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 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, and Personalis Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported a collaboration to leverage Personalis’ ImmunoID NeXT Platform in Advaxis’ ongoing Phase 1/2 ADXS-503 (HOT Lung) program evaluating ADXS-503 alone and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC) (Press release, Advaxis, FEB 11, 2020, View Source [SID1234554169]). The ADXS-503 construct targets 11 public or shared, hotspot neoantigens in KRAS, EGFR and TP53 as well as 11 proprietary tumor-associated antigen targets. Under the terms of the expanded agreement, Personalis will conduct comprehensive tumor immunogenomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.

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!

Via the deep analysis of ~20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one; providing a multidimensional view of the tumor and the immune microenvironment from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery and CDx development.

"We are thrilled to expand our relationship with Personalis and believe the resulting analyses may lead to the establishment of predictive biomarkers and the characterization of immunological impact of treatment which will be relevant to the successful development of ADXS-503 and our other off-the-shelf neoantigen constructs," said Dr. Andres A. Gutierrez, Chief Medical Officer of Advaxis. "With the emerging clinical signals we are seeing in our ongoing ADXS-503 clinical study and the extensive capabilities of ImmunoID NeXT to interrogate a patient’s tumor and immune response at both the DNA- and RNA-level from a single FFPE tissue sample, the analysis will help guide our development plans in order to target the right patient population and to potentially increase the clinical benefit of our off-the-shelf, ADXS-HOT drug constructs."

This new agreement builds upon the prior two-year collaboration between Advaxis and Personalis for the genomic analysis of clinical tumor samples to manufacture the Company’s ADXS-NEO drug construct, its personalized, neoantigen-directed immunotherapy to treat a variety of late stage cancers. As previously published, the ADXS-NEO drug constructs were able to efficiently generate de novo CD8+ T cells versus KRAS and EGFR hotspot mutations in late stage-cancer patients, thus providing proof-of-mechanism for our ADXS-HOT program.

On February 11, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported the enrollment of the first patient in an investigator-sponsored clinical trial of its Wilms tumor-1 (WT1)-targeting peptide immunotherapeutic agent, GPS, in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo), in patients with MPM (Press release, Sellas Life Sciences, FEB 11, 2020, View Source [SID1234554145]).

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!

The Phase 1 open-label clinical study is being conducted by Memorial Sloan Kettering Cancer Center (MSK) and is enrolling patients with MPM who harbor relapsed or refractory disease after having received frontline, standard-of-care multimodality therapy. The principal investigator for the study is Marjorie G. Zauderer, MD, Co-Director, Mesothelioma Program and Associate Attending Physician in the Thoracic Oncology Service, Department of Medicine at MSK.

"We are pleased to be collaborating with Memorial Sloan Kettering on this Phase 1 trial and excited to have expanded the clinical evaluation of GPS in combination with nivolumab to patients with advanced MPM," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "There are few effective therapies for mesothelioma, a disease which is characterized by high expression of the WT1 antigen, and we believe that the combination of GPS and nivolumab could be promising for patients with MPM, due to the combination’s potential synergistic immune-based mechanisms for anti-tumor activity. We look forward to gaining further insights on the safety and clinical outcomes of this combination in MPM."

The trial is investigating the potential of GPS in combination with nivolumab to demonstrate anti-tumor immune responses and meaningful clinical activity in the presence of macroscopic disease in MPM patients and gauging the degree of clinical benefit by assessment of the overall response rate with the combination in comparison with that reported with nivolumab alone in historical comparable patient populations.

"There is significant preclinical and translational science evidence that PD-1 inhibitors may enhance the anti-cancer activity of cancer vaccines, with immuno-biologic and pharmacodynamic synergy from the combination of two such agents," said Dr. Zauderer. "By mitigating the negative effects of tumor microenvironment factors on immune response, PD-1 inhibitors, such as nivolumab, potentially allow for a patient’s immune cells to destroy cancerous growths that may be sensitized by GPS against WT1. I believe that WT1 serves as an ideal target for directly immunizing therapies in MPM, and I look forward to evaluating the combination of GPS and nivolumab in the clinic."

In a previous randomized, controlled, blinded Phase 2 clinical trial in MPM patients, GPS monotherapy, given as maintenance after first line tumor-debulking multimodality treatment, demonstrated meaningful clinical activity with median survival of 22.8 months vs. 18.3 months in the control group (N=41) and with associated sustained immune responses (both CD4+ and CD8+) against the WT1 antigen with the most common adverse events mild (grade 1 and 2) and self-limited injection site reactions.

On February 11, 2020 Astellas and Pfizer reported positive topline overall survival (OS) results from a Phase III trial evaluating Xtandi (enzalutamide) as a treatment in men with non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Pfizer, FEB 11, 2020, View Source [SID1234554162]). The results demonstrated a statistically significant improvement in OS in patients with nmCRPC treated with the therapy, the companies announced.

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!

Prostate cancer is the second most common cancer in men worldwide, with about 164,000 expected diagnoses in the United States this year. Castration-resistant prostate cancer (CRPC) refers to the subset of men whose prostate cancer progresses on androgen deprivation therapy despite castrate levels (less than 50 ng) of testosterone. Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body, and there is a rising prostate-specific antigen (PSA) level. Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.

In the Phase III PROSPER trial, Pfizer and Astellas evaluated Xtandi in combination with androgen deprivation therapy (ADT) in men with nmCRPC against placebo and ADT. The companies said the results demonstrated a statistically significant improvement in OS, which was a key secondary endpoint of the trial. Full OS results from the PROSPER trial will be released at a later date, the companies said.

In 2017, Astellas and Pfizer announced initial top-line results from the Phase III trial that showed the combination of Xtandi and ADT met its primary endpoint of improved metastasis-free survival (MFS). MFS was measured as the time from patients entering the trial until their cancer was radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation. The Phase III trial showed that a combination of Xtandi plus ADT significantly reduced the risk of developing metastases or death by 71 percent. Additionally, the Phase III trial data showed the combination treatment had a 93 percent reduction in relative risk of prostate-specific antigen (PSA) progression, a biomarker tied to the worsening of a disease, compared to patients who received ADT alone. Those results eventually lead to the regulatory approval of Xtandi as a treatment for non-metastatic castration-resistant prostate cancer.

In December, Xtandi won approval from the U.S. Food and Drug Administration as a treatment for patients with metastatic castration-sensitive prostate cancer (mCSPC). It is estimated that more than 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.

In addition to the latest OS news for Xtandi, Astellas and Pfizer said they will share findings from two studies evaluating the same treatment for advanced prostate cancer at the 2020 Genitourinary Cancers Symposium later this week. The two evaluate the treatment in chemotherapy-naïve men with metastatic castration-resistant prostate cancer (mCRPC) in a real-world setting.

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."