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MabVax Therapeutics and Oncotelic Enter into Merger Discussions

On January 4, 2019 MabVax Therapeutics Holdings, Inc. (OTC Pink: MBVX), a clinical-stage immuno-oncology drug development company with a fully human antibody discovery platform focused on the clinical development of products to address unmet medical needs in the treatment of cancer and pancreatitis, reported that it has entered into discussions to merge with Oncotelic, Inc., a privately held cancer immunotherapy company (Press release, MabVax, JAN 4, 2019, View Source [SID1234532459]). Oncotelic is developing a unique TGF-b antisense therapy which has demonstrated the ability to break immune tolerance in mid-stage clinical trials for the treatment of glioblastoma and pancreatic cancer.

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Based on terms of a non-binding letter of intent signed by both companies on January 3, 2019, MabVax and Oncotelic are entering discussions to combine the companies to form a publicly traded company focused on the development of proprietary immunotherapy-based products of both companies to diagnose and treat cancer. Under the terms of the letter of intent, Oncotelic will merge with a wholly-owned subsidiary of MabVax in an all-stock transaction and will become a wholly-owned subsidiary of MabVax. The merger is subject to the approval of the MabVax board of directors and achieving certain financing objectives and other customary conditions. Upon closing of the transaction, MabVax will be re-named Oncotelic, Inc. and will operate under the leadership of the combined Oncotelic and MabVax management teams, with Vuong Trieu, founder of Oncotelic, an experienced and successful biotechnology entrepreneur, as executive chairman. Certain current senior management team members at MabVax will remain with the merged companies to fill key operational roles.

On a pro forma basis, calculated at the close of the merger, the current MabVax stockholders will own 25% and Oncotelic stockholders will own 75% of the combined company, respectively. The merger agreement contemplates securing financing of at least $10 million simultaneous with execution of the merger to support the clinical development of Trabedersen, Oncotelic’s TGF-b antisense therapy, in both glioblastoma and pancreatic cancer trials.

Vuong Trieu, Ph.D., who will be executive chairman of the company post-merger, said, "Our goal has been to grow a strong RNA therapeutic company that leverages innate immunity to achieve durable and effective immunotherapies for solid tumors and the merger with MabVax will allow us to complement that effort with key programs and capabilities from MabVax that will significantly strengthen the effort."

David Hansen, President and CEO of MabVax, said, "Through this transaction we hope to leverage our clinical and operational expertise in the post-merger company to advance the clinical development of Trabedersen while also integrating the development of key assets discovered by MabVax. This will allow us to continue the process of realizing the maximum value of assets we have developed through a process already initiated with Objective Capital while simultaneously maximizing the value of our lead technologies for stockholders."

On December 13, 2018, MabVax announced that it had engaged Objective Capital Partners, LLC to serve as a financial advisor to assist MabVax in exploring the sale of clinical and preclinical assets of the Company with the goal of maximizing the value of these assets within the near term. MabVax’s lead monoclonal antibody product, 5B1 for the treatment of pancreatic cancer, could be one of the assets that potentially could be developed into later stage clinical trials by the combined company.

IDERA PHARMACEUTICALS TO PRESENT AT THE 37TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

On January 4, 2019 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported that the company will present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 8:30 a.m. Pacific Time (11:30 a.m. Eastern Time) at the Westin St. Francis Hotel in San Francisco (Press release, Idera Pharmaceuticals, JAN 4, 2019, View Source [SID1234532458]). Idera’s Chief Executive Officer, Vincent Milano, will present a corporate overview and outlook for 2019 during the presentation.

A live audio webcast of Idera’s presentation will be accessible in the Investors and Media section of Idera’s website at View Source An archived version will also be available on the company’s website after the event for 90 days. As a convenience to investors, a copy of the company’s presentation will be posted on the Idera corporate website at 7:30 a.m. Eastern Time on Monday, January 7, 2019.

Aura Biosciences Announces Successful Outcome of End of Phase 2 Meeting with FDA for AU-011 for the Treatment of Patients with Choroidal Melanoma

On January 4, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that it has received written confirmation from the U.S. Food and Drug Administration (FDA) regarding agreement on the design of its Phase 3 registration trials designed to evaluate light-activated AU-011 for the treatment of patients with choroidal melanoma (Press release, Aura Biosciences, JAN 4, 2019, View Source [SID1234532454]). This written confirmation is the result of successful outcome of an "End of Phase 2" meeting with the FDA.

The STARBRIGHT registration program will consist of two small identical clinical trials designed to assess the safety and efficacy of AU-011 versus sham control for the treatment of patients with small choroidal melanoma and high risk indeterminate lesions. Both trials, which will be titled STARBRIGHT1 and STARBRIGHT3, will be global, multicenter, randomized and masked, and will be conducted in parallel. The primary endpoint will be comprised of a combination of tumor control and vision preservation.

In addition to the design of the Phase 3 trials, the FDA agreed with Aura’s proposed safety database. The FDA also agreed that no further non-clinical studies are needed.

"We are pleased to have received such clear guidance from the FDA with respect to the Phase 3 STARBRIGHT program to be able to meet the scientific and regulatory requirements for marketing approval in the U.S." said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

The currently available treatments for choroidal melanoma come with the risk of severe vision loss, especially for patients with melanomas located close to the fovea or optic disk. The ongoing Phase 1b/2 study with light-activated AU-011 has shown that the drug was well-tolerated, with clear evidence of tumor control and preservation of visual acuity at long term follow up.

"We believe that a minimally invasive, non-radiation-based treatment option that enables early intervention while preserving vision has the potential to transform the therapeutic landscape for this difficult to treat, often deadly form of melanoma," said Cadmus Rich, M.D., Chief Medical Officer of Aura. "Overall, the meeting removed any remaining uncertainty on the regulatory path to approval and highlighted FDA’s commitment to guide Aura toward a potential first drug approved for patients with this highly unmet medical need."

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes to the liver in about 40-50 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

Atara Biotherapeutics to Participate in the 37th Annual J.P. Morgan Healthcare Conference

On January 4, 2019 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that Isaac Ciechanover, M.D., the Company’s President and Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 at 10:30 a.m. Pacific Standard Time (Press release, Atara Biotherapeutics, JAN 4, 2019, View Source [SID1234532447]). The conference will be held at the Westin St. Francis in San Francisco, California.

A live audio webcast of the presentation will be available by visiting the Investors and Media section of the Atara website. An archived replay of the webcast will be available on the Company’s website for 14 days following the live presentation.

Sanofi Invests EUR 80m (approx. USD 91.5m) in BioNTech as Partners Extend Collaboration and Advance mRNA-based Cancer Immunotherapy into Clinical Testing against Multiple Solid Tumors

On January 4, 2019 BioNTech AG, a rapidly growing biotechnology company developing precise and individualized immunotherapies for the treatment of cancer and the prevention of infectious diseases, reported that it has extended its research collaboration with Sanofi initiated in late 2015 and Sanofi is investing* EUR 80 million (approximately USD 91.5 million) in equity in BioNTech (Press release, BioNTech, JAN 4, 2019, View Source [SID1234532446]).

Simultaneously BioNTech has entered into an agreement with Sanofi to co-develop the first cancer immunotherapy candidate from the collaboration that is entering clinical testing in multiple solid tumors. This follows BioNTech’s decision from early 2018 to exercise one of its option rights under the 2015 research collaboration to co-develop and co-commercialize this product candidate with Sanofi.

The investigational therapy consists of an mRNA mixture encoding immunomodulatory cytokines that are injected directly into the tumor. Local administration of immunotherapies to the tumor microenvironment provides the opportunity to stimulate innate and adaptive immune responses against tumors, while potentially avoiding toxicities related to systemic administration of immuno-modulatory therapeutics.

"The extension of the research collaboration and equity investment demonstrates a deepening of our partnership with Sanofi as we seek to rapidly drive novel, disruptive programs through clinical testing to commercialization together," said Prof. Dr. Ugur Sahin, Co-Founder and CEO of BioNTech. "We are pleased that with this program we have moved from concept to clinical stage in well under three years."

"We are pleased to be initiating clinical testing of our first mRNA-based cancer immunotherapy in collaboration with our partners at BioNTech," commented Yong-Jun Liu, Global Head of Research, Senior Vice President R&D, Sanofi. "Our joint team, consisting of scientists and clinicians from both Sanofi and BioNTech, has worked tirelessly to expedite development of this new and innovative clinical candidate because targeted mRNA therapies may have the potential to be effective for cancer patients. We look forward to continuing a productive partnership with BioNTech in the years to come."