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Adaptimmune Announces Completion of Strategic Combination with TCR2 Therapeutics Creating a Preeminent Solid Tumor Cell Therapy Company

On June 1, 2023 Adaptimmune Therapeutics plc (NASDAQ: ADAP) reported completion of an all-stock transaction in which Adaptimmune has combined with TCR² Therapeutics Inc. (NASDAQ: TCRR) to create a preeminent T-cell therapy company to treat solid tumors (Press release, Adaptimmune, JUN 1, 2023, View Source [SID1234632358]).

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Adaptimmune’s lead clinical franchises utilize engineered T-cell therapies targeting MAGE-A4 and mesothelin, which are expressed on a broad range of solid tumors. Use of these cell therapies is supported by compelling clinical data including results in late-stage synovial sarcoma which will form the basis of the Company’s first BLA submission to complete in mid-2023. The Company has access to an enhanced "next-gen toolbox" and an extended preclinical pipeline with development initially focused on PRAME and CD70.

Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "We are delighted to welcome our new colleagues to Adaptimmune. Together, we will advance our industry leading pipeline making cell therapy a mainstream option for people with cancer. This starts with gaining approval for the first engineered T-cell therapy for a solid tumor – afami-cel for the treatment of synovial sarcoma – and progressing our Phase 2 trials for patients with ovarian cancer with both ADP-A2M4CD8 and gavo-cel."

Significant Solid Tumor Opportunity

Solid tumors represent approximately 90% of all cancers. The combined company’s clinical programs targeting MAGE-A4 or mesothelin can address multiple solid tumor indications with the potential to treat ~300,000 patients per year.
The preclinical pipeline, including PRAME and CD70, could expand the addressable population to more than 500,000 patients per year.
The Company plans to complete submission of its first BLA for afami-cel for the treatment of synovial sarcoma in mid-2023. Data will be presented from the pivotal trial, SPEARHEAD-1, at ASCO (Free ASCO Whitepaper) demonstrating that 70% of patients with late-stage synovial sarcoma who respond to afami-cel are alive 2-years post-treatment. Link here for press release.
The Company has a deep pipeline with multiple late-stage products and will evaluate development priorities based on emerging data as outlined in the figure below:
Cannot view this image? Visit: View Source

Clinical development decisions driven by data catalysts

Overview of strategic combination
The strategic combination was consummated on June 1, 2023. Adaptimmune shareholders own approximately 75% of the combined company and prior TCR2 stockholders own approximately 25% of the combined company.

The combined company will continue to trade on the Nasdaq Stock Market under the symbol "[ADAP]". The combined company comprises a team of leading cell therapy experts led by Adrian Rawcliffe, the CEO of Adaptimmune. The Board of Directors is composed of three members from TCR2 and six continuing from Adaptimmune: David Mott (Chair); Andrew Allen, MD, PhD; Lawrence Alleva; Ali Behbahani, MD; John Furey; Priti Hegde, PhD, Kristen Hege, MD (as of November 1, 2023), Garry Menzel, PhD, Adrian Rawcliffe, Elliot Sigal, MD, PhD.

Advisors
Cowen and Company LLC is serving as financial advisor to Adaptimmune and Ropes & Gray LLP is serving as legal counsel to Adaptimmune. Piper Sandler is serving as financial advisor to TCR2 and Goodwin Procter LLP is serving as legal counsel to TCR2.

Webcast Information
The Company will host a live webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) Friday, June 2, 2023. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)-319-4610 (US or Canada) or +1 (416)-915-3239 (International and additional options available HERE). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

Lonza to Acquire Synaffix and Strengthen Antibody-Drug Conjugates Offering

On June 1, 2023 Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, reported it has acquired Synaffix B.V. (Synaffix), a biotechnology company focused on commercializing its clinical-stage technology platform for the development of ADCs (Press release, Synaffix, JUN 1, 2023, View Source [SID1234632357]). Synaffix revenues and margins will be recognized within the Lonza business from the date of acquisition.

While ADCs offer widespread and targeted treatment potential against cancer, they present a range of complex development and manufacturing challenges. Supported by a team of scientific experts, the Synaffix technology platform, which includes payload and site-specific linker technologies, will enhance and extend Lonza’s integrated ADC services, including its early-phase offering. The award-winning Synaffix ADC technology platform comprises proprietary GlycoConnect, HydraSpace and toxSYN technologies that can considerably enhance the efficacy and tolerability of ADCs.

Combining Lonza’s development and manufacturing capabilities with the Synaffix ADC technology platform will provide customers and licensees with a comprehensive service to rapidly discover, develop, scale up and commercialize novel and differentiated ADCs. These enhanced capabilities will streamline the path to clinic and commercialization.

As a Lonza company, Synaffix will continue to operate under the Synaffix name and further expand its operations in Oss (NL) to cater for further innovation and growth.

The acquisition reflects Lonza’s strategy to differentiate through technology and innovation. From its leading bioconjugation offering, to the commercial manufacture of cell and gene therapies and support in producing live biotherapeutics, Lonza’s manufacturing technologies help customers deliver innovative new therapies to patients.

Bird & Bird acted as legal advisor to Lonza. William Blair acted as financial advisor and Goodwin and NautaDutilh acted as legal advisors to Synaffix.

Sensei Biotherapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of SNS-101, a Conditionally Active VISTA-blocking Antibody, for the Treatment of Advanced Solid Tumors

On June 1, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that the first patient has been dosed in its Phase 1/2 clinical trial evaluating SNS-101 for the treatment of advanced solid tumors (Press release, Sensei Biotherapeutics, JUN 1, 2023, View Source [SID1234632356]). SNS-101 is a conditionally active, human monoclonal IgG1 antibody, designed to selectively block the immune checkpoint VISTA in the tumor microenvironment, which acts as a suppressor of T cells by binding the receptor PSGL-1.

"Studying this novel, conditionally active antibody for treating patients with a variety of VISTA-positive solid tumors aligns with our research goals," said James L. Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology at the National Cancer Institute, part of the National Institutes of Health. NCI will be a Phase I site for the trial. "The Center for Cancer Research’s Center for Immuno-Oncology at the NCI was recently established to explore fundamental questions of cancer immunotherapy through rigorous preclinical studies and translate these findings into clinical trials. The goal is developing novel therapies for a spectrum of cancers with high unmet medical needs."

"This milestone is the latest in an exciting journey marked by careful study of VISTA’s role in tumor growth and rigorous experimentation by our research and development team," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We’re excited to bring the promise of Sensei’s approach to VISTA inhibition into the clinical setting, where we believe SNS-101 will be the first drug candidate to effectively test the VISTA axis. We believe clinical validation of SNS-101 and the underlying approach would represent a tremendous advancement for the field and provide a potentially transformative treatment option for patients."

The multi-center Phase 1/2 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of SNS-101 as both monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Preclinical data showing SNS-101’s safety and tolerability profile and linear elimination kinetics support a starting dose of 0.3 mg/kg for the Phase 1 monotherapy dose escalation portion of the trial, substantially higher than other anti-VISTA antibodies. Sensei intends to begin the Phase 1 combination dose escalation portion of the trial, based on emerging clinical data from the monotherapy dose escalation. The Company expects to report topline monotherapy data and initial combination therapy data from Phase 1 in 2024. Once the recommended Phase 2 dose is determined in Phase 1, the Phase 2 cohort expansion portion of the study will begin in selected patient populations. For more information on the clinical trial, visit clinicaltrials.gov, identifier NCT05864144.

Rigel Announces Poster Presentation at the Upcoming 2023 American Society of Clinical Oncology Annual Meeting

On June 1, 2023 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported an upcoming poster presentation highlighting the Company’s IRAK1/4 program at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2-6, 2023, in Chicago, IL, and virtually (Press release, Rigel, JUN 1, 2023, View Source [SID1234632355]).

Rigel continues to advance the open-label, Phase 1b clinical trial of R2891, an investigational, potent, and selective IRAK1/4 inhibitor, in patients with lower-risk myeloid dysplastic syndrome (LR-MDS) who are refractory/resistant to prior therapies. Rigel has completed enrollment of the first cohort of the trial and enrollment of the second cohort is underway.

Poster Presentation Details:

Abstract #: TPS7085
Title: Phase 1b Clinical Study of IRAK 1/4 Inhibition for Low-Risk Myelodysplastic Syndromes Refractory/Resistant to Prior Therapies
Lead Author: Guillermo Garcia-Manero, M.D., Professor, Chief Section MDS, Deputy Chair Translational Medicine, Leukemia, University of Texas MD Anderson Cancer Center
Session Name: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date: June 5, 2023
Presentation Time: 8:00-11:00 AM CDT
Location: Hall A

The conference abstract can be accessed here.

To learn more about Rigel Pharmaceuticals and the Company’s clinical and commercial hematology/oncology portfolio visit booth #20134 during ASCO (Free ASCO Whitepaper).

About R289
R289 is a prodrug of R8351, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias in lower-risk MDS patients.

Replimune to Present at the Jefferies Global Healthcare Conference

On June 1, 2023 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, reported that members from the Replimune management team will present in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 8, 2023 at 1:00 PM ET at the Marriot Marquis in New York NY (Press release, Replimune, JUN 1, 2023, View Source [SID1234632354]).