On October 29, 2019 Femtogenix Ltd, a UK biotechnology company developing the next generation of DNA-interactive Antibody Drug Conjugate (ADC) payloads, reported data demonstrating the potent efficacy and favourable toxicity profile of a reduced potency analogue from its Pyridinobenzodiazepine (PDD) ADC payload platform in solid tumour models (Press release, Femtogenix, OCT 29, 2019, View Source [SID1234549972]). The data is being presented at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), Boston,USA.

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Within its PDD platform, Femtogenix has developed a lower potency DNA mono-alkylator with superior in vivo properties to other DNA alkylating agents, illustrating a promising new approach in the development of ADCs for difficult-to-treat tumours. When attached to antibodies or other targeting moieties, Femtogenix’s novel PDD payload platform allows reversible/irreversible DNA minor groove binding, in a sequence-interactive manner, leading to highly targeted cytoxicity towards tumour cells. The payloads are designed to have a novel mechanism of action and IP space compared to existing DNA-interactive payloads, to have minimal hydrophobicity and to be resistant to P-Glycoprotein pumps in tumour cells.

These new data demonstrate that Femtogenix’s reduced potency payload has a favourable toxicity profile in rats, potent in vivo efficacy (MED < 1 mg/kg), and improved tolerability (i.e., MTD of 40 mg/kg) in solid tumour models when conjugated to antibodies.1 Its toxicity profile and wide therapeutic window is coupled with the ability to increase drug-antibody ratio (DAR) beyond the traditional limit of two, for increased conjugation to antibodies.

Professor David Thurston, Chief Scientific Officer, commented: "The favourable hydrophobicity profile of the low potency mono-alkylator and its ease of conjugation, along with the significant in vivo efficacy and tolerability of the ADCs produced, suggest that this payload represents a promising new approach in ADC development, specifically for the treatment of solid tumour malignancies."

Femtogenix has generated extensive data on mechanism of action (MOA) of the ADC payload, illustrating a primary MOA of DNA alkylation, coupled with an ability to inhibit transcription factors. The molecules have been designed through proprietary molecular modeling methodologies to maximise interaction within the DNA minor groove. Payloads with differing potencies and modes of action may be suitable for particular uses or specific target situations.

Dr Nicolas Veillard, PhD, Team Leader, Femtogenix: ‘A new low potency DNA guanine monoalkylating ADC payload with enhanced in vivo tolerability’ (C030), poster session C 12:30–4:00pm, 29 October 2019, AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper)

On October 29, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Tuesday, November 5, 2019 at 5:00 p.m. ET to report its third quarter 2019 financial results and provide a corporate update (Press release, Fate Therapeutics, OCT 29, 2019, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-third-5 [SID1234549971]).

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In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 4748666. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On October 29, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $218.8 million and screened approximately 456,000 people with Cologuard during the quarter ended September 30, 2019. Third-quarter 2019 revenue and test volume grew 85 percent and 89 percent, respectively, from the same period of 2018 (Press release, Exact Sciences, OCT 29, 2019, View Source [SID1234549970]).

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"The Exact Sciences team delivered another strong quarter and most importantly, has screened more than 3 million people with Cologuard over the last 5 years," said Kevin Conroy, chairman and CEO of Exact Sciences. "The team made significant progress enhancing our internal infrastructure with the opening of our new lab and implementation of Epic’s best-in-class electronic health record system. The foundation we’ve built for Cologuard and our planned combination with Genomic Health position Exact Sciences to be the cancer diagnostics leader for years to come."

Third-Quarter 2019 Financial Results

For the three-month period ended September 30, 2019, as compared to the same period of 2018 (where applicable):

Revenue was $218.8 million, an increase of 85 percent, and Cologuard test volume was 456,000, an increase of 89 percent
Average Cologuard recognized revenue per test was $479, a decline of $13
Average Cologuard cost per test was $114, an improvement of $10 per test
Gross margin was 76 percent, an increase of 130 basis points
Operating expenses were $201.7 million, an increase of 56 percent
Transaction-related costs for the planned Genomic Health combination were $7.1 million, and integration-related costs were $2.1 million
Net loss was $40.5 million, or $0.31 per share, compared to $45.4 million, or $0.37 per share
Non-cash interest expense related to convertible debt was $11.0 million, or $0.08 per share, compared to $8.4 million, or $0.07 per share
Cash utilization was $78.9 million, compared to $36.9 million; the third quarter cash use included $43.2 million of fees paid to Pfizer for services incurred from October 2018 through the end of June 2019
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
2019 Outlook

The company anticipates revenue of $802-$810 million during 2019. The company’s revenue guidance does not include the impact of the pending combination with Genomic Health.
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Forward-Looking Statements" section of this news release.

Third-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Tuesday, October 29, 2019, at 5 p.m. ET to discuss third-quarter 2019 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-235-7650 and international callers should dial +1-647-689-4171.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4168628. The webcast, conference call and replay are open to all interested parties.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer or precancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative).

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On October 29, 2019 Promising research from Exact Sciences Corp. and Mayo Clinic shows new methylation and protein markers detect colorectal cancer and advanced adenomas with high accuracy (Press release, Exact Sciences, OCT 29, 2019, View Source [SID1234549969]). Findings from the blinded, case-control study were presented at the American College of Gastroenterology’s (ACG) 2019 Annual Scientific Meeting today. The study is part of an effort to increase specificity of Cologuard, while maintaining its high level of sensitivity. Working in collaboration with Mayo Clinic, Exact Sciences has identified novel markers and improved laboratory processes to help achieve its performance enhancement goals and has initiated a 10,000-patient prospective study to validate the performance of the enhanced test.

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The new markers were tested alongside the current Cologuard markers on 725 stool samples, including 117 colorectal cancers (CRC), 120 advanced adenomas (AA), 161 non-advanced adenomas (non-AA), and 327 controls. Results showed 92% CRC sensitivity and 65% AA sensitivity at 92% specificity for the new markers. In this study, the new markers exceeded the specificity and sensitivity of the markers currently used in Cologuard.

Current markers * 87%
specificity

New markers

92% specificity

Difference

CRC sensitivity

88%

92%

+4%

AA sensitivity

53%

65%

+12%

Re-weighted AA sensitivity **

39%

46%

+7%

*Cologuard performance was established in DeeP-C, a prospective study of 10,000 average-risk, asymptomatic patients. The data displayed in this table show performance in a smaller case-control study of 725 samples.

**AA sensitivity re-weighted to match distribution by size of adenoma found in DeeP-C. AA sensitivity is expected to be lower in a prospective study.

"The data presented at ACG are promising," said Kevin Conroy, chairman and CEO of Exact Sciences. "This new study demonstrates the potential to make Cologuard, an accurate, convenient screening option, even better for patients and gives us confidence to move forward with a prospective study. We look forward to generating additional evidence, making an enhanced test available to patients, and solidifying Exact Sciences as the leader in the early, accurate detection of colorectal cancer."

To establish the sensitivity and specificity of the novel multi-target stool DNA test, Exact Sciences recently launched the BLUE-C study, a multi-center, prospective study, with the first patient expected to enroll this November. More than 10,000 patients 40 years of age and older and scheduled for a CRC screening colonoscopy will be enrolled. Patients will collect a stool sample and perform a commercially available fecal immunochemical test (FIT) prior to screening colonoscopy. Patients will be invited to provide a blood sample that Exact Sciences intends to use for validation of a potential blood-based screening test for CRC. Collecting stool and blood in one study is expected to provide significant cost and timing efficiencies.

Screening for CRC can help save lives by preventing the disease or detecting it early.1 Tests that can help accurately detect AAs and early-stage CRC provide the best chance of preventing or treating the disease before it progresses. CRC invades more layers of the colon wall and the blood supply as it advances, making it difficult for blood-based tests to accurately detect early-stage disease.2 Even with this biological limitation, blood-based tests could provide another option to get more people screened.

"While further studies will establish the clinical performance of these new markers, we are encouraged by the strong results presented today," said Paul Limburg, MD, MPH, AGAF, chief medical officer of Exact Sciences and gastroenterologist at Mayo Clinic. "The discovery of these markers by the Exact Sciences and Mayo Clinic teams is fueled by our spirit to continuously improve and advance the fight against this deadly disease."

About the BLUE-C study
The primary objective of this multi-center, prospective study is to determine the sensitivity and specificity of a novel multi-target stool DNA (mt-sDNA) screening test for CRC, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination. Patients 40 years of age and older who are scheduled for a CRC screening colonoscopy will be eligible to participate. After providing written consent to participate in the study and before a screening colonoscopy, subjects will be provided with a stool collection kit and will collect a stool sample for the mt-sDNA screening test and for a commercially available FIT test. Subjects will undergo colonoscopy within approximately 60 days of enrollment. Subjects and clinicians will remain blinded to the results of the mt-sDNA CRC screening test and the FIT test, which will not be used in clinical management. Enrolled subjects will have the option to enroll in a blood collection sub-study for the development of a potential blood-based screening test for CRC.

On October 29, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported that two posters updating results from the company’s two Phase 2 clinical trials of VAL-083 will be presented at the 2019 Society for NeuroOncology Annual meeting in Phoenix, Ariz (Press release, DelMar Pharmaceuticals, OCT 29, 2019, View Source [SID1234549968]). Details regarding the posters are as follows:

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Title: "Clinical Trial of VAL-083 in Newly-Diagnosed MGMT-unmethylated GBM: Half-Way Report"
Date/Time: Friday, November 22, 2019, 6:00 PM MT
Lead Author: Dr. Zhong-Ping Chen
This poster will include data from the company’s ongoing Phase 2 trial of VAL-083 being conducted at Sun Yat-sen University Cancer Center as a first line therapy, and includes updates on enrollment, safety and efficacy.

Title: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the recurrent and adjuvant setting"
Date/Time: Friday, November 22, 2019, 6:00 PM MT
Lead Author: Dr. Barbara O’Brien
This poster will include data from the company’s ongoing Phase 2 trial of VAL-083 being conducted at M.D. Anderson Cancer Center as a treatment in the recurrent and adjuvant settings, and includes updates on enrollment, safety and efficacy.

The 2019 Society for NeuroOncology Annual meeting will be held from November 20-24, 2019 at the JW Marriott Desert Ridge, 5350 E. Marriott Drive in Phoenix, Ariz.