On April 9, 2018 Morphotek, Inc., a subsidiary of Eisai Inc., reported that it licensed its eribulin-linker payload to Bliss Biopharmaceutical Co., Ltd. (BlissBio) of China (Press release, Morphotek, APR 9, 2018, View Source [SID1234527215]). The licensing agreement grants BlissBio the exclusive right to use the eribulin-linker payload to develop a therapeutic ADC against an undisclosed oncology target for the China market. The licensing agreement includes an upfront payment, milestones and sales royalty payments, which are undisclosed. BlissBio has an exclusivity option to expand the territory beyond China to the global market and to develop therapeutic ADCs to two additional undisclosed oncology targets.

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Morphotek’s ADC Services offer third parties the opportunity to license the proprietary eribulin-linker payload to develop investigational ADCs using either Morphotek’s REsidue-SPEcific Conjugation Technology (RESPECT) or an alternative approach to conjugation. The eribulin-linker payload consists of a cytotoxic agent, eribulin, modified by a chemical linker to facilitate optimal conjugation. Eribulin’s anti-tumor activity is mediated by the inhibition of microtubule elongation and mitotic spindle formation, resulting in apoptosis. Eribulin mesylate, marketed as Halaven, is approved in the U.S. for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting.

Our end-to-end ADC Services provide multiple entry points for clients, starting from development of an antigen site-specific bioconjugate-ready monoclonal antibody and ADC through in vivo safety and efficacy validation. Additional options include manufacture of GMP clinical trial material, GLP toxicology studies and development of immunohistochemistry (IHC) companion diagnostics for patient screening. For more information on Morphotek’s ADC Services business and RESPECT platform, please contact [email protected].

*The ADCs described herein are investigational, as efficacy and safety have not been established. There is no guarantee that the ADCs will be available commercially.

On April 9, 2018 -TARIS reported that it will present a late-breaking poster related to TAR-200 (GemRIS), the company’s lead clinical program in bladder cancer, at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14-18, 2018 in Chicago (Press release, TARIS Biomedical, APR 9, 2018, View Source [SID1234525235]).

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Poster presentation details are as follows:

Poster Title: Significant cytotoxic and immumomodulatory effects of continuous low dose intravesical gemcitabine in rodent bladder tumor models
Poster Number:

LB-122
Session Title:

LBPO.IM01 – Late-Breaking Research: Immunology 1
Session Date:

April 16, 2018, 8:00 AM – 12:00 PM, Poster Section 45, Board #19

About Muscle Invasive Bladder Cancer

Bladder cancer is the fifth most common neoplasm in industrialized countries, affecting roughly 2.7 million people worldwide. In the United States, there were an estimated 79,000 new cases and nearly 17,000 deaths in 2017; Muscle Invasive Bladder Cancer (MIBC) accounts for 20-25% of the newly diagnosed cases and the majority of disease-related mortality.

While some potentially curative treatments, including surgical organ removal and chemoradiation, are available, 40% or more of patients with MIBC are unfit to undergo these morbid procedures, or opt to not receive them.i Available treatment options for these patients are limited to palliative care.

About TAR-200 (GemRIS)

TAR-200 is TARIS’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder for multiple weeks.

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 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 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy biopharmaceutical company, reported that Geert Kersten, Chief Executive Officer, will present a corporate overview at The MicroCap Conference on Tuesday, April 10th at 10 a.m. Eastern time (Press release, Cel-Sci, APR 9, 2018, View Source [SID1234525236]). The conference will be held April 9-10, 2018 at the Essex House in New York City.

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CEL-SCI Corporation to present at The MicroCap Conference

About The MicroCap Conference

The MicroCap Conference is an exclusive event dedicated to connecting high-performing small and microcap companies with committed investors. It is an opportunity to be introduced to and speak with management at some of the most attractive companies, learn from various expert panels, and network with other small and microcap investors.