On July 13, 2022 IntegraGen (FR0010908723 – ALINT ), an OncoDNA Group company specializing in the decryption of the human genome which performs interpretable genomic analyzes for academic and private laboratories and develops diagnostic tools for oncology, reported its non-audited revenue of 6,439 k€ for the first half of 2022, representing an increase of 34% compared to H1 2021 (Press release, Integragen, JUL 13, 2022, View Source [SID1234616637]). This sales growth across all of the company’s businesses reflects the strong rebound of the general economic business climate compared to H1 2021 which was significantly impacted by the global pandemic.

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R&D sequencing activities have resumed the pre-pandemic growth trend and were fueled by several significant projects realized on the company’s sequencing platform in Évry. The growth was primarily a result of the strong demand for projects that were initiated in Q2 2021. The sequencing platform also benefited from a pandemic-related microbiology project during H1 which resulted from site specific sequencing capacity limitations experienced by one of the company’s partners, representing c. 7% of the company’s revenue in H1. In parallel with the above, sequencing activities associated with external platforms operated by IntegraGen continued to experience increased output with new clinical research projects for oncology also driving revenue growth.

The company’s cash position as of end of June 2022 was 4,489 k€, a decrease of 0.3 M€ compared to December 31, 2021. This was in line with the company’s expectations and 2022 budget. This decrease was primarily due to change in working capital requirement. This position includes a State guaranteed loan (Prêt Garanti par l’État, PGE) totaling 1,763 k€, received at the beginning of 2020, that the Company started to reimburse in June.

Despite a temporary slowdown in the booking orders as of end of June, the company confirms its growth perspectives based on the current sales dynamics and existing long-term contracts along with the synergies now in place with the other entities of the OncoDNA Group.

Bernard Courtieu, IntegraGen CEO, said "The revenue generated during the first half of 2022 confirms the resilience of IntegraGen’s business across each and every line of the company’s business. The company is now well-positioned for the future with rebound in the growth of our business seen in 2022 demonstrating our growth potential. The company’s business remains driven by long term contracts for the operation of external sequencing platforms with additional benefits derived from solid commercial dynamics, including the synergies we are now experiencing as a result of being fully integrated into the OncoDNA Group."

Full financial results for H1 2022 will be published on October 18, 2022.

On July 13, 2022 Hologic, Inc. (Nasdaq: HOLX) reported that will showcase their comprehensive portfolio of breast and skeletal health solutions at the annual European Congress of Radiology (ECR) in Vienna, Austria from July 13-17 (Press release, Hologic, JUL 13, 2022, View Source [SID1234616654]).

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The pioneer behind 3D Mammography technology, Hologic will provide attendees with an interactive experience that underscores a commitment to innovation through advancements in breast screening, surgery, biopsy and ultrasound solutions. As visitors explore the clinically proven, integrated solutions across Hologic’s Breast Health Continuum of Care, they can understand how these technologies support the early detection and diagnostic needs of patients.

"We’re thrilled to return to ECR to showcase how Hologic’s product portfolio can support the needs of radiologists and patients throughout the continuum of breast health," said Tanja Brycker, Vice President, Strategic Development, Breast and Skeletal Health and Gynecological Surgical Solutions at Hologic. "Our portfolio is designed to tackle today’s biggest challenges to early detection‚ such as pandemic delays and radiology backlogs, in order to help remove these barriers to diagnosis and treatment."

Hologic’s ECR presence will also include the Scientific Innovation Hub, where a wide variety of scientific talks led by experts in the field will be hosted throughout the event. Medical education sessions will focus on current topics, ranging from personalization in breast cancer detection, contrast-enhanced mammography in clinical practice, trends and practices in biopsy and lesion localization, and ultrasound in clinical practice for breast and liver. A full list of sessions will be available at the Hub.

Additionally, the booth will feature findings from the Hologic Global Women’s Health Index, developed in collaboration with the Gallup World Poll. This multiyear, comprehensive global survey provides an understanding of women’s perspectives and experiences on key health topics. Throughout ECR, Hologic will share highlights from the inaugural survey released in September 2021, so attendees can learn about the state of women’s health in their region.

For more information, or to register for a scientific session, stop by Hologic’s booth in Foyer O on the first floor of the ACV Main Congress building.

On July 13, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Orion Corporation ("Orion") reported a global development and commercialization agreement for Orion’s investigational candidate ODM-208 and other drugs targeting cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid production (Press release, Merck & Co, JUL 13, 2022, View Source [SID1234616638]). ODM-208 is an oral, non-steroidal inhibitor of CYP11A1 currently being evaluated in a Phase 2 clinical trial for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

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Under the terms of the agreement, Orion and Merck, acting through its subsidiary, Merck Sharp & Dohme LLC, will co-develop and co-commercialize ODM-208. Merck will make an upfront payment to Orion of USD 290 million, which will be expensed by Merck in the third quarter of 2022 and included in non-GAAP results. Of this upfront payment, Orion recognizes approximately EUR 220 million as income at the time of signing and approximately EUR 60 million is reserved to cover Orion’s share of ODM-208 development cost to be accrued in the future. Orion will be responsible for the manufacture of clinical and commercial supply of ODM-208.

In addition, the contract provides both parties with an option to convert the initial co-development and co-commercialization agreement into a global exclusive license to Merck. If the option is exercised, Merck would assume full responsibility for all accrued and future development and commercialization expenses associated with the program. Orion would be eligible to receive milestone payments associated with progress in the development and commercialization of ODM-208 as well as tiered double-digit royalties on sales if the product is approved. The total amount potentially accrued from multiple regulatory and sales milestone events represents a substantial opportunity for Orion.

"Targeting CYP11A1 provides a compelling approach to suppressing the production of steroid hormones, a key driver of prostate cancer," said Dr. Dean Y. Li, president, Merck Research Laboratories. "We believe ODM-208 has the potential to complement our existing program in prostate cancer and look forward to working with the team at Orion."

"We are delighted to enter this collaboration with Merck, which is committed to extend and improve the lives of patients with cancer and has a strong commercial presence globally," said Timo Lappalainen, president and chief executive officer, Orion. "This agreement positions Orion to harness the potential of ODM-208 for the good of patients while continuing to invest in our other programs without compromising our financial targets."

About ODM-208

ODM-208 is an oral, non-steroidal and selective inhibitor of the CYP11A1 enzyme discovered and developed by Orion for the treatment of hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 enzyme activity, ODM-208 is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

About Metastatic Castration-Resistant Prostate Cancer

Globally, prostate cancer is the second most common cancer in people assigned male at birth, with an estimated 1.4 million patients diagnosed worldwide in 2020. Approximately 10-20% of patients with advanced prostate cancer are estimated to develop CRPC within five years, and at least 84% of these patients may develop metastases at the time of CRPC diagnosis. Patients with advanced prostate cancer have a particularly poor prognosis, and the five-year survival rate remains low.

On July 13, 2022 Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, and Sirona Dx, a leading provider of multiomic single-cell analytical services, reported a collaboration to advance the discovery of novel spatial biomarkers in solid tumors (Press release, Nucleai, JUL 13, 2022, View Source [SID1234616655]). The partnership combines Nucleai’s powerful AI spatial analytics platform with Sirona Dx’s leading multiplex assay development expertise to identify novel spatial signatures in high-plex assays that predict response to therapy and inform treatment decisions. Through this strategic collaboration, Sirona Dx will provide Nucleai and its customers with a CRO partner that will enable the deployment of AI-based diagnostic algorithms to support biopharma clinical trials.

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Nucleai’s robust computational AI-powered spatial biology algorithm supports various image modalities (H&E, IHC, Multiplex) and cancer indications, offering a highly customizable, deployable solution across the drug development ecosystem. These capabilities earned Nucleai the position of one of the top 10 spatial biology companies in 2022.

"Multiplex imaging technologies have improved rapidly over the years; however, identifying actionable insights from all the data collected remains immensely challenging," says Avi Veidman, Co-Founder & Chief Executive Officer of Nucleai. "This powerful synergy between Sirona Dx and Nucleai is very exciting as it will allow us to identify actionable spatial signatures that can predict response to immunotherapy."

Sirona Dx is recognized as the original pioneers of spatial biology, having launched the first spatial-omics CRO service to biopharma in 2018. Today, their technology-agnostic, spatial biology suite includes the leading multiplexed imaging platforms and combines deep technical expertise required to develop high-performance multiplexed assays as large as 50 markers. Sophisticated multiplexed tissue imaging capabilities contributed to their selection as a Top 10 CRO of 2021 by Medhealth Outlook.

"We are delighted to announce a partnership with Nucleai," said Andrew Brown, Ph.D. Chief Commercial Officer at Sirona Dx. "Nucleai’s AI-driven analytical capabilities are exceptional. Our combined expertise in multiplexed tissue assay development, data generation and state-of-the-art analysis will unlock new spatial insights and accelerate the spatial biology revolution in precision medicine."

On July 13, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that Company manufacturing leadership will present sessions on cutting edge topics in lipid-based nanoparticle delivery systems at the upcoming Next Generation Lipid-Based Nanoparticles Delivery Summit taking place from July 19-21, 2022 in Boston (Press release, Genprex, JUL 13, 2022, View Source [SID1234616706]).

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"We are extremely fortunate to have our critical manufacturing function led by Dr. Kumar and his talented team, including Dr. Shinde, and are pleased to see their well-deserved recognition as thought leaders in the rapidly evolving field of lipid nanoparticle delivery of therapeutics," said Rodney Varner, President and Chief Executive Officer of Genprex. "As we advance our lead development program in non-small cell lung cancer in Phase 1/2 clinical studies, it is more important than ever to have our gene therapy manufacturing in such capable hands and we are proud of our exceptional team."