On July 9, 2020 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its second quarter 2020 financial results on Thursday, July 30, 2020 after the close of financial markets (Press release, Seattle Genetics, JUL 9, 2020, View Source [SID1234561797]). Following the announcement, Company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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Thursday, July 30, 2020
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 866-248-8441 (domestic) or +1 720-452-9102 (international); conference ID 1128188
Webcast with slides available at www.seattlegenetics.com in the Investors section. A webcast replay will be archived on the Company’s website.

On July 9, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an independent, systematic review and meta-analysis demonstrating that its DecisionDx-Melanoma test is a significant predictor of recurrence and metastatic risk in patients with invasive cutaneous melanoma (Press release, Castle Biosciences, JUL 9, 2020, View Source [SID1234561799]).

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The article titled, "A Systematic Review and Meta-Analysis of Gene Expression Profiling for Primary Cutaneous Melanoma Prognosis," appeared in SKIN: The Journal of Cutaneous Medicine.

The study found that of all gene expression profile tests reported for cutaneous melanoma, DecisionDx-Melanoma was the only test described in the literature or commercially available with sufficient evidence to qualify for inclusion in the study. This is the second recently published systematic review and meta-analysis that demonstrates the independence and significance of DecisionDx-Melanoma prognosis for recurrence and metastatic risk in patients with invasive cutaneous melanoma.

Lichtman et al. Study Background and Results:

The purpose of this systematic review and meta-analysis was to consolidate the rapidly evolving body of data on gene expression profiling (GEP) in melanoma prognosis.
This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)1.
The systematic review identified several GEP assays that have been described in the literature. However, aside from DecisionDx-Melanoma, none of the reported studies were supported by consistent reporting of results or enough evidence for inclusion in the meta-analysis performed by study co-authors.
The DecisionDx-Melanoma test was found to be a consistent, independent and significant predictor of survival, with a significant association between Class 2 test results and recurrence-free (Hazard Ratio [HR] = 7.22; p <0.00001), distant metastasis-free (HR = 6.62; p <0.00001) and overall (HR = 7.06; p <0.00001) survival rates.
DecisionDx-Melanoma test results were also associated with sentinel lymph node biopsy status (odds ratio calculation; p<0.00001).
Results of the study indicate that the DecisionDx-Melanoma test achieved the highest Strength of Recommendation Taxonomy (SORT) level of evidence for a prognostic biomarker (Level 1 evidence). The SORT system is used by the American Academy of Dermatology (AAD) and other organizations to evaluate the quality, quantity and consistency of evidence supporting tests such as DecisionDx-Melanoma. The SORT scale evaluates both the quality of the evidence (Level 1, 2 or 3) and strength of the recommendation (A, B or C).

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through March 31, 2020, DecisionDx-Melanoma has been ordered more than 56,800 times for use in patients with cutaneous melanoma.

On July 9, 2020 IntegraGen (FR0010908723 – ALINT – Eligible PEA PME) (Paris:ALINT), a 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 unaudited sales for the first half of 2020 (Press release, Integragen, JUL 9, 2020, View Source [SID1234561776]).

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Unaudited sales during the first half of 2020 were 4,706 k€, an increase of 13% compared to the first half of 2019 and 15% on a like-for-like basis taking into account the sale of the company’s diagnostic business at the start of 2020. The growth in sales was a result of an increase in all sequencing activities, in particular the SeqOIA platform (+33%), activities related to outsourced platforms (+18%), and sequencing services for research and clinical research (+9%).

Software and genomic consulting (GeCo) activities were limited due to the pandemic, which notably resulted in the delay of projects.

The company’s cash position at the end of June 2020 was 5.8 m€, representing an improvement of almost 3.0 m€ compared to the cash position as of December 31, 2019. This difference is mainly due to the receipt of a State Guaranteed Loan (PGE) totaling 1.8 m€, to the implementation of several safeguarding actions during the confinement period linked to the COVID-19 pandemic, and to an equilibrium between the consumption of cash for current operations and business revenue.

Bernard Courtieu, Chairman and Chief Executive Officer of IntegraGen stated, "our sales revenue during the first half of 2020 builds on the previously reported profitable growth trajectory which we experienced during the second half of 2019. These results reinforce our current strategy of focusing on our genomic services business with an emphasis on sequencing and data interpretation. Despite the difficulties linked to the pandemic, sales of our software tools to assist with genomic data interpretation remain a major strategic focus, as evidenced by the announcement in April of an agreement with a major cancer center in the United States. The sustained growth and healthy cash position we have achieved despite the current crisis will enable us to pursue a positive and ambitious trajectory. Lastly, I would like to thank the employees of IntegraGen who have demonstrated exemplary solidarity and dedication to ensuring continuity of operations during containment linked to the pandemic."

The financial results for the first half of 2020 will be published on September 17, 2020.

On July 9, 2020 Kronos Bio, Inc., dedicated to targeting oncogenic transcription factors and their associated transcriptional regulatory networks, reported results of a preclinical study of KB-0742, a highly potent, orally available and selective cyclin-dependent kinase 9 (CDK9) inhibitor. Results showed that KB-0742 inhibited tumor growth in a prostate xenograft model, as well as other cancers addicted to high levels of oncogenic transcription. The findings were presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II in June 2020 (Press release, Kronos Bio, JUL 9, 2020, View Source [SID1234561800]).

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"Current therapies that block androgen signaling are effective in prostate cancer, but most ultimately develop resistance. These preclinical study results provide strong evidence that KB-0742 inhibits tumor growth in vivo," said Norbert Bischofberger, Ph.D., President and Chief Executive Officer of Kronos. "Based in part on these data, we plan to advance KB-0742 into clinical development for the treatment of transcriptionally-addicted cancers. We anticipate submitting an IND in the fourth quarter of this year and initiating a Phase 1 dose-escalation study in early 2021."

In this study, which was conducted in collaboration with the Koehler Lab at the MIT Center for Precision Cancer Medicine and Koch Institute For Integrative Cancer Research at MIT, researchers used the small molecule microarray (SMM) discovery platform to identify novel modulators of the androgen receptor capable of overcoming therapy resistance in prostate cancer cells. The SMM screen identified KI-ARv-03, a small molecule that blocks androgen receptor dependent gene expression and is a highly selective inhibitor of the androgen receptor cofactor CDK9. KB-0742 is a more potent and drug-like small molecule CDK9 inhibitor designed and optimized at Kronos Bio.

KB-0742 showed selectivity for CDK9 over other CDK family members, downregulated AR-dependent oncogenic transcription, and reduced tumor cell growth and promoted apoptosis in vitro. Additionally, oral administration of KB-0742 (administered as a 3-day on/4-day off regimen) to mice that had been engrafted with castration resistant prostate cancer cells significantly inhibited tumor growth with modest effects on body weight. In a subsequent mouse xenograft study using a MYC-dependent acute myeloid leukemia model, KB-0742 administration again resulted in significant tumor growth inhibition with dose-dependent effects on pharmacodynamic markers of CDK9 inhibition in tumor.

On July 9, 2020 OncoDNA SA and IntegraGen SA (Paris: ALINT) reported the signature on July 8th 2020 of an agreement under which the Belgian company OncoDNA will file today a friendly cash tender offer to purchase the shares of the French company IntegraGen, whose securities are admitted to trading on the Euronext Growth market of Euronext Paris, at a price per share of €2.20, valuing IntegraGen share capital at €14.5m1 for 100% (Press release, OncoDNA, JUL 9, 2020, View Source [SID1234561777]). This transaction represents a premium of +36.2% compared to the last closing price of IntegraGen shares and +23.2% compared to the volume-weighted average price over the previous six months. The offer was approved on a unanimous basis by all members of the Board of both companies.

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According to articles 261-1 I 2° et 4° of the general regulations of the AMF, the Board of IntegraGen has mandated on April 26 2020 as independent appraiser the consulting firm Crowe HAF, represented by Mister Olivier Grivillers, in order to prepare a fairness opinion on the financial terms of the offer. His report will be reproduced in extensor in the draft offer document of IntegraGen.

Subject to the approval of the Autorité des Marchés Financiers (AMF) and pursuant to applicable regulations to foreign investment control in France, the public offer shall be opened at the end of the third quarter of 2020. OncoDNA currently owns no share of IntegraGen.

For the last seven years, OncoDNA, a leading international player in oncology precision medicine, has been developing a comprehensive offer for clinicians that provides innovative molecular tests to guide their clinical decision process for the treatment of patients with advanced cancer. OncoDNA also offers liquid biopsy follow-up solutions to better monitor disease progression. OncoDNA’s strength is its proprietary database that enables remote clinical interpretation via a SaaS model for molecular analyses performed by laboratories around the world. Thanks to its network, OncoDNA has established collaborations within the pharmaceutical industry to assist with clinical trials which focus on new oncology treatments.

Backed by a highly competent and qualified team, IntegraGen is a leading player in DNA sequencing services with specialized expertise in exome and complete genome analyses. The company operates sequencing platforms for major players of the genomic sector and has developed a portfolio of software for genomic data interpretation that are distributed on a SaaS model and already commercialized in Europe and the USA. IntegraGen’s activities are particularly complementary to OncoDNA’s offer.

Comprehensive genomic analysis of cancer cells has become increasingly relevant as a part of the cancer treatment decision making process, especially with the surge in targeted therapies and immunotherapies. The ability to detect and determine genomic differences between tumor and normal cells is critical to providing patients the most appropriate treatment options and to ensure a proper follow-up. Similarly, genomic analysis is a key element for diagnostic and research in the fields of rare diseases and microbiology.

In the context of this transaction, the companies, which are already engaged in commercial agreements, plan to integrate their respective service offers by combining DNA sequencing services and the bioinformatics tools developed by IntegraGen with the innovative portfolio of tests OncoDNA offers to oncologists. This joint offer would enable to provide a unique range of services and software solutions to clinicians, oncologists, researchers and biologists worldwide while also leveraging a proprietary database that includes patient follow-up capabilities and artificial intelligence technology.

"We are very happy to announce this friendly takeover bid that will bring together IntegraGen’s know-how in sequencing services and bioinformatics analyses with our expertise in oncology clinical interpretation, making us a major European player in the emerging field of oncology precision medicine", said Jean-Pol Detiffe, OncoDNA founder and CEO. "By uniting our skills, we will integrate the entire chain of genomic operations and benefit from having a large-scale production capacity ready for tomorrow’s analyses, namely the complete sequencing of the tumor. Giving new hope and provide treatment options to patients on a worldwide basis has always been OncoDNA’s motive since day one."

Bernard Courtieu, CEO of IntegraGen, added "We are pleased to create this close working relationship with OncoDNA, a company recognized for its experience and technical skills. We share a common ambition to provide researchers and clinicians’ communities with the best analysis and genomic interpretation tools. OncoDNA’s international presence will enable IntegraGen to fully exploit its sequencing capacities and the integration of both company’s teams, especially our information technology and bioinformatics expertise, will enhance OncoDNA’s global offer."

OncoDNA is advised by ODDO BHF, White & Case and Osborne Clarke. IntegraGen is advised by Portzamparc and Jones Days.