On October 30, 2023 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis, and inflammation, reported that the company has initiated the Phase 1/2 clinical trial evaluating the safety, tolerability, and antitumor activity of BBT-207 in non-small cell lung cancer (NSCLC) patients with EGFR mutations (Press release, Bridge Biotherapeutics, OCT 30, 2023, View Source [SID1234636463]).

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BBT-207, a novel epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit the signaling pathway of EGFR with C797S mutations, which arises due to osimertinib (Tagrisso)-resistant mutations in NSCLC. The mutation results in a cysteine to serine change on amino acid 797 within the kinase domain sequence of the EGFR. Preclinically BBT-207 has shown activity against treatment-emergent complex EGFR mutations containing T790M and/or C797S as well as drug- naïve mutants providing a possibility to overcome resistance to prior TKIs.

The Phase 1/2 study (NCT05920135), an open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of BBT-207 in patients with NSCLC who have progressed following the use of at least one third-generation EGFR TKI, consists of three parts: dose escalation (Part 1), recommended phase 2 dose selection (Part 2), and dose expansion (Part 3). The study is expected to enroll approximately 92 patient participants who have advanced stage and refractory NSCLC with an activating EGFR mutation, documented partial response, complete response, or durable stable disease after the treatment of an EGFR TKI, and previous treatment with all standard therapeutic options and at least one third-generation EGFR TKI, including Osimertinib and Lazertinib.

The Phase 1a dose escalation cohort will determine the Recommended Dose Range (RDR), based on the totality of the data including toxicity/tolerability, efficacy, pharmacokinetic (PK), and pharmacodynamic (PD). During the Phase 1b RP2D selection stage, the safety monitoring committee will determine the Recommended Phase 2 Dose (RP2D) based on the totality of the data including overall safety, PK, PD, and preliminary antitumor activity including the percentage of patients with partial response (PR) or complete response (CR) based on RECIST Version 1.1. and duration of response (DOR). Finally, the Phase 2 dose expansion cohort will include assessments of preliminary anti-tumor activity utilizing the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. In addition, detailed mutation profiles collected through liquid and tumor biopsy procedures will be analyzed after the study.

"We are highly encouraged to be able to initiate the first-in-patient study of BBT-207, which is expected to address unmet medical needs of advanced NSCLC patients with C797S mutations across the globe," said James Lee, CEO of Bridge Biotherapeutics.

Additional information about the clinical trial may be found at clinicaltrials.gov/study/NCT05920135.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. Lung cancer is classified into two main groups: non-small cell lung cancers (NSCLC) and small cell lung cancers (SCLC), where NSCLC accounts for approximately 85% of all lung cancer diagnoses. In 2019, there were a combined 0.79 million diagnosed cases of NSCLC in men and women, aged 18 years and older, across the US, France, Germany, Italy, Spain, the UK, Japan, and urban China. The incidence of NSCLC is expected to increase at an annual growth rate (AGR) of 3.01% from 2019 to 2029, reaching 1.03 million cases in 2029[1].

In September 2023, Bridge Biotherapeutics announced the discontinuation of the development of BBT-176, another fourth generation EGFR TKI at the Phase 1a stage, dose escalation part. The company will remain committed to the development of a fourth generation EGFR TKI, while seeking to concentrate its capacity and financial resources on BBT-207.

STUDY TITLE: First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment with EGFR TKI
STUDY DESIGN: An open-label, Phase 1/2 study evaluating safety, tolerability, PK, PD, and preliminary antitumor activity of BBT-207 in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI. The study will consist of 3 parts; dose escalation, recommended phase 2 dose selection, and dose expansion phases
TEST PRODUCT: Oral administration of BBT-207 throughout a 21-day cycle for each phase
STUDY OBJECTIVES: To evaluate the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207 in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI

On October 30, 2023 Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui Pharma"), a global pharmaceutical company focused on scientific and technological innovation, reported a licensing agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, for its next-generation potent and selective PARP1 (poly (ADP-ribose) polymerase 1) inhibitor, HRS-1167 (Press release, Hengrui Pharmaceuticals, OCT 30, 2023, View Source [SID1234636462]). This is Hengrui’s first strategic collaboration with a global pharmaceutical company. The agreement includes an option to an exclusive license for its innovative Claudin-18.2 antibody drug conjugate (ADC) SHR-A1904.

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"Given the high unmet need in oncology, we are excited to work closely with Merck KGaA, Darmstadt, Germany, to bring Hengrui’s innovations to cancer patients worldwide," said Frank Jiang, board member and Chief Strategy Officer of Hengrui Pharma. "Partnering with Merck KGaA, Darmstadt, Germany, on our PARP franchise is an important milestone on Hengrui’s globalization journey. We look forward to advancing our molecules rapidly through development and reaching patients in need."

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany, will provide Hengrui Pharma with an upfront payment of €160 million. Hengrui Pharma will receive payments for technology transfer as well as an option exercise for the Claudin-18.2 ADC for up to €90 million. Upon the achievement of certain development, regulatory and commercial milestones, Hengrui is eligible to receive royalty payments on net sales of such products by Merck KGaA, Darmstadt, Germany. Potential payments may total up to €1.4 billion with up to double-digit royalty payments.

"This partnership with Hengrui fully aligns with both our external innovation ambition and our oncology research and development strategy by diversifying our robust internal pipeline in our focus areas of DNA damage response inhibition and antibody-drug conjugates," said Danny Bar-Zohar, Global Head of Research & Development and Chief Medical Officer for the Healthcare business of Merck KGaA, Darmstadt, Germany. "The synergies of these assets with our portfolio offer broad potential for development and the opportunity to advance more therapeutic options for patients with difficult-to-treat cancers. We look forward to leveraging the significant expertise of Hengrui and our strong collaboration ahead."

Merck KGaA, Darmstadt, Germany, will receive exclusive rights to develop, manufacture and commercialize HRS-1167 worldwide, outside of mainland China, an exclusive option to develop, manufacture and commercialize SHR-A1904 worldwide, outside of mainland China, and an option to co-promote HRS-1167 and SHR-A1904 in mainland China.

About HRS-1167 and SHR-A1904

HRS-1167 is a selective, highly active and orally available PARP1 small molecule inhibitor internally developed by Hengrui with intellectual property rights, which belongs to the second generation of PARP inhibitors. Poly (ADP-ribose) polymerase (PARP) is key in DNA repair pathways. Compared to first-generation PARP inhibitors, HRS-1167 has higher selectivity and affinity for PARP1 and induces DNA trapping. HRS-1167 is currently in early clinical development (Phase 1) and has the potential to be used as a monotherapy and as part of a combination therapy for treating a wider range of patients.

SHR-A1904 is an antibody drug conjugate (ADC) targeting Claudin 18.2, internally developed by Hengrui with intellectual property rights. It binds to the target antigen on the surface of tumor cells, allowing the drug to be endocytosed by cells and releasing a small-molecule toxin to kill tumor cells. The product is currently in clinical Phase 1 trials in China, U.S. and Australia. Currently, no Claudin 18.2 targeting ADC product has received marketing authorization.

On October 30, 2023 ImmPACT Bio USA, Inc. ("ImmPACT BIO"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate in the 2023 Truist Securities BioPharma Symposium, to be held from November 8-9, 2023 in New York, NY (Press release, ImmPACT-Bio, OCT 30, 2023, View Source [SID1234636461]).

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Sumant Ramachandra, M.D., Ph.D., ImmPACT Bio’s chief executive officer, will participate in a panel discussion entitled "Considerations for an Oncology Company’s Autoimmune Side Hustle," on Thursday, November 9, 2023 at 11:40 AM ET. ImmPACT Bio management will also participate in one-on-one investor meetings.

To request a one-on-one meeting at the conference, please contact your Truist Securities representative.

On October 30, 2023 Ahead of the 38th annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), Ultivue reported the launch of OmniVUE, a unique portfolio of fully customizable biomarker panels for multiplex immunofluorescence analysis of the tumor immune microenvironment (Press release, Ultivue, OCT 30, 2023, View Source [SID1234636460]). Researchers can now select any combination of up to 8 biomarkers from Ultivue’s validated biomarker core library and design OmniVUE panels tailored to their specific biological questions. Pre-optimized ready-to-use kits with OmniVUE panels will be delivered within four weeks of request, with no additional development costs.

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Ultivue’s biomarker library currently includes 24 validated immune biomarkers with additional biomarkers of clinical relevance being added continually. OmniVUE panels leverage Ultivue’s proprietary InSituPlex platform technology to enable a fast and simple assay workflow with high-quality, reliable, and quantitatively verified assay performance. As such, researchers can generate rapid and reliable insights through their tailored OmniVUE panels to verify their clinical strategies during drug development or clinical trials.

"We are excited to introduce OmniVUE as a powerful spatial proteomics solution to the immuno-oncology research community. OmniVUE enables researchers to accelerate their development timelines through fast and agile hypothesis verification," said Gourab Chatterjee, Ph.D., Associate Director of Product Management and Research and Development at Ultivue. "Scientists can now select and test for biomarkers most relevant to their research, at no extra development cost—within weeks."

In addition, Ultivue announced that during this year’s SITC (Free SITC Whitepaper) meeting (to be held in San Diego on November 1-5) its researchers will present 3 posters, including:

Rapid and efficient removal of hematoxylin & eosin (H&E) staining for fluorescence-based multiplex tissue analysis
A simple strategy for H&E stain removal enabled multiplex immunofluorescence analysis of additional biomarkers in archived FFPE tissue sections.
Primary Author: Kevin Hwang, PhD
Abstract Number: 88

Evaluation of precision and robustness of a flexible multiplex immunofluorescence workflow for immune profiling analysis
Changing the biomarker panel composition did not hinder the reproducibility of individual markers, demonstrating the robustness of InSituPlex to enable the flexibility needed in translational research.
Primary Author: Yvette Cajigas
Abstract Number: 4099

UltiStacker: Easy to use multimodal image co-registration with sub-cellular accuracy
UltiStacker achieved 1 µm co-registration of whole slide images for accurate phenotyping of cells across multiple rounds of fluorescent and brightfield scanning and enabled visualization and analysis of cells in multiple modalities.
Primary Author: Douglas Wood, PhD
Abstract Number: 1313
Ultivue’s President and CEO Rob Carson added, "OmniVUE is the latest innovation in our growing portfolio of kitted assays and services aimed at providing solutions that advance precision oncology. This technology sets a new standard in performance, flexibility and speed and we look forward to introducing OmniVUE at this year’s SITC (Free SITC Whitepaper) meeting and to presenting newly generated evidence supporting our platforms."

To learn more about OmniVUE, you can reach out to the Ultivue team through the media contacts below or register to attend the OmniVUE product launch event at SITC (Free SITC Whitepaper) 2023.

On October 30, 2023 Akeso (9926.HK) announced that the results of a phase Ib clinical trial for PD-1/VEGF bispecific antibody ( ivonecimab AK112/SMT112 ) as first- or second-line therapy for advanced or metastatic immunotherapy naïve non-small-cell lung cancer (NSCLC) were published in the Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer (IASLC) (Press release, Akeso Biopharma, OCT 30, 2023, View Source;or-second-line-therapy-for-advanced-or-metastatic-immunotherapy-naive-non-small-cell-lung-cancer-301971154.html [SID1234636459]). The principal investigator of this study is Prof. Caicun Zhou, MD, PhD, from Shanghai Pulmonary Hospital, affiliated with Tongji University.

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Previously, the clinical results of ivonescimab in combination with chemotherapy for NSCLC were published in the eClinical Medicine (part of The Lancet). The monotherapy results published in JTO represents another significant recognition of the clinical value of ivonescimab.

The phase Ib study, published in JTO, aims to determine the optimal dose, safety, and efficacy of ivonescimab monotherapy as a first- or second-line treatment for advanced NSCLC patients. Early data on ivonescimab in NSCLC was also presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting.

From the data published in JTO, patients with advanced or metastatic NSCLC can benefit from ivonescimab monotherapy regardless of treatment dosage, prior treatment history, and PD-L1 expression. This data was based on a median follow-up of 10.4 months (as of October 5, 2022). Furthermore, updated data from the study (with a median follow-up of 19.3 months) as of June 30, 2023 demonstrates the increased safety and survival benefits of ivonescimab monotherapy.

Currently, following an acceptance of the marketing application with priority review of ivonescimab by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), four registrational phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug, and two international multicenter clinical trials.

About Ivonescimab (PD-1/VEGF bispecific antibody)

Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso and is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic. It combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is currently engaged in multiple Phase III clinical trials worldwide.

In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics ("Summit"). Akeso out-licensed to Summit exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. Ivonescimab is known as AK112 for Akeso’ R&D code at China and Australia, and as SMT112 for Summit’s license territories.