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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.

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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webcast of Idera’s presentation will be accessible in the Investors and Media section of Idera’s website at View Source An archived version will also be available on the company’s website after the event for 90 days.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."

Entry into a Material Definitive Agreement.

On January 4, 2019 Alder BioPharmaceuticals, Inc. reported that it has entered into a Distribution Agreement (the "Distribution Agreement") with J.P. Morgan Securities LLC, as our sales agent (the "Sales Agent"), pursuant to which we may offer and sell from time to time through the Sales Agent up to $100,000,000 maximum aggregate offering price of our common stock, par value $0.0001 per share ("Common Stock"), in such amounts as we may specify by notice to the Sales Agent, in accordance with the terms and conditions set forth in the Distribution Agreement (Filing, 8-K, Alder Biopharmaceuticals, JAN 4, 2019, View Source [SID1234532445]).

Sales, if any, of the Common Stock pursuant to the Distribution Agreement may be made in negotiated transactions or transactions that are deemed to be "at-the-market" offerings as defined in Rule 415 under the Securities Act, including sales made directly on the Nasdaq Stock Market, or sales made to or through a market maker other than on an exchange. Under the Distribution Agreement, we will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. We are not obligated to sell any Common Stock under the Distribution Agreement. The Common Stock will be offered and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-216199) which was automatically effective upon filing with the Securities and Exchange Commission on February 23, 2017. We may terminate the Distribution Agreement upon written notice to the Sales Agent for any reason or by the Sales Agent upon written notice to us for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in our company.

The Distribution Agreement contains customary representations, warranties and agreements by us, and indemnification rights and obligations of the parties. The Distribution Agreement provides that the Sales Agent will be entitled to compensation for its services equal up to 3.0% of the gross sales price per share of all shares sold through the Sales Agent under the Distribution Agreement. Under the terms of the Distribution Agreement, we have agreed to indemnify the Sales Agent against certain specified types of liabilities, including liabilities under the Securities Act of 1933, as amended, to contribute to payments the Sales Agent may be required to make in respect of these liabilities, and to reimburse the Sales Agent for certain expenses. In the ordinary course of business, the Sales Agent or their respective affiliates from time to time have provided and may in the future provide various investment banking, commercial banking and financial advisory services to the company and/or its affiliates, for which they have received or may receive customary compensation.

We intend to use the net proceeds from the sale, if any, of the securities offered in the offering for the commercialization of eptinezumab up to and through launch and the manufacture of commercial supply for eptinezumab, and may also use net proceeds for future eptinezumab clinical trials, the development of ALD1910 and for working capital and general corporate purposes.

The above summary of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the Distribution Agreement, a copy which is attached as Exhibit 1.1 to this Current Report on Form 8-K and incorporated herein by reference. The legal opinion of Cooley LLP relating to the shares of Common Stock being offered pursuant to the Distribution Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.