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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

On November 29, 2018 Tocagen Inc. (Nasdaq: TOCA), a late clinical-stage, cancer-selective gene therapy company and NRG Oncology, a member of the National Cancer Institute’s (NCI) National Clinical Trial Network (NCTN), reported that the NCI Cancer Therapy and Evaluation Program (CTEP) Brain Malignancies Steering Committee has approved a concept to develop a clinical trial utilizing the investigational therapeutic regimen Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) for the treatment of patients with newly diagnosed glioblastoma (GBM) (Press release, Tocagen, NOV 29, 2018, View Source;p=RssLanding&cat=news&id=2378701 [SID1234531707]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

NRG Oncology, as one of the four adult group members of the NCI NCTN, conducts practice-defining, multi-institutional Phase 2 and 3 trials funded primarily by the NCI. The proposed Phase 2/3 trial (NRG-BN006) is expected to begin enrollment in 2019 and will be conducted by NRG Oncology under its NCI-funded grant, with Tocagen supplying investigational drug and supplemental financial support. Additional information about the trial will be provided in 2019.

Standard of care (SOC) for newly diagnosed GBM, the most common and deadly form of primary malignant brain tumor, involves surgical removal of as much of the tumor as possible followed by radiation therapy and temozolomide with use of tumor treating fields in a select group of patients. The proposed NRG-BN006 trial is designed to assess the benefit of adding Toca 511 & Toca FC to chemotherapy and radiation compared to SOC alone.

"The Brain Tumor Committee at NRG Oncology elected to conduct and sponsor the Toca 511 & Toca FC clinical trial in patients with newly diagnosed GBM based on the merits of published clinical data, which show extended overall survival compared to historical controls, durable complete responses and a favorable safety profile in patients with recurrent high grade glioma along with preclinical data that support a novel immune-activating mechanism of action, synergy with radiation therapy and additive efficacy in combination with temozolomide," said Minesh P. Mehta, chair of the Brain Tumor Committee at NRG Oncology.

Added Manmeet Ahluwalia, Principal Investigator of the proposed study, "Glioblastoma remains a very high unmet need and there is excitement among the NRG Oncology membership to explore the potential of Toca 511 & Toca FC to enhance standard treatment to achieve greater tumor response and extend survival of patients with this aggressive type of cancer."

Tocagen is currently studying Toca 511 & Toca FC for the treatment of recurrent high grade glioma (HGG) in the ongoing Phase 3 trial (Toca 5) which has enrolled approximately 400 patients, equally randomized to receive either Toca 511 & Toca FC or standard of care. Across three ascending-dose Phase 1 trials, Tocagen has treated 127 patients with recurrent HGG with Toca 511 & Toca FC. In these trials, Tocagen observed potential benefits, including ongoing durable complete responses, extended overall survival and a favorable safety profile. The proposed NRG-BN006 trial will be the first clinical trial of the Toca 511 & Toca FC regimen in the newly diagnosed GBM setting.