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.

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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.

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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.

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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.

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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.

On February 11, 2020 Biodesix, Inc. reported initiation of the next phase of their biomarker development program with Merck KGaA, Darmstadt, Germany and Pfizer Inc., New York, NY (Press release, Biodesix, FEB 11, 2020, View Source [SID1234554175]). The companies have completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor (BAVENCIO) (avelumab). Development efforts will now focus on transferring the test into Biodesix’s CLIA lab in Boulder, CO for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the proprietary Biodesix Diagnostic Cortex artificial intelligence (AI) platform. Data from the initial test discovery and development program will be presented at an upcoming scientific meeting in 2020.

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The Diagnostic Cortex platform is based on modern AI techniques to design clinically useful tests that are reproducible and robust, and typically use hundreds of different markers. Based on data found in the circulating proteome and genome, Biodesix designs tests that support treatment decisions including patient selection for immunotherapies, novel therapy combinations, and alternative treatment pathways.

"We are pleased to announce this next phase in our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer with the potential to extend treatment options to more patients. This relationship combines Biodesix’s strengths in test discovery and development, artificial intelligence, and their applications to immunotherapy, with the pharmaceutical leadership of Merck KGaA, Darmstadt, Germany and Pfizer," said Scott Hutton, Biodesix CEO. "The successful progression of this project is another example of how our proprietary Diagnostic Cortex AI-based biomarker platform is uniquely suited to advancing clinical research and investigating new indications for existing therapies."

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US, EU, Japan and other countries for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with mMCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.