Palleon Pharmaceuticals Raises $47.6 million to Develop Glycoimmune Checkpoint Inhibitors, a New Class of Medicines Designed to Overcome Resistance to First-Generation Immuno-Oncology Drugs

On October 4, 2017 — Palleon Pharmaceuticals, a company focused on developing the first Glycoimmune Checkpoint Inhibitors to treat cancer, reported the completion of a $47.6 million Series A financing from leading biotech venture investors SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures, and AbbVie Ventures (Press release, Palleon Pharmaceutical, OCT 4, 2017, View Source [SID1234520792]).

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The Series A funding will be used to establish and advance a first-in-class pipeline of drug candidates targeting Glycoimmune Checkpoints — receptors on immune cells that normally distinguish "self" versus "non-self" but get exploited in cancer to create immunosuppression that allows tumors to thrive. Glycoimmune Checkpoints function in ways similar to T cell checkpoints, with a few important differences: they are activated by binding to cell-surface glycans — the sugar molecules found on cell surfaces — rather than to other proteins, and they are expressed in a wider range of immune cells involved in the anti-cancer response, including both innate and adaptive immune cells. In addition, Glycoimmune Checkpoints appear to be exploited by most types of cancer, and a tumor’s unique glycan signature offers the prospect of selecting patients who are likely to respond to therapy.

Palleon has exclusive licenses to the intellectual property of discoveries made by its scientific co-founders, Carolyn Bertozzi, PhD, the Anne T. and Robert M. Bass Professor of Chemistry at Stanford University and an Investigator of the Howard Hughes Medical Institute, and Paul Crocker, PhD, Professor of Glycoimmunology and Head of the Division of Cell Signaling and Immunology at the University of Dundee, Scotland. Bertozzi’s and Crocker’s scientific discoveries in the separate fields of tumor glycoscience and human immunology were brought together to create a unique platform which enables Palleon to develop cancer drugs targeting Glycoimmune Checkpoints.

Jim Broderick, MD, Chief Executive Officer and Founder of Palleon, commented, "The most meaningful breakthroughs often occur at the intersection of diverse and seemingly unrelated scientific disciplines. Palleon was spawned by bringing together new findings in glycoscience and human immunology, which resulted in unexpected implications for oncology. The convergence of these two fields has enabled us to develop a novel class of medicines that could have a significant impact on the lives of cancer patients."

"We have known for decades that certain glycan patterns such as hypersialylation appear on the surface of tumors, and that these patterns are correlated with poor clinical outcomes; however, we did not understand the functional role of these tumor-specific glycans in immunosuppression," said Dr. Bertozzi. "We now know that tumors evolve in such a way that their cell surface glycans "trick" the immune system, which prevents many types of immune cells from detecting and destroying cancer cells. We are using this knowledge to develop new and innovative cancer therapies for patients."

Palleon’s Convergence Platform is driven by the combined expertise of its world-class founding team in tumor glycoscience and human immunology. The company has incorporated a range of technologies to overcome the historic scientific barriers that have made glycoscience a challenging area of study. Armed with a unique understanding of the differences in immune pattern recognition between humans and other species, the company has integrated human biology into every step of the drug development process, including target validation, in vitro models, in vivo models, and translational research. The company has assembled the core expertise needed to pioneer a new field in this complex area of biology, and its proprietary knowledge will define Palleon’s leadership in this rapidly emerging area.

Palleon was originally incubated in the Cambridge offices of SR One, where Dr. Broderick served as the firm’s first Entrepreneur-in-Residence, working closely with SR One President Jens Eckstein. "We are very excited about the launch of Palleon. Within the dynamic field of immuno-oncology, Palleon has forged an entirely new pathway for targeting the immune system. The unique features of Glycoimmune Checkpoints will make possible a much wider range of rational combination therapies to treat cancer," said Dr. Eckstein. "Palleon is built on the discoveries of its exceptional scientific founders who have identified Glycoimmune Checkpoints as a means to transform the treatment of cancer and improve and extend the lives of patients throughout the world."
About Palleon Pharmaceuticals

Palleon Pharmaceuticals is the leading biotechnology company focused on developing Glycoimmune Checkpoint inhibitors to treat cancer. The company’s proprietary Convergence Platform integrates technologies and insights from world-renowned scientific leaders in the fields of glycoscience and human immunology to create a novel approach to treating cancer. By targeting multiple immune cell types, Glycoimmune Checkpoint inhibitors will tackle resistance to first-generation immuno-oncology agents, and make possible a wider range of rational combination therapies to treat cancer. While Palleon is focused primarily on oncology, the Convergence Platform is applicable to other therapeutic areas including infectious diseases, neurodegeneration, inflammation, and fibrosis. The company is advancing its pipeline and development programs with a $47.6 million Series A financing from leading biotech venture investors SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures, and AbbVie Ventures. Learn more at www.palleonpharma.com.

Selexis SA and Pelican Therapeutics Sign Agreement to Advance Pelican’s Immunotherapy Clinical Programs

On October 4, 2017 Selexis SA and Pelican Therapeutics ("Pelican"), a subsidiary of Heat Biologics, Inc. ("Heat") (Nasdaq: HTBX), reported that they have entered into a service agreement to advance the development of Pelican’s proprietary immunotherapy clinical candidates (Press release, Selexis, OCT 4, 2017, View Source [SID1234520784]). Under the agreement, Pelican intends to leverage Selexis’ proprietary SUREtechnology PlatformTM to rapidly develop high-performance research cell banks (RCBs) expressing two of Pelican’s clinical candidates, including PTX-35, a humanized monoclonal antibody that is a functional agonist of human TNFRSF25, and PTX-15, a human TL1A-Ig fusion protein. Both candidates have the potential to improve clinical response when used in combination with Heat’s ImPACT therapeutic platform and other immunotherapy drugs.

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"With immunotherapies dominating the treatment landscape, we continually find that our technology can help our partners, such as Pelican, advance candidates for unmet medical needs including certain cancers," said Yemi Onakunle, PhD, MBA, Selexis vice president, licensing and business development. "By combining our ability to rapidly produce high-expressing and stable research cell banks with KBI Biopharma’s strong development, production and analytical capabilities, we are able to reliably and predictably support Pelican’s clinical development and provide the fastest timelines to the eventual commercialization of both clinical candidates."
In June 2017, JSR Corporation acquired Selexis SA to bring best-in-class cell line development technology to JSR Life Sciences, its life sciences division. JSR Life Sciences is now offering industry partners best-in-class contract development manufacturing organization (CDMO) services by complementing its commercial subsidiary KBI Biopharma with Selexis technologies.

Rahul Jasuja, CEO of Pelican, added: "We chose Selexis for their expertise in cell line expression technologies for recombinant protein therapeutics for the CMC development of our two molecules, PTX-35 and PTX-15. We look forward to advancing our TNFRSF25 agonist program with both KBI Biopharma and Selexis as we prepare for our first-in-human clinical trial."
PTX-35, Pelican’s lead product candidate, is a novel monoclonal antibody against TNFRSF25, an emerging costimulatory receptor on T cells. The agent provides highly selective and potent stimulation of ‘memory’ CD8+ cytotoxic T cells, a class of T cell that is responsible for eliminating tumor cells in patients. PTX-35 has the potential to enhance durability of antigen-specific immune responses in combination with other immunotherapies.

Selexis’ proprietary SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the biologics development continuum, spanning discovery to commercialization.

Siamab Therapeutics and Boehringer Ingelheim Announce Strategic Cancer Immunology Discovery Collaboration to Develop Antibody Therapeutics Targeting Multiple Solid Tumors

On October 4, 2017 Siamab Therapeutics, Inc. and Boehringer Ingelheim reported that they have entered into a strategic discovery collaboration with the goal of developing anti-cancer therapeutics targeting tumor associated carbohydrate antigens (TACAs) (Press release, Siamab Therapeutics, OCT 4, 2017, View Source [SID1234520783]). Siamab will apply its proprietary technology platform to generate TACA-specific antibodies for use in multiple solid tumor applications. Financial terms of the agreement are not being disclosed.

TACAs represent unique cancer-selective targets that are present in the majority of solid tumors including ovarian, pancreatic, prostate, colon, gastric and breast, and are exploited by tumor cells to suppress innate immune function, enable tissue invasion and metastasis, resist chemotherapy and promote a stem-cell phenotype. Selective targeting of TACAs can therefore provide novel approaches for this exciting new era of cancer immunology research.

Under the terms of the agreement, Siamab will use its platform to discover TACA selective targeting antibodies. Boehringer Ingelheim will have the option to conduct further engineering, development and commercialization of the anti-TACA antibodies resulting from the collaboration. The agreement is for one TACA target, with the option for Boehringer Ingelheim to add a second. Siamab will be eligible to receive research funding and technical input, as well as potential milestone and royalty payments for each program.

“We are excited to partner with Boehringer Ingelheim, a global leader in oncology research and development, to leverage our proprietary technology platform to identify anti-TACA antibody therapeutics against new targets,” said Jeff Behrens, president and chief executive officer of Siamab Therapeutics. “This collaboration combines our expertise in the rapid discovery and characterization of highly specific, high affinity anti-TACA antibodies with Boehringer Ingelheim’s antibody drug discovery and development experience in novel cancer therapeutics. We look forward to working together to identify new anti-cancer therapeutics.”

“Boehringer Ingelheim’s collaboration with Siamab provides an opportunity to discover and develop new antibody therapeutics that target TACAs, which are emerging as an important new class to treat cancer and an area that we are actively exploring,” said Jonathon Sedgwick Ph.D., Vice President and Global Head, Cancer Immunology and Immune Modulation Research.

Sierra Oncology to host Key Opinion Leader Meeting “Beyond PARP: The Clinical Potential of Next Generation DNA Damage Response (DDR) Therapeutics” on October 12th in NY

On October 4, 2017 Sierra Oncology, Inc. (SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported that it will host a Key Opinion Leader (KOL) luncheon on the topic of “Beyond PARP: The Clinical Potential of Next Generation DNA Damage Response Therapeutics” on Thursday, October 12th from 12:00-1:30pm at the Lotte New York Palace, Reid Salon, 455 Madison Ave, New York City (Press release, Sierra Oncology, OCT 4, 2017, View Source [SID1234520781]).

The meeting will feature presentations by three KOLs in DDR scientific and clinical development:

Leonard Post, PhD, Chief Scientific Officer of Vivace Therapeutics; former CSO of BioMarin Pharmaceutical, will discuss lessons learned from PARP inhibitor development, with a focus on optimizing drug properties;

Eric J. Brown, PhD, Associate Professor of Cancer Biology at the Perelman School of Medicine of the University of Pennsylvania, will discuss the ATR/Chk1 pathway and its biology, highlighting emerging views on the importance of replication stress;

Geoffrey I. Shapiro, MD, PhD, Associate Professor of Medicine at Harvard Medical School; Clinical Director at the Center for DNA Damage and Repair, and Director of the Early Drug Development Center at Dana-Farber Cancer Institute, will discuss translating emerging DDR science into the cancer clinic, emphasizing the importance of patient selection strategies.

In addition to the KOL presentations, Dr. Nick Glover, President and CEO of Sierra Oncology, will provide a brief overview on the company’s ongoing clinical development program for SRA737, a potent, highly selective, orally bioavailable small molecule inhibitor of the emerging DDR target, Chk1.

Following the presentation, the KOLs, along with members of Sierra’s Senior Management team, will be available to answer questions. If you would like to ask a question during the live Q&A, please submit your request via email at [email protected]

For those who are unable to attend in person, a live webcast and replay will be accessible here:

Webcast: www.sierraoncology.com

Direct link: View Source

About the Key Opinion Leaders

Leonard Post, PhD, is Chief Scientific Officer of Vivace Therapeutics and also serves as an advisor to numerous biotechnology companies and to venture investors. Until July 2016, he was Chief Scientific Officer of BioMarin Pharmaceutical, and before that was CSO and cofounder of LEAD Therapeutics which was acquired by BioMarin in 2010. His work in DNA repair involved the discovery of the PARP inhibitor talazoparib at LEAD and its development into Phase 3 at BioMarin. Talazoparib is currently being tested in EMBRACA, a Phase III clinical study in gBRCA+ locally advanced and/or metastatic breast cancer. From 2000-2006, he was Senior Vice President of Research and Development at Onyx Pharmaceuticals, during the clinical development of Nexavar from IND through NDA approval. Prior to Onyx, he was at Parke-Davis Pharmaceutical where he was VP of Discovery Research; and before that at The Upjohn Company in several positions. Dr. Post is currently a member of the board of directors of Viralytics Ltd., an Australian Stock Exchange-listed company; and of private companies Orphagen Pharmaceuticals, Fedora Pharmaceuticals and Oxyrane Ltd.

Eric J. Brown, PhD is an Associate Professor of Cancer Biology at the Perelman School of Medicine at the University of Pennsylvania. Dr. Brown’s laboratory examines how signaling maintains genome stability during DNA synthesis and how this function is essential to cancer cells. His laboratory was the first to report that oncogenic stress is sufficient to cause selective sensitivity to ATR inhibition. Dr. Brown’s laboratory is currently identifying predictive biomarkers of therapeutic benefit and the mechanisms of action of these drugs through a combination of genome-wide breakpoint mapping and replication fork proteomics. In collaboration with clinical researchers, these biomarkers of response will be exploited in current and future clinical trials. Collectively, the Brown laboratory seeks both to define the mechanisms of action of ATR/Chk1 inhibitors and to identify their optimal uses in cancer therapies. Dr. Brown received his PhD (Immunology) from Harvard University in 1996. He performed his doctoral research with Dr. Stuart Schreiber at Harvard University, where he purified and cloned the mammalian target of rapamycin (mTOR). In his postdoctoral research in Dr. David Baltimore’s laboratory at the California Institute of Technology, Dr. Brown investigated the impact of ATR suppression on genome stability and checkpoint signaling in response to replication stress.

Geoffrey I. Shapiro, MD, PhD is an Associate Professor of Medicine at Harvard Medical School and Director of the Early Drug Development Center at Dana-Farber Cancer Institute. Dr. Shapiro runs one of the largest Phase 1 clinical trials programs in the United States and dedicates his time to developing leading cancer treatments. He is also a member of Dana-Farber’s Thoracic Oncology Program and a member of the Dana-Farber/Harvard Cancer Center SPORE (Specialized Program of Research Excellence) in Lung Cancer. Dr. Shapiro conducts both basic and translational research on cyclin-dependent kinase inhibitors, with a focus on defining the role of these inhibitors in the cellular response to DNA damage. Dr. Shapiro received his PhD in 1987 and his MD in 1988 from Cornell University, followed by postgraduate training in internal medicine at Beth Israel Hospital, Boston. He completed a fellowship in medical oncology at Dana-Farber Cancer Institute, during which he investigated the role of cell-cycle-related proteins in lung cancer. He joined the Dana-Farber faculty in 1994.

Celsion to Host Research and Development Update October 12, 2017

On October 4, 2017 Celsion Corporation (NASDAQ:CLSN), an oncology development company, reported that it will host a Research and Development (R&D) Day for investors and analysts on Thursday, October 12, 2017 (Press release, Celsion, OCT 4, 2017, View Source [SID1234520777]). The event is scheduled to take place from 4:00 to 6:00 p.m. Eastern Time in New York City, and will be simultaneously streamed as a webcast.

The presentations will focus on the Company’s research and development programs and will feature leading experts in directed chemotherapies, DNA-based immunotherapies and immuno-oncology, including:

ThermoDox – Pivotal Phase III OPTIMA Study for Primary Liver Cancer

Won Young Tak, M.D., Ph.D., Professor Internal Medicine, GI & Hepatology Kyungpook National University Hospital Daegu, Republic of Korea
Stephen N. Wong, M.D., Principle Investigator OPTIMA, Chinese General Hospital, Philippines
Robert M. Eisele, M.D., Deputy Head of Department, Dept. of General, Visceral, Vascular and Pediatric Surgery, Medical Faculty of the University of Saarland, Homburg, Germany

GEN-1 Immunotherapy – A Powerful, Pro-Immune Modulator of Cancer’s Microenvironment

Premal H. Thaker, M.D., Associate Professor in Gynecologic Oncology, Washington University School of Medicine, St. Louis, Missouri
Richard C. Koya, MD, PhD, Associate Professor of Oncology and Immunology, Director of the Vector Development & Production Facility, Associate Director of the Center for Immunotherapy, Roswell Park Cancer Institute, Center for Immunotherapy, Buffalo, NY
A live webcast of the presentations will be available on Celsion’s website at View Source beginning at approximately 4:15 p.m. Eastern Time. To ensure a timely connection, users should register at least 15 minutes prior to the scheduled start. The webcast will be archived for replay following the event for 90 days.

About the OPTIMA Study

The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 70 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus optimized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee.

About the OVATION Study

The Phase Ib trial was designed to evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety and tolerability. GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation.