On March 15, 2016 OPKO Health, Inc. (NYSE:OPK) reported the decision of the European Association of Urology (EAU) Prostate Cancer Guidelines Panel to include the 4Kscore Test in the 2016 EAU Guidelines for Prostate Cancer (Press release, Opko Health, MAR 15, 2016, View Source [SID:1234509564]). The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.

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"The EAU Prostate Cancer Guidelines Panel is an international, multi-disciplinary group of specialists in prostate cancer diagnosis and treatment," said Dr. Alberto Briganti, Department of Urology, San Raffaele Scientific Institute, Milan, Italy. "The decision to include the 4Kscore in the guidelines indicates that the Panel views the 4Kscore Test as having achieved an appropriate level of clinical evidence to recommend its use for both assessment of asymptomatic men prior to a first prostate biopsy and as an additional investigational test to be done after a negative prostate biopsy."

The 4Kscore test has been studied on over 22,000 patients with results published in 12 peer-reviewed scientific publications. The 4Kscore test is the only blood test that accurately identifies an individual patient’s risk for high-grade, aggressive cancer.

About the 4Kscore Test

The 4Kscore, a laboratory developed test, is the only blood test that accurately identifies an individual patient’s risk for aggressive prostate cancer, the lethal form of prostate cancer. The 4Kscore test uses a proprietary algorithm that incorporates the blood levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein-2 (hK2), plus the patient’s age, and other clinical information to calculate the percentage risk (probability) of finding a Gleason Score 7 or higher grade of prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions and is included as a standard of care in both the 2016 NCCN Early Detection Guidelines and the 2016 EAU Guidelines for prostate cancer. The 4Kscore test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between the Urologist and the patient.

On March 15, 2016 Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant) (Press release, Hoffmann-La Roche , MAR 15, 2016, View Source [SID:1234509538]). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

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"Atezolizumab was granted Priority Review designation based on results of the IMvigor 210 study, which showed the medicine shrank tumors in a type of advanced bladder cancer, and the majority responding to treatment continued to respond after nearly a year of follow up," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "The treatment options available for advanced bladder cancer are very limited, and we are committed to working with the FDA to bring the first anti-PDL1 cancer immunotherapy to people with this disease as quickly as possible."

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Atezolizumab was granted Breakthrough Therapy Designation by the FDA in May 2014 for the treatment of people whose metastatic bladder cancer expresses the protein PD-L1 (programmed death ligand-1). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results of the IMvigor 210 Phase II study, and the FDA will make a decision on approval by Sept. 12, 2016. Atezolizumab is also being studied in a number of other cancers.

About the IMvigor 210 study

IMvigor 210 is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in people with locally advanced or mUC, regardless of PD-L1 expression. People in the study whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen (n=311) received a 1200-mg intravenous dose of atezolizumab on day one of 21-day cycles until loss of clinical benefit. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR), overall survival, progression-free survival and safety.

In an updated analysis based on 11.7 months of median follow up, atezolizumab shrank tumors (ORR) in 15 percent (95 percent CI: 11, 19) of people evaluable for efficacy and safety (n=310) whose disease progressed after platinum-based chemotherapy.

Atezolizumab shrank tumors in 26 percent (95 percent CI: 18, 36) of people whose disease had medium and high levels of PD-L1 expression (n=100). Median DOR was not reached at the time of analysis; with a median duration of follow up of 11.7 months, 84 percent (38/45) of people had an ongoing response. The most common Grade 3 to 4 treatment-related adverse events included: fatigue (2 percent), decreased appetite, fever (pyrexia), anemia, enzymes in the blood (ALT and AST increase), joint pain (arthralgia), difficulty breathing (dyspnea), inflammation of the lung wall (pneumonitis), inflammation of the lining of the colon (colitis), hypertension and hypotension (all 1 percent). There were no treatment-related Grade 5 adverse events.

In addition to IMvigor 210, Genentech has an ongoing, confirmatory Phase III study (IMvigor 211), which compares atezolizumab to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.

About metastatic urothelial cancer
According to the American Cancer Society (ACS), it is estimated that more than 76,000 Americans will be diagnosed with bladder cancer in 2016, and about 11 percent of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. The ACS estimates that approximately 96 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 39 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are about three to four times more likely to get bladder cancer during their lifetime than women.

About atezolizumab
Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1). Atezolizumab is designed to directly bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.

About personalised cancer immunotherapy
The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. Our PCI research and development programme comprises more than 20 investigational candidates, eight of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab (also known as MPDL3280A), PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche Tissue Diagnostics. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with atezolizumab as a single agent and those who may be appropriate candidates for combination therapies; the purpose is not to exclude patients from atezolizumab therapy, but rather to enable the design of combinations that will provide the greatest chance for transformative responses. The ability to combine atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.

On March 15, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted therapies for cancer and diabetes using its live-cell encapsulation technology, Cell-in-a-Box, reported another in a series of articles that will serve to educate the public on its live-cell encapsulation technology and its use in developing treatments for pancreatic cancer and diabetes (Press release, PharmaCyte Biotech, MAR 15, 2016, View Source [SID:1234510782]). This educational piece addresses PharmaCyte’s intellectual property (IP) and the strategy that PharmaCyte will employ to protect that property.

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PharmaCyte’s IP consists of exclusive license agreements that PharmaCyte has with other parties and IP that PharmaCyte intends to create during the clinical development of its product candidates. In the questions and answers below, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, discusses PharmaCyte’s IP protection strategy, which consists of patents, patent term extensions, regulatory data exclusivity, market exclusivity for orphan drugs, know-how/trade secrets and trademarks.

PharmaCyte’s Intellectual Property Protection Strategy

Which family of patents protects PharmaCyte’s pancreatic cancer therapy and what is your plan to extend those patents?

"Before I answer that question, let me say that our pancreatic cancer therapy has two iron-clad protections that will far surpass any protection that our patents could ever bring if we can obtain FDA approval. I will discuss this a little later in this piece, but keep in mind while reading these responses that our pancreatic cancer therapy is going to remain protected long after the patents expire.

"Everyone interested in PharmaCyte’s pancreatic cancer therapy should be focused on the family of patents that deal with the live-cell encapsulation of genetically altered human cells that overexpress a form of the Cytochrome p450 enzyme system (normally found in the liver), and specifically on only 2 patents in that family. Those patents are set to expire in the United States a little over a year from now on March 27, 2017. These are the only patents that pertain to PharmaCyte’s pancreatic cancer therapy. Now, while these patents are set to expire next year, we certainly aren’t sitting idly by and allowing that to happen.

"We do have a protection strategy in place, which includes filing an application with the U.S. Patent and Trademark Office for interim extensions extending the life of those patents 1 year at a time for up to 5 years, which we believe will be long enough to get us through clinical trials and the regulatory approval process. The earliest the application can be filed is 6 months before the expiration of the patents, and the application can be filed up to 15 days before the expiration date. PharmaCyte can and plans to file its patent extension application between September 27, 2016, and March 12, 2017."

Can PharmaCyte apply for follow-on patents? If so, can you explain what these patents are?

"Yes. New patentable inventions related to a pharmaceutical product, also called ‘follow-on patents,’ generally encompass improvements to, or new uses for, the pharmaceutical not disclosed or suggested in the original patent. PharmaCyte anticipates extending its patent protection for its product candidates through improvements to its core technology, including:

1. New Formulations: New formulations of a known drug compound that are clinically superior to the previous drug formulation may be patentable. Developing new formulations that promote a patient’s successful therapy through such things as reduced dosing or ease of use, or that exhibit improved therapeutic outcomes or more favorable side-effect profiles, are patentable. Examples include sustained-release formulations, extended-release formulations and dosing regimens.

2. New Routes of Administration: Additional patent protection may be obtained for new formulations that permit new routes of administration.

3. New Uses: Patents directed to new uses and treatments may be obtained.

4. Combinations: Combining two or more drugs into one treatment also may be patentable.
New discoveries that may be eligible for patent protection as follow-on patents cannot be predicted at the current time; however, PharmaCyte anticipates improvements to its technology and product candidates to be generated as these product candidates move through clinical testing."

Being that PharmaCyte’s cancer product candidates are biologics, does PharmaCyte qualify for regulatory data protection and the 12 years of data exclusivity that comes with it as outlined by the Biologics Price Competition and Innovation Act (BPCIA), which was enacted as part of the Affordable Care Act in 2010?

"Yes. This is one of the two iron-clad protections that I was speaking of earlier in this article. We will be seeking this protection and the 12 years of data exclusivity it provides. ‘Reference product exclusivity’ or ‘regulatory data protection’ is an IP right available for a limited duration, which protects an innovator’s proprietary safety and efficacy data for its innovative product. This protection prevents any other party, during an exclusivity term of 12 years, from relying on the innovator’s proprietary data in order to obtain marketing approval or authorizations for a follow-on ‘biosimilar’ or generic drug product. A biosimilar product is a follow-on version of an innovator’s biological product.

"PharmaCyte’s cancer product candidates are considered biological products because the capsules that are part of those products contain living, albeit genetically altered, human cells. Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues and recombinant therapeutic proteins. The BPCIA created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.

"The BPCIA establishes a period of 12 years of data exclusivity for reference products in order to preserve incentives for future innovation. Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting others, for a period of 12 years, from gaining FDA approval based in part on reliance on or reference to the innovator’s data in their biosimilar application. PharmaCyte anticipates its 12-year exclusivity will begin as soon as the FDA approves its pancreatic cancer product candidate.

"Countries in the European Union (EU) also provide for such data protection. Further, in October 2015 it was agreed as part of the Trans-Pacific Partnership trade deal between the United States, Australia, Brunei, Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam that biologic drugs will be given a minimum of 5 years data exclusivity."

Can you explain how the Orphan Drug designation that PharmaCyte has received in both the United States and in the European Union is a major source of protection for PharmaCyte’s pancreatic cancer therapy?

"This is the second of the two protections I spoke of earlier. PharmaCyte’s pancreatic cancer product candidate was designated an orphan drug and listed in the official registry of medicinal products for rare diseases by the FDA on December 17, 2014. This orphan drug status assures market exclusivity for PharmaCyte in the United States for 7 years after market approval. Similarly, PharmaCyte has orphan drug status in the EU for its pancreatic cancer product candidate. This designation provides 10 years of market exclusivity in all of the countries in the EU and assistance from the EMA in the product development.

"So it should be understood that once we gain market approval, our pancreatic cancer therapy will have exclusive protections with both the regulatory data protection and the orphan drug designations. In addition, there are a number of know-how/trade secrets and trademark protections built in that we believe will make it exceedingly difficult for any company or entity to ever duplicate our pancreatic cancer therapy and complete clinical trials before we reach market approval. Conservative estimates have indicated that, given the complex nature of the trade secrets/know-how associated with our IP portfolio, we may be able to extend the protection of our IP portfolio by at least several years on this basis alone."

In addition to PharmaCyte’s pancreatic cancer therapy, PharmaCyte also has a diabetes therapy that it is developing that will need protecting. Can you discuss how you’ll protect the therapy that consists of Cell-in-a-Box and Melligen cells?

"PharmaCyte has a License Agreement with the University of Technology Sydney (UTS) in Australia that provides PharmaCyte with an exclusive worldwide right to use genetically modified human liver cells called ‘Melligen cells.’ Those cells have been modified to contain pancreatic islet cell glucokinase for use in developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. The Melligen cells are protected by a patent issued in the EU that is in the process of being validated in each of the major countries. In addition, there is a patent pending in the United States. The License Agreement also provides PharmaCyte with the non-exclusive worldwide rights to ‘know-how’ associated with the Melligen cells.

"PharmaCyte also licensed from Austrianova the exclusive, worldwide rights to use the Cell-in-a-Box cellulose-based live-cell encapsulation technology for the development of a treatment for diabetes and the use of Austrianova’s Cell-in-a-Box trademark for this technology. The diabetes Licensing Agreement grants PharmaCyte exclusive worldwide rights to use the Cell-in-a-Box technology with genetically modified or non-modified non-stem cell lines, designed to produce insulin and/or other critical components for the treatment of diabetes."

In simple terms, how would you summarize PharmaCyte’s strategy for protecting its IP portfolio?

"PharmaCyte has several diverse avenues available to it for protecting its IP portfolio. We plan to pursue all of these in order to extend our IP portfolio to the greatest extent possible."

On March 15, 2016 Champions Oncology, Inc. (CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the third quarter ended January 31, 2016 (Filing, Q3, Champions Oncology, 2016, MAR 15, 2016, View Source [SID:1234509539]).

Third Quarter and Recent Business Highlights:
·
Delivered record core bookings of new contracts to pharma and biotech customers
· TOS revenue growth of 55%
· Launched AML product line
· Reduced cash burn to under $1M for the quarter
·
Initiated sponsored correlative trial of TumorGraft PDX models in sarcoma patients

Joel Ackerman, Champions Oncology CEO, stated, "This was a great quarter for Champions. We are executing against our strategy and the results have been excellent. Our revenue growth remains very strong and our cash burn rate is coming down quickly as we predicted. The pharmaceutical and biotech industry is embracing the depth and breadth of our platform and the leading indicators for future growth are very strong."

Financial Results

Revenue was $2.6 million and $1.8 million for the three months ended January 31, 2016 and 2015, respectively, an increase of $800,000 or 39.5%. Revenue was $8.3 million and $5.6 million for the nine months ended January 31, 2016 and 2015, respectively, an increase of $2.7 million or 48.4%. Total operating expense was $4.9 million and $5.2 million for the three months ended January 31, 2016 and 2015, respectively, a decrease of $300,000 or (6.2%). Total operating expense was $16.1 million and $16.5 million for the nine months ended January 31, 2016 and 2015, respectively, a decrease of $400,000 or (2.1%).

Champions reported a loss before income tax expense of $2.4 million and $2.8 million for the three months ended January 31, 2016 and 2015, respectively, a decrease of $400,000 or (15.1%). Excluding stock-based compensation of $567,000 and $657,000 for the three months ended January 31, 2016 and 2015, Champions recognized a net loss of $1.8 million and $2.2 million, respectively.

Champions reported a loss before income tax expense of $7.8 million and $9.4 million for the nine months ended January 31, 2016 and 2015, respectively, a decrease of $1.6 million or (17.4%). Excluding stock-based compensation of $2.1 million and $2.3 million for the nine months ended January 31, 2016 and 2015, Champions recognized a net loss of $5.8 million and $7.2 million, respectively.

Net cash used in operations was $864,000 and $2.4 million for the three months ended January 31, 2016 and 2015, respectively, a decrease of $1.5M or (64%). The reduction in cash burn is the result of revenue growth, aggressive expense management and payments received in advance of revenue recognition.

Operating Results

Translational Oncology Solutions (TOS):

TOS revenue was $2.1 million and $1.4 million for the three months ended January 31, 2016 and 2015, respectively, an increase of $700,000, or 55.2%. The increase is due to increased bookings, both in the number and size of the studies, in prior quarters due to the expansion of the TOS sales team and growth of the platform.

TOS cost of sales was $1.6 million and $1.3 million for the three months ended January 31, 2016 and 2015, respectively, an increase of $300,000, or 25.1%. Gross margin was 23.8% and 5.5% for the three months ended January 31, 2016 and 2015, respectively. Quarterly gross margins vary based on timing differences between expense and revenue recognition. The improvement in gross margin was due to higher TOS revenue leveraged off the fixed cost component of the lab combined with effective management of the variable lab costs.

Personalized Oncology Solutions (POS):

POS revenue was $416,000 and $453,000 for the three months ended January 31, 2016 and 2015, respectively, a decrease of $37,000 or (8.2%). The decrease is due to a decline of $215,000 in implant and panel revenue offset by an increase of $162,000 in sequencing revenue.

POS cost of sales was $479,000 and $674,000 for the three months ended January 31, 2016 and 2015, respectively, a decrease of $195,000, or (28.9%). Gross margin was (15.1%) and (48.8%) for the three months ended January 31, 2016 and 2015, respectively. The improvement resulted from a shift to a higher margin revenue product contributing to POS revenue and aggressively managing our lab costs.

Research and development expense was $1 million and $1.1 million for three months ended January 31, 2016 and 2015, respectively, a decrease of $100,000, or (8.6%). The decrease is due to lower expenses in genomic characterization of our Champions TumorGraft Bank for the current quarter.

Sales and marketing expense for the three months ended January 31, 2016 and 2015 was $779,000 and $1.1 million, respectively, a decrease of $321,000 or (28.8%). The decrease is due to the consolidation of the sales and marketing resources of the POS and TOS division, including combining both under one commercial business leader.

General and administrative expense for the three months January 31, 2016 and 2015 was $1.04 million and $1.09 million, respectively, a decrease of $50,000, or (4.1%).

Conference Call Information

The Company will host a conference call today at 9:00 a.m. EDT (6:00 a.m. PDT) to discuss its third quarter 2016 financial results. To access the conference call, domestic participants should dial 800-875-3456, Canadian participants should dial 800-648-0973, and international participants should dial 302-607-2001. The participant passcode is "Champions Oncology."

Full details of the Company’s financial results will be available Wednesday, March 16, 2016 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net loss to non-GAAP net loss for an explanation of the amounts excluded to arrive at non-GAAP net loss and related non-GAAP net loss per share amounts for the three and nine months ended January 31, 2016 and 2015. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net loss and non-GAAP net loss per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive loss per share amounts as non-GAAP net loss divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net loss and non-GAAP diluted loss per share may differ from similarly named measures used by others.

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On March 15, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported that safety and immune monitoring data from an investigator-led clinical trial in melanoma using IMP321 as an adjuvant to a therapeutic vaccine has been published in the March 15 edition of the Clinical Cancer Research journal (Filing, 6-K, Prima Biomed, MAR 15, 2016, View Source [SID:1234509754]). The paper is titled "Vaccination with sLAG-3-Ig (IMP321) and peptides induces specific CD4 and CD8 T-cell responses in metastatic melanoma patients: report of a phase I/IIa clinical trial" and is the result of a long-standing academic collaboration between Dr. Frédéric Triebel, Prima’s Chief Scientific Officer and Chief Medical Officer and scientists at the Ludwig Centre for Cancer Research at the University of Lausanne, Switzerland.

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Professor Daniel Speiser, the lead investigator in the study and a key opinion leader in the research of peptide vaccines stated: "It is remarkable that serial vaccinations induced antigen specific T cell responses in all 16 vaccinated melanoma patients. We are very encouraged by the results from this second collaborative study using IMP321 as an adjuvant to boost our peptide vaccine effectiveness, which support the further development of peptide vaccines as part of a combination approach to treating cancer."

Dr. Triebel, a coauthor on the publication commented from Prima’s research laboratory in Paris: "We are very pleased to have demonstrated additional safety and immune monitoring data on IMP321 in this vaccine adjuvant setting. This is another clear demonstration of the potency of IMP321 as an antigen presenting cell (APC) activator able to boost tumor-specific T cells. The fact that the article featured in the highlights section both online and in the print publication is a great honour and recognition of the data’s scientific contribution."