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, 2019 CrystalGenomics, a Korean biopharmaceutical company reported it has signed a co-development agreement with U.S.-based CBT Pharmaceuticals for an investigational combination therapy of CG200745 and CBT-501 across a variety of solid tumors with high unmet medical needs (Press release, CrystalGenomics, APR 25, 2018, View Source;year=2018&no=263708 [SID1234539164]).

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CG200745 from CrystalGenomics is a novel pan-HDAC inhibitor currently in Phase II clinical study for pancreatic cancer and Phase Ib for myelodysplastic syndrome in Korea.

CBT-501 from CBT Pharmaceuticals is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. CBT-501 is under evaluation in two Phase I trials designed to evaluate the safety and efficacy in patients with advanced solid tumors, recurrent or refractory to standard of care therapies.

Under the exclusive agreement, the duo will be responsible for the co-development and global commercialization of the combination of CG200745 and CBT-501 in multiple tumor types, including hepatocarcinoma correlated with poor prognosis.

Immune checkpoint inhibitors such as the programmed death receptor-1 (PD-1) have been proven effective but many patients do not respond due to resistance. Recent reports suggest immune enhancing effects of HDAC inhibitors, in addition to their direct anti-tumor properties, making CG200745 a good candidate for combination therapy with CBT-501, according to CBT Pharmaceuticals.

Shares of Kosdaq-listed CrystalGenomics finished Wednesday down 2.8 percent at 26,000 won ($24.06).
By Shin Chan-ok and Minu Kim

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.

On April 25, 2018 Incyte Corporation (Nasdaq:INCY) reported that multiple abstracts from its research and development portfolio will be presented at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois from June 1-5, 2018 (Press release, Incyte, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344710 [SID1234525693]).

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Data at ASCO (Free ASCO Whitepaper) 2018 include oral presentations from a Phase 1 study of ruxolitinib (Jakafi), lenalidomide and methylprednisolone in patients with relapsed and refractory multiple myeloma, the DeCidE1 trial assessing the combination of DPX-Survivac, cyclophosphamide and epacadostat in patients with recurrent epithelial ovarian cancer, and the Phase 3 ECHO-301/KEYNOTE-252 study evaluating the safety and efficacy of epacadostat in combination with pembrolizumab in patients with unresectable or metastatic melanoma.

"Data featured in the abstracts presented at ASCO (Free ASCO Whitepaper) will contribute to the broader scientific understanding of our targeted and immuno-oncology therapies and their potential role in the treatment of cancer," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We look forward to sharing data from our portfolio at the 2018 ASCO (Free ASCO Whitepaper) annual meeting as we continue to work toward our goal of improving the lives of patients with cancer and other serious diseases."

Select key abstracts and presentations include:

Targeted therapy abstracts

A Phase 1 Trial of Ruxolitinib, Lenalidomide, and Methylprednisolone for Relapsed/Refractory Multiple Myeloma Patients. (Abstract #8005, oral abstract session)

Friday, June 1, 2018, 2:45 – 5:45 p.m. CT, E450

Immuno-oncology abstracts

Clinical Data from the DeCidE1 trial: Assessing the First Combination of DPX-Survivac, Low Dose Cyclophosphamide (CPA), and Epacadostat (INCB024360) in Subjects with Stage IIc-IV Recurrent Epithelial Ovarian Cancer. (Abstract #5510, clinical science symposium)

Sunday, June 3, 2018, 9:45 – 11:15 a.m. CT, S406

Epacadostat (E) Plus Pembrolizumab (P) Versus Pembrolizumab Alone in Patients (pts) with Unresectable or Metastatic Melanoma: Results of the Phase 3 ECHO-301/KEYNOTE-252 Study. (Abstract #108, clinical science symposium)

Sunday, June 3, 2018, 9:45 – 11:15 a.m. CT, Hall D1

Pilot Trial of an Indoleamine 2,3-dioxygenase-1 (IDO1) Inhibitor Plus a Multipeptide Melanoma Vaccine in Patients with Advanced Melanoma. (Abstract #3033, poster session)

Monday, June 4, 2018, 8:00 – 11:30 a.m. CT, Hall A, Poster Board #247

Epacadostat Plus Nivolumab for Advanced Melanoma: Updated Phase 2 Results of the ECHO-204 Study. (Abstract #9511, poster discussion session)

Monday, June 4, 2018, 1:15 – 4:45 p.m. CT, Hall A, Poster Board #338; Discussion at 4:45 – 6:00 p.m. CT, E451

Full session details and data presentations at the ASCO (Free ASCO Whitepaper) 2018 annual meeting can be found here.

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.