On June 1, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported a new collaboration and supply agreement with Merck KGaA , Darmstadt, Germany for a Phase I/IIa clinical trial in patients with solid tumours, called INSIGHT-005 (Press release, Immutep, JUN 1, 2021, View Source [SID1234583365]).

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The trial will evaluate the feasibility, safety and efficacy of Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321), when given in combination with bintrafusp alfa (M7824), an investigational bifunctional fusion protein immunotherapy being jointly developed by Merck, Darmstadt, Germany and GlaxoSmithKline. Bintrafusp alfa aims to block two immunosuppressive pathways, TGF-ß and PD-L1, while efti activates antigen presenting cells, via the LAG-3 – MHC II pathway.

"Through INSIGHT-005, we plan to explore the effect of releasing the brakes and pushing the accelerator of the body’s immune system in three different positions of the cancer immunity cycle. The new trial builds on our knowledge and the encouraging data from the INSIGHT trial of efti, also in solid tumours. We are excited about this new clinical collaboration which allows us to extend and strengthen our relationship with an existing partner in a new and exciting setting, particularly at a time when there is growing awareness and validation of the LAG-3 MHC class II interaction," said Immutep CEO Marc Voigt.

INSIGHT-005 will be conducted by the Institute of Clinical Cancer Research, at Krankenhaus Nordwest in Frankfurt, Germany (IKF) as an investigator-initiated trial, with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study will be run as an amendment to the protocol of the ongoing Phase I INSIGHT trial as the fifth arm (Stratum E). Prof. Al-Batran is also the lead investigator of INSIGHT and INSIGHT-004 and a member of Immutep’s clinical advisory board.

"We are very pleased to be expanding our involvement with Immutep to explore efti in a new combination with bintrafusp alfa. Our experience and knowledge of efti, combined with our extensive nationwide network of more than 500 German clinical facilities, means we are well equipped to lead the INSIGHT-005 study," said Prof. Al-Batran, lead investigator of INSIGHT-005.

INSIGHT-005 is planned to take place in 2 clinical sites in Germany. Immutep is financially supporting the trial to be run by IKF, and Merck, Darmstadt, Germany is financially contributing to the biomarker-related work. Subject to regulatory and ethics committee approval, the first patient is expected to be enrolled in mid-2021 and the trial is expected to deliver first data in early 2022.

On June 1, 2021 CBMG Holdings, a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported the publication of two abstracts of CAR-T therapies for liquid tumors published in conjunction with the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4-8, 2021 (Press release, Cellular Biomedicine Group, JUN 1, 2021, View Source [SID1234583363]). These abstracts will be presented at the upcoming ASCO (Free ASCO Whitepaper) meeting as podium presentations.

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Session: Developmental Therapeutics—Immunotherapy
Abstract #: 2507
Citation: J Clin Oncol 39, 2021 (suppl 15; abstr 2507)
DOI: 0.1200/JCO.2021.39.15_suppl.2507
Drug name: C-CAR039
Mechanism of Action: A 2nd generation novel bi-specific CAR-T therapy targeting both CD19 and CD20 antigens
Indications: Relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL)

C-CAR039 has been developed as a novel 2nd generation 4-1BB bi-specific CAR-T targeting both CD19 and CD20 antigens with an optimized bi-specific antigen binding domain. C-CAR039 can eradicate CD19/CD20 single or double positive tumor cells in vitro and invivo. The tissue cross reactivity and whole genome membrane proteome array studies further confirmed the specificity of C-CAR039.

C-CAR039 demonstrated a favorable safety profile and promising efficacy in this early clinical trial in patients with r/r B-NHL that might allow it to differentiate from existing therapies. The early clinical efficacy signal is encouraging and compares favorably to anti-CD19 CAR-T and peer therapies. These findings will be evaluated in more patients with longer follow-up to confirm safety, efficacy and duration of response. Clinical trial information: NCT04317885, NCT04655677, NCT04696432, NCT04693676.

View full abstract here

Session: Developmental Therapeutics—Immunotherapy
Abstract #: 2508
Citation: J Clin Oncol 39, 2021 (suppl 15; abstr 2508)
DOI: 10.1200/JCO.2021.39.15_suppl.2508
Drug name: C-CAR066
Mechanism of Action: A novel 2nd generation CAR-T therapy targeting CD20 antigen
Indications: Relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) that has failed to an anti-CD19 CAR-T therapy

A phase I clinical trial was conducted to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B-NHL who were previously treated with anti-CD19 CAR-T therapy. Patients (≥ 18 years) with r/r DLBCL, r/r FL or r/r MCL, ECOG < 2 were eligible. GMP manufacture of C-CAR066 was in a serum free and fully closed semi-automatic system. A 3-day cyclophosphamide plus fludarabine regimen was followed by a single infusion of C-CAR066. Bridging therapy was allowed.

C-CAR066 has shown a favorable safety profile and promising efficacy in patients with r/r B-NHL following failure of CD19 CAR-T therapy. These results show that C-CAR066 has a different mechanism of action compared to anti-CD-19 CAR-T therapy and could provide a solution to address the unmet medical need in B-NHL patients that have failed anti-CD19 CAR-T therapy. Clinical trial information: NCT04036019

On June 1, 2021 Ajax Therapeutics, Inc., a biotechnology company applying computational chemistry and structure-based technologies to develop novel small molecules for hematologic malignancies, reported the completion of a $40 million financing (Press release, Ajax Therapeutics, JUN 1, 2021, View Source [SID1234583362]). The round was led by EcoR1 Capital LLC with participation from additional new investor, Boxer Capital, as well as co-founding investors Inning One Ventures and Schrödinger, Inc. (Nasdaq: SDGR). Existing research collaboration partners, Memorial Sloan Kettering Cancer Center (MSK) and NYU Langone Health, also participated in the financing. Concurrent with the financing, Scott Platshon, Partner of EcoR1 Capital, will join the Ajax Board of Directors.

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"We’re excited to be joining the Ajax team through this financing and supporting the company as it advances its drug development programs toward the clinic," said Scott Platshon, Partner, EcoR1 Capital. "Ajax’s world class scientific founders have proprietary insights into treating hematologic malignancies and we have been impressed by the company’s ability to translate these insights into a promising pipeline of treatments for significant unmet needs for patients."

"We are pleased to welcome EcoR1 and Boxer Capital to our investor syndicate," said Martin Vogelbaum, Ajax co-founder, interim CEO and Managing Partner at Inning One Ventures. "We’ve made significant progress at Ajax since founding the company in 2019 and look forward to continuing the momentum we’ve built with our unique approaches to selectively targeting key cytokine signaling pathways that drive hematologic malignancies."

Proceeds from the financing will support the advancement of Ajax’ lead drug development programs targeting hematologic malignancies. The financing will also support the company’s drug discovery pipeline, including the potential expansion of research efforts beyond hematologic malignancies, in addition to building out the company’s scientific and technical leadership team.

"Ajax began as an academic consortium among the scientific founders who recognized the need for new approaches to treating hematologic malignancies," said Ross Levine, MD, Chair of the Ajax Scientific Advisory Board, a member of the company’s board of directors and a physician-scientist at MSK. "We are extremely pleased with the progress that has been made since converting our consortium into Ajax Therapeutics and look forward, with this financing, to continuing to pursue our selectively targeted approaches to treating hematologic malignancies."

Ajax’s pipeline of novel small molecules is based on disease and structural biology insights from the company’s scientific founders combined with computational drug discovery capabilities through its unique partnership with Schrödinger, the industry leader in molecular simulation software for drug discovery. Through this ongoing collaboration, Ajax and Schrödinger scientists work as an integrated team to precisely design compounds with the desired functional activity, selectivity and drug-like properties.

"When the Ajax team approached us about helping launch the company, we recognized that several of the drug targets under consideration were structurally enabled and highly amenable to our industry-leading computational drug discovery platform to develop novel selectively targeted therapeutics," said Ramy Farid, PhD, President and CEO and of Schrödinger, Inc. and a member of the board of directors of Ajax. "We are very pleased with the rapid progress made from the discovery to the advancement of Ajax’s lead programs toward the clinic."

On June 1, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported abstracts and presentations by its collaborators for the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held June 4-8, 2021 (Press release, Halozyme, JUN 1, 2021, View Source [SID1234583360]).

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Janssen Research & Development, LLC (Janssen)-sponsored study with therapeutics utilizing ENHANZE technology:

Subcutaneous daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) in patients with newly diagnosed light chain (AL) amyloidosis

Oral abstract session: Updated results from the Phase 3 ANDROMEDA study of DARZALEX FASPRO in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of newly diagnosed AL amyloidosis (Abstract #8003).
Bristol Myers Squibb-sponsored study with therapeutics utilizing ENHANZE technology:

CheckMate 8KX: Phase 1/2 multi-tumor preliminary analyses of a subcutaneous formulation of nivolumab (± rHuPH20)

Poster session: The first data on the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of subcutaneous nivolumab + rHuPH20 (Abstract #2575).
Roche-sponsored study with therapeutics utilizing ENHANZE technology:

Potential non-drug cost differences associated with the use of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in the treatment of HER2-positive early breast cancer patients in Western Europe and the United States

Poster session: The aim of this study is to estimate the incremental difference in non-drug costs between PH FDC SC and PT IV for a typical patient receiving treatment for HER2-positive early breast cancer in Western Europe and the United States (Abstract #544).

On June 1, 2021 Servier, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that data will be presented from multiple studies across its oncology portfolio during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, June 4-8 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, June 9-17 (Press release, Servier, JUN 1, 2021, View Source [SID1234583359]). Data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include multiple company-sponsored and investigator-initiated trials, which underscore the depth and breadth of Servier’s oncology portfolio that is making strides toward addressing unmet needs of those living with cancer.

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Three abstracts have been selected for oral presentation, spanning multiple hard-to-treat solid tumor types, including glioma, biliary tract cancer, and colorectal cancer. These presentations highlight the potential role of IDH inhibition and the company’s overall innovative research portfolio in generating superior outcomes over current standards of care based on precision approaches. Research from several investigator-initiated trials will also be shared. These studies investigate evolving the standard of care in advanced cancers through the use of combination approaches in metastatic colorectal cancer, myeloid malignancies, gastric and gastroesophageal adenocarcinoma, and biliary tract cancer.

In addition, there will be an encore poster presentation of the final results from ClarlDHy, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma. Data from this study were included in the company’s supplemental New Drug Application for TIBSOVO, which was recently accepted and granted Priority Review by the U.S. Food and Drug Administration. Currently, there are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available for patients with advanced disease.

"Our presence at this year’s ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) showcase the very focused approach we are taking to place an emphasis on difficult-to-treat cancers with significant unmet need," said David K. Lee, CEO, Servier Pharmaceuticals. "We believe that our leadership in hematology and growing position in solid tumors ensures we are well poised to deliver more life-changing medicines to a greater number of individuals impacted by cancer worldwide."

Servier has experienced tremendous growth in the past several years. Much of this expansion is in the oncology space where the company is now allocating 50 percent of its research and development investment. With 19 oncology assets at varying stages of clinical development, and 20 research projects1, Servier is addressing areas of significant unmet need and difficult-to-treat cancers that target different types of lymphoma and leukemia, as well as solid tumors including gastrointestinal and lung cancers.

"Our significant presence at these key congresses is reflective of the successful expansion of our research and development for a variety of tumor types to benefit patients," said Claude Bertrand, Executive Vice President of Research and Development, Servier Group. "We are excited to present data across our hematology and solid tumor portfolio including research on the potential of IDH inhibition in the treatment of cancers with high unmet needs."

Key highlights of data at ASCO (Free ASCO Whitepaper), sponsored by Servier, are listed below and are available online on the ASCO (Free ASCO Whitepaper) website: View Source

Abstract #2008: Impact of mutant IDH (mIDH) inhibition on DNA hydroxymethylation, tumor cell function, and tumor immune microenvironment (TIME) in resected mIDH1 lower-grade glioma (LGG)

Date & Time: Monday, June 7, 2021 at 8:00 a.m. EDT
Oral Session: Oral Abstract Session, Central Nervous System Tumors
Presenting Author: I. Mellinghoff
Abstract #4069: Final results from ClarIDHy, a global, phase 3, randomized, double-blind study of ivosidenib (IVO) vs placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation

Date & Time: Friday, June 4, 2021 at 9:00 a.m. EDT
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: G.K. Abou-Alfa
Abstract #3526: Patient-reported quality of life data from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: interim results of the TALLISUR study

Date & Time: Friday, June 4, 2021 at 9:00 a.m. EDT
Poster Session: Gastrointestinal Cancer – Colorectal and Anal
Presenting Author: M. Karthaus
Investigator-initiated trials to be presented at ASCO (Free ASCO Whitepaper) include:

Abstract #4006: Liposomal irinotecan (nal-IRI) in combination with fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic biliary tract cancer (BTC) after progression on gemcitabine plus cisplatin (GemCis): Multicenter comparative randomized phase 2b study (NIFTY)

Date & Time: Saturday, June 5, 2021 at 1:45 p.m. EDT
Short Oral Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: C. Yoo
Abstract #7012: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated myeloid malignancies

Date & Time: Friday, June 4, 2021 at 9:00 a.m. EDT
Poster Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C.D. DiNardo
Servier will be hosting five continuing medical educational programs at ASCO (Free ASCO Whitepaper) focusing on hematology and solid tumors including:

Hematology

"The AML ‘Hot Seat’: Challenging the Experts on How They Treat and Individualize Care with Novel Therapies," sponsored with Physicians’ Education Resource, June 4, 2021
"Clinical Consults on Modern AML Therapy: Where Precision Care Meets Potent Therapeutics," sponsored with PeerView Oncology, June 4, 2021
"Exploring a Continually Expanding AML Therapeutic Armamentarium: Expert Guidance to Optimize Outcomes," sponsored with National Comprehensive Cancer Network, June 4, 2021
Solid Tumors

"How Evolving Genomics and Molecular Testing are Moving the Treatment of Cholangiocarcinoma Forward," sponsored with Physicians’ Education Resource, June 6, 2021
"Taking Action in Advanced Biliary Cancers: Expert Insights on Integrating Newly-Available and Innovative Therapeutics to Deliver Precision-Based Care," sponsored with PeerView Oncology, June 4, 2021
In addition, an encore presentation from ASCO (Free ASCO Whitepaper) for an investigator-initiated trial will be presented at EHA (Free EHA Whitepaper):

Abstract #S136: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1 mutated myeloid malignancies

Date & Time: Friday, June 11, 2021 at 9:00 CEST (3:00 a.m. EDT)
Oral Session: Developments in AML therapy
Presenting Author: C. Lachowiez