CD206

Aurinia Pharmaceuticals will halt further development of its experimental immune modulating drugs in order to focus on commercialisation of the lupus treatment Lupkynis (voclosporin). The streamlining follows a strategic review started in June last year, which included reaching out to over 60 parties, but failed to lead to a formal takeover offer.The board “determined that the ongoing commercial transformation provides the best means for enhancing near-term value for shareholders and other stakeholders,” remarked chairman Daniel Billen. Lupkynis became the first oral therapy approved for adults with active lupus nephritis in the US when the FDA cleared it in 2021, with EU regulators following suit a year later.Aurinia said Thursday that Lupkynis pulled in sales of $158.5 million in 2023, up from $103.5 million in the previous year.The company’s pipeline contains two other preclinical assets, which will both now be scrapped. These comprise AUR200, an immune modulator of BAFF and APRIL activity, and AUR300, which modulates M2 macrophages via the macrophage mannose receptor CD206. Aurinia indicated that due to the overhaul, it will reduce staff numbers by at least 25% in the first quarter, although commercial roles will not be affected.More to come.

Study shows ctDNA positivity is the most prognostic factor, demonstrating the potential for Signatera to redefine adjuvant treatment pathways in endometrial cancer AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in Gynecologic Oncology validating its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in endometrial cancer. The full study can be found here. Endometrial cancer (EC) is the most common gynecologic malignancy in the United States. Disease incidence has been rising, but mortality has been rising even faster, potentially due to a higher frequency of aggressive high-risk subtypes of the disease.1-4 More accurate risk stratification is needed to identify those patients who will benefit from therapeutic interventions with curative intent. Current guidelines rely on clinicopathological risk factors to define risk groups and aid in adjuvant treatment decision-making.5,6 However, the decision to administer adjuvant therapy for patients with high-risk and high-intermediate-risk EC remains unclear, creating the need for better diagnostic tools to help determine who is most likely to benefit from treatment.7-10 This real-world study analyzed 267 plasma samples drawn after surgery from 101 patients with EC. The patient cohort was composed of multiple histological subtypes, with patients stratified based on clinicopathological risk factors into high-risk (52%), high-intermediate (22%), low-risk (15%), and other (12%). Key findings include: Patients who tested Signatera MRD-positive at either a single time point or longitudinally experienced significantly higher rates of recurrence than those who remained Signatera-negative (58% and 52%, vs. 6% and 0%, respectively), regardless of mismatch repair (MMR) or p53 status. Signatera MRD status was the only significant risk factor for recurrence when adjusted for clinicopathological risk groups and molecular subgroups such as MMR and p53 status (HR=18.9, p=.001). “This study provides clinical validation of Signatera as a powerful post-surgical biomarker of recurrence risk for patients with endometrial cancer,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “Use of Signatera in clinical workflows may help physicians and patients tailor their adjuvant treatment decisions based on direct evidence of molecular residual disease.” About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at and . References Temkin SM, Kohn EC, Penberthy L, Cronin KA, Rubinsak L, Dickie LA, et al. Hysterectomy-corrected rates of endometrial cancer among women younger than age 50 in the United States. Cancer Causes Control. 2018;29:427–33. Siegel RL, Miller KD, Fuchs HE, and Jemal A. "Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: uterine cancer. Accessed February 2, 2024. . Siegenthaler F, Lindemann K, Epstein E, et al. Time to first recurrence, pattern of recurrence, and survival after recurrence in endometrial cancer according to the molecular classification. Gynecol Oncol. 2022;165(2):230-238. Concin N, Matias-Guiu X, Vergote I, et al. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021;31(1):12-39. Abu-Rustum N, Yashar C, Arend R, et al. Uterine Neoplasms, Version 1.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023;21(2):181-209. Keys HM, Roberts JA, Brunetto VL, et al. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004;92(3):744-51. Nout RA, Smit VT, Putter H et al. Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet. 2010;375(9717):816-23. Group AS, Kitchener H, Swart AM, Qian Q, Amos C, and Parmar MK. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet. 2009;373(9658):125-36. de Boer SM, Powell ME, Mileshkin L, et al. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2018;19(3):295-309.

Italian investors, NEVA SGR, LIFTT and Simon Fiduciaria, join the existing syndicate Additional investment brings the total Series B financing to £31.1 million (approx. USD $39.5 million) LONDON, Feb. 1, 2024 /PRNewswire/ -- NeoPhore Limited, a small molecule neoantigen immuno-oncology company, today announces a further extension of £9.6m (approx. USD $12.2m) to its Series B financing round. With participation from its existing syndicate, CPF managed by Sixth Element Capital, Claris Ventures, Astellas Venture Management, 3B Future Health Fund, 2investAG, and the addition of three new investors – NEVA SGR (the venture capital arm of Intesa Sanpaolo banking group), LIFTT (the venture capital focused on deep-tech chaired by Stefano Buono) and Simon Fiduciaria (the fiduciary company of Ersel Group). This extension brings the total raised in Series B financing to £31.1m (approx. USD $39.5m). NeoPhore is building a pipeline of small molecule drugs targeting novel proteins across the DNA mismatch repair ('MMR') pathway to generate next-generation immuno-oncology therapeutics to improve clinical outcomes for cancer patients. NeoPhore's first-in-class MMR inhibitors induce neoantigen expression and increase immunogenicity in solid tumours that become exquisitely sensitive to immunotherapy. 2023 was a great year of progress for NeoPhore. At AACR-NCI-EORTC in Boston in October, the first disclosure of lead compound NP1867 was presented. This demonstrated that NP1867 functionally inhibits MMR in cells and elicits COSMIC mutational signatures consistent with MMR-deficient patient samples. The additional Series B funding will be used to progress NeoPhore's lead oral program, through early pre-clinical development. Dr Matthew Baker, Chief Executive Officer of NeoPhore, said: "NeoPhore has made excellent progress throughout 2023. With the support of our committed and new investors, along with our research collaborations with academic institutions that are in place, we remain on track to deliver a candidate drug for our lead PMS2 program by early 2025." Dr Robert James, Chairman of NeoPhore, said: "Over the past years NeoPhore has made tremendous strides in showing that it is possible to target the MMR pathway with small molecule inhibitors. The recent data the Company has generated and presented at an international conference leads us to believe that NeoPhore's approach may be profoundly important. We are pleased to welcome three new Italian-based investors to our syndicate as well as further funding from existing investors. Their commitment reflects the potential value of NeoPhore's approach that exploits the dynamics of cancer neoantigen evolution, through the discovery and design of effective, well-tolerated medicines that will become a key part of the next-generation of cancer immunotherapies. We are very excited about the next stage in the life of the Company." About NeoPhore Ltd NeoPhore, UK is focused on the discovery and development of novel small molecule therapies to treat cancer through stimulation of the immune system. Generation of cancer neoantigens in tumours can be exploited by the patients' immune system to overcome natural defence mechanisms in cancer. The Company's approach targets the DNA mismatch repair (MMR) pathway, which has been proven to promote neoantigen creation and subsequent immunity against numerous cancers. Using these insights, NeoPhore aims to generate next-generation immuno-oncology therapeutics to improve clinical outcomes for cancer patients. NeoPhore was spun-out of the University of Turin and PhoreMost Ltd by the CRT Pioneer Fund. For more information, please visit About NEVA SGR Neva SGR, venture capital arm of the Intesa Sanpaolo Group and wholly owned by the Intesa Sanpaolo Innovation Center, plans and manages investment funds for professional investors interested in seizing diversification and high-yield opportunities offered by Venture Capital investments. Neva SGR can count on Intesa Sanpaolo Innovation Center's and Intesa Sanpaolo Group's strength, financial resources, know-how and network of relationships, a unique source of value on the market. Neva SGR can watch trends and markets from a privileged position and takes action with the strength and the responsibility of Italy's leading banking group. Intesa Sanpaolo Innovation Center has invested in Neva First, the investment fund designed for excellent, high-tech, high-innovation start-ups, which take advantage of trends with exponential growth potential. To learn more visit About LIFTT Chaired by the scientist and entrepreneur Stefano Buono, LIFTT's aim is to encourage technology development and transfer from University to Industry, but also to clear the way from a simple business idea to the creation of an innovative product, offering a dynamic and modern vision of venture capital as applied to Technology Transfer. To date, LIFTThas raised EUR 103,5 million and has completed 47 investments, from a pipeline of +3000 companies, operating in all market sectors, with a particular focus on Deep Tech. Head of Communications & Investor relations: [email protected] About Simon Fiduciaria Simon Fiduciaria is the fiduciary and trust company of Ersel Group which since 1936 has been a specialist in wealth management and a unique company in Italy for its absolute independence, professionalism, quality of service, and direct and personal relationship with the client. Founded in 1986, Simon Fiduciaria stands out for its independence as well as its operational and professional qualities, to fully meet the needs of its customers. As a reference point for the Italian fiduciary market, with over 7 billion administered assets, Simon Fiduciaria has developed, alongside fiduciary and trust heading services, an innovative service dedicated to large private and institutional assets, with independent and analytical monitoring that offers an aggregated view of allocation, performance, and risks, and highlights potential areas for improvement. About Sixth Element Capital LLP and the CRT Pioneer Fund Sixth Element Capital LLP (6EC) is a UK based fund manager, which manages the CRT Pioneer Fund. 6EC's experienced partners focus on creative and collaborative novel financing solutions designed to fund and manage innovative science in order to bring new therapeutic products and technologies to market, creating long term value and benefit to stakeholders. The CRT Pioneer Fund is a specialist oncology investment fund established by 6EC in 2012. The £70 million fund is dedicated to investments in oncology development programmes in Europe. The fund was established to bridge the investment gap between cancer drug discovery and early clinical development. For more information, please see About Claris Ventures Claris Ventures is a biotech-focused venture capital firm based in Turin (Italy). Its first fund under management, Claris Biotech I, was launched in 2020 to finance high potential biopharma companies arisen from the Italian R&D ecosystem – both local and international. We identify and support innovation in the pharmaceutical space, investing in new companies with transformational drugs under development. We aim at the highest impact possible on highly unmet patients' needs, building value around strong science. Our pursuit for high potential projects involves every research center, clinical structure and company in the Italian life sciences network, whether the founding team is based in Italy or it includes Italian scientists abroad who have strong links with Italy. About 3B Future Health Fund II 3B Future Health Fund II S.C.A. SICAV-RAIF is a Luxembourg based investment fund investing in oncology and rare disease therapeutics in Europe and the United States. The firm's goal is to identify innovative and promising companies that are developing First-in-Class therapeutics for indications with high unmet patient needs and provide them with the financial resources and strategic guidance they need to succeed. The fund targets companies with strong management teams, a solid scientific foundation, and a clear path to regulatory approval and commercialization. We seek to invest in early-stage companies with promising preclinical data. Additionally, the fund's investment team has extensive experience in the pharma industry, a track record of success in drug development and identifying high-potential investments. 3B is committed to creating value for its investors while also making a positive impact on the lives of patients. For more information please see About Astellas Venture Management LLC Astellas Venture Management LLC (AVM) is the corporate venture capital organization dedicated to reinforcing Astellas Pharma Inc. (Astellas) to accomplish the strategic goals. The venture capital activity of AVM is designated since 2005. Astellas, the ultimate parent company of AVM, headquartered in Tokyo is actively engaged in business as an R&D-driven global pharmaceutical company with the business philosophy to "Contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products". Through strategic investments in private early-stage companies, the funds aim to mutual-interact with Astellas, leading to partnering/collaboration in the future. AVM will be able to provide portfolio companies with invaluable R&D advice and assistance. About 2Invest 2Invest AG (2Invest) is an investment company listed on Frankfurt market formed in 2020 from the restructuring of businesses of 4basebio AG. Our investment objective is primarily but not exclusively to identify and support emerging companies with both strong management teams and ground-breaking technologies in the biotechnology, life sciences and IT sectors. Our ambition is to enable those companies to reach new and meaningful value inflexion points. SOURCE NeoPhore