On October 15, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported the presentation of updated clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the first line treatment of primary choroidal melanoma, at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting, being held October 12-15, 2019 in San Francisco, CA (Press release, Aura Biosciences, OCT 15, 2019, View Source [SID1234542258]).

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"With its ability to provide tumor control and vision preservation, AU-011 holds significant potential as a new targeted therapy for the primary treatment of choroidal melanoma," said Cadmus Rich, MD, Chief Medical Officer and Head of Research and Development of Aura Biosciences. "The data presented this year by Dr. Duker provided information on Aura’s proprietary technology platform and key insights that will inform the design and conduct of our pivotal Phase 3 program for AU-011, which we expect to commence in the second half of 2020. Dr. Schefler’s presentation included an update on ongoing research we are conducting into suprachoroidal delivery which, may allow us to increase the range of tumor sizes that AU-011 can treat. Both of these presentations underscore our long-term vision and commitment to bringing this first-in-class technology to patients for this rare and life-threatening disease."

Updated Results from the Phase 1b/2 Study Evaluating AU-011

Jay S. Duker, M.D., Director New England Eye Center, and Professor and Chair, Tufts Medical Center, gave an oral presentation titled, "Novel Management of Choroidal Melanoma – AU-011," which highlighted the potential of Aura’s viral like particle technology, updated data from the ongoing open-label Phase 1b/2 clinical trial, and described the novel design of the planned Phase 3 trial that Aura expects to initiate during the second half of 2020.

The Phase 1b/2 clinical data presented at AAO demonstrate that multiple administrations of light-activated AU-011 were well-tolerated. Among the patients evaluated for safety (n=46), the most common treatment-related adverse events (AEs) were expected and included anterior chamber inflammation, posterior chamber inflammation and increase in intraocular pressure; all were manageable with standard-of-care treatments and the majority resolved without clinical sequelae. Notably, the posterior inflammation appears to originate within and/or around the tumor which is consistent with AU-011’s mechanism of action of acute tumor necrosis. There was one treatment-related severe AE (vision loss; 2%) in one patient with a juxtafoveal tumor.

Tumor control and vision preservation data continue to be supportive of the planned Phase 3 registration trial. In the subset of patients with documented tumor growth prior to trial enrollment (n=17), treatment with AU-011 resulted in tumor control in 15 patients (88%; p=0.0117). The results from this ongoing Phase 1b/2 study will inform the design of Aura’s planned pivotal Phase 3 program for AU-011.

"The data presented this year at AAO show that AU-011 is well tolerated with early signals of efficacy," said Dr. Duker. "AU-011 is administered via a simple, two-step procedure which includes an intravitreal injection followed by a laser application; all of which is completed in the physician’s office. If approved, AU-011 represents the first potential new treatment for choroidal melanoma in several decades."

Exploring Suprachoroidal Delivery for AU-011

Amy C. Schefler, M.D., Weill Cornell Medical College and Retina Consultants of Houston, gave an oral presentation highlighting the data from the ongoing Phase 1b/2 study with intravitreal administration as well as new preclinical research demonstrating the potential advantages of delivering AU-011 using the suprachoroidal route of administration. Aura recently executed a licensing agreement with Clearside Biomedical for use of Clearside’s suprachoroidal space (SCS) Microinjector for the treatment of intraocular cancers. Aura believes that by delivering AU-011 into the SCS, there is the potential for treating a larger number of patients with a good safety profile and a greater range of tumor sizes. Preliminary preclinical pharmacology data showed that AU-011 administered via the SCS Microinjector achieved full necrosis of tumor cells in all animals following laser activation. Further preclinical studies are currently ongoing and Aura expects to initiate clinical testing using suprachoroidal delivery for AU-011 during the first half of 2020.

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults 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 on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane 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 an 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 October 15, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that the first patient has been enrolled in its registration-directed, randomized, controlled Phase 2 clinical trial of RP1 in combination with Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) compared to Libtayo alone in patients with cutaneous squamous cell carcinoma (CSCC) (Press release, Replimune, OCT 15, 2019, View Source [SID1234542256]). The Company also announced plans to initiate a new clinical trial of RP1 as monotherapy in organ transplant recipients with CSCC in early 2020.

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"We are pleased to announce the initiation of our first registration-directed clinical trial for which we believe the data generated to date for RP1 in CSCC is strongly supportive," said Robert Coffin, Ph.D., President and CEO of Replimune. "Having reviewed the initial data in CSCC, we also intend to initiate a new clinical trial of single agent RP1 in organ transplant recipients with CSCC, which we expect to begin enrolling early next year."

The registration-directed Phase 2 clinical trial in CSCC is a multi-center, randomized, controlled clinical trial intended to enroll approximately 240 patients. The study’s primary objective is to compare the response rate following treatment with RP1 in combination with Libtayo to the response rate achieved with Libtayo alone. Libtayo is an anti-PD-1 therapy developed by Regeneron and Sanofi, which was approved by the U.S. Food and Drug Administration (FDA) last year for the treatment of patients with metastatic CSCC or locally-advanced CSCC who are not candidates for curative surgery or curative radiation. This clinical trial is being conducted under the Company’s collaboration agreement with Regeneron. The first patient in the trial has now been enrolled, and multiple clinical trial sites in the U.S. and Australia are open for enrollment. Additional clinical trial sites in these and other countries will be added, with recruitment expected to take approximately 18 to 24 months.

New Clinical Trial Planned of RP1 as Monotherapy in Organ Transplant Recipients with CSCC

Replimune intends to initiate a new Phase 1b clinical trial of single agent RP1 in organ transplant recipients with CSCC, for which the clinical trial protocol has been accepted by the FDA under the Company’s Investigational New Drug application. This clinical trial is intended to enroll approximately 30 patients and assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC, and is expected to initiate in the first quarter of 2020.

"CSCC is a significant unmet medical need in organ transplant recipients, where it is the most prevalent tumor type in an immunosuppressed population already at higher risk for malignancy in general, and where anti-PD1 therapy provides a significant risk of rejection of the transplanted organ," said Howard Kaufman, MD, Chief Medical Officer of Replimune. "We believe that single agent RP1 has the potential to address a significant unmet need for these patients."

Initial Clinical Data with RP1 Strongly Supports the Company’s Programs in CSCC

The Phase 1 part of Replimune’s Phase 1/2 clinical trial of RP1 enrolled 36 patients with advanced heavily pre-treated cancers who have failed available therapy, evaluating treatment with RP1 alone given up to five times, and RP1 given up to eight times in combination with Opdivo (nivolumab) from the second RP1 dose. Following completion of the Phase 1 part of the clinical trial, the Company opened enrollment for Phase 2 cohorts of 30 patients each in patients with melanoma, non-melanoma skin cancers, bladder cancer, and MSI-H tumors. Five patients with CSCC have been enrolled and treated with RP1 combined with Opdivo in this clinical trial, including one from the Phase 1 expansion in combination with Opdivo, and four from the Phase 2 non-melanoma skin cancer cohort. Initial results in these CSCC patients showed:

The first patient achieved a biopsy-confirmed complete response (CR) of extensive disease of the scalp. Clear tumor flattening was observed after the first dose of RP1 and prior to the first dose of Opdivo, prior to the patient ultimately achieving a CR. PD-L1 and CD8 T cell levels were also substantially increased post-treatment as compared to baseline (this data remains pending for the other patients).
The second patient achieved a partial response (PR) of bulky bi-lateral disease in the neck, with substantial reduction observed after the first dose of RP1 and prior to the first dose of Opdivo, including of the uninjected tumor contralateral to the injection site.
The third patient had extensive and rapidly progressing metastatic disease and died from disease progression within 6 weeks of starting therapy.
The fourth patient, also with bulky disease in the neck, had a substantial reduction after the first RP1 dose, which continued to reduce following the introduction of Opdivo.
The fifth patient, with recurrent bone invasive CSCC of the cheek, had substantial flattening after the first RP1 dose and has recently initiated the combination therapy phase with RP1 and Opdivo.
All patients other than the third patient continue on treatment.
The data from these patients can be found in the presentation linked here.

"I have been highly impressed by the initial clinical data in patients with CSCC treated with RP1," said Professor Kevin Harrington, PhD, of The Royal Marsden Hospital in the UK who has treated the majority of CSCC patients in the trial. "The clear demonstration of clinical activity in CSCC, particularly the early and rapid tumor reductions seen in patients with advanced disease including prior to the addition of Opdivo, combined with the emerging safety profile, is very encouraging."

The full Phase 1 safety, clinical efficacy and biomarker data from this clinical trial, which Replimune believes further supports the overall clinical development strategy for RP1, is scheduled to be presented at The Society For Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Maryland. on November 8, 2019.

About CSCC

CSCC is the second most common form of skin cancer and is responsible for an estimated 7,000 deaths each year in the U.S. It currently accounts for approximately 20% of all skin cancers in the U.S., with the number of newly diagnosed cases expected to rise annually. When CSCC invades deeper layers of the skin or adjacent tissues, it is categorized as locally advanced. Once it spreads to other distant parts of the body, it is considered metastatic. Libtayoâ is the only approved therapy in the United States and Brazil, and conditionally approved therapy in the European Union and Canada, for the treatment of locally advanced or metastatic CSCC.

About CSCC in the Organ Transplant Population

The risk of developing cancer following solid organ transplant has been reported to be between 2- and 4-fold higher than in the general population. This includes increased rates of skin cancer, Hodgkin and non-Hodgkin lymphoma, Kaposi sarcoma, and liver, lung, and thyroid cancers. The cumulative incidence of skin cancers, such as CSCC, increases with time from transplantation, with rates as high as 70% after 20 years. When compared with the general population, organ transplant recipients have a 65- to 250-fold increased risk of developing CSCC and a 2- to 8-fold risk of developing melanoma. In the clinical trials in which immune checkpoint blockade drugs have been investigated, organ transplant patients were excluded due to the potential risk of transplanted organ rejection, and as a result, safety and efficacy has not been formally studied. Safety and efficacy of immune checkpoint blockade drugs in organ transplant recipients has, however, recently been obtained from literature reports including 57 organ transplant patients (Fisher et al 2019 J. Am. Acad. Dermatol. Jul 11 Epub ahead of print). Kidney allograft was the most commonly reported transplant (n = 32), followed by liver (n = 20) and heart (n = 5). While the efficacy of immune checkpoint blockade drugs was consistent with that in the general population, 37% of cases resulted in graft rejection and 14% resulted in death due to rejection of the graft. The highest rate of rejection was seen in patients with kidney transplant (41%), followed by liver (35%) and heart (20%).

About RP1

RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

On October 15, 2019 Perrigo Company plc (NYSE; TASE: PRGO), reported that it will release its third quarter calendar year 2019 financial results on Wednesday, November 6, 2019 (Press release, Perrigo Company, OCT 15, 2019, View Source [SID1234542255]). The Company will host a conference call beginning at 8:00 a.m. (EDT).

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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 9864625. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EDT) Wednesday, November 6, 2019 until midnight, November 13, 2019. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10135743.

On October 15, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the results of a metanalysis of 13 clinical studies of the Company’s systemically delivered oncolytic reovirus, pelareorep, were presented during a podium presentation at the annual International Oncolytic Virus Conference (IOVC), hosted at the Mayo Clinic in Rochester, MN on October 9-12, 2019 (Press release, Oncolytics Biotech, OCT 15, 2019, View Source [SID1234542254]). The analyses examined the effectiveness of viral replication within the tumors of patients treated systemically with pelareorep. The data demonstrated that, unlike other oncolytic viruses that require intra-tumoral delivery, intravenous (IV) systemic delivery of pelareorep resulted in 81% of patient tumor samples across multiple types of cancer testing positive for virus replication, with no infection in normal tissue. These results are from studies across a broad range of solid and liquid tumors, including metastatic disease.

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"This metanalysis across multiple clinical studies provides definitive proof that pelareorep can effectively be delivered intravenously, further demonstrating pelareorep’s ability to avoid neutralization, reach primary and metastatic disease and be a valuable therapy and immune adjuvant across a wide range of cancers," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "By effectively and selectively targeting and replicating within tumor cells, systemically delivered pelareorep causes inflammation, labelling the tumor microenvironment with viral RNA priming the patient’s immune system. Combined with PD-1/PD-L1 checkpoint inhibition to enhance the anti-tumor immune response, pelareorep is uniquely positioned to become a backbone for many leading immuno-oncology combination regimens."

Key Findings from the Metanalysis

After IV delivery, 81% of patient tumor samples are positive for replicating reovirus (the average increases to 96% when melanoma and skin biopsies are excluded)
Tumor types that showed a high proportion of active viral replication: breast cancer, pancreatic adenocarcinoma, multiple myeloma, colorectal cancer patients with liver metastases and high-grade glioma
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On October 15, 2019 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2019. "Our third-quarter results represent strong performance, driven by competitive underlying growth in Pharmaceuticals and Medical Devices, as well as continued optimization in our Consumer business," said Alex Gorsky, Chairman and Chief Executive Officer (Press release, Johnson & Johnson, OCT 15, 2019, View Source [SID1234542253]). "As we look ahead, we remain confident in the strength of our broad-based business model, which is fueled by our disciplined portfolio management, focus on transformational innovation and dedicated employees around the world who position us for success today and well into the future."

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1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT COMMENTARY:

Consumer
Consumer worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 1.3%* driven by NEUTROGENA beauty products and over-the-counter products including TYLENOL analgesics, international upper respiratory products and digestive health products, partially offset by lower sales of baby care products due to prior year U.S. re-launch activities.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 6.4%* driven by STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, SIMPONI/SIMPONI ARIA (golimumab), biologics for the treatment of a number of immune-mediated inflammatory diseases, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization and OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, partially offset by biosimilar and generic competition, primarily declines in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer and international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma.

Medical Devices
Worldwide Medical Devices operational sales, excluding the net impact of acquisitions and divestitures grew 5.3%* driven by the growth of electrophysiology products in the Interventional Solutions business, ACUVUE contact lenses in the Vision business, international energy products in the Advanced Surgery business, wound closure products in the General Surgery business and trauma products in the Orthopaedics business.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the company’s website at news releases.
Pipeline Updates
Regulatory Approvals
XARELTO (rivaroxaban) – U.S. FDA Approves to Help Prevent Blood Clots in Acutely Ill Medical Patients (U.S.)1

(press release)
INVOKANA (canagliflozin) – U.S. FDA Approves for Treatment of Diabetic Kidney Disease (U.S.)1
(press release)

DARZALEX (daratumumab) – U.S. FDA Approves Combination Regimen for Newly Diagnosed, Transplant-eligible Patients with Multiple Myeloma (U.S.)

(press release)

ERLEADA (apalutamide) – U.S. FDA Approves Supplemental New Drug Application for the Treatment of Metastatic Castration-Sensitive Prostate Cancer (U.S.)

(press release)

STELARA (ustekinumab) – EU Commission Approves Extended Use for the Treatment of Moderately to Severely Active Ulcerative Colitis (EU)
(press release)

IMBRUVICA (ibrutinib) – EU Commission Approves Expanded Use in Combination with Obinutuzumab in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia and in Combination with Rituximab in Waldenström’s Macroglobulinemia (EU)
(press release)
Regulatory Submissions
SPRAVATO (esketamine) CIII Nasal Spray – Janssen Submits Supplemental New Drug Application to U.S. FDA for the Rapid Reduction of Depressive Symptoms in Adults with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent (U.S.)1

(press release)
STELARA (ustekinumab) – Janssen Submits Application to U.S. FDA for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis (U.S.)1

(press release)

TREMFYA (guselkumab) – Janssen Submits Application to U.S. FDA for Treatment of Adults with Active Psoriatic Arthritis (U.S.)

(press release)
Rilpivirine and Cabotegravir – Janssen Submits Application to EMA for Monthly, Injectable, Two Drug Regimen for Treatment of HIV (EU)

(press release)
DARZALEX (daratumumab) – Janssen Submits Application to EMA for Novel Subcutaneous Formulation (EU)

(press release)
Other
Niraparib – Breakthrough Therapy Designation for the Treatment of Metastatic Castration-Resistant Prostate Cancer (U.S.)1

(press release)

Launch of ECHELON CIRCULAR, the Industry’s First Powered Circular Stapler

(press release)

Launch of ATTUNE Cementless Knee in a Rotating Platform Option

(press release)

Investigational Prophylactic Vaccine – Breakthrough Therapy Designation for Prevention of Respiratory Syncytial Virus in Older Adults (U.S.)

(press release)

1 Subsequent to the quarter

FULL YEAR 2019 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: October 2019 = $1.12; Euro Average Rate: July 2019 = $1.12 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.