On August 7, 2020 Guardant Health reported the U.S. Food and Drug Administration (FDA) has approved liquid biopsy, Guardant360 CDx, for tumor mutation profiling in patients across all solid cancers (Press release, Guardant Health, AUG 7, 2020, View Source [SID1234563190]).

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For Guardant Health Asia, Middle East and Africa (AMEA), this FDA approval represents a landmark achievement for the Guardant360 test. Currently, the liquid biopsy is commercially available in 41 countries in AMEA. For advanced cancer patients, this FDA approval lends even greater credibility to the test and its ability to provide comprehensive genomic profiling information that is critical to their cancer treatment.

"This FDA approval is a significant milestone for us and it will certainly boost our efforts in offering Guardant360 as the preferred liquid biopsy option in AMEA. We remain committed to making the Guardant360 test available to as many advanced cancer patients as possible so that they can undergo complete genotyping and have the best opportunity to receive the right treatment for their cancer," said Mr Simranjit Singh, Chief Executive Officer of Guardant Health AMEA.

"The US FDA approval validates the technology behind the Guardant360 assay that we offer to advanced stage cancer patients in AMEA. Treatment guidelines recommend testing for more than 20 different genomic biomarkers. Evaluating each mutation individually wastes time and delays treatment. With Guardant360, physicians and patients can feel confident that relevant genes are being assessed with a single blood test. Results are available within 7 days from receipt in the laboratory. This will help more patients start treatment sooner with appropriate precision cancer medicines," said Dr. Steve Olsen, Chief Medical Officer of Guardant Health AMEA.

Guardant Health AMEA hopes to accelerate wider adoption of guideline-recommended genomic profiling in clinical practice among medical oncologists so that advanced cancer patients in AMEA can benefit from reliable and comprehensive liquid biopsies such as Guardant360 and be treated quickly and accurately.

On August 7, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the pricing of an underwritten offering of $1.250 billion aggregate principal amount of senior unsecured notes due 2030 (the "2030 notes") and $750 million aggregate principal amount of senior unsecured notes due 2050 (the "2050 notes" and, together with the 2030 notes, the "notes") (Press release, Regeneron, AUG 7, 2020, View Source [SID1234563189]). The 2030 notes will bear interest at 1.750% per annum and will mature on September 15, 2030. The 2050 notes will bear interest at 2.800% per annum and will mature on September 15, 2050. The issuance of the notes is expected to close on or around August 12, 2020, subject to customary closing conditions.

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Regeneron intends to use the net proceeds from the offering to repay in full the $1.5 billion principal amount of loans outstanding under the bridge facility incurred to fund a portion of the repurchase by Regeneron of shares of its common stock held by Sanofi in May 2020, and to pay accrued interest and related fees and expenses in connection therewith. The remainder will be used for other general corporate purposes.

Goldman Sachs & Co. LLC, BofA Securities, and J.P. Morgan are acting as joint book-running managers for the offering. US Bancorp, Barclays, Citigroup, Fifth Third Securities, and MUFG are also acting as book-running managers for the offering. Bank of Ireland, Citizens Capital Markets, Loop Capital Markets, and PNC Capital Markets LLC are acting as co-managers for the offering. Regeneron has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (the "SEC") for the offering. Before you invest, you should read the prospectus in that registration statement and other documents Regeneron has filed and will file with the SEC, including the preliminary prospectus supplement filed by Regeneron with the SEC, for more complete information about Regeneron and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the preliminary prospectus supplement, when available, if you request them by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: (866) 471-2526, or via email: [email protected], BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at [email protected], and J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or toll free at (866) 803-9204.

On August 7, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conference and invited investors to participate via webcast (Press release, Illumina, AUG 7, 2020, View Source [SID1234563188]).

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UBS Genomics 2.0 and MedTech Innovations Virtual Summit
Wednesday, August 12, 2020 at 10:00am Pacific Time

The live webcasts can be accessed in the Investor Info section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentations will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On August 7, 2020 Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company, reported that the NIH awarded CTT $1.44M on the second year of a competitive Small Business Innovation Research (SBIR) Phase IIB grant (Press release, Cancer Targeted Technology, AUG 7, 2020, View Source [SID1234563187]). The three year grant commenced in 2019 and totals $3.3M and this second year of funding supports the current CTT1403 clinical trial.

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The clinical trial, conducted at University of California, San Francisco with Dr. Rahul Aggarwal as Principal Investigator, is a 30-40 patient dose escalation/expansion trial in men with advanced castration-resistant prostate cancer. The trial is designed to show safety and efficacy of CTT1403 and is halfway through the initial dose escalation phase. To date there have been no safety issues with the drug and the pharmacokinetic data support the longer circulation time of CTT1403 in the blood stream as compared to other PSMA agents currently in clinical trials. "These PSMA-targeted agents are already transforming how prostate cancer is diagnosed and treated and we are very pleased that the NIH continues to support the development of these exciting new agents. CTT1403, with its longer circulating time and better tumor targeting characteristics, offers distinct advantages in this treatment arena providing the patient with cost and treatment benefits," commented Dr. Beatrice Langton-Webster, CTT’s CEO and Principal Investigator on the grant. The unique chemical structure for CTT1403 was conceived of by Dr. Cliff Berkman, Professor at Washington State University (WSU).

CTT1403 targets Prostate Specific Membrane Antigen (PSMA) which is over-expressed on prostate cancer. Two features make CTT1403 unlike other PSMA-targeted drugs currently in development: 1) Due to a unique core scaffold, CTT’s molecules bind irreversibly to PSMA and this distinctive mode of binding enables rapid uptake of the drug within the tumor; and 2) CTT1403 is engineered to increase the circulation time of the drug in the body which further substantially increases the dose of drug that accumulates at the tumor sites. CTT1403 is labeled with the radionuclide Lutetium-177 and once delivered to the tumor, the radionuclide acts to destroy the tumor cells.

CTT completed two clinical trials at UCSF with CTT1057, the companion PET diagnostic imaging agent to CTT1403, with excellent safety and imaging results for both prostate cancer and renal cell carcinoma. CTT1057 is undergoing further development for prostate cancer by CTT’s licensing partner AAA/Novartis. CTT1057 and CTT1403 serve as a theranostic pair to both diagnose and treat solid tumors that express PSMA, and are being used together in the current clinical trial. More information on the trial can be found at clinicaltrials.gov.

On August 7, 2020 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) ("Merrimack" or the "Company") reported its second quarter 2020 financial results for the period ended June 30, 2020 (Press release, Merrimack, AUG 7, 2020, View Source [SID1234563186]).

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We are pleased by recent news releases from both Ipsen Pharmaceuticals and Elevation Oncology, which are conducting separate programs which could result in milestone payments to Merrimack. Ipsen announced receipt of Fast Track designation from the FDA for liposomal irinotecan (ONIVYDE) and also recently presented Phase I/II clinical data evaluating liposomal irinotecan (ONIVYDE) as an investigational first-line combination treatment for metastatic pancreatic cancer. Elevation Oncology has recently announced that it has raised $32.5 million in a Series A financing which will enable it to progress the clinical development of seribantumab" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "In addition, Merrimack made continued progress in reducing our operating expenses during the second quarter of 2020, and we expect to see continued reductions during the second half of 2020."

Second Quarter 2020 Financial Results

Merrimack reported net loss of $1.2 million for the second quarter ended June 30, 2020, or $0.09 per basic share, compared to a net loss of $9.4 million, or $0.71 per basic share, for the same period in 2019.

No research and development expenses were recognized for the second quarter ended June 30, 2020 compared to $4.7 million for the same period in 2019.

General and administrative expenses for the second quarter ended June 30, 2020 were $1.2 million, compared to $5.9 million for the same period in 2019.

As of June 30, 2020, Merrimack had cash and cash equivalents and investments of $15.7 million, compared to $16.6 million as of December 31, 2019.

As of June 30, 2020, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen Pharmaceuticals

On June 17, 2020 Ipsen Pharmaceuticals publicly announced that it had received FDA Fast Track designation for liposomal irinotecan (ONIVYDE) as a first-line combination treatment for metastatic pancreatic cancer.
On July 1, 2020 Ipsen Pharmaceuticals publicly announced that it has presented Phase I/II clinical data evaluating liposomal irinotecan (ONIVYDE) as an investigational first-line combination treatment for metastatic pancreatic cancer at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer, and confirmed that is has initiated the NAPOLI-3 Phase III clinical study (NCT04083235) comparing the safety and efficacy of liposomal irinotecan + 5-fluorouracil/leucovorin (5-FU/LV) + oxaliplatin (OX) (NALIRIFOX) to gemcitabine + nab-paclitaxel in the first-line setting.
Elevation Oncology

On July 21, 2020 Elevation Oncology publicly announced that it had raised a $32.5 M Series A financing to support various activities including the clinical development of seribantumab.