On October 14, 2020 Rain Therapeutics Inc., a privately-held, clinical stage biotechnology company focused on targeted therapies for patients with cancer, reported a late-breaking presentation at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Virtual Symposium being held October 24-25, 2020 (Press release, Rain Therapeutics, OCT 14, 2020, View Source [SID1234568516]). The oral presentation will provide an update on data from the Phase 1 clinical trial of RAIN-32 (Milademetan), an oral MDM2 inhibitor.

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!

Additional presentation details can be found below:
Oral Presentation
Title: Milademetan, an oral MDM2 inhibitor, in well-differentiated/dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas

Session Title: New Drugs on the Horizon

Presenter: Mrinal M. Gounder, M.D., Memorial Sloan Kettering Cancer Center
Session Date: Sunday, October 25
Session Time: 9:00 p.m. – 10:45 p.m. CET/4:00 p.m.-5:45 p.m. EDT
Presentation Time: 10:00 p.m. CET/5:00 p.m. EDT

The session will be followed by a Q&A from 10:10 p.m.to 10:30 p.m. CET/5:10 p.m. to 5:30 p.m. EDT. Additional details can be found on the conference website.

About RAIN-32
RAIN-32 has been evaluated in patients with various solid tumors, acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), and has received Orphan Drug Designation for the treatment of liposarcoma. RAIN-32 also has been evaluated in continuous and intermittent dose schedules that may offer a differentiated tolerability profile as compared to other MDM2 programs.

A separate clinical study for RAIN-32 is ongoing to evaluate safety and efficacy in patients with FLT3-ITD AML in combination with the FLT3 inhibitor, quizartinib. In addition, multiple investigator sponsored studies are being conducted by MD Anderson Cancer Center (MDACC) as well as National Cancer Center Hospital (NCCH) in Tokyo, Japan.

On October 14, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the company has entered into a loan agreement with the European Investment Bank (EIB), granting the company access to an unsecured loan facility of up to €40 M (Press release, Oncopeptides, OCT 14, 2020, View Source [SID1234568501]). The loan may be used to further support the clinical development of melflufen, and the company’s transition from a R&D company into a fully integrated global biopharmaceutical company.

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 loan facility is divided into three tranches, each with a maturity of up to five years, which will become available provided that the company reaches certain milestones related to the commercialization of melflufen in the U.S. and the EU, respectively.

If the company utilizes the facility, the EIB will be entitled to a predetermined number of warrants in Oncopeptides, in excess of interest on the loan amount. The warrants are divided into three tranches and assuming full drawdown under the loan facility, the EIB will be entitled to warrants corresponding to 0.7 percent of the total number of shares in the company on a fully diluted basis. The total number of warrants will be issued by Oncopeptides’ board of directors pursuant to the authorization granted by the AGM 2020, and each relevant tranche will be delivered to the EIB upon the company’s potential decision to draw the relevant tranche of the loan.

"This is the kind of project that the Investment Plan for Europe was set up to support. There is still a market gap when it comes to what is called "non-dilutive growth capital", allowing innovative, fast growing EU-based SMEs to grow without giving up ownership of their ideas or company", says Thomas Östros, Vice-President of EIB. "We are very happy to get behind yet another innovative Swedish company that has ground-breaking plans for the future."

"As the company is approaching a potential commercialization of its lead product melflufen, several new financing options become available. The EIB facility is a flexible solution that can be drawn upon with limited dilution for the shareholders, which is highly valuable to the company in this transition phase. We are grateful for the support from the EIB and look forward to working together through the continued expansion of Oncopeptides", says Anders Martin-Löf, CFO of Oncopeptides.

Melflufen in clinical development
On August 29th the U.S. Food and Drug Administration FDA granted priority review for Oncopeptides´ New Drug Application of melflufen (INN melphalan flufenamide). The FDA has set a target date for their review to February 28, 2021.

The submission is based on the results from the pivotal phase 2 HORIZON study, which demonstrates that melflufen in combination with dexamethasone has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple-class refractory myeloma and patients with extramedullary disease (EMD). Oncopeptides has a comprehensive clinical development program and is currently conducting one randomized phase 3 study and six clinical phase 2 studies.

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on October 14, 2020 at 18:00 (CET).

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.

On October 14, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported that the Louis Stokes Cleveland VA Medical Center in Cleveland, Ohio has purchased the MRIdian Linac MRI-Guided Therapy System, a cutting-edge radiation therapy device that combines the latest innovations in precision radiation delivery and ground-breaking MR-guidance (Press release, ViewRay, OCT 14, 2020, View Source [SID1234568498]).

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!

MRIdian offers advantages for the delivery of safe and effective radiotherapy, including the ability to see the tumor and surrounding tissue during treatment, adapt the therapy in response to changes in patient anatomy and tumor size during treatment, continuous tracking of the tumor during treatment, and automatic pausing of the radiation if the tumor moves outside of the boundary. As a result, the system delivers ablative, high-dose radiation to the tumor while protecting the surrounding healthy tissue from damage.

The ability to deliver high-dose radiation treatments, referred to as stereotactic body radiation therapy (SBRT), means patients can receive their treatment in fewer sessions than conventional radiation therapy. Instead of 25 to 40 treatment sessions, patients receiving SBRT may complete treatment in as few as one to five treatment sessions. This is particularly beneficial for patients who may have to travel a long distance for treatment.

The Louis Stokes Cleveland VA Medical Center is part of the VA Northeast Ohio Healthcare System, which provides comprehensive, seamless health care and social services for 112,589 Veterans across Northeast Ohio. The VA Northeast Ohio Healthcare System focuses on treating the whole Veteran through health promotion and disease prevention. VA Northeast Ohio Healthcare System contributes to the future of medicine through education, training, and research programs.

"We’re proud to support the Louis Stokes Cleveland VA Medical Center in their mission to offer the most advanced technologies to Veterans," said Paul Ziegler, Senior Vice President of Sales and Marketing at ViewRay. "Their investment in a MRIdian program furthers their commitment to delivering the highest quality health care to our nation’s heroes."

Currently 39 MRIdian systems are installed at hospitals around the world, where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts and presentations. More than 10,000 patients have been treated with MRIdian. For a list of treatment centers, please visit: View Source

On October 14, 2020 Perrigo Company plc (NYSE; TASE: PRGO), a leading provider of Quality, Affordable Self-Care Products, reported that it will release its third quarter financial results on Wednesday, November 4, 2020 (Press release, Perrigo Company, OCT 14, 2020, View Source [SID1234568497]). The Company will also host a conference call beginning at 8:00 a.m. (EST).

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 conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 3180501. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Wednesday, November 4, until midnight Wednesday, November 11, 2020. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10148815.

On October 14, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and its partner PharmaMar (MSE: PHM) reported they will present new data for Zepzelca (lurbinectedin) in small cell lung cancer (SCLC) at the International Association for the Study of Lung Cancer (IASLC) 2020 North America Conference on Lung Cancer, which will be held October 16-17, 2020 as a virtual event (Press release, Jazz Pharmaceuticals, OCT 14, 2020, View Source [SID1234568496]).

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!

"Jazz is committed to improving outcomes for patients with SCLC where there continues to be a high unmet need despite research and treatment advancements," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "At this year’s IASLC virtual meeting, we look forward to presenting, along with our partner PharmaMar, data on lurbinectedin, our newest oncology medicine to be approved by the U.S. FDA."

Highlights at the 2020 North America Conference on Lung Cancer include:

A poster presentation of the outcomes in patients treated with lurbinectedin who were candidates for platinum re-challenge in the relapsed SCLC cohort from the Phase 2 basket trial, including those with a chemotherapy-free interval (CTFI) ≥180 days
A poster presentation of the outcomes by baseline patient characteristics for the relapsed SCLC cohort from the Phase 2 basket trial
A poster presentation featuring the results in the subset of patients who achieved a response to lurbinectedin in the relapsed SCLC cohort from the Phase 2 basket trial
The IASLC 2020 North America Conference on Lung Cancer presentations will be presented on October 16 from 5 – 6 p.m. CDT at View Source

A full list of presentations follows below:

Presentation Title

Author

Abstract Number

Activity of Lurbinectedin in Second-line SCLC Patients Who Are Candidates for Platinum Re-challenge

Subbiah et al.

109

Phase 2 Basket Trial of Lurbinectedin in Small Cell Lung Cancer: Analysis of Efficacy by Baseline Characteristics

Sands et al.

110

Phase 2 Basket Trial of Lurbinectedin in Second-line Small-Cell Lung Cancer: Characteristics and Outcomes in Treatment Responders

Subbiah et al.

111

Zepzelca is approved in the U.S. for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. Zepzelca was approved by the U.S. Food and Drug Administration (FDA) under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

About Zepzelca (lurbinectedin)
Zepzelca, also known as PM1183, is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.1

Zepzelca for injection 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.

As previously announced in December 2019, PharmaMar and Jazz entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to Zepzelca.

Important Safety Information

Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems.
are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.
You should use effective birth control (contraception) during treatment with and for 6 months after your final dose of ZEPZELCA.
Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA.

are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your final dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.

What should I avoid while using ZEPZELCA?

Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment with ZEPZELCA.

ZEPZELCA can cause serious side effects, including:

Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you develop:
fever or any other signs of infection
unusual bruising or bleeding
tiredness
pale colored skin
Liver problems. Increased liver function tests are common with ZEPZELCA, and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop symptoms of liver problems including:
loss of appetite
nausea or vomiting
pain on the right side of your stomach area (abdomen)
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop low blood cell counts or liver problems during treatment with ZEPZELCA.

The most common side effects of ZEPZELCA include:

tiredness
low white and red blood cell counts
increased kidney function blood test (creatinine)
increased liver function blood tests
increased blood sugar (glucose)
nausea
decreased appetite
muscle and joint (musculoskeletal) pain
low level of albumin in the blood
constipation
trouble breathing
low levels of sodium and magnesium in the blood
vomiting
cough
diarrhea
These are not all of the possible side effects of ZEPZELCA.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.