On September 10, 2024 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, reported a poster presentation of PK/PD modeling data for uliledlimab at the International Association for the Study of Lung Disease (IASLD)’s 2024 World Conference on Lung Cancer (WCLC 2024) held September 7-10, 2024 in San Diego, CA (Press release, I-Mab Biopharma, SEP 10, 2024, View Source [SID1234646482]).

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Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Blocking CD73 allows anti-tumor immunity to proceed without the presence of an adenosine-induced "immunological fog". The WCLC 2024 presentation includes data from uliledlimab PK/PD analyses from three Phase 1 studies including patients with treatment naïve metastatic non-small cell lung cancer (mNSCLC).

"The PK/PD analysis presented at WCLC underscores our view that uliledlimab has the potential to be a differentiated, best-in-class, CD73 inhibitor. The data support our dose selection work and upcoming combination studies, with a study of uliledlimab plus pembrolizumab plus chemotherapy expected to begin in the first half of 2025," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "We are particularly encouraged by the E-R analysis, which showed a positive relationship between uliledlimab exposure and the probability of an overall response in patients with NSCLC, as well as positive target engagement data and dose proportional PK results. These data, plus a previously presented favorable safety profile and clinical efficacy, fortify our view that uliledlimab has the potential to meaningfully improve the care of patients with mNSCLC."

Poster Title: Integrated PK/PD Modeling for Uliledlimab, an Anti-CD73 Monoclonal
Antibody, in Non-Small Cell Lung Cancer Patients (Poster #2979)

Data are based on analysis of three Phase 1 studies conducted in China evaluating uliledlimab, as a monotherapy and in combination studies with the checkpoint inhibitors, toripalimab or atezolizumab, in patients with advanced cancers, including mNSCLC.

Key Findings Include:

Most of the simulated population (95%) could achieve the target threshold with 30 mg/kg of uliledlimab
Integrated PK/PD modeling and pharmacometrics analyses indicate there is a positive relationship between the probability of overall response and uliledlimab trough concentration in NSCLC patients
CD73 receptor occupancy (RO) in peripheral B cells achieved 90% or above and maintained at high levels until the end of treatment
The 30 mg/kg dose with a single boost dose on C1D8 provided uliledlimab concentrations that achieved the target concentration of 80 μg/mL immediately after the first dose and maintained this threshold afterward
A Ctrough target threshold of 80 μg/mL may be clinically meaningful, associated with PFS benefit and is achievable by a 30 mg/kg initial dose followed by a booster dose on Cycle 1, Day 8 (C1D8)
A full copy of the poster is available on the I-Mab website, on the "Innovation, Publications & Presentations" tab.

On September 10, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that it has received positive feedback from its Pre-IND meeting with the U.S. Food and Drug Administration (FDA), which is a step forward to opening an IND to conduct a Phase 1/2 study of its personalized off-the-shelf immunotherapy, Bria-PROS+, in advanced prostate cancer (Press release, BriaCell Therapeutics, SEP 10, 2024, View Source [SID1234646467]).

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"We were truly impressed by the FDA team of experts’ keen interest in Bria-PROS+ as a potential novel personalized approach for advanced prostate cancer," stated Dr. William V. Williams, BriaCell’s President and CEO. "Despite numerous approved drugs, prostate cancer remains the second-leading cause of cancer death in American men. We view the FDA’s positive feedback as a major step forward in the clinical development of our Bria-PROS+ and in our efforts to bring hope to patients and families suffering from this deadly disease."

As a result of the Pre-IND meeting, FDA waived the animal toxicology and animal pharmacokinetic (PK) studies requirement for opening the IND, greatly simplifying the development pathway for Bria-PROS+. Other areas of discussion included BriaCell’s plan to initiate the Phase 1/2 study pending completion of standard manufacturing and testing requirements. These interactions also inform the further development of the proprietary Bria-OTS+ platform as the company pursues the development of Bria-BRES+, Bria-LUNG+ and Bria-MEL+, for breast cancer, lung cancer and melanoma, respectively.

BriaCell is currently evaluating its personalized immunotherapy Bria-BRES in a phase 1/2a study in metastatic breast cancer (ClinicalTrials.gov NCT06471673).

On September 10, 2024 Qilu Pharmaceutical reported that during the World Conference on Lung Cancer (WCLC) held from September 7-10, 2024, in San Diego, California, updated findings from the Phase II clinical trial (INTELLECT study) were presented (Press release, Qilu Pharmaceutical, SEP 10, 2024, View Source [SID1234646483]). The study assessed the efficacy and safety of Qilu Pharmaceutical’s iruplinalkib tablets (Qixinke) in treating patients with anaplastic lymphoma kinase (ALK)-positive crizotinib-resistant non-small-cell lung cancer (NSCLC). The highlights were showcased in a poster presentation.

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Iruplinalkib, a next-generation ALK/ROS1 kinase inhibitor formulated by Qilu Pharmaceutical, was approved by NMPA in June 2023 for the treatment of patients with ALK-positive locally advanced or metastatic NSCLC who had disease progression after treatment with crizotinib or who were intolerable to crizotinib. In January of this year, iruplinalkib was approved for the first-line treatment of patients with ALK-positive NSCLC.

The trial is led by principal investigator, Prof. Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. The results of the study were published in BMC Medicine in 2023. Updated data with an extended two-year follow-up were presented during the WCLC.

A total of 146 subjects were enrolled in this study. As of December 29, 2023, the median follow-up time was 42.41 months, revealing a median overall survival (OS) of 41.79 months. The investigator-evaluated objective response rate (ORR) was 63.7%, while the disease control rate (DCR) reached 94.5%. Additionally, the median duration of response (DoR) and median progression-free survival (PFS) were reported to be 14.06 months and 14.55 months, respectively.

According to the RECIST v1.1 evaluation criteria, the ORR and DCR in the subgroup with CNS metastasis at baseline (90 patients) were 55.6% and 93.3%, respectively. Both the median DoR and median PFS were 17.25 months, while the median OS stood at 43.01 months.

Based on RANO-BM criteria, intracranial complete response (CR) was achieved in 17 (18.9%) of the 90 patients with CNS metastasis at baseline. Among the 42 subjects with measurable intracranial lesions at baseline, the intracranial objective response rate (iORR) was 64.3% while the intracranial disease control rate (iDCR) reached 95.2%.

The safety profile was characterized by a 93.8% (137 cases) incidence of treatment-related adverse events (TRAEs), with 30.8% (45 cases) being grade 3 or 4. The most common TRAEs included elevated aspartate aminotransferase (45.2%), hypercholesterolemia (37.7%), and increased alanine aminotransferase (37.0%). No new safety signals were identified.

Long-term follow-up results from the INTELLECT study demonstrated that iruplinalkib provided an OS benefit with no new safety signal in patients with ALK-positive crizotinib-resistant advanced NSCLC.

On September 10, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported it has successfully delivered a second development candidate to Biogen and earned an $8 million milestone payment (Press release, C4 Therapeutics, SEP 10, 2024, View Source [SID1234646468]). This marks the final development candidate under this strategic collaboration.

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"We are thrilled to deliver a highly catalytic, brain penetrant orally bioavailable BiDAC degrader development candidate to Biogen in their pursuit of discovering, developing and delivering innovative therapies that improve the lives of patients," said Andrew Hirsch, president and chief executive officer. "It is rare that discovery collaborations deliver one, much less two, development candidates to the partner. This result is a testament to the dedication of the Biogen and C4T teams and the productivity of our TORPEDO platform, which has demonstrated its potential to design innovative degraders against a broad range of target classes. Since our founding in 2015, we have discovered and advanced four development candidates for our clinical pipeline and delivered two development candidates to Biogen, an impressive feat for a company of our size. We are proud to continue advancing the exciting field of targeted protein degradation and bring new medicines to patients."

Under the terms of the strategic collaboration established in 2018, C4T provided expertise and research services in targeted protein degradation and Biogen provided scientific and drug development capabilities. Biogen is responsible for all future clinical development and commercialization for development candidates delivered under the collaboration. Previously, C4T earned an $8 million payment in April 2024 after Biogen accepted delivery of a first development candidate in an undisclosed indication as part of this collaboration.

On September 10, 2024 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, reported a new milestone in the global introduction of the liquid biopsy test MSK-ACCESS powered with SOPHiA DDM, first announced in October 2023 (Press release, AstraZeneca, SEP 10, 2024, View Source [SID1234646484]). Under a definitive partnership agreement with AstraZeneca (LSE/STO/Nasdaq: AZN), SOPHiA GENETICS will accelerate the deployment of MSK-ACCESS powered with SOPHiA DDM to 20 locations worldwide over the next 12 months.

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Liquid biopsy testing offers a complementary alternative to solid tumor testing, which is not always feasible due to insufficient tissue, low quality tissue, or the invasiveness of the procedure. The testing works by isolating cell-free DNA (cfDNA) from blood plasma to uncover circulating tumor DNA (ctDNA). Isolating these DNA samples from a simple blood draw is less invasive than a traditional biopsy, helping to simplify patient monitoring and more quickly guide clinical decision-making.

MSK-ACCESS powered with SOPHiA DDM is a decentralized version of the highly validated liquid biopsy test developed by Memorial Sloan Kettering Cancer Center (MSK), a top cancer treatment and research institution. The solution combines the sophisticated analytics, state-of-the-art algorithms, and decentralized, cloud-based offerings of the SOPHiA DDM Platform, with the scientific and clinical expertise of MSK in cancer genomics to provide a best-in-class liquid biopsy solution.

By increasing availability of MSK-ACCESS powered with SOPHiA DDM, SOPHiA GENETICS and AstraZeneca aim to understand how liquid biopsy testing can complement solid tissue testing, and in some cases, provide greater benefit for labs and patients. This understanding will help support the case for broad global implementation. Additionally, through a dedicated real-world evidence study, researchers will be able to evaluate the operational benefits of liquid biopsy testing, including the speed of results and the ability of users to consistently achieve high-quality data in a variety of laboratory settings.

"Our collaboration with AstraZeneca has the potential to dramatically accelerate global access to liquid biopsy testing, especially in underserved populations, which in turn could contribute to reshaping diagnostics, treatment, and monitoring of cancer cases throughout the world. Their support is instrumental to making this improved access a reality," said Philippe Menu, M.D., Ph.D, Chief Medical and Chief Product Officer, SOPHiA GENETICS. "Additionally, the breadth and depth of real-world data that we will generate through the implementation of this decentralized liquid biopsy testing platform on a global scale will be unprecedented, providing novel avenues to accelerating cancer research."

Since launching MSK-ACCESS powered with SOPHiA DDM in April 2024, a first wave of 14 leading healthcare institutions worldwide have signed on to piloting and adopting the application. These institutions include renowned cancer centers and reference laboratories such as:

BioReference and Tennessee Oncology in the U.S.; Oncohelix in Canada; Dasa in Brazil; Universitätsklinikum Heidelberg in Germany; Stavanger University Hospital in Norway; IUCT Oncopole in France; Synnovis and South West Genomic Laboratory Hub, operating out of North Bristol NHS Trust in the U.K.; Sofiva Genomics in Taiwan; Syndicate Bio in Nigeria; A.O.U. Senese in Italy; and Karkinos Healthcare and Strand Life Sciences in India.

The partnership with AstraZeneca will further catalyze the adoption of MSK-ACCESS powered with SOPHiA DDM.

As more hospitals and labs go into routine, SOPHiA GENETICS and AstraZeneca, in collaboration with leading cancer institutes within the SOPHiA GENETICS community, will generate a vast set of real-world data from patients around the world with a variety of cancers. This data set has the potential to generate unique insights towards advancing cancer research and drug development.

"We are deeply committed to bringing liquid biopsy expertise to labs and institutions throughout the globe at an expedited pace, and are confident this rollout will further support access to testing and aid in providing data-driven treatment options to patients around the world," said Kristina Rodnikova, Head of Global Oncology Diagnostics, AstraZeneca.

The deployment of MSK-ACCESS powered with SOPHiA DDM was announced in October 2023 as part of a collaboration between SOPHiA GENETICS, AstraZeneca and MSK. Together, the three companies are working to combat global health inequities and advance cancer research.