1stOncology™: Cancer Intelligence Service – Page 6757 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ImaginAb and Cyclotek Enter into Manufacturing and Distribution Agreement for CD8 ImmunoPET Agent in Australia

On October 17, 2022 ImaginAb, Inc., a global biotechnology company focused on developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET) imaging agent and radiopharmaceutical therapies (RPT) products, reported the completion of a Master Services Agreement with Cyclotek, a leading radiopharmaceutical manufacturer in Australia and New Zealand, for the commercial manufacturing and distribution of its investigational CD8 ImmunoPET agent in Australia (Press release, ImaginAb, OCT 17, 2022, View Source [SID1234622086]).

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, Cyclotek will initially supply patient-specific unit doses of the imaging agent from its Melbourne-based radiopharmacy to clinical sites across Australia, for ImaginAb’s clinical trials and the clinical sites for immunotherapy studies sponsored by pharma and biotech companies that have licensed CD8 ImmunoPET.

Ian Wilson, Chief Executive Officer of ImaginAb, said:

"ImaginAb is very pleased to be partnering with Cyclotek, a well-established and reliable supplier of quality PET radiopharmaceuticals in Australia as we continue to strengthen and expand our CD8 ImmunoPET manufacture network in Australia and across the globe. This agreement is part of our continued thrust to establish a worldwide leading manufacturing distribution network for our imaging agent, as we progress towards our goal to gain regulatory approval of our technology in multiple geographies."

Greg Santamaria, Chief Executive Officer of Cyclotek, added:

"Cyclotek is delighted to be working with ImaginAb to supply its investigational CD8 ImmunoPET imaging agent as we continue to expand and develop our operational capacity for the benefit of patients across Australia and New Zealand."

Nuvalent to Host Conference Call to Discuss Preliminary Phase 1 Data from ARROS-1 Clinical Trial of NVL-520 and Additional Preclinical Updates in Conjunction with 34th EORTC-NCI-AACR Symposium

On October 17, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that management will host a live webcast and conference call in conjunction with its data presentations at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium in Barcelona, Spain on Friday, October 28, 2022 at 8:30 a.m. EDT (Press release, Nuvalent, OCT 17, 2022, https://www.prnewswire.com/news-releases/nuvalent-to-host-conference-call-to-discuss-preliminary-phase-1-data-from-arros-1-clinical-trial-of-nvl-520-and-additional-preclinical-updates-in-conjunction-with-34th-eortc-nci-aacr-symposium-301650281.html [SID1234622085]).

The event will be accessible through the "Events" section of the Investors page of www.nuvalent.com or by dialing (866) 652-5200 (domestic) or (412) 317-6060 (international) and referring to conference ID 10171503. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.

PharmAbcine Announces Poster Presentations on Its anti-VISTA Antibody Candidate at SITC 2022

On October 17, 2022 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the Company will present preclinical data of PMC-309, one of the Company’s first immuno-oncology drug candidates, at SITC (Free SITC Whitepaper) (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) Annual Meeting taking place November 8-12 in Boston (Press release, PharmAbcine, OCT 17, 2022, View Source [SID1234622084]).

On November 7, the abstract of the presentation will be made available on SITC (Free SITC Whitepaper) website.The full poster can be accessed at Poster Hall between 9:00 a.m. and 9:00 p.m. ET on November 10.

About PMC-309
PMC-309 is a novel anti-VISTA (V-domain Ig Suppressor of T cell Activation) antagonizing antibody that can be used for the treatment of various tumor types. By inhibiting VISTA, an immune checkpoint receptor mainly expressed on MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells), it can play a pivotal role in maintaining the immunosuppressive environment around the tumor cells. In the nonclinical studies, it has been discovered that PMC-309 can promote both innate immunity (monocyte activation, M1 macrophage proliferation) and adaptive immunity (T cell activation) unlike the existing drugs which show significant changes only in adaptive immunity. In addition, the in vivo data showed that PMC-309 demonstrated significantly improved tumor growth inhibition when used in combination with an anti-PD-1 drug compared to both monotherapies of PMC-309 and an anti-PD-1 drug. These findings suggest that PMC-309 can offer a new treatment strategy in immuno-oncology area as it can be used in combination with other drugs to improve their low-response rates. The GLP-Toxicology studies are already completed, and no serious safety issues were observed. The Company plans to submit Clinical Trial Application in late 2022.

EXACIS BIOTHERAPEUTICS GRANTS ETERNA THERAPEUTICS AN OPTION TO LICENSE UP TO FOUR ALLOGENEIC IPSC-DERIVED NK AND T CELL THERAPIES

On October 17, 2022 Exacis Biotherapeutics Inc. ("Exacis" or the "Company"), a development-stage immuno-oncology company working to harness the immune system to cure cancer, reported that it has signed an option agreement with Eterna Therapeutics Inc. ("Eterna") providing Eterna the right to license up to four off-the-shelf, iPSC derived NK cell and T cell cancer treatments to be produced using Exacis’ proprietary mRNA-reprogrammed iPSCs that will be engineered with Exacis’ mRNA-based gene editing platform (Press release, Exacis Biotherapeutics, OCT 17, 2022, View Source [SID1234622083]). The option agreement provides Exacis and Eterna until December 31, 2022 to negotiate the license agreement. Terms include an upfront license fee, development and commercialization milestones, and single-digit royalties.

Exacis’ non-viral platform uses mRNA-reprogrammed iPSCs engineered for stealthing and performance using Exacis’ proprietary mRNA-based gene editing system including mRNA vector RiboSlice and nuclease NoveSlice. The Exacis process avoids use of potentially harmful DNA and viruses by using mRNA.

Dr. Dimitri Goundis, Exacis’ Chief Business Officer commented, "Exacis is committed to using its powerful platform to produce safe and effective immune cell therapies for cancer. Eterna is well positioned to rapidly advance products toward the clinic and patients".

Dr. Matt Angel, Eterna’s Interim Chief Executive Officer added, "The opportunity to partner with Exacis and add next-generation mRNA-based NK and T cell therapies to our oncology portfolio is an important step in advancing Eterna’s mission to realize the potential of cell engineering to provide patients with transformational new medicines."

InxMed Releases Data Demonstrating IN10018 Therapeutic Potential in Patients with Metastatic Melanoma at SMR 2022

On October 17, 2022 InxMed Co., Ltd, a clinical-stage biotechnology company dedicated to developing innovative therapies targeting drug resistance for hard-to-treat solid tumors, reported that the clinical data from an open-label, phase Ib trial evaluating the efficacy and safety of IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), alone or in combination with cobimetinib (Cobi, an approved mitogen-activated protein kinase [MEK] inhibitor from Roche) in patients with Uveal Melanoma (UM) and NRAS-mutant melanoma (Press release, InxMed, OCT 17, 2022, View Source [SID1234622082]). The clinical data is being presented in the form of poster at the Society for Melanoma Research (SMR) 19th International Congress from October 17-20, 2022 (Abstract #: P-141). The released data showed that IN10018 in combination with Cobi demonstrated promising antitumor activities and acceptable safety profile in patients with metastatic melanoma. InxMed has entered into a global clinical collaboration with Roche to evaluate IN10018 in combination with Cobi before.

This phase Ib study is to evaluate the safety, tolerability, and antitumor activities of IN10018 alone or in combination with Cobi in patients with UM or NRAS-mutant melanoma. The study is ongoing at 8 centers (US/AUS). As of Jun 30, 2022, a total of 45 patients with UM or NRAS-mutant melanoma were enrolled, and 93% of them had prior immune checkpoint inhibitors (ICIs) treatment. IN10018 100 mg QD either as monotherapy or in combination with Cobi 60 mg per label was determined as the recommended phase 2 dose (RP2D).

IN10018 in combination with Cobi showed an acceptable safety profile and promising antitumor activities in patients with UM or NRAS-mutant melanoma. In patients with UM, a median progression-free survival (mPFS) of 2.73 month was reported in 10 efficacy evaluable patients for IN10018 monotherapy. For IN10018 in combination with Cobi, a mPFS of 6.52 months was reported. In patients with NRAS-mutant melanoma, a mPFS of 2.79 months was observed in 7 efficacy evaluable patients with 1 PR for patients treated with IN10018 monotherapy. For IN10018 in combination with Cobi, a total of 5 PRs and 5 SDs were reported in 13 evaluable subjects. The ORR was 38.5% (5/13), the DCR was 76.9% (10/13), and the mPFS was 5.45 months. Notably that 93% of all enrolled patients have received prior immune related therapy.

FAK is a non-receptor tyrosine kinase that plays an important role in cell adhesion, migration, and regulation. It’s expression is up-regulated in multiple tumor types. Researchers have found that inhibiting the FAK signaling pathway in preclinical models can effectively reverse previously failed chemotherapy and targeted therapy caused by drug resistance and enhance the response and efficacy of immunotherapy against solid tumors.

InxMed started the global clinical development program for IN10018, as one of the most advanced FAK inhibitors. Clinical trials currently underway in the US, China and Australia with multiple hard to treat indications. IN10018 received fast track designation from the U.S. Food and Drug Administration (FDA) in August 2021, and breakthrough designation from China National Medical Products Administration (NMPA).

InxMed is going to initiate a triple combination of IN10018, Cobi and atezolizumab for treatment of Nras melanoma. ClinicalTrials.gov Identifier: NCT04109456, enrollment is ongoing. For more information, please visit View Source