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.

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.

On April 25, 2018 ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, reported that it has terminated the Phase I clinical trial to evaluate its antibody drug conjugate (ADC) ADCT-502 in patients with advanced solid tumors with HER2 expression (Press release, ADC Therapeutics, 25 25, 2018, View Source [SID1234525671]).

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Dr. Jay Feingold, Chief Medical Officer and Senior Vice President of Clinical Development at ADCT said: "We are very pleased with the efficacy and tolerability achieved with our lead hematological PBD-based ADC programs, but regrettably this has not been the case with our HER2 targeted ADC. PBD’s (pyrrolobenzodiazepine dimers) are extremely potent and have a well characterized safety profile that includes fluid retention and pulmonary edema. For most PBD ADCs this can be managed by selecting dosing regimens that are efficacious with manageable toxicities. However, during dose escalation in this trial we did not achieve the necessary efficacy at tolerated doses required for patient benefit. This was possibly due to the extensive expression of HER2 in pulmonary tissue. Our next two solid tumor ADCs progressing into the clinic over the next nine months incorporate site specific conjugation technology which based on pre-clinical models has the potential to substantially improve tolerability and efficacy in difficult to treat solid tumors. Preclinical data on these programs was presented at the recent American Association of Cancer Research conference."

Chris Martin, CEO at ADCT said: "Patients with HER2 expressing tumors have multiple therapeutic options including novel therapies in clinical development that are producing encouraging data. ADC Therapeutic’s strategy is to progress a deep pipeline of ADCs into Phase I in order to assess their clinical and market potential based on actual human data, and only to progress into later stage development those ADCs that demonstrate the potential to be best in class in areas of high unmet medical need. We currently have three other ADC programs in the clinic, and we plan to commence clinical trials for three additional programs in the next 9 months, including a third hematological program. Moreover, our two most advanced clinical programs are progressing into later stage development over 2018."

At this time, ADC Therapeutics is collecting and evaluating the study data from the ADCT-502 Phase I trial, which will be presented for publication later this year.

About ADCT-502

ADCT-502 is an investigational antibody drug conjugate (ADC) composed of the humanized monoclonal antibody trastuzumab directed against the human epidermal growth factor receptor 2 (HER2). The antibody is site-specifically conjugated to the PBD-based linker-drug tesirine. Once bound to the HER2 receptor on the cell surface, ADCT-502 is internalized into the cell where enzymes release the PBD-based warhead. HER2 is a well-established, clinically validated target expressed in a wide variety of solid tumors, including breast, gastric, esophageal, bladder and lung cancer

On April 25, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) announced today that nine industry sponsored daratumumab abstracts, one industry sponsored ofatumumab abstract and one tisotumab vedotin abstract have been accepted for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 1-5 (Press release, Genmab, APR 25, 2018, View Source [SID1234525692]). The daratumumab abstracts, submitted by Janssen Research & Development, LLC, include an oral presentation of a subgroup analysis of the MMY1001 (EQUULEUS) trial, two poster discussion sessions regarding the PAVO (MMY1004) and ANDROMEDA (AMY3001) studies, as well as trial in progress poster presentations on multiple other Phase III trials. These include SMM3001 (AQUILA) in smoldering multiple myeloma and MMY3012 (COLUMBA), the study comparing subcutaneous with intravenous daratumumab administration. In addition there are two posters on MMY3007 (ALCYONE) in patients with newly diagnosed multiple myeloma. One abstract on ofatumumab maintenance treatment in relapsed chronic lymphocytic leukemia (CLL), sponsored by Novartis, will be presented in a poster discussion session. One abstract regarding the Phase II study of tisotumab vedotin in cervical cancer was also accepted for a trial in progress poster presentation. The titles of the abstracts are currently available on the ASCO (Free ASCO Whitepaper) iPlanner website, with the full abstracts scheduled to be published on May 16, 2018.

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"We are pleased with the selection of these abstracts for presentation at this year’s ASCO (Free ASCO Whitepaper) meeting in Chicago. Attendees of this prestigious conference will be able to view for themselves both some of the very exciting data generated by these products, as well as additional information on a variety of currently running key clinical trials," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts:

Daratumumab:

Daratumumab in Combination with Carfilzomib and Dexamethasone in Lenalidomide-refractory Patients with Relapsed Multiple Myeloma: Subgroup Analysis of MMY1001 – Oral presentation, Friday, June 1, 3:09 PM – 3:21 PM CDT

Subcutaneous Daratumumab Plus Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis: Safety Run-in Results of ANDROMEDA (AMY3001) – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM CDT

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO) (MMY1004) – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-Label, Phase 3 Study of Subcutaneous Daratumumab Versus Active Monitoring in Patients with High-risk Smoldering Multiple Myeloma: AQUILA (SMM3001) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA (MMY3012) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Pomalidomide and Dexamethasone with or without Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: a Multicenter, Randomized, Phase 3 Study (APOLLO) (MMY3013) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-label, Phase 2/3 Study of Daratumumab with or without JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Relapsed/Refractory Multiple Myeloma (MMY2036) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Elderly (≥75 y) Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplantation (ALCYONE) (MMY3007) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Improved Health-related Quality of Life for Patients with Newly Diagnosed Multiple Myeloma who are Ineligible for Stem Cell Transplantation: Results from the ALCYONE Trial (MMY3007) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Tisotumab vedotin
A single arm, Phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF ADC) in previously treated, recurrent or metastatic cervical cancer – Poster presentation, Monday, June 4, 1:15 PM – 4:45 PM CDT

Ofatumumab

Role of ofatumumab maintenance treatment in relapsed CLL: Final analysis of PROLONG study – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM

On April 25, 2018 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported that it will release its first quarter 2018 financial results on Wednesday, May 2, 2018 (Press release, Insmed, APR 25, 2018, View Source [SID1234525672]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Wednesday, May 2, 2018 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (844) 707-0669 (domestic) or (703) 639-1223 (international) and referencing conference ID number 4567628. The call will also be webcast live on the internet on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately two hours after its completion through May 9, 2018 by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) and referencing conference ID number 4567628. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.