On December 12, 2016 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported positive preclinical findings generated using the Company’s Immune Repertoire Capture (IRC) technology, presented at the IBC Antibody Engineering & Therapeutics Conference being held in San Diego, California, December 11-15, 2016 (Press release, Atreca, DEC 12, 2016, View Source [SID1234522960]). In a presentation entitled "Analyzing B-cell Receptor Repertoires from Human Studies," Daniel Emerling, Ph.D., Atreca’s Senior Vice President, Research, provided a summary of key findings from the Company’s preclinical programs, including:

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!

Atreca’s IRC technology has identified and generated antibodies from active human immune responses, including antibodies from cancer patients who have responded well to immunotherapy and other treatments, patients with autoimmune disease, vaccinated subjects, and patients with infections.
Atreca’s immuno-oncology program is advancing antibodies that selectively bind tumor tissue types beyond that of the original patient and display potent antitumor activity in vivo.
Dr. Emerling stated, "Atreca’s IRC platform has demonstrated in preclinical disease models the power of mining a patient’s own anti-tumor immunity. In one of our applications of IRC, we generate natively paired antibody heavy and light chain sequences from blood plasmablasts – activated B cells – that are critical to the body’s own immune response to cancer and pathogens. As our programs progress, we anticipate being able to advance these promising biologic agents for potential use in cancer immunotherapy, vaccines, and diverse additional therapeutic applications."

"Over the past year, Atreca has made substantial progress both in advancing our internal and partnered programs and attracting world-class experts to our leadership team and advisory group," said Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-Founder. "We will continue to advance multiple programs through preclinical studies to the clinic, with a primary focus on cancer immunotherapy applications of our novel and proprietary IRC platform."

More information on the Antibody Engineering & Therapeutics Conference is available at: View Source

On December 12, 2016 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, and Synthon Biopharmaceuticals B.V., an international biopharmaceutical company with highly focused development activities for new molecular entities in the therapeutic areas of oncology and autoimmune diseases, reported they have entered a license and collaboration agreement for the development of MGC018, an antibody-drug conjugate (ADC) directed against solid tumors expressing B7-H3 (Press release, MacroGenics, DEC 12, 2016, View Source [SID1234517232]). This molecule is based on a MacroGenics proprietary B7-H3 antibody and Synthon’s proprietary duocarmycin-based, linker-drug technology.

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!

Under the terms of the agreement, Synthon has licensed rights to its linker-drug technology to MacroGenics to enable future development and commercialization of MGC018. Synthon will also provide manufacturing support and supply ADC to MacroGenics and will be entitled to receive license fees, milestone payments and royalties based on successful development and commercialization of MGC018. Additional details of the transaction were not disclosed.

Based on favorable activity and safety profiles in the non-clinical setting, MacroGenics has selected MGC018 as its lead anti-B7-H3 ADC candidate. MacroGenics has recently initiated IND-enabling studies for this molecule.

"We are encouraged by the data generated with Synthon’s ADC platform and believe that MGC018 will nicely complement our broader portfolio of B7-H3-directed agents," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "The team at Synthon brings tremendous expertise in linker-drug chemistry and product development that complements our existing capabilities. We look forward to continuing to collaborate with them on this important molecule."

Jacques Lemmens, founder and CEO of Synthon added: "We are very pleased with this commercial licensing agreement with MacroGenics, which enables us to deploy our unique linker-drug technology against a therapeutic target that is complementary to those in our own pipeline. We believe that such collaborations are an important means to accelerate the availability of important therapeutic treatment options to patients who need them."

MacroGenics’ B7-H3 Franchise

MGC018 represents the third molecule in MacroGenics’ franchise of B7-H3-directed molecules. In addition to MGC018, MacroGenics is pursuing two other therapeutic product candidates utilizing different and complementary immune-based mechanisms of action. The leading program, enoblituzumab, is an Fc-optimized monoclonal antibody directed against B7-H3 and is currently in clinical testing as both monotherapy and in combination with either pembrolizumab or ipilimumab. The second program, MGD009, also in clinical testing, is a bispecific DART molecule designed to target tumors expressing B7-H3 by recruiting and expanding T cells at the tumor site. MacroGenics retains worldwide development and commercialization rights to all three of these programs.

Synthon’s Unique Technology Based on Duocarmycin Analogs

Antibody-drug conjugates are designed to combine the specificity of antibodies directed against tumor-associated targets with potent cytotoxicity. Upon internalization of the ADC, the antibody-bound cytotoxins are released intracellularly, leading to programmed tumor cell death.

While the cytotoxins used in the majority of advanced programs in the field prevent tubulin polymerization during cell division, Synthon’s differentiating linker-drug technology − which applies valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA) − is based on synthetic duocarmycin analogs, which bind to the minor groove of DNA and subsequently cause irreversible alkylation of DNA. This disrupts the nucleic acid architecture, which eventually leads to tumor cell death.

Duocarmycins are able to exert their mode of action at any phase in the cellular cycle, whereas tubulin binders will only attack tumor cells when they are in a mitotic phase. Growing evidence suggests that DNA damaging agents, such as duocarmycins, are more efficacious in tumor cell killing than tubulin binders, particularly in solid tumors.

Although based on natural products, Synthon’s proprietary ADC linker-drug technology uses fully synthetic duocarmycin analogs. The unique design of the selectively cleavable linker connecting the antibody to a duocarmycin prodrug leads to high stability in circulation, and induces efficient release of the cytotoxin in the tumor.

On December 12, 2016 Novocure (NASDAQ: NVCR) presented data from its phase 2 pilot PANOVA clinical trial at its research and development day suggesting that Tumor Treating Fields (TTFields) plus first-line chemotherapies nab-paclitaxel and gemcitabine may be tolerable and safe in patients with advanced pancreatic cancer (Press release, NovoCure, DEC 12, 2016, View Source [SID1234517056]). The data also suggested an improved one-year survival rate among patients who received TTFields therapy with nab-paclitaxel and gemcitabine compared to a recent phase 3 trial of patients who received nab-paclitaxel and gemcitabine alone¹. Progression free survival and one-year survival rate of patients treated with TTFields plus nab-paclitaxel and gemcitabine were more than double those of nab-paclitaxel and gemcitabine-treated historical controls¹. Novocure will submit data for presentation at an upcoming medical conference.

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 second cohort of the prospective, single-arm study included 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received chemotherapy or radiation therapy prior to the clinical trial. The primary endpoint measured the incidence and severity of treatment-related adverse events. Patients reported no serious adverse events related to TTFields. Nine patients suffered from serious adverse events unrelated to TTFields therapy.

"We are extremely pleased with these results," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "The results of the second cohort of our PANOVA trial support our preclinical work that has demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel. We are finalizing plans and are eager to begin a phase 3 pivotal trial in advanced pancreatic cancer."

About Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death in the U.S. The American Cancer Society estimated that about 53,000 people would be diagnosed with pancreatic cancer and about 42,000 people would die from the disease in 2016. Five-year survival among patients with metastatic pancreatic cancer is 2 percent. Tumor Treating Fields (TTFields) therapy is not approved for the treatment of pancreatic cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for pancreatic cancer has not been established.

On December 12, 2016 Novocure (NASDAQ: NVCR) presented data from its phase 2 pilot INNOVATE clinical trial at its research and development day suggesting that Tumor Treating Fields (TTFields) in combination with weekly paclitaxel is tolerable and safe in patients with recurrent ovarian cancer (Press release, NovoCure, DEC 12, 2016, View Source [SID1234517055]). The data also suggested more than doubling of the progression free survival and an improvement in overall survival among patients who received TTFields therapy with paclitaxel compared to a recent phase 3 trial of patients who received paclitaxel alone¹.

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!

Novocure will submit the data for presentation at an upcoming medical conference and will begin planning a phase 3 pivotal trial in recurrent ovarian cancer.

"These results are promising," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "Recurrent ovarian cancer is a very difficult to treat disease that quickly develops resistance to multiple types of chemotherapies. We are committed to researching TTFields as a potential treatment for ovarian cancer and look forward to beginning a phase 3 pivotal trial."

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women in the United States. The National Cancer Institute estimated that in 2016, there were approximately 22,000 new cases of ovarian cancer diagnosed and approximately 14,000 deaths in the United States. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. The five-year survival rate is 44 percent, and the majority of patients present at advanced stage with 60 percent having metastatic disease. TTFields therapy is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for ovarian cancer has not been established.