On April 11, 2023 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in T-cell therapy to treat cancer, reported entry into a transition agreement with GSK plc (LSE:GSK) (NYSE:GSK) regarding the return of rights and materials comprised within the PRAME and NY-ESO cell therapy programs (Press release, Adaptimmune, APR 11, 2023, View Source [SID1234629931]).

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"The return of these T-cell programs to Adaptimmune bolsters our pipeline and our leadership position in the field of engineered TCR T-cells for solid tumors," said Dr. Helen Tayton-Martin, Adaptimmune’s Chief Business and Strategy Officer. "As we have outlined in our focus areas for 2023, we are especially eager to continue development of the PRAME asset, as it is a highly expressed and validated target across a broad range of solid tumor cancers and further complements the work we have done to-date with our MAGE-A4 clinical programs. We will continue to evaluate the emerging data for the NY-ESO asset to determine next steps."

Transition Plan

● Adaptimmune and GSK are collaborating to transition materials and data relating to the preclinical PRAME targeted TCR T-cell therapy program to Adaptimmune during 2023.
● Adaptimmune and GSK are targeting transfer of sponsorship for GSK IGNYTE-ESO clinical trial (NCT03967223) and long-term follow-up clinical trial (NCT03391778) during Q3 of 2023. The parties are collaborating to ensure a smooth transition. All other clinical trials within the NY-ESO targeting program are already closed to enrollment and have already been or will soon be completed by GSK.

Per the terms of the Agreement, Adaptimmune will receive an upfront amount plus milestone-based payments totaling £30 million in relation to the transfer of the clinical trials for the NY-ESO targeted programs.

On April 11, 2023 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that following a review of safety data collected to date, the ACCENT clinical trial’s Safety Review Committee has approved dose escalation of AMP945 and recruitment of a third patient cohort (Press release, Amplia Therapeutics, APR 11, 2023, View Source;TE [SID1234629916]).

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The ACCENT trial explores whether addition of Amplia’s FAK inhibitor AMP945 to standard of care chemotherapy of gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients improves patient outcomes in this devastating disease. The first stage of the trial is designed to identify the most suitable dose of AMP945 to combine with gemcitabine/nab-paclitaxel and thus ascending doses of AMP945 are given in combination with the chemotherapy while safety, pharmacokinetics and pharmacodynamics are monitored. Dose escalation of AMP945 will continue until either a doselimiting safety signal is identified or the pharmacodynamic effect of AMP945 reaches a plateau.

The second patient cohort in the ACCENT trial was recruited over one month in February 2023, and drug safety and tolerability was monitored for a minimum of one treatment cycle (28 days). The ACCENT trial’s Safety Review Committee has now examined the available safety, pharmacokinetic and pharmacodynamic data and concluded that dose escalation to a further cohort is warranted.

On April 10, 2023 Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui Pharma"), a global pharmaceutical company, reported that there will be five poster presentations showcased at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Orlando, April 14-19, 2023 (Press release, Hengrui Pharmaceuticals, APR 10, 2023, View Source [SID1234633493]). The plasma stability of an antibody-drug conjugate (ADC) is of crucial importance as it impacts both safety and efficacy. The free payload in plasma contributes to certain adverse events that are commonly seen in marketed ADCs. Hengrui Pharma developed a unique ADC platform with an improved molecular design to increase plasma stability and enhance bystander effect. Better safety and efficacy were observed in both preclinical and clinical studies for multiple ADC assets of Hengrui Pharma. These posters will highlight:

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Superior bystander effect of SHR-A1811, a novel anti-HER2 antibody-drug conjugate (ADC), with optimal drug-antibody ratio (DAR), and favorable safety profiles;
Clinical data of SHR-A1811 in phase 1 study for patients with HER2-expressing/mutated advanced solid tumors;
Clinical data of SHR-A1811 in phase 1/2 study for patients with advanced HER2-mutant non-small cell lung cancer (NSCLC);
An optimized design and well-balanced profile between efficacy and safety of SHR-A1921, a novel TROP-2 ADC; and
Clinical data of SHR-A1921 in phase 1 study for patients with advanced solid tumors.

Details of the presentations are as follows:

Title: SHR-A1811, a novel anti-HER2 ADC with superior bystander effect, optimal DAR and favorable safety profiles

Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1

Session Date and Time: Sunday April 16, 2023 1:30 PM – 5:00 PM

Location: Poster Section 35

Poster Board Number: 23

Abstract Presentation Number: LB031

Title: Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: a global phase 1, multi-center, first-in-human study

Session Title: First-in-human Phase 1 Clinical Trials 2

Session Date and Time: Tuesday April 18, 2023 9:00 AM – 12:30 PM

Location: Poster Section 45

Poster Board Number: 7

Abstract Presentation Number: CT175

Title: Safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811, an antibody-drug conjugate, in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC): a multi-center, open-label, phase 1/2 study

Session Title: Phase 1 Clinical Trials 1

Session Date and Time: Tuesday April 18, 2023 9:00 AM – 12:30 PM

Location: Poster Section 46

Poster Board Number: 17

Abstract Presentation Number: CT204

Title: SHR-A1921, a novel TROP-2 ADC with an optimized design and well-balanced profile between efficacy and safety

Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1

Session Date and Time: Sunday Apr 16, 2023 1:30 PM – 5:00 PM

Location: Poster Section 35

Poster Board Number: 22

Abstract Presentation Number: LB030

Title: A first-in-human (FIH), phase 1 study of SHR-A1921, a TROP-2 targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors

Session Title: First-in-human Phase 1 Clinical Trials 2

Session Date and Time: Tuesday April 18, 2023 9:00 AM – 12:30 PM

Location: Poster Section 45

Poster Board Number: 13

Abstract Presentation Number: CT181

About SHR-A1811

SHR-A1811, a HER2-targeted ADC, features an optimized molecular design to enhance plasma stability and bystander effect. Hengrui Pharma is currently conducting more than 10 clinical studies of SHR-A1811 from phase 1 to phase 3 to evaluate its safety and efficacy as single agent or combination therapy in a wide variety of cancer indications. Breakthrough Therapy Designations were granted to SHR-A1811 by the China National Medical and Products Administration for three indications, which include:

For the treatment of HER2-mutant, advanced NSCLC after platinum-based chemotherapy
For the treatment of HER2-positive, recurrent or metastatic breast cancer
For the treatment of HER2-low, recurrent or metastatic breast cancer

About SHR-A1921
SHR-A1921 consists of an anti-TROP-2 antibody attached to a novel topoisomerase I inhibitor payload via a cleavable linker. This molecular design enhances plasma stability and bystander effect with a well-balanced profile between efficacy and safety. A pivotal phase 3 trial of SHR-A1921 versus docetaxel for the second- or later-line treatment of NSCLC is expected to be initiated in China in 2023.

On April 10, 2023 Aviceda Therapeutics, a clinical-stage biotech company focused on developing next-generation immuno-modulators to treat diseases such as cancer, reported a strategic partnership with the Patrick G Johnston Centre for Cancer Research at Queen’s University Belfast (Queen’s) (Press release, Aviceda Therapeutics, APR 10, 2023, View Source [SID1234629929]). Aviceda’s HALOS (High-Affinity Ligands of Sigelcs) nanotechnology platform, based on an invention from the research team led by Professor Chris Scott, Scientific Co-Founder and Chief Scientific Officer of Aviceda & Interim Dean of Research, Faculty of Medicine, Health, and Life Sciences, at Queen’s, harnesses the power of glycobiology to modulate the innate immune system to develop next-generation breakthrough therapeutics, with a focus on immuno-oncology.

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This revolutionary technology was made possible only through collaborative research on the island of Ireland. The founding of Aviceda Glycotech Ltd, an oncology-focused spin-off company from Aviceda Therapeutics and Queen’s, based in Northern Ireland, highlights US-Ireland translational research collaborations which are a direct legacy of the Good Friday Agreement. This historic agreement brought an end to 30 years of conflict and allowed Belfast to develop the Patrick G Johnston Centre for Cancer Research as an international powerhouse in precision oncology. Aviceda Glycotech looks forward to this collaboration aimed at developing the next generation of cancer checkpoint immune therapeutics in Belfast.

"It is critical that the biotechnology industry and academic institutions work together to foster innovation and accelerate drug development for diseases with significant unmet medical needs, and Queen’s is an ideal partner with a substantial track record in innovation to support us in this effort," said Doctor Mohamed Genead, M.D., Co-Founder & President, and Chief Executive Officer. "We are excited to work with the Queen’s team in realizing our vision of developing next generation glyco-therapeutics together."

As part of the 25th Anniversary of the Belfast Good Friday Agreement (Agreement 25), Dr. Genead, will participate on an expert panel and Professor Scott will chair a session during the Cancer Knows No Borders Agreement 25 Showcase Event at Queen’s to recognize the impact of the Good Friday Agreement on cancer research and cancer care. Professor Mark Lawler, Professor of Digital Health, Chair in Translational Cancer Genomics at Queen’s, Co-Lead of the All Island Cancer Research Institute and organizer of the Cancer Showcase event said, "This Showcase Event during the Agreement 25 Conference will reflect on the legacy and impact of the Good Friday Agreement on cancer research at Queen’s and how it is driving the development of an innovation cluster in Northern Ireland that can attract biotech companies like Aviceda Glycotech to benefit from the talent, infrastructure and precision medicine focus that Northern Ireland has to offer."

"We are excited and honored to be in Belfast on this historic occasion and look forward to our collaboration with Queen’s as we aim to develop new approaches that will hopefully lead one day to the conquering of hard-to-treat cancers, building on a technology that was originally pioneered in Northern Ireland," said Michael Tolentino MD, Co-Founder & Chief Technology Officer of Aviceda.

"This commercial investment is testament to collaboration across the island of Ireland and the US. It shows the potential of Northern Ireland to become an internationally renowned life and health science hub, aligning with Belfast Region City Deal investments in data science and clinical trial provision and the All-Island Cancer Research Institute. These developments are essential cogs in an ecosystem that will drive the discoveries we make in our laboratories into treatments that can alleviate suffering of patients worldwide," said Professor Scott.

On April 10, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) reported that its team of oncology experts will attend the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, with 19 scientific posters and a spotlight presentation to highlight its enhanced oncology portfolio (Press release, Charles River Laboratories, APR 10, 2023, View Source [SID1234629928]). The meeting is taking place from April 14-19, 2023, at the Orange County Convention Center in Orlando, Florida, with Charles River at Booth #943.

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"Cancer is the second leading cause of death worldwide, and patients are relying on the research and development of new therapeutics. AACR (Free AACR Whitepaper) offers our researchers a unique opportunity to learn from leaders in the industry and share critically important knowledge to further innovation."

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Charles River’s team of industry-leading oncology experts have contributed to 84 percent of the cancer therapies approved by the Food and Drug Administration from 2018-2022. Additionally, Charles River has been named as co-inventors on 78 patents, and supported 16 clinical candidates and 11 FDA-approved cell and gene therapies. At the AACR (Free AACR Whitepaper) Annual Meeting, researchers will present recent work utilizing emerging tools and approaches for cancer research.

Navigating Cell Therapy Discovery and Development

Cell therapies continue to be a focus in the field of advanced therapies. During a Spotlight Session, scientific leaders from across disciplines will discuss cell therapy discovery and development, including insights into the discovery journey from materials, research models, and quality assessment, as well as considerations and capabilities to streamline research and mitigate self-inflicted risks.

Tuesday, April 18, 3:00-4:00 p.m., Theater A: Navigating Cell Therapy Discovery and Development, featuring:
Nicholas Ostrout, Senior Advisor Cell & Gene Therapy
Arif Khan, Senior Scientist Lead
Gemma Moiset, Group Leader Advanced Modalities
Steven Bronson, Scientific Product Manager
Utilizing Technology to Fuel Discovery Innovation

Mutation-targeting therapies have become a new paradigm for cancer treatment. In a joint poster presentation, Charles River and Cypre, Inc. will present the use of 3D in vitro tumor panels, that include a hydrogel matrix and fibroblasts to replicate the stromal compartment of the tumor microenvironment to test mutation-targeting therapies. The strategic partnership between Charles River and Cypre provides clients with access to Cypre’s proprietary 3D hydrogel patterning technology – Symphony and VersaGel – to predict therapeutic efficacy of targeted and immuno-oncology agents in a more representative and high throughput model of the tumor microenvironment. The models incorporate patient-derived xenografts (PDX) from Charles River’s Cancer Model Database, enabling a seamless transition to in vivo studies following indication and model selection.

Monday, April 17, 9:00 a.m.-12:30 p.m., Section 20: KRAS, BRAF, BRCA1 and EGFR Mutation-Specific Panels using Hydrogel-Based 3D in vitro Tumor Models
Identifying how to optimally combine immunotherapies with other available anti-cancer therapies is a major challenge in oncology. In February 2021, Charles River announced a strategic partnership with Kibur Medical to offer exclusive access to its implantable microdevice (IMD) for in vivo preclinical oncology studies. Now, in a joint poster presentation, Charles River and Kibur Medical highlight the use of an implantable microdevice that allows cassette microdosing and measurement of intratumor drug responses and anti-tumor immunity for up to 20 different agents in parallel.

Tuesday, April 18, 1:30-5:00 p.m., Section 21: Transcriptomic Analysis in a Renal Cancer PDX Model Enables the Deconvolution of Additive and Synergistic Effects of the Six Different Standard of Care Compounds with Anti-PD-1 Treatment
Lastly, the increased use of machine learning (ML) in drug discovery has allowed medicinal chemists to operate at a vastly different scale than traditional approaches by enabling them to search much larger universes of potential compounds. In 2022, Charles River and Valo Health launched LogicaTM, an artificial intelligence (AI) powered solution that directly translates clients’ biological insights into optimized preclinical assets. Experts from the Logica team will be available at the Charles River Booth #943 to discuss the unique risk-sharing model of Logica that ties costs to value generation points.

A full schedule of Charles River’s activities during AACR (Free AACR Whitepaper) 2023, as well was reprints of each poster, are available online. Charles River experts will be available for meetings to discuss how an integrated approach can support drug discovery and development programs from hit identification to IND (Investigational New Drug) filing.

Throughout the conference, Charles River will be providing live updates on the Eureka Blog, including reviews of scientific sessions and input on the research being presented.

Approved Quotes

"Cancer is the second leading cause of death worldwide, and patients are relying on the research and development of new therapeutics. AACR (Free AACR Whitepaper) offers our researchers a unique opportunity to learn from leaders in the industry and share critically important knowledge to further innovation." – Aidan Synnott, Corporate Vice President, Global Discovery Services, Charles River
"Logica integrates world-leading laboratory capabilities with best-in-class AI-driven molecular design. The offering is packaged in a unique, success-based pricing model that produces a development candidate that is ~50% less expensive than alternatives. Given the breadth of Logica’s capabilities, we are confident that the molecules we deliver will be considerably better than what can be provided by other offerings. It’s a win-win." –Guido Lanza, Senior Vice President, and Logica General Manager, Valo Health

"Kibur Medical provides drug developers with the unique ability to simultaneously profile in situ anti-tumor activity of up to 20 unique agents or combinations independently. This deep molecular insight into in vivo tumor-drug pharmacodynamics significantly accelerates and de-risks oncology drug development and precision medicine." – Professor Oliver Jonas, co-Founder, Kibur Medical Inc.

"Cypre 3D Tumor Panels offer PDX IC50 data in 30 days. Leveraging the Cypre hydrogel patterning technology, targeted- and immuno-therapeutic leads of various modalities (small molecules, antibodies, and cell therapy) are screened against proprietary 3D in vitro models of the tumor microenvironment using high content image analysis. We look forward to serving our clients with our pre-configured Cypre Tumor Panel Catalog." – Kolin C. Hribar, PhD, CEO & Founder, Cypre Inc.