On July 22, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Bellberry Human Research Ethics Committee (HREC) in Australia has approved the clinical trial application of the phase 1 trial of ATG-101 in patients with metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, Antengene, JUL 22, 2021, View Source [SID1234585036]). This approval marks an important milestone for Antengene as ATG-101 is the in-house developed innovative molecule with global rights entering clinical stage. In addition, ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical stage in Australia. This multi-center, open-label, Phase I trial is designed to evaluate the safety and tolerability of ATG-101 as a single agent in patients with advanced solid tumors and NHL.

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According to the World Health Organization’s (WHO) estimates, there were approximately 19.3 million diagnoses of cancer and 10 million cancer-related deaths worldwide in 2020 and most of the top 10 cancer types were solid tumors. As the most common blood cancer, non-Hodgkin lymphoma accounted for 544,000 new cases and 260,000 deaths in 2020 globally with some of the highest incidence rates reported in Australia and New Zealand. Since the majority of cancers become resistant or refractory to conventional therapies (including hormonal treatments, chemotherapy regimens and monoclonal antibodies), there remains enormous unmet needs in the treatment of patients with this disease. While immuno-oncology therapy has improved patient outcomes dramatically over the last 10 years, a growing body of evidence also has shown that bispecific antibodies have the potential to be effective treatments for multiple malignant cancers.

ATG-101, a novel PD-L1/4-1BB bi-specific antibody, can activate anti-tumor immune effectors by blocking the immunosuppressive binding of PD-L1 to PD-1 while at the same time activating 4-1BB immunostimulatory signals, thereby enhancing safety and efficacy. Preclinical studies showed that ATG-101 could activate 4-1BB in a very controlled manner in human peripheral blood mononuclear cells (PBMC). Testing in various animal models, including those resistant to or progressing on anti-PD(L)1 treatment, has confirmed the potent in vivo anti-tumor activity and safety of ATG-101. In addition, in vivo testing has shown that ATG-101 can increase the number of CD8+ T-cells and reduce regulatory T-cells (Treg), a unique mechanism of action that enhances anti-cancer immune profile and can potentially improve treatment outcomes.

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, said "Having gained approval for this first-in-human trial of ATG-101 as planned marks a milestone achievement that validates Antengene’s capability in effectively advancing preclinical programs. Exploring a novel mechanism of action, multiple bispecific antibodies have begun entering clinical development in recent years. Compared to monoclonal antibodies, bispecific antibodies have the advantages of being able to target multiple epitopes, with a lower production cost and shorter production cycle than using a combination of conventional monoclonal antibodies, therefore representing a novel therapeutic approach with enormous clinical potential. We have observed that ATG-101 has anti-tumor activities in vivo and in vitro and so we are very enthusiastic to test this approach in the clinic. We will advance the clinical development program and prepare to submit Investigational New Drug (IND) applications for ATG-101 in the U.S. and China this year."

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking PD-L1/PD-1 binding and inducing 4-1BB stimulation. In the presence of PD-L1 over-expressed cancer cells, ATG-101 has shown a significant and PD-L1 crosslinking-dependent 4-1BB agonist activity, thus enhancing therapeutic efficacy, and mitigating hepatoxicity simultaneously.

On July 21, 2021 EpiVax reported that new dates for this year’s Amsterdam Immunogenicity & Tolerance Seminar (Press release, EpiVax, JUL 21, 2021, View Source [SID1234590457])!

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The seminar is now a two-day, afternoon-only format. This arrangement leaves mornings free for attendees to network, collaborate in small groups, and enjoy the beautiful city of Amsterdam.

All events will take place at the Hilton Apollolaan. Apollolaan 138, 1077 BG, Amsterdam, Netherlands

Day 1, Thursday, November 4th
12:00 PM- 6 PM CET (Central European Time)

Lunch will be provided from 12-1 PM

A cocktail reception will be held at immediately following completion of Day 1 talks, from 6 – 8 PM

Day 2, Friday November 5th
1 PM – 5 PM CET (Central European Time)

Lunch will provided from 12-1 PM

The seminar will focus on translational research in the fields of immunogenicity and tolerance, with case studies touching on vaccines and biologics.

Interested in attending this free event? Register here!

We are so excited to return to Amsterdam and meet safely and responsibly with our colleagues for this in-person event. Please note that we will be monitoring the COVID-19 pandemic and travel restrictions, and we will communicate any changes in advance if the events cannot safely take place.

Special Guest Speakers will include:

Annie De Groot, MD
Research Professor, Center for Vaccines and Immunology, University of Georgia
CEO/CSO, EpiVax, Inc.

Amy Rosenberg, MD
Senior Director of Immunology and Protein Therapeutics, EpiVax, Inc.

On July 21, 2021 Advanced Proteome Therapeutics Corporation ("APC" or the "Company") (TSXV: APC) (FSE: 0E8), reported that as previously planned, Dr. Benjamin Krantz has taken over the role of CEO at its US subsidiary, Advanced Proteome Therapeutics Inc. ("APTI") (Press release, Advanced Proteome Therapeutics, JUL 21, 2021, View Source [SID1234587378]).

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Prior to this appointment, Benjamin Krantz MD, MBA was the Chief Fellow in hematology/oncology at New York University Langone Medical Center and served on the Board of Directors of APTI. His research has focused on biomarker and therapeutic development in pancreas ductal adenocarcinoma and has resulted in peer-reviewed articles on novel therapeutics for pancreas cancer and emerging biomarkers for therapeutic selection. He has also been the architect of investigational protocols for the development of new pancreas cancer biomarkers and an early phase therapeutic candidate. Dr. Krantz received a Bachelor of Arts from the University of Pennsylvania and received his Doctor of Medicine and Master of Business Administration from Tufts University. He completed his residency in internal medicine at New York-Presbyterian Hospital – Columbia University Medical Center during which time he analyzed investigator intellectual property disclosures as a Columbia Technology Ventures fellow. He subsequently worked as a hospitalist and clinical/translational researcher at Memorial Sloan Kettering Cancer Center. He is maintaining an academic affiliation at NYU as a Clinical Assistant Professor in the Division of Hematology and Medical Oncology.

Since the initial announcement of Dr. Krantz’ planned appointment on December 17, 2020, he has been working diligently in preparation for this transition. Over this period, renowned scientist, Dr. Ravi Chari, has joined the company’s Scientific Advisory Board and Dr. Rajeshkumar Manian has joined as Lead Synthetic Organic Chemist. Furthermore, existing projects with the Zeglis lab continue to advance and APTI has engaged with new potential collaborators.

Dr. Benjamin Krantz, Director and CEO stated, "I am extremely excited to be taking on the CEO of role at APTI. It is with high conviction for the potential of APTI’s technology and my ability to generate value from it that I have left a promising academic track to lead APTI. APTI is at an exciting crossroads, where we have a developed a platform that continues to demonstrate exciting results with promising novel complementary technologies in the laboratory to generate better antibody drug conjugates. As a clinical and translational focused researcher, it is my vision to rapidly move our technologies from the lab to incorporation into prospective therapeutics leading to clinical development. We have certainly received external validation for this approach with the joining of Dr. Chari to our Scientific Advisory Board and Dr. Manian as our Lead Synthetic Organic Chemist, as well as current and potential collaborator interest. Additionally, we are looking to scale up with new hires and expansion of lab capabilities to accelerate achievement of key milestones over the next 6 months. Antibody drug conjugates continue to be a hot area in biotech where multi-billion-dollar licensing deals for early-stage assets are not uncommon. With our strategy to build wholly owned clinical candidates using APTI technology, it is my goal to position APTI for that type of success."

Paul Woodward, CEO of the Company stated "I’m excited for what the next six months will bring the company. Ben has been brought on board with a singular mandate – commercialize the technology, and he is already rapidly moving down that road. Our near-term goals (within the next 12 months) are to be formally engaged with collaborators, as a precursor to licensing deals, with the longer-term goal of having those partnerships funding proprietary drug development. We believe this to be a logical pathway and the optimal program for driving valuation. In addition to commercialization opportunities, we will continue to develop IP to enhance and add to our current conjugation technologies."

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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

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On July 21, 2021 Samsung Biologics, one of the world’s leading contract development and manufacturing organization (CDMO), reported that signed a strategic partnership agreement with Kineta, Inc., a clinical-stage biotech company developing novel immunotherapies in oncology (Press release, Kineta, JUL 21, 2021, View Source;schBoardCtgryCcd=&schString=&schBoardYear=&boardDtm=1626706800000&page=1#new_tab&utm_source=rss&utm_medium=rss&utm_campaign=kineta-and-samsung-biologics-announce-development-and-manufacturing-agreement-for-anti-vista-antibody-immunotherapy [SID1234586786]). Samsung Biologics will provide end-to-end CDMO service from cell line development, clinical drug substance, and drug product manufacturing services to support IND filing for KVA12.1, Kineta’s novel anti-VISTA antibody in development for the treatment of solid tumors.

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VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate anti-tumor immune function. Preclinical studies demonstrate single agent anti-tumor activity with KVA12.1, and also demonstrate that targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the anti-tumor efficacy of those checkpoint inhibitors. Kineta’s KVA12.1 aims to reprogram the TME in hard-to-treat solid tumors.

The manufacturing cell line will be developed with support from Samsung Biologics’ R&D Center in San Francisco, and its corresponding clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.

"We are very glad to be partnering with Kineta, to provide support in bringing this cancer immunotherapy to market," said John Rim, CEO of Samsung Biologics. "We will fully utilize our capabilities and streamlined end-to-end processes from both our headquarters and US R&D Center, to enable high-quality development of KVA12.1 with faster speed to accelerate Kineta’s success."

"Establishing this strategic partnership with Samsung is a critical step for Kineta as we advance KVA12.1 to IND and into first-in-human clinical trials next year", said Shawn Iadonato, PhD, Chief Executive Officer at Kineta. "We are excited to collaborate with Samsung to initiate and scale up drug product manufacturing of our VISTA immunotherapy".

Samsung Biologics offers seamless one-stop CDMO research and development services both at its headquarters in Incheon, South Korea and its newly built R&D Center in San Francisco. Bringing quality-driven development services at a greater speed, the company delivers cell line development to drug substance manufacturing in six months, and to drug product manufacturing in seven months, the fastest pace in the industry. Currently building its fourth and largest facility in Incheon, Korea, Samsung Biologics will have 620,000 liters of biomanufacturing capacity upon completion of the plant in 2023.