On October 6, 2014 NeoStem reported that the United States Adopted Name Council (USAN) has approved the generic name "eltrapuldencel-T" for the Company’s patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma (Press release NeoStem, OCT 6, 2014, View Source [SID:1234500876]). This investigational treatment, planned to be evaluated in the Company’s Phase 3 Intus study, has been granted Orphan Drug, and Fast Track designations by the U.S. Food and Drug Administration and will be conducted under a protocol that has been granted Special Protocol Assessment (SPA). NeoStem plans to begin the trial by the end of 2014.

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Eltrapuldencel-T is an autologous immunotherapy intended to eliminate cancer-initiating (stem) cells capable of causing disease recurrence and progression. Creation of the therapy begins with cancer initiating (stem) cells that have been isolated from the patient’s resected tumor sample, enriched and inactivated. These newly created cancer initiating (stem) cells are then combined with dendritic cells (antigen-presenting immune cells) derived from the patient’s own blood, and granulocyte-macrophage colony stimulating factor (GM-CSF, a natural growth factor that stimulates white blood cells in the body). The product is then introduced back into the patient via a series of subcutaneous injections.

"We welcome the receipt from USAN of the generic name for use in this important program and look forward to the launch of our pivotal Phase 3 trial to evaluate eltrapuldencel-T," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

Eltrapuldencel-T was developed by recent NeoStem acquisition California Stem Cell, Inc., based on a technology developed over the course of 10 years at Hoag Memorial Hospital Presbyterian in Newport Beach, California. Two previous Phase 2 clinical studies conducted at Hoag had resulted in a combined median 5-year survival of 50% in patients with Stage IV melanoma, double that of any current treatment.

Following on the success of those trials, the Intus study is a multi-national randomized, double-blind Phase 3 clinical trial in which patients will be randomized in a 2:1 ratio to receive either eltrapuldencel-T or a control treatment (autologous mononuclear cells in GM-CSF). An expected 250 enrolled patients throughout the U.S., Canada, Australia and New Zealand will receive weekly injections for three consecutive weeks, and then once monthly for five months.

On October 3, 2014 Sorrento Therapeutics reported that China Oncology Focus Limited, an Affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharma), has licensed Sorrento’s fully human immune-oncology anti-PD-L1 monoclonal antibody (mAb) STI-A1014 (Filing 8-K , Sorrento Therapeutics, OCT 6, 2014, View Source [SID:1234500791]).

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Under the terms of the agreement, Lee’s Pharma received exclusive rights to develop and commercialize the antibody for the greater Chinese market, including Mainland China, Hong Kong, Macau, and Taiwan. In turn, Sorrento will receive an up-front payment, potential future milestone payments and high single digit to double digit royalties on future net sales. In total, Sorrento has the potential to receive more than $46 million upon the successful attainment of key milestones. Additionally, Lee’s Pharma will invest $3.6 million by purchasing common stock in Sorrento at a substantial premium to the current market price.

Sorrento’s proprietary G-MAB library platform was used to identify and generate STI-A1014. The theoretical diversity of the library has been calculated to be more than one quadrillion unique antibodies, making it one of the largest fully human antibody libraries available to pharmaceutical and biotechnology companies for drug discovery and development partnerships.

The immuno-oncology field has emerged as the most exciting and fastest developing pharmaceutical market in decades. Antibodies targeting CTLA-4, PD-1, and PD-L1, thus, harnessing the cancer patient’s own immune system for treatment of various solid and hematological malignancies have demonstrated tremendous therapeutic potential rarely seen with conventional oncolytic drugs. A recent forecast by Citigroup predicts this market to become the biggest blockbuster drug class in history with potential sales of up to $35 billion a year over the next 10 years.

"Lee’s commitment to addressing high unmet oncology needs by bringing new effective immuno-oncology therapy to the Chinese market is reflected in this transaction. Sorrento’s antibody technologies as well as its therapeutic mAb programs are truly cutting edge. We look forward to working closely with Sorrento. Our long standing development and commercial experience in the Chinese pharmaceutical industry together with Sorrento’s immunotherapy expertise will ensure timely and efficient development of this exciting therapy, with special focus on cancers with high prevalence in China. We expect to start a Phase 1 clinical trial of the anti-PD-L1 antibody in China in 2015," said Dr. Xiaoyi Li, Chief Executive Officer and Executive Director of Lee’s Pharma.

"We are extremely pleased to work with Lee’s Pharma, a leading Chinese pharmaceutical company with an excellent track record in drug development and commercialization. This partnership further validates our G-MAB antibody technology and underscores Sorrento’s commitment for seeking strategic alliances in bringing its diverse portfolio of fully human monoclonal antibodies, antibody-drug conjugates (ADCs) and bi-specific antibodies into the clinic," said Henry Ji, President and CEO of Sorrento.

On October 3, 2014 Kancera reported that an initial efficacy study of KAN0439834 (a small molecule inhibitor of ROR1) has been completed in an animal model of chronic lymphocytic leukemia (Press release Kancera, OCT 3, 2014, View Source;releaseID=932197 [SID:1234500830]). Preliminary results show that KAN0439834 reduces the number of ROR-expressing leukemia cells after 7 days of treatment in the examined organs of the animals. Deeper and more comprehensive analyzes are performed in order to verify the preliminary findings and to investigate the full effect of the treatment with KAN0439834 in the lymphatic system, which often suffers from infiltrating leukemia cells that are difficult to treat. Following this a decision can be made whether to select a first candidate drug in the ROR project.

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The conducted animal study is based on primary cancer cells from patients which adds clinical relevance to the model. Further studies during Q3 2014 have been performed to characterize the pharmaceutical properties of KAN0439834. Overall, the findings suggest that oral administration of KAN0439834 can provide a concentration of the substance in the blood sufficient to reach the desired effect against cancer cells.

On October 3, 2014 Argos Therapeutics reported plans for development of a state of the art biomanufacturing facility in the Research Triangle Park area in Durham, North Carolina (Filing 8-K , Argos Therapeutics, OCT 3, 2014, View Source [SID:1234500793]). The facility will be used to support automated production of the company’s Arcelis-based personalized immunotherapy product candidates, beginning with AGS-003, the company’s lead oncology product candidate, currently being evaluated in the pivotal ADAPT phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC).

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In support of the development and implementation of the nearly 100,000 square foot facility, Argos will receive approximately $9.5 million in incentives as well as logistical and planning support from the State of North Carolina, Durham County, the City of Durham, and the North Carolina Biotechnology Center.

"Argos was initially formed based on groundbreaking research conducted at Duke University and has experienced significant growth in Durham over the past decade. We are pleased to be expanding our operations here with the construction of our new automated manufacturing facility which we believe is critical to the successful commercialization of personalized immunotherapies such as AGS-003," stated Jeff Abbey, President and Chief Executive Officer of Argos. "Support for this project is a great example showing how our leaders in state, city and county government are committed to job growth and to enhancing North Carolina’s position as a leader in biotechnology."

"Argos’ cutting edge work in personalized immunotherapy may lead to new treatments for people living with cancer, HIV and other serious illnesses," said Pat McCrory, Governor of the State of North Carolina. "It is exciting to see this biopharma company continue to grow in North Carolina. We want to help more companies like Argos bring innovative new therapies and technologies to the commercial market."

The incentive package from the North Carolina Department of Commerce to support the project totals $7.1 million, including a $4.5 million Job Development Investment Grant, $600,000 in education and on-the-job training assistance, a $1.8 million sales tax exemption on qualifying equipment, and a $200,000 Economic Development Award from the North Carolina Biotechnology Center. In addition to NC Commerce, the City of Durham and Durham County awarded an incentives package totaling $2.35 million including a cash grant of $1.85 million and $500,000 in on-the-job training assistance. Argos has entered into a lease with The Keith Corporation of Charlotte, NC, to construct the facility on T.W. Alexander Drive in Durham, NC.

"Durham, known as ‘The City of Medicine,’ prides itself on being on the cutting edge of personalized medical treatment and technology. Argos Therapeutics is one of the many forward thinking companies that maintain Durham’s position as a leader in medicine," said Bill Bell, Mayor of Durham.

"I am excited to see Argos grow in Durham and I am particularly excited, as are my fellow commissioners, that the company plans to create 236 new jobs and keep 100 existing jobs, offering a broad range of employment opportunities for all segments of Durham’s workforce," said Michael Page, Chairman of the Durham County Board of Commissioners.

"The Durham Chamber of Commerce worked in close cooperation with our economic development colleagues with Durham County, the City of Durham, the North Carolina Department of Commerce, the North Carolina Biotechnology Center, Durham Technical Community College, Duke University, North Carolina Central University with its BRITE Program and North Carolina State University to make the case that Argos Therapeutics will be most successful here in Durham, North Carolina. We are ecstatic by Argos’ decision to remain here and we applaud their plan to expand and grow in Durham, NC!" said Lisa Yarborough, Durham Chamber Board Chair.

"The North Carolina Biotechnology Center has had a long relationship with Argos dating back to the late 1990s when they had just a few employees," said Doug Edgeton, President and CEO of NC Biotech, referring to a loan that helped get the company started. "We consider Argos one of North Carolina’s great life science success stories, starting as a local university spinout. We are proud they chose to continue their growth here."

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.