On June 27, 2018 Oxford Vacmedix, the UK based biopharma company focused on the development of a new generation of cancer vaccines, reported that its novel Recombinant Overlapping Peptide (ROP) technology had been presented at the 2018 Myongji International Cancer Symposium .

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The meeting was held in Seoul, South Korea and focused on new horizons in the development of treatments for cancer on immunotherapy and on precision medicine. Other speakers included researchers from the MayoClinic and the University of Chicago in the US as well as from St Luke’s International hospital in Japan.

Dr. Jiang, CSO and Founder of Oxford Vacmedix (OVM) and a researcher in the Department of Oncology at University of Oxford, presented the role of TNF as a potential target for cancer therapy and the exciting preclinical data of OVM’s leading development programmes for two Cancer vaccines. OVM-100 is an HPV vaccine targetedat cervicalcancer,and OVM-200 represents a new type of vaccine utilising survivin to target solid tumours. Bothvaccines are being developed as single agents and in combination with immuno-oncology agents. The company will also continue to develop its diagnostic kits for cellular immunity.

William Finch, CEO of Oxford acmedix said: "We were very pleased to present ROP technology at this important meeting and to have the opportunity to discuss the novel research and the exciting development programme which could lead to significant benefit for patients with cancer"

Wang-Jun Lee, Chairman of Myongji Hospital Group, added: "We are delighted DrJiang could participate in this meeting and we look forward to a productive collaborations with OVM especially in research and in clinical trials. We are confident that we can support the continued growth and development of the company"

On June 27, 2018 Forty Seven, Inc. (Nasdaq:FTSV), a clinical stage immuno-oncology company, reported the pricing of its initial public offering of 7,035,000 shares of common stock at a price to the public of $16.00 per share (Press release, Forty Seven, JUN 27, 2018, View Source [SID1234527522]). In addition, Forty Seven has granted the underwriters a 30-day option to purchase up to an additional 1,055,250 shares of common stock solely to cover over-allotments, if any, at the initial public offering price less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market under the symbol "FTSV" on June 28, 2018.

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Morgan Stanley and Credit Suisse are acting as lead bookrunners, Canaccord Genuity is acting as lead manager, and BTIG and Oppenheimer & Co. Inc. are acting as co-managers for the offering.

The offering is being made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, New York, 10010 or by email at [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

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 Purdue Pharma L.P. reported successful completion of a first-in-human Phase 1 dose escalation study of tinostamustine in patients with relapsed or refractory hematological malignancies for which there are no available therapies (Press release, Purdue Pharma, JUN 27, 2018, View Source [SID1234527497]). The study evaluated the safety and pharmacokinetics, and sought to determine the maximum tolerated dose and inform a Phase 2 dose of tinostamustine. 1

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The multi-acting therapy candidate tinostamustine, previously known as EDO-S101, is a novel and potentially first-in-class alkylating deacetylase inhibitor (AK-DACi) therapy being studied for its potential to improve access to the DNA strands within cancer cells, break them, and counteract the cancer cells’ attempt to repair the DNA damage. It is in development for a range of rare or difficult to treat blood cancers and solid tumors. Based on the results of this Phase I human trial, Purdue will support advancement of tinostamustine into further clinical studies.

"We are pleased with the outcome of this promising early stage oncology program and we believe it has the potential to make meaningful clinical contributions in areas with significant unmet needs," said Craig Landau, MD, president and CEO, Purdue Pharma. "In addition to our established commitments in oncology and neuroscience, we are actively seeking opportunities to collaborate across a number of therapeutic areas as part of our ongoing efforts to diversify our scientific research and bring therapies to market that may improve outcomes for patients."

The reported completion of this study is the first clinical update since Purdue announced in November 2017 significant oncology-related investments to establish a portfolio of drug candidates with the potential to deliver new cancer therapies, in areas of high unmet medical need, to physicians and patients. As part of these investments, Purdue is currently supporting research for four drug candidates across 14 different cancer types. Research on these compounds is being advanced on behalf of Purdue by Mundipharma EDO.

In addition to tinostamustine, Purdue’s clinical stage oncology portfolio includes etoposide toniribate, a novel target-activated topoisomerase inhibitor that delivers the chemotherapy etoposide to tumors in an inactive form where it is ‘switched on’ by enzymes called carboxylesterases. Purdue also has two late pre-clinical stage antibody-drug conjugates, EDO-B776 and EDO-B278, in development. EDO-B776 is being studied for its potential to target the cancer antigen 125 (CA-125) in ovarian cancer. EDO-B278, which targets human tissue factor, is in development for treatment of various solid tumors.

The decision to move tinostamustine into Phase 1 human trials was supported by preclinical studies, which suggest that tinostamustine may deliver both alkylating activity and pan-histone deacetylase (HDAC) inhibition to improve access to the DNA strands within cancer cells, break them, and counteract the cancer cells’ attempt to repair the DNA damage.

Purdue will also continue to selectively seek additional oncology product assets through licensing and acquisition, and the company will maintain a priority interest in candidates with mechanisms complementary to emerging immuno-oncology based treatment paradigms

On June 27, 2018 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO) inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), a type of chemotherapy (Press release, Pfizer, JUN 27, 2018, View Source [SID1234527490]).

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"Patients with acute myeloid leukemia who are ineligible for intensive chemotherapy are in critical need of new treatment options to improve their overall survival," said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. "In an investigational Phase 2 study, glasdegib in combination with low-dose cytarabine showed a significant improvement in overall survival compared to patients who received low-dose cytarabine alone. Glasdegib is the first smoothened inhibitor to potentially offer such a benefit to patients with acute myeloid leukemia, and we are proud that our application was accepted by the FDA for Priority Review."

The FDA grants Priority Review designation to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2018.

The submission is based on results from the Phase 2 BRIGHT 1003 study, a randomized, open-label, multicenter trial investigating glasdegib combined with LDAC (n=88) versus LDAC alone (n=44) in 132 patients with previously untreated AML or high-risk myelodysplastic syndrome (MDS) who were not eligible for intensive chemotherapy. Results demonstrated a significant improvement in the primary endpoint of overall survival (OS). Median OS was 8.8 months for patients treated with glasdegib plus LDAC compared with 4.9 months for patients treated with LDAC only. This difference represented a 49.9 percent reduction in the risk of death for patients treated with glasdegib plus LDAC (HR: 0.501, 95% CI: 0.334, 0.752, one-sided p-value 0.0003). The BRIGHT 1003 results were presented in 2016 at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

The most frequently (≥30% of patients) reported adverse events (AEs) in patients treated with glasdegib plus LDAC compared to LDAC alone were anemia (45% vs 42%), febrile neutropenia (36% vs 27%), nausea (36% vs 12%), decreased appetite (32% vs 12%), fatigue (31% vs 20%) and thrombocytopenia (30% vs 27%). The most frequently (≥15% of patients) reported serious AEs for patients treated with glasdegib plus LDAC compared to LDAC alone were febrile neutropenia (29% vs 20%) and pneumonia (21% vs 17%).

About Glasdegib

Glasdegib is an investigational, oral, once-daily therapy that is thought to inhibit the SMO receptor, thereby disrupting the Hedgehog pathway. Abnormal Hedgehog pathway activation is thought to play a role in the development of multiple types of cancers, including solid tumors and hematologic malignancies. It has not received regulatory approval in any country.

The Phase 3 BRIGHT AML 1019 trial (NCT03416179), which is evaluating the addition of glasdegib to intensive or non-intensive chemotherapy in patients with newly diagnosed AML, began enrolling earlier this year.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is the most common type of acute leukemia in adults and accounts for approximately 80 percent of all cases of acute leukemia.1 An estimated 19,520 people are expected to be diagnosed with AML in the U.S. in 2018.1 Despite recent advancements, only approximately one in four patients with AML survive longer than five years, and additional treatment options are needed to reduce incidence of disease progression and relapse.2,3 This is especially true for patients who are unable to receive intensive chemotherapy and are triaged to other treatments associated with poorer outcomes.