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Site Visit Planned for December 19, 2018 to Initiate Phase 2 Trial of ProscaVax for Early-Stage Prostate Cancer

On December 7, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, is reported to provide an update on the Phase 2 clinical trial of ProscaVax being hosted at Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard University (Press release, Oncbiomune, DEC 7, 2018, View Source [SID1234531944]). In the clinical trial, ProscaVax, the Company’s lead immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), is being evaluated for safety and efficacy in patients with low-risk localized prostate cancer compared to patients in "Active Surveillance."

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OncBioMune has confirmed that a site visit is scheduled for December 19, 2018. This is the check-off meeting before beginning enrollment in the clinical trial, which is expected to transpire in the coming weeks.

"I’m very pleased to say that we are now staring down a major milestone for our company with the site visit to be followed by patient enrollment," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Enrollment of the first patient in the study is not only a watershed moment for our company and stakeholders, but for the oncology community as a whole. This is the first Phase 2 clinical trial of its type evaluating a therapeutic immunotherapy vaccine in early stage prostate cancer, a stage in disease where patients are left with no options other than to wait for disease progression. We are optimistic that ProscaVax will demonstrate a meaningful benefit to these patients in great need and that ProscaVax will set a new benchmark as a front-line treatment for prostate cancer."

Pacira Pharmaceuticals to Present at the 2018 BMO Capital Markets Prescriptions for Success Healthcare Conference

On December 7, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported that it will present at the 2018 BMO Capital Markets Prescriptions for Success Healthcare Conference at 1:20 PM ET on Wednesday, December 12, 2018. Live audio of the presentation can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event (Press release, Pacira Pharmaceuticals, DEC 7, 2018, View Source;p=RssLanding&cat=news&id=2379929 [SID1234531942]).

PULSE BIOSCIENCES, INC. ANNOUNCES OVERSUBSCRIPTION, PRICING AND PRELIMINARY RESULTS FOR ITS $45 MILLION RIGHTS OFFERING

On December 7, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE) ("Pulse Biosciences" or the "Company"), a novel medical therapy company bringing to market its proprietary CellFX Nano-Pulse Stimulation (NPS) platform, reported reported the completion of its rights offering, which expired at 5:00 p.m. Eastern Time on December 6, 2018 (the "Expiration Date") (Press release, Pulse Biosciences, DEC 7, 2018, View Source [SID1234531940]).

In accordance with the pricing structure of the rights offering described in the prospectus relating to the offering, Pulse Biosciences has determined that the final subscription price per share for the shares offered in the rights offering is $12.5658 per share, which is the volume weighted average price of the Company’s common stock as calculated for the five-trading day period through and including the Expiration Date.

Based on a preliminary tabulation by Broadridge Corporate Issuer Solutions, Inc. (the "Subscription Agent"), as of the Expiration Date, the Company had received basic subscriptions and over-subscriptions for a total of 4,023,779 shares, exceeding the 3,581,148 shares offered in the rights offering, subject to adjustment upon expiration of the guaranteed delivery period. Available shares will be distributed proportionately among rights holders who exercised their over-subscription right based on the number of shares each rights holder subscribed for under the basic subscription right, in accordance with the procedures described in the prospectus relating to the rights offering. The Company expects the Subscription Agent to distribute the shares and the sale proceeds on or about December 14, 2018.

"We are pleased with the results of the rights offering," said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. "The rights offering offered our stockholders an opportunity to participate in this important financing that will enable us to continue progress towards our goal of commercializing our proprietary CellFX Nano-Pulse Stimulation platform, initially in aesthetic dermatology. We remain committed to building a viable company and to stockholder value, and look forward to updating you on our progress as we continue to generate important results in the future."

The Company will receive aggregate gross proceeds from the rights offering of $45 million. The results of the rights offering, including the allocation of shares to be issued in the rights offering, are preliminary and subject to change pending the expiration of the guaranteed delivery period under the offering and finalization of subscription procedures by the Subscription Agent.

A registration statement relating to the shares of common stock was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on November 6, 2018. A prospectus relating to the offering was filed with the SEC on November 19, 2018 and is available on the SEC’s website. Subscription rights that were not exercised by 5:00 p.m. Eastern Time on December 6, 2018 have expired.

Xspray Pharma has carried out a directed share issue raising gross proceeds of approximately SEK 92 million

On December 6, 2018 Xspray Pharma AB (publ) ("Xspray" or the "Company") reported the company has successfully carried out a directed share issue at a subscription price of SEK 67 per share (Press release, Xspray, DEC 6, 2018, View Source [SID1234650105]). The subscription price corresponds to a discount of approximately 3 percent compared with today’s VWAP, 6 December 2018. The subscription price has been determined through an accelerated book-building procedure.

A group of Swedish and international institutional investors, among others Unionen, Third Swedish National Pension Fund and Forth Swedish National Pension Fund, have subscribed for shares in the directed share issue. The Company believes that the flexibility of a placing without pre-emption right for existing shareholders is the most appropriate way to diversify the shareholder base among institutional investors prior to the planned list change of the Company’s share to Nasdaq Stockholm’s main list during 2019, and at the same time raise capital in a time efficient manner.

Following the positive data announced on 10 October 2018 for the Company’s lead product, HyNap-Dasa, the Company intends to use the proceeds from the directed share issue to i) continue development of its product portfolio; ii) develop its product candidates through registration; and iii) accelerate the development of product candidate HyNap-Nilo in order to be ready to launch the product earlier than previously planned.

Per Andersson, CEO, Xspray Pharma, comments:

"As a result of the positive results for the product candidate HyNap-Dasa, presented earlier this fall, we are in a strong position to bring our unique HyNap compositions, comprising a number of protein kinase inhibitors (PKIs), to the market. This is an important step towards becoming a powerhouse for PKIs where we address relevant medical needs and more accessible pharmaceuticals to the cancer market."

The directed share issue is expected to raise proceeds for the Company of approximately SEK 92 million before transaction costs. The subscription price has been determined through an accelerated book-building procedure. The directed share issue will result in an increase of the number of shares in Xspray of 1,370,000, from 13,706,460 to 15,076,460, and an increase in the share capital by SEK 1,370,000, from SEK 13,706,460 to SEK 15,076,460, resulting in a dilution of approximately 9.1 percent.

In connection with the directed share issue, the Company has, with customary exceptions, agreed to a lock-up undertaking on future share issuances for a period of 90 days after the directed share issue. In addition, the management and board of directors have undertaken not to sell any shares in Xspray during the same period, subject to customary exceptions.

Advisers

In conjunction with the capital raising, the Company has engaged Carnegie Investment Bank as bookrunner and adviser, Zonda Partners as adviser and Vinge as legal adviser.

Neon Therapeutics and Apexigen Announce First Patient Dosed in Neon’s NT-003 Phase 1b Combination Trial of NEO-PV-01 in Metastatic Melanoma

On December 6, 2018 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, and Apexigen, Inc., a clinical-stage biopharmaceutical company, reported that patient dosing has begun in NT-003, Neon’s Phase 1b combination trial of NEO-PV-01 in metastatic melanoma (Press release, Apexigen, DEC 6, 2018, View Source [SID1234591000]). NEO-PV-01 is a personal neoantigen vaccine custom-designed and manufactured based on the unique mutational fingerprint of each individual patient.

The Phase 1b trial is evaluating NEO-PV-01 and nivolumab in combination with other agents in first-line patients with advanced or metastatic melanoma. One arm of the multi-arm study will evaluate the vaccine and nivolumab in combination with Apexigen’s APX005M, an investigational CD40 agonist. Another will evaluate NEO-PV-01 and nivolumab in combination with ipilimumab.

"We believe that there is very strong scientific rationale for treating patients with these additional agents as they may enhance neoantigen immune responses induced by NEO-PV-01 with the potential to drive additional clinical benefit," said Richard Gaynor, M.D., President of Research and Development at Neon Therapeutics.

"CD40 agonists such as APX005M have been shown to enhance antigen presentation, resulting in improved magnitude and quality of T cell responses and we share the enthusiasm of the team at Neon to conduct this clinical trial," said Ovid Trifan, M.D., Ph.D., Chief Medical Officer of Apexigen.

James P. Allison, Ph.D., a Nobel Prize winner, developer of the first FDA-approved checkpoint inhibitor (ipilimumab) and one of Neon’s founders, commented, "Both preclinical and clinical work have demonstrated that CTLA-4 antagonism enhances the priming of de novo immune responses and increases T cell infiltration into the tumor. These findings provide clear rationale for combining a checkpoint inhibitor such as ipilimumab with NEO-PV-01 to augment the immune response and potentially transform how we treat cancer."

About NT-003
NT-003 is a Phase 1b, open-label, multicenter clinical study of NEO-PV-01 with nivolumab, in combination either with APX005M or low dose ipilimumab, for the treatment of advanced or metastatic melanoma. APX005M or ipilimumab will only be dosed during the vaccination period.

More information regarding NT-003 can be found here.