Instil Bio to Present at the Jefferies Virtual Healthcare Conference

On June 1, 2021 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that management will present a company overview at the Jefferies Virtual Healthcare Conference on Friday, June 4, 2021 at 9:30 a.m. ET (Press release, Instil Bio, JUN 1, 2021, View Source [SID1234583998]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation may be accessed at: View Source or by visiting the News & Events section of the Instil Bio website at www.instilbio.com. An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

Kiniksa Pharmaceuticals to Present at Goldman Sachs 42nd Annual Global Healthcare Conference

On June 1, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will present at the Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 at 9:40 a.m. Eastern Time (Press release, Kiniksa Pharmaceuticals, JUN 1, 2021, View Source [SID1234583398]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will be available on Kiniksa’s website for 14 days following the conference.

Immutep enters into a New Collaboration with Merck KGaA, Darmstadt, Germany for LAG-3 Therapy, Efti

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

CBMG Holdings Announces Data from Two CAR-T Clinical Studies Selected for Podium Presentations at ASCO Annual Meeting

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

Ajax Therapeutics Raises $40 Million Financing To Develop Novel Small Molecules Targeting Cytokine Signaling Pathways for Hematologic Malignancies

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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."