On May 31, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it it will present a poster on the 4-1BB conditional agonist antibody ATOR-1017 at the 2022 ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) Annual Meeting, being held in Chicago June 3-7 (Press release, Alligator Bioscience, MAY 31, 2022, View Source [SID1234615246]).

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The poster, entitled "Initial findings from a first-in-human, multicenter, open-label study of ATOR-1017, a 4-1BB antibody, in patients with advanced solid malignancies", outlines results from Alligator’s first-in-human clinical trial with ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic solid cancers.

The results, to be presented at ASCO (Free ASCO Whitepaper), demonstrate an excellent safety profile. Five (22.7%) of the 22 patients treated with ATOR-1017 experienced grade 3-4 treatment-related adverse events (TRAEs). None of the TRAEs resulted in treatment discontinuation. No dose-limiting toxicity was observed, and thus the maximum tolerated dose (MTD) of ATOR-1017 has not been reached. ATOR-1017 exhibits a dose dependent and favorable pharmacokinetic profile. Activation of peripheral T cells and increased levels of soluble 4-1BB was observed across active dose levels of ATOR-1017, demonstrating biological activity and proof of mechanism.

Stable disease was achieved as best objective response in 10 (45%) of patients, with the longest treatment duration being 16 months.

Overall, the data showed that ATOR-1017 is safe and well-tolerated at doses up to 600 mg and has shown signs of clinical benefit. Dose escalation continues at the 900 mg dose and data from this cohort is expected to be reported in 2022.

"We are excited to be able to present these very promising data at ASCO (Free ASCO Whitepaper), outlining the strong safety profile and signs of efficacy of our ATOR-1017 drug candidate," said Søren Bregenholt, PhD, CEO of Alligator Bioscience. "4-1BB antibodies have been plagued with poor efficacy or unacceptable safety profile, but ATOR-1017 is distinct from other 4-1BB antibodies, partly because of its unique binding profile but also because its immunostimulating function is dependent on cross-linking to Fc-gamma receptors on immune cells. This localizes the immunostimulation to the tumor region, where both 4-1BB and Fc-gamma receptors are expressed at high levels. This means that ATOR-1017 has the potential to address a significant unmet medical need, and we look forward to finalizing this study and selecting a recommended dose for the upcoming Phase 2 study."

The Phase I study with ATOR-1017 is an open-label, dose-escalation study in patients with histologically confirmed, advanced, and/or refractory solid cancer (NCT04144842). The primary objective of the study is to investigate the safety and tolerability of ATOR-1017 and to determine the recommended dose for subsequent Phase 2 studies.

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 Immedica Pharma AB ("Immedica") and Japanese company OrphanPacific, Inc. ("OrphanPacific") reported that they on May 2, 2022, entered an agreement under which OrphanPacific gains the exclusive rights to Ravicti in Japan (Press release, Immedica Pharma, MAY 31, 2022, View Source [SID1234615240]).

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The pharmaceutical drug product Ravicti is approved in Europe and North America for treatment of urea cycle disorders (UCD).

Under the announced partnership, OrphanPacific is granted a license to develop, register and commercialize the product in UCD in Japan. OrphanPacific will initiate a clinical trial for obtaining approval for glycerol phenylbutyrate in Japan. OrphanPacific is already Immedica’s commercial partner in Japan for the commercialization of the drug product Buphenyl.

"It is with great pleasure that we announce this expanded partnership with OrphanPacific, under which we will be able to make Ravicti available to UCD patients also in Japan. The entered agreement also further strengthens Immedica’s geographical footprint, by introducing yet another product collaboration in Japan," says Anders Edvell, CEO of Immedica.

About Urea Cycle Disorders (UCD)

Urea cycle disorders are a group of metabolic diseases that affect a specific enzyme or transporter in the urea cycle leading to elevated ammonia or glutamine levels in the circulation. Symptoms of the disorder can begin at any age, with more severe defects beginning early in life. UCD patients may experience episodes, called hyperammonemic crises, when ammonia levels in the blood become excessively high, which can result in irreversible brain damage, coma or death. In Japan, UCDs occurs in 1 in 8,000 to 44,000 people and is one of the designated intractable diseases.

On May 31, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported the acquisition of a targeted nanobody platform to its Discovery pipeline (Press release, Clarity Pharmaceuticals, MAY 31, 2022, View Source [SID1234615238]). The intellectual property, including a provisional patent and know-how, has been acquired from leading nanotechnology researcher Dr Kurt Gehlsen, who developed the technology for a maximum consideration of 400,000 options over Clarity Pharmaceuticals shares with a strike price of $1.40 together with cash consideration of up to US$250,000. Both the cash consideration and options are subject to certain provisions that relate to the achievement of development milestones for new products. In addition, Dr Gehlsen has joined the Company as a consultant to help drive the new nanobody program forward within Clarity.

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Nanobodies are attractive targeting molecules which can be engineered to bind to a wide range of cancers. The nanobody platform allows the development of high affinity products suitable for targeting receptors specific to cancer cells. By only targeting cancer cells and not healthy cells, this approach aims to kill cancer cells while limiting the side effects elsewhere in the body.

The nanobody platform adds exciting new opportunities to Clarity’s Targeted Copper Theranostics (TCTs) Discovery pipeline. Dr Gehlsen will work with Clarity’s R&D team to combine the platform with the Company’s proprietary SAR Technology and advance it from the lab, through preclinical studies and into clinical development.

Dr Gehlsen commented, "Clarity’s proprietary SAR Technology is ideally positioned to fully exploit the benefits of the nanobody platform. In combination with copper-64 for imaging and copper-67 for therapy, we are hoping to achieve high accuracy and high precision of the nanobody-based targeted radiopharmaceuticals for the diagnosis and treatment of a range of cancers. I look forward to working together with the Clarity team on progressing this technology through the preclinical studies and into clinical development".

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Clarity has always built its TCT products from the ground up, and the addition of targeted theranostic (diagnostic and therapeutic) nanobodies directed to novel cancer targets in combination with our proprietary SAR Technology is a logical step for our platform. The introduction of the nanobody platform solidifies Clarity as a pioneering developer of next-generation radiopharmaceuticals and will launch a new class of Targeted Copper Theranostics to our development pipeline, aiming to make the safest and most effective treatments to address unmet clinical needs in the large oncology market in a scalable and sustainable manner. We are excited to now have additional capability to develop further cutting-edge theranostics with Dr Gehlsen’s nanobody platform and streamline their development into clinical trials."

Dr Gehlsen’s academic experience is focused on cancer research and he held positions as an Associate Professor at the Sidney Kimmel Cancer Center, as an Associate Staff Scientist at the California Institute for Biological Research and as Founder, Vice President (VP) and Chief Operating Officer at the La Jolla Institute for Experimental Medicine. Dr Gehlsen has published over 140 manuscripts, book chapters and meeting abstracts and has over 100 patents and patent applications.

Previously, he was VP and Chief Scientific Officer (CSO) at Research Corporation Technologies, Inc. (RCT) Tucson, AZ., an investment and development company focused on early-stage technologies in the life sciences. He was Senior VP, Development and CSO at Maxim Pharmaceuticals, a public biopharmaceutical company that developed and launched Ceplene, the first immune counter-suppression therapeutic as a remission maintenance therapy for acute myeloid leukaemia. Dr Gehlsen was also Director of Research in the Experimental Medicine Division of Pharmacia, AB., Sweden, and La Jolla, CA, and was a Postdoctoral Fellow and Research Associate at the Sanford Prebys Burnham Institute.

This announcement has been authorised for release by the Executive Chairman.

On May 30, 2022 Cureteq AG (Cureteq), a clinical stage company developing innovative medicines with the support of a sophisticated artificial intelligence (AI) platform, reported the company has in-licensed its first compound, and will develop it as a potential first-in-class treatment for multiple cancers, initially for brain and kidney cancer (Press release, Oncoteq, MAY 30, 2022, View Source [SID1234651596]). The development path is guided by AI and builds on strong preclinical and clinical data.

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The compound, M8891, is a small-molecule methionine aminopeptidase 2 (MetAP2) inhibitor licensed from global science and technology company Merck based in Darmstadt, Germany. This is the first of what is planned to be a series of acquisitions by Cureteq as the company looks to build a pipeline of novel and better potential medicines against a range of diseases. Cureteq sets out to pioneer a new standard for AI-supported drug development to the benefit of patients, doctors and society.

Cureteq leverages AI to identify the top potential indications of a given molecule and to devise optimized and de-risked clinical development plans. Such an approach provides for accelerated development of new medicines to treat the diseases for which they will be most effective and have the highest chance of becoming available to patients. The AI-platform differentiates from other AI approaches by its breadth and depth, connecting billions of data points according to the most relevant medical concept; this greatly enhances the quality and impact.

Mads Dalsgaard, Chief Executive Officer of Cureteq AG, commented:
"We are very excited to complete our first in-licensing deal and commence development, combining the AI-technology and our medical expertise. M8891 has the potential to be a first-inclass treatment for cancers, such as kidney and brain cancers, which both have a devastating impact on patients’ lives. We are pleased to collaborate with Merck by carrying forward this promising molecule and excited about proving the power of AI in drug development".

M8891, through a unique mechanism of action (MetAP2 inhibition), inhibits both the cancer cells and their ability to generate new blood vessels in vitro, which is necessary for tumor growth. It is thought that this can potentially suppress the progression of the malignant disease, shrink, or even eliminate the cancer, especially if M8891 is combined with other anti-tumor treatments. Preventing disease progression or shrinking the tumor with safe and tolerable drugs is usually associated with an improved quality of life and helps patients to minimize fatal complications from their disease or may even prolong an otherwise drastically shortened life expectancy.

In a recent phase 1, dose-escalation study in patients with solid tumors, M8891 as monotherapy was demonstrated to have acceptable safety and also showed preliminary signs of anti-tumor efficacy. Such data add to the robust preclinical data package supporting potential anti-tumor activity across a broad range of tumors. Cureteq plans to validate the AI generated hypotheses preclinically and in a multi-cohort, Phase 1b study of M8891 in combination with current standardof-care treatments for kidney and brain cancer; patient enrollment is expected to commence in 2023.

M8891 will be developed by Oncoteq AG, a newly established subsidiary of Cureteq.