On April 2, 2020 Exact Sciences Corp. (NASDAQ: EXAS) reported it would be devoting significant patient education resources toward the ability to request Cologuard online through a telehealth provider (Press release, Exact Sciences, APR 2, 2020, View Source [SID1234556086]). During the COVID-19 pandemic, people are staying home to avoid spreading the virus. Telehealth offers a way to screen more people at home, even during a public health crisis.

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"Cancer doesn’t stop for anything. As the country faces a pandemic, we are letting people know they can request Cologuard online from a health care provider, without an office visit," said Kevin Conroy, Exact Sciences chairman and CEO. "While Americans are at home trying to prevent the spread of COVID-19 in their communities, they can address another pressing public health issue and get screened for colorectal cancer."

Colorectal cancer, the second leading cancer killer in the U.S.,1 is more treatable when detected early, making timely screening essential. 2 Despite this, an estimated 53,000 Americans will die this year from colorectal cancer.1 As the only FDA-approved stool DNA test for colorectal cancer, Cologuard found 92% of all colorectal cancers,3 including 94% in stages I and II4 in a large clinical study of patients 50 and older. The United States Preventive Services Task Force (USPSTF) recommends Cologuard as a screening test for average risk patients.5 Patients can use Cologuard without any preparation or changes in diet and medication. The Cologuard collection kit is delivered to a patient’s door, and home pick-up can be scheduled by calling Exact Sciences Laboratories’ 24/7 Customer Care Center at 1-844-870-8870. Test results are provided to the ordering physician in approximately 14 days.

People can visit Cologuardtest.com to learn more about telehealth options for their screening needs, including how telehealth providers can review patient information and risk factors and, if appropriate, prescribe Cologuard. Cologuard is intended to screen adults 45 years of age or older, who are at average risk for colorectal cancer. It is not a replacement for colonoscopy in high-risk individuals. Cologuard is available by prescription only.

Any positive Cologuard test result should be referred for a diagnostic colonoscopy. Recognizing it may be challenging to schedule a follow-up colonoscopy immediately during the COVID-19 pandemic, Exact Sciences is actively exploring ways we may be able to support patients as they navigate those next steps.

Exact Sciences’ testing labs remain operational at this time. Business continuity plans are in place at all sites to help sustain operations and ensure continuity of service for patients during this unprecedented time. Customer Care teams are available 24/7 to help patients complete their Cologuard collection kit and schedule an at-home pick-up by calling 1-844-870-8870. Cologuard kits can also be dropped at any UPS location.

On April 2, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that all three patients of the first dose cohort have been enrolled into the brain cancer clinical trial testing the CXCL12 inhibitor, NOX-A12, and have already received the planned initial treatment (Press release, NOXXON, APR 2, 2020, View Source [SID1234556076]). The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients in a Phase 1/2 clinical trial.

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Once the last patient in the first cohort reaches four-weeks of therapy of NOX-A12 combined with radiotherapy, the independent Data Safety Monitoring Board (DSMB) will determine whether it is safe to proceed from the low to the middle dose level of NOX-A12. Under the approved protocol, it is planned that each patient is treated with NOX-A12 for up to six months.

"The combination of NOX-A12 and radiotherapy has so far been well-tolerated by the patients that participated in this clinical trial. This is a very important first step in the clinical assessment of a new treatment option for these very difficult-to-treat patients with highly aggressive brain cancer," said Dr. Frank Giordano, Chairman of the Department of Radiation Oncology at the University Hospital Bonn.

"Due to the seriousness of the disease we are studying, recruitment into this trial continues in two of our three study centers, despite the challenges that hospital staff face as a result of the COVID-19 pandemic. Provided the next safety analysis after four weeks of treatment confirms the benign safety profile NOX-A12 has shown thus far, the trial will progress so the next patients can receive a higher dose as planned in the protocol," commented Aram Mangasarian, CEO of NOXXON. "Six months of data from the first cohort of patients should be available in October 2020, and from the second and third cohorts in the end of Q1 2021 and mid-2021, respectively. As a measure to ensure the timely completion of the study under the current challenging conditions of the COVID-19 pandemic, we are planning to include additional clinical sites to increase recruitment capacity."

In April 2020, Alnylam Pharmaceuticals, Inc. (the "Company") reported that entered into a strategic financing collaboration with certain affiliates of The Blackstone Group Inc., including funds or accounts managed or advised by GSO Capital Partners LP, Blackstone’s credit platform, to support the Company’s advancement of its innovative RNA interference (RNAi) therapeutics (Filing, 8-K, Alnylam, APR 1, 2020, View Source [SID1234563904]). As part of this collaboration, the Company and Blackstone Life Sciences Advisors L.L.C., an affiliate of The Blackstone Group Inc., agreed in principle on a non-binding term sheet that described a $150 million funding arrangement for certain of the Company’s development programs. In furtherance of this effort, on August 15, 2020, the Company entered into a Co-Development Agreement (the "Funding Agreement") with BXLS V Bodyguard – PCP L.P. and BXLS Family Investment Partnership V – ESC L.P. (collectively, "Blackstone"), pursuant to which Blackstone will provide up to $150 million in funding for the clinical development of vutrisiran and ALN-AGT, two of the Company’s cardiometabolic programs. Blackstone’s funding for vutrisiran is a commitment to provide up to $70 million to fund development costs related to the HELIOS-B Phase 3 clinical trial. In addition, Blackstone has the right, but is not obligated, to fund up to $26 million for development costs related to a Phase 2 clinical trial of ALN-AGT and up to $54 million for development costs related to a Phase 3 clinical trial of ALN-AGT. Alnylam retains sole responsibility for the development and commercialization of both vutrisiran and ALN-AGT.

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As consideration for Blackstone’s funding for vutrisiran clinical development costs, the Company has agreed to pay Blackstone a 1% royalty on net sales of vutrisiran for a specified royalty term, as well as tranched payments over a two-year period upon regulatory approval of vutrisiran for ATTR-cardiomyopathy in specified countries, unless it is later withdrawn from the market following a mandatory recall. As consideration for Blackstone’s funding for Phase 2 clinical development costs of ALN-AGT, the Company has agreed to pay Blackstone tranched payments over a four-year period upon the successful completion of the ALN-AGT Phase 2 clinical trial, unless certain regulatory events affecting the continued development of ALN-AGT occur. As consideration for Blackstone’s funding for Phase 3 clinical development costs of ALN-AGT, the Company has agreed to pay Blackstone tranched payments over a four-year period upon regulatory approval of ALN-AGT in specified countries, unless it is later withdrawn from the market following a mandatory recall. In each case, the aggregate tranched payment amount represents an agreed multiple of Blackstone’s investment in the applicable program and will be decreased if Blackstone does not fund the maximum amount of the funding obligation or right, as applicable. The Company’s payment obligations under the Funding Agreement will be secured, subject to certain exceptions, by security interests in intellectual property owned by the Company relating to vutrisiran and ALN-AGT, as well as in the Company’s bank account in which Blackstone’s funding deposits will be made.

The funding arrangement will be governed by a joint steering committee that will be comprised of an equal number of representatives from each party.

The Company and Blackstone each have the right to terminate the Funding Agreement in its entirety in the event of the other party’s bankruptcy or similar proceedings. The Company and Blackstone may each terminate the Funding Agreement in its entirety or with respect to either product in the event of an uncured material breach by the other party, or with respect to a product for certain patient health and safety reasons, or if regulatory approval in specified major market countries is not obtained for the product following the completion of clinical trials for the product. In addition, Blackstone has the right to terminate the Funding Agreement in its entirety upon the occurrence of certain events affecting the Company’s ability to make payments to Blackstone or to develop or commercialize the products, or upon a change of control of the Company. Blackstone may also terminate the Funding Agreement with respect to a product if the joint steering committee elects to terminate the development program for that product in its entirety, if certain clinical endpoints are not achieved for that product or, with respect to vutrisiran only, if the Company’s right to develop or commercialize vutrisiran is enjoined in a specified major market as a result of an alleged patent infringement. In certain termination circumstances, the Company will be obligated to pay Blackstone an amount that is equal to, or otherwise based on, the development funding received from Blackstone, and the Company may remain obligated under certain circumstances to make the tranched payments to Blackstone described above, or the royalty described above in the case of vutrisiran, should the Company obtain regulatory approval for vutrisiran or ALN-AGT following termination.

The Funding Agreement includes various representations, warranties, covenants, dispute escalation and resolution mechanisms, indemnities and other provisions customary for transactions of this nature.

Amendment to Credit Agreement

In connection with the Funding Agreement, on August 15, 2020, the Company entered into the First Amendment (the "First Amendment") to the Credit Agreement dated April 10, 2020 among the Company, certain subsidiaries of the Company, funds or accounts managed or advised by GSO Capital Partners LP and certain other affiliates of The Blackstone Group Inc. and the other lenders from time to time party thereto, and Wilmington Trust, National Association, as the administrative agent for the lenders (the "Credit Agreement"). The First Amendment adds certain intellectual property owned by the Company relating to ALN-AGT as collateral under the Credit Agreement and makes certain other amendments related thereto and the Funding Agreement.

On April 1, 2020 Invitae Corporation (NYSE: NVTA) reported that it has commenced an underwritten public offering of $125.0 million of shares of its common stock, before deducting underwriting discounts and commissions and other offering expenses (Press release, Invitae, APR 1, 2020, View Source [SID1234561377]). All of the shares are being offered by Invitae. In addition, Invitae expects to grant the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. 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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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as the book-running managers for the offering.

An automatic shelf registration statement relating to the shares was filed with the Securities and Exchange Commission and became effective on March 4, 2019. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926.

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

On April 1, 2020 Oncoceutics, Inc., reported that it was informed by its Japanese licensee, Ohara Pharmaceutical Co., Ltd., of the initiation of a Phase I/II clinical study of OP-10 (the Japanese name for ONC201) in Japan and the administration of the drug to the first patient (Press release, Oncoceutics, APR 1, 2020, View Source [SID1234558313]).

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ONC201 is a novel small molecule with a unique mechanism of action that has demonstrated anti-cancer activity and safety in preclinical models and in several ongoing clinical trials, including clinical trials in adult and pediatric patients with high-grade glioma. In February 2019, Oncoceutics outlicensed rights to ONC201 for Japan to Ohara. Under this strategic partnership, Ohara is responsible for conducting clinical trials required to obtain Marketing Authorization in Japan and the commercialization of ONC201 in the Japanese market.

"We are excited to continue to work with the dedicated team of experts at Ohara as we expand the development of ONC201 to important markets outside the U.S.," said Lee Schalop, MD, Chief Operating Officer of Oncoceutics. "This clinical trial provides Japanese patients with high-grade glioma immediate access to ONC201, and data from this study will be an important part of working toward a Japanese market approval for ONC201."