PBMD Immutep Limited

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13A-16 OR 15D-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

Dated November 25, 2015

Commission File Number 001-35428

 

 

PRIMA BIOMED LTD

(Exact Name as Specified in its Charter)

 

 

N/A

(Translation of Registrant’s Name)

Level 7, 151 Macquarie Street

Sydney, 2000 New South Wales, Australia

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  x            Form 40-F  ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b) (1):  ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b) (7):  ¨

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  ¨            No   x

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): Not applicable.

 

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: November 25, 2015

 

 

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EXHIBIT INDEX

 

Exhibit		Description of Exhibit
99.1		Prima BioMed Ltd 2015 Annual General Meeting Address by Russell Howard, Non-Executive Director
99.2		Annual General Meeting CEO Presentation

 

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Exhibit 99.1

 

Prima BioMed Ltd

2015 Annual General Meeting

Address by Russell Howard, Non-Executive Director

Dear Fellow Shareholder,

On behalf of our Board, I would like to welcome you to the Prima BioMed Annual General Meeting for 2015. Prima’s Chair, Lucy Turnbull and Deputy Chair, Albert Wong both send their apologies that they are unable to attend today’s meeting. This is due to unavoidable international travel commitments.

The Board is delighted that Lucy is standing for re-election. Despite her considerable new responsibilities, she remains committed to development of Prima’s immunotherapy products for the benefit of cancer patients, as well as Prima shareholders. Lucy has made a highly valued contribution to the Board over the past 5 years. We have her ongoing support and counsel going forward.

This past year embodies some of the most significant events in Prima’s history. Most notably, these were the Immutep acquisition in December 2014 and the subsequent unveiling of the AIPAC clinical trial for our lead product IMP321 in metastatic breast cancer in conjunction with chemotherapy Paclitaxel.

We welcomed US healthcare investor Ridgeback Capital’s A$15 million investment in our Company, as approved by shareholders at our July EGM. In parallel, we raised A$10 million through a Share Purchase Plan for existing shareholders, for which there was overwhelming demand. On both counts, we appreciate your continued support, affirming our belief that shareholders appreciate the value embedded in our portfolio of immunotherapy assets.

Along with the Ridgeback investment, these assets are attracting a lot of attention from other investors. We were pleased to raise a further A$3.55 million through two separate placements to European and Australian funds. These follow the introduction by the ASX of new Listing Rule 7.1A, part of a package of amendments to strengthen Australia’s equity capital markets.

The rule provides the ability to increase a company’s placement capacity, recognizing the importance of equity placements as a capital raising mechanism for small- and mid-cap companies. An ASX consultation paper released last month states that “the rule has been well received by small and mid-cap companies and their investors, providing valuable assistance during a period when uncertainty in equity markets made capital raising challenging.”

Collectively, the funds raised will support Prima’s operations into 2017 and leave us well positioned financially to commence two studies of IMP321 over the next few months. Firstly the AIPAC clinical trial, which I have mentioned and which recently received Scientific Advice from the European Medicines Agency; and secondly a Phase I trial with IMP321 in combination with a checkpoint inhibitor in melanoma.

The Phase I trial will be started in Queensland. Queensland has one of the highest instances of melanoma in the world. We are pleased once again to be running clinical trials in Australia, with the first patients expected to be enrolled early next year.

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I would like to thank our CEO, Marc Voigt and his team for their extensive efforts in realizing the potential of IMP321 and our other programs. Today, Prima is in a strong position clinically, commercially and financially. We look forward to reporting on further progress in the year ahead.

Yours sincerely,

 

Russell Howard

Non-Executive Director

Prima BioMed

Exhibit 99.2

 

 

Prima BioMed

Annual General Meeting CEO Presentation

November 25, 2015

ASX:PRR; NASDAQ:PBMD

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Notice: Forward Looking Statements

The purpose of the presentation is to provide an update of the business of Prima BioMed Ltd ACN 009 237 889 (ASX:PRR; NASDAQ:PBMD). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Prima BioMed and should not be relied upon as an independent source of information. Please refer to the Company’s website and/or the

Company’s filings to the ASX and SEC for further information.

The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Prima BioMed’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Prima BioMed’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. This presentation should not be relied on as a recommendation or forecast by Prima BioMed. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

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2015 Highlights – a Transformative

Year!

Planning of 2 new trials – EMA scientific advice

Announcement of Final CVacTM OS data

Ridgeback $15M placement

SPP $10M placement

Partners beginning trials (GSK and Novartis)

New patent filings

New Collaborations – NEC/Yamaguchi

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We have raised Prima’s market profile

Institutional and

Improved independent sell-side

market interest

standing

Active

marketing of

the new

Prima story

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Our stock is now actively traded in the US

20

18

(million) 16

day 14

per 12 Nasdaq ASX

traded 10

8

shares 6

.

Ord 4

2

0

Jan-15 Oct-15

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Prima attracting institutional grade

Market cap – now >US$70m Specialist healthcare funds now on register ~30% of stock now held in ADRs

% of Prima shares held in ADRs

0% 5% 10% 15% 20% 25% 30% 35%

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Prima SP YTD benchmark

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Participation at Investor and Industry Events

Multiple Roadshows

Investor JP Morgan Jan 2015

Bioshares July 2015

Meetings Rodman & Renshaw Sep 2015

Leerink Sept 2015

Business AusBiotech Oct 2015

BioEurope Nov 2015

Development Multiple other contacts

Scientific ASCO May 2015

SITC Nov 2015

Conferences Checkpoint Conf Nov 2015

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Technology

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Immune Checkpoints

Checkpoints are hot – Prof Frédéric Triebel interviewed about LAG-3 in Nature Biotechnology interview – published July 2015

(Volume 15pp673-675)

Immune checkpoints are junctions in immune signalling mechanisms between cells where decisions are made – make good targets for therapies

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IMP321

Soluble dimeric recombinant form of LAG-3 (fusion protein)

IMP321 binds to MHC class II on monocytes

DC/ monocyte activation induced

Leads to T cell expansion and proliferation

Highly efficacious in multiple animal models of cancer and infectious disease Shown to be safe, non-immunogenic and efficacious in humans At low doses can be used as a T cell adjuvant for cancer vaccines

(Clin Cancer Res. 2008 Jun 1;14(11):3545-54)

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Chemo-Immunotherapy: IMP321

Treatment of cancer cells with chemotherapy, radiotherapy or other drugs will kill off the cells causing tumour debris to be created and antigen release.

Adding an APC activator like IMP321 post cancer treatment enhances antigen uptake by APC’s.

They then migrate to lymph nodes and present a wide range of cancer antigens to CD8 T cells which then actively seek and destroy tumours.

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Other Applications: IMP321

IMP321 can be combined with other immune checkpoint treatments to help drive optimal immune responses to cancer (eg upcoming combo study)

IMP321 can be used as an adjuvant in vaccine combination studies where it helps to boost the magnitude of an antigen specific response (e.g. NEC/Yamaguchi collaboration)

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Upcoming trials

AIPAC

Ph I Combo pilot

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Planned Phase IIb Chemoimmunotherapy in MBC: AIPAC trial

Multicentre, randomised, double blind, placebo-controlled

15 + 196 patients: IMP321 + paclitaxel vs. paclitaxel + placebo

Primary objective: efficacy (as Progression-Free Survival)

Scientific advice from EMA received in July 2015

Trial initiation expected in Q4 2015

Belgium regulatory approval received in October 2015

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Planned Phase I Study in Immuno-Oncology Combination

Multicentre, open label, dose escalation

Up to 30 patients with unresectable or metastatic melanoma

IMP321 + Anti-PD-1 combination study

Primary objective: safety, tolerability

Trial initiation expected in Q1 2016

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Major Addressable Markets in MBC

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Metastatic Breast Cancer

Annual global incidence of 1.67M new cases of all breast cancer

Standard of care is variable but includes hormone therapy, chemotherapy and targeted therapies.

We are specifically targeting Her2- cancer; refractory to hormone therapy.

Five year survival rate is 22% (American Cancer Society)

Sales of all breast cancer drugs are estimated to grow from $9.8Bn to $18.2Bn/year by 2023

(Pharmatimes, 2015)

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Partnership Updates

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IMP731

for Autoimmune Diseases

GSK’s investigational product, GSK2831781, which is derived from IMP731 antibody, aims to kill the few activated LAG-

3+ T cells that are auto-reactive in autoimmune disease leading to long term disease control without generalised immune suppression

GlaxoSmithKline holds exclusive WW rights to IMP731

Jan 2015: Prima announced a single-digit million US$ milestone

Up to ?64m in total upfront and milestones + royalties

GSK2831781 in Phase I trials with potential regulatory filing expected within 2021-2025 timeframe (See from slide 108 of GSK investor presentation

Phase II expected to initiate in 2016

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IMP701: Antagonist mAb

IMP701 is an anti-LAG-3 antibody that blocks LAG-

3-mediated immune down-regulation

LAG-3 is a prime target for immune checkpoint blockade as it is readily expressed at a high level in many human tumours.

Novartis holds exclusive WW rights

Aug 2015: Start of Phase 1 study by Novartis (Novartis milestone payment to be received for IMP701 Phase 1 initiation)

LAG-525 to be used in combination with PD-1 in solid tumours before end of this year (See slide 10 of Novartis IR presentation )

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Other Partnerships

Eddingpharm

NEC/

Yamaguchi

University

Neopharm for CVac

R&D to support new patent filings

CRO and data managers for clinical trials

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Upcoming Milestones

Clinical

Q4 2015: Initiation of AIPAC (metastatic breast cancer) // First data in 2016 (e.g. safety/PK)

Q1 2016: Initiation of Anti-PD-1 combination Phase I study (melanoma) // First data in

2016(e.g. safety/PK)

Expected commencement of Phase II study with IMP731 (GSK)

Continued development of Phase I study IMP701 (Novartis)

Other

Ongoing discussions re CVac

Strategic partnering and collaboration discussions re IMP321

Progress in IP

Ongoing investor relations efforts

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A solid foundation

Hot

Space

Institutional Investment

First class partnerships

Experienced global team

Robust science

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NASDAQ: PBMD, ASX: PRR

Thank you!

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