On July 12, 2023 OncoBone Ventures reported its founders participated in writing a newly published invited review article for the Journal Frontiers in Immunology (Press release, OncoBone Ventures, JUL 12, 2023, View Source [SID1234636481]). The publication titled ‘Insights into immuno-oncology drug development landscape with focus on bone metastasis’ provides a comprehensive review of the competitive drug development landscape for bone metastasis.

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The full publication can be found from the following link: Kähkönen et al., Frontiers in Immunology, Vol 14, 2023.

Tiina Kähkönen, CSO of OncoBone Ventures and the lead author of the publication says: ‘It was a great pleasure to be invited to contribute a publication in Frontiers in Immunology. By using a sophisticated drug development database we were able to provide for the first time a comprehensive analysis of the drug development landscape for bone metastasis. This information is very important not only for OncoBone Ventures, but also globally for researchers working in the bone metastasis field.’

On July 12, 2023 Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, reported a $50 million investment by NVIDIA, which was executed as a private investment in public equity (PIPE) (Press release, Recursion Pharmaceuticals, JUL 12, 2023, View Source [SID1234635362]). Recursion also announced plans to accelerate development of its AI foundation models for biology and chemistry, which, in collaboration with NVIDIA, it intends to optimize and distribute to biotechnology companies using NVIDIA cloud services.

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"Our collaboration with NVIDIA represents two best-in-class companies coming together to help solve one of the world’s most difficult challenges, drug discovery," said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. "With our powerful dataset and NVIDIA’s accelerated computing capabilities, we intend to create groundbreaking foundation models in biology and chemistry at a scale unlike anything that has ever been released in the biological space."

Recursion plans to utilize its vast proprietary biological and chemical dataset, which exceeds 23 petabytes and 3 trillion searchable gene and compound relationships, to accelerate the training of foundation models on NVIDIA DGX Cloud for possible commercial license/release on BioNeMo, NVIDIA’s cloud service for generative AI in drug discovery. NVIDIA will also help optimize and scale Recursion foundation models leveraging the NVIDIA AI stack and NVIDIA’s full-stack computing expertise. BioNeMo was announced earlier this year as a cloud service for generative AI in drug discovery, offering tools to quickly customize and deploy domain-specific, state-of-the-art biomolecular models at-scale through cloud APIs. Recursion anticipates using this software to support its internal pipeline as well as its current and future partners.

"Generative AI is a revolutionary tool to discover new medicines and treatments," said Jensen Huang, founder and CEO of NVIDIA. "We are delighted to collaborate with Recursion’s world-class team, which is doing pioneering work in digital biology and chemistry with NVIDIA DGX and NVIDIA AI software to accelerate the development of the world’s largest biomolecular generative AI models and speed drug discovery for biotech and pharmaceutical companies."

Recursion, through its recent acquisition of Valence Discovery, aims to accelerate the development of new technologies to feed the biopharma industry, while simultaneously democratizing access to large-scale models that have maximum impact in drug discovery.

On July 12, 2023, Bicycle Therapeutics plc (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC, Jefferies LLC and SVB Securities LLC (the "Representatives"), as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell 9,411,766 American Depositary Shares ("ADSs"), each representing one of the Company’s ordinary shares, nominal value £0.01 per share, and, in lieu of ADSs to investors that so choose, non-voting ordinary shares, nominal value £0.01 per share ("Non-Voting Ordinary Shares"), each at a public offering price of $21.25 per share (the "Offering") (Filing, Bicycle Therapeutics, JUL 12, 2023, View Source [SID1234633217]). The net proceeds to the Company from the Offering are expected to be approximately $187.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company also granted the Underwriters an option to purchase 1,411,764 additional ADSs at the public offering price.

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The Offering is being made pursuant to the Company’s automatic shelf registration statement on Form S-3ASR (File No. 333-272248), which became effective upon filing with the Securities and Exchange Commission (the "SEC") on May 26, 2023, a base prospectus dated May 26, 2023 and the related prospectus supplement dated July 12, 2023. The Offering is expected to close on or about July 17, 2023, subject to customary closing conditions.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties. The Company’s directors and executive officers have agreed, subject to certain exceptions, not to sell or transfer any ordinary shares (including ADSs representing ordinary shares) for 60 days, and the Company has agreed not to sell or transfer any ordinary shares or non-voting ordinary shares (including ADSs representing ordinary shares) for 60 days, in each case, after July 12, 2023, without first obtaining the written consent of the Representatives.

For information on the Non-Voting Ordinary Shares, reference is made to the description of Non-Voting Ordinary Shares, which is filed as Exhibit 4.1 hereto and incorporated by reference herein.

The foregoing description of the terms of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, which is filed as Exhibit 1.1 hereto and incorporated by reference herein.

A copy of the opinion of Cooley (UK) LLP relating to the legality of the issuance and sale of ADSs and Non-Voting Ordinary Shares sold in the Offering is attached as Exhibit 5.1 hereto.

On July 12, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test [NCT03766958]) achieved the primary endpoint of a statistically significant change in the proportion of benign lung nodules managed by Nodify XL2 experiencing invasive procedures (Press release, Biodesix, JUL 12, 2023, View Source [SID1234633206]). The data was published in PLOS ONE this week.

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Lung nodules are a common clinical finding with the increased use of medical imaging for general diagnostic purposes and the expansion of lung cancer screening eligibility. Lung nodules represent an opportunity for early detection of lung cancer but pose a diagnostic dilemma because up to 95% of lung nodules are benign. In this patient population, high rates of invasive procedures, such as biopsies or surgeries, on benign nodules have been documented in the pursuit of lung cancer diagnosis and an analysis of Medicare claims has showed that greater than 40% of the total cost of lung cancer diagnosis was accounted for by biopsied patients without a lung cancer diagnosis.

In ORACLE, the prospective, real-world clinical utility study, patients with benign nodules managed with the Nodify XL2 test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group.

"The findings from the ORACLE study represent a significant advancement in the clinical evidence for use of the Nodify XL2 test in nodule management," said Scott Hutton, President and CEO of Biodesix. "Clinical utility is an important step to demonstrate that the test is informing diagnostic decision making in a clinical setting. Avoiding diagnostic procedures on benign nodules reserves healthcare resources for patients with a higher risk of lung cancer, avoids unnecessary interventions for patients, and supports increases in early diagnosis and treatment."

On July 12, 2023 Tempus, a leader in artificial intelligence and precision medicine, reported its GEMINI Non-small Cell Lung Cancer (NSCLC) study (NCT05236114) (Press release, Tempus, JUL 12, 2023, View Source [SID1234633205]). The Tempus-sponsored study, being run in collaboration with AstraZeneca, aims to create a robust multi-omic dataset for patients with NSCLC to facilitate future novel research related to precision medicine, diagnostic development, and biomarker discovery.

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The study is open for enrollment for two cohorts of patients, one of which will focus on patients who have been recently diagnosed with Stage IV NSCLC and will receive standard of care checkpoint inhibitor therapy, and the other cohort will focus on patients who have early-stage NSCLC and are candidates for surgery. Tempus is leveraging its comprehensive molecular profiling portfolio – including its solid tumor assay, xT, liquid biopsy, xF, and an investigational minimal residual disease (MRD) assay – throughout the study to better understand this high-need patient population on a longitudinal basis. Patients enrolled in the trial will be studied for up to three years to assess the impact of their underlying tumor biology on disease progression and therapy efficacy. The results of this study will be used for biomarker discovery, including potential use of circulating tumor DNA (ctDNA) testing to measure MRD.

"The GEMINI study addresses research gaps in a high-need patient population that the Tempus platform is uniquely positioned to undertake," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "By taking a multi-omics approach, we believe that we can generate one of the most comprehensive analyses of early and late stage NSCLC patients, and one that will power significant advancements in biomarker discovery."

The study employs the full power of Tempus’ platform, including its intelligent diagnostics, multimodal data library, and clinical trial matching program (TIME), to develop a powerful multi-omic dataset at scale. In leveraging its TIME Trial Network, Tempus is broadening access to patients in communities across the country, while also helping to ensure that the study’s results are representative of this patient population in the United States.