On October 16, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported the publication of an abstract reporting clinical data for lifileucel which will be presented at the European Society for Medical Oncology ESMO (Free ESMO Whitepaper) Congress 2023, October 20-24, 2023 in Madrid, Spain (Press release, Iovance Biotherapeutics, OCT 16, 2023, View Source [SID1234636003]).

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The abstract reports outcomes of a subset of 12 patients with advanced mucosal melanoma treated with lifileucel in the pooled consecutive cohorts from the C-144-01 trial. All patients had progressed on or after immune checkpoint inhibitor therapy. Patients with mucosal melanoma, which is rare and difficult to treat, have worse outcomes after anti–PD-1 therapy compared to patients with other melanoma subtypes.

The ORR assessed by an independent review committee (IRC) using RECIST v1.1 was 50% (95% CI: 21%–79%). At median study follow-up of 35.7 months, median duration of response (DOR) was not reached (NR; 95% CI: 12.5 months–NR), median progression free survival (PFS) was NR (95% CI: 1.4 months–NR), and median overall survival (OS) was 19.4 months (95% CI: 7.9 months–NR). Treatment emergent adverse events (TEAEs) were consistent with known safety profiles of lymphodepleting chemotherapy and interleukin-2 (IL-2).

The clinically meaningful and durable activity for lifileucel in the subgroup of patients with the rare and difficult-to-treat mucosal melanoma subtype, as well as in the total population of 153 patients treated in the C-144-01 trial, support the potential benefit of lifileucel as a one-time treatment that is differentiated from other immunotherapies for advanced melanoma.

Additional details will be presented in a mini-oral presentation at ESMO (Free ESMO Whitepaper):

Mini Oral Session – Melanoma and Other Skin Tumours: 1086MO – Lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients (pts) with advanced mucosal melanoma after progression on immune checkpoint inhibitors (ICI): Results from the phase 2 C-144-01 study
Saturday, October 21, 3:15 PM – 3:20PM CEST (9:15 AM – 9:20 AM EDT)

On October 16, 2023 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class cancer therapeutics, reported that data from the ongoing Phase 1b/2 study of ompenaclid (RGX-202) in combination with FOLFIRI and bevacizumab (BEV) in RAS-mutated (RASm) advanced or metastatic colorectal cancer (CRC) will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 being held October 20-24, 2023 in Madrid, Spain (Press release, Inspirna, OCT 16, 2023, View Source [SID1234636002]).

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Ompenaclid is a first-in-class oral inhibitor of the creatine transport channel SLC6A8, a novel target that is enriched under hypoxic conditions and provides tumor cells with an additional energy source. Ompenaclid triggers tumor regressions in CRC patients by inducing apoptosis of tumor cells. The Phase 1b/2 study of ompenaclid in combination with FOLFIRI/BEV in second-line (2L) advanced or metastatic CRC patients has completed enrollment, with an ongoing follow up period. The primary endpoint of the study is to determine maximum tolerated dose (MTD), objective response rate (ORR), and treatment-emergent adverse events (TEAEs). In the dose escalation stage of the study, two dose levels of ompenaclid with FOLFIRI/BEV have been evaluated in patients with CRC with disease progression after a first-line oxaliplatin-containing regimen.

Poster Presentation Details

Title: Phase 1b/2 study of ompenaclid (RGX-202-01), a first-in-class oral inhibitor of the creatine transporter SLC6A8, in combination with FOLFIRI and bevacizumab (BEV) in RAS mutated (RASm) second-line (2L) advanced/metastatic colorectal cancer (mCRC)
Presenter: Andrew Hendifar, M.D., Assistant Professor of Medicine at Cedars-Sinai Medical Center and Study Principal Investigator
Onsite Poster Display Date: Sunday, October 22, 2023 at 9:00 AM CEST
Presentation Number: 646P

Conference Call and Webcast

Inspirna will host a virtual KOL panel on Sunday, October 22, 2023 at 6:30 PM CEST / 12:30 PM ET with Andrew Hendifar, M.D., to discuss these clinical data. The event may be accessed by registering at View Source A webcast of the event will be available on the "Events and Presentations" page of the Company’s website at View Source The archived webcast will be available on the Company’s website within 24 hours after the event.

On October 16, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the following presentations will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, taking place October 20-24 in Madrid, Spain (Press release, Innate Pharma, OCT 16, 2023, View Source [SID1234636001]).

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Abstract details:

SAR’579 / IPH6101 (from a Joint Research Collaboration with Sanofi)

Presentation Number: 823O
Presentation Title: Preliminary Pharmacokinetics (PK) and Pharmacodynamic (PD) Analysis of the CD123 NK Cell Engager (NKCE) SAR443579 in Patients (pts) with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-Myelodysplasia (HR-MDS)
Speaker: Mojca Jongen-Lavrencic (Rotterdam, Netherlands)
Session Type/Title: Oral Session: Proffered Paper Session / Hematologic Malignancies
Session Date and Time: Sun, 22.10.2023 16:30 – 18:00

IPH5201 (AstraZeneca collaboration)

Abstract: 1290TiP
Abstract Title: A Phase II multicenter, open label, non-randomized study of neoadjuvant and adjuvant treatment with IPH5201 and durvalumab in patients with resectable, early-stage (II to IIIA) non-small cell lung cancer (MATISSE)
Speaker: Fabrice Barlesi (Villejuif, France)
Session Type/Title: Poster Session: NSCLC, early stage
Onsite Poster display date: Sat, 21.10.2023

Monalizumab (AstraZeneca collaboration; ISS)

Abstract: 935P
Abstract Title: A phase II study of monalizumab and durvalumab in patients with recurrent/metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN): results of the I2 cohort of the EORTC-HNCG-1559 trial (UPSTREAM).
Speaker: Rachel Galot (Woluwe-Saint-Lambert, Belgium)
Session Type/Title: Poster Session: Head and neck cancers, excl. thyroid
Onsite Poster display date: Sun, 22.10.2023

Monalizumab (AstraZeneca collaboration)

Presentation Number: 854O
Presentation Title: INTERLINK-1: Phase 3 study of cetuximab (CTX) ± monalizumab (M) in participants (pts) with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) with disease progression on/after platinum chemotherapy (CT) and previously treated with an immune checkpoint inhibitor (ICI)
Speaker: Jérôme Fayette (Lyon, France)
Session Type/Title: Oral Session: Proffered Paper Session / Head and neck cancer
Session Date and Time: Mon, 23.10.2023 08:30 – 10:00

On October 16, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that new and updated clinical data from several ongoing studies of fruquintinib, in combination with chemotherapies and/or immunotherapies, will be presented at the upcoming European Society for Medical Oncology ("ESMO") Congress 2023, taking place on October 20-24, 2023 in Madrid, Spain (Press release, Hutchison China MediTech, OCT 16, 2023, View Source [SID1234636000]).

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Details of the presentations are as follows:

Abstract title

Presenter / Lead author

Presentation details

SPONSORED STUDY

Fruquintinib plus Sintilimab in patients with either treatment naïve or previously treated advanced gastric or gastroesophageal junction adenocarcinoma: results from a multicenter, single-arm phase Ib/II study

Xiaoli Wei, Harbin Medical University Cancer Hospital, Harbin, China

1519P
Poster presentation (Oesophagogastric cancer)
Monday, October 23, 2023

INVESTIGATOR-INITIATED STUDIES

First report of the safety/tolerability and preliminary antitumor activity of fruquintinib plus capecitabine versus capecitabine as maintenance treatment for metastatic colorectal cancer: an open-label, randomized phase Ib/II study

Wenhua Li, Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China

639P
Poster presentation (Colorectal cancer)
Sunday, October 22, 2023

Updated results from the multicenter phase II study of fruquintinib plus mFOLFOX6/FOLFIRI as first-line therapy in advanced metastatic colorectal cancer (mCRC)

Fuxiang Zhou, Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China

612P
Poster presentation (Colorectal cancer)
Sunday, October 22, 2023

A phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic artery infusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases (CRLM)

Lu Wang, Liver surgery department, Fudan University Shanghai Cancer Center, Shanghai, China

637P
Poster presentation (Colorectal cancer)
Sunday, October 22, 2023

Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naive EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results of a phase II trial

Pei Ma, Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

1494P
Poster presentation (NSCLC, metastatic)
Monday, October 23, 2023

About Fruquintinib

Fruquintinib is a selective oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has been shown to be generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE. A marketing submission to the U.S. Food and Drug Administration ("FDA") was granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2023. In addition, a submission to the European Medicines Agency ("EMA") was validated and accepted for review in June 2023, and a submission to the Japan Pharmaceuticals and Medical Devices Agency ("PMDA") took place in September 2023.

Takeda has the exclusive worldwide license to further develop, and commercialize, and manufacture fruquintinib outside of China. Fruquintinib is developed and marketed in China by HUTCHMED, in partnership with Eli Lilly and Company.

On October 16, 2023 LegoChem Biosciences Inc. (LCB) and Glycotope GmbH (Glycotope) reported to have entered into an exclusive worldwide licensing agreement to develop an antibody drug conjugate (ADC) by combining LCB’s proprietary ADC technology with one of Glycotope’s investigational antibodies, building on a previously announced 2022 collaboration and license agreement (Press release, Glycotope, OCT 16, 2023, View Source [SID1234635999]).

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Under the terms of the licensing agreement, LCB has worldwide exclusive rights to develop and commercialize the selected antibody as an ADC. Glycotope will receive an upfront payment and is eligible for clinical, regulatory and sales milestone payments, as well as royalties on net sales worldwide from LCB. Specific financial terms have not been disclosed.

"With the licensing of the antibody for the development as an ADC, we are further expanding the number of ADCs we have under development, which demonstrates our commitment to maximizing the value of our ADC payload and linker technology," said Dr. Yong-Zu Kim, CEO & President of LCB. "We look forward to advancing the program to clinical stage."

"We are excited by the collaboration with LCB on this ADC program", added Henner Kollenberg, CEO of Glycotope. "Our antibody discovery platform based on protein/carbohydrate combined glyco-epitopes (GlycoTargets) is constantly expanding, and it is great to see another of our antibodies being further developed in a highly potent therapeutic setting."

"We believe this antibody has excellent potential for the treatment of several solid tumor indications with high medical need. The continued progress of our collaboration with LCB, a leading developer of next-generation therapeutics, further highlights the importance of tumor-associated glycosylation in the treatment of cancer and underlines the strengths of our technology," said Patrik Kehler, CSO of Glycotope.

ADCs are a type of targeted cancer medicine that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. LCB’s ADC platform technologies overcome the existing limitations of ADCs by imparting a trinity of improved properties, (1) site-specific stable bioconjugation (2) cancer selective linker activation and (3) cancer-selective activation of potent payload, all of which in a significantly broader Therapeutic Window.

Glycotope’s antibodies target specific tumor-associated carbohydrate structures or protein/carbohydrate combined glyco-epitopes (GlycoTargets). Targeting these specific antigens enables broad indication range, long-term treatment potential and reduced on-target/off tumor toxicity, key elements of highly potent therapies. Based on this unrivalled tumor-specificity, Glycotope’s antibodies are highly suitable for a multi-function platform approach with independent modes of action to provide a tailored therapy format for as many patients as possible.