to launch a digital system for tracking and verifying prescription drugs. It is currently testing multiple options, including some that include blockchain technology.
Unlike government-run healthcare systems, the U.S. privatized healthcare system is fragmented. Therefore, the implementation of a centralized system may prove difficult, and a decentralized blockchain solution connecting multiple siloed databases could prove more advantageous.
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