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 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported its selection to present a poster at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, which will take place from September 13 to 17, 2024, in Barcelona, Spain (Press release, OncoHost, SEP 10, 2024, View Source [SID1234646481]).

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The abstract, titled "A plasma proteomic based algorithm is associated with prognosis in renal cell carcinoma," highlights the extended application of OncoHost’s PROphet platform beyond non-small cell lung cancer (NSCLC) to renal cell carcinoma (RCC). This research represents a collaboration between OncoHost and Dana-Farber Cancer Institute, a world leader in adult and pediatric cancer treatment and research. The findings will be presented by Dr. Eddy Saad, MD, MSc, a Postdoctoral Research Fellow at Dana-Farber.

"In this work, we demonstrated that OncoHost’s plasma-based proteomic model, initially trained and validated in NSCLC, can also be applied to another tumor type, RCC, to risk stratify patients," said Dr. Eddy Saad, MD, MSc, Postdoctoral Research Fellow at Dana-Farber, and co-author of the abstract. "Moving forward, we aim to further develop and train an RCC-specific model and assess its predictive abilities to guide patient treatment."

The study explored the use of OncoHost’s PROphet platform in a cohort of 201 RCC patients treated with various therapies, including VEGFR tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or a combination of both. The results demonstrated that patients identified as PROphet-POSITIVE had significantly improved overall survival (OS) and progression-free survival (PFS) compared to PROphet-NEGATIVE patients, indicating the platform’s potential to predict clinical outcomes across various cancer types.

Furthermore, the research uncovered distinct subsets of circulating proteins associated with clinical benefit among patients treated with different therapies, suggesting that the proteomic features leveraged by the PROphet platform may have broad predictive value. These findings provide a strong foundation for further exploration of PROphet’s application in other cancer indications and treatment contexts.

"This research marks another important milestone for OncoHost, as it demonstrates the versatility and potential of our PROphet platform across different cancer types. By validating the use of our proteomic model in renal cell carcinoma, we are moving closer to our goal of providing personalized treatment plans that significantly improve patient outcomes," said Ofer Sharon, MD, CEO of OncoHost. "We are honored to partner with Dana-Farber in presenting these findings at ESMO (Free ESMO Whitepaper) 2024 and look forward to further expanding the clinical applications of our technology."

Poster Presentation Details
Title: A plasma proteomic based algorithm is associated with prognosis in renal cell carcinoma
Presentation #: 1707P
Title: A plasma-based proteomic platform for predicting clinical benefit from immune checkpoint inhibitors in multiple cancers.
Presenter: Eddy Saad, MD, MSc, Postdoctoral Research Fellow at Dana-Farber Cancer Institute
Date: Sunday, 15 September 2024

On September 10, 2024 GC Cell, a leading innovator in cell therapy, has officially reported the execution of a landmark ‘Technology Transfer and License Agreement’ with PT Bifarma Adiluhung (Bifarma), a premier stem cell therapy company in Indonesia (Press release, GC Cell, SEP 10, 2024, View Source [SID1234646480]). This strategic partnership, which began in June, solidifies approximately three months later with the signing of the final license agreement.

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Under the terms of the agreement, Bifarma will be granted the exclusive rights to develop, manufacture, and commercialize Immuncell-LC for 15 years.

GC Cell and PT Bifarma Adiluhung sign a licensing agreement for Immuncell-LC to expand access in Indonesia (PRNewsfoto/GC Cell)
GC Cell and PT Bifarma Adiluhung sign a licensing agreement for Immuncell-LC to expand access in Indonesia (PRNewsfoto/GC Cell)
Bifarma is recognized for operating Indonesia’s first GMP-certified cell therapy production facility and possesses a comprehensive sales and marketing infrastructure focused on oncology, specializing in a cold chain distribution network that spans across Indonesia. This infrastructure is expected to maximize the accessibility and commercial success of Immuncell-LC.

James Park, CEO of GC Cell, expressed his enthusiasm about the partnership’s potential, stating, "The initiation of technology transfer concurrent with the signing of the license agreement sets us on a path to introduce Immuncell-LC in Indonesia by next year, leveraging both our expertise and a firm partnership with Bifarma. This milestone is pivotal as we work to introduce Immuncell-LC, South Korea’s first anticancer drug cell therapy, to a global audience, offering new treatment avenues to a broader patient demographic."

The Indonesian pharmaceutical market, the largest in Southeast Asia, is rapidly expanding with an average growth rate exceeding 8% annually, representing a significant opportunity for innovative treatments like Immuncell-LC. The introduction of the product is expected to mark a significant advancement in Indonesia’s cancer treatment landscape, particularly for Hepatocellular Carcinoma (HCC), which affects approximately 23,000 new patients annually in the country.

Dr. Sandy Qlintang, MBiomed., President Director of PT Bifarma Adiluhung said, "We are excited to announce our collaboration in Immuncell-LC with GC Cell, focusing on innovative treatments for hepatocellular carcinoma (HCC) in Indonesia. By combining our expertise, we aim to enhance therapeutic strategies and bring groundbreaking advancements to liver cancer treatment through cutting-edge immune cell therapies. Together, we are committed to make a significant impact in the fight against HCC."

Immuncell-LC, an anti-cancer immune cell therapy, has demonstrated significant efficacy in solid tumors, particularly liver cancer, and has been recognized as an FDA-designated orphan drug. It consists primarily of autologous blood-derived T lymphocytes enhanced to improve cancer cell killing capabilities. The therapy has proven its effectiveness in large-scale Phase 3 clinical trials for early-stage Hepatocellular Carcinoma (HCC) patients, significantly reducing recurrence risk and mortality with a favorable safety profile.

As GC Cell continues to engage with major pharmaceutical entities across emerging markets, the partnership with Bifarma is poised to set a precedent for the introduction of innovative therapies in underserved regions, promising enhanced clinical outcomes and increased accessibility to cutting-edge treatments.

On September 10, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, reported it has been selected for a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Advances in Pancreatic Cancer Research which will be held on September 15-18, 2024, in Boston, Massachusetts (Press release, Purple Biotech, SEP 10, 2024, View Source;id=319393&p=2339869&I=1206939-c7Z3G6f3m8 [SID1234646479]).

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Purple Biotech’s poster titled, "Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer" will be presented during a poster session on Tuesday, September 17 from 6:45-9:00 pm ET.

The Company’s Phase 2 study is evaluating CM24 in combination with Bristol Myers Squibb’s PD-1 inhibitor nivolumab plus standard of care (SoC) chemotherapy in second line pancreatic ductal adenocarcinoma (PDAC) patients compared to SoC chemotherapy alone. Sixty-three patients have been enrolled in the randomized study across 18 centers in the U.S., Spain, and Israel.

Interim data from the Phase 2 study presented in June at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated improvement in overall survival (OS), progression free survival (PFS), objective response rate (ORR) and all other efficacy endpoints in the CM24+nivolumab+Nal-IRI/5FU/LV experimental arm as compared with the SoC control arm. Topline data are expected in the fourth quarter of 2024.

On September 10, 2024 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the acceptance of a late-breaking abstract of the mature data from the ongoing Phase 2 RAMP 201 (ENGOT-ov60/GOG-3052) clinical trial to be presented as an oral presentation at a plenary session at the International Gynecologic Cancer Society (IGCS) Annual Meeting taking place October 16-18, 2024 in Dublin, Ireland (Press release, Verastem, SEP 10, 2024, View Source [SID1234646478]). The presentation will include updated safety and efficacy data from the RAMP 201 trial evaluating the combination of avutometinib, a RAF/MEK clamp, and defactinib, a selective FAK inhibitor, in patients with low-grade serous ovarian cancer (LGSOC), including overall response rate, progression free survival, and duration of response.

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"The robust interim data from the ongoing RAMP 201 clinical trial in LGSOC, announced earlier this year, enabled us to initiate the rolling NDA submission to the FDA," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We look forward to the oral presentation at IGCS of the mature RAMP 201 data and engaging with experts in ovarian cancer as part of the international gynecologic community. We also remain on track to finalize our clinical module and complete our NDA submission in the fourth quarter of this year."

About the Avutometinib and Defactinib Combination

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. In contrast to currently available MEK-only inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other MEK-only inhibitors.

Verastem Oncology is currently conducting clinical trials with avutometinib in RAS/MAPK driven tumors as part of its Raf And Mek Program or RAMP. RAMP 301 (NCT06072781) is an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib, a selective FAK inhibitor, versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC). RAMP 201 (NCT04625270) is a Phase 2 registration-directed trial of avutometinib in combination with defactinib in patients with recurrent LGSOC and enrollment has been completed for the entire RAMP 201 trial, including regimen selection and expansion of the go forward regimen.

Verastem has initiated a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the investigational combination of avutometinib and defactinib in adults with recurrent LGSOC and expects to complete its NDA submission in the second half of 2024 with a potential FDA decision in the first half of 2025. The FDA granted Breakthrough Therapy Designation of the investigational combination of avutometinib and defactinib for the treatment of all patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC.

Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) in combination with avutometinib and defactinib and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 (NCT05074810) and RAMP 204 (NCT05375994) trials, respectively. The RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer, is supported by the PanCAN Therapeutic Accelerator Award. FDA granted Orphan Drug Designation to avutometinib and defactinib combination for the treatment of pancreatic cancer.