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ArQule to Host Analyst Call Highlighting Clinical Progress from Ongoing Phase 1 Study of Reversible BTK Inhibitor, ARQ 531, in Patients with Relapsed/Refractory Hematologic Malignancies

On November 29, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that it will host a call to discuss the updated safety, PK, biomarker and anti-tumor activity data from the company’s Phase 1 dose escalation study in patients with relapsed or refractory hematologic malignancies (ARQ 531-101) that are being presented in a poster presentation at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on December 3, 2018 in San Diego (Press release, ArQule, NOV 29, 2018, View Source [SID1234531719]).

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Call Details

Date: Monday, December 3, 2018
Time:6:00 a.m. PT/9:00 a.m. ET

The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

About BTK and ARQ 531
Bruton’s tyrosine kinase, BTK, is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers. ARQ 531 is an orally bioavailable, potent and reversible BTK inhibitor. Biochemical and cellular studies have shown that ARQ 531 inhibits both the wild type and C481S-mutant forms of BTK. The C481S-mutation is a known resistance mechanism for first generation irreversible BTK inhibitors. In preclinical studies, ARQ 531 has demonstrated good oral bioavailability as well as favorable pharmacokinetic, pharmacodynamic and metabolic properties

OncoSec Presents New Data During Oral Presentation At Melanoma Bridge Demonstrating Intratumoral Monotherapy TAVO™ Induces Abscopal Responses In Metastatic Melanoma Patients

On November 29, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported the presentation of new data from the company’s Phase 2 study of TAVO (tavokinogene telseplasmid) for the treatment of metastatic melanoma (Press release, OncoSec Medical, NOV 29, 2018, View Source [SID1234531716]). The newly presented data reports abscopal responses with TAVO monotherapy, finding that treatment with TAVO monotherapy resulted in 47 percent of patients experiencing tumor regression in at least one untreated lesion. These data were selected for an oral presentation at Melanoma Bridge 2018, taking place November 30 to December 1, Naples, Italy.

"These findings are significant because they clearly demonstrate that intratumoral treatment with TAVO is having a systemic effect that goes beyond the treated tumor, and to see that effect in nearly half of treated patients is remarkable, particularly with such a well-tolerated therapy," said Alain Algazi, M.D., Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center and Strategic Clinical Advisor to OncoSec. "These findings build upon our previous report from this study showing an approximate 30 percent overall response rate with monotherapy TAVO and further support the potential value of TAVO therapy for this patient population."

OMS-100 is a Phase 2 study of monotherapy TAVO for the treatment of patients with metastatic melanoma. In all, 51 subjects were enrolled in three treatment arms. Reponses data from the study were previously reported, with approximately 30 percent of subjects achieving a best overall response based on RECIST criteria. In addition, 47 percent of patients had stable disease, resulting in a DCR (Disease Control Rate) of 77 percent. Among patients who responded to monotherapy, investigators noted upregulation of innate immune mediators in the periphery of responding patients after treatment. TAVO was well tolerated, with predominantly grade 1 procedural related adverse events.

Slides from the Melanoma Bridge will be available following the conference on www.oncosec.com

Bristol-Myers Squibb to Take Part in Citi 2018 Global Healthcare Conference

On November 29, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will take part in the Citi 2018 Global Healthcare Conference on Thursday, December 6, 2018 in New York (Press release, Bristol-Myers Squibb, NOV 29, 2018, View Source [SID1234531711]). Tom Lynch, chief scientific officer, will answer questions about the company at 2:10 p.m. ET.

Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

Clinical Genomics partners with the Colorectal Cancer Alliance in the Life After Cancer Mission

On November 29, 2018 Clinical Genomics, a leading provider of cancer diagnostic solutions including liquid biopsy tests, reported its partnership with the Colorectal Cancer Alliance in a yearlong collaboration for the Life After Cancer mission (Press release, Clinical Genomics, NOV 29, 2018, View Source [SID1234531709]). The Alliance is the largest US-based nonprofit patient advocacy group for colorectal cancer patients, providing resources and education to patients in their fight against this disease. The Life After Cancer initiative focuses on helping patients navigate their survivorship path by creating awareness about recurrence monitoring as part of their follow up care, allowing those who have overcome the disease to become an advocate of their long-term health and well-being. This expanded partnership between Clinical Genomics and the Colorectal Cancer Alliance builds upon an existing relationship to continue the mission to support this patient community.

Clinical Genomics is the sole provider of COLVERA, a unique blood test for patients who have been diagnosed with colorectal cancer (CRC) that identifies circulating tumor DNA (ctDNA) for early detection of residual and recurrent disease, at a stage when more treatment options are available for these patients. COLVERA is currently marketed in the USA and available through our CLIA-certified laboratory in Bridgewater, NJ.

"Early detection has been shown to improve overall survival from this deadly disease. Colorectal cancer affects a wide range of ages with increasing incidence in younger patients. Partnerships like this with Clinical Genomics are critical in order to make an impact on this devasting disease and provide patients with cutting edge tools and resources they need in order to navigate their choices," stated Michael Sapienza, CEO of the Colorectal Cancer Alliance.

"We had the great pleasure to meet patients and their circle of support at the Alliance’s National Conference in Houston this year. Working with the Alliance on Life After Cancer, we can contribute to providing important education and awareness resources to this community. Colorectal cancer screening is an important focus in the US and now we must emphasize the importance of follow-up care surveillance monitoring of CRC with tests like COLVERA, for patients who have been diagnosed with the disease," said Betsy Hanna, Chief Commercial Officer of Clinical Genomics.

About Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer related deaths in the United States, with more than 140,000 people per year expected to be diagnosed with CRC and as many as 50,000 succumbing to the disease. For patients who survive, 30-50% will experience a recurrence, most within the first two to three years of primary treatment. On average, the lifetime risk of developing colorectal cancer is about one in 23 for men and women combined, however, this varies widely according to individual risk factors.

Chi-Med Enters into Multiple Collaborations to Evaluate Combinations of Surufatinib and Fruquintinib with PD-1 Checkpoint Inhibitors

On November 29, 2018 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has entered into four collaboration agreements to evaluate the safety, tolerability and efficacy of Chi-Med’s surufatinib (HMPL-012 or sulfatinib) and fruquintinib in combination with checkpoint inhibitors (Press release, Hutchison China MediTech, NOV 29, 2018, https://www.chi-med.com/a181129/ [SID1234531708]). It is an important part of Chi-Med’s strategy to explore the potential synergies of its drug candidates in combination with other anti-cancer treatments. These four new immunotherapy collaborations add to our ongoing studies combining savolitinib, Chi-Med’s highly selective c-Met inhibitor, with AstraZeneca PLC’s checkpoint inhibitor, durvalumab (Imfinzi).

Today, Chi-Med is announcing the first steps to develop its vascular endothelial growth factor receptor ("VEGFR") inhibitors, surufatinib and fruquintinib, in combination with various programmed cell death protein-1 ("PD-1") monoclonal antibodies in several solid tumor settings:

A global collaboration to evaluate the combination of surufatinib with toripalimab (JS001), a PD-1 monoclonal antibody being developed by Shanghai Junshi Biosciences Co. Ltd.;
A global collaboration to evaluate the combination of fruquintinib with sintilimab (IBI308), a PD-1 monoclonal antibody being developed by Innovent Biologics (Suzhou) Co. Ltd.;
A collaboration in China to evaluate the combination of surufatinib with HX008, a PD-1 monoclonal antibody being developed by Taizhou Hanzhong Pharmaceuticals, Inc.; and
A collaboration in China to evaluate the combination of fruquintinib with genolimzumab (GB226), a PD-1 monoclonal antibody being developed by Genor Biopharma Co. Ltd.
The global market for angiogenesis inhibitors was over US$18 billion in 2017, based on their use in around 30 different tumor settings. Each of the agreements announced today will pursue different initial indications within the field of solid tumors.

"Recent innovations in solid tumor drugs have focused on targeted therapies and immunotherapies which, as monotherapies, have both provided improved patients outcomes," said Christian Hogg, Chief Executive Officer of Chi-Med. "We believe that the future of oncology treatments increasingly lies in combining therapies, utilizing multiple mechanisms of action ("MOA") to confront tumors. Our unique next-generation anti-angiogenesis VEGFR inhibitors, with high selectivity and tolerability, make them ideal candidates for such combinations with immunotherapy agents such as PD-1/L1 monoclonal antibodies to prolong and expand the benefits of these therapies to more patients."

Chi-Med’s proof-of-concept studies have already demonstrated the benefits of combinations with other kinase inhibitors or with chemotherapy.

Surufatinib (HMPL-012 or sulfatinib) is a novel, oral angio-immuno kinase inhibitor that inhibits VEGFR and fibroblast growth factor receptor (FGFR) which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R) which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. This dual angiogenesis-checkpoint inhibitor’s MOA may be very suitable for combination use with other immunotherapies. Surufatinib, as a monotherapy, is in late-stage clinical trials in China and began proof-of-concept clinical trials in the United States in July 2018.

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR. Its unique kinase selectivity has been shown to reduce off-target toxicity thereby allowing possible use in combination with other agents. It was first approved for colorectal cancer in China in September 2018. It is in several late-stage clinical trials for lung and gastric cancer, including in combination with chemotherapy such as paclitaxel (Taxol) and other kinase inhibitors such as gefitinib (Iressa), and is in a Phase I clinical trial in the United States.