On May 4, 2023 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported its financial results for the first quarter ended March 31, 2023, and provided a business update (Press release, Nuvation Bio, MAY 4, 2023, View Source [SID1234631072]).

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"We saw strong clinical execution in the first quarter as we continued to enroll patients in the Phase 1 monotherapy and Phase 1b combination studies of NUV-868," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We look forward to submitting an IND for our first DDC clinical candidate by the end of this year, demonstrating our ongoing effort to tackle some of the greatest unmet needs in oncology."

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

Dosing underway in both regimens of the Phase 1b combination study. The Company continues to enroll the Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC.
Dosing underway in the Phase 1 monotherapy study. The Company continues to enroll the Phase 1 monotherapy study in advanced solid tumors.
Drug-Drug Conjugate Platform: Solid tumors

Nominated first clinical candidate. Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.
First Quarter 2023 Financial Results

As of March 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $646.6 million. For the three months ended March 31, 2023, research and development expenses were $18.8 million, compared to $20.7 million for the three months ended March 31, 2022. The decrease was primarily due to a $1.3 million decrease in personnel-related costs driven by a headcount reduction as well as a $0.6 million decrease in third-party costs related to research services and manufacturing primarily due to the termination of the NUV-422 program.

For the three months ended March 31, 2023, general and administrative expenses were $7.7 million, compared to $7.5 million for the three months ended March 31, 2022. The increase was primarily due to a $1.1 million increase in personnel-related costs driven by stock-based compensation and other benefits offset by a $0.3 million decrease in insurance, a $0.3 million decrease in legal fees and a $0.3 million decrease in other professional fees.

For the three months ended March 31, 2023, Nuvation Bio reported a net loss of $21.7 million, or $(0.10) per share. This compares to a net loss of $21.3 million, or $(0.10) per share, for the comparable period in 2022.

On May 4, 2023 Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, reported its participation in the 26th American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, May 16-20, in Los Angeles (Press release, Ginkgo Bioworks, MAY 4, 2023, View Source;cell-therapy-asgct-annual-meeting-301815435.html [SID1234631071]). Ginkgo will present data on its high-throughput screening platform for chimeric antigen receptor (CAR) libraries, which can enable discovery of CAR variants with desired characteristics. This capability has the potential to discover CAR-T therapeutic candidates that are effective against solid tumors.

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Ginkgo recently announced the launch of Ginkgo Cell Therapy Services at its annual Ferment conference. These services empower customers with massively parallel testing of genetic designs, allowing them to leverage vast biological diversity to improve their products. Ginkgo’s ultra high throughput mammalian cell engineering foundry is well suited to address many outstanding problems in cell therapy, including CAR-T. Ginkgo is actively developing high throughput platforms to enhance CAR efficacy and safety by exploring novel construct designs and incorporating synthetic regulatory elements like inducible promoters. In addition to CAR optimization, Cell Therapy Services include immune cell armoring, synthetic promoters, immune cloaking and novel gene editing tools. You can learn more at Ginkgo’s Cell Therapy Services Virtual Event on May 31. Register here.

"All six of the approved CAR-T therapies on the market use one of two signaling domains, which were identified 20 years ago. Since then, the ability to read and write DNA has improved dramatically. Ginkgo is harnessing its ability to generate massive libraries of unique CAR designs with different signaling domains, which can then be screened in an assay that mimics a solid tumor environment," said Shawdee Eshghi, Senior Director, Mammalian Engineering, Ginkgo Bioworks. "In head-to-head tests of these designs, Ginkgo is identifying a number of designs that show improved performance compared to designs with standard signaling domains. We’re excited to present this data to the ASGCT (Free ASGCT Whitepaper) community, especially as this flexible platform is available to partners and can also be used for other applications like natural killer cells."

Info on the poster presentation is listed below, and the full abstract is available on the ASGCT (Free ASGCT Whitepaper) meeting website.

High-Throughput Pooled Screen of CAR Library Identifies Essential Signaling Features of CAR-T Cells That Resist Immunosuppression
Abstract number: 858
Session: Thursday Poster Session
Date and Time: Thursday, May 18, 2023 12:00 PM PT

On May 4, 2023 XNK Therapeutics AB ("XNK") reported that the company’s autologous natural killer (NK) cell therapy candidate XNK04 will be evaluated in combination with an ADCC competent PD-L1 inhibitor in liver cancer under a research agreement with a global pharma company (Press release, XNK Therapeutics, MAY 4, 2023, View Source [SID1234631070]).

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The preclinical validation study aims to test the cell therapy candidate XNK04 alone and in combination with an antibody checkpoint inhibitor against autologous cancer cells isolated from patients with hepatocellular carcinoma (HCC). The study will provide data to support initiation of a potential future clinical phase I/II trial.

"We will explore synergistic effects of the combination. This is a study where we test an individualized NK cell-based therapy on isolated patient-specific tumor material, and it is our ambition to validate this combination approach in HCC," said Johan Liwing, CEO at XNK.

The study will test the hypothesis that the well documented big pharma PD-L1 antibody, when combined with the expanded and activated NK cells, will facilitate NK cell-mediated cytotoxicity against HCC tumor cells.

"We are excited about entering into this collaborative study. This preclinical research agreement with a renowned big pharma company lends valuable support to our clinical strategy and shows that there is strong interest in the industry for our technology," said Markus Thor, Chief Business Officer at XNK.

The HCC study adds to XNK’s clinical phase II program in multiple myeloma and preclinical programs in urothelial cancer and acute myeloid leukemia (AML). XNK retains all commercial rights to XNK04.

About Hepatocellular Cancer

Cancer in the liver is a major health problem and is the fourth leading cause of cancer-related death worldwide. Each year more than 800,000 people are diagnosed with liver cancer worldwide. HCC constitutes around 80% of all primary liver cancers. Risk factors for developing HCC include e.g. fatty liver disease, alcohol consumption and hepatitis B and C. Treatments include surgery, trans-arterial chemoembolization (TACE), chemotherapy, targeted drug therapy and checkpoint inhibitors. The medical need remains significant with high recurrence rates and with 5-year survival rates around 20%.

On May 4, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that it was awarded a $2 million, two-year Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) (Press release, Sapience Therapeutics, MAY 4, 2023, View Source;catenin-antagonist-301816245.html [SID1234631069]). The proposed non-clinical studies will investigate pharmacodynamic biomarkers for ST316, a first-in-class β-catenin antagonist, and evaluate the impact of ST316 on the tumor microenvironment (TME) in patient-derived cancer models.

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"This award provides further validation of our novel approach with ST316 to impact the Wnt/β-catenin signaling pathway, a known oncogenic driver of many cancers and a key regulator of the tumor microenvironment," said Jim Rotolo, Ph.D., SVP, Translational Pharmacology and Head of Research of Sapience Therapeutics. "ST316 has tremendous therapeutic promise, with a robust preclinical data package that includes a favorable safety profile and significant anti-tumor activity. We look forward to building upon these data with this grant award and evaluating ST316 in patients in our upcoming Phase 1-2 clinical study."

ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator BCL9, a complex that drives oncogenesis in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. In March 2023, Sapience announced that it received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1-2 clinical trial of ST316 for the treatment of solid tumors. In addition, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, Sapience presented late-breaking data on ST316 highlighting its immunotherapeutic potential.

The award will utilize patient-derived xenograft (PDX) models to investigate pharmacodynamic (PD) biomarkers and evaluate the impact of ST316 on the TME, namely macrophage polarization, tumor infiltrating lymphocyte (TIL) expression in tumors and the impact in combination with a PD-1 inhibitor. This grant was supported by the National Cancer Institute of the National Institutes of Health under Award Number 2R44CA265503-02A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About ST316

ST316, a first-in-class β-catenin antagonist, is in Phase 1 clinical development following the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration in March 2023. β-catenin is a critical member of the canonical Wnt signaling pathway, a well-known development stage pathway that has been considered an "undruggable" cancer target, as small molecules have proven ineffective or toxic. Disruption of the interaction between BCL9 and β-catenin with ST316 reduces oncogenic Wnt-signaling, suppressing transcription of Wnt target genes resulting in tumor cell death and a pro-inflammatory tumor microenvironment, without disruption of homeostatic Wnt function.

In the second quarter of 2023, the Phase 1 dose-escalation portion of the Phase 1-2 study will begin enrolling patients with selected advanced solid tumors likely to harbor abnormalities of the Wnt/β-catenin signaling pathway. The Phase 2 dose-expansion portion aims to continue to assess the safety of ST316 as well as proof of concept in four specific tumor types known to harbor abnormalities of the Wnt/β-catenin signaling pathway.

On May 4, 2023 CRB091, a novel drug candidate developed by Cancer Research and Biotechnology AG (CRB), reported to have shown significant promise in reducing cancer cell proliferation in difficult-to-treat cancers such as colorectal and triple-negative breast cancers (Press release, Cancer Research and Biotechnology, MAY 4, 2023, View Source [SID1234631068]). The preclinical studies conducted by an independent research laboratory in the UK demonstrated a significant reduction in human cancer cell proliferation in vitro, with a synergistic effect between the product’s single ingredients.

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TNBC is the most aggressive type of breast cancer in women with a 5-years survival rate of 66% and a very low survival rate of 12% after metastasis. Conventional cancer treatments often come with severe side effects, limiting their use and efficacy. Furthermore, targeted therapies and new immunological treatments suit only a limited patient population, while drug resistance can develop rapidly. CRB091 offers a well-tolerable and effective therapy that could address the shortfalls of existing treatments.

CRB091’s active molecules have been proven safe for human use, and CRB anticipates initiating the first-in-human clinical trials in the US in 12 months. The FDA’s Pre-Investigational New Drug (Pre-IND) application advice is scheduled in Q3 2023, with the IND filing in Q3 2024.

As a preclinical oncology company, CRB is focused on developing drugs that address the metabolic disease that induces carcinogenesis. By providing a particularly effective and well-tolerated therapy, CRB091 has the potential to significantly improve the treatment of triple-negative breast cancer and other difficult-to-treat cancers.

With the meaningful efficacy demonstrated on human cancer cell lines, the Switzerland-based startup is poised to take a significant step towards human use of the novel treatment.