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Pitt Street Research Initiates Coverage of Race Oncology

On October 17, 2022 Race Oncology Limited (ASX:RAC) is an Australian pharmaceutical company reported that focused on the development of its key drug, Zantrene, which is currently being studied for pre-clinical and clinical efficacy in several cancer indications (Press release, Race Oncology, OCT 17, 2022, View Source [SID1234622381]).

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Zantrene is a highly targeted precision oncology agent as well as a chemotherapy cardioprotective. The drug is the most potent small molecule inhibitor of the key epitransgenomic Fatso/Fat mass and obesity-associated (FTO) protein.

Zantrene’s dual blockbuster potential

The market opportunity for Zantrene is large with the global FTO addressable cancer market estimated to be more than US$120bn in 2020. RAC expects to generate oncology revenues from: (a) FTO-driven cancers including acute myeloid leukaemia (AML), melanoma, renal cancer, breast and pancreatic, and colorectal cancers; and (b) Protection from anthracycline and proteasome inhibitor cardiac damage which is an independent multi-billion dollar opportunity.

Notably, in pre-clinical models Zantrene protects the heart from anthracycline and proteasome inhibitor induced damage while providing improved anti-cancer treatments. We believe this is an unmatched differentiator for the company.

Success in AML is likely to drive growth in near term

RAC has completed a Phase II single agent clinical trial pertaining to the use of Zantrene in treating relapsed/refractory AML and is currently in another two Phase I/II trials exploring combination treatment in AML as well as treatment of extra-medullary AML. Furthermore, it is in the process of preparing to file an Investigational New Drug application in the US (US IND) for extramedullary AML, besides owning an orphan drug designation for the treatment of AML in the US.

We think that success in the AML field will be a springboard for the company to support its other growth pillars, viz., cardioprotection (breast and other cancers), melanoma and renal cancer programmes.

Valuation range of A$6.61-A$11.91 per share

We value RAC at A$3.4bn base case and A$6.1bn bull case. Adjusting for probability and accounting for future capital raises, this equates to A$6.61 per share base case and A$11.91 per share bull case. We have used a DCF approach assuming Zantrene is commercialised according to forecasted timelines. Commercialisation could occur either by RAC or a potential partner that would acquire Zantrene and/or RAC. Key risks to our model include clinical, regulatory, commercial and competition risks.

Evotec launches PanOmics data analysis platform PanHunter at Bio-IT World

On October 18, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the launch of the first commercial version of its PanOmics data analysis platform PanHunter at Bio-IT World (18-19 October in Berlin, Germany) (Press release, Evotec, OCT 17, 2022, View Source [SID1234622120]). PanHunter is Evotec’s PanOmics data access and analytics platform and was developed and used successfully internally and in industry-shaping drug discovery partnerships over many years. Evotec now makes PanHunter available to collaborators and partners as a software-as-a-service ("SaaS") product.

PanHunter originates from Evotec’s commitment towards patient-centric, PanOmics-driven drug discovery. The amount of available PanOmics data is growing at exponential rates in the public domain and in the pharmaceutical industry. More PanOmics data has been generated in the last two years than in all previous years combined. These PanOmics data hold an overwhelming amount of information about the condition of the respective patients, the molecular biological context, and causes of diseases. To extract such insights and new knowledge from data, it is paramount to use the smartest and easiest-to-use analytical tools and make them available to all scientists across disciplines.

PanHunter is unique in its ability to integrate the analysis of PanOmics data, designed as an easy-to-use yet fully comprehensive PanOmics data analysis platform. It thereby supports, for instance, the stratification of patient populations via molecular mechanisms and the prediction of efficacy and toxicity profiles of drug candidates given appropriate data inputs. With the launch of the first commercial version of the software at Bio-IT World Europe, Evotec makes PanHunter available to interested partners to accelerate their data-driven research.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "In the ever-accelerating world of Omics driven drug discovery we are excited to release PanHunter. PanHunter is our contribution to enable scientists to handle huge high-dimensional data sets to better understand diseases on a molecular level. Improved molecular understanding of disease as well as drug candidates accelerates the drug discovery process and improves probabilities of success in the pre-clinic and clinic."

Dr Matthias Evers, Chief Business Officer of Evotec, said: "With our first commercial release, we are making a bold claim that the future of successful drug discovery lies in convergence between science and tech. With PanHunter we enable scientists across disciplines to explore this potential and engage in patient-driven, PanOmics-informed drug discovery towards deep disease understanding and achieving tractable insights. It is another step to overcome the limitations of a reductionist R&D approach and use AI to unleash disease understanding and improve success rates ("POS")."

SELLAS Life Sciences to Host Update Call on Phase 3 REGAL Study on November 14, 2022

On October 17, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it will host an update call on its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) on November 14, 2022 (Press release, Sellas Life Sciences, OCT 17, 2022, View Source [SID1234622071]).

The call will be facilitated by SELLAS management, including SELLAS’ President and CEO, Angelos Stergiou, MD, ScD h.c., and Senior Vice President, Clinical Development, Dragan Cicic, MD, who will be joined by leading cancer researcher, M. Yair Levy, M.D., Director of Hematologic Malignancies Research at the Baylor University Medical Center, and member of the REGAL Steering Committee. Further details regarding how to access the update call will be provided in the coming weeks.

Telix Partnership Expands GE Healthcare Immuno-Diagnostics Offering to the Global Clinical Research Market

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.

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.

Immunovia launches a strategic partnership with Proteomedix to leverage R&D efforts with increased focus on commercialization

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.  

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. 