On April 8, 2022 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the filing of its universal registration document for the financial year ended December 31, 2021 with the French financial market authority (Autorité des marchés financiers or AMF), as well as of the Annual Report on Form 20-F for the financial year ended December 31, 2021 with the U.S. Securities and Exchange Commission (SEC) (Press release, Nanobiotix, APR 8, 2022, View Source [SID1234611770]).

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These documents are available on the Nanobiotix website at View Source In addition, the 2021 universal registration document is available on the AMF website (www.amf-france.org) and the 2021 Annual Report on Form 20-F is available on the SEC website (www.sec.gov).

In particular, the Company’s 2021 universal registration document includes its:
– 2021 annual financial report,
– Management report including the report on corporate governance
– Reports from the Company’s statutory auditors and information on their fees
– Required information in relation to the Company’s share buyback program

2022 Financial Agenda

May 10, 2022 – First Quarter 2022 Corporate and Financial Update
June 21, 2022 – Annual General Meeting, Paris, France
September 7, 2022 – 2022 Half-Year Corporate and Financial Update
November 9, 2022 – Third Quarter 2022 Corporate and Financial Update
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About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product, composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly, with immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company sponsored phase I clinical study, evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC and for patients with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy, either naïve or resistant to prior PD-1 (either primary or secondary as per SITC (Free SITC Whitepaper) criteria).

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies.

On April 8, 2022 Exscientia plc (Nasdaq: EXAI) reported that details of its participation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 8-13 2022 at the Ernest N. Morial Convention Center in New Orleans, La (Press release, Exscientia, APR 8, 2022, View Source [SID1234611769]). Exscientia scientists will present new research in three poster presentations.

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"We are looking forward to meeting with some of the world’s leading cancer clinicians and researchers at this year’s AACR (Free AACR Whitepaper) meeting, as we continue to build our human tissue precision medicine platform and expand the areas we are exploring to include additional indications such as breast and ovarian cancers," said Nikolaus Krall, Exscientia’s VP of Precision Medicine. "In addition, we will share data highlighting our translational research capabilities and AI-driven drug discovery platform and the potential to redefine cancer drug discovery. We believe these studies continue to validate our novel approaches as we seek to improve clinical and patient outcomes by efficiently identifying the most promising therapeutic assets."

Exscientia will have a booth (#2016) where attendees can meet the team and learn more about the company’s AI-driven precision oncology platform, broad pipeline, and newly launched collaboration with the University of Oxford, Xcellomics, to help accelerate early-stage drug discovery.

Poster presentations:

Poster Title: Enriching for adenosine antagonist patient responses through deep learning
Session Title: Immunomodulatory Agents and Interventions
Abstract Number: #4150
Date/Time: Wednesday, April 13 / 9:00 AM – 12:30 PM CT

Poster Title: AI-driven discovery and profiling of GTAEXS-617, a selective and highly potent inhibitor of CDK7
Session Title: Emerging New Anticancer Agents
Abstract Number: #3930
Date/Time: Wednesday, April 13 / 9:00 AM – 12:30 PM CT

Poster Title: Deep Learning Supported Analysis of Primary Samples Identifies ALK Pathway as a Novel Sensitivity in Ovarian Cancer
Session Title: New Technologies for Drug Discovery
Abstract Number: #1893
Date/Time: Monday, April 11 / 1:30 PM – 5:00 PM CT

On April 8, 2022 PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, reported that their recent research will be presented at the 2022 AACR (Free AACR Whitepaper) annual meeting, which will be held in New Orleans from April 8 to April 13, 2022 (Press release, PathAI, APR 8, 2022, View Source [SID1234611768]). PathAI will share a total of six posters, three of which were developed in collaboration with pharmaceutical partners. These new findings have promising implications for improving the diagnosis and treatment of multiple cancer subtypes with the use of AI-powered digital pathology.

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"Our research demonstrates how PathAI’s algorithms can uncover novel insights or generate important molecular inferences from standard pathology samples that could not be identified using traditional manually-interpreted pathology or with more expensive and less accessible molecular approaches," said Mike Montalto, Chief Scientific Officer at PathAI. "These translational insights are critically important to help accelerate drug development and get life-saving medicines to patients more quickly."

A key example of this capability is highlighted in the poster, "AI-powered segmentation and analysis of nuclei morphology predicts genomic and clinical markers in multiple cancer types," which describes PathAI’s machine learning-based nuclear segmentation model that associates features of nuclear morphology with clinically-relevant molecular and genomic markers across multiple tumor types.

The model was trained using over 29,000 annotations across multiple cancer types as well as five non-cancer tissues, to identify nuclei in any tissue type. Features related to nuclear shape, texture, and color were automatically extracted from the model and evaluated for their ability to predict genomic and molecular markers important for treatment selection and disease prognosis. When applied to breast, lung, and prostate tumor tissue, these models identified key combinations of nuclear features that were predictive of biomarkers including whole genome doubling, homologous recombination deficiency, HER2 positivity or elevated Gleason grade. These models could provide a way to rapidly genotype patients for selection of the most appropriate treatments without the need for extra tissue samples or sequencing protocols.

The full list of PathAI’s poster presentations is highlighted below. More information on each abstract can be found here.

Title: Quantification of TGFβ protein levels and digital pathology-based immune phenotyping reveal biomarkers for TGF-β blockade therapy patient selection in NSCLC

Session Date and Time: Online Only. E-poster available April 8, 2022, 12:00 PM CT.
Abstract: 5099
Developed in partnership with Sanofi

Title: Machine learning models identify histological features that can predict KEAP1 mutations in lung adenocarcinoma

Session Date and Time: April 10, 2022, 1:30 PM – 5:00 PM CT
Abstract: 449
Title: AI-powered segmentation and analysis of nuclei morphology predicts genomic and clinical markers in multiple cancer types

Session Date and Time: April 10, 2022, 1:30 PM – 5:00 PM CT
Abstract: 464
Title: AIM PD-L1-NSCLC: Artificial intelligence-powered PD-L1 quantification for accurate prediction of tumor proportion score in diverse, multi-stain clinical tissue samples

Session Date and Time: April 10, 2022, 1:30 PM – 5:00 PM CT
Abstract: 471
Title: AI-powered and manual assessment of PD-L1 are comparable in predicting response to neoadjuvant atezolizumab in patients (pts) with resectable non-squamous, non-small cell lung cancer (NSCLC)

Date and Time: April 11, 2022, 9:00 AM – 12:30 PM CT
Abstract: CT112
Developed in partnership with Genentech, a member of the Roche Group

Title: Application of interpretable neural graph network to predict gene expression signatures associated with tertiary lymphoid structures in histological images

Session Date and Time: April 11, 2022, 1:30 PM – 5:00 PM CT
Abstract: 1922
Posters will be available for registered attendees for on-demand viewing on the AACR (Free AACR Whitepaper) website on April 8, 2022, at 1:00 PM ET.

On April 8, 2022 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that two posters presenting preclinical data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 for zandelisib, an orally administered phosphatidylinositol-3-kinase (PI3K) inhibitor, and ME-344, a tumor selective mitochondrial inhibitor (Press release, MEI Pharma, APR 8, 2022, View Source [SID1234611767]).

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"The preclinical data presented at AACR (Free AACR Whitepaper) is supportive of the promise of our pipeline and we look forward to continuing to advance our clinical candidates in an effort to provide new therapeutic options for patients with cancer," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma.

To view the posters click here.

Title: Efficacy and immune profiling of the PI3K delta inhibitor zandelisib (ME-401) in a preclinical model of chronic lymphocytic leukemia (CLL)
Authors: Dr. Maharaj, et. al.
Date: Friday, April 8, 2022, 8:30 AM ET
AbstractID: 5496

Summary: Data from preclinical studies with zandelisib ex vivo in normal human T cells and in vivo in a murine CLL model suggest that zandelisib has immunomodulatory properties on human T cells. Zandelisib in combination with ibrutinib further reduced normal human T cell proliferation and inducible regulatory T cells (Tregs), while zandelisib alone decreased activation and expression of suppressive markers, such as PD-1 and CTLA-4 on inducible regulatory (Tregs) and CD4+ T cells, comparably to zandelisib/ibrutinib combination. In the murine CLL model, a reduction in Treg numbers, markers of terminal memory differentiation and T-cell exhaustion on CD4+ and CD8+ T cells – all of which are features that have been shown to permit CLL immune evasion – as well as improvement in overall survival was observed.

Title: ME-344, a novel isoflavone mitochondrial inhibitor, in combination with venetoclax constitutes a new metabolism-targeted approach to overcome resistance to Bcl-2 inhibition and standard of care treatment in AML
Authors: Katie Hurrish, et. al.
Date: Wednesday, April 13, 2022, 10:00 AM – 1:30 PM ET
AbstractID: 3785

Summary: ME-344 is an investigational isoflavone that has been shown to suppress OXPHOS in solid tumor cells. However, it has not been tested extensively in hematologic malignancies. This study analyzes the ability of ME-344 to enhance the activity of venetoclax against acute myeloid leukemia (AML). Data from the presented in vitro and in vivo preclinical studies evaluating the combination of ME-344 with venetoclax in standard-of-care-resistant AML cell lines and relapsed or refractory AML patient samples suggest that ME-344, both alone and in combination with venetoclax, inhibits purine biosynthesis, suppresses oxidative phosphorylation, induces apoptosis and decreases Mcl-1, which together target metabolic vulnerabilities of AML cells. The data demonstrated that ME-344 and venetoclax prolong survival in MV4-11- and MV4-11/AraC-R-derived xenograft AML models. Overall, it’s concluded that ME-344 enhances venetoclax activity against AML cells including resistant AML.

About Zandelisib

Zandelisib, a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. Clinical trials are investigating the efficacy and safety of zandelisib as a single agent and in combination with other modalities while administered on an Intermittent Dosing Regimen (IDT). The IDT leverages molecular and biologic properties specific to zandelisib.

Ongoing zandelisib studies include the Phase 2 TIDAL study (NCT03768505) evaluating patients with relapsed or refractory follicular and marginal zone lymphomas. Also ongoing is the Phase 3 COASTAL study (NCT04745832) comparing zandelisib plus rituximab to standard of care chemotherapy plus rituximab, in patients with relapsed or refractory follicular or marginal zone lymphomas who received more than one prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide. COASTAL is intended to support marketing applications in the U.S. and globally.

About ME-344

ME-344 is a novel and tumor selective mitochondrial inhibitor drug candidate. It directly targets the OXPHOS complex 1, a pathway involved in the production of adenosine triphosphate, or ATP, in the mitochondria. Treatment of tumor cells with ME-344 as a single-agent results in a rapid loss of ATP and cancer cell death.

Although clinical investigation of ME-344 has demonstrated single agent activity in patients with solid tumors, using it in combination with other cancers therapies is thought to hold more significant potential for patients. Data reported from an investigator-initiated, multi-center, randomized study of ME-344 in combination with the VEGF inhibitor bevacizumab (Avastin) demonstrated biologic activity in the ME-344 treatment group supporting further clinical investigation.

A Phase 2 study of ME-344 plus Avastin in patients with relapsed colorectal cancer is planned to start towards the end of 2022.

On April 8, 2022 Hangzhou Qihan Biotechnology Co., Ltd, an innovative biotechnology company dedicated to applying genome editing technology to cell therapies and organ transplants, reported preclinical data from its NK cell programs, presented during the poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans, Louisiana (Press release, Qihan Biotech, APR 8, 2022, View Source [SID1234611766]).

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NK cells derived from genetically engineered human induced pluripotent stem cells (iPSCs) hold great potential to become the next-generation allogeneic cell therapy products.

"We are excited to share the promising data with the community, as we believe that we can utilize our platform to advance the cell therapy medicine to the patients," said Dr. Luhan Yang, CEO of Qihan Biotech. "The data presented in one poster highlight the "Super NK" cells, genetically engineered with enhanced NK function, demonstrating superior killing capacity against blood and solid tumors. Additionally, we presented our immune privileged cell therapy platform in a non-human primate model in a separate poster. Creating a library of monkey iPSCs with up to 21 genetic modifications to evade allogeneic immune rejection and successfully differentiating them into functional monkey NK cells provided us with the unique translational opportunity to study NK Pharmacokinetics (PK) and Pharmacodynamics (PD)."

Poster Presentations:

Functional natural killer cells derived from engineered hiPSC with hypoimmunity gene combo demonstrate hypoimmunity features in evading host attacks.
Session: OPO.TB02.01 – Stem Cell Biology
"Super NK cells" – natural killer cells derived from engineered hiPSC with enhanced NK receptor expression demonstrate excellent anti-tumor effects for solid tumors.
Session: PO.TB02.02 – Stem Cells and Regulatory Pathways in Cancer