On October 19, 2020 Varian (NYSE: VAR), a leading provider of cancer care technologies and solutions, reported to reinforce its commitment to delivering Intelligent Cancer Care during the 2020 American Society for Radiation Oncology (ASTRO) taking place virtually from October 24-31 (Press release, Varian Medical Systems, OCT 19, 2020, View Source [SID1234568644]). At this year’s show, the company will showcase its progress in helping more people access advanced cancer care, making cancer care more personalized, and delivering more data-driven insights to improve efficiencies and outcomes. In addition to a "best in class" virtual experience, Varian’s contributions to Intelligent Cancer Care will be highlighted in eleven presentations including data from the use of Varian’s adaptive radiotherapy system, Ethos, for lung, prostate, bladder, upper abdomen, head & neck cancers, and the first-look data presented by the recently-formed AI-driven Adaptive Intelligence Consortium.

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"Despite the transition to a virtual platform, our entire global Varian team is looking forward to connecting with ASTRO 2020 attendees and showcasing our innovations that help providers deliver the best cancer care to patients throughout their entire journey," said Dow Wilson, Chief Executive Officer of Varian. "Since its launch at last year’s ASTRO, our Ethos Therapy has demonstrated significant impact toward personalizing treatment for patients resulting in 10 featured presentations during this year’s meeting."

At this year’s virtual event, Varian will participate with a dynamic booth presence and provide one-on-one product demonstrations, as well as highlight how it pioneers for the future with sessions during the ASTRO Innovation Hub. The company will also have a presence at the American Society of Radiologic Technologists (ASRT) and Society of Radiation Oncology Administrators (SROA) concurrent meetings. Attendees can register for all Varian educational and demo sessions at View Source

ASTRO attendees will be able to view the following data presentations featuring Varian products and innovation. Registration links are available here: View Source

Topic

Session/Time and Day

Brain Cancer

– Semi-Automated Hippocampal Sparing Avoidance Whole-Brain Radiotherapy Using a Commercially Available Artificial Intelligence Toolkit

Digital Poster Q&A

Oct 25, 2:00 p.m. ET

Upper Abdomen Cancer

– Feasibility of AI-assisted CBCT-guided Stereotactic Online Adaptive Radiotherapy (CT-STAR) for Upper Abdominal SBRT: Results of a Prospective in Silico Clinical Trial

Oral Presentations

Oct 25, 9:10 a.m. ET

– Evaluation and validation of artificial intelligence (AI) delineation models for CBCT-guided stereotactic online adaptive radiotherapy (STAR) targeting upper abdominal malignancies

Oct 25, 12:20 a.m. ET

Prostate Cancer

– Adaptive radiotherapy can be applied routinely, using an artificial intelligence solution, to treat prostate cancer patients

Digital Poster Q&A

Oct 25, 2:15 p.m. ET

Head & Neck Cancer

– Evaluation of dosimetric quality of auto-generated plans by a novel online adaptive system for head and neck radiotherapy

Digital Posters Q&A

Oct 25, 2:15 p.m. ET

– Evaluation of the Auto-Segmentation Performance of a Novel Online Adaptive Radiotherapy System for Head and Neck Cancer Treatment

Oct 25, 2:15 p.m. ET

– Head and neck quad shot using CT based adaptive treatment on a ring gantry LINAC

Oct 26, 4:30 p.m. ET

AI and Cancer Treatment

– First AI-driven Adaptive System-International Consortium lead Failure Mode and Effect Analysis (FMEA)

Oral Presentation

Oct 26, 12:50 a.m. ET

Bladder Cancer

– Results of a pilot study on online adaptive radiotherapy of bladder cancer with artificial intelligence-driven full re-optimization on the anatomy of the day

Oral Presentation

Oct 27, 1:00 a.m. ET

Lung Cancer

– Improved treatment quality in stage III lung cancer patients using online adaptive radiotherapy in a simulation setting

Digital Poster Q&A

Oct 27, 2:00 p.m. ET

Treatment Planning

– Accuracy of the Treatment Plan Dose Preview Functionality of a Newly Commercially- Available, CBCT-Based, Online Adaptive Radiotherapy Treatment System

Digital Posters Q&A

Oct 25, 2:15 p.m. ET

– Data-Driven Margin Determination for Online Adaptive Radiotherapy Using Batch Automated Planning

Oct 25, 2:15 p.m. ET

– Plan quality and fidelity evaluation of CBCT-Guided stereotactic online adaptive radiotherapy (CT-STAR) with an artificial intelligence (AI) aided plan re-optimization

Oct 28, 2:00 p.m. ET

Clinical Workflow

– Dosimetric Impact and Required Clinician Time of Online Adaptive Radiotherapy using a Newly Commercially-Available, CBCT-Based Adaptive Treatment System

Digital Poster Q&A

Oct 25, 2:15 p.m. ET

– Feasibility of Expediting Radiotherapy Clinical Workflow by Planning on Diagnostic Images and Adapting on a Commercial Adaptive Radiotherapy System

Oral Presentation

Oct 28, 3:15 p.m. ET

On October 19, 2020 Veracyte, Inc., (Nasdaq: VCYT) reported that new data presented at the CHEST Annual Meeting 2020 show that a genomic smoking index developed for use on samples obtained from the main lung airway can also be detected in nasal samples (Press release, Veracyte, OCT 19, 2020, View Source [SID1234568643]). The findings, shared in an oral presentation at the virtual meeting, reinforce the foundational "field of injury" technology behind Veracyte’s noninvasive nasal swab test being developed to identify lung cancer risk in patients with lung nodules.

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Every year in the U.S. alone, an estimated 750,000 patients with lung nodules detected through imaging tests are referred for diagnostic evaluation. These nodules are typically the first sign of lung cancer; however, determining which are cancerous and which are benign is often challenging, leading to unnecessary invasive procedures or delayed treatment. Because survival rates are significantly better for patients whose lung cancer is detected and treated earlier, it is extremely important to identify the lung nodules most likely to need intervention.

Veracyte’s in-development nasal classifier is designed to help physicians determine whether patients with lung nodules are at high or low risk for lung cancer so that those deemed "high-risk" by the test can proceed promptly to diagnosis and treatment, while patients classified as "low-risk" may safely be monitored over time.

At the CHEST meeting, Dr. Carla Lamb from Lahey Hospital & Medical Center in Burlington, Massachusetts, presented data from a study evaluating the ability of a 248-gene smoking index derived from whole-transcriptome sequencing to distinguish current versus former smokers in nasal samples collected from 144 patients and bronchial epithelial samples collected from 439 patients. All patients had lung nodules suspicious for cancer and were current or former smokers with no history of cancer. Results indicate that the genomic smoking index, while developed using samples from the main airway, can accurately distinguish current versus former smokers in samples obtained from the nose (89 percent sensitivity and 61 percent specificity).

"Our analysis suggests that the ‘field of injury’ technology underlying the nasal classifier can distinguish smoking-related genomic changes whether samples are derived from the nasal passages or from brushings of the main lung airway," said Dr. Lamb. "This finding is meaningful, because an accurate nasal swab-based lung cancer test developed from this technology would be a game-changer in lung-nodule management."

Veracyte continues to refine the algorithm for its nasal genomic classifier, accounting for variables such as nodule size and characteristics, smoking status, age, and more. The company plans to unveil early data for the test before the end of 2020, and to introduce the test in the United States in the second half of 2021.

"The data presented at the CHEST meeting provide additional feasibility evidence for our ‘field of injury’ approach to lung cancer diagnosis," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We look forward to sharing early data for our nasal swab test and detailing the scientific rigor behind it. Moreover, we remain on track to launch our novel test next year, as part of a comprehensive lung cancer portfolio that we believe is going to transform lung cancer diagnosis."

On October 19, 2020 Locust Walk Partners reported Each quarter our team at Locust Walk compiles key statistics and trends on strategic transactions and financings (Press release, Locust Walk Partners, OCT 19, 2020, View Source;utm_medium=rss&utm_campaign=q3-2020-biopharma-report [SID1234568642]). Our Q3 2020 Report: Global Trends in Biopharma applies the latest data to analyze current activities in the life science deal landscape.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This quarter shaped to be another positive one for biopharma IPOs and strategic transactions across the globe. And in the US, the rapid need to raise capital without the lengthy IPO process brought back a financing vehicle to take small companies public – SPACs.

A few highlights:

US

Private financings saw one of the strongest Q3s on record, and 2019/2020 biopharma IPOs continue to perform well in the public markets, suggesting investors are bullish long-term on new biopharma opportunities
EU

European biotech financings set a historical record this quarter, demonstrating robust equity markets and increased interest in the region
China

In the Chinese stock market, the SSE Composite Index has fully recovered and stabilized while the top 16 pharma companies listed in mainland China peaked out in early August
Japan

Venture financing deals in 2020 continues its record-setting pace in Japan, as it already exceeds all-time high in the volume and value previously set in 2018
We hope you find this latest data that analyzes current activities in the life sciences deal landscape to be helpful.

On October 19, 2020 Cytocom, Inc. (Cytocom), a leading biopharmaceutical company in the area of immune-modulation, and Cleveland BioLabs, Inc., (NASDAQ: CBLI), an innovative biopharmaceutical company developing novel approaches to activate the immune system, reported that they have entered into a definitive merger agreement to combine their businesses in an all-stock transaction (Press release, Cleveland BioLabs, OCT 19, 2020, View Source [SID1234568641]). Cytocom shareholders will have a majority position in the newly combined entity, which the parties anticipate will continue to be listed on the Nasdaq, and the initial Board of Directors for the combined company will consist of four members selected by Cytocom and three members selected by Cleveland BioLabs. The Boards of Directors of both companies have approved the combination.

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Each party to the proposed merger believes that the combined company will create near-term commercial opportunities in numerous areas of significant unmet medical needs including acute radiation injury, oncology, infectious disease, inflammation and autoimmune-mediated conditions, with multiple commercial, regulatory and clinical milestones expected over the next 12 to 18 months. Operating as "Cytocom, Inc." and under the leadership of Cytocom’s experienced management team, the combined company will be positioned for consistent growth.

Overview

Michael K. Handley, President and Chief Executive Officer of Cytocom, stated, "Our merger with Cleveland BioLabs and its subsequent immune-focused platform will be a transformative growth opportunity for Cytocom and Cleveland BioLabs shareholders. We believe that the combination of these highly complementary late-stage pipelines will strengthen our position and advance our efforts to unlock the potential of immune-modulating agents in the treatment of serious medical conditions. Further, this merger will enhance our ability to become a recognized leader in immune-modulating treatments and builds on the momentum created by our recent acquisition of ImQuest Life Sciences. We plan to utilize the combined platform to further drive value with additional clinical and commercial products and continue to seek strategic partnerships and acquisitions."

Dr. Andrei Gudkov, Chief Scientific Officer of Cleveland BioLabs, said: "This is an exciting day for Cleveland BioLabs and a great opportunity for our stockholders. The merger with Cytocom will allow us to add the strength of our science and bright perspectives associated with Entolimod development in cancer treatment and radiation defense arenas with a string of immunomodulators developed by Cytocom to form a powerful blend of conceptually and scientifically aligned products. We believe that the merger with Cytocom is the ideal way to unlock the value of our technology platform and our lead drug candidate, Entolimod, and I look forward to seeing this exciting new therapy advance through the clinic."

Conditions

The proposed transaction is subject to customary closing conditions, including approval by the stockholders of Cleveland Biolabs, the shares of the combined company being approved for listing on Nasdaq and a registration statement under the Securities Act becoming effective. Cytocom and Cleveland Biolabs expect the transaction to close during the first quarter of 2021.

Conference Call

Cytocom will host a conference call and live audio webcast at 8:00 a.m. EDT on October 28th to discuss the merger and provide a strategic vision for the combined company. To access the conference call supported with slides, please dial 646-558-8656 with the meeting ID: 841 7826 2704 and passcode: 281020. The conference call can also be accessed at https://cleartrustonline.com/cytocom. Approximately two hours following the live event, a webcast replay of the conference call will be available on Cytocom’s website for approximately 30 days.

On October 19, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported it has entered into an exclusive license agreement with Voronoi, Inc., an innovative drug discovery company dedicated to advancing novel therapeutics. ORIC secured exclusive rights worldwide excluding the People’s Republic of China, Hong Kong, Macau and Taiwan (the ORIC Territory) for the development and commercialization of ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) with high potency against exon 20 insertion mutations (Press release, ORIC Pharmaceuticals, OCT 19, 2020, View Source [SID1234568640]). ORIC expects to initiate a global Phase 1/2 tumor-agnostic trial in genetically defined cancers during the second half of 2021.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"ORIC-114 is well aligned with our mission of overcoming cancer resistance by leveraging our expertise in precision oncology and key tumor dependencies, and it puts us in position for three INDs or equivalents next year," said Jacob Chacko, M.D., president and chief executive officer of ORIC. "ORIC-114 fits with our team’s success in developing therapies for tumor-agnostic mutations, including in patients with brain metastases, and will leverage our team’s prior experience in the pioneering development of entrectinib for genetically defined cancers. We believe Voronoi’s highly selective and brain penetrant inhibitors targeting exon 20 insertion mutations may address an area of significant unmet medical need for which no FDA-approved therapies exist today."

"We are thrilled to be partnering with ORIC to further develop our potential best-in-class EGFR/HER2 exon 20 inhibitor program," said Daekwon Kim, chief executive officer of Voronoi. "With ORIC’s focus on developing targeted cancer therapies and their team’s prior experience in leading efforts for multiple global regulatory approvals for mutant NSCLC and tumor-agnostic indications, ORIC is an ideal partner to further the development of this program."

Under the terms of the agreement, in exchange for an exclusive license to develop and commercialize Voronoi’s EGFR and HER2 exon 20 inhibitor program in the ORIC Territory, ORIC paid to Voronoi a one-time payment comprising $5 million in cash and $8 million in shares of ORIC common stock. The number of shares issued to Voronoi was based on a price of $28.24 per share, representing a premium of 25% to the 30-day trailing volume-weighted average trading price of ORIC’s common stock. In addition, ORIC will pay Voronoi success-based payments of up to $111 million in development and regulatory milestones and up to $225 million in sales milestones with respect to the first licensed product. If ORIC pursues a second licensed product, ORIC would pay Voronoi up to an additional $272 million in success-based milestones. ORIC will also pay tiered mid-single-digit to low double-digit royalties based on annual net sales in the ORIC Territory. ORIC will be responsible for development activities and expenses in the ORIC Territory.

Webcast and Conference Call

ORIC will host a webcast and conference call today, October 19th, at 4:30 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID: 8129902. Please join the conference call at least 15 minutes early to register. A live webcast will be available in the Investors section of the company’s website at www.oricpharma.com. The webcast will be archived for 60 days following the presentation.

About ORIC-114 and Exon 20 Insertion Mutations in EGFR and HER2

The ErbB receptor tyrosine kinase family is involved in key cellular functions, including cell growth and survival. Epidermal growth factor receptor (EGFR, or ErbB1) and human epidermal growth factor receptor 2 (HER2, or ErbB2) exon 20 insertion mutations are observed across multiple solid tumors, including NSCLC, breast, gastrointestinal, bladder and other cancers. EGFR exon 20 insertion mutations are observed in approximately 2% of all patients with NSCLC and have a worse prognosis than patients with NSCLC driven by other EGFR mutations. HER2 exon 20 insertion mutations are observed in approximately 1.5% of all patients with NSCLC. Approximately one-third of patients with exon 20 insertion mutations may develop brain metastases, which contributes to poor prognosis.