On June 18, 2018 Gamida Cell, a leading cellular and immune therapeutics company, reported that preliminary data from an ongoing phase I study from the nicotinamide-based natural killer cell expansion, or NAM-NK, program will be presented during the Inaugural AACR (Free AACR Whitepaper) International Meeting on Advances in Malignant Lymphoma, held June 22 – 26 in Boston, Massachusetts (Press release, Gamida Cell, 18 18, 2018, View Source [SID1234527379]).

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Veronika Bachanova, M.D., Ph.D., hematologist/oncologist at the Blood and Marrow Transplantation and Cellular Therapy Program of the University of Minnesota, and lead investigator of the investigator-sponsored phase I NAM-NK clinical study at the Masonic Cancer Center, will present a poster of early patient outcomes from the study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.

Title: Phase I study of nicotinamide-expanded related donor Natural Killer (NK) cells for the treatment of relapsed/refractory CD20+ non-Hodgkin lymphoma (Abstract: B05)
Session: Poster Session B: Therapeutics and Clinical Trials in Lymphoma 2
Location: Salon F, Boston Marriott Copley Place
Date: Sunday June 24, 2018 11:45 AM – 1:45 PM

About NAM-NK
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with SoC antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in phase I development (NCT03019666) through an investigator-sponsored trial in patients with refractory non-Hodgkin lymphoma and multiple myeloma.

On June 18, 2018 Ziopharm Oncology, Inc. (Nasdaq:ZIOP) reported the U.S. Food and Drug Administration (FDA) placed on clinical hold a Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care and requested additional information in support of the investigational new drug (IND) application for the trial (Press release, Ziopharm, JUN 18, 2018, View Source [SID1234527386]).

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Ziopharm, Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON) and The University of Texas MD Anderson Cancer Center, the IND sponsor, are seeking to conduct a clinical trial to evaluate CAR+ T cells manufactured with Sleeping Beauty technology as an investigational treatment for patients with relapsed or refractory, CD19+ leukemias and lymphomas. CAR+ T cells very-rapidly manufactured with the Sleeping Beauty platform for this third-generation trial are designed to co-express CD19-specific chimeric antigen receptor, or CAR, membrane-bound interleukin 15 and a safety switch. The FDA has requested additional information relative to Chemistry, Manufacturing and Controls. Ziopharm and its partners will address the FDA’s requests, and the initiation of this trial may be delayed.

"We know what is needed to address the hold issues and are looking forward to responding to the agency in a timely manner," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "We are undertaking cutting-edge science and are on the verge of a paradigm shift based on our approach to very-rapidly manufacture CD19-specific T cells within two days using our non-viral approach to CAR-T therapy based on the Sleeping Beauty platform."

Ziopharm believes this feedback from the FDA does not affect timelines for the Company’s planned trial at the National Cancer Institute using the Sleeping Beauty platform to target solid tumors infusing TCR-modified T cells. The second-generation clinical trial evaluating Sleeping Beauty-manufactured CD19-specific CAR-T cells continues enrolling and infusing patients at MD Anderson.

On June 18, 2018 NeuroVive Pharmaceutical AB and BridgeBio Pharma reported that BridgeBio has entered into an exclusive licensing agreement for a subset of succinate prodrug chemistry under NeuroVive’s NVP015 program (Press release, BridgeBio, JUN 18, 2018, View Source [SID1234576278]). BridgeBio also announced that it has launched a subsidiary company Fortify Therapeutics to further develop this chemistry for local treatment of Leber’s Hereditary Optic Neuropathy (LHON), with an initial financial commitment of $20 million USD. NeuroVive’s NVP015 program for other mitochondrial disorders will continue without any changes in focus or timelines.

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LHON is caused by mitochondrial DNA mutations in subunits of NADH dehydrogenase (complex I), leading to reduced oxidative phosphorylation and energy production in retinal cells. The disease predominantly affects young adults, and results in sudden onset of progressive and severe vision loss. The licensed succinate prodrugs have the potential to overcome the disease by bypassing the dysfunctional metabolic pathway, providing an alternate source of energy to the retinal cells.

"As a targeted treatment for a genetic disease, the LHON program is a clear fit with the BridgeBio model," said Neil Kumar, Ph.D., CEO of BridgeBio. "We have been impressed with the ability of these compounds to rescue specific genetic mitochondrial deficiencies, and we have assembled a team of international experts to further develop a subset of the NVP015 chemistry to address this devastating disease."

Fortify Therapeutics will develop selected lead compounds derived from NeuroVive’s novel NVP015 succinate prodrug program into drug candidates for the localized treatment of LHON. These compounds have been selected because they have properties that make them suitable for delivery to the eye.

The licensing agreement for this particular subset of the NVP015 program has a total deal value of approximately $60 million USD, which includes limited initial funding for research, and later milestone payments and a single digit royalty stream, that are dependent on successful development and market approval.

"The agreement with BridgeBio is important to both NeuroVive and our innovative NVP015 program, as it validates the quality of the program, our business development model and potential in a variety of mitochondrial disorders," commented NeuroVive CEO Erik Kinnman, M.D., Ph.D. "We will work closely with BridgeBio to further develop this chemistry subset and make the LHON program successful. It is important to note that our intentions for the NVP015 program are unchanged, and we are progressing towards experimental proof-of-principle during 2018."

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CET on 18 June 2018.

About LHON
Leber’s Hereditary Optic Neuropathy (LHON) is a disease caused by mitochondrial DNA mutations in subunits of NADH dehydrogenase (complex I), a component of the electron transport chain. This results in dysfunctional oxidative phosphorylation and ATP production, leading to degeneration of the retinal ganglion cells and loss of central vision. LHON most commonly affects males in their second or third decade of life. The prevalence of LHON in Europe is between 1:30,000-1:50,000.

About NVP015
One of the most common causes of mitochondrial diseases relates to Complex I dysfunction, i.e. when energy conversion in the first of the five protein complexes in the mitochondrion that are essential for effective energy conversion does not function normally. This is apparent in disorders including Leigh’s Syndrome and MELAS, both of which are very serious diseases with symptoms such as muscle weakness, epileptic fits and other severe neurological manifestations. The NVP015 project is based on a NeuroVive innovation in which the body’s own energy substrate, succinate, is made available in the cell via a prodrug technology. A prodrug is an inactive drug that is activated first when it enters the body by the transformation of its chemical structure. Results from the NVP015 project were published in the prestigious Nature Communications journal in August 2016.

On June 17, 2018 Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral capsid conjugates, reported new interim safety and efficacy data from an open-label Phase 1b/2 study of its lead program, light-activated AU-011 for the treatment of primary choroidal melanoma (Press release, Aura Biosciences, JUN 17, 2018, View Source [SID1234527354]). The findings were presented by Ivana Kim, M.D., Co-Director of the Ocular Melanoma Center at Massachusetts Eye and Ear, at the 2018 World Ophthalmology Congress in Barcelona.

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AU-011 is an investigational, first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. FDA has already granted Fast Track Designation and orphan drug designation, recognizing that there are no FDA-approved therapies and that the disease is serious and life-threatening.

AU-011 is being evaluated in a Phase 1b/2 open-label, multicenter trial designed to evaluate the safety and efficacy of single and multiple ascending doses in 30 adult subjects with clinically diagnosed small to medium primary choroidal melanoma.

Interim data presented today show that AU-011 has been generally well-tolerated with no related serious adverse events, no severe adverse events and no dose-limiting toxicities observed. Adverse events were manageable with standard of care treatments and had no further clinical sequelae. Pre-treatment visual acuity was maintained in all subjects that have been followed for 6 to 12 months.

Early efficacy results are very promising with two subjects in the first multiple-ascending-dose cohort showing evidence of reduction in tumor height at 3 months. Further evidence of preliminary efficacy has also been demonstrated with subtherapeutic doses in the single-ascending-dose cohorts providing stable disease with vision preservation up to 12 months.

"We are excited by these preliminary findings showing AU-011 provided local tumor control without loss of visual acuity for a majority of subjects dosed to date," said Dr. Kim. "That is an encouraging sign of progress toward developing a new treatment for this cancer that could preserve much more vision than radiotherapy, which is the current standard of care but not FDA approved for this indication."

"These findings indicate that Aura’s novel, targeted, light-activated treatment could hold real promise for patients with choroidal melanoma," said Cadmus Rich, M.D., Chief Medical Officer of Aura. "Our team is looking forward to continuing our Phase 1b/2 study with Dr. Kim and our other collaborators at leading ophthalmology centers across the country."

About choroidal melanoma
Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy, optic nerve damage and loss of vision. The alternative is enucleation, or removal of the eye. Choroidal melanoma metastasizes to the liver in about 40 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

About light-activated AU-011
AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of patented viral capsid conjugates (VCC) with IR-700DX dye molecules that are activated with an ophthalmic laser. The VCCs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. The IR-700DX dye molecules are produced by LI-COR Biosciences and are licensed exclusively to Aura for treating ocular cancers. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in the ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

On June 17, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti (elotuzumab) to pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM), achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with EPd compared with pomalidomide and dexamethasone (Pd) alone (Press release, Bristol-Myers Squibb, JUN 17, 2018, View Source [SID1234527359]). ELOQUENT-3 is the only randomized, active-controlled trial to investigate a pomalidomide-based triplet combination in patients with RRMM who received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI).

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Patients randomized to EPd experienced a 46% reduction in risk of disease progression (HR 0.54; 95% CI: 0.34 to 0.86, p=0.0078) compared with patients randomized to Pd alone, with median PFS, the study’s primary endpoint, of 10.3 months (95% CI: 5.6 to not estimable) compared with 4.7 months (95% CI: 2.8 to 7.2) in Pd patients. The PFS benefit experienced among patients randomized to EPd was consistent among patients who had received two to three prior lines of therapy (HR 0.55; 95% CI: 0.31 to 0.98) and four or more prior lines of therapy (HR 0.51; CI 95%: 0.24 to 1.08). The safety profile for EPd was consistent with prior findings for Empliciti and pomalidomide regimens. The full results will be presented in a late-breaking oral session on Sunday, June 17, at 12:30 CEST during the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden.

"The ELOQUENT-3 trial is the first randomized trial comparing the standard of care, pomalidomide and low dose dexamethasone, with and without the addition of a monoclonal antibody. These data support the hypothesis that the addition of elotuzumab to pomalidomide and dexamethasone elicits a synergistic effect and prolongs, significantly, the progression-free survival of heavily pretreated patients with myeloma, regardless of the number of prior therapies," said Meletios A. Dimopoulos, M.D., professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens, School of Medicine. "We believe that EPd, if approved by regulatory authorities, could become an important potential treatment option for patients with relapsed/refractory multiple myeloma whose disease has progressed after treatment with lenalidomide and a proteasome inhibitor."

Twice as many patients randomized to EPd responded to therapy compared to patients randomized to Pd alone. Patients randomized to EPd demonstrated an overall response rate (ORR) of 53% (95% CI: 40 to 66), compared with 26% (95% CI: 16 to 40) among patients randomized to Pd. Time to first response was comparable for patients receiving EPd and Pd at 1.95 and 1.91 months, respectively. Median duration of response had not been reached among patients randomized to EPd at time of analysis. Overall survival, a secondary endpoint, although not mature at this time, showed a positive trend favoring EPd over Pd alone (HR 0.62; 95% CI: 0.30 to 1.28).

"Based on survival data we’ve seen to date in relapsed or refractory multiple myeloma, Empliciti in combination with lenalidomide and dexamethasone has been established as an important treatment option for patients," said Jeffrey Jackson, Ph.D., hematology development lead, Bristol-Myers Squibb. "These new data evaluating the EPd combination build on our commitment to understanding the full potential of Empliciti when used in different combinations. We look forward to discussing these data with health authorities."

Treatment-related Grade 3-4 adverse events (AEs) were comparable between EPd and Pd groups. Any-grade infections occurred in 65% of patients in both arms. Rates of the most commonly occurring Grade 3-4 hematologic AEs, neutropenia and anemia, were lower among patients receiving EPd (13% and 10%, respectively) than patients receiving Pd (27% and 20%), despite longer exposure within the EPd arm and similar dose intensity of pomalidomide between arms. AEs led to discontinuation in 18% of patients in the EPd arm, compared with 24% of patients in the Pd arm.

About ELOQUENT-3

The Phase 2 ELOQUENT-3 trial randomized 117 patients with RRMM who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a PI. Patients were randomized 1:1 to receive either EPd (n=60) or Pd (n=57) in 28-day cycles until disease progression or unacceptable toxicity. Patients in both the EPd and Pd arms received 4 mg of pomalidomide for days 1-21 of each cycle, and the weekly equivalent of 40 mg or 20 mg dexamethasone for patients ≤75 years or >75 years, respectively. In the EPd arm, elotuzumab was administered at the dose of 10 mg/kg IV weekly for the first 2 cycles and 20 mg/kg monthly starting from cycle 3.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational medicines, including Immuno-Oncology (I-O) therapeutic approaches, for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the integrated scientific understanding of both tumor cell and immune system pathways, through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 24 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of transformational medicines like I-O therapies a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Empliciti

Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 also is expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

U.S. FDA-APPROVED INDICATION FOR EMPLICITI

EMPLICITI (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

IMPORTANT SAFETY INFORMATION

Infusion Reactions

EMPLICITI can cause infusion reactions. Common symptoms include fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose. If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
Premedicate with dexamethasone, H1 Blocker, H2 Blocker, and acetaminophen prior to infusing with EMPLICITI.
Infections

In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28% (ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly.
Second Primary Malignancies

In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and 5.7% (Rd). The rate of hematologic malignancies were the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd). Monitor patients for the development of SPMs.
Hepatotoxicity

Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered.
Interference with Determination of Complete Response

EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Pregnancy/Females and Males of Reproductive Potential

There are no studies with EMPLICITI with pregnant women to inform any drug associated risks.
There is a risk of fetal harm, including severe life-threatening human birth defects associated with lenalidomide and it is contraindicated for use in pregnancy. Refer to the lenalidomide full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.
Adverse Reactions

Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients.
Serious adverse reactions were 65.4% (ERd) and 56.5% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15.4%, 11%), pyrexia (6.9%, 4.7%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
The most common adverse reactions in ERd and Rd, respectively (>20%) were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%), and pneumonia (20.1%, 14.2%).
Please see the full Prescribing Information for EMPLICITI.