On September 6, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported entry into a $35 million non-dilutive long-term debt facility with Runway Growth Capital LLC (Runway), a leading provider of loans to venture and non-venture backed companies seeking non-dilutive capital (Press release, Tracon Pharmaceuticals, SEP 6, 2022, View Source [SID1234619070]).

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"This non-dilutive financing extends our cash runway to support the robust accrual of the pivotal ENVASARC trial while we await completion of the Phase 1 TJ4309 clinical trial that triggers I-Mab’s license termination option for $9 million as well as the outcome of the binding arbitration with I-Mab, both of which are expected this quarter," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are pleased to partner with Runway, which seeks long-term relationships with late-stage life science companies who will benefit from non-dilutive capital."

"We are excited to enter into this facility with TRACON to help them achieve their goal of bringing envafolimab, the world’s first subcutaneous checkpoint inhibitor, to market in the underserved indication of sarcoma," said Igor DaCruz, Managing Director, Life Sciences at Runway.

$10 million of the $35 million loan was funded upon closing. The additional $25 million available under the facility may be funded upon achievement of certain clinical milestones and at Runway’s discretion. The loan has a 24-month interest-only period followed by 24 monthly payments of principal and interest. In connection with the debt financing, TRACON issued Runway warrants to purchase up to 150,753 of its common stock at an exercise price of $1.99 per share.

Proceeds from the facility will be used to support the ongoing pivotal ENVASARC trial and for general corporate purposes.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

On September 6, 2022 Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, reported new data showing that the deep learning capabilities of the Nucleai platform accurately analyzed and classified the spatial arrangement of immune cells in the tumor microenvironment (TME) to identify metastatic non-small cell lung cancer (mNSCLC) patients who are likely to benefit from pembrolizumab, an immune checkpoint inhibitor (ICI) therapy (Press release, Nucleai, SEP 6, 2022, View Source [SID1234619087]). This work is part of several ongoing studies examining the spatial arrangement of immune cells in the TME and the significance of this research is its potential to identify new predictive spatial immune signatures in a large-scale, multi-site patient dataset.

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Nucleai will present the new data in a poster presentation at ESMO (Free ESMO Whitepaper) Congress 2022 in Paris on Monday, September 12.

Lung cancer is among the leading causes of cancer death for men and women worldwide, as well as the second most commonly diagnosed cancer. NSCLC is the most common type of lung cancer in the United States, accounting for 82% of all lung cancer diagnoses, according to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

While ICI is the standard treatment for mNSCLC, only a small proportion of patients derive durable clinical benefit. PD-L1 has been shown to be limited as a predictive indicator. However, spatial arrangements of immune cells in the TME have emerged as a potential biomarker for ICI efficacy. The new data from Nucleai’s spatial biology-centric study of lung cancer patients directly addresses the medical community’s need for better predictive biomarkers for improving clinical decision-making. Nucleai teamed up with the Hospital of the University of Pennsylvania, Thomas Jefferson University Hospital, Sheba Medical Center and Rabin Medical Center for the study.

"Identifying NSCLC patients who are exceptionally sensitive to immune checkpoint inhibitor therapy as monotherapy may improve clinical decision making," said Ori Zelichov, MD, VP of Clinical Development at Nucleai. "The results of our NSCLC study can help pharma companies select patients for clinical trials based on the likelihood of response to an ICI therapy and support physicians in planning the optimal treatment for their patients."

Overview of the Study

Nucleai evaluated this predictive role by utilizing deep learning models to extract TME features from digitalized H&E whole slide images. mNSCLC patients treated with first line single-agent pembrolizumab in four medical centers in Israel and the US were identified. Patients were randomly assigned into training and test sets.

Pre-treatment H&E WSI were analyzed using a deep learning model to identify and classify tumor, immune and fibroblast cells as well as tumor, necrotic and stromal areas and dozens of spatial features were calculated per patient. Baseline patient characteristics and PD-L1 scores were similar between the positive and negative groups. Details will be shown at the medical oncology-focused ESMO (Free ESMO Whitepaper) conference.

Poster Presentation

Nucleai will present the scientific poster on Monday, September 12 during the NSCLC session at the ESMO (Free ESMO Whitepaper) Congress in France. The poster number is 1068P.

On September 6, 2022 Insmed Incorporated ( Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that management will present at the following investor events (Press release, Insmed, SEP 6, 2022, View Source [SID1234619106]):

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The Morgan Stanley 20th Annual Global Healthcare Conference in New York, NY on September 12, 2022 at 9:55 a.m. ET in a fireside chat
The H.C. Wainwright 24th Annual Global Investment Conference in New York, NY on September 13, 2022 at 5:00 p.m. ET in a fireside chat
Each fireside chat will be webcast and can be accessed by visiting the investor relations section of the Company’s website at www.insmed.com. Each webcast will be archived for a period of 30 days following the respective presentation dates.

On September 6, 2022 Illumina, Inc. (NASDAQ:ILMN), reported a decision from the European Commission prohibiting the company’s acquisition of GRAIL (Press release, Illumina, SEP 6, 2022, View Source [SID1234619123]). The company is reviewing the Commission’s order and intends to appeal the decision. The EC decision follows last week’s ruling by US Federal Trade Commission judge in favor of Illumina’s acquisition of GRAIL.

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"We are disappointed with the European Commission’s decision prohibiting us from acquiring GRAIL back to Illumina," said Charles Dadswell, General Counsel of Illumina. "Illumina can make GRAIL’s life-saving multi-cancer early detection test more available, more affordable, and more accessible – saving lives and lowering healthcare costs. As we continue to believe, this merger is pro-competitive and will accelerate innovation. Last week the Chief Judge of the US Federal Trade Commission issued a decision supporting Illumina acquiring GRAIL."

In addition, to prepare for the anticipated divestment order from the European Commission in the coming months, the company will begin reviewing strategic alternatives for GRAIL in the event the divestiture is not stayed pending Illumina’s appeal.

The merger of Illumina and GRAIL would usher in a transformational phase in the detection and treatment of cancer by facilitating equal and affordable access to the life-saving early cancer detection Galleri test.

With a single blood test, Galleri can screen asymptomatic patients for more than 50 types of cancer, many of which have no other form of screening and are often caught too late to treat effectively. In addition, Galleri can identify the tissue in which a cancer has developed. Galleri is unique as a multicancer early detection test suitable for general population screening. There is no other test available for this purpose. Galleri is available today in the US and the UK, but not in the European Union.

Illumina would accelerate GRAIL’s commercial entry into the EU at scale by at least five years, saving tens of thousands of lives in the EU and billions of euros in healthcare costs.

A combined Illumina and GRAIL is key to helping the European Union achieve the goals outlined in Europe’s Beating Cancer Plan, which states: "Early detection through screening offers the best chance of beating cancer and saving lives." Today, 71% of cancer-related deaths are in cancers with no recommended screening. With limited screening, cancer is more likely to be detected in late stages but when we diagnose cancer too late, less than 20% of patients will survive more than 5 years. In contrast, if we diagnose cancer early, approximately 90% of patients are expected to survive beyond five years.1 The GRAIL merger would not only accelerate multicancer early detection in the EU but would also reduce inequity in cancer care by making early diagnosis affordable and widespread, another key priority of Europe’s Beating Cancer Plan.

1 Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov)

Illumina is separately appealing a July 2022 decision by the General Court of the European Union regarding the European Commission’s jurisdiction to challenge the GRAIL deal.

On September 6, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that the company is scheduled to participate in the following investor conferences (Press release, Cytokinetics, SEP 6, 2022, View Source [SID1234619173]):

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Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022 at 8:10 AM ET in a fireside chat with Fady I. Malik, M.D., Ph.D., Executive Vice President of Research and Development, and Andrew Callos, Chief Commercial Officer, at the Sheraton New York.
H.C. Wainwright 24th Annual Global Investment Conference on Tuesday, September 13, 2022 at 12:30 PM ET in a presentation with Fady I. Malik, M.D., Ph.D., Executive Vice President of Research and Development, at the Lotte New York Palace Hotel.
Interested parties may access the live webcast of these presentations by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.