On June 27, 2018 Sarah Cannon Research Institute – UK, Part of HCA Healthcare UK, reported the European initiation of a Phase II clinical trial studying the effectiveness of TIL therapy in the treatment of patients facing metastatic melanoma (Press release, Sarah Cannon Research Institute, JUN 27, 2018, View Source [SID1234527503]). Sarah Cannon is the first clinical site in Europe to treat a patient on this trial.

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Sarah Cannon Research Institute – UK, which provides access to clinical trials to both private and NHS cancer patients, is one of 25 centres around the world taking part in Iovance Biotherapeutics’ Phase II TIL trial. The patient population participating in the trial will include people with late-stage melanoma where prior treatments have proven ineffective. The initiation of this trial took place at HCA Healthcare UK at University College Hospital, a complex cancer facility in London.

"We are pleased to offer this cutting-edge immunotherapy option for patients facing melanoma throughout Europe," said Carol Woodward, Vice President of Sarah Cannon Development Innovations and European Operations. "Through Sarah Cannon Research Institute – UK, Part of HCA Healthcare UK, we can ensure patients have access to the latest treatments in their cancer journey."

TIL therapy is a procedure in which white blood cells that have left the bloodstream and migrated towards a tumour, TIL (tumour infiltrating lymphocytes), are enriched to help fight and reduce cancers. As part of the therapy, TIL cells are extracted from a patient’s tumour, amplified in a laboratory to increase their number, and then infused back into the patient. At the recent 2018 ASCO (Free ASCO Whitepaper) Annual Meeting, research for TIL therapy in abstract TPS9595, indicated the potential for durable and complete responses, even in heavily pre-treated patients.

"We are excited to offer this therapy to melanoma patients seeking the latest options," said Hendrik-Tobias Arkenau, MD, PhD, FRCP, Executive Medical Director of the Drug Development Program, Sarah Cannon Research Institute – UK. "TIL therapy is an innovative treatment that brings together a multidisciplinary team to provide patients with access to a complex and cutting-edge treatment approach."

For more information, contact [email protected] / 020 7025 1363 / 07876 899 925

On June 27, 2018 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical stage immunotherapy company, reported its operational and financial results for the year ended March 31, 2018 (Press release, Medicenna Therapeutics, JUN 27, 2018, View Source [SID1234527482]).

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"We are quite pleased with the progress we have made this year," said Fahar Merchant, PhD, Chairman, President and CEO. "We are past the mid-stage of the Phase 2b clinical trial of MDNA55 in patients with recurrent glioblastoma (rGBM), a uniformly fatal form of brain cancer, and have seen early signs of tumor response and impressive overall survival rate at 6 months (OS-6) of 90 percent following a single treatment with low doses of MDNA55. With exceptional drug distribution and a desirable safety profile to date, we plan to treat the remaining patients before the end of 2018 at the higher maximum tolerated dose with an option for repeat treatment in patients showing benefit. We have also accelerated the development of MDNA109, the only CD122 biased high-affinity IL-2 in development, designed to selectively stimulate cancer-fighting T and natural killer (NK) cells and expect to have a long-acting lead candidate in the next six months. Finally, we graduated to the main board of the TSX and listed on the OTCQX. We have laid the groundwork for success in fiscal 2018 and look forward to achieving key milestones in fiscal 2019."

Program updates for the year ended March 31, 2018 are as follows:

MDNA55

On October 10, 2017, results from the Cancer Prevention and Research Institute of Texas (CPRIT) funded on-going Phase 2b rGBM study were presented at the 2017 Congress of Neurological Surgeons (Boston, MA) demonstrating successful delivery in brain cancer patients and a reassuring safety profile for MDNA55 as well as a substantially higher proportion of the target tissue being covered than in similar previously conducted trials. In some cases, close to 100 percent of the tumor and the 1cm margin around it (at risk for tumor spread) had been successfully covered.

In November, further drug distribution and safety data were presented at the Annual Meeting of the Society for Neuro-Oncology (San Francisco, CA) on the first 15 patients in the study confirming earlier results presented at the 2017 Congress of Neurological Surgeons.

On May 2, 2018, Medicenna announced that half the patients in the ongoing Phase 2b study of MDNA55 in recurrent glioblastoma had been recruited and that the data to date demonstrated solid safety results and early signals of efficacy based on the findings of the Safety Review and Clinical Advisory Committees, comprised of key opinion leaders and study investigators. Following the recruitment milestone, the protocol was amended to implement optimal methodologies for treatment of the remaining patients, including more personalized dosing based on tumor load, incorporation of advanced imaging to more reliably measure treatment responses, and the ability to administer a second dose of MDNA55 where appropriate.

On April 27, 2017 we announced the issuance of a US Patent related to our lead clinical candidate MDNA55. U.S. Patent 9,629,899, issued to the U.S. Department of Health and Human Services and licensed exclusively to Medicenna, covers the combination of MDNA55 with other anti-cancer therapeutic agents.
Superkine Platform

MDNA109 is an IL-2 Superkine licensed from Stanford University and has been engineered to make existing cancer therapies work for more people. By selectively boosting the cancer fighting T and NK cells, it can dramatically improve the anti-tumor activity of treatments such as checkpoint inhibitors, cancer vaccines, CAR-T therapies and oncolytic viruses. New long-acting variants of MDNA109 have shown promising early pre-clinical results in aggressive models of melanoma when administered sub-cutaneously (under the skin) potentially allowing convenient once weekly or bi-weekly treatments as opposed to daily intravenous (IV) infusions.

The U.S. Patent & Trademark Office issued Medicenna a patent related to the Company’s Superkine platform. U.S. Patent 9,738,696, issued to the Board of Trustees of the Leland Stanford Junior University ("Stanford") and licensed exclusively to Medicenna, covers the composition of engineered IL-4 Superkines.
Operational Highlights

On August 1, 2017, the Company announced the graduation of its common shares to the main board of the TSX, the premier stock exchange in Canada.

On September 21, 2017, the Company appointed William W. Li, MD, an experienced oncology drug development expert, to its Board of Directors.

On October 18, 2017, the Company’s common shares were listed on the OTCQX, a segment of the OTC marketplace reserved for high-quality non-U.S. companies, under the symbol, "MDNAF."
Annual Financial Results

Net loss for the year ended March 31, 2018 was $7,465,452, compared to a net loss of $7,631,265 for the year ended March 31, 2017. The decrease in net loss in the year ended March 31, 2018 compared with the year ended March 31, 2017 was primarily a result of one-time costs incurred in the prior year including a liquidity payment and a non-cash listing expense of $1,784,414 resulting from the reverse takeover transaction completed in the year ended May 31, 2017. These decreases from the prior year were offset by increased spending on the Phase 2b clinical trial of MDNA55 as well as increased costs incurred on the pre-clinical pipeline, specifically MDNA109 during the year ended March 31, 2018.

Research and development expenses for the year ended March 31, 2018 were $5,090,146, compared to $4,229,110 for the year ended March 31, 2017. The increase is primarily due to costs associated with the initiation of discovery and pre-clinical activities associated with the Superkine programs including MDNA109 as well as the development of MDNA57 (second generation MDNA55). In addition, clinical costs increased significantly in the current year due to patient treatment and related expenses in the Phase 2b clinical trial of MDNA55 for which the first patient was treated in April 2017. These increases were partially offset by reduced costs associated with the manufacture, testing and stability studies of MDNA55 drug product, as well as lower licensing, patent legal fees and royalty expense due to the one-time liquidity payment discussed above.

General and administrative expenses for the year ended March 31, 2018 were $2,334,684, compared to $1,684,671 for the year ended March 31, 2017. The increase is primarily due to higher stock-based compensation expense, fees associated with the graduation of Medicenna’s common shares from the TSX Venture exchange to the main TSX Board, the OTCQX listing, investor relations activities and fees paid to the Board of Directors. The noted increases are partially offset by lower salary and benefit costs in the year ended March 31, 2018 due to severance costs incurred in the prior year as well as lower legal, professional and finance expenses in the year ended March 31, 2018 due to costs related to the reverse takeover transaction incurred in the prior year.

Medicenna had a cash balance of $3,938,734 at March 31, 2018.

Outlook

The Company will focus on completing patient enrollment for its Phase 2b clinical trial for MDNA55 in the fourth quarter of calendar 2018 and expects top-line clinical results in early 2019. Medicenna also plans to select a MDNA109 lead candidate with extended half-life characteristics.

On June 26, 2018 BerGenBio ASA (OSE:BGBIO) reported that on a top-line, preliminary basis, the first efficacy endpoint has been met in its Phase II clinical trial (BGBC008) evaluating bemcentinib, a first-in-class oral selective AXL inhibitor, in combination with the Merck & Co., Inc., Kenilworth, N.J., USA anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a potential new treatment regimen for advanced non-small cell lung cancer (NSCLC)(Press release, BerGenBio, JUN 26, 2018, View Source [SID1234527463]) . The primary efficacy endpoint requires at least four patients (out of the first 22 treated patients) to achieve clinical responses when treated with the novel drug combination, defined as either complete or partial response, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).

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Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "Immunotherapy has become a major component of the treatment of many cancers – patients who respond to immune checkpoint inhibitors like KEYTRUDA enjoy long-term disease control with excellent quality of life. Unfortunately, only a minority of lung cancer patients receiving KEYTRUDA monotherapy in second-line respond to treatment. The BGBC008 combination trial of bemcentinib with KEYTRUDA evaluates whether the addition of our selective AXL inhibitor will improve the outcome of immunotherapy.

"Clearing the first efficacy threshold in this ongoing Phase II trial is very encouraging and we intend to begin enrolment for Stage 2 of this study in which 24 further patients will be enrolled under the same protocol. Thus far, we are delighted to see activity in a number of patients receiving this novel treatment regimen. A particularly encouraging finding is that we see responses in patients who are negative for the PD-L1 biomarker, for whom KEYTRUDA monotherapy is not indicated. The second stage of the trial is intended to confirm activity and biomarker correlation in a larger group of patients – comprehensive analysis of the Phase II data will continue and will be presented at a future scientific conference.

"Successfully completing this important milestone further supports our belief in the potential of bemcentinib to become a cornerstone of cancer therapy. We look forward to sharing more details from our Phase II clinical programme during major clinical conferences in the coming months."

About the BGBC008 trial combining bemcentinib with KEYTRUDA (pembrolizumab) conducted in collaboration with Merck & Co., Inc.
Design
The BGBC008 trial is a Phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination and responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).

A pre-defined efficacy endpoint was set at four or more responses observed in the first 22 patients based on previously reported response rates to KEYTRUDA monotherapy in the second line setting in NSCLC.

Status June 2018
To date, 4 responses (partial responses as per RECIST v1.1) have been observed in the first 22 patients. A number of patients remain ongoing and are awaiting the confirmation of their best response.

Patients generally tolerated the novel drug combination well – no new safety events were reported from the combination of bemcentinib with KEYTRUDA at full dose.

A preliminary interim analysis of the trial (from 15 patients evaluable for response) was presented at ASCO (Free ASCO Whitepaper) 2018, where tumour shrinkage was observed in about half of the patients analysed to date. Results looked particularly promising in patients who did not express the PD-L1 biomarker, i.e. representing 1/3 of NSCLC patients, a group for whom KEYTRUDA monotherapy as a second line is not indicated.

For more information please access trial NCT03184571 at www.clinicaltrials.gov.

On June 26, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients 12 years and older (Press release, Hoffmann-La Roche, JUN 26, 2018, View Source [SID1234527464]). The FDA is expected to make a decision on approval by 24 December 2018. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

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"The severity of the recent flu season underscores the need for new options beyond currently available treatments, and if approved, baloxavir marboxil would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "Baloxavir marboxil has been shown in clinical trials to decrease the duration of symptoms with one dose, and demonstrated a significant reduction in viral shedding in just one day. We look forward to working with the FDA during the review process."

Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the flu virus, including oseltamivir-resistant strains and avian strains (H7N9, H5N1).7,8,9 Unlike other currently available antiviral treatments, baloxavir marboxil is designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication.10,11

The NDA is based on results from the phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with flu. Additionally, results from a placebo-controlled phase II study in otherwise healthy people with the flu is included as supporting data in the NDA.

About CAPSTONE-1
CAPSTONE-1 is a phase III multicentre, randomised, double-blind, placebo-controlled study that evaluated the efficacy and safety of baloxavir marboxil in 1,436 people in the United States and Japan. The primary endpoint of the study was time to alleviation of symptoms (TTAS), and important secondary endpoints were time to resolution of fever, time to cessation of viral shedding and the proportion of participants positive for influenza virus titre, or virus levels in the body, by time point. The study found the following results:

Baloxavir marboxil met its primary and secondary endpoints compared to placebo:
Significantly reduced the duration of flu symptoms by more than one day (median time 53.7 hours versus 80.2 hours; p<0.0001);
Significantly reduced the duration of fever by nearly a day (median time 24.5 hours versus 42.0 hours; p<0.0001);
Significantly reduced the length of time viruses continued to be released from the body (median time of viral shedding; 24.0 hours versus 96.0 hours; p<0.0001);
Significantly reduced the levels of virus in the nose and throat from 24 hours through 120 hours.
Similar efficacy results were seen between baloxavir marboxil and oseltamivir in relation to duration of symptoms and fever reduction, but significant differences were observed in time to cessation of viral shedding favouring baloxavir marboxil:
No significant reduction in duration of symptoms (median time 53.5 hours versus 53.8 hours; p=0.7560);
No significant reduction in time to resolution of fever (median time 24.4 hours versus 24.0 hours; p=0.9225);
Significantly reduced the length of time the virus continued to be released from the body (viral shedding; 24.0 hours versus 72.0 hours; p<0.0001);
Significantly reduced the levels of virus in the nose and throat at 24 hours and 72 hours.
Baloxavir marboxil was well-tolerated and had a numerically lower overall incidence of adverse events (20.7%) reported compared with placebo (24.6%) or oseltamivir (24.8%). The most common adverse events reported were diarrhoea (3.0%), bronchitis (2.6%), nausea (1.3%) and sinusitis (1.1%), and all of these adverse events occurred at a lower frequency than placebo.

About baloxavir marboxil
Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza ("flu") A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1).7,8,9 Unlike other currently available antiviral treatments, baloxavir marboxil is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication.

Baloxavir marboxil is being studied in an ongoing phase III development program including paediatric populations with influenza. Data from the global phase III study (CAPSTONE-2) in patients 12 years and older with a high risk of complications from influenza, as defined by the Centers for Disease Control and Prevention (CDC), will be shared at a later date.

Baloxavir marboxil was discovered by Shionogi & Co., Ltd. and is being developed globally by the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to baloxavir marboxil excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd. Baloxavir marboxil was approved in February 2018 by the Japanese Ministry of Health, Labour and Welfare for the treatment of influenza types A and B in adult and paediatric patients and is being commercialised in Japan and marketed under the brand name Xofluza.

On June 26, 2018 Oncorena reported a completely new and potentially groundbreaking treatment for patients with metastatic kidney cancer (Press release, Oncorena, JUN 26, 2018, View Source [SID1234527466]). The company is approaching a more intense development phase that will require a full-time CEO. Lars Grundemar has served as the Chief Scientific Officer of Oncorena and he will now assume the CEO position on July 1, 2018.

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Dr. Jan Törnell has successfully led Oncorena since 2013 as part-time CEO. Because of other ongoing commitments, he is unable to fill this position full-time.

Lars Grundemar, M.D., Ph.D. has more than 20 years leadership experience from the global pharmaceutical industry with assignments in major corporations and different countries in Europe and in the US. Dr. Grundemar has been leading multiple drug development projects across various therapeutic areas, including oncology. He has established new departments and introduced novel ways to improve research and development functions.

"We are excited to work with Lars Grundemar as CEO to bring Oncorena into the clinical phase in the near future," says Bengt-Åke Bengtsson, Chairman of the Board of Oncorena. "We would also like to thank Jan Törnell for his excellent leadership through the company’s preclinical development phase."

"I am very honored over this trust and look forward to this challenge. It’s a great privilege to be able to contribute to the development of a novel therapeutic principle to combat cancer and to improve the quality of life for patients suffering from kidney cancer," says Lars Grundemar, new CEO of Oncorena.

"I strongly believe in the success for Oncorena and I’m certain that the company is in the best of hands moving forward. I will make every effort to contribute to a smooth transition for Lars Grundemar into his new role as CEO," says Jan Törnell, currently CEO of Oncorena.

For further information, please contact
Bengt-Åke Bengtsson, Chairman of the Board, Oncorena AB,
[email protected], phone +46 (0)70 746 0000

Lars Grundemar, CEO of Oncorena from July 1, [email protected],
phone +46 (0) 76 209 5518

Jan Törnell, CEO, Oncorena AB, [email protected]
phone +46 (0)70 676 0008

About kidney cancer
Approximately 1,000 patients are affected by kidney cancer annually in Sweden and around 600 of them die. 80% of the patients are between 40 and 69 years of age when they are diagnosed (median age 63 years). The disease can often be cured with surgery if detected in time, but unfortunately the diagnosis is often made when the tumor has already spread to other organs. The prognosis is then considerably less favorable and certain groups have a median survival of only approx. 1.5 years. Today the disease is treated with various types of targeted and immuno-active drugs, often with severe side effects, and standard chemotherapy drugs have only very limited effect. There is therefore a great need for new, effective and safe drugs.

About the project
The substance, orellanine, originally emanates from a mushroom and has been ingested by mistake by a number of people. The effects are well documented and are limited to the kidneys. As the target group for the treatment is patients with metastatic kidney cancer who are undergoing dialysis the side effect profile is believed to be relatively mild. Experimental studies indicate that the effect may be dramatically positive. The preclinical studies will be completed during 2018, whereupon the clinical study is expected to start in the spring of 2019. Learn more at www.oncorena.com.