On July 24, 2018 A-Alpha Bio reported that it has been awarded a National Science Foundation Phase I Small Business Innovation Research (SBIR) grant for $225,000 to develop AlphaSeq: a cell-based platform that will accelerate cancer drug development by enabling high-throughput and quantitative characterization of protein-protein interactions (Press release, A-Alpha Bio, JUL 24, 2018, View Source [SID1234636894]).

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!

Proteins bind to one another, like Lego pieces, to form complex biological machines. In cancer cells, these machines are dysregulated, causing cell-survival and uncontrolled growth. Pharmaceutical companies are developing drugs that kill cancer cells by blocking key protein-protein interactions. However, blocking any of the millions of protein-protein interactions that occur in healthy cells could cause serious side-effects, making specificity a major concern.

"A-Alpha Bio’s AlphaSeq technology is a game-changer for preclinical drug screening," said Randolph Lopez, CTO and Co-founder of A-Alpha Bio. "It lets us measure the effect of a drug on thousands of protein-protein interactions simultaneously, instead of having to measure each one individually. Pharmaceutical companies will not have to limit their preclinical testing to a small number of likely off-target effects. With AlphaSeq, they can avoid costly and potentially life-threatening surprises during clinical trials by screening their drugs against whole protein networks"

Protein interactions are already widely recognized as being critically important for the development of many different types of drugs. AlphaSeq provides a unique advantage over existing approaches by combining high accuracy and throughput, which is enabled by advances in the fields of synthetic biology and DNA sequencing. This SBIR grant is aimed at expanding the capabilities of AlphaSeq for screening interactions with challenging proteins and insoluble small molecule drugs. Once completed, A-Alpha Bio will be eligible to apply for a Phase II grant (up to $750,000) for pilot testing and scale-up.

On July 23, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that data on the adjuvant treatment of women with triple-negative breast cancer (TNBC) with the combination of trastuzumab (Herceptin) +/-nelipepimut-S (NeuVax) will be presented as a Proffered Paper in an oral presentation at the 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany (Press release, Sellas Life Sciences, JUL 23, 2018, View Source;Herceptin-at-Upcoming-European-Society-for-Medical-Oncology-ESMO-2018-Meeting/default.aspx [SID1234527830]).

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!

The abstract, "Pre-specified interim analysis of a randomized phase 2b trial of trastuzumab + nelipepimut-S (NeuVax) vs trastuzumab for the prevention of recurrence demonstrates benefit in triple negative (HER2 low-expressing) breast cancer patients," describes research undertaken at Cancer Insight, LLC by a team of clinicians-scientists led by COL (ret) George E. Peoples, MD, FACS, the principal investigator for the study.

Data will be presented from a prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial (IST) of Herceptin +/- NeuVax in HER 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences. As previously announced, a pre-specified interim analysis of safety and efficacy conducted by the study independent data safety monitoring board (DSMB), demonstrated a clinically meaningful and statistically significant difference between the TNBC cohort of patients and the control arm with a hazard ratio of 0.26, p-value = 0.023, in favor of the NeuVax + Herceptin combination compared to Herceptin alone. The analysis also showed an adverse event profile with no notable differences between treatment arms and no additional cardiotoxicity in the NeuVax + Herceptin arm. Based on these positive results, the DSMB recommended to expeditiously seek regulatory guidance from the U.S. Food and Drug Administration for further development of the combination of NeuVax + Herceptin in TNBC, a population with a large unmet medical need.

Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

About ESMO (Free ESMO Whitepaper)

The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) is Europe’s leading non-profit medical oncology organization. ESMO (Free ESMO Whitepaper) is a membership-based society, comprising of 500 expert committee members and 18,000 oncology professionals. ESMO (Free ESMO Whitepaper) organizes a large number of meetings to provide its members and the community with the resources they need and also plays a major role in public policy and European affairs. The ESMO (Free ESMO Whitepaper) 2018 Annual Meeting represents a multi-professional platform for oncology education and exchange, and for immense international visibility for scientific research, and will be held under the tagline "Securing access to optimal cancer care".

On July 23, 2018 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage company developing novel epigenetic therapies, reported the appointment of Dr. Shefali Agarwal as chief medical officer, effective July 23, 2018 (Press release, Epizyme, JUL 23, 2018, View Source [SID1234527842]). In this role, Dr. Agarwal will oversee all of the company’s activities related to the global strategic development of tazemetostat, a potent, selective, orally available EZH2 inhibitor, as well as additional pipeline candidates. A trained physician with expertise in medical oncology, Dr. Agarwal brings nearly two decades of clinical research and regulatory experience to Epizyme.

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!

"Dr. Agarwal’s distinguished career in both academia and the biotech industry make her an ideal candidate to lead our clinical organization and oversee the development of innovative therapies to potentially treat a range of solid tumor and hematological malignancies for which significant needs exist," said Robert Bazemore, president and chief executive officer of Epizyme. "Her proven leadership and understanding of the patient community, as well as the healthcare providers who care for them, will be instrumental as we continue to advance our lead product candidate, tazemetostat."

"I look forward to joining this dynamic management team, and leading the next phase of clinical development for tazemetostat, as well as for EZM8266, our novel agent that targets G9a for the treatment of sickle cell disease, as we prepare it to enter the clinic," said Dr. Agarwal. "I believe that Epizyme’s scientific vision and innovative approach will drive the continued success of the company, as we work together to deliver promising new options for underserved patients."

Over the span of her career, Dr. Agarwal has held leadership positions across medical research, clinical development, clinical operations, and medical affairs. She has led clinical and regulatory engagements for small molecules, biologics, liposomal and cell therapy products across the full spectrum of drug development, from pre-IND work to filing. Dr. Agarwal most recently served as chief medical officer at SQZ Biotech, where she built and led the clinical development organization, which included clinical research operations and the regulatory function. She brings significant oncology experience to Epizyme, having held leadership positions at Curis and Tesaro. At Curis, Dr. Agarwal oversaw the Phase 2 study for its dual HDAC/PI3K inhibitor in diffuse large B-cell lymphoma, and the Phase 1 study in solid tumors for its oral checkpoint inhibitor. At Tesaro, Dr. Agarwal led the NDA and EMA submissions for ZEJULA (niraparib) in ovarian cancer. She has also held positions of increasing responsibility at Covidien, AVEO Oncology and Pfizer.

In addition to receiving her MBBS medical degree from Karnataka University’s Mahadevappa Rampure Medical School in India, Dr. Agarwal earned a master’s of public health from Johns Hopkins University, where she led clinical research in the Department of Anesthesiology and Critical Care Medicine. She also holds a master’s of science in business from the University of Baltimore’s Merrick School of Business.

On July 23, 2018 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated a Phase Ib/II proof-of-concept study of sulfatinib in pancreatic neuroendocrine tumors ("NET") patients and in biliary tract cancer ("BTC") patients in the U.S.. Sulfatinib is an oral small molecule angio-immuno kinase inhibitor that can simultaneously block tumor angiogenesis and immune evasion (Press release, Hutchison China MediTech, JUL 23, 2018, https://www.chi-med.com/sulfatinib-poc-pnet-btc-us/ [SID1234528657]). This study follows several trials that are underway in China, including two Phase III studies in pancreatic and non-pancreatic NET that commenced after positive results from a Phase II study, and a Phase II study in BTC patients. In addition, a Phase I dose escalation part of this study in the U.S. was recently completed.

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!

This proof-of-concept study is a multi-center, single-arm, open-label study to evaluate the efficacy and safety of sulfatinib as a monotherapy in (a) patients with advanced BTC that have progressed on standard first-line chemotherapy, and (b) in patients with advanced pancreatic NET. The primary and secondary endpoints include progression-free survival ("PFS") rate, objective response rate ("ORR"), disease control rate ("DCR"), duration of response ("DoR"), time to response, overall survival ("OS"), safety and tolerability. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT02549937.

About Sulfatinib
Sulfatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor ("VEGFR"), fibroblast growth factor receptor ("FGFR") and colony stimulating factor-1 receptor ("CSF-1R"), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Inhibition of the VEGFR signaling pathway can act to stop angiogenesis, the growth of the vasculature around the tumor, and thereby starve the tumor of the nutrients and oxygen it needs to grow rapidly. Aberrant activation of the FGFR signaling pathway, which can be increased by anti-VEGFR therapy treatment, is shown to be associated with cancer progression by promoting tumor growth, angiogenesis and formation of the myeloid derived suppressor cells. Inhibition of the CSF-1R signaling pathway blocks the activation of tumor-associated macrophages, which are involved in suppressing immune responses against tumors. Its unique angio-immuno kinase profile supports sulfatinib as a potentially attractive candidate for exploration of possible combinations with checkpoint inhibitors against various cancers.

Sulfatinib is the first oncology candidate that we have taken through proof-of-concept in China and subsequently started clinical development in the U.S. We are currently conducting studies in six target patient populations on sulfatinib and retain all rights to sulfatinib worldwide.

About Sulfatinib Development in China
Sulfatinib is currently in development as a single agent for patients with NET, thyroid cancer and BTC in China.

Pancreatic NET: In March 2016, we initiated the SANET-p study, which is a randomized, double-blind, placebo-controlled, multi-center, Phase III pivotal registration trial to treat about 190 patients with low- or intermediate-grade, advanced pancreatic NET in China. The primary endpoint is PFS, with secondary endpoints including ORR, DCR, DoR, time to response, OS, safety and tolerability. Additional details of the SANET-p study may be found at clinicaltrials.gov, using identifier NCT02589821. We expect to complete enrollment in 2019 and present top-line results thereafter.

Extra-pancreatic NET: The SANET-ep study, which was initiated in December 2015, is similar to the SANET-p study and is targeted at treating about 270 patients with advanced extra-pancreatic NET in China. Additional details of the SANET-ep study may be found at clinicaltrials.gov, using identifier NCT02588170. We expect to complete enrollment in 2019 and present top-line results thereafter.

Thyroid cancer: In March 2016, we initiated Phase II in two target patient populations in China to evaluate the efficacy and safety of sulfatinib in patients with advanced medullary thyroid cancer and iodine-refractory differentiated thyroid cancer. Additional details of this study may be found at clinicaltrials.gov, using identifier NCT02614495.

BTC: In January 2017, we began a Phase II study in patients with BTC (also known as cholangiocarcinoma), a heterogeneous group of rare malignancies arising from the biliary tract epithelia. Gemzar is the currently approved first-line therapy for biliary tract cancer patients, with a total of approximately 18,000 new patients per year in the U.S. according to the National Cancer Institute, but median survival is less than 12 months for patients with unresectable or metastatic disease at diagnosis. As a result, we see a major unmet medical need for patients who have progressed when being treated with Gemzar, and sulfatinib may offer a new targeted treatment option in this tumor type. Additional details of this study may be found at clinicaltrials.gov, using identifier NCT02966821.

On July 23, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed a study on the stability after "hand thawing" syringes of the Cell-in-a-Box encapsulated cells that will be used, in combination with low doses of the cancer prodrug ifosfamide, for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, JUL 23, 2018, View Source [SID1234528930]). The data obtained from this "hand thawing" study is required by the U.S. Food and Drug Administration (FDA).

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!

The filing of an Investigational New Drug Application (IND) requires that the clinical product, as well as the product’s use, should be well characterised. PharmaCyte’s Cell-in-a-Box is a cutting edge Advanced Therapy Medicinal Product (ATMP). Therefore, numerous studies are needed since such a product has never been tested before in the United States. The laboratory scale "thawing" study previously conducted (View Source) determined how long the once-frozen Cell-in-a-Box encapsulated cells are still fit for use after thawing, as would occur in a clinical setting before the Cell-in-a-Box capsules are implanted into a patient with LAPC. That study defined one of the important parameters for the upcoming planned clinical trial for LAPC.

At individual study sites, the frozen cells in the Cell-in-a-Box capsules within syringes will be hand-thawed and then kept at room temperature until they are implanted into a patient with LAPC. The results of the "hand thawing" study announced today show that the viability of the cells remains essentially the same for at least 30 minutes at room temperature. This serves to define the time that the interventional radiologist has to implant the Cell-in-a-Box capsules after thawing to ensure cellular viability within the patient.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained the significance of the study saying, "This is yet another important study that PharmaCyte has completed to comply with the FDA’s requirements for our planned, upcoming clinical trial in LAPC. The Cell-in-a-Box encapsulated cells are in a frozen state before they are administered to the patient. This study was designed to determine how long after unfreezing the Cell-in-a-Box encapsulated cells can they be held at room temperature before being introduced into the patient without losing their effectiveness.

"This is important since the treatment depends on the viability of our genetically engineered live human cells in order to produce the cytochrome P450 enzyme for the activation of the chemotherapy prodrug ifosfamide. The study’s goal was to determine how long the cells remained viable at room temperature after thawing; thus, mimicking how long the clinicians and interventional radiologists will have to administer the capsules to the patient in the hospital. The newly completed studies show how long that Cell-in-a-Box encapsulated cells can be kept at room temperature for optimal activity."