On October 16, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported the first Phase 1/2 positive clinical results with high affinity anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held in Boston, MA (October 11 – 15, 2023 – Abstract number 35371, Poster C063) (Press release, OSE Immunotherapeutics, OCT 16, 2023, View Source [SID1234636046]).

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Silvia Comis, Head of Clinical Development and Regulatory Affairs of OSE Immunotherapeutics, comments: "These first efficacy and safety positive results from clinical Phase 1/2 assessing the therapeutic potential of our proprietary anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors are very promising. These results encourage further clinical development of OSE-279 in the future as a monotherapy treatment in pre-identified cancer niche indications, with still high unmet medical needs. This product will also be available for combination with other OSE drug candidates or with external assets opening new potential partnerships."

The communication reported on the first positive results from the Phase 1/2 clinical trial evaluating OSE-279 monotherapy in patients with advanced solid tumors, with no therapeutic option available. These data have shown a manageable safety profile with preliminary signs of efficacy in the first 13 patients included with 8 tumor types and treated by a dose of 100 and 300 mg every 3 weeks (q3w) or 600 mg every 6 weeks (q6w). One confirmed partial response in a hepatocellular carcinoma patient (-81% tumor shrinkage) after a single dose of OSE-279 300 mg and 2 yet unconfirmed partial responses in anal squamous cell carcinoma (-46% tumor shrinkage) and undifferentiated pleomorphic sarcoma (-33% tumor shrinkage) with OSE-279 600 mg, were reported out of 11 patients with at least one post baseline tumor assessment. Furthermore, stable disease longer than 16 weeks was observed in 3 patients (Disease Control Rate: 55%). Pharmacokinetic profile showed good exposure and dose-proportionality and both pharmacokinetic and pharmacodynamic profiles were consistent with modelling. Receptor occupancy was maintained and within the boundaries of simulation. A Phase 2 dose (RP2D) of 300 mg was recommended every 3 weeks and 600 mg appears to be a good candidate for the RP2D every 6 weeks.

OSE-279 is a high affinity humanized anti-PD1 monoclonal antibody blocking both PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells and tumor microenvironment. OSE-279 is also the key anti-PD1 backbone component of OSE’s bifunctional checkpoint inhibitor BiCKI platform that is targeting PD1 and other new immune targets.

The first-in-human open label Phase 1/2 dose escalation and expansion study aims to determine the Maximum Tolerated Dose (MTD) and/or the RP2D of OSE-279 as a monotherapy in advanced solid tumors with two possible administration rates. Secondary objectives include assessment of OSE-279’s antitumor activity, evaluation of the safety profile, pharmacokinetic and receptor occupancy or pharmacodynamic profile (NCT05751798).

On October 16, 2023 Median Technologies (ALMDT:PA) reported that the Company will be participating in the prestigious 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, set to take place in Madrid, Spain (venue: IFEMA) (Press release, MEDIAN Technologies, OCT 16, 2023, View Source [SID1234636045]).

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The event, scheduled from October 20th to 24th, promises to be a remarkable platform for the exchange of groundbreaking insights and cutting-edge developments in the field of oncology.

"As a testament to the commitment of advancing cancer care worldwide, we will be participating with the goal of sharing our expertise in clinical trial imaging as well as advanced, AI-powered insights," said Nicolas Dano, Chief Operating Officer, iCRO, of Median Technologies. "We are thrilled to be bringing together for the first time our expert teams spanning across the Europe, United States, and China, and invite all attendees to visit booth #552 to engage with our experts and experience firsthand the impact of our pioneering solutions."

More about the ESMO (Free ESMO Whitepaper) congress: View Source

On October 16, 2023 Antiverse Ltd (Antiverse), a biotechnology company developing a computational antibody drug discovery platform, and GlobalBio, Inc. (GlobalBio), an antibody engineering company developing methods to engineer improved and more developable therapeutic antibodies, reported that they will be extending their collaboration to advance immune checkpoint inhibitors in cancer therapy (Press release, Global BioPharma, OCT 16, 2023, View Source [SID1234636044]). The initial collaboration successfully resulted in the generation of a panel of anti-PD-1 antibodies with diverse binding and functional profiles, with two candidates from this panel now entering preclinical development.

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The collaboration leveraged Antiverse’s proprietary AI-driven Antibody Discovery platform, which uses state-of-the-art machine learning techniques and advanced cell line engineering to develop antibodies for difficult drug targets, alongside GlobalBio’s ALTHEA semisynthetic libraries for the discovery and optimization of antibody-based therapeutics.

Through rounds of selection using recombinant human PD-1 as a selector, more than 300 clones were tested for their ability to bind human PD-1 and PD-1 orthologs of mouse, dog and cynomolgus. Among these clones, over a hundred were demonstrated to be positive binders to PD-1, with several dozen showing high specificity for human PD-1 and/or cross-reactivity with mouse, dog and cynomolgus orthologs. The best-performing clones were converted to antibody isotypes to minimize toxicity.

Several antibodies exhibited the ability to block PD-1:PD-L1 and PD-1:PD-L2 interactions in ELISA assays and Jurkat cells, and some promoted expression of Interferon-gamma in a mixed lymphocyte reaction co-culture assay. Antibodies D6, highly specific for human PD-1, and D13, cross-reactive with dog PD-1 and related variants, are now progressing to preclinical development in an extension of the collaboration.

Ben Holland, Co-founder and CTO of Antiverse, said: "This Agreement is further validation of our AI-driven drug discovery platform, successfully generating a panel of anti-PD-1 antibodies, with at least two potential candidates entering preclinical development. Through these types of innovative collaborations, Antiverse plays a vital role in accelerating the identification and development of novel antibody therapeutics for cancer, reducing drug discovery timelines and costs. We aim to continue to ‘open up’ the druggable antibody space."

Dr Juan Carlos Almagro, Founder and CEO at GlobalBio, Inc., added: "Antiverse’s antibody discovery platform complements our libraries and antibody engineering capabilities well. Through this collaboration, we have highlighted an exciting new avenue for us to bring new antibody-based checkpoint inhibitors into the immuno-oncology market for the treatment of cancers in both humans and animals."

For more information about Antiverse’s antibody drug discovery platform, please visit: View Source

On October 16, 2023 Exscientia plc (Nasdaq: EXAI) reported that two abstracts to be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 from October 20-24, 2023 in Madrid, Spain (Press release, Exscientia, OCT 16, 2023, View Source [SID1234636043]).

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"We are excited to share new preclinical data on our precision-designed LSD1 and MALT1 inhibitors, which we introduced to our oncology pipeline earlier this year," said Professor Andrew Hopkins FRS FMedSci, founder and Chief Executive Officer of Exscientia. "We believe these compounds bear strong potential for differentiation, patient benefit and value creation. This data underlines how Exscientia can bring together AI design and novel translational research capabilities to create better quality drug candidates. This also allows us to systematically identify those patient populations who have the most potential benefit well before we start clinical trials."

Both ESMO (Free ESMO Whitepaper) posters will be available on the Exscientia website from their time of presentation.

Poster Presentations

Title: Determining anti-cancer efficacy of a reversible LSD1 inhibitor, EXS74539, in primary AML tissues with limited thrombocytopenic effects
Session Title: Translational research (agnostic)
Abstract Number: 2289P
Date/Time: Saturday, October 21 / 12:00 PM – 1:00 PM CEST

‘539 is a novel, potent, selective and reversible LSD1 inhibitor under preclinical investigation as a monotherapy or in combination with standard of care for oncology and haematology indications including acute myeloid leukaemia (AML) and small cell lung cancer (SCLC)
Leveraging primary human material and Exscientia’s proprietary precision medicine platform, the Company confirmed ‘539’s general efficacy, demonstrating that ‘539 induces AML cell differentiation marker expression when used on primary AML patient tissue ex vivo
Combination data with first line AML and targeted therapies will be presented
Title: Characterisation of EXS73565, a potent and selective MALT1 inhibitor with low drug-drug interaction risk and potential in lymphoma
Session Title: Haematological malignancies
Abstract Number: 832P
Date/Time: Monday, October 23 / 12:00 PM – 1:00 PM CEST

Exscientia utilised generative design, machine learning and molecular dynamics approaches to precision-design ‘565, a potent and selective allosteric MALT1 inhibitor with a differentiated profile exhibiting low drug-drug interaction and hyperbilirubinemia risk
Preclinically, ‘565 exposure resulted in limited inhibition of UGT1A1, an enzyme involved in bilirubin metabolism. This approach has the potential to offer safety benefits compared to other clinical stage MALT1 inhibitors which carry a high UGT1A1 inhibition and hyperbilirubinemia risk
Significant tumour growth inhibition was observed for ‘565 in vivo in activated B-cell diffuse large B-cell lymphoma (ABC-DLBCL) xenograft models. Significant synergistic effects were observed for combination ‘565 and the BTK inhibitor ibrutinib in a xenograft model with low sensitivity to either single agent
Overall, the profile of ‘565 offers the potential for clinical exploration of MALT1 inhibition as a monotherapy and/or in combination with other targeted agents in haematological malignancies

On October 16, 2023 Incyte (Nasdaq:INCY) reported that abstracts featuring new data from its oncology portfolio will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, held October 20-24 in Madrid (Press release, Incyte, OCT 16, 2023, View Source [SID1234636042]).

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"We look forward to sharing data from our oncology portfolio with the scientific community at this year’s ESMO (Free ESMO Whitepaper) Congress"

"We look forward to sharing data from our oncology portfolio with the scientific community at this year’s ESMO (Free ESMO Whitepaper) Congress," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Presentations, including results from studies of retifanlimab and capmatinib, focused on patients with endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer, showcase our continued efforts to pursue innovative therapies for patients with cancer."

Key abstracts from Incyte-sponsored and partner programs include:

Poster Presentations

Immuno-oncology (IO)

Retifanlimab in Patients with Recurrent Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) Endometrial Cancer: Final Results from the POD1UM-101 Study (Cohort H) (Abstract #755P. Topic: Gynecological Cancers. Sunday, October 22, 6:00 a.m. – 7:00 a.m. ET)

Updated Results from POD1UM-201: A Phase 2 Study of Retifanlimab in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC) (Abstract #1146P. Topic: Melanoma and Other Skin Tumors. Sunday, October 22, 6:00 a.m. – 7:00 a.m. ET)

Capmatinib

Efficacy of Capmatinib Compared to Standard of Care for German Patients with Locally Advanced or Metastatic NSCLC Harboring METex14 Mutations: Results from the RECAP Study1 (Abstract #1383P. Topic: NSCLC, Metastatic. Monday, October 23, 6:00 a.m. – 7:00 a.m. ET)

Capmatinib vs Docetaxel as Second- or Third-line (2/3L) Therapy in Patients (Pts) with METex14-Mutated Advanced NSCLC (aNSCLC): The GeoMETry-3 Trial1 (Abstract #1391P. Topic: NSCLC, Metastatic. Monday, October 23, 6:00 a.m. – 7:00 a.m. ET)

For full session details and data presentation listings, please see the ESMO (Free ESMO Whitepaper) Congress 2023 (View Source) online program.

About Zynyz (retifanlimab-dlwr)

Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a trademark of Incyte.

About Tabrecta (capmatinib)

Tabrecta is approved in several countries including the EU, United States (U.S.), Japan and Switzerland. It is the number one prescribed targeted therapy for patients with advanced non-small cell lung cancer (NSCLC) with alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping globally2.

Tabrecta is a kinase inhibitor that targets mesenchymal-epithelial transition (MET). Tabrecta was discovered by Incyte and licensed to Novartis in 2009. Under the agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.