On January 2, 2019 AVEO Oncology (NASDAQ:AVEO) reported that Michael Bailey, president and chief executive officer, will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 9, 2019 at 4:00 p.m. Pacific Time (Press release, AVEO, JAN 2, 2019, View Source [SID1234532359]).

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A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

On January 2, 2019 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that Kenneth C. Frazier, chairman and chief executive officer, and Dr. Roger M. Perlmutter, president, Merck Research Laboratories, are scheduled to participate at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Jan. 7, 2019 at 4:30 p.m. PST (7:30 p.m. EST) (Press release, Merck & Co, JAN 2, 2019, View Source [SID1234532339]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

On January 2, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported positive, preliminary, top-line data from the ongoing dose escalation part of the Phase 1 clinical study with DCC-3014, the Company’s investigational small molecule switch control inhibitor of CSF1R, in patients with advanced malignancies (Press release, Deciphera Pharmaceuticals, JAN 2, 2019, View Source [SID1234532360]). In addition, the Company announced a plan to expand the Phase 1 study to evaluate DCC-3014 in patients diagnosed with Tenosynovial Giant Cell Tumors (TGCT). A review of further data from this Phase 1 study will be presented at a medical meeting in 2019.

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The Phase 1 study was designed to evaluate the safety, pharmacokinetics and pharmacodynamics of multiple doses of DCC-3014 in up to 55 patients.

As of the data cut-off date of November 9, 2018, increasing doses of DCC-3014 were assessed in five dose cohorts across 24 patients with advanced solid tumor malignancies. This included one dose cohort that received 10 mg once daily (QD) and four dose cohorts that followed a schedule of once or twice-weekly maintenance dosing preceded by a five-day loading dose regimen at doses of up to 30 mg per dose. In addition, four patients are currently enrolled in a dose cohort that will receive 40 mg twice weekly preceded by a five-day loading regimen.
Preliminary pharmacokinetic (PK) analysis showed dose-proportional exposure for DCC-3014 that we believe supports twice-weekly maintenance dosing preceded by a five-day loading dose regimen.
Biomarker data demonstrated strong target engagement of CSF1R, including material reductions in CSF1R positive macrophages in the blood that we believe constitutes mechanistic proof-of-concept (mPoC) for DCC-3014.
DCC-3014 was generally well tolerated in patients enrolled in the dose cohorts that received twice-weekly maintenance doses of DCC-3014 preceded by a five-day loading regimen at doses of up to 30 mg, which is summarized below:
Treatment emergent adverse events (TEAEs) were mostly Grade 1 or 2;
No Grade 3 or 4 DCC-3014 related TEAEs in ≥10% of patients;
No dose-limiting toxicities; and
A maximum tolerated dose has yet to be established.
In the dose-cohort that received 10 mg QD, clinically asymptomatic laboratory values were recorded as dose-limiting toxicities in two of seven patients.
"We are very pleased with the progress made to date in the Phase 1 clinical study with DCC-3014, our selective, and potent small molecule inhibitor of CSF1R," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "Based on the preliminary tolerability, PK, and mechanistic proof-of-concept data observed to date, we believe DCC-3014 is well suited for further development. While we will continue to enroll further patients in this Phase 1 study, we are planning to expand this study to enroll patients with tenosynovial giant cell tumors and to explore combinations with other therapies in the first half of 2019."

About DCC-3014

DCC-3014 is an investigational, orally administered, potent and highly selective inhibitor of CSF1R. DCC-3014 was designed using the Company’s proprietary switch control kinase inhibitor platform to selectively bind to the CSF1R switch pocket. DCC-3014 has greater than 100-fold selectivity for CSF1R over the closely related kinases FLT3, KIT, PDGFRα, PDGFRß and VEGFR2 and has an even greater selectivity for CSF1R over approximately 300 other human kinases. CSF1R controls the differentiation and function of macrophages including Tumor Associated Macrophages (TAMs) whose density within certain tumors including cancers of the breast, cervix, pancreas, bladder and brain correlates with poor prognosis. Tumors induce TAMs to suppress a natural immune response mediated by cytotoxic T-cells, a type of lymphocyte that would otherwise eradicate the tumor; a process known as macrophage checkpoints. Through inhibition of CSF1R DCC-3014 has in preclinical studies demonstrated potent macrophage checkpoint inhibition as both a single agent and in combination with PD1 inhibitors and other T-cell checkpoint inhibitors. DCC-3014 is currently being evaluated in a Phase 1 clinical study. For more information about the clinical trial design please visit www.clinicaltrials.gov (NCT03069469).

About Tenosynovial Giant Cell Tumors (TGCTs)

Tenosynovial giant cell tumors (TGCTs) are a group of benign tumors that involve the synovium, bursae and/or tendon sheath. Although benign, these tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in pigmented villonodular synovitis, a diffuse-type of TGCT. If untreated or if the tumor continually recurs damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. A genetic mutation in certain cells within the tumor causes overproduction of CSF-1, the ligand for the CSF1R receptor, which attracts macrophages and certain other cells that become the bulk of these tumors and cause the associated inflammatory changes.

On January 2, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that it will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 9th at 8:00 a.m. PST/ 11:00 a.m. EST. Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer will provide a corporate update at the conference (Press release, Mirati, JAN 2, 2019, View Source [SID1234532381]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The presentation will be webcast and made available through the "Investors" section of www.mirati.com, and replays will be made available for 90 days following the events.

On January 1, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the first patient has been dosed in a phase III clinical trial (ORIENT-15) that is to evaluate Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection), in combination with paclitaxel and cisplatin, as first-line treatment in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Innovent Biologics, JAN 1, 2019, View Source [SID1234532324]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The ORIENT-15 study is a randomized, double-blind, multi-center, phase III trial conducted in China to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic ESCC. The phase III study will enroll 640 patients. The study follows a phase Ib study that evaluated Tyvyt (sintilimab injection) in patients with esophageal cancer and a phase II study that evaluated Tyvyt (sintilimab injection) versus paclitaxel/irinotecan as second-line therapy for patients with advanced/metastatic ESCC.

"The incidence of esophageal squamous cell carcinoma in Asian countries is much higher than in western countries. Today, patients have no treatment options other than chemotherapy and radiation therapy. Immune checkpoint inhibitors have brought new hope to patients with this life-threatening disease. Based on the efficacy signals and the safety profile from previous trials, we hope to validate the therapeutic potential of Tyvyt (sintilimab injection) in combination with chemotherapy in ORIENT-15, a phase III trial," said Professor Lin Shen from the Beijing Cancer Hospital.

"Esophageal cancer is the third most common malignant tumor in China. The development of new agents for the treatment of advanced esophageal squamous cell carcinoma has been stagnant, so there is a huge unmet medical need. Based on the preliminary result or the ongoing phase II study, we have decided to conduct ORIENT-15, a phase III study as a first-line treatment for patients with esophageal squamous cell carcinoma. Our goal is to provide more effective cancer treatment options for these patients and for their families," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1（Programmed Cell Death-1 Ligand-1, PD-L1 pathway）and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.

About ORIENT-15 Study

The ORIENT-15 study is a randomized, double-blind, multi-center, phase III trial that evaluates the efficacy and safety of Tyvyt (sintilimab injection) in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic ESCC in China. Patients will receive Tyvyt (sintilimab injection) or placebo in combination with paclitaxel and cisplatin until disease progression. Participants will be randomly assigned in a 1:1 ratio into experimental or control groups. The study will enroll 640 patients. The primary endpoint is overall survival in both the entire population and in PD-L1 positive population of patients.

About Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Esophageal cancer is the eighth most common cancer in the world, and the sixth leading cause of cancer death. Nearly four out of five cases occur in developing countries. China has the largest population of patients with esophageal cancer in the world. The incidence and mortality in China are higher than the worldwide average, ranking 3rd and 4th respectively. The histopathological type of esophageal cancer in China is different than that in Europe and the United States. In China the major type of esophageal cancer is squamous cell carcinoma which accounts for more than 90% of cases. In the United States and Europe adenocarcinoma of the esophagus is the predominant histopathology. The prognosis of patients with advanced and metastatic esophageal cancer is poor with an overall survival of about 10 months.