On April 8, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company",NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported the early results of a first-in-human clinical study of GC502, an allogeneic CD19/CD7 dual-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) (Press release, Gracell Biotechnologies, APR 8, 2022, View Source [SID1234611773]). Gracell will share the data in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 on April 12.

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GC502 leverages the novel dual-directed CAR design of Gracell’s proprietary TruUCAR platform, designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with faster patient’s access. TruUCAR-enabled GC502 utilizes the dual-directed CAR design with one CAR targeting CD19 on malignant cells and a second CAR targeting CD7 to suppress host-versus-graft rejection. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells.

"We are very excited to present our data on GC502 at this year’s AACR (Free AACR Whitepaper) annual meeting. CD19 is a validated target in the treatment of r/r B-ALL," said Dr. Martina Sersch, Chief Medical Officer of Gracell. "As an allogeneic, off-the-shelf CAR-T therapy, GC502 has the potential to provide patients who may not be eligible for autologous CAR-T therapy with hope to achieve a deep response. The early results show the potential of GC502 and warrant further evaluation in the ongoing clinical investigator-initiated-trial (IIT). Being the second product candidate from our allogeneic TruUCAR platform, GC502 further validates TruUCAR’s platform approach and potential wide applicability."

Between September 2021 and January 2022, four r/r B-ALL patients were enrolled and treated in an open-label, non-randomized, prospective IIT study in China in two different dose levels and with two different formulations. Patients were heavily pretreated, and all had previously received either autologous or donor derived CD19 or CD19/CD22 targeted CAR-T therapy. As of the January 28, 2022 data cutoff date, all four patients had received a single dose of GC502, including one patient at dose level 1 (DL1) 1.0×107 cells/kg and three patients at dose level 2 (DL2) 1.5×107 cells/kg. Patients received a Flu/Cy based lymphodepletion regimen prior to treatment with GC502.

As highlighted in the AACR (Free AACR Whitepaper) poster, three out of four patients achieved minimal residual disease negative complete response or complete response with incomplete count recovery (MRD- CR/CRi), and one patient achieved a partial response at month one and subsequently received allogeneic hematopoietic stem-cell transplantation (allo-HSCT) on day 39.

Cytokine release syndrome (CRS) presented as Grade 2 and Grade 3 with no Grade 4 or 5 events. No immune effector cell-associated neurotoxicity syndrome (ICANS) or acute graft-versus-host disease (aGvHD) were observed.

For more information on the ongoing trial, refer to the ClinicalTrials.gov Identifier: NCT05105867.

Details of the presentation are as follows:

Presentation Title: Early results of a safety and efficacy study of allogeneic TruUCAR GC502 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
Session Title: Phase I Clinical Trials 2
Session Date and Time: Tuesday, April 12, from 9:00AM – 12:30PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 33
Poster Board Number: 21
Permanent Abstract Number: CT196
Additional meeting information is available on the AACR (Free AACR Whitepaper) website. The full text of the abstract is available on the AACR (Free AACR Whitepaper) Online Itinerary Planner and the e-poster is viewable to registered attendees on the AACR (Free AACR Whitepaper)’s e-poster website through Wednesday, July 13, 2022.

About GC502

GC502 is a TruUCAR-enabled CD19/CD7 dual-directed, off-the-shelf allogeneic CAR-T product candidate that is being studied in an ongoing Phase 1 IIT in China for the treatment of B-cell malignancies. GC502 is manufactured using T cells from non-human leukocyte antigen (HLA) matched healthy donors. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells. Optimized for CD19/CD7 dual-CAR functionality and in vivo durability, GC502 has demonstrated robust anti-tumor effects with potential to suppress host versus graft (HvG) rejection in preclinical models.

About B-ALL

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with an estimated 6,660 new cases to be diagnosed in the United States in 2022[1]. B-ALL accounts for 75% of ALL diagnoses in adults.

About TruUCAR

TruUCAR is Gracell’s proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host versus graft rejection (HvG) as well as graft versus host disease (GvHD) without the need for being co-administered with additional immunosuppressive drugs after standard lymphodepletion. The novel dual-CAR design allows tumor antigen-CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress HvG response.

On April 8, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported safety and preliminary efficacy data of the combination of the Company’s lead immunotherapy candidate, maveropepimut-S (MVP-S), with pembrolizumab from a Phase 2 basket study of patients with advanced, metastatic bladder cancer (Press release, IMV, APR 8, 2022, View Source [SID1234611771]). Data will be presented at a mini-symposium on Immunotherapy Combination Strategies in Clinical Trials at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 8-13, 2022, in New Orleans, Louisiana.

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Seventeen subjects with advanced, metastatic bladder cancer, who on average had received two prior lines of therapy, were enrolled in this arm of the Phase 2 basket study (NCT03836352) and treated with the combination of MVP-S/CPA and pembrolizumab. The preliminary results, described below, suggest that IMV’s therapy may provide a well-tolerated therapeutic alternative for advanced, metastatic bladder cancer patients in need of new treatment options.

"The basket trial was designed to identify signals of clinical benefit for the combination of MVP-S/ CPA and pembrolizumab," said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV Inc. "We are very encouraged to see such positive clinical results, particularly in advanced, metastatic bladder cancer patients that had already been treated with immune checkpoint inhibitors. We are now meeting with top key opinion leaders in the field to design follow-on trials to deepen our understanding of this clinical benefit."

Key Findings

Five out of 17 subjects showed response (2 confirmed complete responses (CRs) and 3 additional partial responses);
Three of these, including both confirmed CRs, had progressed on prior anti-PD-1/L1 therapy;
Long-term clinical benefit was observed in several subjects as was an increase in detectable survivin-specific T cells in peripheral blood; one patient remains on treatment after 18 months;
The combination treatment was well-tolerated, with the majority of adverse events being grade 1 or grade 2.
This presentation will be available on the conference platform and on the IMV website under the Scientific Publications & Posters section following the meeting.

Presentation details:

Safety, preliminary efficacy and pharmacodynamic (PD) analysis of maveropepimut-S, intermittent low-dose cyclophosphamide and pembrolizumab in patients with advanced, metastatic bladder cancer

Presenter: Jeremy R. Graff, Ph.D., Chief Scientific Officer at IMV
Session Title: Immunotherapy Combination Strategies in Clinical Trials
Presentation Number: CT035
Session Date and Time: Tuesday, Apr. 12, 2022, 2:30 p.m. – 4:30 p.m. CST

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.