On May 31, 2022 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) platform, reported that it will present interim data from its Phase 1 clinical study of SQ3370 in advanced solid tumors, at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held at McCormick Place in Chicago, IL, on June 3-7, 2022 (Press release, Shasqi, MAY 31, 2022, View Source [SID1234615278]).

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Presentation details:

Abstract Title: Interim Phase 1 results for SQ3370 in advanced solid tumors
Abstract Number: 3085
Poster Number: 77
Poster Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Key highlights include:

26 patients received treatment with SQ3370 and as of the data cutoff date, 21 patients were evaluable
77% of patients had metastases with a median number of 2 metastatic sites (1-5); most frequently lung (50%) and more than 50% being previously treated with doxorubicin
Escalating doses of SQP33 protodrug ranging from 0.38x to 12x the molar equivalent of conventional doxorubicin per cycle along with a dose of 10 or 20 mL of SQL70 were administered
SQ3370 was well tolerated with 62% of patients receiving more than 500 mg/m2 cumulative doxorubicin equivalents given as SQP33
The most common treatment emergent adverse events reported were nausea, fatigue, anemia, and constipation
At a median follow-up of 9.2 weeks, of the 21 evaluable patients, 71% had stable disease, with a median duration of 80 days
Dose escalation continues as the maximum tolerable dose has not yet been reached
SQ3370 demonstrates proof of concept for the CAPAC platform
About CAPAC and SQ3370

SQ3370 is the first click chemistry-based treatment to be tested in humans. It utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the tumor site. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing therapeutics across various modalities with a limited therapeutic window.

On May 31, 2022 Selvita S.A. – [ticker: WSE: SLV] – one of the largest preclinical contract research organizations in Europe, reported its development in all business segments in the first quarter of 2022 (Press release, Selvita, MAY 31, 2022, View Source [SID1234615241]).

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The increase in the scale of operations along with high margins

In the first quarter of 2022, Selvita Group reported revenues in the amount of EUR 20.5 million, indicating an increase of 35% y/y. EBITDA and net profit (excluding the impact of the non-cash incentive program) amounted to EUR 6.0 million and EUR 3.6 million, respectively, which translates into an increase of 56% and 119%. Margins grew in line with the expanding scale of the business. The EBITDA margin increased from 25.2% in the previous year to 29.1% in 2022, while the net profit margin increased from 10.9% to 17.7%.

Services provided in Poland closed the first quarter of 2022 with revenues of EUR 9.8 million, an increase of 43% y/y. EBITDA in the reporting period amounted to EUR 2.9 million, achieving the annual growth dynamics of 110%. The segment also significantly improved the EBITDA margin, which increased from 19.0% in the previous year to 28.1% in 2022. A significant increase in the revenues in the area of ​​regulatory research was noted, from EUR 1.5 million achieved in the first quarter of 2021, to EUR 2.7 million in 2022 (+ 83% y/y).

The segment of services provided in Croatia increased the commercial revenues generated by 22% y/y, reaching EUR 7.8 million. EBITDA in the analyzed period amounted to EUR 2.4 million, showing an increase of 21% y/y. The margin on the services remained at a similar level, 31.3% in Q1 2021 vs. 31.1% in Q1 2022.

In the reporting period, Ardigen generated EUR 2.2 million in commercial revenues, compared to EUR 1.4 million last year, which translated into an improvement of 60% y / y. EBITDA increased from EUR 0.4 million to EUR 0.6 million (+44% y/y), and the EBITDA margin was 24.3%, which means a minimal decrease compared to Q1 2021 (-2 pp).

– I am very pleased with the results achieved. The high pace of growth in all our business segments, as well as the improvement in EBITDA profitability and net profit, show that dynamic development can go hand in hand with good margins. This is the result of the work of our scientists who strive to provide our clients with high quality services every day. At Selvita, we believe that people are the most important asset, and our financial results reflect this – comments Bogusław Sieczkowski, Chief Executive Officer at Selvita S.A.

The backlog of Selvita Group also grew dynamically in the reported period, and currently amounts to EUR 58.8 million, indicating an increase of 38% y/y. In the area of ​​drug discovery, backlog reached EUR 44.6 million, increasing by 30% as compared to the same period previous year. The regulatory research segment has been growing even faster, with backlog amounting to EUR 6.2 million (+ 111% y/y). Ardigen reported EUR 6.5 million of backlog, almost EUR 2.0 million more than in 2021.

– The high value of contracted orders allows us to be optimistic about the entire year 2022 – adds Sieczkowski.

New Development Strategy 2022 – 2025

– During the first quarter of this year, we worked intensively on our new strategy. Rapid development of the Group over the last years meant that our previous, four-year strategy, was implemented in a little over two years. As part of the assumptions of the new development plan, we plan to grow three times by 2025, and achieve annual revenues of EUR 200 million, while maintaining a stable, high margin. We are convinced that the implementation of these goals will allow us to become a global, preclinical CRO, offering clients an increasingly comprehensive range of services – said Sieczkowski.

In the first months of 2022, Selvita made several operational steps supporting further development of the Group. Integration of services in the area of ​​drug discovery, integration of sales and business development, as well as creation of a department supporting the management of operational activities, investments, and infrastructure, constitute a strong foundation for the implementation of the assumptions of the new strategy for 2022-2025.

On May 31, 2022 InveniAI LLC, a global leader in applying Artificial Intelligence (AI) and Machine Learning (ML) to transform drug and target discovery and development, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported the achievement of the first milestone in disease model systems that triggered a milestone payment that has been received by InveniAI under the research collaboration between the companies (Press release, Kyowa Hakko Kirin, MAY 31, 2022, View Source [SID1234615262]).

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Yoshifumi Torii, Ph.D., Executive Officer, Vice President, and Head of R&D Division of Kyowa Kirin, added, "We are excited to achieve a successful outcome by leveraging InveniAI’s platform AlphaMeld that detected very early signals of association between targets/mechanism of action and clinical utility based on the platform’s analytics. We have since validated this program which, as predicted, has shown signals of efficacy in preclinical proof-of-concept studies for the treatment of a disease indication where current therapeutic options lack efficacy and have adverse effects. We are eager to test this very promising candidate for further studies. We also look forward to the selection of additional novel programs identified by InveniAI’s truly game-changing platform and believe that our collaboration will contribute to addressing enduring unmet medical needs."

"We are delighted with the progress of our synergistic collaboration with Kyowa Kirin and the advancement of an AI-identified target and associated clinical utility at unprecedented speed," said InveniAI’s President and Chief Executive Officer, Krishnan Nandabalan, Ph.D., "Our AI-powered drug and target discovery platform, AlphaMeld, has repeatedly demonstrated the ability to generate concepts that have been validated by our partners from preclinical to late-stage clinical success. The ability to translate data into meaningful efficacy, safety, and clinical endpoints is pushing the current probability of clinical success from 1 in 10 to 3 in 10 – a significant impact in today’s drug discovery and development paradigm," he added.

InveniAI and Kyowa Kirin have been collaborating since 2018 and have expanded the framework of their collaboration twice so far (2020 and 2021)*. This milestone achievement is the result of the first joint research to maximize the portfolio value that began in 2018. In addition to the above-mentioned projects, there are ongoing projects aimed at discovering new drug candidates in several disease areas.

About AlphaMeld
AlphaMeld is an Artificial Intelligence (AI) and Machine Learning (ML) powered platform that accelerates innovation for the discovery of targets, drugs, and healthcare products and technologies. The platform generates testable hypotheses by taking into account the ideal mode of pharmacotherapy (antibody, protein replacement, siRNA, mRNA, small molecule, cell and gene therapy, and gene-editing modalities), disease severity, gene ontology, disease pathways, proteinopathies, standard of care, emerging innovation, and enabling technologies while factoring in medical, scientific, strategic, and commercial considerations.

On May 31, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported the launch of the Twist Human Methylome Panel, a product now available to customers that can advance applications in cancer metastasis, human development and functional genetics (Press release, Twist Bioscience, MAY 31, 2022, View Source [SID1234615279]). The panel can be used to identify a robust, collated set of CpG sites, methylated cytosine and guanine nucleic bases, across the human genome to identify biologically relevant methylation markers. Compared to traditional array based or whole genome bisulfite sequencing approaches, this panel provides overall cost savings while also covering previously unknown methylation markers. The Twist Human Methylome Panel can also be used as a first pass discovery tool to identify methylation biomarkers that can then be used in a variety of applications, such as more targeted liquid biopsy panels.

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The DNA methylome is the comprehensive set of nucleotides within the genome that have a methyl group attached. DNA methylation plays a key role in many biological processes, including cancer. When present on a single nucleotide, a methyl group can alter genetic behavior without changing the DNA sequence. Analyzing the pattern in which methylation occurs within a specific genetic sequence as well as the fraction of the genome that has a methyl group attached (methylated) provides a unique understanding of disease pathology. CpG sites, which often repeat to create CpG islands, turn a gene "on" or "off" and are associated with neurodegeneration, cancer and multiple rare diseases. Detection of CpG islands therefore can inform diagnoses or development stage of multiple diseases.

The Twist Human Methylome Panel is highly targeted to capture and detect the most recently identified and relevant CpG methylation regions in the genome. Twist uses hybrid capture panels to explore the methylome and the content that can be investigated to include 84.2% of CpG islands as well as other CpG sites.

"With the customizable Twist Human Methylome Panel, we are able to cover four times the amount of CpG sites compared to average microarrays. Using our NGS-based panel provides a higher dynamic range, allowing more accurate identification of differentially methylated regions, which we believe will enhance research-based assays and diagnostic tests that incorporate this dynamic tool," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Previously, when identifying methylation markers, researchers had to choose between a low-cost, static option or a very expensive panel that covers a significant portion of the methylome, but often more than needed. As technology progresses, the compromise that researchers need to make between cost and coverage becomes less and less."

"We look forward to expanding our work with Twist as well as extending our epigenomics expertise and offerings to customers by incorporating the Twist Human Methylome Panel into our Epigenomics Profiling Services. This aligns with our efforts to continue offering new solutions to link methylation research with a wide range of disease indications and progression," said Didier Allaer, CEO of Diagenode, a leading epigenomics company and early access customer for the Twist Human Methylome Panel. "The new panel will enable us to offer a solution with broad coverage of the human methylome and to bring epigenetics research to new frontiers of biomarker discovery on clinical samples."

About Twist Human Methylome Panel

The Twist Human Methylome Panel enables the identification and study of methylation biomarkers spanning a wide range of targets and applications. The 123 megabase panel covers 84.2% of CpG island sites contained within the human genome and is optimized with the Twist Methylation workflow for robust end-to-end performance. The high capture efficiency increases the sensitivity of detection and internal data show that the Twist Human Methylome Panel achieves a depth of coverage of 90% of bases at 30x coverage with high probe specificities of 95% on-target rates, as well as high uniformity across the target region.

On May 31, 2022 Greenfire Bio, LLC reported that its subsidiary, Green3Bio, and its collaborators at MD Anderson Cancer Center will present an update on the ongoing first-in-human clinical trial of GRN-300 at the upcoming ASCO (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Greenfire, MAY 31, 2022, View Source [SID1234615297]). GRN-300 is a first-in-class, orally bioavailable novel small molecule inhibitor of the Salt Inducible Kinases 2 and 3 (SIK2/SIK3) that is highly expressed in ovarian cancer and has been identified to play a pivotal role in several other cancers. The transition of this emerging biologic pathway and a novel agent into the clinic marks a successful step in the progress of the GRN-300 program. The goal of the clinical study is to determine the recommended Phase 2 Dose (RP2D), safety/tolerability and the tumor response of GRN-300 as a monotherapy or in combination with paclitaxel in subjects with ovarian cancer.

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This study is registered at ClinicalTrials.gov Identifier: NCT04711161.
Format: Poster Presentation
Abstract number: TPS5616
Session: Poster Session/Gynecologic Cancer
Time: Saturday, June 4, 2022, 1:15 PM-4:15 PM CDT
Presenter: Siqing Fu, PhD, MD (Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center)

Title: GRN300–001: Phase 1/1b evaluation of the safety, pharmacokinetics and efficacy of GRN-300, a salt-inducible kinase inhibitor, alone and in combination with paclitaxel, in recurrent ovarian, primary peritoneal, and fallopian tube cancers

About Ovarian Cancer
According to the American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women. They estimate that in 2022 there will be about 19,880 new cases of ovarian cancer diagnosed in the United States and that about 12,810 will die of the disease. According to the World Cancer Research Fund International, there were about 313,000 new cases of ovarian cancer diagnosed worldwide in 2020. Ovarian cancer is difficult to detect at an early, more treatable stage; therefore, the current lack of salvage treatment for women, who experience a recurrence, results in a 5-year survival rate of less than 30%.

About GRN-300
GRN-300 (previously ARN3261) is an orally bioavailable first-in-class novel, small molecule, dual inhibitor of the salt-inducible kinases 2 and 3 (SIK2, SIK3). This agent has the potential to overcome chemoresistance based on its mechanism of action (MOA) and synergistic effects with standard of care including chemotherapy, PARP inhibitors, and immune checkpoint inhibitors (ICIs). SIK2 is overexpressed in 30% of ovarian cancer specimens suggesting a multifunctional role of SIK2/3 in tumorigenesis. SIK2 and SIK3 are known to play an oncogenic role in other tumor types, including prostate cancer, breast cancer, diffuse large B-cell lymphoma, and melanoma. Higher levels of expression of SIK2 have been shown to be significantly correlated with poor progression-free survival in patients with high-grade serous ovarian cancers. GRN-300 attenuated tumor growth in several preclinical xenograft ovarian cancer models as a single agent and in combination with paclitaxel. The compound completed the first dose escalation groups without DLT, and preliminary PK analysis indicate dose proportionality.