On September 16, 2020 Canexia Health reported a new financing round from PacBridge Capital Partners (HK) Limited to propel the company’s long-term global growth and accelerate its roadmap to make cancer testing for treatment selection and monitoring accessible to all cancer patients (Press release, Contextual Genomics, SEP 16, 2020, View Source [SID1234565256]). The investment signals Canexia Health’s record-breaking growth in 2020 to date, with new customer collaborations and studies, product enhancements, and reimbursement progress.

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"This has been a year of incredible growth for Canexia Health. Since the beginning of 2020, we have welcomed new customers and collaborators, and we are well on the path to democratize how oncologists gain information about cancer treatment selection and monitoring"

Highlights include:

● New collaborations. In the first half of 2020, the company increased commercial partner agreements by 65%. One new collaborator is Genolife, a private clinic that provides access to personalized genetic tests and genetic counselling services. Genolife will offer Canexia Health’s circulating tumor DNA (ctDNA) assay, Follow It, in Quebec. Additional new commercial partner agreements include AstraZeneca Canada, the Eastern Ontario Regional Laboratory Association (EORLA), and Queen’s University. All are involved in Project ACTT, and EORLA and Queens University will adopt Canexia’s technology transfer model to bring ctDNA testing in-house. Project ACTT is a CAD $2.59M initiative led by Canexia Health and supported by Canada’s Digital Technology Supercluster to deploy and enhance Follow It for 2,000 patients during COVID-19 as an alternative to surgical tissue biopsies.

● Monitoring studies. Monitoring is a $15B market opportunity in the US alone. Adding to its portfolio of monitoring studies, Canexia Health is collaborating with Exactis Innovation, a pan-Canadian Networks Centres of Excellence comprising 14 oncology centers. The research study, led by Dr. Simon Turcotte at the Centre de Recherche Centre Hospitalier de l’Université de Montréal, will deploy Follow It to analyze ctDNA and investigate non-invasive early detection of treatment failure in patients with metastatic colorectal cancer who are undergoing systemic chemotherapy and liver resection. Following definitive surgery, disease recurrence is seen in 50-75% of patients within 2 years, highlighting the importance of recurrence risk prediction and disease monitoring in this patient population.

● Product enhancements. Canexia Health continues to expand the genomic content of its assays, including MSI and CNV content, as well as recently releasing updates to the Canexia Health Fusions panel. The company has also improved the sensitivity of its liquid biopsy assays for use in monitoring and leveraged tens of thousands of processed samples to improve its AI and machine learning algorithms.

● Reimbursement progress. Via partner Lab Genomics, Follow It has received a unique Z code, representing a key reimbursement milestone with the US Centers for Medicare and Medicaid.

● Corporate rebrand and growth. In July, the company rebranded from Contextual Genomics to Canexia Health to reflect the company’s deep focus on cancer patients and on building a community nexus to make precision oncology affordable and accessible. The company has also increased its full-time workforce by 35% since March 2020 with the addition of new hires in the laboratory, as well as in computational science, software, business development, and marketing.

"This has been a year of incredible growth for Canexia Health. Since the beginning of 2020, we have welcomed new customers and collaborators, and we are well on the path to democratize how oncologists gain information about cancer treatment selection and monitoring," said Michael Ball, CEO of Canexia Health. "Further, we have built a clinically focused molecular test specifically for those who want to bring this technology in-house. The faster you can get an individual on targeted therapy, the better their outcomes are likely to be. Building in-house capabilities and thus making cancer testing more accessible, that’s really the focus for our company moving forward."

On September 16, 2020 Roche reported that it will publish its Sales Results for the 3rd Quarter of 2020 prior to the opening of the Swiss Stock Exchange on Thursday, October 15th, 2020 (Press release, Hoffmann-La Roche, SEP 16, 2020, View Source [SID1234565217]).

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On September 16, 2020 NuCana plc, a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, reported that it has commenced an underwritten public offering of its American Depositary Shares ("ADSs") (Press release, Nucana BioPharmaceuticals, SEP 16, 2020, View Source [SID1234565240]). Each ADS represents one ordinary share of NuCana. In addition, NuCana expects to grant the underwriters a 30-day option to purchase up to an additional 15% of its ADSs at the public offering price, less underwriting discounts and commissions. All of the ADSs are being offered by NuCana. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

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Jefferies, Cowen, William Blair, and Truist Securities are acting as joint book-running managers for the offering.

The securities are being offered pursuant to a registration statement on Form F-3 which has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on October 22, 2018. This offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. Copies of the preliminary prospectus supplement related to this offering and the accompanying prospectus will be filed with the SEC and will be available on the SEC’s website at www.sec.gov and may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340 or by e-mail at [email protected], or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, email: [email protected], telephone: 1-833-297-2926, or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at [email protected], or Truist Securities, Inc., 3333 Peachtree Road NE, 9th Floor, Atlanta, GA 30326, Attention: Prospectus Department; email: [email protected]. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of the Prospectus Regulation (as defined below) and will not have been reviewed by any competent authority in any EEA member state or the United Kingdom.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

On September 16, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 showing that MammaPrint’s Ultra-Low risk threshold can identify postmenopausal breast cancer patients who will have an excellent prognosis with limited or no tamoxifen treatment (Press release, Agendia, SEP 16, 2020, View Source [SID1234565257]).

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The presentation, "Avoid systemic overtreatment of postmenopausal breast cancer patients with Ultralow MammaPrint result," can be found in the ESMO (Free ESMO Whitepaper) virtual exhibit.

Adjuvant anti-estrogen therapy is a widely-used therapy for estrogen receptor positive breast cancers, but as with many cancer treatments, may cause serious side effects. In this analysis, researchers sought to validate whether the MammaPrint Ultra-Low risk category can accurately identify postmenopausal, node-negative breast cancer patients who would have an excellent survival rate after surgery with no chemotherapy and a limited duration of or even no endocrine therapy.

This study confirms findings from the STO-3 Trial, previously published in 2017 in JAMA Oncology, and continues to show that the use of MammaPrint to stratify patient populations could help prevent the overtreatment of breast cancer patients.

"These data are particularly exciting because they continue to demonstrate utility for MammaPrint in the clinically low risk patient population. The study suggests that we may be able to de-escalate endocrine treatment for these patients," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "We are pleased to present results that illustrate not only the potential of MammaPrint to identify which patients may be spared chemotherapy, but also to indicate patients who may not require five years, and certainly not ten years, of endocrine therapy. These data could be used to spare some women with ultra-low risk breast cancer from being over-treated."

Agendia is committed to providing immediate, actionable data points and furthering research that will allow for breast cancer patients and their care teams to confidently make the most personalized treatment decisions

On September 15, 2020 Carina Biotech and Sydney-based immuno-oncology company Glytherix reported a co-development agreement that could result in a promising new CAR-T therapy that is effective in killing a range of cancers (Press release, Carina Biotech, SEP 15, 2020, View Source [SID1234565138]).

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Glytherix is developing its proprietary antibody Miltuximab for the targeted treatment of a number of cancers. Miltuximab is specific for GPC-1, a protein found in solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal and ovarian cancers, and is not present in healthy tissue.

The agreement with Glytherix will see Carina use its CAR-T development platform to create and optimise a library of CAR-T cells targeted at GPC-1, creating jointly owned IP.

This is the second recent commercial deal for Carina, after it sold the IP rights to its first successful CAR-T cell to UK-based biopharmaceutical company Biosceptre in July 2020.

Deborah Rathjen, PhD, CEO of Carina Biotech says: "We are delighted to have partnered with Glytherix, a company that shares our vision of defeating cancer. Carina Biotech has substantial experience in creating potent, targeted CAR-T cell-based therapies. Combining our knowledge and expertise, we believe will lead to the identification of a GPC-1-targeted CAR-T cell that is effective in killing a range of cancers."

Brad Walsh, PhD, CEO of GlyTherix Ltd, commented: "We are excited to commence our CAR-T development program with Carina Biotech, whose expertise, track record and experienced management made it an easy choice. We are looking forward to working together on this unique target with a view to making a difference in the lives of cancer patients, particularly those with currently limited treatment options."

ABOUT GLYTHERIX Glytherix, is an Australian immuno-oncology company specialising in therapeutics for solid tumours expressing Glypican-1 (GPC-1), the basis for its proprietary antibody Miltuximab. Glytherix are investigating multiple mechanisms of action including radioimmunotherapy, bi-specific antibodies and immune cell engagement and activation. They have completed a ‘first-in-human’ clinical trial of 12 patients with advanced prostate, bladder and pancreatic cancer using Miltuximab, with no drug-related adverse events observed. Glytherix are based in Sydney, adjacent to Macquarie University and the Macquarie University Hospital, one of their key collaborators.