On July 9, 2018 Syntimmune, Inc., a clinical-stage biotechnology company developing antibody therapeutics targeting FcRn, reported the appointment of biopharma executive Mario Saltarelli, M.D., Ph.D., as chief medical officer (Press release, Syntimmune, JUL 9, 2018, View Source [SID1234527619]).

Dr. Saltarelli, who most recently served as senior vice president at Vertex, brings broad experience in discovery research, clinical development, pipeline strategy and global regulatory operations. Dr. Donald Johns, who has been acting chief medical officer, will become the executive vice president of medical and scientific affairs for Syntimmune."Mario’s deep expertise in drug development and strong leadership skills will be a tremendous asset to Syntimmune as we advance our pipeline of novel therapies targeting a broad range of autoimmune diseases," said Jean-Paul Kress, M.D., Syntimmune’s president and CEO. "We’re thrilled to have him on board to lead our medical organization. I’d also like to thank Don for his support as acting CMO, and I’m pleased that he’ll be continuing to help Syntimmune strengthen our medical and scientific leadership position."Dr. Saltarelli comes to Syntimmune from Vertex, where he managed clinical development projects across multiple therapeutic areas as senior vice president, early development and neurology. At Vertex, he supported the NDA/MAA preparation and filing of Symdeko (tezacaftor/ivacaftor), leading to FDA approval. He also advanced multiple early development assets. Prior to Vertex, Dr. Saltarelli served as chief medical officer of Annexion Biosciences and as senior vice president and chief science officer at Mallinckrodt Pharmaceuticals. Dr. Saltarelli has also held leadership roles at Shire, Abbott (AbbVie) and Pfizer. Throughout his career, Dr. Saltarelli has worked on the full range of pharmaceutical research and development needs, including translational sciences, clinical strategy, pharmacology and medical affairs. Dr. Saltarelli earned both an M.D. and a Ph.D. in neurosciences from Johns Hopkins University School of Medicine.

"This is an exciting moment for Syntimmune, with multiple clinical trials underway and planned, and I am delighted to be able to contribute," Dr. Saltarelli said. "Syntimmune has a strong vision of leveraging its unique insights into FcRn, honed over 25 years of research, to develop novel therapies that will truly help patients. I’m honored to be part of the team."

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. Johns is an accomplished drug development leader with extensive experience in drug discovery and development. He is a board-certified clinical neurologist and scientific leader with 25+ years of experience in rare and orphan diseases. Prior to joining Syntimmune, Dr. Johns held leadership positions at Biogen, Novartis Institutes for BioMedical Research, the Center for the Integration of Medicine and Innovative Technology and Beth Israel Deaconess Medical Center. He contributed to three successful New Drug Applications (EXELON PATCH: Alzheimer Disease, GILENYA: Relapsing Remitting Multiple Sclerosis, SPINRAZA: Spinal Muscular Atrophy). He is the founding principal of Axon Guidance LLC, a neuroscience-focused drug development consultancy. He has also held teaching positions at Harvard Medical School and Johns Hopkins University School of Medicine. Dr. Johns received his M.D. from the Yale University School of Medicine. He completed his Neurology residency and fellowship at Massachusetts General Hospital.

On July 9, 2018 Teneobio, Inc., a next generation multi-specific antibody therapeutics company, announced today the initiation of a research collaboration and licensing agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop novel multi-specific antibodies for undisclosed oncology targets (Press release, TeneoBio, JUL 9, 2018, View Source [SID1234527703]). Under the terms of the agreement, Teneobio will generate product candidates using its proprietary UniRat transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. For resulting therapeutic candidates, Janssen would have exclusive global licensing rights to the antibodies for clinical development and commercialization. The deal was facilitated by Johnson & Johnson Innovation LLC through its California Innovation Center.

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!

Teneobio Inc. will receive an upfront payment and is eligible to receive future research, development and commercial milestone payments per potential candidate. Teneobio would also receive royalties on world–wide net sales of each multi-specific product. Financial terms of the agreement were not disclosed.

Roland Buelow, CEO of Teneobio, added, "We are excited to collaborate with Janssen and its oncology scientists to develop the next generation of therapeutic multispecific antibodies. Our UniRat-derived modular human variable heavy-chain antibody domains (UniDabs) enable the assembly of robust, optimized, multispecifics for T-cell redirection, as antibody drug-conjugates, and as extracellular domains of CAR T-cells to target cancers. Through Teneobio’s state-of-the-art discovery platforms, we look to discover and advance differentiated biotherapeutics to the clinic. Janssen‘s deep oncology expertise complements our interests and goals to address unmet medical needs with novel breakthrough therapeutics."

On July 9, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, and Beijing Apollo Venus Biomedical Technology Limited, an affiliate of ApolloBio Corp., a biopharmaceutical company focused on oncology (collectively, "ApolloBio"), reported the closing of an agreement providing ApolloBio with the exclusive right to develop and commercialize Toca 511 & Toca FC within the greater China region (Press release, Tocagen, JUL 9, 2018, View Source;p=RssLanding&cat=news&id=2357366 [SID1234527620]). ApolloBio has garnered all regulatory approvals for the agreement and paid Tocagen the upfront payment of $16 million.

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 signed with ApolloBio in April 2018, Tocagen is also eligible to receive potential payments of $4 million in near-term development milestones, including a milestone for the completion of enrollment in the ongoing Phase 3 Toca 5 study. Tocagen will be eligible for additional future payments totaling up to $111 million upon meeting certain development and commercial milestones. In addition, the agreement provides for low double-digit tiered royalty payments based on net sales. ApolloBio will be responsible for all development and commercialization costs in the licensed territory.

"We’re pleased to have completed our strategic partnership agreement with ApolloBio, allowing us to expand the global commercial opportunity for Toca 511 & Toca FC amidst important recent developments in China to facilitate patient access to medical innovations," said Marty Duvall, chief executive officer of Tocagen. "This partnership also strengthens Tocagen’s cash position to fuel our pivotal Phase 3 Toca 5 trial and our pipeline-expanding R&D efforts."

"We are eager to collaborate closely with Tocagen and advance the development of Toca 511 & Toca FC in greater China," said Dr. Weiping Yang, chief executive officer of ApolloBio. "This partnership is an example of our commitment to bringing novel immuno-oncology treatments to the large patient population in China as soon as possible."

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

On July 9, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that the company will participate in the Oppenheimer Boston Oncology Insight Summit July 10 – 11, 2018 (Press release, VBI Vaccines, JUL 9, 2018, View Source [SID1234527621]). The two-day summit will feature a series of discussions with primary investigators at the Whitehead Institute in Cambridge, Massachusetts, followed by one-on-one meetings with institutional investors at the Four Seasons Hotel in Boston, MA.

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!

Event Details
Event: Oppenheimer Boston Oncology Insight Summit
Dates: July 10 – 11, 2018
Location: Boston, MA
Event Website: View Source

On July 9, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported that ClinicalTrials.gov has updated its website to now include OncBioMune’s Phase 2 clinical trial evaluating ProscaVax as the first ever therapeutic vaccine for prostate cancer patients in the active surveillance group (Press release, Oncbiomune, JUL 9, 2018, View Source [SID1234527803]). The trial is being hosted at Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA, and includes the Dana-Farber Cancer Institute.

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!

ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study will evaluate the safety and efficacy of ProscaVax in patients with localized prostate cancer. The goal of the study is to determine if ProscaVax administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. Active surveillance is a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy.

Details on the trials can be viewed at: View Source

"The initiation of this study represents a milestone moment for our company, shareholders and the more than 160,000 men that will learn they have prostate cancer this year," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "For the first time ever, prostate cancer patients in the trial will have a therapeutic vaccine as an option rather than waiting for disease progression or jumping into more invasive treatments options that frequently are accompanied by very unpleasant side effects, such as urinary incontinence and impotence. We look forward to the commencement of enrollment and to the future where we will learn more about the efficacy of ProscaVax as a front-line treatment for prostate cancer."

Sign up for OncBioMune email alerts at: View Source

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.