On May 8, 2023 Primmune Therapeutics, a biotech company harnessing the power of the innate immune system to treat solid tumors in the advanced cancer setting and to clear human papillomavirus and related pre-cancerous cervical lesions, reported that Primmune’s Senior Vice President & Chief Scientific Officer James Appleman, Ph.D., will present at the 4th STING & TLR-Targeting Therapies Summit being held in Boston, Massachusetts from May 9-11, 2023 (Press release, Primmune Therapeutics, MAY 8, 2023, View Source [SID1234631193]).

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The oral presentation will cover the recent clinical progress of PRTX007, a systemically active, orally administered prodrug of a novel, small molecule toll-like receptor 7 (TLR7)-specific agonist and will evaluate how the unique pharmacology elicited by PRTX007 distinguishes Primmune’s lead candidate from other TLR7 agonists in human cellular models, in non-human primates, and in the clinical setting. The presentation at the Summit will also review how PRX034, the TLR7 agonist systemically delivered by PRTX007, has been shown to induce engagement of the innate and adaptive immune responses while avoiding systemic inflammation in healthy volunteers, and why PRTX007’s favorable profile is expected to correlate with efficacy in cancer therapy.

Presentation Details:

Title: PRTX007, a Novel Orally Administered TLR7 Agonist Prodrug from Primmune Therapeutics for the Treatment of Cancer
Presenter: James Appleman, Ph.D.
Date and Time: Wednesday, May 10 at 10 a.m. ET
Location: Hilton Boston Back Bay

More information on the conference can be found here.

About PRTX007

PRTX007, Primmune’s lead clinical development candidate, is designed to provide well-tolerated, controlled, long-term stimulation of the innate immune response while also potentiating long-term effective innate and adaptive immune responses. PRTX007 administration uniquely activates plasmacytoid dendritic cells (pDCs), leading to a systemic immune poly-IFN response without stimulating production of NF-κB-driven proinflammatory factors like IL-6, TNFα or IL-1β. Activated pDCs directly deliver interferons to target cells by paracrine transfer. Conceptually, this is equivalent to administering a therapeutically effective cocktail of all Type I/III IFNs while avoiding the associated side effects and adverse events. Furthermore, PRTX007 administration leads to systemic activation of anti-tumor effector CD8+ T cells and NK cells. PRTX007 is being rapidly advanced towards clinical trials for solid tumors in the advanced cancer setting and for clearing human papillomavirus-transformed pre-cancerous cervical lesions.

On May 8, 2023 Cullgen Inc., a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE platform of targeted protein degradation technology, reported that it has raised $40 million in new financing (Press release, Cullgen, MAY 8, 2023, View Source [SID1234631192]). A $35 million series C financing round was led by AstraZeneca-CICC Venture Capital Partnership ("AZ-CICC"), and included Sincere Capital, Voyagers Capital, Wuxi Capital Group (subject to pending ODI approval), as well as existing shareholder GNI Group Ltd. In conjunction with the series C round, AZ-CICC will have the right to designate a representative to join Cullgen’s board of directors. Concurrent with this financing, GNI Group Ltd. has elected to exercise its outstanding warrants for Cullgen stock, resulting in an additional $5 million in proceeds for Cullgen. The total $40 million financing will support the development of Cullgen’s technology platform and internal pipeline of targeted protein degraders in oncology and other diseases.

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"This new round of financing will enable Cullgen to accelerate development of its promising pipeline of targeted protein degraders featuring novel E3 ligands to potentially introduce new treatment approaches for patients battling cancer," said Dr. Ying Luo, Chairman and CEO of Cullgen. "We are extremely pleased with AstraZeneca’s support, and grateful to all our pre-eminent financial partners for their conviction in Cullgen’s position as world-class targeted protein degradation company."

On May 8, 2023 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that two posters for clinical trials of its ADCC enhanced anti-CLDN18.2 monoclonal antibody Osemitamab (TST001) in combination with CAPOX or CAPOX plus Nivolumab for first-line G/GEJ cancer will be presented at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting (Press release, Transcenta, MAY 8, 2023, View Source [SID1234631191]).

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The first poster is an update of the clinical results (TranStar102) for the combination of Osemitamab (TST001) with CAPOX in first-line G/GEJ cancer patients with CLDN18.2 expression (membranous staining ≥1+ intensity in ≥10% of tumor cells) as assessed centrally using IHC 14G11 LDT assay: long term endpoints such as progression free survival ("PFS") and duration of response ("DOR") will be presented. The second one is a trial in progress (TranStar101), including the chemotherapy-free combination of Osemitamab (TST001) and Nivolumab, and the triple combination of Osemitamab (TST001), Nivolumab and mFOLFOX6 in G/GEJ caner. This year’s meeting will take place both online and in-person from June 2, 2023 to June 6, 2023, in Chicago, Illinois, USA.

The ASCO (Free ASCO Whitepaper) Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community.

A brief summary of the presentations is as follows:

Abstract#: 4046
Poster Bd#: 367
Title: Osemitamab (TST001) in Combination with Capecitabine and Oxaliplatin (CAPOX) as a First-line Treatment of Advanced G/GEJ Cancer: Updated Data of Cohort C from a Phase I/IIa, Multi-center Study (TranStar102/TST001-1002)
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Monday June 5, 2023 8:00 AM – 11:00 AM (EDT)
First Author: Prof. Lin Shen, Beijing Cancer Hospital

Abstract#: TPS4176
Poster Bd#: 494b
Title: A Multi-cohort Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Osemitamab (TST001) Administered as a Monotherapy, with Nivolumab or Standard of Care in Patients with Locally Advanced or Metastatic Solid Tumors (TransStar101/TST001-1001)
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Monday June 5, 2023 9:00 AM – 12:00 PM (EDT)
First Author: Dr. Yelena Janjigian, Memorial Sloan Kettering Cancer Center

About Osemitamab (TST001)

Osemitamab (TST001) is a high affinity humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC") and complement-dependent cytotoxicity ("CDC") activities and potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC and CDC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Multiple clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer.

On May 8, 2023 Biosion USA, Inc. (Biosion), a global R&D biotechnology company, reported the upcoming presentation of discovery and development data for BSI-038, an anti-CD40 agonistic antibody at the PEGS Boston conference to be held from May 15 to 19, 2023 (Press release, Biosion, MAY 8, 2023, View Source [SID1234631190]).

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BSI-038 is an anti-CD40 agonistic monoclonal antibody, discovered through Biosion’s H³ antibody discovery platform. BSI-038 exhibits enhanced binding affinity and bioactivity when compared to Selicrelumab analog. It exhibited potent and dose-dependent anti-tumor activity in animal models. It was well tolerated in pre-clinical studies with the highest non-severely toxic dose (HNSTD) established at 150 mg/kg in non-human primates.

Biosion has a licensing agreement with Chia Tai Tianqing Pharmaceutical Group (CTTQ) in which CTTQ has an exclusive license to develop and commercialize BSI-038 (also referred to as TQB2916 by CTTQ) in Greater China. CTTQ is currently conducting a Phase 1 clinical study of BSI-038 in advanced tumors in China. Learn more about clinical trials of CD40，please visit View Source

About PEGS Boston Conference & Expo

PEGS Boston is the world’s largest gathering of protein engineering and biotherapeutics experts. PEGS is the leading biologics event with comprehensive programming covering all aspects of biologic drug development with in-depth presentations on protein and antibody engineering, immunotherapy, oncology, expression, analytics, immunogenicity, and more. Please visit www.PEGSUMMIT.com for more information.

On May 8, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, and Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported a strategic partnership aimed at increasing diversity in clinical study recruitment practices (Press release, Mirati, MAY 8, 2023, View Source [SID1234631189]).

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According to the American Association for Cancer Research (AACR) (Free AACR Whitepaper), nearly 85 percent of patients living with cancer are treated in community centers1. Ensuring equitable access to and participation in clinical studies requires improved awareness and targeted efforts to remove systemic barriers that may limit access to clinical studies for underrepresented patient groups.

As part of this partnership, Mirati and SCRI will implement practices and programs focused on removing obstacles to clinical study participation, including expanding physician and patient education and increasing access to community-based clinical trials. Initiatives will be focused on reducing complexities associated with activating clinical trials thereby enabling a greater number of community practices to participate in research studies.

"The opportunity to partner with SCRI enables Mirati to advance diversity in our clinical studies, which is a key pillar of our Diversity, Equity, and Inclusion efforts. We are excited about the opportunity to leverage the expertise and scale of SCRI as we collaborate on a range of initiatives aimed at improving health outcomes for a broad range of patients." said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "By focusing on community-based sites, we can better understand the health needs of patients living with cancer and provide more tailored, patient-centered care. This partnership will allow us to gain a deeper understanding of the challenges patients face to enable us to better design our clinical studies to be representative of all patient communities."

SCRI’s research network brings together more than 1,300 physicians who are actively accruing patients to clinical trials at more than 250 locations in 24 states across the U.S. Mirati will work directly with Development Innovations, SCRI’s full-service, oncology-focused contract research organization (CRO), to execute the collaboration initiatives across the SCRI network. Through SCRI’s Personalized Medicine Program, the partnership will utilize robust clinical trial matching data to better understand barriers to trial participation and ultimately design protocols to address challenges.

"SCRI is uniquely positioned to advance diversification strategies given our national reach, physician expertise and personalized medicine capabilities," said Howard A. "Skip" Burris, III, MD, president, SCRI. "Through our collaboration with Mirati, we can advance our goals to design and deliver clinical trials that can be accessed by more patient populations and accelerate drug development."