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Immune-Onc Therapeutics IND Application for First-In-Human Trial of IO-202, a Novel Antibody for the Treatment of Acute Myeloid Leukemia, Receives FDA Clearance

– Immune-Onc Expects Enrollment in its Phase 1 Trial to Begin in Q3 2020 –

PALO ALTO, CA, May 29, 2020 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-202, an antibody targeting an immune inhibitory receptor LILRB4. IO-202 is the first T-cell activator for acute myeloid leukemia (AML). In preclinical studies, IO-202 has shown evidence of activating T cell cytotoxicity against leukemia cells and blocking tumor infiltration. Immune-Onc’s first Phase 1 trial with IO-202 will evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in AML patients with monocytic differentiation and in chronic myelomonocytic leukemia (CMML) patients.

“The FDA clearance to proceed with the first-in-human trial of IO-202 in AML and CMML is an important milestone for our company,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "Acute myeloid leukemia is a devastating disease that needs new approaches and better treatment options. We look forward to working with investigators as we advance the first anti-LILRB4 antibody into the clinic.”

The Phase 1 trial will begin with a dose-escalation phase to identify the optimal dose of IO-202. Once the recommended dose of IO-202 is selected, the trial will enroll patients in an expansion cohort to evaluate IO-202 as monotherapy. There is potential to evaluate IO-202 in combination with other agents with a protocol amendment. Biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials.

ABOUT AML and CMML

AML, the most common acute leukemia (blood and bone marrow cancer) in adults, is characterized by the proliferation of abnormal myeloblasts (a type of white blood cell) in the bone marrow. Nearly 20,000 new cases are expected in the U.S. in 2020. Despite advances in treatment, less than 30 percent of acute myeloid leukemia patients are alive five years after initial diagnosis.

CMML is a cancer that starts in blood-forming cells in the bone marrow and invades the blood. The condition is rare, with about 1,100 cases in the U.S. each year.

ABOUT IO-202

IO-202 is a first-in-class monoclonal antibody that blocks signaling of leukocyte immunoglobulin-like receptor B4 (LILRB4), an immune inhibitory receptor, with high binding affinity and specificity. In October 2018, Immune-Onc and The University of Texas announced the publication of pioneering research in Nature (DOI: 10.1038/s41586-018-0615-z) illuminating the roles of LILRB4 in immune suppression and tumor infiltration in AML. IO-202 is the first T-cell activator for AML. Preclinical studies showed that IO-202 can convert a “don’t kill me” to “kill me” signal by activating T cell killing of AML cells and a “don’t find me” to “find me” signal by inhibiting leukemia infiltration. IO-202 will be evaluated in AML and CMML in a Phase 1 trial, and Immune-Onc plans to explore its potential in other hematologic malignancies and solid tumors in future trials.

ABOUT IMMUNE-ONC THERAPEUTICS

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients. Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies.

The company aims to translate unique scientific insights in myeloid biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that target novel immunosuppressive myeloid checkpoints. Immune-Onc has a promising pipeline built upon strategic collaborations and cutting-edge research from The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center.

Immune-Onc’s lead program IO-202, a first-in-class antibody targeting LILRB4, is being developed to treat acute myeloid leukemia and other cancers. IO-202 is the first T-cell activator for AML. Immune-Onc’s preclinical pipeline includes an anti-LILRB2 antibody, an anti-LAIR1 antibody, and multiple undisclosed programs for solid tumors and hematologic malignancies. For more information, please visit www.immune-onc.com.

MEDIA CONTACTS

Tara Cooper
The Grace Communication Group, LLC
media@immuneonc.com
650-303-7306

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Immune-Onc Therapeutics Prepares for its Next Phase of Growth with New Leadership Appointments and Key Board Member Additions

– Paul Woodard, M.D. appointed Chief Medical Officer –

– An Song, Ph.D. promoted to Chief Scientific Officer –

– Zhengbin (Bing) Yao, Ph.D. joins Board of Directors and Gregory Cosma, Ph.D. appointed to Scientific Advisory Board –

PALO ALTO, CA, November 19, 2019 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a privately held cancer immunotherapy company, announced today the addition of several industry veterans to its executive team and advisory boards and the promotion of An Song, Ph.D. to Chief Scientific Officer from Senior Vice President of Development Sciences. Dr. Paul Woodard joins Immune-Onc from Bellicum Pharmaceuticals, Inc. where he most recently served as Senior Vice President, Clinical and Medical Affairs.

“We are thrilled to add such seasoned and strategic individuals to the executive and advisory teams guiding Immune-Onc through its next phase of growth as a clinical stage company,” said Charlene Liao, Ph.D., Co-founder and Chief Executive Officer of Immune-Onc. “As our Chief Medical Officer, Paul brings the right combination of deep expertise in oncology paired with proven strategic leadership and experience building teams and functions in a startup environment. The appointment of An to Chief Scientific Officer is a reflection of the contributions she has already made to the company in her current role and a recognition of the value that her experience will bring in guiding the translation of our science into development.”

“I can’t imagine a more exciting time to join Immune-Onc,” said Dr. Woodard. “I was first drawn to the novel science underlying the portfolio. As I learned more about Immune-Onc and their authentic passion for improving patient lives, it became clear to me that this was a company that I wanted to contribute to in a meaningful way with the goal of bringing much needed new treatment options to people with hard-to-treat cancers like acute myeloid leukemia.”

About Paul Woodard, M.D.

As Chief Medical Officer, Dr. Woodard will be responsible for clinical leadership and medical oversight of the Immune-Onc portfolio. These activities will include review and input of IND submissions, clinical protocol development and medical oversight of Immune-Onc trials, and oversight of internal and external clinical development, biometrics, safety, and regulatory functions and compliance.

Dr. Woodard has an extensive hematology and oncology background gained in academia and industry. His academic experience focused on pediatric hematopoietic stem cell transplantation and hematologic disorders at world-renowned institutions, including St. Jude Children’s Research Hospital, University of California, San Francisco, and Children’s Hospital, Los Angeles. In addition to patient care, at St. Jude, Dr. Woodard was responsible for Phase 1/2 trials in pediatric hematopoietic stem cell transplantation for malignant and non-malignant disorders.

Prior to joining Immune-Onc, Dr. Woodard worked on a wide range of drug development projects in solid tumors, hematologic malignancies, and non-malignant hematologic disorders. At Exelixis, Dr. Woodard worked on small molecule tyrosine kinase inhibitors for solid tumors. At Amgen, Dr. Woodard was the global development leader for Nplate® (romiplostim) in immune thrombocytopenia and myelodysplastic syndromes. At Genentech, Dr. Woodard was the global development team leader for Tecentriq® (atezolizumab) in hematologic malignancies and was an integral team member for the development of Tecentriq® combinations in solid tumors (including triple negative breast cancer) and hematologic malignancies. At Bellicum, Dr. Woodard was the Senior Vice President of Clinical and Medical Affairs, with oversight of the company’s cellular therapy portfolio and clinical trials in hematologic malignancies and solid tumors.

Dr. Woodard earned his medical degree at the University of North Carolina and completed his residency at the University of Virginia and fellowships in pediatric hematology-oncology at the University of North Carolina and in pediatric blood and marrow transplantation at the University of Minnesota.

About An Song, Ph.D.

Dr. Song joined Immune-Onc in July 2018 as Senior Vice President of Development Sciences. In the newly created role of Chief Scientific Officer, Dr. Song will have overall accountability for translational development of Immune-Onc’s portfolio and strategic oversight of research and antibody engineering.

Dr. Song is a translational scientist with 22 years of experience across basic research and drug development in oncology, autoimmunity, metabolic, infectious, and neurodegenerative diseases. Dr. Song joins Immune-Onc from Genentech where, as a Senior Director in BioAnalytical Sciences, she led the Assay Development and Technology group for the company’s large molecule portfolio globally and was a member of numerous scientific review bodies within the Genentech Research and Early Development (gRED) organization. During her 16-year tenure at Genentech, Dr. Song contributed to, and oversaw 40+ IND/CTA and BLA/MAA regulatory filings for products including Rituxan®, Avastin®, Herceptin®, Lucentis®, Kadcyla® and Tecentriq®. In addition, Dr. Song played a significant role in the development and approval of Ocrevus®.

Dr. Song received her Ph.D. in Biochemistry & Molecular Biology from Indiana University and completed a postdoctoral fellowship in immunology, followed by a faculty position as Assistant Professor (Research) at Stanford University. As an active member of the American Association of Pharmaceutical Scientists (AAPS), Dr. Song has served as an executive member of the Biotech Section and chair of the Therapeutic Product Immunogenicity (TPI) Focus Group/Community.

BOARD APPOINTMENTS

In addition, Immune-Onc bolstered its cadre of advisors with the appointment of Zhengbin (Bing) Yao, Ph.D. to its Board of Directors and Gregory Cosma, Ph.D. to its Scientific Advisory Board. “Both Bing and Greg bring significant experience in helping early-stage companies navigate the complexity of drug development,” commented Dr. Liao. “Bing and Greg’s perspectives are invaluable in supporting Immune-Onc in our mission to deliver transformative therapies to cancer patients.”

About Zhengbin (Bing) Yao, Ph.D.

Dr. Yao has more than 20 years of experience in the biopharmaceutical industry, with a proven track record of successfully leading the discovery and development of multiple biotherapeutics. Dr. Yao is currently Chairman of the Board and CEO of Viela Bio. Prior to this role, he was Senior Vice President, Head of Respiratory, Inflammation and Autoimmune iMED at MedImmune/AstraZeneca. During his tenure at MedImmune, he played key leadership roles in the development and approval of three novel biologics for autoimmune, respiratory, and immune-oncology indications. Previously, Dr. Yao also served as Senior Vice President, Head of Immuno-Oncology Franchise, AstraZeneca, as well as CEO for WuXi-MedImmune Joint Venture. Dr. Yao joined MedImmune in 2010 from Genentech, where he was the Head of Project Team Leaders for Immunology, Infectious Diseases, Neuroscience, and Metabolic Disease. He was Vice President and Head of Research for Tanox, before the company was acquired by Genentech in 2007. Dr. Yao also held several positions of increasing responsibility at Aventis and Amgen and currently serves on the Board of Directors for NexImmune. Dr. Yao received his Ph.D. in Microbiology and Immunology from the University of Iowa, followed by postdoctoral work at Immunex.

About Gregory Cosma, Ph.D.

As a former executive at Genentech and Bristol-Myers Squibb, Dr. Cosma has a long track record of success leading companies in translating science into approved therapies. As Vice President of Research and Early Development at Genentech from 2010-2019, Dr. Cosma led the Safety Assessment organization comprising Toxicology, Pathology, Product Quality and Occupational Toxicology and Nonclinical Operations. He also chaired the Genentech Development Review Committee (DRC), overseeing nonclinical development of the Genentech pipeline from Research to First-in-Human studies. While at Bristol-Myers Squibb from 2003-2010, Dr. Cosma held roles as the Executive Director for Drug Safety Evaluation and as the Therapeutic Area Head for Metabolic Diseases. Prior to these roles, Dr. Cosma was a Research Fellow at Pharmacia-Pfizer and an assistant professor in the College of Veterinary Medicine and Biomedical Sciences at Colorado State University. Dr. Cosma earned his doctorate in Pharmacology/Toxicology at the University of Kansas.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that disarm immune suppression in the tumor microenvironment. Immune-Onc has a promising pipeline built upon strategic collaborations and cutting-edge research from The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center. Its lead program, an antibody targeting LILRB4, is being developed to treat acute myeloid leukemia and other cancers. Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies. For more information, please visit www.immune-onc.com.

MEDIA CONTACTS

Tara Cooper
Cooper Communication Group
media@immuneonc.com
650-303-7306

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Immune-Onc Therapeutics and University of Texas Report a Novel Target for Acute Myeloid Leukemia in Nature

PALO ALTO, Calif. & DALLAS & HOUSTON, October 17, 2018 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients, announced today the publication of a study in Nature (DOI: 10.1038/s41586-018-0615-z) that provides new insights into immune regulation and the progression of acute myeloid leukemia (AML).

The study, led by The University of Texas Southwestern Medical Center (“UT Southwestern”) and The University of Texas Health Science Center at Houston (“UTHealth”), demonstrated that leukocyte immunoglobulin-like receptor B4 (LILRB4), an immune inhibitory receptor, orchestrates leukemia invasion pathways by creating an immune suppressive microenvironment. Researchers discovered that blocking LILRB4 signaling with antagonistic antibodies can impede AML development in preclinical models, making it a compelling therapeutic target.

“The immune suppressive microenvironment represents the next frontier in the development of novel approaches to treat cancers like acute myeloid leukemia that have a very poor prognosis,” said senior author Dr. Cheng Cheng “Alec” Zhang, Professor of Physiology at UT Southwestern. “Our findings provide new insights into the underlying biological mechanisms that drive immune suppression and tumor infiltration in acute myeloid leukemia.” Dr. Zhang is a Scientific Advisory Board member with Immune-Onc Therapeutics, who also owns stock and has a sponsored research agreement with Immune-Onc Therapeutics.

This publication is an outcome of multi-year research collaborations between UT Southwestern, UTHealth and Immune-Onc, which has exclusive global rights to develop and commercialize novel biotherapeutics stemming from the sponsored research, including product candidates targeting LILRB4. Leveraging these strategic partnerships with UT Southwestern and UTHealth together with the company’s drug development expertise, Immune-Onc aims to bring much needed new medicines to patients with acute myeloid leukemia and other cancers.

“This pioneering study is a significant milestone in what continues to be a fruitful multi-year collaboration,” said Charlene Liao, Ph.D., co-founder and chief executive officer of Immune-Onc Therapeutics, and a co-author of the Nature publication. “We are proud of this discovery and excited to continue advancing our program toward the clinic on behalf of cancer patients.”

“We are enthusiastic about the research and the potential for new treatment approaches in acute myeloid leukemia,” said Dr. Zhiqiang An, Professor of Molecular Medicine, the Robert A. Welch Distinguished University Chair in Chemistry, and Director of the Texas Therapeutics Institute (TTI) at the Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases at McGovern Medical School at UTHealth in Houston. “While immune checkpoint blockade therapies have worked in other cancers, the same benefits have not yet been seen in leukemia. Inhibition of LILRB4 signaling may represent a novel treatment strategy for acute myeloid leukemia.”

About Acute Myeloid Leukemia (AML)

AML, the most common acute leukemia (blood and bone marrow cancer) in adults, is characterized by the proliferation of abnormal myeloblasts (a type of white blood cell) in the bone marrow. Approximately 103,000 new cases of acute myeloid leukemia were diagnosed globally in 2016 [1] and 19,520 new cases are expected to be diagnosed in the United States in 2018 [2]. Despite advances in treatment, only about 27 percent of acute myeloid leukemia patients are alive five years after initial diagnosis [2].

About UT Southwestern Medical Center

UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received 6 Nobel Prizes, and includes 22 members of the National Academy of Sciences, 16 members of the National Academy of Medicine, and 15 Howard Hughes Medical Institute Investigators. The faculty of more than 2,700 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately 2.4 million outpatient visits a year.

About University of Texas Health Science Center at Houston (UTHealth)

Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth is home to Jane and Robert Cizik School of Nursing, John P. and Kathrine G. McGovern Medical School, and schools of biomedical informatics, biomedical sciences, dentistry and public health. UTHealth includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services. The university’s primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children’s Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital. For more information, visit www.uth.edu.

About Immune-Onc Therapeutics, Inc.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients. The company aims to translate unique scientific insights in the tumor microenvironment and immune suppressive pathways to develop first-in-class biotherapeutics. Immune-Onc has a promising pipeline built upon strategic collaborations and cutting-edge research from The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center. Its lead program, an antibody targeting LILRB4, is being developed to treat acute myeloid leukemia and other cancers. Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies. For more information, please visit www.immune-onc.com.

Media Contact

UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER
Communications
news@utsouthwestern.edu
214-648-3404

THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON (UTHEALTH)
Media Relations
Robert.Cahill@uth.tmc.edu
713-500-3042

IMMUNE-ONC THERAPEUTICS, INC.
Tara Cooper
Cooper Communication Group
media@immuneonc.com
650-303-7306

References

1. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncology. Published online June 2, 2018. doi:10.1001/jamaoncol.2018.2706.

2. National Cancer Institute. SEER Cancer Stat Facts: Leukemia – Acute Myeloid Leukemia (AML). Available at https://seer.cancer.gov/statfacts/html/amyl.html. Accessed July 31, 2018.

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Immune-Onc Therapeutics Announces Key Executive Appointments and Series B Funding

PALO ALTO, CA, September 18, 2018 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients, today announced the appointments of Dr. Adrian Jubb as Chief Medical Officer and of Dr. An Song as Senior Vice President of Development Sciences. Dr. Jubb joins Immune-Onc from Achaogen where he served as Vice President and Head of Early Development. Dr. Song joins Immune-Onc from Genentech where she held positions of increasing responsibility over her 16-year tenure at the company and most recently served as a Senior Director within Genentech’s Research and Early Development (gRED) organization.

In addition, Immune-Onc announced it received Series B funding of more than $33 million from leading investors, including Northern Light Venture Capital, Vivo Capital, and the Stanford-StartX Fund, to advance its pipeline programs.

“As we prepare to move from translational research into the clinic, Adrian and An’s decades of industry expertise in drug development will be critical in advancing our mission to develop novel biotherapeutics for hard-to-treat cancers,” said Charlene Liao, Ph.D., co-founder, president and chief executive officer of Immune-Onc Therapeutics. “Adrian and An embody many of the core values of Immune-Onc: dedication to patients, passion for science, and excellence in execution. I am delighted to have them join Immune-Onc’s leadership team.”

As Chief Medical Officer, Dr. Jubb is accountable for the clinical and regulatory strategy and execution of Immune-Onc’s portfolio. As Senior Vice President of Development Sciences, Dr. Song has overall accountability for translational development of Immune-Onc’s portfolio, including preclinical PKPD and toxicology evaluation, clinical pharmacology, bioanalytical and biomarker/diagnostic development and certain analytical aspects of technical development. Both Dr. Jubb and Dr. Song are based at Immune-Onc’s headquarters in Palo Alto and will join the company’s Executive Committee.

About Dr. Adrian Jubb

Adrian Jubb, M.B. Ch.B., Ph.D., F.R.C.Path., is a physician-scientist with 17 years of experience across research and clinical development in oncology, infectious disease and neuroscience. Most recently, Dr. Jubb served as Vice President and Head of Early Development at Achaogen, where he played a leading role in the development and FDA approval of ZEMDRI for the treatment of serious multi-drug resistant infections. Prior to Achaogen, Dr. Jubb was a Medical Director in Oncology at Genentech and supported numerous oncology clinical development programs over the course of his tenure, including AVASTIN®, MetMAb, COTELLIC® and Apo2L.

Dr. Jubb holds an M.B. Ch.B. (Bachelor of Medicine and Surgery) degree, with honors, from the Faculty of Medicine and Health at the University of Leeds, United Kingdom. His scientific training was conducted in the research laboratories of Genentech, leading to the award of a Ph.D. through the University of Leeds. Dr. Jubb is also a Fellow of the Royal College of Pathologists (F.R.C.Path.), having completed joint clinical and academic postgraduate training at the Oxford Deanery and the University of Oxford, United Kingdom. Following his training, Dr. Jubb was appointed to a faculty position in the Nuffield Department of Clinical Laboratory Sciences, University of Oxford, where he led several projects in the fields of angiogenesis and oncology as a principal investigator. Dr. Jubb has authored over 55 scientific publications, including numerous first and senior author papers in top-tier journals (e.g., Journal of Clinical Oncology, Lancet Oncology, Nature Reviews Cancer), and is a named inventor on 4 issued patents.

About Dr. An Song

An Song, Ph.D., is a translational scientist with 22 years of experience across basic research and drug development in oncology, autoimmunity, metabolic, infectious, and neurodegenerative diseases. Dr. Song joins Immune-Onc from Genentech where, as a Senior Director in BioAnalytical Sciences, she led the Assay Development and Technology group for the company’s large molecule portfolio globally and was a member of numerous scientific review bodies within the Genentech Research and Early Development (gRED) organization. During her 16-year tenure at Genentech, Dr. Song contributed to, and oversaw 40+ IND/CTA and BLA/MAA regulatory filings for products including Rituxan®, Avastin®, Herceptin®, Lucentis®, Kadcyla® and Tecentriq®. In addition, Dr. Song played a significant role in the development and approval of Ocrevus®.

Dr. Song holds a B.S. in Biochemistry from Nanjing University in China. She received her Ph.D. in Biochemistry & Molecular Biology from Indiana University and completed a postdoctoral fellowship in immunology at Stanford University. Upon completion of postdoctoral work in T-cell activation she joined Stanford as a Research Assistant Professor and as faculty of the Immunology Program. Dr. Song has published a number of original manuscripts, review articles and book chapters, as well as contributed to several industry white papers on immunogenicity and antibody Fc effector function evaluation. She is an active member of American Association of Pharmaceutical Scientist (AAPS), having served as an executive member of the Biotech Section and the chair of Therapeutic Product Immunogenicity (TPI) Focus Group/Community.

About Immune-Onc Therapeutics, Inc.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients. The company aims to translate unique scientific insights in the tumor microenvironment and immune suppressive pathways to develop first-in-class biotherapeutics. Immune-Onc has a promising pipeline built upon strategic collaborations and cutting-edge research from The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center. Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies. For more information, please visit www.immune-onc.com.

Media Contact

Tara Cooper
Cooper Communication Group
media@immuneonc.com
650-303-7306

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Immune-Onc Therapeutics, Inc. Awarded “Buzz of BIO”

Company to Showcase Achievements at the 2017 BIO Investor Forum

PALO ALTO, CA, October 12, 2017 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a new biopharmaceutical company focused on advancing immuno-oncology therapeutics, announced that the Biotechnology Innovation Organization (BIO) has named the Company “Buzz of BIO” winner in the “Early Stage Entrepreneurs” category. In recognition of the Company’s tremendous achievements as a newly established biopharmaceutical company, BIO has invited Dr. Charlene Liao, Chief Executive Officer of Immune-Onc to present at the 2017 BIO Investor Forum to be held on October 17-18, 2017 in San Francisco, California.

Immune-Onc was founded in 2016 and is focused on advancing novel immuno-oncology products to bring new treatment options to cancer patients. By leveraging strategic collaborations with leading investigators from Albert Einstein College of Medicine, the University of Texas and other institutions the company has made significant progress in building a promising pipeline of therapeutic antibodies targeting immune suppressive cell types or pathways in the tumor microenvironment.

“It is a great honor to be recognized by BIO, the world’s largest biotechnology trade association and a champion for the biotechnology industry,” said Charlene Liao, Ph.D., Co-Founder and CEO of Immune-Onc. “We have made great strides in advancing our product portfolio towards the clinic and I look forward to sharing our latest achievements at the upcoming BIO Investor Forum.”

BIO is the largest biotechnology trade association in the world, representing life sciences related companies and organizations across the United States and in more than 30 other nations. BIO is the organizer of the BIO Investor Forum, a highly anticipated international biotech investor conference focused on investment trends and business development opportunities in life sciences. The forum has over 880 attendees representing over 500 companies worldwide. Buzz of BIO is a contest organized by BIO to recognize the most innovative companies at the 2017 BIO Investor Forum.

Dr. Charlene Liao will be presenting at the 2017 BIO Investor Forum on Wednesday October 18th at 9:15 am PT in Elizabethan A of Westin St. Francis Hotel. This is the first public presentation of Immune-Onc, and Dr. Liao will be sharing the company’s key corporate objectives and showcasing the company’s pipeline progress.

To learn more about BIO, please visit: www.bio.org.

About Immune-Onc Therapeutics, Inc.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a newly established biopharmaceutical company focused on developing innovative therapeutic antibodies for cancer treatment. The Company is applying the latest scientific insights and expertise in drug development to advance novel immuno-oncology products and bring new treatment options to cancer patients. The company was founded in 2016 with headquarters in Palo Alto, California. www.immune-onc.com.

Contact: info@immuneonc.com

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Immune-Onc Therapeutics, Inc. Selected to Join the Prestigious Stanford-backed StartX Community

PALO ALTO, CA, June 28, 2017 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a new biopharmaceutical company focused on advancing immuno-oncology therapeutics, announced that StartX has selected the Company and its co-founders to participate in the StartX Med Accelerator Summer 2017 Program. This is one of the world’s top startup accelerator programs conducted by StartX, a Stanford University-affiliated nonprofit organization.

Founded in 2016, Immune-Onc is applying the latest scientific insights and extensive industry expertise in drug development to advance novel immuno-oncology products and bring new treatment options to cancer patients. The Company, supported by strategic collaborations with leading investigators from Albert Einstein College of Medicine and University of Texas, among others, is building a promising pipeline of therapeutic antibodies targeting the tumor microenvironment.

“Immune-Onc is developing a strong portfolio of innovative immuno-oncology drugs with first-in-class potential,” said Dr. Andrew Lee, co-founder of StartX Med. “With the wealth of industry expertise in drug discovery and development coupled with relentless focus on execution, they will be achieving exciting new milestones while working with StartX.”

StartX is an educational non-profit organization with the mission to accelerate the development of top entrepreneurs in the Stanford University network. Their highly-competitive program has historically accepted approximately 8 percent of applicants. StartX Med is a medical and life science vertical within the StartX accelerator. Over 120 StartX Med companies have raised $740M and obtained 7 FDA approvals in the past 4 years. StartX is industry- and stage-agnostic and provides exclusive access to the Stanford-StartX Fund, backed by Stanford University and Stanford Health Care. The organization collects no fees and takes zero equity.

“We are honored and excited to be selected by StartX, one of the leading accelerators in the world. This is a great opportunity for Immune-Onc to leverage the powerful networks, resources and funding available through StartX,” commented Dr. Charlene Liao, Co-Founder and Chief Executive Officer of Immune-Onc. “We look forward to joining StartX and contributing to this prestigious community.”

"StartX is a movement that empowers founders and entrepreneurs,” said Joseph Huang, CEO of StartX. “We are pleased to welcome Immune-Onc co-founders to the StartX community.”

About StartX

StartX is a 501(c)(3) Stanford-affiliated nonprofit in Silicon Valley that runs one of the world’s top startup accelerator programs. Its mission is to advance the development of the best entrepreneurs through experiential education and peer learning. Since launching in 2010, StartX has supported more than 450 companies and over 1000 entrepreneurs, from early to pre-IPO stage, working across a wide spectrum of industries. StartX and StartX Med, dedicated to medical and biotechnology innovation, provide founders with access to a powerful network of entrepreneurs, investors, mentors, and industry partners, along with office space and a variety of other resources. Based in Palo Alto, the accelerator also operates StartX-QB3 Labs and the Stanford-StartX Fund. www.startx.com.

About Immune-Onc Therapeutics, Inc.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a newly established biopharmaceutical company focused on developing innovative therapeutic antibodies for cancer treatment. The Company is applying the latest scientific insights and expertise in drug development to advance novel immuno-oncology products and bring new treatment options to cancer patients. The company was founded in 2016 with headquarters in Palo Alto, California. www.immune-onc.com.

Contacts

Immune-Onc Therapeutics, Inc.
info@immuneonc.com

StartX
info@startx.com

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Immune-Onc Therapeutics, Inc. Announces Partnership with University of Texas to Develop Novel Cancer Immunotherapy

PALO ALTO, Calif. and HOUSTON, Texas, April 6, 2017 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a newly established biopharmaceutical company focused on advancing promising immuno-oncology therapeutics, announced today it has entered into an exclusive license and collaboration agreement with The University of Texas Health Science Center at Houston (“UTHealth”) and The University of Texas Southwestern Medical Center (“UTSW”), two member institutions of The University of Texas System (“UT System”).

Under the terms of the license agreement, Immune-Onc will acquire the exclusive global rights to develop and commercialize novel biotherapeutics with applications in cancer immunotherapy and other diseases. In addition, Immune-Onc has entered into a multi-year research collaboration with UTHealth and UTSW to discover and develop a new generation of biotherapeutics that modulate the immune system.

This collaboration will leverage the Cancer Prevention & Research Institute of Texas (“CPRIT”) Therapeutic Monoclonal Antibody Lead Optimization and Development Core Facility at UTHealth to advance lead antibodies from academic laboratories, and will utilize the preclinical and clinical drug development expertise of Immune-Onc to move them to clinical trials and eventually to eligible patients.

"UTHealth is a comprehensive academic health center and a valuable resource for health care education, biomedical research, and patient care. UTSW is a world renowned academic medical center with a distinguished record of breakthrough scientific discoveries,” commented Dr. Charlene Liao, Chief Executive Officer of Immune-Onc. “Immune-Onc is very pleased to license innovative biotherapeutic candidates from UTHealth and UTSW. We are honored to initiate this collaboration with members of the UT System that has the potential to provide new treatment options for cancer patients in the near future.”

“This is an important step in translating our therapeutic antibody from discovery to development,” said Dr. Zhiqiang An, Professor of Molecular Medicine, the Robert A. Welch Distinguished University Chair in Chemistry, and Director of the Texas Therapeutics Institute (TTI) at the Brown Foundation Institute of Molecular Medicine at UTHealth.

“Immune-Onc has assembled a strong team of drug development experts from leading biopharmaceutical companies,” commented Dr. Bruce D. Butler, Vice President, Research and Technology at UTHealth. “We look forward to collaborating with Immune-Onc to bring benefits to patients.”

About UTHealth

The University of Texas Health Science Center at Houston (UTHealth) was established in 1972 as Houston’s health university. The most comprehensive academic health center in The UT System and the U.S. Gulf Coast region, UTHealth is home to the John P. and Kathrine G. McGovern Medical School and schools of biomedical informatics, graduate biomedical sciences, dentistry, nursing and public health. UTHealth educates more health care professionals than any health-related institution in the State of Texas and features one of the nation’s largest medical schools and the highest ranked nursing graduate school in Texas. It also includes a psychiatric hospital and a growing network of clinics throughout the region. The university’s primary teaching hospitals include Memorial Hermann-Texas Medical Center, Children's Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital. www.uth.edu.

About UT Southwestern

UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty includes many distinguished members, including six who have been awarded Nobel Prizes since 1985. The faculty of almost 2,800 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in about 80 specialties to more than 100,000 hospitalized patients and oversee approximately 2.2 million outpatient visits a year. www.utsouthwestern.edu.

About Immune-Onc Therapeutics, Inc.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a newly established biopharmaceutical company focused on developing innovative therapeutic antibodies for cancer treatment. The Company is applying the latest scientific insights and expertise in drug development to advance novel immuno-oncology products and bring new treatment options to cancer patients. The company was founded in 2016 with headquarters in Palo Alto, California. www.immune-onc.com.

Contacts

Immune-Onc Therapeutics, Inc.
info@immuneonc.com

The University of Texas Health Science Center at Houston (UTHealth)
Deborah.M.Lake@uth.tmc.edu

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Immune-Onc Therapeutics, Inc. Announces Licensing and Collaboration with Albert Einstein College of Medicine and Memorial Sloan Kettering Cancer Center to Develop Novel Cancer Immunotherapy

PALO ALTO, Calif., March 28, 2017 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a newly established biopharmaceutical company focused on advancing promising immuno-oncology therapeutics, announced today that it has entered into an exclusive worldwide license agreement with Albert Einstein College of Medicine (“Einstein”) and Memorial Sloan Kettering Cancer Center (“MSK”).

Under the terms of the license agreement with Einstein and MSK, Immune-Onc will acquire the exclusive global rights to develop and commercialize novel biotherapeutics with applications in cancer immunotherapy and other diseases. In addition, Immune-Onc and Einstein have entered into a multi-year research collaboration to discover and develop a new generation of biotherapeutics that modulate the immune system.

"Einstein is recognized globally as a premier medical institution focused on discovery and translation of innovative biomedical research to clinical applications. MSK is the world's oldest and largest private cancer center and is renowned for having successfully produced nine US FDA approved drugs,” commented Dr. Charlene Liao, Chief Executive Officer of Immune-Onc. “Immune-Onc is very pleased to license innovative biotherapeutic candidates from Einstein and MSK. We are honored to partner with world-class investigators at Einstein to provide new treatment options for cancer patients in the near future.”

About Immune-Onc Therapeutics, Inc.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a newly established biopharmaceutical company focused on developing innovative therapeutic antibodies for cancer treatment. The Company is applying the latest scientific insights and expertise in drug development to advance novel immuno-oncology products and bring new treatment options to cancer patients. The company was founded in 2016 with headquarters in Palo Alto, California. www.immune-onc.com.

Contact: info@immuneonc.com

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Immune-Onc Therapeutics, Inc. Announces $7 Million Series A Financing

PALO ALTO, Calif., Sept. 1, 2016 /PRNewswire/ -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a newly formed biopharmaceutical company focused on advancing promising immuno-oncology therapeutics, announced a Series A financing of $7 million. Major investors include Fame Mount Limited and CLI Ventures. The financing will support discovery and development of novel antibodies with breakthrough potential in the area of cancer immunotherapy.

"Immuno-oncology drugs are transforming cancer care worldwide. We are grateful for the support of our Series A investors who share our vision to pursue novel therapeutic antibodies targeting the immune system and tumor microenvironment,” said Charlene Liao, Ph.D., Chief Executive Officer of Immune-Onc. “Our immuno-oncology programs leverage the latest scientific insights to advance new treatment options for cancer patients.”

Immune-Onc was co-founded by Charlene Liao, Ph.D., who serves as its President and CEO, and Guo-Liang Yu, Ph.D., a serial entrepreneur and industry veteran. Dr. Liao was Project Team Leader at Genentech, a member of the Roche Group, where she spent nearly 14 years leading oncology and immunology drug development programs from preclinical to Phase 3. Dr. Liao was a Fellow of the Damon Runyon Cancer Research Foundation and a Special Fellow of the Leukemia and Lymphoma Society. Dr. Yu was the co-founder and CEO of Epitomics Inc., an antibody company acquired by Abcam for $170 million. He currently holds numerous board and management positions, including Executive Chairman of Crown Bioscience Inc., a leading oncology platform company, and Venture Partner of OrbiMed, a healthcare and life sciences-dedicated investment firm.

About Immune-Onc Therapeutics, Inc.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a newly established biopharmaceutical company focused on developing innovative therapeutic antibodies for cancer treatment. The Company is applying the latest scientific insights and expertise in drug development to advance novel immuno-oncology products and bring new treatment options to cancer patients. The company was founded in 2016 with headquarters in Palo Alto, California. www.immune-onc.com.

Contact: info@immuneonc.com

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