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Prima BioMed Announces Strategic Acquisition of Immutep SA

On October 2, 2014 Prima BioMed reported that it has reached an agreement to acquire Immutep SA ("Immutep"), a late stage privately owned biopharmaceutical company in the rapidly growing field of immuno-oncology ("Acquisition") (Press release, Prima Biomed, OCT 2, 2014, View Source [SID1234507308]). Prima will pay consideration of up to approximately US$28 M through a combination of cash, shares and warrants subject to the achievement of certain performance milestones. The transaction is to be funded via an investment agreement with Bergen Global Opportunity Fund, LP ("Bergen").

Immutep has been developing a number of complementary types of cancer immunotherapies based on its patented Lymphocyte Activation Gene 3 (LAG-3) technology. Its lead product IMP321 has been tested in various clinical trials to date, both alone and in combination with other therapies. Immutep holds the world-wide rights (excluding China and Taiwan) to commercialise IMP321. This includes trials in chemo-immunotherapy, a combination of immunotherapy and chemotherapy which significantly enhances patients’ immune response to cancers.

Lucy Turnbull, Chair of Prima BioMed, said: "This is the most significant announcement in Prima’s history. It is the result of a long and diligent search process led by new Chief Executive Marc Voigt as part of our business development program. It considerably strengthens our position in immuno-oncology, which is forecast to grow to a US$35B industry by 20231."
"It significantly expands our clinical development product portfolio to other categories of immunotherapies beyond cancer vaccines, which includes our current lead product CVacTM. It also provides us with partnerships with several of the world’s largest pharmaceutical companies," she said.

Immutep’s development partnerships, which will provide future milestone payments and royalties to Prima, include:
* IMP321: a Phase II chemo-immunotherapy trial combining IMP321 with first line chemotherapy for metastatic breast cancer ("MBC") in partnership with Chinese pharma company Eddingpharm. Eddingpharm has exclusively sub-licensed IMP321 for development in China, Hong Kong, Macau and Taiwan and this could result in undisclosed milestone payments and royalties. Prima will take over responsibility for the development of IMP321 in the rest of the world;
* IMP731: a Phase I clinical trial program in auto-immune diseases in partnership with GlaxoSmithKline ("GSK") with potential milestone payments of up to approx. US$100m and additional royalties;
* IMP701: an immune checkpoint blocker pre-clinical program in cancer immunotherapy partnered with CoStim (Novartis). Financial details are undisclosed but include milestone payments and royalties.

In addition, Immutep currently generates modest revenues from commercial sales of LAG-3 research reagents.
The completed Phase II trial of IMP321 in MBC demonstrated a doubling of the tumour response rate in 30 patients treated with chemo-immunotherapy versus chemotherapy alone. Planning for a new Phase II clinical trial program with IMP321 in chemoimmunotherapy or in other combinations will commence following completion of the transaction.

Marc Voigt, Chief Executive of Prima, said: "This presents a major opportunity to grow and strengthen the Company. It provides Prima with a diverse pipeline of early- and mid-stage development candidates and the opportunity to develop other pre-clinical candidates. This is based on a technology which has been endorsed by several major pharmaceutical companies. Through strategic partnerships with these companies we also now have potential near term and future revenue streams with no development cost to Prima."

"Through this transaction, combining experience of personalised cancer therapy at Prima Biomed with the immunotherapy innovation and expertise of novel cancer targets at Immutep, Prima steps to the forefront of cancer immunotherapy development, including mono-therapy and combined approaches. This is a very exciting prospect," he said.

Immutep has a R&D laboratory outside Paris, France where additional research projects for its LAG-3 technology are being explored. Immutep has 11 patent families covering its technology which are all exclusively licensed or owned, with one jointly owned with the Institut National de la Santé et de la Recherche Médicale ("INSERM"), a major French public health research organisation.
John Hawken, Chief Executive of Immutep said: "I have every confidence in the Prima team and it gives me great personal satisfaction to hand over Immutep to Marc and his colleagues."

Immutep’s founder and Scientific and Medical Director, Professor Frédéric Triebel will join Prima as its Chief Scientific Officer, along with his scientific team, to oversee the LAG-3 development program and to advise on the ongoing development of CVac. Professor Triebel, an eminent scientist in cancer immunotherapy, originally developed the LAG-3 technology in collaboration with the Institut Gustave Roussy (IGR), one of the world’s leading cancer-research institutes based in Paris, and Merck Serono. He was Professor of Immunology at Paris University and a Director of an INSERM Research Unit from 1991-1996 prior to founding Immutep in 2001.
Commenting on the transaction, Prof. Triebel said: "The team is very excited about joining Prima. We believe that the combination of therapies targeting different tumour escape mechanisms is about to change the way we treat a complex disease such as cancer. In immuno-oncology combination is key."

Acquisition funding
The total consideration of up to approximately US$28 M will be funded with:
* up to US$18 M in cash, partly based on the achievement of key milestones;
* the issue of Prima Ordinary Shares totalling approximately US$3 M and based on a VWAP calculation; and
* the issue of 200 M warrants equating to a consideration value of approximately US$7 M
In order to fund the acquisition and provide ongoing working capital, Prima has secured an investment agreement with Bergen Global Opportunity Fund, LP ("Bergen"), a New York institutional investor managed by Bergen Asset Management for up to US$37.4 M over a 24-month period (the "Funding"). Details of the Funding are set out in a separate announcement lodged with the ASX simultaneously with this announcement.

The Acquisition is conditional on obtaining shareholder approval at the Company’s AGM for an increase in its share placement capacity in order to fund the Acquisition.

About Immunotherapy and LAG-3/IMP321
Immunotherapy is a process whereby a disease such as cancer is treated by either activating or suppressing components of the immune system to generate a response. LAG-3, or Lymphocyte Activation Gene 3, is able to stimulate and in other cases inhibit an immune response, through involvement in a number of immune pathways.
Immutep’s lead product IMP321 (a LAG-3Ig fusion protein) works by binding to a receptor on antigen presenting cells (APC’s) such as dendritic cells to activate them. The APC’s are important for showing cancer antigens to T cells and activating them to destroy cancer cells. IMP321 is a first-in-class APC activator.
Immutep’s other products include IMP701, an antagonist antibody that acts to stimulate T cell proliferation in cancer patients, licensed to CoStim (Novartis) and IMP731, a depleting antibody that removes T cells involved in autoimmunity, licensed to GSK. In addition, there is the potential for a number of other products coming out of the company’s research efforts.

ARIAD’s AP26113 Receives FDA Breakthrough Therapy Designation For ALK+ Non-Small Cell Lung Cancer Resistant to Crizotinib

On October 2, 2014 ARIAD Pharmaceuticals reported that its investigational cancer medicine, AP26113, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib (Press release Ariad, OCT 2, 2014, View Source [SID:1234500777]). This designation is based on results from the ongoing Phase 1/2 trial (NCT02094573) that show sustained anti-tumor activity of AP26113 in patients with ALK+ NSCLC, including patients with active brain metastases.

“We are very pleased that the FDA has granted Breakthrough Therapy designation to AP26113,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We are encouraged by the clinical data on AP26113 that were presented recently at the European Cancer Congress, particularly in patients whose tumor had spread to the brain. We are focused on accelerating patient enrollment in the ongoing ALTA trial and on planning a front-line trial of AP26113 in treatment-naive patients.”

Phase 1/2 Data

Updated clinical data from the Phase 1/2 trial of AP26113 were recently shared at the 2014 European Cancer Congress. A total of 137 patients have been enrolled in the trial in the United States and Europe. Objective responses were observed in ALK+ NSCLC patients, and responses were observed in patients who were either TKI-naïve or resistant to crizotinib. Of the 72 ALK+ NSCLC patients evaluable for response, 52 (72%) demonstrated an objective response. The median duration of response was 49 weeks, and the median progression-free survival (PFS) was 56 weeks. In a subgroup analysis, 10 of 14 (71%) ALK+ NSCLC patients with active, untreated or progressing, brain metastases had evidence of radiographic improvement in those metastases. Of the seven evaluable TKI-naïve ALK+ NSCLC patients treated with AP26113, all demonstrated an objective response, including two complete responses (CR).

The most common adverse events (AEs), regardless of treatment relationship and including all grades, were nausea (45%), diarrhea (37%), and fatigue (37%). Adverse events, grade 3 or higher, occurring in three or more patients were dyspnea (4%), increased lipase (4%), hypoxia (4%), fatigue (3%), alanine aminotransferase (ALT) increased (2%) and amylase increased (2%). Serious AEs, all causality, occurring in three or more patients were dyspnea (7%), pneumonia (5%), hypoxia (4%), neoplasm progression (4%), pyrexia (2%) and pulmonary embolism (2%).

The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) established the Breakthrough Therapy designation to expedite the development and review of new drugs with preliminary clinical evidence demonstrating that they may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. The Breakthrough Therapy designation is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met. As of September 3, 2014, FDA listed 213 total requests for Breakthrough Designation, and 61 requests were granted. Approximately 41% of the designated products are in cancer. (View Source).

(Press release, CanTx, OCT 1, 2014, View Source [SID:1234505854])

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Immunovaccine Announces Plans for Phase II Clinical Trial of DPX-Survivac in Patients with Recurrent Lymphoma

On October 1, 2014 Immunovaccine reported a clinical development program update for DPX-Survivac, the Company’s lead cancer vaccine candidate. Following the presentation of positive Phase I/II clinical trial data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2014 Annual Meeting earlier this year, the Company plans to advance DPX-Survivac into a Phase II clinical study in diffuse large B cell lymphoma (DLBCL) later this year (Press release Immunovaccine, OCT 1, 2014, View Source [SID:1234501176]). The trial will evaluate DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL. This combination therapy trial design fits with Immunovaccine’s clinical development strategy of maximizing therapeutic impact through concurrent treatment with various classes of promising immunotherapies.

"Our presentation of the first evidence of clinical activity for DPX-Survivac at the ASCO (Free ASCO Whitepaper) conference generated considerable interest from researchers around the world for studying the cancer vaccine in a range oncologic indications and with various combination approaches," said Dr. Marc Mansour, chief executive officer of Immunovaccine. "Following discussions with many key thought leaders and clinical researchers, we have outlined a clinical development strategy designed to generate meaningful data supporting the therapeutic benefit of DPX-Survivac in multiple cancer types with important unmet treatment needs. To this end, we are excited to initiate this trial in recurrent lymphoma, as well as studies in other cancer types, in the coming quarters."

The efficacy Phase II trial will launch at the Odette-Sunnybrook Cancer Centre with the expectation of adding additional sites in the coming months. Researchers will seek to enroll up to 24 patients, with the first patient expected to be dosed by early 2015. The open label study is designed to determine the objective response rate of patients with recurrent survivin-expressing DLBCL when treated with DPX-Survivac in combination with low dose oral cyclophosphamide. Immunovaccine expects to have initial clinical data from this study available approximately mid 2015. Positive clinical data from this study could provide rationale for the initiation of a pivotal trial in recurrent DLBCL.

Study investigators will monitor patients’ immune response to treatment and examine lymphoma deposit biopsies to evaluate immunological changes and gene expression profiles in the tumor. Additionally, the duration of patient clinical responses will also be documented in extended follow-up.

Lymphoma is a relevant oncologic target for DPX-Survivac as more than half of all aggressive non-Hodgkin’s lymphomas such as DLCBL express survivin, the tumor-associated antigen that serves as the basis for the vaccine. Furthermore, there is a growing body of clinical research that shows activity for immune modulatory agents such as cyclophosphamide in DLCBL. Importantly, lymphoma represents a significant unmet medical need as patients who are not transplant candidates or who experience recurrence following an autologous stem cell transplant (ASCT) lack additional treatment options.

"The promising results from the DPX-Survivac Phase I/Ib ovarian cancer studies, as well as expanding scientific literature highlighting the clinical activity of immune modulators in lymphoma, provide a strong scientific rationale for this study. There is a clear and important unmet medical need in this area of lymphoma management and we are eager to evaluate the potential of this combination therapy to deliver clinical benefit to those patients," said Neil Berinstein, M.D., Professor, Department of Medicine at the University of Toronto and medical oncologist at the Odette-Sunnybrook Cancer Centre, one of the sites at which the lymphoma trial will be conducted.

Ignyta Secures $31 Million Term Loan Facility from Silicon Valley Bank

On October 1, 2014 Ignyta reported that it has secured a $31 million term loan facility from Silicon Valley Bank (Press release Ignyta, OCT 1, 2014, View Source [SID:1234500806]). Under the loan facility, the company received initial funding of $21 million, approximately $11 million of which was used to repay the company’s existing loan with Silicon Valley Bank, and has a conditional option to receive an additional $10 million.

"This loan facility strengthens our balance sheet as we aggressively expand the clinical development of our highly promising lead program, RXDX-101, and continue the development of the rest of our precision medicine oncology pipeline," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We appreciate the support Silicon Valley Bank has provided to us as we have grown."

The loan agreement, in addition to customary conditions, provides that the second tranche of $10 million may be drawn down by Ignyta at any time prior to September 30, 2015, provided that Ignyta has initiated the Phase IIa portion of the ongoing STARTRK-1 Phase I/IIa clinical study of its lead product candidate RXDX-101.

Ignyta will be required to pay interest on borrowings at the fixed, per-annum rate of 8.56% on a monthly basis through October 31, 2015. Thereafter, the company will be required to repay the principal plus interest in 30 equal monthly installments. The number of months of interest-only payments and the number of months over which the principal will be amortized will each be increased by six months if the second tranche has been drawn down or the company has raised sufficient funds through the offering of its capital stock, in each case prior to October 31, 2015.