On October 17, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) has reported a collaborative development and reseller agreement with GE Healthcare to supply its investigational positron emission tomography (PET) imaging radiotracers, TLX250-CDx (89Zr-DFO-girentuximab), and [18F]-FLac (18F-3-fluoro-2-hydroxypropionate) for use in third party clinical research and development activities (Press release, Telix Pharmaceuticals, OCT 17, 2022, View Source [SID1234622089]). These novel tracers offer the potential to provide key information about the metabolic environment of tumours, which could help to inform and improve therapy selection. The agreement was announced during the European Association of Nuclear Medicine (EANM) Congress in Barcelona, Spain.

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!

TLX250-CDx – the subject of Telix’s recently completed Phase III ZIRCON study in clear cell renal cell carcinoma1 – targets the antigen, carbonic anhydrase IX (CAIX). Expressed in many solid tumour types, CAIX can be used to identify hypoxic tumours,2 cells that have been deprived of oxygen, which can correlate with disease progression and resistance to therapy, including immunotherapy. Identifying such tumours may guide changes in care, from immune checkpoint inhibitor (ICI) monotherapy to combination treatments that overcome the hypoxic barrier.

[18F]-FLac, which Telix in-licensed in 2021,3 has shown promise in imaging lactate metabolism in oxygenated tumours. High lactate in tumours could prevent ICI responses and additionally be harmful in patients receiving ICI therapies.4 Understanding tumour lactate metabolic status could guide treatment decisions towards immunotherapy combinations that overcome this barrier.

TLX250-CDx and [18F]-FLac complement GE Healthcare Pharmaceutical Diagnostics’ pipeline of investigational non-invasive [18F]-CD8 and [18F]-Granzyme-B imaging tracers for use by pharmaceutical companies in clinical trials, with the potential to predict and monitor response to immunotherapy. Currently an average of only 20-40 percent of patients respond to immunotherapies, and patient suitability is typically determined by taking tumour biopsies.5

Jonathan Barlow, SVP Global Business Development & Alliance Management, Telix, said, "This partnership will see our investigational imaging agents used more widely in third-party clinical trials. Excitingly, it will also help to expedite the development of [18F]-FLac, while expanding the utility of our TLX250-CDx imaging candidate."

Sanka Thiru, Global Business Leader, Immuno-Oncology, at GE Healthcare’s Pharmaceutical Diagnostics business, said: "This partnership expands our pharmaceutical services offering, including our toolbox of investigational PET imaging diagnostics. These aim to enrich clinical trials for pharmaceutical companies with the possibility of determining the metabolic environment and immune status of tumours, and if successful, help to improve speed to market for potential therapies. Ultimately, these PET imaging diagnostics could assist in delivering effective oncology therapies to patients."

Under the agreement, GE Healthcare will be responsible for the directed marketing and sales of Telix’s imaging agents to pharmaceutical companies, with the close support of Telix, whilst Telix will be responsible for manufacturing and ongoing development of each product. Telix and GE Healthcare will explore validation of [18F]-FLac for use in GE Healthcare’s FASTlab, an automated PET radiochemistry synthesiser, widely used for onsite production of FDG6 and other PET tracers.

The agreement has an initial term of five years, subject to review and termination rights based on performance after three years.

On October 17, 2022 Immunovia AB (Nasdaq: IMMNOV) (Stockholm: IMMNOV) reported that it enters into a strategic partnership with Proteomedix to leverage its substantial joint development experience in diagnostic technologies for the detection of cancer (Press release, Immunovia, OCT 17, 2022, View Source [SID1234622088]). This will enable increased R&D productivity for Immunovia as the Company continues to strengthen its commercial development in the US.  

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!

The partnership between Immunovia and Proteomedix leverages the companies’ complementary R&D capabilities and advances their R&D efforts. With this partnership, Immunovia will gain a more flexible R&D organization, increase its R&D productivity, and will focus internal resources on the commercial build up, thus further accelerating the roll-out of IMMray PanCan-d.  The partnership capitalizes on the combined expertise of two leading innovators in proteomics-based diagnostics, who have both launched innovative oncology tests, Immunovia with IMMray PanCan-d in the U.S. and Proteomedix with Proclarix in Europe.

Proteomedix, a Swiss-based Company, was founded 2010 as a spin-off company of ETH Zurich to bring together the expertise of a multi-disciplinary group of world-leading scientists and clinicians in proteomic-based diagnostics. The Company is focused on research and development that relies on a network of clinicians, IVD experts, laboratories, and marketers. Proteomedix has developed a blood-based prostate cancer test using proteomics technology that measures cancer-associated proteins, using highly reproducible immunoassays. 

"We are very excited to enter this partnership with Immunovia, an early-commercial company like us with an innovative diagnostic test in oncology. This partnership enables both companies to faster take critical steps forward by leveraging our combined expertise to increase R&D efficiency. For Proteomedix, this partnership demonstrates how our biomarker assay development expertise can be deployed beyond prostate cancer," said Helge Lubenow – CEO, Proteomedix.

"Immunovia is entering a new phase with an increased focus on the commercialization of our IMMray PanCan-d test in the US while maximizing our R&D productivity. This partnership with Proteomedix will combine leading proteomics-based researchers with state-of-the art capabilities from both companies to create an outstanding R&D platform," said Philipp Mathieu – CEO and President, Immunovia.

In connection with the new R&D partnership, Linda Dexlin Mellby, Vice President Research & Development at Immunovia, will be leaving the company as of 4 November.

"Linda has been instrumental in the development of Immunovia’s IMMray PanCan-d test over the past nine years. We thank her for her many contributions to the company and wish her all the best in her future endeavors," continued Philipp Mathieu – CEO and President, Immunovia. 

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."

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]).

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!

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.

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]).

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!

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.