Palo Alto, California – HepaTx to present at the next the American Association for the study of Liver Diseases Meeting (AASLD) - HepaTx, a biotechnology company focused on innovative off-the-shelf cell therapy to treat severe late-stage liver disease, is pleased to announce that Eric Schuur, PhD, CSO and COO, will be presenting next week at the Liver Meeting – Digital Experience, from the 12th to the 15th of November, organized by the American Association for the Study of Liver Diseases (AASLD).
Dr. Schuur will be presenting the latest in-vitro and in-vivo results for their next-generation cell therapy treatments for severe acute liver injury and chronic liver disease, employing their proprietary off-the-shelf cell therapy technology.
“These data are an important step in preparing our product candidates for future human clinical trials. I want to congratulate Eric and our entire scientific staff at HepaTx for their hard work and dedication to advancing HepaTx cell therapies toward our goal of helping those individuals suffering from Liver disease who currently have limited therapeutic options,” said Salah Kivlighn, PhD. CEO at HepaTx.
About HepaTx’s Platform: - HepaTx is developing a proprietary platform that differentiates adipose stromal cells obtained from lipoaspirate into functional hepatocytes-like cells without genetic manipulation of cells. Off-the-shelf, ready for immediate use, hepatocyte-like cells which may be directly infused into the liver where they have the potential to preserve and regenerate liver function. The platform is designed to be scalable to meet expected demand of major unmet medical needs in liver disease.
About HepaTx: - HepaTx is a regenerative medicine company developing new types of stem cell-based treatments for patients with severe acute liver injury, late-stage liver disease and a broad pipeline including expansion into NASH, chronic decompensated liver failure, cirrhosis, and other liver-focused indications with large unserved markets. The technology is licensed from Stanford and well protected by global issued IP. To learn more, visit our website, Hepatx.com. and follow us on Twitter, @hepatx.
Contacts Claudia Preziosi,
NEW YORK – Geller Biopharm, Inc successfully represented Klox Technologies Limited, a subsidiary of Klox Technologies Inc., in its transfer of selected patents and patent applications to Vetoquinol. Through this agreement, Vetoquinol now has full exclusive ownership of the rights to develop and commercialize Klox’s fluorescent light energy (FLE) products in animal health.
Matt Geller, Managing Director of Geller Biopharm, Inc., stated that “this is of significant value for both Klox and Vetoquinol. It provides Klox funding to pursue expansion of the use and markets for their product and provides Vetoquinol full rights to utilize Klox’s technology in the animal health field.”
About Klox Technologies
Klox Technologies Inc. is a regenerative medicine company focused on the development and commercialization of Fluorescent light energy Biomodulation Systems (`FB System') for applications in dermatology, wound care, and rare diseases. For more information, go to: www.kloxtechnologies.com
Vetoquinol is a leading global animal health company that supplies drugs and non-medicinal products for the livestock (cattle and pigs) and pet (dogs and cats) markets. As an independent pure player, Vetoquinol designs, develops and sells veterinary drugs and non-medicinal products in Europe, the Americas and the Asia Pacific region. Since its foundation in 1933, Vetoquinol has pursued a strategy combining innovation with geographical diversification. The Group's hybrid growth is driven by the reinforcement of its product portfolio coupled with acquisitions in high potential growth markets. At April 30th 2020, Vetoquinol employs 2,403 people. Vetoquinol has been listed on Euronext Paris since 2006 (symbol: VETO). For more information, go to: www.vetoquinol.com.
About Geller Biopharm, Inc
Geller Biopharm, Inc is an investment banking group focused on licensing advisory services in the healthcare industry. Broker/Dealer services provided by Pickwick Capital Partners, LLC. Member FINRA/ SIPC.
NEW YORK /PRNewswire/ -- EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) clearance to proceed with a Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial (EB-CMF), as a potential treatment for ramus continuity defects in the mandible. The ramus is a key component of the jaw bone which attaches to the muscles associated with chewing.
EB-CMF is a living anatomically correct bone graft manufactured from a patient's own adipose derived stem cells. This eliminates the need to harvest bone from a patient's body, potentially reducing pain, surgical and hospitalization time while creating a precision fit with the defect.
"We are proud of the work that has been put into this IND, and are grateful to our entire team, as well as all our investors, consultants, and champions in the field who have made this possible," commented Dr. Nina Tandon, CEO and Co-Founder of EpiBone. "Our technology has the potential to change the field of skeletal reconstruction as we know it. Our goal is to help as many patients as we can to regain optimal form and function, in the most seamless, long-term, and natural way possible."
The Phase 1/2 clinical study will evaluate the EB-CMF product directly in patients with mandibular ramus continuity defects which require reconstruction. In addition to the primary safety of EB-CMF, the study is also designed to demonstrate the effectiveness of EB-CMF in bone reconstruction in addition to integration with the native tissue. The company expects to enroll 6 patients in this study. The company hopes this study will inform the exploration of other potential indications for other facial reconstructive surgeries requiring bone grafts, as well as studies for cartilage replacement in the knee, and other areas of the body.
EpiBone, Inc. is privately-held regenerative medicine company focused on skeletal reconstruction. Sitting at the intersection of biology and engineering, the company harnesses the power of a patient's own cells to create living solutions that become a seamless part of a patient's body. EpiBone is currently developing a pipeline of bone, cartilage, and compound (bone and cartilage) products.
For more information, please visit: https://www.epibone.com/
This communication contains forward-looking statements which can generally can be identified by words such as "plans," "change," "will," "following", "strengthening," "developing, the negative of these words and similar words and expressions, which are based on EpiBone's current expectations, assumptions, estimates and projections about its business, technology, product development and industry. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and include, without limitation, EpiBone's ability to (1) adequately protect or enforce its intellectual property rights, (2) develop and commercialize new products and technologies on a timely basis (or at all), (3) risks associated with acquisitions and strategic investments and (4) attract and retain qualified personnel. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. Additionally, this communication does not constitute an offer to sell or a solicitation of an offer to buy securities.
SOURCE EpiBone, Inc.
Amunix Announces Licensing Agreement with Merck for ProTIA Immune Activator Platform
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Amunix Pharmaceuticals Inc. (“Amunix”), a biopharmaceutical company focused on the discovery and development of novel immuno-oncology therapeutics, today announced that it has entered into a licensing agreement with Merck, known as MSD outside the United States and Canada, for rights to develop therapeutics against an undisclosed target using Amunix’s proprietary protease-triggered immune activator (ProTIA) technology platform.
“We are very pleased to enter into the collaboration with Merck, an acknowledged leader in the field of novel cancer therapeutics,” said Volker Schellenberger, Ph.D., President and CTO of Amunix. “The agreement with Merck is a testament to Amunix’s protein engineering expertise reflected in our ProTIA platform. This powerful new platform technology enables the rapid generation of tumor activatable cytokines, signaling peptides/proteins or immune cell engagers. We look forward to a productive and successful relationship.”
“Amunix’s ProTIA technology offers the potential to create novel tumor-targeted molecules for evaluation in our immuno-oncology clinical development programs,” said Rob Kastelein, Ph.D., Associate Vice President, Immune-Oncology Discovery, Merck Research Laboratories. “We look forward to working with the Amunix team.”
Under terms of the agreement, Amunix will receive an upfront payment from Merck and is eligible to receive payments associated with the achievement of certain developmental milestones as well as royalties on sales of any products derived from the collaboration. Further financial details were not disclosed.
Amunix Pharmaceuticals, based in Mountain View, CA, is a privately held drug discovery and development company with two proprietary technologies, XTEN® and ProTIA, that enable the rapid generation of protein therapeutics that are engineered to be fit for purpose. The company’s goal is to leverage its protein engineering platform and know-how to discover and develop safe and effective therapeutics for patients with cancer and other serious diseases. Amunix’s robust technology platforms have been validated through multiple collaborations with leading biopharmaceutical companies including Celgene, Genentech, Janssen, Roche, Bioverativ, and Baxter.
For additional information about the company, please visit www.amunix.com.
For General Inquiries, please contact:
Volker Schellenberger, Ph.D.
President and CTO
CerRx, Inc. Announces Cancer Prevention and Research Institute of Texas (CPRIT) Product Development
Grant Award of $11.7M to Conduct a Phase I/IIa Trial in Cutaneous T-Cell Lymphoma
Lubbock, Texas, August 24, 2018 – CerRx, Inc. (CerRx), a private biotech company developing novel therapeutics to treat cancer, announced the award of a Product Development Grant of $11.7 million by the Cancer Prevention and Research Institute of Texas (CPRIT). The Company will use this investment to initiate a phase I/IIa combination clinical trial for the treatment of cutaneous T-cell lymphoma (CTCL). This second CPRIT award to CerRx further expands upon its growing portfolio in T-cell lymphoma. This trial is expected to start in 1H, 2019.
CerRx is currently enrolling patients into a pivotal registration study with IV fenretinide in refractory/resistant patients with peripheral T-cell lymphoma (PTCL). Fenretinide is available for licensing.
IV fenretinide targets and stimulates large increases in ceramides and reactive oxygen species selectively in cancer cells. In an early phase clinical study tested as a single agent, fenretinide produced multiple responses in T-cell lymphoma including complete remissions lasting more than five years.
The newly funded combination trial in CTCL with IV fenretinide + HDACi (histone deacetylase inhibitor) is based upon recently published research by CerRx scientists that demonstrated a synergistic killing of tumor cells in 15 different human T-cell lymphoid malignancy models compared to either drug alone, with a doubling of event-free-survival in animal models of human cancer. If such results can be replicated in human studies, this drug combination could revolutionize how CTCL is treated.
Bill Simpson, Chief Executive Officer, said, “The CPRIT review process is very rigorous and we are very pleased to have successfully completed a second CPRIT program approval. The CPRIT funding, coupled with angel investor monies, allows CerRx to begin a combination program in CTCL in addition to our ongoing pivotal monotherapy study in PTCL.”
C. Patrick Reynolds, M.D., Ph.D., Chief Scientific Officer of CerRx and Director of the Texas Tech University Health Sciences Center School of Medicine Cancer Center, said, “Our laboratory data demonstrated that fenretinide and HDAC inhibitors act together via a novel mechanism that has the potential for being both well-tolerated and highly active in patients.”
“We are proud that CerRx is accelerating its clinical development of IV fenretinide which has the potential to benefit many patients, including children,” added Chris Del Vecchio, Director of the Center for Innovation at Children’s Hospital Los Angeles, licensor of the IV fenretinide technology.
Cutaneous T-cell lymphoma (CTCL) is a type of cancer that starts as slow growing lesions on skin, but advances as tumors growing throughout the body. About 3,000 new cases of CTCL are diagnosed every year in the US. The early stages of disease are treatable by a variety of therapies but most begin to fail within months leading to further disease progression. Of all patients newly diagnosed with CTCL one-third overall will progress to an advanced stage of the disease, and one-quarter will die from their disease regardless of therapies. Currently available therapy responses are limited and generally are short-lived (6 – 12 months). They are often complicated by serious side-effects (gastrointestinal toxicities, and hematologic toxicities, including anemia or thrombocytopenia).
About CerRx – CerRx is an intermediate stage, targeted oncology drug discovery and development company that is developing anticancer therapeutics that target the ceramide pathway. ‘Ceramides’ are key wax-like building blocks used by cells to make membranes and as signaling molecules. CerRx drugs trick cancer cells to overproduce certain ceramides and also reactive oxygen species that kill the cancer cells with little or no ill effects to healthy normal cells. To date, CerRx agents have shown multiple, sustained, complete responses in T-cell lymphomas, and with early indications of activity in adenocarcinomas of the colon and esophagus and in pediatric neuroblastoma.
CerRx is developing several clinical and preclinical compounds in collaboration with both investigators at the Texas Tech University Health Sciences Center School of Medicine Cancer Center and with the support of the National Cancer Institute Developmental Therapeutics Program.
For more information, visit www.CerRx.com.
Forward Looking Statements This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the planned Phase I/II trials. These forward-looking statements represent the Company’s judgment as of the date of this release. The Company disclaims any intent or obligation to update these forward-looking statements.
For Business Development Inquiries, please contact:
Geller Biopharm Inc.
Dr Matthew Geller
For General Inquiries, please contact:
Chief Executive Officer
MOUNTAIN VIEW, CA--(GlobeNewswire – February 20, 2018) – Amunix announces XTEN® and ProTIA technology licensing agreement with Celgene.
MOUNTAIN VIEW, CA–(GlobeNewswire – February 20, 2018)
Amunix Operating Inc. (Amunix), a biopharmaceutical company focused on the discovery and development of novel immuno-oncology therapeutics, is pleased to announce that it has entered into a licensing agreement with Celgene.
The agreement allows for the utilization of Amunix’s proprietary XTEN and ProTIA technology to augment ongoing discovery and development of therapeutics with the potential for improved delivery, enhanced safety, targeted delivery, and half-life attributes against specified targets selected by Celgene.
Volker Schellenberger, PhD, CEO of Amunix commented: “We are extremely pleased by the decision made by the Celgene team in selecting Amunix’s XTEN and ProTIA technologies to further enhance the development of its therapeutic drug pipeline. We look forward to future milestone achievements in the development of novel entities from the collaborative effort between our companies.” Geller Biopharm, Inc. served as Amunix’s exclusive agent for this licensing agreement.
Amunix, based in Mountain View, CA, is a privately held biotechnology company with two proprietary technologies, XTEN and ProTIA. XTEN is a half-life extension technology is based on hydrophilic, unstructured, biodegradable proteins that impart a number of favorable properties upon the molecules to which they are attached. In addition to the advantages of reduced dosing frequency, XTENylation stabilizes plasma drug concentrations, which often results in increased efficacy as well as reduced side effects. Amunix has licensed this technology to numerous companies in a wide range of therapeutic areas. Two genetically fused XTENylated products have been clinically tested.
ProTIAs are bispecific molecules that bind tumor antigens and T cells. ProTIAs are administered as long-acting prodrugs that can be activated in the tumor environment by tumor-associated proteases. Amunix is developing internally a pipeline of ProTIA-based (Protease Triggered Immune Activator) immuno-oncology therapeutics, as well as offering partners access to the ProTIA technology for augmenting the safety and efficacy of their molecules.
For additional information about the company, please visit www.amunix.com.
Volker Schellenberger, Ph.D.
President and CEO
Business Development Contact:
Matthew Geller, Ph.D.
MOUNTAIN VIEW, CA--(GlobeNewswire – February 13, 2018) – Amunix CEO to deliver keynote address on ProTIA, Amunix’s novel immuno-oncology technology, at the Biologics & Biosimilars Congress Europe (March 2018)
MOUNTAIN VIEW, CA–(GlobeNewswire – February 13, 2018) – Amunix Operating Inc. (Amunix), a biopharmaceutical company focused on the discovery and development of novel immuno-oncology therapeutics, announced today that Dr. Volker Schellenberger will be delivering the keynote address at the 4th Biologics & Biosimilars Congress Europe being held March 5 & 6, 2018 in Berlin. Dr. Schellenberger’s presentation, entitled “ProTIA – Bispecific T cell engagers designed for local activation in the tumor environment”, will provide an overview of the ProTIA technology that Amunix has developed, with the aim of initiating clinical trials with their lead candidate in 2019. Dr. Schellenberger will also chair a panel discussion on March 6 on the impact of bispecific antibodies on oncology and challenges in developing novel cancer treating biologics.
Dr. Schellenberger, CEO of Amunix, commented: “Harnessing the power of T cell engagers, potentially a leading class of immuno-oncology compounds, has been hindered by the toxicity of the current molecules. It is an honor to have been chosen as a keynote speaker at this important conference, where I will discuss Amunix’s approach to mitigating toxicity by taking advantage of proteases in the tumor environment, to increase the therapeutic index of T cell engagers. We look forward to demonstrating the potential of our technology, both in our own proprietary pipeline, and through partnerships with biopharmaceutical companies.”
Amunix, based in Mountain View, CA, is a privately held biotechnology company with two proprietary technologies, ProTIA and XTEN. ProTIAs are bispecific molecules that bind tumor antigens and T cells. ProTIAs are administered as long-acting prodrugs that can be activated in the tumor environment by tumor-associated proteases. Amunix is developing internally a pipeline of ProTIA-based (Protease Triggered Immune Activator) immuno-oncology therapeutics, as well as offering partners access to the ProTIA technology for augmenting the safety and efficacy of their molecules. XTEN is a half-life extension technology is based on hydrophilic, unstructured, biodegradable proteins that impart a number of favorable properties upon the molecules to which they are attached. In addition to the advantages of reduced dosing frequency, XTENylation stabilizes plasma drug concentrations, which often results in increased efficacy as well as reduced side effects. Amunix has licensed this technology to numerous companies in a wide range of therapeutic areas. Two genetically fused XTENylated products have been clinically tested.
For additional information about the company, please visit www.amunix.com.
Volker Schellenberger, Ph.D.
President and CEO
Business Development Contact:
Matthew Geller, Ph.D.
DURHAM, N.C., March 08, 2017 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, announced that the company has entered into a definitive agreement with the holders of 75.5% of the outstanding capital stock of Pelican Therapeutics, Inc. (“Pelican”) to acquire an 80% controlling interest in Pelican. Headquartered in Austin, Texas, Pelican is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a highly differentiated and potentially “best-in-class” T cell costimulatory receptor.
Key highlights include:
1. Pelican was the recipient of a highly competitive $15.2 million New Company Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT), which should enable the company to advance multiple products through preclinical development and at least one program through a 70-patient Phase 1 clinical trial. The CPRIT grant is subject to customary CPRIT funding conditions and was awarded in 2016 following a rigorous scientific and clinical evaluation process.
2. Pelican’s T cell costimulator, PTX-25, in combination with other immunotherapies, including Heat’s ImPACTand ComPACT technologies, has the potential to enhance durability of responses due to its preferential specificity to ‘memory’ CD8+ T cells.
3. Preclinical studies demonstrate PTX-25 has superior “best-in-class” costimulatory activity for CD8+ cytotoxic T cells as compared to other costimulators.
“The acquisition of Pelican aligns with our strategic focus targeting exciting immuno-oncology combinations, strengthening Heat’s portfolio in the emerging T cell activation space,” said Jeff Wolf, Heat’s Founder and Chief Executive Officer. “Pelican’s two product candidates are transformative assets for us as there are compelling data indicating that targeting TNFRSF25 may have significant advantages over competing costimulatory receptors currently under development. This is important because many of the leading global pharmaceutical companies are focused on T cell costimulators to enhance the effectiveness of their existing immuno-oncology therapies.”
“Pelican’s PTX-25 has the potential to dramatically improve the durability of antigen-specific immune responses due to its preferential specificity for stimulating the production of ‘memory’ CD8+ T cells,” added Jeff Hutchins, Ph.D., Heat’s Chief Scientific Officer and Senior Vice President of Preclinical Development. “We look forward to advancing these new product candidates with synergistic combinations including Heat’s existing T cell-activating platform technologies, ImPACT and ComPACT, vastly expanding our reach within oncology and possibly beyond.”
The acquisition is contingent upon certain closing conditions, including agreements of the holders of 80% of the outstanding capital stock of Pelican, on a fully diluted basis, to participate in the acquisition and enter into a stockholders agreement with respect to their remaining Pelican shares. As consideration for the sale of 80% of the Pelican Stock, Heat will pay the Pelican stockholders that participate in the acquisition an upfront cash payment not to exceed $500,000 and will issue an aggregate of 1,323,021 shares of Heat common stock, representing 4.99% of the outstanding shares of Heat common stock. In addition, Heat will cause Pelican to pay certain clinical and commercialization milestone payments, royalty and sublicensing income payments, and Heat will loan Pelican amounts sufficient to pay Pelican’s transaction expenses. Cassel Salpeter & Co. served as financial advisor to the Heat special committee and Geller Biopharm served as financial advisor to the Pelican special committee and Pelican stockholders.
The acquisition is expected to close no later than April 30, 2017, subject to applicable regulatory approvals and other customary terms and conditions.
About Pelican Therapeutics, Inc. - Pelican Therapeutics, Inc. is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a differentiated and potentially "best-in-class" T cell costimulatory receptor. TNFRSF25 has shown great promise due to its preferential specificity for stimulating the production of "memory" CD8+ T cells, the strongest predictive biomarker of clinical benefit from cancer immunotherapy. T cell costimulatory therapy, when combined with checkpoint inhibitors and other treatments, could significantly improve clinical responses for a broader range of patients. Pelican has conducted extensive preclinical studies and completed humanization of its lead monoclonal antibody, PTX-25.
About the Cancer Prevention and Research Institute of Texas (CPRIT) - Beginning operations in 2009, CPRIT has to-date awarded $1.78 billion in grants to Texas researchers, institutions and organizations. CPRIT provides funding through its academic research, prevention, and product development research programs. Programs made possible with CPRIT funding have reached all 254 counties of the state, brought more than 123 distinguished researchers to Texas, advanced scientific and clinical knowledge, and provided more than three million life-saving education, training, prevention and early detection services to Texans. Learn more at www.cprit.texas.gov.
About Heat Biologics, Inc. - Heat Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology company developing novel therapies that are designed to activate a patient’s immune system against cancer utilizing an engineered form of gp96, a protein that activates the immune system when cells die. Heat’s highly specific T cell-stimulating therapeutic vaccine platform technologies, ImPACT and ComPACT, in combination with other therapies, such as checkpoint inhibitors, are designed to address three distinct but synergistic mechanisms of action: robust activation of CD8+ “killer” T cells (one of the human immune system’s most potent weapons against cancer); reversal of tumor-induced immune suppression; and T cell co-stimulation to further enhance patients’ immune response. Currently, Heat is conducting a Phase 1b trial with HS-110 (viagenpumatucel-L) in combination with an anti-PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC) and a Phase 2 trial with HS-410 (vesigenurtacel-L) in patients with non-muscle invasive bladder cancer (NMIBC).
Heat’s wholly-owned subsidiary, Zolovax, Inc., is developing therapeutic and preventative vaccines to treat infectious diseases based on Heat’s gp96 vaccine technology, with a current focus on the development of a Zika vaccine in conjunction with the University of Miami.
For more information, please visit www.heatbio.com.
Forward Looking Statements - This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and include statements regarding the ability of the parties to satisfy all closing conditions and consummate the Pelican transaction, and to develop Pelican’s potential products singly or in combinations with Heat’s existing product portfolio, the advantages that TNFRSF25 may have over competing costimulatory receptors currently under development, the potential of PTX-25, to enhance durability of responses due to its preferential specificity to ‘memory’ CD8+ T cells, the availability of the CPRIT grant and the potential of Heat’s ImPACT and ComPACT therapies. These statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, including the ability of Heat to consummate the Pelican transaction and develop its product candidates and prove them safe and efficacious, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, the company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the company’s ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, the company’s ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, and its ability to retain its key scientists or management personnel and the other factors described in the company’s annual report on Form 10-K for the year ended December 31, 2015 and other filings with the SEC. The information in this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Investor and Media Relations
Source: Heat Biologics
Lundbeck and Ovid Therapeutics Announce Exclusive Worldwide Licensing Agreement for Gaboxadol Ovid plans to commence Phase 2 trials in two orphan neurological indications, Angelman Syndrome and Fragile X Syndrome, in 2016 NEW YORK & VALBY, Denmark--(BUSINESS WIRE)--H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY), A global pharmaceutical company specialized in brain diseases
A global pharmaceutical company specialized in brain diseases, and privately-held Ovid Therapeutics Inc. (Ovid), a biopharmaceutical company focused on developing therapies for rare and orphan diseases of the brain, today announced that on March 25, 2015 they entered into an exclusive worldwide license agreement for gaboxadol, the first oral medicine which holds the potential to treat patients with Angelman Syndrome and Fragile X Syndrome. Gaboxadol (OV101) is the only small molecule, highly selective extrasynaptic GABA(A) receptor agonist (SEGA) that has been tested in clinical trials.
Under the terms of the agreement, Ovid obtained exclusive worldwide development and commercialization rights for OV101. In connection with the license, Lundbeck became a minority shareholder in Ovid, and will receive certain milestone payments and royalties on sales. Ovid is responsible for all future development and commercialization for OV101. Additional financial terms were not disclosed.
Ovid plans to pursue the development of OV101 in Angelman Syndrome and Fragile X Syndrome, two orphan neurological disease indications with no available treatment options, and expects to commence a Phase 2 trial for Angelman Syndrome in 2016, followed by a Phase 2 trial in Fragile X Syndrome.
"We are delighted to secure OV101, and are proud to have Lundbeck as a stakeholder in Ovid,” stated Dr. Jeremy Levin, Chairman and Chief Executive Officer of Ovid. “This agreement comes at a time as we simultaneously experience a revolution in the understanding of the genetics and molecular basis of neurological diseases, coupled with a similar advance in understanding the molecular pharmacology of existing drugs. This nexus of new knowledge creates an important opportunity for us to match the right molecule to the right indication. OV101 is the first such molecule for Ovid. We are actively taking advantage of this approach to identify and add products to our growing pipeline."
“We are happy with this agreement allowing development of gaboxadol as a potential treatment for patients who have no medical options available today. If successful, these development programs can change the lives of these patients, and we look forward to following Ovid in their pursuit of realizing gaboxadol’s potential in these indications,” said Anders Gersel Pedersen, Executive Vice President and Head of R&D at Lundbeck.
“OV101 is the only SEGA that has been tested in clinical trials to date. By restoring tonic inhibition at low doses, it has shown promising functional improvement in models of Angelman Syndrome, Fragile X Syndrome, as well as genetic epilepsy models. It is fitting that on the 50-year anniversary of Dr. Harry Angelman’s first description of the syndrome, the development of a potential new therapeutic option is underway,” stated Dr. Matthew During, President and Chief Scientific Officer of Ovid. “There is a critical need for therapies that address rare and orphan neurological diseases such as Angelman Syndrome and Fragile X Syndrome. We look forward to working with the Food and Drug Administration, key thought leaders as well as patients, families and disease foundations, including Foundation for Angelman Syndrome Therapeutics, the Angelman Syndrome Foundation and Fragile X Foundation, to advance gaboxadol through the clinic.”
The selection of Angelman Syndrome and Fragile X Syndrome as initial indications is based upon Ovid’s expectation of a highly favorable benefit-to-risk profile for OV101. The company believes that clinical and preclinical evidence to date strongly support OV101’s anti-epileptic, motor improvement and cognitive enhancement effects. OV101 is the only drug that has been shown to correct the motor deficit, a cause of major morbidity in patients, in a mouse genetic model for Angelman Syndrome. OV101 has been shown to be well tolerated in clinical trials involving approximately 3,000 patients.
About Angelman Syndrome and Fragile X Syndrome
Angelman Syndrome is a rare genetic neurological disorder characterized by global severe developmental delay, movement and balance disorder, seizures, sleep disturbances, severe speech impairment and a happy, excitable demeanor. Approximately 1 in 15,000 live births have Angelman Syndrome, with an estimated 4,000 patients in the United States. There are no therapeutic agents approved to treat Angelman Syndrome. Fragile X syndrome is a genetic neurological disorder that causes intellectual disability, behavioral and learning challenges and various physical characteristics. There are approximately 100,000 patients with Fragile X Syndrome in the United States. No therapeutic agents have been approved to date to treat this disease.
About Ovid Therapeutics Inc.
Ovid Therapeutics Inc. is a privately-held, New York based, biopharmaceutical company committed to transforming the lives of patients with rare and orphan diseases of the brain and few, if any, treatment options - patients who currently have no hope of cure or improvement. Ovid focuses on patients and their needs. Using the significant operational, product development and business development experience of its management team, Ovid aims to become a leading neurology company, with multiple products and a rich pipeline coupled with compelling research and development.
Geller Biopharm Inc. and Hogan Lovell US LLP represented Ovid in its negotiations.
For more information on Ovid, please visit http://www.ovidrx.com.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are alcohol dependence, Alzheimer's disease, bipolar disorder, depression/anxiety, epilepsy, Huntington's disease, Parkinson's disease, schizophrenia and symptomatic neurogenic orthostatic hypotension (NOH).
In 2015, Lundbeck celebrates its 100th anniversary. During the past century, millions of people have been treated with our therapies. It is complex and challenging to develop improved treatments for brain disease, but we keep our focus: There is still so much we need to achieve in the next 100 years to ensure a better life for people living with brain disease.
Our approximately 6,000 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China, Denmark and the United States and production facilities in China, Denmark, France and Italy. Lundbeck generated core revenue of DKK 13.5 billion in 2014 (EUR 1.8 billion; USD 2.4 billion).
For additional information, we encourage you to visit our corporate www.lundbeck.com.
Ovid Therapeutics Inc.
Anna Kazanchyan, MD, +1 212-776-4381
SVP, Product Development
Burns McClellan, on behalf of Ovid Therapeutics
+1 212-213-0006, ext. 327
As companies seek to negotiate the volatility of emerging markets, the uncertainties of healthcare reforms, and changing customer demands, accurate forecasting will need to come to the fore as a way to address the changing pharma landscape.
Experts say one of the greatest concerns for the industry is the health of global economies — from lingering concerns related to debtladen countries in the European Union to trade surpluses fueled by purposefully devalued currencies. The impact of these issues and the stability of global markets and currencies will have significant influence on the pharmaceutical industry.
Download the PDF to keep reading...
Dr. Matthew Geller, president of Geller Biopharm, offers his outlook for Biotech stocks in 2012. Watch the video by clicking below.
DOWNLOAD: The Street Video
Biotech companies raised just $2.8 billion in the third quarter of 2011, according to an analysis published in Monday’s BioWorld Insight. That’s a 60 percent drop from the second quarter of this year, and – just in case you thought seasonality was to blame – a 48 percent drop from the third quarter of last year.
On the bright side, biotech fundraising for the first nine months of 2011, at $16.1 billion, is still 18 percent ahead of the $13.6 billion raised in the same period last year, thanks to a strong first half. Another surprising bright spot: although public offerings and public company alternative financings slumped in the third quarter, private company financings actually trended up (if you include the $600 million raised by newly formed Russian nanotech company Pro Bono Bio.)
No one knows for sure, of course, but two bankers did a little crystal ball gazing for us.
Matthew Geller, president of Geller Biopharm, attributed the third quarter slowdown to macroeconomic issues, including uncertainty about the economic climate in Europe, and concerns about whether or not the U.S. is headed into another recession. “There’s so much uncertainty,” Geller said – but if some of that uncertainty resolves before the end of the year, there could be a lot of fund managers looking to make up lost ground by betting on risky biotech plays.
“If things do turn, they would turn on a dime,” Geller predicted. “The market is bipolar.”
Shiv Kapoor, managing director at investment bank Morgan Joseph TriArtisan, also is optimistic that things will turn around, though he thinks it might take a bit longer. He noted that large cap biopharmas are currently outperforming the market, while small cap biotechs are underperforming, a situation that “drives M&A.” He added that while Q4 2011 or Q1 2012 could bring a “valley” for small biotechs, deal flow could start to pick up in the first or second quarter of next year and, “it only takes a few good deals to drive prices back up.”
Broker / Dealer services provided by
Pickwick Capital Partners, LLC. Member
Get a digital copy of our PDF presentationDownload PDF