On July 15, 2019 Vaccitech, a clinical-stage T cell immunotherapy company developing viral vectors as vaccines to treat and prevent Cancer and Infectious Diseases, reported that it has appointed Mariem Charafeddine as Chief Medical Officer (Press release, Vaccitech, JUL 15, 2019, View Source [SID1234537519]).

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Mariem brings over 15 years’ experience in the Biopharmaceutical Industry, spent both advancing the clinical development and commercialisation of Infectious Disease products, and in delivering post-marketing monitoring of licensed medical products. Mariem has previously worked in international medical leadership roles and drug development in Infectious Diseases.

She joins Vaccitech after 6 years at Abbvie, where she most recently served as Medical Director for Pharmacovigilance and Patient Safety Sciences, Infectious Diseases and Neurosciences. Mariem’s prior roles include Global Clinical Development at AbbVie and Hoffmann-La Roche/Genentech, as well as Medical Manager at Hoffmann-La-Roche in France. She is a qualified physician, with clinical practice and research experience focused in Infectious Diseases and Hepatology. Mariem also holds a Master’s degree in Marketing Management, gained from ESCP Europe.

Mariem will oversee the development of Vaccitech’s growing clinical-stage pipeline and will help implement the global clinical development strategy and medical plans across Vaccitech’s therapeutic and prophylactic vaccine products.

"We are delighted to have Mariem join our team as we advance towards the Phase 2b read-outs of our lead clinical program in influenza," said Tom Evans, Vaccitech CEO. "Her wide-ranging clinical development and post-marketing expertise in infectious diseases also puts us in great stead ahead of first in human studies for our HPV and HBV therapeutics. We look forward to her input on how best to develop our vaccines for the patients that need them."

On July 15, 2019 GlaxoSmithKline plc (LSE/NYSE: GSK) reported positive results from PRIMA (ENGOT-OV26/GOG-3012), the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in patients with first-line ovarian cancer following platinum-based chemotherapy (Press release, GlaxoSmithKline, JUL 15, 2019, View Source [SID1234537517]). The study met its primary endpoint of a statistically significant improvement in progression free survival for women regardless of their biomarker status.

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The safety and tolerability profile of niraparib was consistent with previous clinical trials.

Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: "Almost 300,000 women around the world are diagnosed with ovarian cancer every year, yet only about 15% of patients are currently eligible to receive PARP inhibitors as their initial therapy. These exciting data demonstrate that ZEJULA has the potential to significantly benefit even more women with this devastating cancer."

The full results from PRIMA will be presented at an upcoming scientific meeting.

Niraparib is marketed in the United States and Europe under the trade name ZEJULA.

About PRIMA

PRIMA is a double-blind, randomized Phase 3 study designed to evaluate niraparib versus placebo in first-line Stage III or IV ovarian cancer patients. The study assesses the efficacy of niraparib as maintenance treatment, as measured by progression free survival. Platinum responsive patients were randomized 2:1 to niraparib or placebo. The trial incorporated an individualized niraparib starting dose of 200 mg once-daily in patients with baseline weight <77kg or platelet count <150K/μL and 300 mg in all other patients.

About Ovarian Cancer

Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years.

About niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three pivotal trials. The ongoing development program for niraparib includes the Phase 3 PRIMA trial, a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab in metastatic, triple-negative breast cancer and advanced, platinum-resistant ovarian cancer (the TOPACIO trial) and niraparib plus bevacizumab in recurrent, platinum-sensitive ovarian cancer (the ENGOT-OV24/AVANOVA trial). Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

Important Safety Information for ZEJULA

Myelodysplastic Syndrome/Acute Myeloid Leukaemia (MDS/AML), including some fatal cases, was reported in 1.4% of patients receiving ZEJULA vs 1.1% of patients receiving placebo in Trial 1 (NOVA), and 0.9% of patients treated with ZEJULA in all clinical studies. The duration of ZEJULA treatment in patients prior to developing MDS/AML varied from <1 month to 2 years. All patients had received prior chemotherapy with platinum and some had also received other DNA damaging agents and radiotherapy. Discontinue ZEJULA if MDS/AML is confirmed.

Hematologic adverse reactions (thrombocytopenia, anaemia and neutropenia) have been reported in patients receiving ZEJULA. Grade ≥3 thrombocytopenia, anaemia and neutropenia were reported in 29%, 25%, and 20% of patients receiving ZEJULA, respectively. Discontinuation due to thrombocytopenia, anaemia, and neutropenia occurred, in 3%, 1%, and 2% of patients, respectively. Do not start ZEJULA until patients have recovered from haematological toxicity caused by prior chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically thereafter. If haematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a haematologist for further investigations.

Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 9% of patients receiving ZEJULA vs 2% of patients receiving placebo in Trial 1, with discontinuation occurring in <1% of patients. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose, if necessary.

Based on its mechanism of action, ZEJULA can cause foetal harm. Advise females of reproductive potential of the potential risk to a foetus and to use effective contraception during treatment and for 6 months after receiving their final dose. Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women to not breastfeed during treatment with ZEJULA and for 1 month after receiving the final dose.

In clinical studies, the most common adverse reactions (Grades 1-4) in ≥10% of patients included: thrombocytopenia (61%), anaemia (50%), neutropenia (30%), leukopenia (17%), palpitations (10%), nausea (74%), constipation (40%), vomiting (34%), abdominal pain/distention (33%), mucositis/stomatitis (20%), diarrhoea (20%), dyspepsia (18%), dry mouth (10%), fatigue/asthenia (57%), decreased appetite (25%), urinary tract infection (13%), aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation (10%), myalgia (19%), back pain (18%), arthralgia (13%), headache (26%), dizziness (18%), dysgeusia (10%), insomnia (27%), anxiety (11%), nasopharyngitis (23%), dyspnoea (20%), cough (16%), rash (21%) and hypertension (20%).

Common lab abnormalities (Grades 1-4) in ≥25% of patients included: decrease in haemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%) and increase in ALT (28%).

On July 14, 2019 Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, reported that the company recently dosed the first patient successfully in a Phase I clinical trial of APG-2575, a novel Bcl-2 selective inhibitor, for the treatment of hematologic malignancies in China (Press release, , JUL 14, 2019, View Source [SID1234537515]). The Company also has an ongoing multi-center Phase I dose-escalation study of APG-2575 as a single agent in the United States and Australia. APG-2575 could potentially be the first China-made Bcl-2 inhibitor.

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APG-2575 is a novel, orally administered Bcl-2 selective inhibitor. It is designed to treat hematologic malignancies by selective blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

Bcl-2 is the founding member of the Bcl-2 family proteins which are most notable for their critical roles in the regulation of apoptosis through the formation of heterodimers with pro-apoptotic proteins (BIM, BAD and most others). Due to the very large and hydrophobic interfaces of Bcl-2 proteins, it is difficult to develop a drug that targets Bcl-2 family protein. The marketed Bcl-2 inhibitor venetoclax/ABT-199 approved by the U.S. FDA in April 2016 has validated the clinical basis for further targeted drug development. Ascentage Pharma’s APG-2575 is one of the few Bcl-2 selective inhibitors in active clinical trials other than Venetoclax.

This Phase I trial is designed to assess the safety and tolerance of APG-2575 in patients with hematologic malignancies and confirm the maximal tolerated dose (MTD) or recommended Phase II dose (RP2D) of APG-2575. Included in this trial are patients with acute myelogenous leukemia (AML), non-Hodgkin’s lymphoma (NHL). Currently, the first patient enrolled in China has been dosed at Institute of Hematology, Blood Disease Hospital of Chinese Academy of Medical Sciences during the first stage of dose-escalation.

The Phase I dose-escalation clinical trial of APG-2575 in the United States and Australia is being conducted at several academic institutions including MD Anderson Cancer Center and Mayo Clinic. Included in this trial are patients with various types of blood cancer, such as CLL, NHL, MM, AML. At present, 4 dose cohorts have been completed in the United States and Australia. Preliminary data suggested that APG-2575 was well tolerated and safe, it had promising anti-tumor activity in the treatment of relapsed/refractory CLL.

During the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, Ascentage Pharma released several preclinical research results of APG-2575, which demonstrated the potential in combination therapy.

"APG-2575 is a key product in our development pipeline of apoptosis. Initiating the clinical trial in China represents a new step in our global clinical development. We believe that APG-2575 may provide more therapy options to patients with blood diseases," said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma.

About APG-2575
APG-2575 is a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma. It is designed to treat hematologic malignancies by selective blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

The Company recently initiated a phase I clinical trial of APG-2575 in China, which is the first domestic Bcl-2 selective inhibitor entered the clinical stage. Ascentage previously has initiated a multi-center Phase I dose-escalation study of APG-2575 as a single agent in multiple hematologic malignancies in the United States and Australia in August 2018.

On June 12, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of antibody drug conjugates (ADCs), reported that it has closed a $76 million expansion of its Series E financing, bringing the total gross proceeds raised in the Series E financing to $276 million (Press release, ADC Therapeutics, JUN 12, 2019, View Source [SID1234596060]). The financing was supported by existing and new investors. The company has raised $531 million since its inception in 2011 to advance the development of pyrrolobenzodiazepine (PBD)-based ADCs for the treatment of hematological cancer and solid tumors.

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Chris Martin, PhD, Chief Executive Officer of ADC Therapeutics, said, "We are delighted to expand our Series E round, which provides us with a strong balance sheet to fund preparations for a potential Biologic License Application (BLA) for ADCT-402 (loncastuximab tesirine) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the second half of 2020, as well as preparations for a pivotal Phase II trial of ADCT-301 (camidanlumab tesirine) in Hodgkin lymphoma based on our recent end of Phase I meeting with the U.S. Food and Drug Administration. We look forward to our presentations on ADCT-402 and ADCT-301 at the upcoming 15th International Conference on Malignant Lymphoma (15-ICML) in Lugano, Switzerland, for which we announced details in a separate press release today."

ADC Therapeutics plans to complete enrollment in its pivotal Phase II trial of ADCT-402 in patients with relapsed or refractory DLBCL imminently and report interim results in the third quarter of 2019. ADCT-402 is also being evaluated in a Phase Ib trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL) and a Phase Ib trial in combination with durvalumab in patients with relapsed or refractory DLBCL, MCL or follicular lymphoma. In addition, the company plans to commence a pivotal Phase II trial of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma in the coming months. ADCT-301, with its novel mechanism of action targeting regulatory T cells, is also being evaluated in a Phase Ib trial in patients with selected advanced solid tumors.

On July 12, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC PINK: IPATF), an industry leader in the discovery of novel, therapeutic monoclonal antibodies, reported that it has entered into a new antibody discovery collaboration with Entos Pharmaceuticals Inc., to develop a therapeutic candidate against an undisclosed, immuno-oncology target, by leveraging ImmunoPrecise’s proprietary B cell Select platform (Press release, ModiQuest Therapeutics, JUL 12, 2019, View Source [SID1234537526]).

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ImmunoPrecise’s well-established B cell Select platform is capable of screening tens of millions of cells, to identify a greater diversity of antibodies, with very little manipulation. This proprietary platform is species and tissue independent, allowing for the generation of antibodies from samples not possible using other methods. The B cell Select platform takes advantage of the diversity of the animal’s immune repertoire, and allows for screening of any protein class, complex therapeutic targets, post-translational modifications, and small molecules.

"Our B cell Select platform has a proven track record of discovering large panels of high-affinity antibodies against a broad range of antibody targets, including difficult membrane proteins. Our North American B cell laboratory boasts over one decade of experience with a 94% success rate. This is, in part, why we are very confident in these collaborations, and continue to field requests from such reputable groups," said Dr. Jennifer Bath, IPA President and CEO. "We are pleased that Entos Pharmaceuticals Inc., a global leader in next generation nucleic acid-based therapies, considers us to be a trusted partner in antibody discovery."

"The team at Entos is committed to developing breakthrough medicines to address pressing clinical unmet needs," said Dr. John Lewis, CEO of Entos. "We have been extremely impressed with IPA’s B cell Select platform, which provides an ideal approach to develop therapeutic candidates."

Andy Nixon stepping down from ImmunoPrecise’s Board.

The Company also announces that board director Andy Nixon has stepped down from his duties due to an arisen conflict of interest.

ImmunoPrecise’s Chair, James Kuo, stated they "regretfully" accepted Andy’s resignation "We will miss Andy’s contribution on the ImmunoPrecise board. He is a highly qualified Director and we wish him every success in the future", Kuo said.

Erratum

In May 30th news Release Extension of Warrant Expiry Dates, the actual placement date should’ve read June 18, 2018.

"The Company also announces that it will apply to the TSX Venture Exchange to extend the expiry date of 875,000 share purchase warrants issued in a private placement financing on June 18, 2018 (see news release dated June 19, 2018). The share purchase warrants are exercisable at a price of $1.00 per share and the expiry date is being extended from June 18, 2019 to June 18, 2020. The extension of the expiry date is subject to the acceptance of the TSX Venture Exchange."