AstraZeneca shares its comprehensive scientific approach at the World Conference on Lung Cancer 2017

On October 16, 2017 AstraZeneca and Medimmune, its global biologics research and development arm, reported it continue to demonstrate their progress in lung cancer research at the IASLC 18th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan, 15-18 October 2017 (Press release, AstraZeneca
, OCT 16, 2017, View Source [SID1234520928]). With 43 data presentations, including 16 oral presentations, AstraZeneca is focusing on four key scientific drivers of progress in lung cancer: treating earlier stages of the disease; strategies to overcome tumour resistance; improved testing to match the right treatments to the right patients; and continued exploration of the potential of immuno-oncology combinations.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The data we are presenting at WCLC 2017 illustrate the science-led strength of our clinical programme focused on tackling multiple mechanisms associated with this complex disease. We are constantly striving to deliver on our ambition of one day eliminating cancer as a cause of death.”

Treating lung cancer at earlier stages of the disease

To date, the majority of research has been focused on metastatic disease, where the medical need is most urgent. But with the potential for clinical benefit becoming clearer in earlier stages of disease, long-term quality of life is an increasingly important component in deciding the right treatment.

At WCLC, patient-reported outcomes from the Phase III Imfinzi PACIFIC trial will be presented during the Presidential Symposium. The PACIFIC trial of Imfinzi (durvalumab) in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemoradiation therapy, is the first to demonstrate superior progression-free survival (PFS) in this setting.

Rina Hui, MD, PhD, clinical associate professor of medicine, Westmead Clinical School at the University of Sydney and Principal Investigator on the trial, said: “As we treat patients with earlier stages of disease and pursue curative intent, quality-of-life considerations definitely affect the choice of treatment. If quality-of-life data support significant clinical benefits, then we may be looking at a new treatment paradigm for these patients.”

Overcoming tumour resistance

More patients taking therapies targeting mutations are experiencing longer periods before their disease worsens; however, tumours often adapt and develop new resistance mechanisms. At WCLC, AstraZeneca is presenting new data on novel combinations that may help overcome a common secondary resistance and established driver of disease progression in patients treated with EGFR TKIs – mesenchymal epithelial transition factor (MET).

Early safety and efficacy results from the multi-arm, Phase Ib TATTON study will be presented, investigating the c-Met receptor tyrosine kinase inhibitor (TKI) savolitinib in combination with EGFR T790M inhibitor Tagrisso (osimertinib) in patients with MET-positive resistance. [Abstract #8985]. These data will be supplemented by the first results of a multi-centre Phase Ib study investigating the combination of savolitinib and Iressa (gefitinib) in a similar patient population. [Abstract #8995].

Myung-Ju Ahn, MD, PhD, Professor, Department of Hematology & Oncology, Samsung Medical Center, Seoul, South Korea, said: “Cancer is stealthy and we must continue to find new ways to combat resistance. The early results for both gefitinib and osimertinib in combination with savolitinib show exciting progress and are an important area of continued focus.”

Testing to identify the most suitable treatment

Biomarker-guided lung cancer research is continuing to improve ways to identify patients who are most likely to benefit from treatment with precision medicines. In NSCLC, this has meant improving the accuracy and availability of blood-based testing to facilitate diagnosis and identification of the most suitable treatments throughout the disease continuum. At WCLC, AstraZeneca is presenting progress in ctDNA testing in EGFRm NSCLC across multiple lines of therapy and technologies.

In the 1st-line setting, new analyses across the Tagrisso FLAURA [Abstract #8978] and Iressa BENEFIT [Abstract #9278] trials reveal good concordance between tissue and plasma ctDNA testing, and support the utility of blood-based testing to determine eligibility for both Tagrisso and Iressa. In addition, concordance studies comparing multiple plasma ctDNA diagnostics in two different studies of Tagrisso [Abstract #8984 and #9811] in the 2nd line setting continue to build understanding of the comparability of different technologies and expand testing across platforms.

Jhanelle Gray, MD, Medical Oncologist and Director of Clinical Research in the Department of Thoracic Oncology at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, said: “Testing continues to be a critical part of lung cancer care, but the rapid development and evolution of multiple testing modalities and platforms can be challenging for physician teams to manage. Continued understanding of how assays compare builds confidence in treatment decisions, leading to better patient outcomes”

Combining with IO

As the promise of IO continues to build through the use of monotherapies, the next era in cancer control may involve combinations with a goal of achieving long-term survival for a broader population of patients. At WCLC, AstraZeneca is sharing results from two early trials of checkpoint inhibitor combinations, with and without chemotherapy.

When combined with chemotherapy, Imfinzi with or without tremelimumab could be administered safely and demonstrated encouraging preliminary clinical activity in patients with NSCLC in a study conducted by the Canadian Cancer Trials Group [Abstract #8700].
The Phase II, open-label, NIBIT-MESO-1 study [Abstract #9202] of Imfinzi plus tremelimumab as 1st- or 2nd-line treatment in patients with malignant mesothelioma demonstrated a safety profile consistent with our previous observations/publications in NSCLC, and clinical activity in this difficult-to-treat cancer.
Rosalyn A. Juergens MD., PhD. Assistant Professor, Department of Oncology. McMaster University, Canada said: “As we continue to explore the full benefit of immunotherapies, the promise of combinations is really starting to be seen for patients who may not be expected to benefit from the current monotherapies. We continue to push research boundaries in this area with the hope that we can make a real difference to patients in need.”

Vical Announces News Release and Conference Call Schedule for Third Quarter 2017 Financial Results

On October 16, 2017 Vical Incorporated (Nasdaq:VICL) reported that the company will report financial results for the three months ended September 30, 2017, before the opening of trading on Monday, October 23, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Monday, October 23 (Press release, Vical, OCT 16, 2017, View Source [SID1234520969]). The call will be open on a listen-only basis to any interested parties. The company will also provide a business update, including details on independent and partnered development programs in the conference call and webcast.

Conference Call
To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 457-2619 (preferred), or (888) 349-9582 (toll-free), and reference confirmation code 3889356. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 3889356. The call also will be available live and archived through the events page at www.vical.com.

Invited participants may ask questions during the conference call. Others may submit questions before the call by e-mail addressed to [email protected] or by fax to (858) 646-1150. Submitted questions will be screened for appropriateness and general interest. Selected questions received with sufficient notice before the call will be answered as time permits at the end of the call. For further information, contact Vical’s Investor Relations department by phone at (858) 646-1127 or by email at [email protected].

Commencement of Collaborative Research on Measurement of Exosomes in Blood from Cancer Patients

On October 16, 2017 The National Cancer Center Japan (hereafter, National Cancer Center), JVCKENWOOD Corporation (hereafter, JVCKENWOOD), Sysmex Corporation (hereafter, Sysmex) and Daiichi Sankyo Company Limited (hereafter, Daiichi Sankyo) reported that they have commenced collaborative research with the aim of raising the quality of cancer diagnosis and treatment (Press release, Daiichi Sankyo, OCT 15, 2017, View Source [SID1234520930]). The collaborative research will target exosome, a microparticle released from tissues.

It has been demonstrated in recent years that cancer patients have high levels of cancer-specific exosomes in their blood. The collaborative research aims to detect such cancer-specific exosomes (for instance, HER2 protein expressing exosome) from patient blood. The research is expected to provide a new option for patients to make decision for cancer therapy and evaluating drug treatment outcomes from blood, in addition to current tumor tissue sampling approach.

Regarding individual roles in the collaborative research, JVCKENWOOD will build technologies that detect cancer-specific exosomes by using its exosome measurement device. Sysmex will evaluate the device created by JVCKENWOOD and will apply its proprietary gene and protein measurement technologies toward clinical use. National Cancer Center and Daiichi Sankyo will make effective use of exosome measurement data in improving the diagnosis and treatment of cancer patients.

The research collaboration among a specialist cancer research organization, diagnostic and electronic device manufacturers and a pharmaceutical company makes it possible to establish this new technology for exosome measurement in clinical use. As a result, this exosome measurement is expected not only to greatly reduce the stress of patients by avoiding multiple tissue biopsies, but also to provide new therapeutic opportunities to patients in whom the sampling of lesion tissue is difficult.

(Reference information)

National Cancer Center
The National Cancer Centeris a specialist cancer research organization actively engaged in developing body fluid diagnosis techniques that reduce discomfort for patients. Regarding exosomes, the research group led by Takahiro Ochiya, Head of the Center’s Division of Molecular and Cellular Medicine, has achieved world-leading breakthroughs, such as the development of a system capable of high sensitivity detection of exosomes in patients’ blood, and has abundant experience in body fluid diagnosis using exosomes and its clinical application.

JVCKENWOOD
JVCKENWOOD has created a high accuracy exosome measurement system applying optical disk technology called ExoCounter (Note 1) and is in the process of developing it for commercial use. The company aims to contribute to the collaborative research by providing technology for the high accuracy detection of exosomes specifically derived from cancer cells, through the further development of the system.
(Note 1) Joint development with Department of Biochemistry & Integrative Medical Biology, School of Medicine, Keio University

Sysmex
In the field of in vitro diagnostics which examine samples of blood, urine and cell, Sysmex is a major global player in such areas as hematology, immunochemistry, and hemostasis. Sysmex will contribute its proprietary gene and protein measurement technologies to the collaborative research. It will also provide development expertise, including that to achieve reliability, to enable JVCKENWOOD’s exosome measurement system to be used in clinical practice.

Startup Impact Biomedicines Raises $22M to Bring Fedratinib to Myelofibrosis Patients

On October 13, 2017 Impact Biomedicines ("Impact") reported its launch to pioneer the development of life-changing treatments for patients with myeloproliferative neoplasms and other cancers (Press release, Impact Biomedicines, OCT 13, 2017, View Source [SID1234520974]). The Company’s pipeline is centered around fedratinib, a potent and highly selective oral small molecule JAK2 kinase inhibitor that is being developed initially for the treatment of myelofibrosis (MF) and polycythemia vera (PV). In conjunction with this launch, Impact is pleased to share that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on fedratinib and that the company has received $22.5 million from Medicxi through a Series A financing.

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Impact was formed in 2016 after acquisition of Sanofi’s full rights for the global development and commercialization of fedratinib. The majority equity holders in Impact include the co-founders and Medicxi, with Sanofi retaining a minority stake.

In 2013, the development of fedratinib was discontinued by Sanofi after the FDA issued a clinical hold subsequent to reports of a few potential cases of Wernicke’s encephalopathy (WE), an acute neurological condition usually indicative of a vitamin B deficiency, in patients participating in fedratinib clinical trials. Following a Type A meeting and review of additional data, the FDA concluded that Impact provided the necessary documentation to support lifting the clinical hold – opening the path for Impact’s continued development of fedratinib.

The clinical package for fedratinib includes data from a total of 18 studies completed in 877 subjects. In JAKARTA-1, a completed international Phase 3 pivotal trial for the treatment of myelofibrosis, fedratinib met its primary and secondary endpoints by reducing spleen size in 47% of patients by ≥35% at 24 weeks (p<0.0001) and improving symptom score in 36% of patients by ≥50% at 24 weeks (p< 0.0001). Comparable responses were seen in patients with normal or low platelet counts and thrombocytopenia was similar between placebo and the target dose of 400mg. In JAKARTA-2, a follow-on study in patients who were unresponsive to all other available therapies, including patients who were either Jakafi (ruxolitinib) resistant or intolerant, fedratinib showed similar activity. In that study, 55% of patients who had failed or were intolerant to ruxolitinib experienced a spleen size reduction of ≥35% with fedratinib. Notably, responses were noted in 63% of patients intolerant to ruxolitinib and 61% of patients who had lost ruxolitinib response. Currently, ruxolitinib is the only drug approved by the FDA to treat patients with MF and PV. The most common adverse events for fedratinib were hematological (anemia) and gastrointestinal (nausea, diarrhea and vomiting). The results of these trials have been published in leading peer-reviewed journals.

"The decision to discontinue the development of fedratinib in 2013 was heartbreaking for the patients who were experiencing positive responses while in clinical trials. There are very limited therapeutic options for these patients and fedratinib was active in most patients when nothing else had worked. Because of the very high unmet medical need in MF, the Impact team completed a thorough review of the available data, including careful due diligence into the potential cases of WE and I am glad to report that as a result of this effort, the FDA has lifted the clinical hold," said John Hood, Ph.D., Chief Executive Officer of Impact. "In addition to MF, Impact intends to pursue multiple clinical indications for fedratinib to realize its potential as a best-in-class JAK2 kinase inhibitor."

To support the Company’s drug development and manufacturing efforts and the build out of the management team, Impact closed a $22 million Series A financing with Medicxi.

"We’ve made it a point to double down and invest more in maturing life science companies who are delivering innovation where it’s needed most. In line with our ‘asset-centric’ approach, we believe Impact is doing just that by reviving fedratinib with a thoughtful development approach and due diligence," said Kevin Johnson, Impact board member and Co-Founder of Medixci. "We are confident that the dedicated team at Impact has the vision and skill to create a sustainable long-term business around fedratinib."

The development of fedratinib is being led by a highly skilled and devoted team, including members of the original TargeGen team, where fedratinib was first developed prior to its acquisition by Sanofi.

Dr. Hood serves as Chief Executive Officer of Impact Biomedicines. Prior to founding Impact, he was co-founder and Chief Scientific Officer of Samumed, a pharmaceutical platform company focused on advancing regenerative medicine and oncology applications. Prior to that, Dr. Hood was Director of Research and co-inventor of fedratinib at TargeGen, Inc., (subsequently acquired by Sanofi SA), where he led a team identifying small molecule kinase inhibitors for the treatment of eye diseases and cancer. He is an inventor on 100+ patents and author on 50+ scientific articles. Dr. Hood obtained a Ph.D. in medical physiology and B.S. in biochemistry from Texas A&M University.

Dr. Catriona Jamieson serves as Interim Chief Medical Officer of Impact Biomedicines, and co-founder. Concurrently, Dr. Jamieson is a Professor of Medicine and Chief of Regenerative Medicine, Deputy Director of the Sanford Stem Cell Clinical Center, Co-leader of the Hematologic Malignancies Program, and Director of Stem Cell Research at the Moores UC San Diego Cancer Center. She specializes in myeloproliferative neoplasms and leukemia, and was the principal investigator on several fedratinib trials. Dr. Jamieson obtained an M.D., a Ph.D. in microbiology and a B.S. in Genetics from the University of British Columbia prior to completing fellowships in hematology and bone marrow transplantation at Stanford University and being recruited to UC San Diego.

About Myeloproliferative Neoplasms
Myeloproliferative Neoplasms (MPN) are a closely-related group of blood cancers in which the body, specifically the bone marrow, makes too many red blood cells, platelets, or certain white blood cells. There are three types of blood cancers that comprise MPNs: Myelofibrosis, Polycythemia Vera and Essential Thrombocythemia. MPNs are characterized by the mutations of JAK2, MPL o

Startup Impact Biomedicines Raises $22M to Bring Fedratinib to Myelofibrosis Patients

On October 13, 2017 Impact Biomedicines ("Impact") reported its launch to pioneer the development of life-changing treatments for patients with myeloproliferative neoplasms and other cancers (Press release, Impact Biomedicines, OCT 13, 2017, View Source [SID1234522384]). The Company’s pipeline is centered around fedratinib, a potent and highly selective oral small molecule JAK2 kinase inhibitor that is being developed initially for the treatment of myelofibrosis (MF) and polycythemia vera (PV). In conjunction with this launch, Impact is pleased to share that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on fedratinib and that the company has received $22.5 million from Medicxi through a Series A financing.

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!

Impact was formed in 2016 after acquisition of Sanofi’s full rights for the global development and commercialization of fedratinib. The majority equity holders in Impact include the co-founders and Medicxi, with Sanofi retaining a minority stake.

In 2013, the development of fedratinib was discontinued by Sanofi after the FDA issued a clinical hold subsequent to reports of a few potential cases of Wernicke’s encephalopathy (WE), an acute neurological condition usually indicative of a vitamin B deficiency, in patients participating in fedratinib clinical trials. Following a Type A meeting and review of additional data, the FDA concluded that Impact provided the necessary documentation to support lifting the clinical hold – opening the path for Impact’s continued development of fedratinib.

The clinical package for fedratinib includes data from a total of 18 studies completed in 877 subjects. In JAKARTA-1, a completed international Phase 3 pivotal trial for the treatment of myelofibrosis, fedratinib met its primary and secondary endpoints by reducing spleen size in 47% of patients by >35% at 24 weeks (p<0.0001) and improving symptom score in 36% of patients by >50% at 24 weeks (p< 0.0001). Comparable responses were seen in patients with normal or low platelet counts and thrombocytopenia was similar between placebo and the target dose of 400mg. In JAKARTA-2, a follow-on study in patients who were unresponsive to all other available therapies, including patients who were either Jakafi (ruxolitinib) resistant or intolerant, fedratinib showed similar activity. In that study, 55% of patients who had failed or were intolerant to ruxolitinib experienced a spleen size reduction of >35% with fedratinib. Notably, responses were noted in 63% of patients intolerant to ruxolitinib and 61% of patients who had lost ruxolitinib response. Currently, ruxolitinib is the only drug approved by the FDA to treat patients with MF and PV. The most common adverse events for fedratinib were hematological (anemia) and gastrointestinal (nausea, diarrhea and vomiting). The results of these trials have been published in leading peerreviewed journals.

"The decision to discontinue the development of fedratinib in 2013 was heartbreaking for the patients who were experiencing positive responses while in clinical trials. There are very limited therapeutic options for these patients and fedratinib was active in most patients when nothing else had worked. Because of the very high unmet medical need in MF, the Impact team completed a thorough review of the available data, including careful due diligence into the potential cases of WE and I am glad to report that as a result of this effort, the FDA has lifted the clinical hold," said John Hood, Ph.D., Chief Executive Officer of Impact. "In addition to MF, Impact intends to pursue multiple clinical indications for fedratinib to realize its potential as a best-in-class JAK2 kinase inhibitor."

To support the Company’s drug development and manufacturing efforts and the build out of the management team, Impact closed a $22 million Series A financing with Medicxi.

"We’ve made it a point to double down and invest more in maturing life science companies who are delivering innovation where it’s needed most. In line with our ‘asset-centric’ approach, we believe Impact is doing just that by reviving fedratinib with a thoughtful development approach and due diligence," said Kevin Johnson, Impact board member and Co-Founder of Medixci. "We are confident that the dedicated team at Impact has the vision and skill to create a sustainable long-term business around fedratinib."

The development of fedratinib is being led by a highly skilled and devoted team, including members of the original TargeGen team, where fedratinib was first developed prior to its acquisition by Sanofi.

Dr. Hood serves as Chief Executive Officer of Impact Biomedicines. Prior to founding Impact, he was co-founder and Chief Scientific Officer of Samumed, a pharmaceutical platform company focused on advancing regenerative medicine and oncology applications. Prior to that, Dr. Hood was Director of Research and co-inventor of fedratinib at TargeGen, Inc., (subsequently acquired by Sanofi SA), where he led a team identifying small molecule kinase inhibitors for the treatment of eye diseases and cancer. He is an inventor on 100+ patents and author on 50+ scientific articles. Dr. Hood obtained a Ph.D. in medical physiology and B.S. in biochemistry from Texas A&M University.

Dr. Catriona Jamieson serves as Interim Chief Medical Officer of Impact Biomedicines, and co-founder. Concurrently, Dr. Jamieson is a Professor of Medicine and Chief of Regenerative Medicine, Deputy Director of the Sanford Stem Cell Clinical Center, Co-leader of the Hematologic Malignancies Program, and Director of Stem Cell Research at the Moores UC San Diego Cancer Center. She specializes in myeloproliferative neoplasms and leukemia, and was the principal investigator on several fedratinib trials. Dr. Jamieson obtained an M.D., a Ph.D. in microbiology and a B.S. in Genetics from the University of British Columbia prior to completing fellowships in hematology and bone marrow transplantation at Stanford University and being recruited to UC San Diego.