On October 25, 2021 Guardant Health, Inc. (Nasdaq: GH), reported that data at the American College of Gastroenterology Annual Scientific Meeting being held from October 22-27, showing its LUNAR-2 blood test, which has been developed to screen average-risk patients for colorectal cancer (CRC), offers optimized sensitivity and specificity in identifying those with early-stage CRC (Press release, Guardant Health, OCT 25, 2021, View Source [SID1234591912]). This study was selected by the ACG Abstract Selection Committee as the recipient of the International Award.

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In the study, researchers evaluated the LUNAR-2 test in a cohort of 699 patients with early-stage (Stage 1, 2, or 3) CRC and found the test achieved an overall sensitivity of 96% in detecting CRC and 94% specificity. These findings are on par with other currently available modalities, such as stool-based screening.1 The limitation of this retrospective study is that the biobanked samples are from individuals with known CRC and 37% of cases had asymptomatic disease.

"We know that the earlier CRC is detected, the better a person’s chances are of surviving it," said Dr. Hee Cheol Kim, study investigator and Professor of Surgery at Samsung Medical Center in Seoul, South Korea. "The clinically meaningful sensitivity and specificity of the LUNAR-2 blood test in detecting CRC, most notably in people with early-stage disease, indicates that it could be a very useful tool in improving patient outcomes."

A further analysis showed that in patients with Stage 1 and 2 CRC, whereby blood-based detection can be especially challenging, the test offered 93% overall sensitivity. Additionally, the blood-based test identified 90% of patients with asymptomatic Stage 1 or 2 CRC, suggesting the test may have meaningful performance in an average-risk screening population. These findings need to get further validated in a registrational screening trial.

"CRC screening saves lives, but we know that only about two-thirds of individuals get screened for CRC2 because current options, like a colonoscopy, are invasive and the preparation can be challenging, and other modalities, like stool based testing, have their own challenges to screening adherence," said AmirAli Talasaz, Guardant Health Co-CEO. "During the COVID-19 pandemic, screening rates have dropped, wellness visits have declined, and postponements of non-emergency medical procedures have made it harder for people to complete life-saving CRC screening. The study results show that the LUNAR-2 test could provide both patients and physicians with an easy-to-use and highly accurate CRC screening alternative in the form of a blood test."

The LUNAR-2 blood test aims to detect early-stage cancer in screen-eligible asymptomatic adults from a simple blood draw. The ECLIPSE trial (NCT04136002), a registrational study with more than 10,000-patients, is currently underway to evaluate the performance of the LUNAR-2 blood test to detect early-stage colorectal cancer. One of the largest cancer screening studies of its kind, ECLIPSE is expected to complete enrollment in 2021 and, if successful, data will support a pre-market approval (PMA) submission to the United States Food and Drug Administration (FDA).

Data Presented at ACG:

Title

Oral Abstract No.

Presenter

Multimodal circulating tumor DNA (ctDNA) blood-based colorectal cancer (CRC) screening test demonstrates clinically meaningful sensititive across multiple clinical perameters

24

Dr. Hee Cheol Kim

On October 25, 2021, Selecta Biosciences, Inc. (the "Company") reported that it entered into a Sales Agreement (the "Sales Agreement") with SVB Leerink LLC ("SVB Leerink") to sell shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), from time to time, through an "at the market" equity offering program under which SVB Leerink will act as sales agent (Filing, 8-K, Selecta Biosciences, OCT 25, 2021, View Source [SID1234591928]). The shares of Common Stock sold pursuant to the Sales Agreement will be issued pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-241692), filed on August 6, 2020 with the Securities and Exchange Commission and related prospectus supplement, with respect to up to $75.0 million in sales of Common Stock, filed on October 25, 2021 with the Securities and Exchange Commission.

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Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitations on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, SVB Leerink may sell the shares by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), at market prices prevailing at the time of sale or at prices related to such prevailing market prices and/or any other method permitted by law. If expressly authorized by the Company, the SVB Leerink may also sell Common Stock in privately negotiated transactions. The Company will pay SVB Leerink a commission of up to 3.0% of the gross sales proceeds of any shares of Common Stock sold through SVB Leerink under the Sales Agreement, and also has provided SVB Leerink with customary indemnification rights. The offering of shares of Common Stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all shares of Common Stock subject to the Sales Agreement and (ii) the termination of the Sales Agreement as permitted therein.

The foregoing description of the material terms of the Sales Agreement is qualified in its entirety by reference to the full agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The legal opinion of Covington & Burling LLP relating to the Common Stock being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On October 25, 2021 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, reported it will host a conference call on Nov 9, 2021 at 8:30 AM Eastern Time to discuss results for its third quarter ended September 30, 2021 (Press release, Delcath Systems, OCT 25, 2021, View Source [SID1234595188]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

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On October 25, 2021 Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, reported that it has raised an additional $25 million in an expansion of its Series B financing, bringing the total amount raised to $82.6 million (Press release, Cedilla Therapeutics, OCT 25, 2021, View Source [SID1234591879]). The oversubscribed Series B expansion includes new investors RA Capital Management, Janus Henderson Investors, Woodline Partners LP and Logos Capital, along with participation from existing investor Third Rock Ventures.

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"We are grateful for the support from our new and existing investors, which reflects the promise of our novel approach to conditionally modulating proteins as well as the unique potential of our lead programs, inhibitors against TEAD and CDK2, two critical but historically undruggable targets," said Alexandra Glucksmann, Ph.D., President and Chief Executive Officer of Cedilla Therapeutics. "With this financing, we plan to accelerate and expand our development efforts by progressing our most advanced programs toward the clinic while continuing to invest in ongoing discovery efforts against additional high value cancer targets."

Proceeds from the financing will support Cedilla’s continued growth and development of its two lead programs, an inhibitor of TEAD for the treatment of solid tumors, such as mesothelioma and certain squamous cell carcinomas, and a highly selective inhibitor of CDK2/Cyclin E for the treatment of multiple tumor types, including CDK4/6-resistant breast cancer, ovarian, uterine, stomach and esophageal cancers. The company plans to initiate investigational new drug application-enabling studies for the TEAD program in the first half of 2022 and for the CDK2 program in the second half of 2022.

In conjunction with the financing, Jake Simson, Ph.D., Partner at RA Capital Management, joins Cedilla’s Board of Directors.

Dr. Glucksmann continued, "We are pleased to welcome Jake to our Board of Directors. He brings a wealth of experience advising companies from the earliest stages of company formation through their maturation into fully integrated biopharmaceutical organizations. We look forward to his many contributions as we continue to grow Cedilla into a clinical-stage organization with a robust and growing portfolio of product candidates."

"Cedilla brings a new dimension to precision oncology by conditionally modulating proteins in their functional state," said Jake Simson, Ph.D., Partner at RA Capital Management. "Preclinical data generated to-date suggest that Cedilla’s lead programs may challenge historical perceptions of TEAD and CDK2 as undruggable targets and could offer patients new options that would be well-tolerated and extremely effective. In addition, Cedilla’s approach, based on a deep understanding of how the cellular context modulates protein activity, could deliver superior inhibitors against a range of other key cancer drivers. I look forward to partnering with the team with the aim to deliver a broad portfolio of small molecule medicines, each with potential profound benefit to patients."

On October 25, 2021 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the Jefferies Gene Therapy/Editing Summit on October 28, 2021 at 3:30 PM ET (Press release, Ultragenyx Pharmaceutical, OCT 25, 2021, View Source [SID1234591897]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.