On April 9, 2018 Immunomedics, Inc., (NASDAQ:IMMU) ("Immunomedics" or the "Company"), a leader in the field of antibody-drug conjugates (ADCs), reported the appointment of Robert Iannone, M.D., M.S.C.E., as Head of Research & Development and Chief Medical Officer, effective today (Press release, Immunomedics, APR 9, 2018, View Source [SID1234525811]). In his new role, Dr. Iannone will oversee and lead all clinical development, regulatory, pre-clinical, translational research and medical affairs strategies and activities of the Company. Dr. Iannone brings more than thirteen years of experience in clinical drug development, including the approval of several targeted and immuno-oncology medicines at AstraZeneca/MedImmune and Merck & Co.

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"Rob is not only a highly accomplished oncology drug developer but also is deeply rooted in science with outstanding development experience and an established track record in a number of disease settings of interest to Immunomedics. We are thrilled that Rob is bringing his strong industry, medical, scientific and strategic leadership to Immunomedics," commented Michael Pehl, President and Chief Executive Officer. "Through his unique expertise, Rob will be instrumental in aggressively advancing development of our programs with the right drug combinations and in the most appropriate patient segments. I look forward to working closely with Rob to unlock the full potential of our ADC platform and further strengthen Immunomedics as a leader in this field."

Dr. Iannone comes to Immunomedics from AstraZeneca/MedImmune where he oversaw the development of Imfinzi and was, most recently, Senior Vice President and Head of Immuno-oncology, Global Medicines Development. He joined AstraZeneca/MedImmune in July 2014 as Global Products Vice President. Prior to AstraZeneca/MedImmune, Dr. Iannone served as Executive Director, Clinical Research, and Section Head of Oncology at Merck Research Laboratories and was a development leader for Keytruda.

"Immunomedics has a unique and highly differentiated ADC pipeline and platform technology. I am very excited to be joining the Company to help develop sacituzumab govitecan and other pipeline assets, to be foundational therapies in a wide variety of hard-to-treat solid cancer indications, in both early- and late-line settings, including the potential for combining with immune checkpoint inhibitors and other targeted cancer therapies," remarked Dr. Iannone.

Dr. Iannone received his M.D. from Yale University School of Medicine with Alpha Omega Alpha honors and a Master of Science in Clinical Epidemiology from the University of Pennsylvania School of Medicine. Dr. Iannone completed his Residency at Johns Hopkins

Hospital, where he also served as Chief Resident for one year and completed his Pediatric Hematology and Oncology Fellowship. Dr Iannone is the author or co-author of numerous articles in peer-reviewed journals and has served on the Biomarkers Consortium of the Cancer Steering Committee of the Foundation for the National Institutes of Health since 2011.

On April 9, 2018 Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product candidate duvelisib (Press release, Verastem, APR 9, 2018, View Source [SID1234529549]). Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The FDA target action date is October 5, 2018.

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"Obtaining Priority Review in the U.S. for duvelisib marks another important milestone for Verastem and speaks to the unmet need in relapsed/refractory CLL/SLL and FL and the urgency to identify effective therapies to treat these patients," said Robert Forrester, President and Chief Executive Officer of Verastem. "As an orally administered therapy, we believe duvelisib will provide an important treatment option for patients with CLL/SLL and FL, and for the physicians who treat them. We look forward to working with the FDA during the review process. We are continuing our commercial preparations for duvelisib to execute the launch promptly in the U.S. if approved. In parallel, we are exploring ex-U.S. partnering opportunities for duvelisib and plan to file a European Marketing Application towards the end of the year."

Priority Review is granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. Duvelisib has received Fast Track Designation from the FDA for patients with CLL who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL and FL.

About Duvelisib

Duvelisib is a first-in-class investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints and the FDA is reviewing a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). Duvelisib is also being developed by Verastem for the treatment of peripheral T-cell lymphoma (PTCL), which has Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On April 9, 2018 Amgen (NASDAQ:AMGN) reported that new pre-clinical data for several of its novel investigational oncology candidates will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, April 14-18, 2018 (Press release, Amgen, APR 9, 2018, View Source;p=RssLanding&cat=news&id=2341642 [SID1234525232]). Data spans Amgen’s early pipeline, including the first presentation of data for its most advanced chimeric antigen receptor (CAR) T cell therapy programs, targeting DLL3 in small cell lung cancer and FLT3 in acute myeloid leukemia (AML). In addition, pre-clinical data for Amgen’s DLL3 CAR T cell therapy and bispecific T cell engager (BiTE) program will be featured in an oral presentation.

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"As part of our overarching research and development strategy, Amgen is committed to advancing multiple modalities to gain biological insights before selecting the optimal treatment approach," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "With a variety of tools in our toolkit, we have the ability to comprehensively evaluate these novel approaches to determine how each may perform in different treatment settings. We look forward to seeing how the pre-clinical data ultimately translate in the clinic."

Research presented at the meeting will also include pre-clinical studies examining pharmacodynamic markers for Mcl-1 inhibition, as well as the combination of Amgen’s Mcl-1 inhibitor (AMG 176) with a selective BCL-2 inhibitor in models of AML. AMG 176 is a highly selective and reversible Mcl-1 inhibitor and is being studied in a Phase 1 clinical trial involving patients with relapsed or refractory AML or multiple myeloma. Studies have shown that hematologic malignancies including AML, multiple myeloma and non-Hodgkin lymphoma are particularly sensitive to Mcl-1 inhibition.

In addition, Amgen will present for the first time pre-clinical data evaluating its half-life extended (HLE) anti-BCMA BiTE for the treatment of multiple myeloma. A phase 1 study evaluating Amgen’s anti-BCMA HLE-BiTE (AMG 701) is ongoing.

With the exception of late-breaking research, abstracts are available and can be reviewed on the AACR (Free AACR Whitepaper) website at View Source Identified below are select abstracts of interest on Amgen research:

Immuno-oncology

Targeting DLL3 with BiTE antibody constructs and cell-based therapies for the treatment of SCLC
Abstract #DDT02, Oral Presentation, Sunday, April 15 from 3:24-3:48 p.m. CT at McCormick Place South (Level 1), Room S103
Generation and evaluation of a FLT3 CAR-T cell therapy for the treatment of acute myeloid leukemia
Abstract #2559/18, Poster Session, Monday, April 16 from 1-5 p.m. CT at McCormick Place, Exhibit Hall A, Poster Section 24
Cynomolgus monkey plasma cell gene signature to quantify the in vivo activity of a half-life extended anti-BCMA BiTE for the treatment of multiple myeloma
Abstract #LB-299/21, Poster Presentation, Tuesday, April 17 from 1-5 p.m. CT at McCormick Place, Exhibit Hall A, Poster Section 44
Mcl-1 Inhibition

The utilization of a human MCL-1 knock-in mouse suggests that reductions in B-cells and monocytes may serve as clinically relevant pharmacodynamic markers of MCL-1 inhibition
Abstract #2978, Oral Presentation, Monday, April 16 from 4:35-4:50 p.m. CT at McCormick Place North (Level 4), Room N427
Combined inhibition of MCL-1 and BCL-2 with AMG 176 and venetoclax induces apoptosis and tumor regression in models of acute myeloid leukemia
Abstract #3972/6, Poster Session, Tuesday, April 17 from 8 a.m.-noon CT at McCormick Place, Exhibit Hall A, Poster Section 41
About CAR T Cell Therapy
CAR T cell therapy is an evolving area of personalized medicine in which a patient’s own T cells (a type of white blood cell) are engineered to recognize tumor-specific antigens and incite an immune system attack against the cancer cells. Amgen is exploring the application of CAR T cell therapy across hematologic and solid tumor malignancies. Amgen and Kite Pharma, a subsidiary of Gilead Sciences Inc., are collaborating on engineering and commercializing Car T cell therapies.

About BiTE Technology
Bispecific T cell engager (BiTE) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to bridge T cells to tumor cells, using the patient’s own immune system to eradicate cancer. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.

About Amgen’s Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

On 9 April 2018, RhoVac reported the board of directors resolved to propose the annual general meeting of 9 May 2018 to resolve on a rights issue of approximately SEK 24.5 million before issue costs (Press release, RhoVac, APR 9, 2018, View Source [SID1234555937]). The net proceeds of the rights issue are primarily intended to strengthen the Company’s position, thereby creating better conditions in the work of identifying potential partnerships or outsourcing opportunities. As part of this, the Company will also initiate preparations for Phase IIb clinical trials.

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Persons, who on the record date 16 May 2018 are shareholders of RhoVac, have pre-emptive rights to subscribe for new shares in the rights issue, whereby six (6) existing shares entitle to subscription for one (1) new share at a subscription price of SEK 18 per share. The subscription period runs from 18 May 2018 up to and including 1 June 2018.

The rights issue is secured up to 80 percent through subscription undertakings on approximately 6.0 MSEK equal to approximately 24.4 percent and entered guarantee undertakings on approximately 13.6 MSEK equal to approximately 55.6 percent. All the members of the Board of Directors and senior executives participate through subscription undertaking. All external investors who entered guarantee undertakings also participate through subscription undertaking.

Background and reasons

RhoVac is a biotechnology company conducting research and development of an immunotherapeutic cancer vaccine. The Company’s primary focus is the development of the drug candidate RV001 with the potential to prevent or limit the spread and recurrence of cancer in the treatment of several different cancer indications. The Company’s development strategy is based on licensing or selling all or parts of the business as soon as possible after completion of clinical phase I/II trial regarding RV001. As the ongoing phase I/II study is in its final stages, RhoVac is investing aggressively in its business development through, among other things, to, as previously announced, employ David Colpman at Colpman Consulting Ltd. The reason for the rights issue of approximately SEK 24.5 million at full subscription (before issue costs) is to primarily strengthen the business development with the purpose of identifying possible licensing opportunities or partnerships, follow-up of clinical phase I/II study, regulatory preparations for a clinical phase IIb study and general working capital required.

A fully subscribed rights issue would provide the Company with SEK 21.5 million (after issue costs), which exceeds the Company’s capital requirements over the next 12 months. In this case, the Company will adjust scheduled activities and allocation of capital taking into account the status of potential licensing and partnership discussions. Focus will be on activities that at the time are deemed most relevant in order to increase the value of the Company. In a step to further strengthen the business development in the next 12 months, the Board will propose Gunnar Gårdemyr as a new Board member at the AGM. The Company wishes to use Mr. Gårdemyr’s extensive experience and contact network in the Life Science area to further strengthen the Company’s business development.

The rights issue

On 9 April 2018, the board of directors of RhoVac AB resolved to propose the annual general meeting of 9 May 2018 to resolve on a new share issue with pre-emptive rights for the Company’s existing shareholders of approximately SEK 24.5 million before issue costs. Persons, who on the record date 16 May 2018 are shareholders of RhoVac, have pre-emptive rights to subscribe for new shares in the rights issue, whereby six (6) existing shares entitle to subscription for one (1) new share (i.e. a 1:6 subscription ratio).

The subscription price amounts to SEK 18.00 per share. The subscription period runs from and including 18 May up to and including 1 June 2018. Through the rights issue, not more than 1,360,507 new shares will be issued, corresponding to a share capital increase of SEK 244,891.26.

Subscription and guarantee undertakings

The rights issue is secured through subscription and guarantee undertakings up to 80 percent of the rights issue, corresponding to approximately SEK 19.6 million. RhoVac has received subscription undertakings of approximately SEK 6.0 million, corresponding to approximately 24.4 percent of the rights issue, from all the members of the Board of Directors and senior executives and, in particular, from a limited number of external investors by overtaking subscription rights. In addition, the Company has received guarantee undertakings of approximately SEK 13.6 million, corresponding to approximately 55.6 percent of the rights issue, whereof all of them have agreed to takeover subscription rights.

Shareholders who choose not to participate in the rights issue will have their shareholdings diluted by approximately 14.3 percent but are able to fully or partially financially compensate for this dilution by selling their subscription rights. In the event that all shares are not subscribed for with subscription rights, the board will, within the framework of the maximum amount of the rights issue, decide on the allotment of shares subscribed for without subscription rights

The rights issue is subject to approval from the annual general meeting of 9 May 2018. The convening notice of the annual general meeting is announced through a separate press release.

The full terms and conditions of the rights issue, as well as other information about the Company, will be outlined in an information memorandum, which will be published prior to the commencement of the subscription period.

Indicative timetable

9 May 2018 Annual general meeting for resolution on the rights issue
14 May 2018 Last day of trading in the RhoVac share, including the right to participate in the rights issue
16 May 2018 Record date for the right to participate with pre-emptive right in the rights issue
18 May – 1 June 2018 Subscription period
18 May – 30 May 2018 Trading in subscription rights
Around 7 June 2018 Announcement of the results of the rights issue
Advisers

Arctic Securities AS, Sweden branch, is acting as financial adviser to RhoVac in connection with the rights issue. Advokatfirman Lindahl is acting as legal adviser to the Company.

On April 9, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that five posters will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 14-18, 2018, in Chicago (Press release, OncoMed, APR 9, 2018, View Source [SID1234525233]). Among the presentations will be preclinical data for OncoMed’s novel anti-TIGIT (OMP-313M32) immuno-oncology program, which is currently in a Phase 1a single-agent clinical study. Preclinical data for OncoMed’s differentiated clinical-stage GITRL-Fc (OMP-336B11) program will also be featured. In addition, preclinical immuno-oncology data for OncoMed’s Wnt antagonist vantictumab (anti-FZD, OMP-18R5) in combination with immune checkpoint inhibitors will be presented.

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Details on the poster presentations are provided below:

Poster 20; Abstract 70: Effect of aging on the antitumor activity of GITRL-Fc
Session: Tumor Biology, Dormancy and Aging: The Influential Microenvironment
Date and Time: Sunday Apr 15, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 3

Poster 28; Abstract 1733: Wnt antagonists synergize with immune checkpoint inhibitors to enhance anti-tumor responses
Session: Immunology, Immune Responses to Therapies 2
Date and Time: Monday Apr 16, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Poster 18; Abstract 2726: In vitro functional activity of OMP-336B11, a GITRL-Fc fusion protein, on primary human immune cells
Session: Immunology, Immune Checkpoints 2
Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Poster 16; Abstract 3826: GITRL-Fc biomarker and mechanism study: GITRL-Fc reduces Treg frequency in tumors and requires effector function for inhibition of tumor growth
Session: Immunology, Therapeutic Antibodies, Including Engineered Antibodies 3
Date and Time: Tuesday Apr 17, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 34

Poster 22; Abstract 5627: Anti-TIGIT biomarker study: Inhibition of TIGIT induces loss of Tregs from tumors and requires effector function for tumor growth inhibition
Session: Clinical Research, Therapeutic Antibodies, Including Engineered Antibodies 4
Date and Time: Wednesday Apr 18, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 28

Following the presentations, the posters will be available on the Pipeline section of OncoMed’s website, www.oncomed.com.

Additional information on the meeting can be found on the AACR (Free AACR Whitepaper) website www.aacr.org