Moderna to Present at Upcoming Investor Conferences

On May 27, 2020 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported its participation in the following upcoming virtual investor conferences (Press release, Moderna Therapeutics, MAY 27, 2020, View Source [SID1234558571]):

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Jefferies Global Healthcare Conference on Wednesday, June 3, 2020 at 10:30 a.m. ET.
Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 2:10 p.m. ET.
A live webcast of each presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of each webcast will be archived on Moderna’s website for 30 days following the presentation.

Imaging Endpoints Supports FDA Approvals For Two New Cancer Treatments

On May 27, 2020 Imaging Endpoints reported that it has supported two additional U.S. Food and Drug Administration (FDA) approvals this month for new, life-saving therapies (Press release, Imaging Endpoints, MAY 27, 2020, View Source [SID1234558588]). The two New Drug Application (NDA) approvals, for two of the Company’s pharmaceutical company clients, included indications for adult patients with non-small cell lung cancer (NSCLC), adult and pediatric patients with thyroid cancer, and adult patients with advanced gastrointestinal stromal tumors (GIST).

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Imaging Endpoints serves as the imaging CRO that performed the blinded independent central review of imaging for these new cancer treatments. The large, global clinical trials that supported these approvals included complex imaging requirements, a double read paradigm with real-time reporting, and included imaging within the primary endpoint.

Imaging Endpoints’ robust processes are designed to meet or exceed industry standards. All inspections to date, including inspections in 2018, 2019 and 2020 by FDA and the European Medicines Agency (EMA), have resulted in zero observations, clearly demonstrating the Company’s leadership in quality and compliance.

Doug Dean Burkett, PhD., Chief Executive Officer and President of Imaging Endpoints added: "We are honored to have supported the FDA approval of these two additional life-saving therapeutics as part of our relentless endeavor to Connect Imaging to the CureTM. Our rapid growth and success is the result of our dedication to provide industry-leading expertise, technologies and services through our amazing global team."

Iovance Biotherapeutics, Inc. Announces Proposed Public Offering of Common Stock

On May 27, 2020 Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) ("Iovance" or "Company"), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL and peripheral-blood lymphocyte, PBL), reported that it intends to offer and sell $500 million of its common stock, subject to market and other conditions, in an underwritten public offering (Press release, Iovance Biotherapeutics, MAY 27, 2020, View Source [SID1234558627]). All of the shares in the offering are to be sold by Iovance. Iovance intends to grant the underwriters a 30-day option to purchase up to $75 million of additional shares of common stock at the public offering price, less the underwriting discounts and commissions.

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Iovance intends to use the proceeds from this offering to fund the expansion of its organization to support the potential commercial launch of lifileucel for advanced melanoma and LN-145 for advanced cervical cancer, to initiate a program directed at registration of Iovance’s tumor infiltrating lymphocyte therapies in non-small cell lung cancer, to continue support of ongoing commercial manufacturing activities, and for the development of Iovance’s IL-2 analog, IOV-3001, and for other general corporate purposes. Additional indications or TIL products may be explored with the use of proceeds.

Jefferies LLC and Goldman Sachs & Co. LLC are acting as joint lead book-running managers for the offering. Wells Fargo Securities, LLC is also serving as book-running manager.

The shares of common stock described above are being offered by Iovance pursuant to its shelf registration statement on Form S-3 that became automatically effective upon filing with the Securities and Exchange Commission (the "SEC") on May 27, 2020. The offering may be made only by means of a prospectus supplement and accompanying prospectus, copies of which may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor New York, New York, 10022, by telephone at (877) 547-6340, or by email at [email protected] or Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected] or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York, 10001, at (800) 326-5897 or email a request to [email protected].

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

DREAMM-2 and DREAMM-6 data at ASCO reinforce the potential of GSK’s investigational belantamab mafodotin in patients with relapsed/refractory multiple myeloma

On May 27, 2020 GlaxoSmithKline (GSK) plc reported new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical programme, which further highlight the potential of the investigational anti-BCMA (antibody drug conjugate against B-cell maturation antigen) agent belantamab mafodotin for relapsed/refractory multiple myeloma both as a monotherapy and in combination (Press release, GlaxoSmithKline, MAY 27, 2020, View Source [SID1234558521]). The data are being presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

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In the 13-month follow-up data from the DREAMM-2 study (abstract #8536), treatment with single-agent belantamab mafodotin, administered as a 2.5 mg/kg dose every three weeks (Q3W), showed a median duration of response (DoR) of 11 months (95% CI, 4.2–not reached) and a median overall survival (OS) of 14.9 months (95% CI, 9.9–not reached) in a heavily pre-treated patient population who received a median of seven prior lines of treatment and were refractory to an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. The overall response rate (ORR) was consistent with the six-month data at 32% (31 out of 97 patients). Of these patients, the majority (58%) had a very good partial response or greater, including two stringent complete responses and five complete responses. The proportion of patients achieving clinical benefit (minimal response or better) was 36% (95% CI, 26.6–46.5).

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "The updated results from the DREAMM-2 study being presented at ASCO (Free ASCO Whitepaper) further demonstrate the potential of belantamab mafodotin to help address a significant unmet need for patients whose multiple myeloma continues to progress despite available treatment options. We are encouraged by these data as we work to bring belantamab mafodotin to patients suffering from this aggressive disease."

No new safety signals were identified with longer term follow-up with belantamab mafodotin. The most commonly reported grade 3 or higher adverse events (occurring in more than 10% of patients) in patients receiving the 2.5 mg/kg dose were keratopathy/microcyst-like epithelial changes (MECs) (46%), thrombocytopenia (22%), anaemia (21%), lymphocyte count decreased (13%) and neutropenia (11%). The first event of keratopathy (MECs) – characterised as changes in the corneal epithelium as seen on eye examination which can manifest with or without symptoms – had resolved in 77% of patients in the 2.5 mg/kg arm at time of data cut-off and no permanent loss of vision has been reported to date.

Belantamab mafodotin is not currently approved for use anywhere in the world.

Dr Sagar Lonial, Chief Medical Officer of the Winship Cancer Institute of Emory University and principal investigator of the DREAMM-2 study said: "Despite our best efforts, a significant number of patients will relapse following treatment with an immunomodulatory drug, proteasome inhibitor and an anti-CD38 antibody. For this reason, we need novel therapies that not only induce responses, but maintain them as long as possible. These latest results from DREAMM-2 continue to reinforce that belantamab mafodotin has the potential to be an important treatment option for patients whose disease continues to progress despite currently available therapies."

The DREAMM-2 study serves as the basis for the belantamab mafodotin Biologics License Application and Marketing Authorisation Application, which are currently under review by the US Food and Drug Administration and European Medicines Agency, respectively.

Initial results from the DREAMM-6 study (abstract #8502) examining belantamab mafodotin in combination with bortezomib/dexamethasone (BorDex) in patients whose disease has become refractory or relapsed after one or more prior lines of treatment are also being presented at ASCO (Free ASCO Whitepaper). In this analysis, belantamab mafodotin 2.5 mg/kg Q3W plus BorDex (B-Vd) resulted in an ORR of 78% (14 out of 18 patients), with 50% achieving a very good partial response and 28% achieving a partial response (95% CI, 52.4–93.6). The proportion of patients achieving clinical benefit (minimal response or better) was 83% (95% CI 58.6–96.4). The median DoR has not yet been reached at a median of 18.2 weeks on treatment.

Grade 3 or greater adverse events included keratopathy (MECs) (56%) and thrombocytopenia (61%). There were no cases of grade 4 keratopathy (MECs).

Hoos added: "We are encouraged by these initial results from the DREAMM-6 study showing the potential of combination therapy with belantamab mafodotin in patients with earlier stages of multiple myeloma and look forward to sharing the full data once it is available."

About DREAMM-2
DREAMM-2 is an open label study of belantamab mafodotin. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin Q3W. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.

About DREAMM-6
DREAMM-6 is an open label phase I/II study evaluating the safety, tolerability and efficacy of belantamab mafodotin when administered in combination with approved regimens of either lenalidomide plus dexamethasone (Len/Dex; Arm A) or Bor/Dex (Arm B) in patients with RRMM who have become refractory or relapsed after one or more prior lines of treatment. Part 1 of the study is a dose escalation phase to evaluate the safety and tolerability of up to three dose levels and up to two dosing schedules of belantamab mafodotin in combination Len/Dex or Bor/Dex. Part 2 will further evaluate the safety and preliminary clinical activity of belantamab mafodotin at selected dose levels and dosing schedules in combination with Len/Dex or Bor/Dex.

About multiple myeloma
Multiple myeloma is the third most common blood cancer and is generally considered treatable, but not curable.[1] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[2]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[3]

About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker.[4] The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Trial Name

GSK ID/NCT ID

Status

Design

DREAMM-1

117159/ NCT02064387

Completed

A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA

DREAMM-2

205678/ NCT03525678

Active, not recruiting

A Phase II Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 Antibody

DREAMM-3

207495/ NCT04162210

Recruiting

A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-4

205207/ NCT03848845

Recruiting

A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-5

208887/

NCT04126200

Recruiting

A Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-6

207497/ NCT03544281

Recruiting

A Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-7

207503/

NCT04246047

Recruiting

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-8

207499

Planned

A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-9

209664/ NCT04091126

Recruiting

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Transplant

DREAMM-10

207500

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoC

ISS/GSK Co-Sponsored Study

209418/ NCT03715478

Recruiting

A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

John Theurer Cancer Center/RCCA collaborate with GTC to internalize proprietary NGS DNA and RNA testing

On May 27, 2020 John Theurer Cancer Center (JTCC), at Hackensack Meridian Health Hackensack University Medical Center in New Jersey, and Genomic Testing Cooperative (GTC), Irvine, CA, reported an agreement to establish a state-of-the-art, next generation sequencing (NGS) laboratory for molecular profiling (Press release, Genomic Testing Cooperative, MAY 27, 2020, View Source [SID1234558537]). This NGS laboratory, located at John Theurer Cancer Center, will serve all physicians within Regional Cancer Care Associates (RCCA), a network of cancer care professionals in New Jersey, Connecticut, and Maryland.

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As a leading cancer institute and a member of the NCI-approved Georgetown Lombardi Comprehensive Cancer Center Consortium, John Theurer Cancer Center will perform molecular profiling of all cancers in its patients with solid tumors or blood cancers. The results of such profiling will facilitate precision medicine: matching patients with therapies that target the molecular abnormalities driving the growth of their cancers. Furthermore, this molecular profiling will drive the expansion of the cancer center’s innovation and dedication to advancing the science of oncology practice in the community.

The John Theurer Cancer Center NGS laboratory will adapt highly validated tests developed by GTC for DNA and RNA profiling. Paired DNA and RNA profiling is increasingly employed in genomics research to uncover molecular mechanisms underlying the development and progression of disease and to explore personal genotype and phenotype correlations.

"Collaborations such as these demonstrate the commitment of the Hackensack Meridian Health system to improving the care of people with cancer, one of the country’s most common illnesses and a leading cause of death in the United States," noted Robert C. Garrett, FACHE, chief executive officer, Hackensack Meridian Health. "Technologies such as NGS with DNA and RNA profiling put us at the forefront of cancer care and research."

"The sophisticated algorithms and artificial intelligence software used for analyzing sequencing data and linking them to clinical data are based on deep knowledge in technical and clinical needs," added Andre Goy, MD, physician-in-chief for Oncology at Hackensack Meridian Health and chair of John Theurer Cancer Center.

"We are delighted to be working with the team at GTC. We selected GTC tests because of the significant diligence and scientific rigor used in their development," said David S. Siegel, MD, PhD, chief, Myeloma Division at John Theurer Cancer Center and founding director, Institute for Multiple Myeloma at the Hackensack Meridian Center for Discovery and Innovation. "We believe that profiling both RNA and DNA in cancers is crucial — not only for increasing accuracy and providing thorough evaluation, but also for innovation and the development of new clinical research approaches."

"Given the increasing number of novel therapies, particularly targeted therapies in solid tumors, having the ability to identify ‘mutation drivers’ that help us make healthcare decisions is becoming an increasingly routine practice in oncology," said Martin Gutierrez, MD, head of Phase I and Thoracic Oncology at John Theurer Cancer Center. "Real world experience have shown that this genomic information should be used more frequently to improve patients’ outcomes."

Maher Albitar, MD, chief executive officer and chief medical officer at GTC, stated, "Working with John Theurer Cancer Center to establish an NGS laboratory at a patient care site aligns with our mission as a cooperative company focused on making high-quality molecular profiling available and affordable for every patient with cancer. Furthermore, this collaboration will allow GTC to co-develop new tests with John Theurer Cancer Center by utilizing clinical and outcomes data from John Theurer Cancer Center, which will accelerate innovation in oncology and result in better patient care."

"When you help one person overcome cancer, you make life better for their families, friends, and coworkers, too," explained Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack Meridian Health. "Bringing a tool like NGS into the routine care of people with cancer can improve lives — and by extension, entire communities."

"Cancer affects many residents and their loved ones in northern New Jersey. Having NGS at John Theurer Cancer Center, coupled with the technologies of GTC, puts our doctors in a strong position to better understand what is driving the growth of their patients’ cancers so they can match them with the most effective therapies," said Ihor Sawczuk, MD, FACS, Regional President of the Northern Market. "We are incredibly fortunate to have this resource right here in Hackensack."

More than 30,000 new cancer patients are treated by RCCA physicians annually. John Theurer Cancer Center participates in more than 350 ongoing clinical trials.

About Hackensack Meridian Health

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children’s hospitals – Joseph M. Sanzari Children’s Hospital in Hackensack, K. Hovnanian Children’s Hospital in Neptune; nine community hospitals – Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital – Carrier Clinic in Belle Mead; and two rehabilitation hospitals – JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 34,100 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The network’s notable distinctions include having four hospitals among the top 10 in New Jersey by U.S. News and World Report. Other honors include consistently achieving Magnet recognition for nursing excellence from the American Nurses Credentialing Center and being named to Becker’s Healthcare’s "150 Top Places to Work in Healthcare/2019" list.

The Hackensack Meridian School of Medicine at Seton Hall University, the first private medical school in New Jersey in more than 50 years, welcomed its first class of students in 2018 to its On3 campus in Nutley and Clifton. Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it.

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

For additional information, please visit www.HackensackMeridianHealth.org.

About the Center for Discovery and Innovation

The Center for Discovery and Innovation, a newly established member of Hackensack Meridian Health, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions. The CDI, housed in a fully renovated state-of-the-art facility, offers world-class researchers a support infrastructure and culture of discovery that promotes science innovation and rapid translation to the clinic.