On January 5, 2023 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), an immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer, reported a clinical supply agreement with Regeneron for its anti-PD1 therapy Libtayo (cemiplimab) (Press release, Sensei Biotherapeutics, JAN 5, 2023, View Source [SID1234625910]). The supply agreement supports the evaluation of SNS-101, a conditionally active VISTA-blocking antibody, in combination with Libtayo in a Phase 1/2 trial in solid tumors. Sensei is on track to submit an Investigational New Drug application for SNS-101 in or before April 2023 and the trial is expected to commence in 2023 pending regulatory clearance.

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"We are excited for the opportunity to work with Regeneron on our planned clinical trial of SNS-101, which has demonstrated strong anti-tumor activity in combination with PD-1 inhibition in preclinical studies. We look forward to exploring the potential of SNS-101 to inhibit tumor growth across a range of indications," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "We have built a robust preclinical data package supporting the biological rationale for our pH-sensitive approach, which we believe offers both safety and efficacy advantages over pH-independent VISTA antibodies, including the potential to avoid poor pharmacokinetics from target-mediated drug disposition and lower the risk of cytokine release syndrome."

Under the terms of the agreement, Sensei will sponsor and fund the planned clinical trial and Regeneron will provide Libtayo. Sensei will maintain global development and commercial rights to SNS-101. Regeneron develops and commercializes Libtayo globally.

SNS-101 is currently under preclinical development, and the safety and efficacy of SNS-101 or its administration with Libtayo have not been reviewed by any regulatory authorities.

On January 5, 2023 QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) reported an exclusive strategic partnership with California-based population genomics leader Helix to advance companion diagnostics for hereditary diseases (Press release, Qiagen, JAN 5, 2023, View Source [SID1234625909]).

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As the development of precision medicines accelerates, so does the need for companion diagnostics devices and tests detecting clinically relevant genetic abnormalities. These diagnostics help guide clinical decision-making by identifying patients most likely to benefit – or be at increased risk – from a particular therapeutic product. Principally used in oncology to date, companion diagnostics that employ whole exome sequencing are widely believed to have great potential in hereditary disease areas such as cardiovascular, metabolic, neuro-degenerative, and auto-immune diseases.

Under the agreement announced today, QIAGEN will be the exclusive marketing and contracting partner in the U.S. for Helix’s companion diagnostic services. The partnership will leverage the Helix Laboratory Platform, which was granted the first-ever U.S. Food & Drug Administration de novo class II authorization for a whole exome sequencing platform. This brings a new innovative solution to biopharmaceutical customers in support of hereditary disease therapies, complementing solutions both companies already provide such as Helix’s population genomics programs and QIAGEN’s diagnostic expertise, QIAseq Human Exome Kits and global reach supporting research initiatives outside the U.S.

A pioneer in precision medicine, QIAGEN has more than 30 master collaboration agreements with global pharmaceutical and biotechnology companies to develop and commercialize companion diagnostic tests for their drug candidates. QIAGEN’s companion diagnostic offerings encompass technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) and digital PCR (dPCR), sample types from liquid biopsy to tissue, and disease areas from cancer to Parkinson’s – including 11 FDA-approved PCR based companion diagnostics and a collaboration with Neuron23 announced in September 2022 to develop an NGS-based companion diagnostic for a novel Parkinson’s disease drug.

"This partnership represents another step toward bringing the power of companion diagnostics to hereditary diseases by powering Helix’s leading products with QIAGEN’s extensive pharma and biopharma relationships, NGS capabilities, and global regulatory expertise," said Thierry Bernard, Chief Executive Officer of QIAGEN. "Access to a genomic database can help researchers find patients with particular biomarker signatures almost instantaneously, making trial recruitment a matter of months instead of years."

"Helix’s technology and regulatory capabilities coupled with QIAGEN’s well-established worldwide companion diagnostic development capabilities results in a powerful partnership that will allow us to expand critical access to genomic testing for both patients and providers working daily to fight life-threatening conditions," said Helix CEO and Co-Founder, James Lu, MD, PhD. "QIAGEN’s mission to fill the clinical gap for patient access and provide technology platform options to address the needs of physicians to target treatment with genomic medicine is well in line with our mission."

Helix has built an end-to-end platform that enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Helix has partnered with leading health systems to enable population genomics programs of at least 100,000 patients each across the U.S. These programs dramatically accelerate patient identification and recruitment for clinical trials in hereditary diseases such as Parkinson’s, cardiovascular or inflammatory disease like non-alcoholic steatohepatitis (NASH), power real-world data (RWD) or real-world evidence (RWE) services and insights, and bring deep genetic expertise and methodologies to examine sub-cohorts within both drug discovery and a clinical trial.

On January 5, 2023 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized immunotherapies, reported that it has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate Nouscom’s wholly-owned lead candidate, NOUS-209, in combination with
MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) versus KEYTRUDA alone in randomized Phase 2 trials in patients with Mismatch Repair/Microsatellite Instable High (dMMR/MSI-H) Metastatic Colorectal Cancer (CRC) (Press release, NousCom, JAN 5, 2023, View Source;utm_medium=rss&utm_campaign=nouscom-announces-clinical-trial-collaboration-and-supply-agreement-with-msd-to-evaluate-nous-209-in-combination-with-keytruda-pembrolizumab-in-a-phase-2-randomized-trials-in-dmmr-msi-high-met [SID1234625906]). NOUS-209 is an off-the-shelf immunotherapy targeting 209 specific, shared neoantigens found in dMMR/MSI-H unresectable or metastatic gastric, colorectal and gastro-esophageal junction tumors.

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The Phase 2 study includes two cohorts in dMMR/MSI-H unresectable and metastatic CRC assessing the efficacy and safety of NOUS-209 in combination with pembrolizumab at multiple active sites across Europe and the US (NCT04041310).

1. A randomized cohort enrolling patients who are eligible for first line treatment, randomized

2:1 to NOUS-209 plus pembrolizumab versus pembrolizumab alone;

2. A single arm cohort enrolling patients who have stopped responding to previous anti-PD1 treatment.

Dr Marina Udier, Chief Executive Officer of Nouscom, added: "We are thrilled to collaborate with MSD, a global leader in immuno-oncology, and to work with their highly experienced and talented clinical development team, allowing us to accelerate the ongoing US and EU Phase 2 trial with NOUS-209. Based on our published and presented Phase 1 clinical data1,2 we see great potential of this combination approach in addressing the unmet medical need in these patients.
We look forward to presenting preliminary data in 2023."

Under the terms of the agreement, MSD will supply KEYTRUDA. Nouscom retains all worldwide commercial rights to NOUS-209.

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

References

1. ASCO (Free ASCO Whitepaper) Presentation: First clinical and immunogenicity results including all subjects enrolled in a phase I study of NOUS-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR), Professor Marwan G. Fakih, M.D.

2. A.M. D’Alise et al. Adenoviral Based-Vaccine Promotes Neoantigen Specific CD8+ T Cell Stemness And Tumor Rejection, Science Translational Medicine; 14, 657, 2022

About NOUS-209

NOUS-209 is an off-the-shelf cancer immunotherapy for Microsatellite Instable High (MSI-H) tumors. MSI-H tumors are characterized by a defective DNA mismatch repair system, which generates highly immunogenic neoantigens called frame shift peptides (FSP) that are not present in healthy tissue.

NOUS-209 encodes for 209 shared FSP neoantigens, selected by Nouscom’s proprietary GENESIS (GE(netic)NE(oantigen)S(election)I(n)S(ilico)) algorithm. In published prospective validation studies, approximately 50 of the 209 neoantigens are expressed in any one patient’s tumor. These FSPs are cloned into Nouscom’s heterologous prime / boost viral vector platform of a Great Ape Adenoviral (GAd) and Modified Vaccinia Ankara (MVA) and potently generate FSP neoantigen specific CD8+ T cells, which have been shown to successfully infiltrate tumor microenvironments to exert anti-tumor activity.

NOUS-209 is being investigated in multi-center EU and US Phase 2 randomized clinical trials in patients with dMMR/MSI-H unresectable and metastatic colorectal cancer (CRC) (NCT04041310) in combination with checkpoint inhibitors (CPI) versus CPI alone and in patients who have stopped responding to previous anti-PD1 and other approved CPI therapies.

On January 5, 2023 Protara Therapeutics presented its corporate presentation (Press release, Protara Therapeutics, JAN 5, 2023, View Source [SID1234625908]).

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On January 5, 2023 PDX Pharma reported that its proprietary platform (Pdx-NP) utilizes polymer-modified mesoporous silica nanoparticles and can effectively co-deliver a plethora of therapeutic modalities while maintaining a small size, suitable for infusion and tumor accumulation (Press release, PDX Pharmaceuticals, JAN 5, 2023, View Source [SID1234625907]). ARAC-02, one of our leading candidates, targets PD-L1, PLK1, and TLR9, and has the ability to simultaneously kill cancer while also inducing a potent anti-tumor immune response. ARAC-02 development won a $2.3M fast track SBIR award from the NCI with a rare perfect score in September 2021. In December 2022, ARAC-02 was selected into the NCL’s Assay Cascade Characterization Program, during which its physicochemical properties and in vitro and in vivo compatibility (immunology, pharmacology, and toxicology) will be characterized at no cost using a standardized assay cascade developed in collaboration with the FDA and NIST. This program will directly support our IND enabling studies toward the clinical adoption of ARAC-02.

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