On November 18, 2019 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to support the initiation of a phase 1/1b clinical study of SRF617 (targeting CD39) (Press release, Surface Oncology, NOV 18, 2019, View Source [SID1234551411]). At an inaugural R&D day today, the Company will share progress across its portfolio including clinical development plans for SRF617 and SRF388 (IL-27), and preclinical data supporting its new development candidate, SRF813, which targets the recently identified checkpoint protein CD112R to promote natural killer (NK) and T cell activation.

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"We welcome this opportunity to dive into the compelling data underpinning our lead programs’ differentiated approaches to overcoming the immunosuppressive tumor microenvironment, as we work to break through and bring the benefits of immunotherapy to more patients suffering with cancer," said Jeff Goater, chief executive officer of Surface Oncology. "We look forward to furthering the incredible scientific work of our team with the initiation of our phase 1 clinical trials for both SRF617 and SRF388 in early 2020."

SRF617 is a fully human anti-CD39 antibody designed to promote anti-tumor immunity through a dual mechanism of reducing immunosuppressive adenosine and driving the extracellular accumulation of immunostimulatory ATP within the tumor microenvironment. Due to this dual mechanism, Surface Oncology believes CD39 is the most promising therapeutic target on the adenosine axis, a notable immunosuppressive pathway. The Company’s planned phase 1/1b study will evaluate SRF617 in patients with advanced solid tumors both as a monotherapy and in combination with other cancer therapies.

Surface Oncology also anticipates the filing of an IND for SRF388 before the end of 2019, with the subsequent initiation of a phase 1/1b clinical study in early 2020. The Company has identified particular tumor types, including hepatocellular and renal cell carcinoma, where IL-27 appears to play an important role in tumor progression. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388, which has the potential to be the first IL-27 targeted antibody to enter clinical trials.

"The Surface team is energized by the compelling preclinical datasets across our programs, and is excited about advancing SRF617 and SRF388 into clinical development," said Rob Ross, M.D., chief medical officer of Surface Oncology. "Both SRF617 and SRF813 have best-in-class potential related to targeting the adenosine axis and NK cells, respectively, and we believe SRF388 has the ability to inhibit the highly immunosuppressive cytokine IL-27, which gives it the potential to be a potent therapeutic. We look forward to providing clinical updates from the SRF388 and SRF617 programs in late 2020."

Surface Oncology’s preclinical data demonstrates that SRF813 increases NK and T cell activity, has strong, differentiated preclinical efficacy and promotes immunological memory. Currently, there are no

therapeutic strategies to overcome resistance to T cell checkpoint inhibitor blockade, and emerging data highlights the potential of NK cell-based therapies, such as SRF813, to overcome checkpoint inhibitor resistance.

Surface Oncology recently presented data from a number of its programs, including SRF388 and SRF617, at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD. These can be viewed on the Pipeline page of the Surface Oncology corporate website.

The R&D Day presentations and a live broadcast will be viewable from 8:15am ET at investors.surfaceoncology.com.

On November 18, 2019 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the selection of an abstract highlighting updated single agent data from the Phase 1 clinical trial evaluating the HER2-targeted bispecific antibody, ZW25, in patients with HER2-expressing solid tumors for a mini oral presentation at the ESMO (Free ESMO Whitepaper) Asia 2019 Congress, taking place November 22 – 24 in Singapore (Press release, Zymeworks, NOV 18, 2019, View Source [SID1234551427]).

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The presentation, entitled "Safety, Anti-Tumor Activity, and Biomarker Results of the HER2-Targeted Bispecific Antibody ZW25 in HER2-Expressing Solid Tumors," is scheduled for Friday November 22 at 3:30 pm SGT (local Singapore Time) during the mini oral session Developmental and Precision Medicine in room 311. The presentation number is 61O.

About the Phase 1 Clinical Trial

Zymeworks’ Phase 1 study has three parts. From part one of the study (the dose-escalation phase), the recommended single-agent dose was determined to be 20 mg/kg once every two weeks or 10 mg/kg weekly. In the second part of the study (the cohort expansion phase), additional patients are being enrolled to further assess ZW25’s single-agent tolerability and anti-tumor activity against a variety of cancer types in different settings. The third part of the study (the combination phase) is underway and evaluating ZW25 in combination with selected chemotherapy agents in gastroesophageal and breast cancer patients with HER2 high or lower HER2 expression levels. More information about ZW25 clinical trials can be found at clinicaltrials.gov.

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2. The FDA has granted Fast Track designation to ZW25 for first-line gastroesophageal adenocarcinoma in combination with standard of care chemotherapy and Orphan Drug designation to ZW25 for the treatment of both gastric and ovarian cancers.

On November 18, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that the ninth and final patient was recruited to the phase Ia study of MIV-818 in patients with advanced liver cancer (Press release, Medivir, NOV 18, 2019, View Source [SID1234551443]). Based on data from phase Ia, the initial dose of MIV-818 for the phase Ib study has been determined at 200 mg / week. The dosage is given as 40 mg / day for five days.

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The phase I study with MIV-818, evaluating safety, tolerability and pharmacokinetics, consists of two parts: Phase Ia is an interpatient study while phase Ib has a classic 3 + 3 intrapatient dose-escalating design. A recommended dose for phase II will be based on the data in the phase Ib study. Medivir has previously reported that the intended liver-directed effect of MIV-818 could be verified already in the analysis of data from the first six patients. Efficacy data from the complete phase Ia study will be presented next year at a scientific conference.

"The initial data observed in the phase I study support our view that MIV-818 has the potential to provide a clear and much needed improvement in treatment for patients with liver cancer," said Dr. Uli Hacksell, CEO of Medivir. "MIV-8I8 is the most advanced drug candidate in a series of proprietary and wholly owned prodrugs that we intend to develop for the treatment of various cancer indications."

For further information, please contact:

Uli Hacksell, CEO
Medivir AB
phone: +46 (0)8 5468 3100

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer. A phase I study in patients with liver cancer is ongoing.

About liver cancer

Liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC are capable of extending the lives of patients, treatment benefits are low while death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without specific mutations seen in other tumor types. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On November 18, 2019 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the extension of the expiration date of the offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") any and all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc (Press release, AbbVie, NOV 18, 2019, View Source [SID1234551412]). ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (the "Allergan Notes") for new notes to be issued by AbbVie (the "AbbVie Notes") and the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes. AbbVie hereby extends such expiration date from 11:59 p.m., New York City time, on November 22, 2019 to 5:00 p.m., New York City time, on December 31, 2019 (as the same may be further extended, the "Expiration Date").

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On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture. Such supplemental indentures will become operative only upon settlement of the Exchange Offers.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the "Acquisition") and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended hereby (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and the Expiration Date of each of the Exchange Offers is expected to be extended to occur on or about the closing date of the Acquisition, which is expected to occur in early 2020. As a result, the Expiration Date may be further extended one or more times. AbbVie currently anticipates providing notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on November 15, 2019, the principal amounts of Allergan Notes set forth in the table below were validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Allergan Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" as defined in Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), or not a "U.S. person" and outside the United States within the meaning of Regulation S under the Securities Act. Except as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the Offering Documents, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-3900 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source

This news release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the Offering Documents and only to such persons and in such jurisdictions as are permitted under applicable law.

The AbbVie Notes offered in the Exchange Offers have not been registered under the Securities Act or any state securities laws. Therefore, the AbbVie Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and any applicable state securities laws.

On November 18, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported the appointment of Badrul Chowdhury, M.D., Ph.D., to the newly created position of Chief Medical Officer (CMO), effective immediately (Press release, Savara, NOV 18, 2019, View Source [SID1234551428]). Dr. Chowdhury will be Savara’s senior physician overseeing the medical and regulatory strategy of the Company’s investigational programs from late-stage development through to approval. He will also provide oversight of medical affairs and patient safety across the portfolio.

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Dr. Chowdhury joins Savara from AstraZeneca, where he was Senior Vice President, Chief Physician-Scientist for Respiratory, Inflammation, and Autoimmunity Late Stage Development, in Biopharmaceuticals R&D. For 16 years prior to that, Dr. Chowdhury served as Director, Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) where he provided scientific and regulatory oversight of both common and rare diseases such as asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, rheumatoid arthritis, systemic lupus erythromatosis, and various autoimmune and inflammatory diseases. Dr. Chowdhury is a medical doctor, and also holds a Ph.D. in Immunology. He completed Internal Medicine residency training from the Wayne State University School of Medicine, Detroit, Michigan, and Fellowship training in Allergy and Immunology from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, Maryland. He is double board certified in Internal Medicine and Allergy and Immunology.

Over the course of his career, Dr. Chowdhury has been a member of many committees within the FDA, NIH, World Health Organization (WHO), United Nations Environmental Programme (UNEP), and the American Academy of Allergy, Asthma, and Immunology (AAAAI). Additionally, he has published scientific articles in more than 60 peer-reviewed scientific and medical journals and has been bestowed numerous research, academic, and service awards/honors.

"It is with great enthusiasm that we welcome an accomplished regulatory strategist, Dr. Chowdhury, to the role of CMO," said Rob Neville, Chief Executive Officer, Savara. "His appointment comes at a critical time as we continue discussions with the FDA and EMA on the best path forward for the Molgradex aPAP program. With two decades of regulatory leadership experience at the FDA’s Pulmonary Division, where he presided over numerous approvals of medicines for pulmonary and orphan diseases, Dr. Chowdhury brings a unique perspective to the Company and we believe he will be instrumental in helping us achieve our goals."

"As a physician and researcher with a passion for addressing significant unmet needs in pulmonary diseases, I am excited to join the Savara team," said Dr. Chowdhury. "I am inspired by the Company’s dedication to becoming THE orphan lung disease company, spearheaded by the Molgradex aPAP program. After reviewing the clinical data from the Phase 3 IMPALA study, I believe that Molgradex can provide a meaningful therapy for these patients. I look forward to working with the executive team to navigate the regulatory pathway for Molgradex in aPAP and the Company’s other pipeline programs."