On September 19, 2023 Bio-Techne Corporation (NASDAQ: TECH) and Cizzle Biotechnology Holdings plc, the UK-based diagnostics developer, reported recent progress evaluating specific monoclonal antibodies for Cizzle’s CIZ1B cancer biomarker (Press release, Bio-Techne, SEP 19, 2023, View Source [SID1234635216]). Cizzle has successfully completed an evaluation programme aimed at assessing the feasibility of using the Simple Western platform from ProteinSimple (a Bio-Techne Brand) for high throughput detection of the CIZ1B cancer biomarker which may be useful in the detection of early-stage lung cancer.

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The global lung cancer screening market is projected to grow from US$2.80 billion in 2021 to US$4.85 billion in 2028, representing a CAGR of 8.1% during the forecast period.* Furthermore, in 2021 the United States Preventive Services Task Force (USPSTF) updated its lung cancer screening guidelines** for annual screening with low-dose computed tomography (LDCT), reducing the lower limit of the screening age from 55 to 50 years and the minimum smoking history from 30 to 20 pack-years. Under the new guidelines, 14.5 million Americans may be eligible for annual screening with LDCT and other early-lung cancer screening tests which is estimated could save an additional 10,000–20,000 lives each year.

Allan Syms, Executive Chairman of Cizzle, commented: "We are very pleased to be working with Bio-Techne, a global leader in bioscience solutions. We believe the Simple Western platform is an excellent fit for use in our development of a high throughput assay for the detection of the Company’s CIZ1B biomarker. Cizzle has shown that CIZ1B is highly associated with lung cancer at its earliest stage when surgical or other therapeutic intervention is possible, which is key to saving lives. We look forward to building on this important project as we push forward in bringing our novel diagnostic solution to market."

Will Geist, President of Bio-Techne’s Protein Sciences Segment Commented: "We are pleased that Cizzle has chosen the Simple Western platform for the development of its novel biomarker. The automation, sensitivity, small sample input and quantitative nature of the Simple Western system makes it ideal for supporting an assay of this nature. We are excited about the progress so far and hopeful Simple Western can aid in making such a life-saving innovation available to the patients that need it."

On September 18, 2023 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported that the Company has received approval from the HREC (Human Research Ethics Committee) in Australia for the Phase 1a/b trial (MarkV-01 Trial) of PMC-309, an anti-VISTA (V-domain Ig Suppressor of T cell Activation) antibody candidate (Press release, PharmAbcine, SEP 18, 2023, View Source;bmode=view&idx=16374112&t=board [SID1234649178]).

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The MarkV-01 trial is a first-in-human, open-label Phase 1a/b study which will proceed in two parts, the first part with PMC-309 monotherapy followed by the second part in combination with KEYTRUDA (pembrolizumab), MSD (Merck & Co., Inc., Rahway, NJ., USA)’s anti-PD-1 therapy. PharmAbcine already announced in December 2022 that the Company signed a clinical collaboration agreement with MSD, under which MSD would supply KEYTRUDA for the combination cohort.

The primary objective of the study is to evaluate the safety, tolerability, and determine the recommended RP2D (Recommended Phase 2 dose) in both parts. The second objective is to evaluate PK profile (pharmacokinetics) and clinical efficacy, including ORR (overall response rate), DCR (disease control rate), and PFS (progression-free survival).

PMC-309 is a novel anti-VISTA antagonizing antibody that can be used for the treatment of various tumor types. It inhibits VISTA, an immune checkpoint receptor mainly expressed on MDSCs (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). By inhibiting the VISTA pathway on immunosuppressive cells, PMC-309 can promote anti-tumor effects by indirectly activating T cells unlike the existing immuno-oncology drugs that directly target and activate T cells. This unique mode of action allows PMC-309 to play a pivotal role in regulating the VISTA-expressing immunosuppressive cells found abundantly in tumor microenvironment.

The antibody already demonstrated in nonclinical studies that it can promote both innate immunity (monocyte activation, M1 macrophage proliferation) and adaptive immunity (T cell activation) unlike the existing drugs, which show notable changes only in adaptive immunity. In addition, the in vivo data showed significantly improved tumor growth inhibition when PMC-309 is used in combination with an anti-PD-1 drug compared to both monotherapies of PMC-309 and an anti-PD-1 drug.

"The approval of our clinical trial for the anti-VISTA antibody marks a significant milestone for PharmAbcine, bringing us one step closer to providing a groundbreaking treatment option for patients with unmet medical needs in the field of immuno-oncology," commented Dr. Jin-San Yoo, CEO of PharmAbcine. "We are very excited to begin this trial and looking forward to evaluating PMC-309’s safety and efficacy across multiple tumor types in both mono and combo therapy."

Dr. Yoo also added, "We are grateful for the collaborative work with MSD and would like to thank everyone, including the regulatory, our colleagues, partners, shareholders, and investors, who has contributed to making this achievement possible."

For more information about the MarkV-01 trial, visit clinicaltrials.gov and search for the reference identifier NCT05957081.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About PMC-309

PMC-309 is a novel IgG1 anti-VISTA antagonizing antibody that can be used for the treatment of various tumor types. By inhibiting VISTA, an immune checkpoint receptor mainly expressed on MDSC and Tregs, it can play a pivotal role in maintaining the immunosuppressive environment around the tumor cells.

In the nonclinical studies, it has been demonstrated that PMC-309 can promote both innate immunity (monocyte activation, M1 macrophage proliferation) and adaptive immunity (T cell activation) unlike the existing drugs which show significant changes only in adaptive immunity. In addition, the in vivo data showed that PMC-309 significantly improved tumor growth inhibition when used in combination with an anti-PD-1 drug compared to both monotherapies of PMC-309 and an anti-PD-1 drug. These findings suggest that PMC-309 can offer a new treatment strategy in immuno-oncology area as it can be used in combination with other drugs to improve their low-response rates.

About MarkV-01 Trial

The MarkV-01 trial is a Phase 1a/b, first-in-human (FIH), open label study to evaluate the safety, tolerability, and PK of PMC-309, a mAb against the human VISTA ligand, in participants with advanced or metastatic solid tumors administered as a monotherapy and in combination with pembrolizumab. The primary objective of the study is to evaluate the safety, tolerability, and determine recommended RP2D in both parts. The second objective is to evaluate PK profile and clinical efficacy, including ORR, DCR, and PFS.

Phase 1a is a 2-part dose escalation; both parts will adopt the modified toxicity probability interval (mTPI) design with a dose limiting toxicity (DLT) rate of 30% for dose finding.

Part A is planned as a PMC-309 dose escalation.
Part B is planned as a PMC-309 dose escalation in combination with pembrolizumab.
Phase 1b is planned as a cohort expansion with PMC-309 administered as a monotherapy (Cohort A) at the preliminary RP2D found at Phase 1a (Part A) and in combination with pembrolizumab (Cohort B) with PMC-309 at the maximum tolerated dose (MTD)/preliminary RP2D found at Phase 1a (Part B).

A minimum of 67 participants are to be enrolled to the study.

On September 18, 2023 Osmol Therapeutics, a privately held biopharmaceutical company focused on developing a treatment to prevent chemotherapy-induced peripheral neuropathy (CIPN), reported that the U.S. Food and Drug Administration (FDA) notified the company that the first-in-human clinical trial of OSM-0205 in healthy subjects for the prevention of CIPN may proceed (Press release, Osmol Therapeutics, SEP 18, 2023, View Source [SID1234637886]). Osmol filed the Investigational New Drug application (IND) with the FDA for OSM-0205 in August 2023.

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Microtubule-based chemotherapy treatments, which destroy cancer cells based on microtubule disruption, produces an intracellular calcium surge that damages neurons, leading to CIPN. Each year, approximately 360,000 cancer patients in the U.S. and E.U. are treated with taxanes most commonly for the treatment of breast cancer but also for prostate cancer as well as other malignant solid tumors. Approximately 80% of breast cancer patients experience some degree of CIPN. Currently there are no FDA-approved treatments for CIPN, and the only way to mitigate the effect of this painful and often debilitating condition is by interrupting treatment or reducing the dosage of chemotherapy, which can adversely impact patient outcomes.

"Preventing CIPN would address a major women’s health issue for which there are currently no FDA-approved disease modifying treatment options," said Arthur DeCillis, MD, Chief Medical Officer, Osmol Therapeutics. "OSM-0205 is administered intravenously immediately prior to chemotherapy treatment and has the potential to protect neurons in patients by preventing the surge in intracellular calcium associated with CIPN. This first-in-human Phase 1 clinical trial in healthy subjects will determine the safety, tolerability, and pharmacokinetics of single ascending doses of OSM-0205 intravenous infusion to select a dose to evaluate in Phase 2 clinical studies in breast cancer patients."

About OSM-0205

Osmol’s lead drug, OSM-0205, is based on Dr. Barbara Ehrlich’s research in neuronal calcium sensor-1 (NCS1) at Yale School of Medicine and is designed to prevent the off-target calcium surge caused by taxanes and potentially other chemotherapy treatments associated with peripheral nerve damage. Data from preclinical studies conducted by Osmol show that pre-treatment with OSM-0205 prevents the pathologic damage caused by these chemotherapy agents.

On September 18, 2023 Cellectar Biosciences, Inc., a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to iopofosine I 131, the company’s lead small-molecule drug candidate, for Waldenstrom’s macroglobulinemia (WM) in patients who have received two or more prior treatment regimens (Press release, Cellectar Biosciences, SEP 18, 2023, View Source [SID1234637602]).

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The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. These medicines are considered priority medicines by the EMA and are intended to reach patients earlier. To be accepted for PRIME, new therapies must demonstrate the potential to significantly address an unmet medical need in clinical trials.

"PRIME designation from the EMA further underscores our confidence in iopofosine I 131 to provide a differentiated and highly needed new treatment option for patients with WM," said James Caruso, president and CEO of Cellectar. "We expect to release top-line data from the CLOVER-WaM pivotal trial in the fourth quarter of 2023 and submit our NDA in March, 2024. With PRIME designation now in hand we look forward to advancing our EU strategy to bring this potential targeted treatment option to patients in the US and EU as quickly as possible."

The U.S. Food and Drug Administration (FDA) has granted Cellectar’s lead asset iopofosine I 131, a small-molecule Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope), Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as relapsed (or refractory) multiple myeloma and relapsed (or refractory) diffuse large B-cell lymphoma (DLBCL). The company expects to complete our ongoing Phase 2b WM pivotal trial (NCT02952508) in the second half of 2023 and assuming an FDA Priority Review and approval, remains on target for a 2024 US product launch.

On September 18, 2023 Vividion Therapeutics, Inc. (Vividion), reported that it has initiated dosing of patients in a Phase I oncology clinical trial of its investigational oral Kelch-like ECH Associated Protein 1 (KEAP1) activator, VVD-130037 (Press release, Bayer, SEP 18, 2023, View Source [SID1234635305]). Vividion is a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, and a wholly owned and independently operated subsidiary of Bayer AG. The start of the trial represents a major milestone for Vividion’s innovative chemoproteomics platform.

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"The initiation and dosing of this clinical trial marks a major inflection point for Vividion as we advance to a clinical stage company. We are proud of the progress we have made in a relatively short amount of time with our novel pipeline of previously undruggable protein targets for prominent oncology and immunology diseases," said Aleksandra Rizo M.D., Ph.D., Chief Executive Officer of Vividion. "We are energized by the future, as we work to deliver multiple programs to the clinic starting in 2023."

"We are leveraging Vividion’s innovative chemoproteomics technology to develop new therapies with the potential to stop or reverse the progression of diseases," said Christian Rommel, Ph.D., Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. "For millions of patients and their families, cancer continues to be a devastating disease, and new treatments are needed to address key drivers of tumor cell survival and growth. The start of Vividion’s first clinical trial takes us a step closer to a potentially meaningful new oncology treatment for various forms of cancer."

Vividion’s proprietary chemoproteomic approach, which allows the company to unlock high value, traditionally undruggable target biology with precision therapeutics for cancers and immune disorders, has been thriving following the company’s acquisition by Bayer in August 2021. The transaction allows Vividion to operate at arm’s length in a best-of-both-worlds’ model, preserving its innovative, entrepreneurial culture while also leveraging Bayer’s deep expertise in small molecule development, global capabilities and financial strength.

"We are excited to announce the initiation and dosing of Vividion’s first drug in clinical development from our chemoproteomic platform," said Jenna Goldberg, M.D., Chief Medical Officer of Vividion. "This is a first-in-class clinical candidate, aimed to target cancers with activation of the KEAP1-NRF2 pathway. This would be a novel opportunity in cancer treatment."

The company is advancing multiple novel biology programs toward the clinic and has more than a dozen similar pipeline opportunities emerging in early discovery in the fields of oncology and immunology. The Phase I clinical trial will evaluate the safety, pharmacokinetics and pharmacodynamics and preliminary efficacy of VVD-130037 in patients with advanced solid tumors. Trial participants will have a histologically confirmed metastatic or unresectable solid tumor. Participants will receive ascending doses of VVD-130037, orally, once daily in 21-day treatment cycles.