Immune Design to Report First Quarter 2018 Financial Results and Provide Corporate Update

On April 25, 2018 Immune Design (Nasdaq:IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported that it will report first quarter 2018 financial results after the close of U.S. financial markets on Wednesday, May 2, 2018 (Press release, Immune Design, APR 25, 2018, View Source [SID1234525707]). Immune Design management will host a webcast conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on May 2, 2018 to discuss the financial results and provide a corporate update.

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The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 1088768.

Blueprint Medicines to Report First Quarter 2018 Financial Results on Wednesday, May 2, 2018

On April 25, 2018 Blueprint Medicines Corporation (NASDAQ:BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Wednesday, May 2, 2018 to report its first quarter 2018 financial results and provide a corporate update (Press release, Blueprint Medicines, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344484 [SID1234525670]).

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To access the live conference call, please dial 1-855-728-4793 (domestic) or 1-503-343-6666 (international), and refer to conference ID 7572918. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

Five Prime to Present at 2018 ASCO Annual Meeting

On April 25, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it will present two posters during the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 1-5, 2018, in Chicago (Press release, Five Prime Therapeutics, APR 25, 2018, View Source [SID1234525691]).

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Abstract Number and Title: #TPS4135, "FIGHT: A Phase 3 Randomized, Double-Blind, Placebo Controlled Study Evaluating (Bemarituzumab) FPA144 and Modified FOLFOX6 (mFOLFOX6) in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer with a Dose Finding Phase 1 Lead-In"
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Session Date and Time:Sunday, June 3, 2018; 8:00 – 11:30 a.m. CT
Location: Hall A,PosterBoard Number: #322a

Abstract Number and Title: #3020, "Pharmacodynamics (PD) and Genomic Profiling of Pts Treated with cabiralizumab (cabira) + nivolumab (NIVO) Provide Evidence of On-Target Tumor Immune Modulations and Support Future Clinical Applications"
Poster Session: Developmental Therapeutics – Immunotherapy
Session Date and Time:Monday, June 4, 2018; 8:00 – 11:30 a.m. CT
Location: Hall A, Poster Board Number: #234
Discussion Session Date and Time:Monday, June 4, 2018; 11:30 a.m. – 12:45 p.m. CT
Discussion Session Location: Hall B1

About Bemarituzumab (FPA144)

Bemarituzumab is an isoform-selective, humanized monoclonal antibody in clinical development as a targeted immuno-therapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Clinical results to date suggest that the specificity of FPA144 avoids toxicities that have been seen with less selective FGFR2 small molecule therapeutics. FPA144 has also been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells.

About Cabiralizumab (FPA008)

Cabiralizumab is an investigational antibody that inhibits the CSF-1 receptor and has been shown in preclinical models to block the activation and survival of monocytes and macrophages. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. Cabiralizumab is currently in clinical trials in oncology indications and in pigmented villonodular synovitis (PVNS). Cabiralizumab is being developed under an exclusive worldwide license and collaboration agreement entered into with Bristol-Myers Squibb (BMS) in October 2015.

Sarah Cannon Development Innovations Collaborates with Pivotal on Immuno-Oncology Trials

On April 25, 2018 Sarah Cannon Development Innovations reported a new strategic collaboration with Pivotal to expand access to novel immunotherapies in early phase clinical trials in Europe (Press release, Sarah Cannon Research Institute, APR 25, 2018, View Source [SID1234525708]). In late 2016, Sarah Cannon and Boehringer Ingelheim announced a strategic collaboration for a joint clinical development program in the U.S. for immune checkpoint inhibitors for the treatment of multiple difficult-to-treat cancers. Through Sarah Cannon´s collaboration with Pivotal, a European Contract Research Organization (CRO), patients in Europe will have greater access to innovative cancer therapies.

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"The combined expertise in drug development and clinical research excellence of Pivotal and Sarah Cannon will enable us to accelerate research and provide access to novel investigational agents," said Lourdes Huarte, PharmD, MBA, VP Regulatory and Clinical Operations, Pivotal. "We look forward to collaborating with these experts to impact the lives of people facing cancer throughout Europe."

Through Sarah Cannon Development Innovations, a full-service, oncology-focused CRO, Sarah Cannon provides comprehensive clinical development services and operational delivery of Boehringer Ingelheim’s early stage development programs. With Pivotal’s expertise as a European CRO, the organization will facilitate rapid patient enrollment into clinical trials across selected sites in Europe.

"The collaboration with Pivotal to expand clinical research access in Europe further advances Sarah Cannon’s mission to bring the latest therapies to patients close to home," said Dawn Sauro, President of Sarah Cannon Development Innovations. "Working together with Boehringer Ingelheim over the last two years has further accelerated drug development in immunotherapies that will continue to impact patients around the world."

The expansion of Boehringer Ingelheim and Sarah Cannon’s joint clinical development program with the incorporation of Pivotal’s deep knowledge of the European populations in the clinical trials field will address a critical need for many cancer patients. Immunotherapy is showing very promising results for patients with unmet medical needs such as melanoma and metastatic non-small-cell lung cancer among others. Immunotherapy has shown impressive response rates compared to standard chemotherapy, improving progression-free survival in this population with some patients experiencing long-lasting responses. This therapeutic approach is becoming available for more cancer populations, but despite these advances, there are still many cancer patients with unmet needs. The current trial program by Boehringer Ingelheim supported by Sarah Cannon as CRO, and to which Sarah Cannon expands the reach by collaborating with Pivotal, is focused on the clinical development of BI 754091 (anti- PD-1) and BI 754111 (anti-LAG- 3) monoclonal antibodies, immune checkpoint inhibitors that mobilize the patient’s immune system to defeat cancer.

"As part of our dedication to transforming the lives of cancer patients, we are pleased to see that Sarah Cannon expands its reach by collaborating with Pivotal to help speed development of novel immunotherapies," said Mehdi Shahidi, Global Medical Head Oncology, Boehringer Ingelheim. "The power of partnerships, such as the one Sarah Cannon and Pivotal are embarking on, brings together the best minds and capabilities to accelerate this dynamic area of research. This is in line with our goal to transform the lives of patients and help win the fight against cancer."

About Pivotal

Pivotal was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. After working for over two decades in the pharmaceutical industry, Dr. Farr recognized the need for a medium-sized CRO with a solid internal medical franchise that could act not only as the "doers" but also as the "co-thinkers" for their clients, through its strategic scientific advice. To date, we are the trusted advisor and counselor for many companies to deliver maximum value in their drug development programmes. We are a leading privately-held European CRO and, since inception, we have experienced a fast and steady organic growth in Europe.

Pivotal clients’ portfolio spans major pharmaceutical, biotechnological, medical device and nutrition companies, and we have long-standing relations with over 188 clients. Pivotal has extensive experience across major therapeutic areas and phases I to IV. Our highly customized teams bring to each client a combination of broad industry knowledge and operational excellence, to offer our clients fresh perspectives and breakthrough business insights. Additionally, we have built a strong oncology, innovative therapies, rare diseases and early phases hub that enables us to tackle our customers most difficult challenges, turning recommendations into concrete actions. By remaining true to our core principles and values, our vision is to become our client’s preferred outsourcing solution partner.

For more information, please visit www.pivotal.es.

RhoVac AB participates in a discussion meeting with the European Medicines Agency

On April 25, 2018 RhoVac AB (publ) ("RhoVac") reported that the company has received an invitation to meet with the European Medicines Agency (EMA) to further discuss a phase IIb clinical trial (Press release, RhoVac, APR 25, 2018, View Source [SID1234555936]).

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RhoVac initiated a Scientific Advice procedure with EMA immediately after completion of a pre-submission meeting end of February 2018; the procedure was originally estimated to be completed end of April 2018. Following invitation to participate at the EMA’s Scientific Advice Working Party’s meeting in London the entire procedure is, according to standard regulatory procedures, extended by approximately one month and completion is now estimated to be at the end of May 2018.

Invitation to a discussion meeting with the Working Party is not standard in a Scientific Advice procedure; however, EMA can provide this opportunity to a company to ensure that the development strategy of the company is fully understood and thereby to ensure that the most accurate advice is provided to the company for the design of the coming clinical phase IIb study.