Panacea Pharmaceuticals, Inc. Presents Data on Targeted Killing of Leukemia Cells By Its Radiolabeled Monoclonal Antibody to the Cancer Biomarker HAAH

Radioimmunotherapy Targeting HAAH in Leukemia is Presented at the American Association for Cancer Research (AACR) Meeting in Washington, DC, April 3, 2017

GAITHERSBURG, Md., March 30, 2017 /PRNewswire/ --

Panacea Pharmaceuticals, Inc. presents a paper regarding targeted killing of leukemia cells by a radiolabeled monoclonal antibody at the annual American Association for Cancer Research (AACR) meeting in Washington DC held April 1-5, 2017. The paper is titled:

“Radioimmunotherapy for Acute Myeloid Leukemia Targeting Human Aspartyl (Asparaginyl) β-Hydroxylase”

The paper demonstrates the use of Panacea’s fully human monoclonal antibody (PAN-622) to human aspartyl (asparaginyl) β-hydroxylase (HAAH) as a radiolabeled therapeutic that kills leukemia cells in vitro.  The PAN-622 was radiolabeled with 213Bi, a short half-life α-emitter.   Eight acute myeloid leukemia cell lines were killed by the 213Bi-PAN-622, but not by a radiolabeled control antibody.  Importantly, normal human leukocytes mixed with the tumor cells were unaffected by the 213Bi-PAN-622.  Thus, radiolabeled HAAH-specific PAN-622 antibody can selectively target and kill leukemia cells.

“We are very excited to report that our radiolabeled fully human monoclonal antibody to the cancer biomarker HAAH specifically targets and kills leukemia cells.  This advance provides evidence for a potential therapeutic application to a devastating cancer and poorly-met healthcare need,” said Hossein Ghanbari, Ph.D., CEO and CSO of Panacea.

 

About Panacea Pharmaceuticals, Inc.

Panacea Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company developing novel biologically targeted cancer therapies and diagnostics for unmet medical needs and is headquartered in Gaithersburg, Md. The company has recently initiated a Phase 1 trial of its PAN-301-1 therapeutic cancer vaccine in prostate cancer patients and has late-nonclinical stage projects in serodiagnosis of cancer, immuno-imaging of cancer, monoclonal antibody-based immunotherapy of cancer and neuroprotection, specifically in prevention of chemotherapy-induced cognitive impairment and peripheral neuropathy.

 

Contact:  Steven Fuller, Panacea Pharmaceuticals, Inc., 240-454-8010, sfuller@panaceapharma.com

Panacea Pharmaceuticals, Inc. Presents Data That Its Cancer Biomarker HAAH is Readily Detectable in Serum Exosomes

Improved Detection of the Exosomal HAAH is Presented at the American Association for Cancer Research (AACR) Meeting in Washington, DC, April 2, 2017

GAITHERSBURG, Md., March 30, 2017 /PRNewswire/ --

Panacea Pharmaceuticals, Inc. presents a paper regarding detection of the cancer biomarker HAAH at the annual American Association for Cancer Research (AACR) meeting in Washington DC held April 1-5, 2017. The paper is titled:

“Improved Detection of Cancer Specific Serum Exosomal Aspartyl (Asparaginyl) beta Hydroxylase (HAAH)”

The paper demonstrates major refinements to Panacea’s multi-cancer HAAH-exosome detection assay   that targets the cancer-specific blood serum biomarker HAAH. The cancer field is intensely focused upon exosomes, which are small cell-like nanoparticles derived from the cancer cells that are proving to be important  biomarkers and mediators of cancer cell metastasis and progression.

The association of Panacea’s target molecule HAAH with exosomes has led to a better individual understanding of these biomarkers as well as further development of a markedly improved diagnostic test with higher sensitivity and specificity than previous versions of the assay.

“We are excited to report our continued advances in the understanding of the role of serum exosomes in the detection and monitoring of cancer,” said Hossein Ghanbari, Ph.D., CEO and CSO of Panacea.

 

About Panacea Pharmaceuticals, Inc.

Panacea Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company developing novel biologically targeted cancer therapies and diagnostics for unmet medical needs and is headquartered in Gaithersburg, Md. The company has recently initiated a Phase 1 trial of its PAN-301-1 therapeutic cancer vaccine in prostate cancer patients and has late-nonclinical stage projects in serodiagnosis of cancer, immuno-imaging of cancer, monoclonal antibody-based immunotherapy of cancer and neuroprotection, specifically in prevention of chemotherapy-induced cognitive impairment and peripheral neuropathy.

 

Contact: Steven Fuller, Panacea Pharmaceuticals, Inc., 240-454-8010, sfuller@panaceapharma.com

3M Drug Delivery Systems announces collaboration with Panacea Pharmaceuticals, Inc. on New Cancer Vaccine

3M Drug Delivery Systems announces collaboration with Panacea Pharmaceuticals, Inc. on New Cancer Vaccine

January 10, 2017 

ST. PAUL, MN – (Jan. 10, 2017) – Today, 3M Drug Delivery Systems announces a new phase of an ongoing collaboration with Panacea Pharmaceuticals, Inc. in delivering an investigational therapeutic cancer vaccine directly to the dermis via the 3M™ Hollow Microstructured Transdermal System (hMTS). The first patient in the Phase 1 clinical study has been dosed with Panacea’s innovative cancer vaccine, marking a milestone for both companies.

“Panacea and 3M have had a great relationship and we’re excited to continue working with them,” said Silvia Perez, President and General Manager of 3M Drug Delivery Systems. “Our hollow microneedles bring a new value proposition to their work with therapeutic cancer vaccines – offering the convenience of a transdermal patch paired with a coveted high-volume, reproducible delivery capability to the dermis.”

“Our pre-clinical studies have shown a potentially better immune response with the hMTS when compared to intramuscular dosing, and we’ve also seen good tolerability in safety studies,” said Steve Fuller, Ph.D., Chief Operating Officer for Panacea Pharmaceuticals, Inc. “Because we need to deliver a 1 mL volume of our vaccine to the dermis, 3M’s hMTS is the delivery method of choice for our therapeutic cancer vaccine project moving forward.”

3M hMTS continues to demonstrate a number of unique benefits, including reproducible intradermal delivery, a proven ability to deliver formulations up to 2 mL with various viscosities, and better immune response for vaccines than classic intramuscular injection.

For more information, please visit www.3m.com/mts

About 3M Drug Delivery Systems
3M Drug Delivery Systems partners with pharmaceutical and biotech companies to develop and manufacture pharmaceutical products using 3M's inhalation, transdermal or microneedle drug delivery technology. 3M offers a full range of feasibility, development and manufacturing capabilities to help bring products to market. Regulatory expertise, quality assurance, operations, marketed product support and other in-house resources are available for each step of the development and commercialization process. For more information, please visit www.3M.com/dds or call 1-800-643-8086.

About 3M
At 3M, we apply science in collaborative ways to improve lives daily. With $30 billion in sales, our 90,000 employees connect with customers all around the world. Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M or @3MNewsroom.

3M is a trademark of 3M Company. 

Contact:
Michael Gugala
Karwoski & Courage
(612) 342-9604
m.gugala@creativepr.com

3M Drug Delivery Systems
3M Center, Bldg 275-3E-10
St. Paul, MN 55144

 

Panacea Pharmaceuticals Initiates Phase I Study of First-in-Class Cancer Vaccine Therapy Candidate in Patients with Persistent Prostate Cancer

Panacea Pharmaceuticals Initiates Phase I Study of First-in-Class Cancer Vaccine Therapy Candidate in Patients with Persistent Prostate Cancer

First Patient Dosed in Four-Center Clinical Trial

Company Research Focused on Range of Cancers through Novel,

HAAH-Based Diagnostics & Targeted Active Immunotherapy

GAITHERSBURG, Md., Jan. 17, 2017 – Panacea Pharmaceuticals, a clinical stage biopharmaceutical company developing novel biologically targeted cancer therapies and diagnostics for unmet medical needs, announced today that the first patient has been enrolled and dosed in the open-label, parallel designed, multi-center Phase I clinical trial of PAN-301-1 for the treatment of persistent prostate cancer to assess safety and immunogenicity. Clinical sites for the PAN-301-1 trial are located in Alabama, California, Nebraska and South Carolina and the trial is managed by Accelovance, Inc.

PAN-301-1, a novel, HAAH-directed nanoparticle immunotherapy vaccine candidate, functions as an immune stimulator nanoparticle with hundreds of copies of an HAAH fragment on the surface of the nanoparticle.  This vaccine is highly immunogenic and produces an HAAH-specific antibody response and significantly stimulates immune cells to target HAAH. 

HAAH, human aspartyl (asparaginyl) β-hydroxylase (HAAH) or aspartate β-hydroxylase (ASPH), is an enzyme that is normally expressed in fetal development, where it plays a role in cell growth, movement and cell-cell interaction in tissues during formation. At the time of birth, the gene is silenced. However, in adults, expression of HAAH is uniquely associated with cancer and is related to cancer cell growth, cell motility and invasiveness. In cancer cells, HAAH is only expressed on the surface of the cells and has been detected in more than 20 different types of cancer. HAAH expression levels are inversely correlated with disease prognosis.  When normal cells are transfected with the HAAH gene, they behave like cancer cells and when HAAH is inhibited in cancer cells, they behave like normal cells.

“Based on data from the American Cancer Society, there are more than 160,000 cases of prostate cancer anticipated in 2017 and approximately 30 percent of men treated will relapse after five years, with limited treatment options for patients living with persistent prostate cancer,” said Luke Nordquist, M.D., GU Research Network in Omaha, Neb. and Lead Principal Investigator for the study. “HAAH provides a new potential treatment pathway for patients living with persistent prostate cancer, and with the enrollment of the first patient at our center, we are eager to understand the safety and immunogenicity for PAN-301-1 to address this unmet medical need in cancer diagnosis and treatment.”

In the Phase I trial, PAN-301-1 will be administered through intradermal injection in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose-escalation schema every 21 days to establish the recommended Phase II dose, with an opportunity to extend the study at the same dose. Approximately 18 patients will be enrolled and studied.

“At Panacea, we have created a promising new vaccine therapy drug candidate that targets a specific and novel cancer-relevant marker, overcoming self-tolerance, yet avoiding autoimmune-like side effects of check-point inhibitors throughout our pre-clinical studies,” said Hossein A. Ghanbari, Ph.D., President, Chief Executive Officer and Chief Science Officer, Panacea Pharmaceuticals. “The initiation of the Phase I PAN-301-1 serves as a starting point for utilizing HAAH in treatment to prevent the recurrence of cancer. We are excited to explore this new targeted biological pathway in cancer.”

In animal models of cancer using immune competent mice and rats, which have an HAAH sequence and expression similar to humans, the PAN-301-1 HAAH vaccine has significantly inhibited tumor growth and metastasis, and has enhanced survival, compared to non-treated animals. The vaccine has also been demonstrated as safe in a pre-clinical, multiple-dose toxicology study, which contrasts with the significant side effects that are present in current cancer therapies.  

About PAN-301-1

PAN-301-1 is a de novo-engineered vaccine candidate that functions as an immune stimulator nanoparticle with hundreds of copies of an HAAH fragment on the surface of the nanoparticle.  This vaccine is highly immunogenic and produces an HAAH-specific antibody response and significantly stimulates immune cells to target HAAH. The vaccine is delivered through intradermal injection using the 3M Drug Delivery Systems’ hollow microstructured transdermal system (hMTS). The candidate is delivered as a small-volume, quick, virtually painless injection via the hMTS, not requiring time-consuming and uncomfortable infusions, greatly facilitating the ease of use and patient acceptance.

PAN-301-1 is designed to overcome self-tolerance by altering the presentation of the antigen and by providing an immunostimulant. The nanoparticle, a neutralized bacteriophage, is easy to produce and is generally regarded as safe. The nanoparticle vaccine also contains DNA fragments that present the phage CpG motif to activate the MHC class II pathway. The vaccine has been engineered and manufactured in-house to meet FDA requirements for human use.

About Panacea Pharmaceuticals, Inc.

Panacea Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company developing novel biologically targeted cancer therapies and diagnostics for unmet medical needs and is headquartered in Gaithersburg, Md. The company has late-nonclinical stage projects in serodiagnosis of cancer, immuno-imaging of cancer, monoclonal antibody-based immunotherapy of cancer and neuroprotection, specifically in prevention of chemotherapy-induced cognitive impairment and peripheral neuropathy.

Forward Looking Statements Disclosure

This release contains “forward-looking statements.” Forward-looking statements can be identified by words such as “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects” and similar references to future periods. Forward-looking statements include, but are not limited to, statements we make regarding our expectations concerning the clinical study discussed in this release and the clinical outcomes we anticipate through use of our technologies as discussed in this release.

Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ from those contemplated by the forward-looking statements in this release and such differences may be substantial and material. We caution you therefore against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include scientific uncertainty, risks and defects in the manufacturing or administration of our products, inability to recruit sufficient patients for ongoing clinical studies, reports of adverse or unanticipated outcomes in these clinical studies, development of competing products, technologies, or services, and changes in economic and regulatory conditions.

Any forward-looking statement made by us in this release speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

 

 

Media Contact:

Leticia Diaz

Spectrum

ldiaz@spectrumscience.com

P: 202-587-2517

Panacea Pharmaceuticals closes its Series E financing for a total of $15 million

GAITHERSBURG, Md., Dec. 8, 2015 /PRNewswire/ -- Panacea Pharmaceuticals, Inc., has closed its Series E financing for a total of $15 million and is in a strong position to complete the Phase 1 clinical study of its lead cancer immunotherapeutic drug, as well as pursuing its late-stage pre-clinical candidates toward integrated cancer management. The company has also secured an additional $2 million optional financing commitment in this series.  

"Our lead drug candidate, our late-stage pipeline of pre-clinical candidates, as well as our cancer diagnostic products, constitute Panacea Pharmaceuticals' integrated cancer management program.  We are delighted to have sufficient funding to enable us to pursue this program," said Hossein Ghanbari, PhD, Chairman & CEO/CSO of Panacea Pharmaceuticals, Inc.

Panacea Pharmaceuticals' lead drug candidate is a nanoparticle-based anti-cancer therapeutic vaccine. This targeted drug candidate enables the immune system to control cancer cells by enhancing patients' antibody and cellular defense mechanisms solely against cancer cells. In several animal models (mouse and rat) of aggressive liver, breast, and prostate cancers, it has significantly inhibited tumor growth, decreased tumor size, increased survival, and inhibited metastasis. Our therapeutic vaccine dosage is at microgram level and is delivered intradermally using 3M's Hollow Microstructured Transdermal System. The company has met with FDA earlier in the year to discuss a pre-IND submission that included the manufacturing, animal toxicology and human trial strategies for the vaccine. Based on the outcome of this meeting, the company is targeting 1st quarter 2016 to file an IND. Upon regulatory review, Panacea plans to initiate the Phase 1 clinical study in cancer patients in the 2nd quarter of 2016. 

Beyond our lead immunotherapeutic drug candidate, our late-stage pipeline of products consists of:

  1. Radio-immunoimaging to determine the site and size of tumor, using a radioisotope-labeled all human anti-HAAH antibody 
  2. Radio-immunotherapy using high-energy short-lived alpha or beta emitting radioisotopes bound to the anti-HAAH antibody to specifically target cancer cells 
  3. BrainGuard, our neuroprotectant compound, to guard the brain against damages commonly caused by chemotherapy 
  4. Anti-cancer antibody drug, using naked all human anti-HAAH antibody products

About Panacea
Panacea Pharmaceuticals, Inc. was founded in 1999 to discover, develop, and commercialize novel therapeutic and diagnostic products for oncology and diseases of the central nervous system. Since its inception, the Company's primary approach to cancer treatment has been immunotherapy and development of companion diagnostics for comprehensive patient management. The Company's lead drug product candidate is a nanoparticle-based therapeutic cancer vaccine that targets a novel patented tumor marker, human aspartyl (asparaginyl) β-hydroxylase (HAAH). The company relies on a close collaboration with Brown University where teams of researchers are continuing advances on the Company's core technologies. For more information, visit the company's Web site at www.panaceapharma.com.

Contact
Hossein A. Ghanbari, Ph.D. , hag@panaceapharma.com

Steve Fuller, Ph.D. ,  sfuller@panaceapharma.com

 

SOURCE Panacea Pharmaceuticals, Inc.

Panacea Pharmaceuticals Engages Accelovance For Clinical Development Of Its Novel Nanoparticle-Based Therapeutic Cancer Vaccine

GAITHERSBURG, Md., Feb. 10, 2015 /PRNewswire/ -- Panacea Pharmaceuticals, Inc. and Accelovance, Inc. today announced the establishment of a clinical development services agreement to develop and advance Panacea's oncology immunotherapy pipeline. Through this agreement, Accelovance will support Panacea's clinical development strategies by offering scientific/medical and regulatory expertise, in addition to providing Contract Research Organization (CRO) support through Project Management, Clinical Monitoring, Data Management, Biostatistics, and Safety services for Panacea's clinical trials. The Panacea and Accelovance partnership will bring together highly complementary capabilities to advance and expedite Panacea's drug development and clinical advancement.

Under the agreement, Panacea will maintain stringent oversight and quality standards relating to patient safety and regulatory compliance, with Accelovance assisting with the development and implementation of clinical strategies. Panacea will rely on Accelovance's knowledge in the areas of vaccines, oncology, and clinical management. Providing advanced insight into Panacea's development pipeline will enable both organizations to enhance operational planning, consistency, and execution.

"We are extremely excited to enter into this partnership, as Oncology immunotherapeutic development is vital for the future of patient treatment. We are confident about our preclinical data in animal models and are ready for the next step in our company's development. With Accelovance we have found the best team to support our clinical development needs, which will continue to drive our oncology immunotherapy pipeline forward," commented Hossein Ghanbari, Ph.D., Panacea's Chief Executive Officer.

About Panacea

Panacea Pharmaceuticals, Inc. was founded in 1999 to discover, develop, and commercialize novel therapeutic and diagnostic products for oncology and diseases of the central nervous system. Since its inception, the Company's primary approach to cancer treatment has been immunotherapy and development of companion diagnostics for comprehensive patient management. The Company's lead drug product candidate is a nanoparticle-based therapeutic cancer vaccine that targets a novel patented tumor marker, human aspartyl (asparaginyl) beta-hydroxylase (HAAH). The company relies on a close collaboration with Brown University/Rhode Island Hospital in Providence, Rhode Island where teams of researchers are continuing advances on the Company's core technologies. For more information, visit the company's Web site at www.panaceapharma.com.

About Accelovance

Accelovance, Inc., headquartered in Rockville, MD, is an Industry award-winning Contract Research Organization (CRO) focused primarily in Oncology, Vaccines, and General Medicine. As a clinical services provider to the pharmaceutical and biotechnology industries, Accelovance offers comprehensive clinical development services including management and implementation of Phase I-IV clinical trials and a Clinical Call Center utilized for recruitment, post-marketing surveillance, and long-term survival follow-up. For more information, visit the company's Web site at www.accelovance.com.

Contact Information:

Steven Fuller, Ph.D., COO
sfuller@panaceapharma.com
240-454-8010

Hossein Ghanbari, Ph.D., CEO
hag@panaceapharma.com
240-305-4601

 

SOURCE Panacea Pharmaceuticals, Inc.

Panacea Pharmaceuticals Presents Three Papers Regarding Its Nanoparticle-Based Therapeutic Cancer Vaccine at the Society for Immunotherapy of Cancer Annual Meeting at National Harbor, MD

http://www.prnewswire.com/news-releases/panacea-pharmaceuticals-presents-three-papers-regarding-its-nanoparticle-based-therapeutic-cancer-vaccine-at-the-society-for-immunotherapy-of-cancer-annual-meeting-at-national-harbor-md-231155791.html

 

 GAITHERSBURG, Md.Nov. 8, 2013 /PRNewswire-iReach/ -- Panacea Pharmaceuticals, Inc. presents three papers regarding its Nanoparticle-Based Therapeuti

c Cancer Vaccine at the Society for Immunotherapy of Cancer Annual Meeting at National Harbor, MD held November 8-10, 2013.  The three papers are titled:

Design, Development and Production of Nano-Particle-Based Anticancer Vaccine Targeting Human Aspartyl (Asparaginyl) β-Hydroxylase (HAAH)

Immunogenicity of a Lambda Phage-Based Anti-Cancer Vaccine Targeting HAAH

Inhibition of Tumor Growth in vivo by a Nanoparticle-Based Therapeutic Cancer Vaccine Targeting HAAH

(Photo: http://photos.prnewswire.com/prnh/20131108/MN13284)

Panacea has chosen to target the HAAH molecule for its proprietary therapeutic cancer vaccine because HAAH is expressed on cancer cells and not on non-cancer cells and its function is consistent with the etiology of cancer, i.e., is associated with growth, motility and invasiveness of cancer cells.  Monoclonal antibodies to HAAH have proven to have efficacy in both in vitroand in vivo tumor models.  HAAH is, however, an embryonic antigen, and as such, presents self-antigen tolerance.  The present vaccine entity is designed to overcome this tolerance by altering the presentation of the antigen and by providing an immunostimulant.  The nanoparticle is neutralized bacteriophage construct containing portions of HAAH, is easy to produce and is generally regarded as safe.  The nanoparticle vaccine carries 200-300 copies of HAAH fragments of approximately 25 kDa molecular weight on its surface.  The nanoparticle vaccine also contains DNA fragments that present the phage CpG motif to activate the MHC class II pathway.  We have engineered and manufactured the nanoparticle vaccine to meet FDA requirements for human use.

The nanoparticle therapeutic cancer vaccine targeting HAAH is clearly immunogenic in mice despite the high degree of homology to the human protein that makes the AAH resemble a self-antigen.  All three HAAH-lambda constructs were immunogenic and the antibody response was dose-dependent.  The nanoparticle therapeutic cancer vaccine targeting HAAH is effective in inhibition of tumor growth in mice under various conditions.  Each of the three constructs can inhibit tumor growth.  The vaccine can slow the growth of tumors prophylactically or by treatment simultaneous with or subsequent to establishment of solid tumors.

"We are excited to report that the nanoparticle-based therapeutic cancer vaccine targeting HAAH can be manufactured readily and is effective in tumor models", said Hossein Ghanbari, Ph.D., CEO and CSO of Panacea.  "The HAAH phage constructs are now being developed as clinical candidate vaccines and we are taking all the steps to prepare for an IND submission to FDA", said Steven Fuller, Ph.D., COO of Panacea.

Media Contact: Hossein Ghanbari, Panacea Pharmaceuticals, Inc., 240-305-4601, hag@panaceapharma.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE Panacea Pharmaceuticals, Inc.

 

Licensing Agreement

 

Panacea Pharmaceuticals, Inc. has licensed the worldwide (except USA) rights to HAAH tumor marker-based diagnostic laboratory services to Panacea Global, Inc. (PANG, OTC).  The terms included an upfront licensing fee and a significant portion of the stock in Panacea Global, Inc.  A supply and service agreement has also been signed to provide the HAAH diagnostic test reagents and technical support at a pre-negotiated fee.