On February 11, 2020 Dana-Farber Cancer Institute and Kronos Incorporated reported that they have joined forces to provide dedicated oncology care navigation services via a new benefit for Kronos employees and their beneficiaries (Press release, Dana-Farber Cancer Institute, FEB 11, 2020, View Source [SID1234554180]). As part of the Dana-Farber Direct Connect program, each patient receives patient navigation assistance, highly specialized clinical care, and an expert team providing a multi-disciplinary approach to care that encompasses the full continuum of their oncology journey. Kronos, a global leader in workforce management and human capital management cloud solutions known worldwide for its award-winning WorkInspired culture, is the first employer to provide its employees with the Dana-Farber Direct Connect benefit.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Through this innovative program, Dana-Farber Direct Connect provides companies with dedicated support services for their employees and is proud to align with an organization like Kronos known for a culture steeped in caring for its employees, their families, and the communities where Kronos employees live and work. All Kronos employees and beneficiaries enrolled in the benefit will have access to a dedicated phone line and email that is staffed by experienced liaisons who are trained to support the unique needs of each patient and can help identify the right treatment options, facilitate appointments, and access support services based on the cancer type and the individual’s specific needs. Dana-Farber’s specialized treatment centers are comprised of teams of experts who work closely together to provide patients the latest therapies and strategies, including access to innovative clinical trials, integrative medicine services, stem-cell transplants, cell therapies, and immunotherapy.

"Finding out that you or someone you care about has cancer is a devastating and life-altering experience. There are so many questions to be answered – everything from, ‘Where can I find the best doctors?’ to ‘What does my insurance cover?’ Managing treatment, doctor visits, and billing can quickly become a full-time job when the patient’s focus and effort should be spent healing and fighting. By formalizing this new benefit with Dana-Farber Direct Connect, Kronites and their family members will have special access to top oncology doctors in Massachusetts along with all the support resources that the world-class Dana-Farber Cancer Institute has to offer," said David Almeda, Chief People Officer at Kronos.

In addition to helping all patients at a challenging time, Dana-Farber Direct Connect aims to:

reduce the variability in misdiagnosis
improve cancer outcomes, care, and experience for all patients across the country
assist employers in reducing health care costs by ensuring the right treatment, at the right time with coordinated care to improve outcomes
"We are pleased to work closely with Kronos to provide their employees and family members access to the exceptional patient care that Dana-Farber is known for and to work together on initiatives that will reduce health care costs," said James Terwilliger, Chief Operating Officer and Executive Vice President at Dana-Farber Cancer Institute. "Oncology care is complex, with advances in treatment and drug options being made at dramatic pace. The Dana-Farber Direct Connect program ensures that the best care and treatment options are offered to each patient so that they can focus on getting healthy."

On February 11, 2020 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported that on February 10, 2020 it has entered into privately negotiated agreements (the "Exchange Agreements") with certain holders of its outstanding 5.75% Convertible Senior Notes due 2021 (the "Old Notes") (Press release, Rocket Pharmaceuticals, FEB 11, 2020, View Source [SID1234554179]). Pursuant to the Exchange Agreements, Rocket will exchange approximately $35.9 million aggregate principal amount of the Old Notes (which represents approximately 69% of the aggregate outstanding principal amount of the Old Notes) for (a) approximately $35.9 million aggregate principal amount of its new 6.25% Convertible Senior Notes due 2022 (the "New Notes") (an exchange ratio equal to 1.00 New Notes per exchanged Old Note) and (b) an amount of cash equal to the accrued and unpaid interest, if any, on the exchanged Old Notes from, and including, February 1, 2020, to, but excluding, the closing date of the exchange transactions. Following the closing of the exchange transactions, approximately $16.2 million aggregate principal amount of the Old Notes will remain outstanding. The exchange transactions are expected to close on or about February 19, 2020, subject to customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

When issued:

The New Notes will represent senior unsecured obligations of Rocket and pay interest semi-annually in arrears on February 1 and August 1 of each year, commencing on August 1, 2020, at a rate of 6.25% per annum;
The New Notes will mature on August 1, 2022, unless earlier converted, redeemed or repurchased;
The New Notes will be convertible at the option of holders in certain circumstances and during certain periods into shares of Rocket’s common stock, together with a cash payment, if applicable, in lieu of delivering any fractional share of common stock. The initial conversion rate is 31.1876 shares of Rocket’s common stock per $1,000 principal amount of the New Notes, which is equivalent to an initial conversion price of approximately $32.06 per share and will be subject to customary anti-dilution adjustments; and
Rocket may redeem for cash all or any portion of the New Notes, at its option, under certain circumstances at a redemption price equal to 100% of the principal amount of the New Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.
Additionally, Rocket repurchased all of the available shares of its common stock from certain holders of the Old Notes participating in the exchange transactions in privately negotiated, off-market transactions. Such repurchases could increase (or reduce the size of any decrease in) the market price of Rocket’s common stock prior to, concurrently with or shortly after the pricing of the New Notes.

The New Notes and any of Rocket’s common stock issuable upon conversion of the New Notes have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and may not be offered or sold without registration under, or an applicable exemption from, the registration requirements.

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

On February 11, 2020 Elicio Therapeutics, a next generation immuno-oncology company, and Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported their collaboration in a prospective, multicenter Phase 1/2 study of ELI-002, an Amphiphile immuno-oncology therapeutic targeting KRAS mutations in the adjuvant setting for patients with pancreatic ductal adenocarcinoma (PDAC) who have undergone neoadjuvant chemotherapy followed by pancreatectomy (Press release, Elicio Therapeutics, FEB 11, 2020, View Source [SID1234554178]). IND submission for the 108-patient trial which will open at 10-12 US sites will be in the first half of 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Natera’s tumor-informed and personalized ctDNA platform, Signatera, will be used to select eligible patients whose tumors harbor a mutant KRAS allele and are at high risk for relapse because they have detectable molecular residual disease (MRD) post-surgery. Signatera will also be used to perform serial monitoring to assess the percentage of patients achieving MRD clearance throughout the study.

"This study addresses an unmet need in the adjuvant setting for PDAC patients," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "Pancreatic cancer remains one of the deadliest forms of cancer, with a high rate of relapse post-surgery and 90% of patients are affected by KRAS mutations. ELI-002 brings the common KRAS mutated peptides together with a powerful immune activating adjuvant and Elicio’s proprietary lymph node targeting technology. Potent immune responses from sending the T cells for education in the lymph node hold promise to stop recurrence. We are excited to partner with Natera to select and monitor patients using breakthrough Signatera technology."

ELI-002 targets all seven position 12 and 13 KRAS mutations, representing approximately 25% of all human solid tumors. Elicio believes that ELI-002 has the potential to become a universal mKRAS therapy with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal and lung cancer.

"I think this is a unique clinical trial implementing novel trial design and a novel therapeutic vaccine approach to address an unmet need in the treatment of pancreas cancer," said Colin Weekes, M.D., Ph.D., Director for Medical Oncology Research for Pancreatic Cancer at Massachusetts General Hospital and the principal investigator for the ELI-002 study.

"We are proud to partner with Elicio Therapeutics on this groundbreaking research," said Alexey Aleshin, M.D., MBA, Natera’s Senior Medical Director. "We’re confident that this study will further demonstrate Signatera’s ability to enrich clinical trials and accelerate the development of much needed therapies, like the ELI-002 KRAS-targeted Amphiphile."

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On February 11, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, reported upcoming presentations of additional analyses from the FALCON clinical trial (NCT02578940) of Axumin (fluciclovine F18) injection), which evaluated its impact on the management of patients with recurrent prostate cancer (Press release, Blue Earth Diagnostics, FEB 11, 2020, View Source [SID1234554177]). The presentations are part of the scientific programs for the ASCO (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium (ASCO GU), February 13 – 15, 2020, in San Francisco, Calif., and the Radiation Oncology Summit: ACRO 2020, February 26 – 29, 2020, in Fort Lauderdale, Fla. Details of the presentations to be given by Blue Earth Diagnostics and its collaborators are listed below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Blue Earth Diagnostics also provided an update that full results from the FALCON study will be published in an upcoming issue of the International Journal of Radiation Oncology, Biology, Physics.

ASCO 2020 Genitourinary Cancers Symposium (ASCO GU), February 13 – 15, 2020

Date:

Thursday, February 13, 2020 11:30 a.m. − 1:00 p.m. and 5:30 − 6:30 p.m. PT

Presentation:

Impact of 18F-fluciclovine PET on salvage radiotherapy plans for men with post-radical prostatectomy recurrence of prostate cancer

Abstract Number:

19

Presenter:

Professor Heather Payne, FRCP, FRCR, University College Hospital, London

Session Title & Times:

Prostate Cancer and Trials in Progress

Poster Session A:

Prostate Cancer, Board A7

11:30 a.m. – 1 p.m., 5:15 – 6:15 p.m. PT

Location:

Moscone West Building, San Francisco, Calif.

Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium 2020 to attend the presentation above and to visit the company at Exhibit Booth 46.

Radiation Oncology Summit: ACRO 2020, February 26 – 29, 2020, Fort Lauderdale, Fla.

Date:

Saturday, February 29, 2020

Presentation:

The impact of prior prostatectomy on the detection of prostate cancer recurrence with 18F-fluciclovine: Imaging results from the FALCON trial

Abstract Number:

20

Presenter:

Eugene Teoh, MD, Blue Earth Diagnostics (Oxford University Hospitals NHS Trust at time of study)

Session Title & Times:

Poster Presentations

8:00 a.m. – 1:30 p.m. ET

Location:

Westin Fort Lauderdale Beach Foyer, Las Olas ballrooms, Fort Lauderdale, Fla.

Blue Earth Diagnostics invites participants at ACRO 2020 to attend the presentation above and to visit the company at Exhibit Booth 27. The company is also hosting a satellite symposium event, "Detecting and Localizing Recurrent Prostate Cancer with Axumin (fluciclovine F 18)," with invited speaker Dr. Steven Finkelstein, MD, DABR, FACRO, Florida Cancer Affiliates, US Oncology Network, which will be held on Thursday, February 27, 2020, from 12:00 – 1:00 p.m. ET, in the Rio Vista room.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On February 11, 2020 SIRION Biotech GmbH ("SIRION"), a world leader in viral vector-based gene delivery technologies for gene and cell therapy, reported preliminary financial results for 2019 (Press release, Sirion Therapeutics, FEB 11, 2020, View Source [SID1234554176]). SIRION’s annual service and licensing revenues in 2019 exceeded €10M (US$11.2M). With a growing staff of 35 employees, the company reports a record profit and plans to invest a portion of these proceeds into an additional Munich site with expanded lab and process development capacities. In addition, SIRION’s offices in Paris and Boston will continue to expand.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, the company’s intellectual property is included in more than 10 clinical programs by leading drug developers, one of which was granted market approval in 2019. SIRION’s core fee-for-service business, providing vector materials for discovery and pre-clinical applications, experienced historic growth of more than 50% over the previous year. The company expanded into a new avenue of growth by assigning its share in joint intellectual property rights to both a client in USA and the Danish start-up, InProTher Aps, in return for shares and milestone payments as well as royalties on product net sales.

SIRION Biotech’s business model comes from service revenue and licensing fees. The company provides high-grade viral vector materials for preclinical use, offering up to 1015 GMP-ready AAV vector genomes and 1010 infectious units of Lentivirus, currently paving all the way to toxicology studies. In addition, the company is forecasting significant increased demand for its clinical and commercial grade vectors.

As SIRION continues its growth trajectory, it will focus on attracting funding to expand preclinical development with collaborators from its large client network. With more than 2,000 single projects for over 200 recurring clients worldwide, SIRION is committed to building significant intelligence and insights into latest gene therapy drug developments.

"After only 12 years in business, SIRION has been instrumental in bringing new gene therapy treatments to patients. Assigning intellectual properties to collaborators validates our comprehensive viral vector technology platforms and the highly skilled and creative lab staff that stands behind them. We continue our dedication and commitment to developing gene therapy on a global scale with the opening of our second Munich site this year that will expand our capacity for research and process development," said Dieter Lingelbach, Chief Operating Officer of SIRION.

Mr. Lingelbach continued, "In 2020, we look forward to continued expansion of our US presence through our wholly-owned subsidiary, SIRION Biotech International Inc., as well as continued growth in Paris."

Gene and cell therapies are among the hottest topics in modern drug development. Viral vector technologies are the most promising gene editing tools available today, with significant potential both as therapeutics for a growing number of indications, for tumor vaccines and for further technical improvements. Key challenges include quality, yields, and improved transduction in order to make novel gene therapies reliable and affordable. Costs for gene therapies per patient remain high, and can be prohibitive for larger patient populations, even in well-developed markets.