On January 8, 2018 Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, reported the successful completion of its previously announced acquisition of The Medicines Company’s (NASDAQ: MDCO) infectious disease business (Press release, Cempra, JAN 9, 2018, View Source [SID1234523042]).

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"The completion of this acquisition marks yet another milestone in what has been a very exciting time for Melinta as we focus on creating the leading pure-play antibiotics company," said Dan Wechsler, President and CEO of Melinta. "The combination of our two companies gives us a world-class infectious disease portfolio led by renowned experts in antibiotics discovery, development, and commercialization. We are eager to build upon our synergies and leverage our collective expertise and scale to offer patients and providers battling serious bacterial infections with additional life-saving treatment options."

Expanded Portfolio and Pipeline

The close of the acquisition solidifies Melinta’s position as the world’s largest pure-play antibiotics company, and expands upon the company’s existing product Baxdela (delafloxacin) by adding three additional marketed products to its portfolio: Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Minocin (minocycline) for Injection.

Melinta’s existing portfolio of approved medicines has peak combined sales potential of more than $1 billion. As the new Melinta moves into its next stage of growth, the company will focus on seamless continuity of additional clinical studies designed to enhance and expand the potential for its four marketed products.

Strong Combined Commercial Capabilities

The close of the acquisition will also allow the company to deploy its expanded sales force cross-portfolio to increase efficiencies and drive incremental value, and deepen its global relationships with both new and existing partners.

Melinta also announced that The Medicine Company’s Mike McGuire has joined the new organization’s leadership team as Senior Vice President, Commercial. He replaces Melinta Chief Commercial Officer, John Temperato, who left the company to pursue other opportunities. McGuire, who reports to Dan Wechsler, has over 25 years of commercial experience in launching and commercializing antibiotics.

The combined company has a broad global footprint with potential to expand and a novel proprietary discovery platform that make it the leading pure-play antibiotics company from discovery to commercial.

The company’s President and Chief Executive Officer Dan Wechsler will present additional details on the company’s strategic priorities post-close at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA from January 8-11, 2018. Melinta’s presentation will take place on Wednesday, January 10, 2018 at 10:30 am Pacific Time.

A webcast of the presentation can be accessed on the investor page of Melinta’s website at View Source A replay of the webcast will also be archived on Melinta’s website following the conference.

On January 9, 2018 BeiGene, Ltd. (NASDAQ: BGNE) and Boehringer Ingelheim Biopharmaceuticals (China) Ltd. reported that the two companies have entered into a commercial supply agreement for tislelizumab, BeiGene’s investigational anti-PD-1 antibody (Press release, Boehringer Ingelheim, JAN 9, 2018, View Source [SID1234523038]). Tislelizumab will be manufactured in Boehringer Ingelheim’s world-class biopharmaceutical manufacturing facility in Shanghai as part of a Marketing Authorization Holder (MAH) trial project pioneered by BeiGene and Boehringer Ingelheim.

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"As we advance tislelizumab towards potential regulatory approval and commercialization in China, we are pleased to have secured our commercial product supply from Boehringer Ingelheim BioXcellence, one of the world’s leading biopharmaceutical contract manufacturers. Over the years, working with the Boehringer Ingelheim team for our clinical supply, we have built a strong partnership based on a shared commitment to providing high-quality medicine to patients," said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. "In addition to working with Boehringer Ingelheim, we are also building our manufacturing facility for biologics commercial supply in Guangzhou, China, in a joint venture with the Guangzhou Development District, that we expect will further expand our capacity to meet anticipated demand for tislelizumab and other biologics in our pipeline."

Under the terms of the supply agreement, Boehringer Ingelheim will manufacture tislelizumab in China under an exclusive multi-year arrangement, with contract extension possible. In addition, BeiGene also obtained certain preferred rights for future capacity expansion by Boehringer Ingelheim in China.

"The agreement marks the first biopharmaceutical MAH trial project entering into commercial supply in China," said Dr. Jiali Luo, General Manager of Boehringer Ingelheim Biopharmaceuticals (China) Ltd. "Boehringer Ingelheim is focused on manufacturing innovative therapeutics to treat unmet medical needs of patients around the world. We are confident that our quality competence and contract manufacturing capabilities are best-in-class, and excited to plan for the commercial supply of tislelizumab, which has the potential to help patients with a broad array of cancers as both a monotherapy and in combination with other therapies."

About Tislelizumab (BGB-A317)
Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

On January 9, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that the company, along with its partner Ipsen, will host a live briefing event for the financial community to discuss data presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) (Press release, Exelixis, JAN 9, 2018, View Source;p=RssLanding&cat=news&id=2325694 [SID1234523039]). The webcast event will be held following the closing of the ASCO (Free ASCO Whitepaper)-GI day’s sessions on Friday, January 19, 2018, beginning at 9:30 p.m. EST / 6:30 p.m. PST (local San Francisco time).

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During the briefing, Exelixis and Ipsen management, along with an invited guest, will discuss and provide context for the cabozantinib clinical data presented earlier that day at the Symposium. Exelixis previously announced that detailed results from the CELESTIAL trial will be the subject of a late-breaking oral presentation at ASCO (Free ASCO Whitepaper)-GI. CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib versus placebo in patients with advanced hepatocellular carcinoma who have received prior treatment with sorafenib.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 2478857 to join by phone.

A webcast replay will be archived on www.exelixis.com for one year. A telephone replay will also be available until 11:59 p.m. EST on January 26, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 2478857.

On January 9, 2018 BeiGene, Ltd. (NASDAQ:BGNE) and Boehringer Ingelheim Biopharmaceuticals (China) Ltd. reported that the two companies have entered into a commercial supply agreement for tislelizumab, BeiGene’s investigational anti-PD-1 antibody (Press release, BeiGene, JAN 9, 2018, View Source;p=RssLanding&cat=news&id=2325746 [SID1234523037]). Tislelizumab will be manufactured in Boehringer Ingelheim’s world-class biopharmaceutical manufacturing facility in Shanghai as part of a Marketing Authorization Holder (MAH) trial project pioneered by BeiGene and Boehringer Ingelheim.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"As we advance tislelizumab towards potential regulatory approval and commercialization in China, we are pleased to have secured our commercial product supply from Boehringer Ingelheim BioXcellence, one of the world’s leading biopharmaceutical contract manufacturers. Over the years, working with the Boehringer Ingelheim team for our clinical supply, we have built a strong partnership based on a shared commitment to providing high-quality medicine to patients," said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. "In addition to working with Boehringer Ingelheim, we are also building our manufacturing facility for biologics commercial supply in Guangzhou, China, in a joint venture with the Guangzhou Development District, that we expect will further expand our capacity to meet anticipated demand for tislelizumab and other biologics in our pipeline."

Under the terms of the supply agreement, Boehringer Ingelheim will manufacture tislelizumab in China under an exclusive multi-year arrangement, with contract extension possible. In addition, BeiGene also obtained certain preferred rights for future capacity expansion by Boehringer Ingelheim in China.

"The agreement marks the first biopharmaceutical MAH trial project entering into commercial supply in China," said Dr. Jiali Luo, General Manager of Boehringer Ingelheim Biopharmaceuticals (China) Ltd. "Boehringer Ingelheim is focused on manufacturing innovative therapeutics to treat unmet medical needs of patients around the world. We are confident that our quality competence and contract manufacturing capabilities are best-in-class, and excited to plan for the commercial supply of tislelizumab, which has the potential to help patients with a broad array of cancers as both a monotherapy and in combination with other therapies."

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

On January 9, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and the Parker Institute for Cancer Immunotherapy reported that they have entered into a clinical collaboration agreement that provides for Inovio and the Parker Institute to undertake clinical evaluation of novel combination regimens within the field of immuno-oncology (Press release, Inovio, JAN 9, 2018, View Source [SID1234523036]). The goal of the partnership is to design innovative studies that have the potential to address cancers with high unmet need. The initial trial under consideration between Inovio and the Parker Institute would address muscle invasive bladder cancer with INO-5401 in combination with checkpoint inhibitors and immune modulators.

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Under the agreement, the Parker Institute will have responsibility for clinical study execution, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers. Based on Parker’s novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio’s product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

The collaboration with Inovio represents the Parker Institute’s first agreement within the field of DNA-based Immunotherapeutics. Inovio will benefit from the Parker Institute’s innovative research model which brings together top academic cancer institutions and companies to share resources, data, and technology, accelerate research through unifying and managing clinical trial design, and conduct multi-center clinical trials.

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "We thank the Parker Institute for their confidence in our technology. This partnership aligns with our goal to address cancer with our ASPIRE immunotherapies. Through the Parker Institute’s unique business model, Inovio will be able to work with university research pioneers and combination oncology therapy partners while leveraging the Institute’s unique capabilities and expertise."

"This collaboration between the Parker Institute and Inovio exemplifies the mission of the Parker Institute for Cancer Immunotherapy to unlock the promise of immunotherapy by rapidly progressing next generation treatments into clinical trials," said Fred Ramsdell, PhD, Vice President, Research, Parker Institute for Cancer Immunotherapy. "If this collaboration leads to better cancer patient responses to immunotherapy, this would mark an important milestone for the field."

In addition to the work with the Parker Institute, Inovio also is collaborating to advance two immuno-oncology products through late-stage development for treatment of HPV-related cancers, advanced bladder cancer, and GBM. The products are being studied in combination with checkpoint inhibitors, in collaboration with Medimmune, Genentech, and Regeneron respectively.

About Inovio’s ASPIRE Immunotherapy Technology Platform

Inovio is advancing the medical potential of a unique class of immunotherapy technology. Its ASPIRE (Antigen SPecific Immune REsponses) immunotherapies platform, which is the foundation for all of Inovio’s products is unique in its ability to leverage the body’s naturally existing mechanisms to generate robust, highly targeted immune responses to prevent and treat disease – and to do so in the body without harmful side effects. Its SynCon immunotherapy design and CELLECTRA delivery transform novel genetic blueprints into functional antibody and killer T cell responses. Inovio was the first to report the activation – in the body – of significant, antigen-specific functional T cells correlated to statistically significant efficacy in a placebo-controlled, randomized, double-blind phase 2b clinical trial (HPV-related pre-cancer), with a very favorable safety profile. These data were published in The Lancet and independently described as a "major breakthrough" in the field by U.S. National Cancer Institute scientists. Inovio has achieved significant antigen-specific immune responses against multiple diseases and is advancing a growing pipeline of cancer and infectious disease immunotherapies and vaccines.