On January 4, 2019 KalGene Pharmaceuticals Inc., a biotechnology company developing therapeutics to slow the progression of Alzheimer’s disease, reported the appointment of James Callaway, Ph.D. as chief executive officer, effective immediately (Press release, KalGene Pharma, JAN 4, 2019, View Source [SID1234532493]).

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"This has been a very important transition year as we have confirmed our initial thesis with respect to validating the company’s lead KG207, which in pre-clinical studies was shown to successfully cross the blood brain barrier and safely reduce plaque load. The company has successfully completed early toxicology studies and has carried out all the requisite steps to manufacture product," said Dr. Jacki Jenuth, Chairperson of the Kalgene’s board of directors. "We are very pleased to have executed on the next key step of our strategy in attracting an accomplished new CEO to the company as we leverage this foundation and address significant inbound interest for the company and its lead program. Jim brings an ideal set of leadership skills and domain expertise to guide the team through the transition from a pre-clinical to a clinical stage company."

"KG207 has shown exceptional potential in pre-clinical studies, and I am excited about the prospect of bringing such a promising compound into the clinic," Dr. Callaway commented. "I look forward to working with the savvy and talented team at KalGene as we strive to make a difference in the lives of individuals affected by Alzheimer’s disease."

Dr. Callaway has over three decades of biopharmaceutical development experience, primarily targeting CNS therapeutics, and has served most recently as CEO for two privately-held biotech companies. As the CEO of ArmaGen, he brought its products from the laboratory to the clinic, helping the company emerge as the first to demonstrate the ability of engineered biologics to cross the blood-brain barrier. In addition, Dr. Callaway led the Alzheimer’s immunotherapy program at Elan Pharmaceuticals, which became the first company to introduce disease-modifying biologics (e.g., AN1792, bapinuzumab, ACC001) into clinical studies. Dr. Callaway has filed and defended numerous NDAs and INDs during his career, including shepherding the approval of MyoBloc and the production of Tysabri. He previously served in senior development roles at Bayer Pharmaceuticals, SmithKline Beecham (GSK), and InGene (since acquired by Xoma Corporation). He holds a Ph.D. in Biological Chemistry from UCLA, with a focus on peptide chemistry

On January 4, 2019 Synaffix B.V. reported it has entered into a license agreement with Mersana Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet need (Press release, Synaffix, JAN 4, 2019, View Source [SID1234532485]). This agreement provides Mersana access to Synaffix’s industry-leading site-specific GlycoConnect ADC technology that has consistently demonstrated an ability to improve both the safety and the efficacy profiles of ADC product candidates. Synaffix is eligible to receive upfront and milestone payments on a per-target basis with a projected total deal value of $295 million, plus royalties­­.

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Under the terms of the agreement, Mersana has been granted a non-exclusive license to incorporate GlycoConnect into one of its ADC development candidates, as well as an option to expand to additional programs. This agreement follows a research collaboration between the two companies that was centered around multiple product candidates.

"After evaluating several site-specific conjugation platforms, we have chosen Synaffix’s GlycoConnect technology for use in future ADC candidates," said Anna Protopapas, President and Chief Executive Officer of Mersana. "We are excited about the potential of this technology as it is designed not to require additional antibody engineering or cell-line modifications, which would offer us the potential to create site-specific antibodies for use in our ADCs when required."

"We are particularly excited to enter into this agreement with a leading company in the field of ADCs such as Mersana," said Peter van de Sande, CEO of Synaffix, who added "This collaboration is another testimony of the additional value that GlycoConnect is able to provide to already cutting-edge ADC technologies, thereby enabling novel medicines that are uniquely positioned to address areas of unmet medical need."

Per the agreement, Mersana is responsible for the research, development, manufacturing and commercialization of any resulting ADC product while Synaffix will supply components that are specifically related to its proprietary GlycoConnect technology.

About GlycoConnect

The proprietary GlycoConnect technology of Synaffix is a platform ADC technology that utilizes proprietary enzymes and metal-free click conjugation to stably attach ADC payloads specifically to the native glycan of any antibody, a privileged site for ADC applications. This approach can be applied directly to an existing antibody without any DNA and or protein engineering and is compatible with all ADC payload classes. The growing experience of Synaffix and its collaboration partners continues to confirm the ability of GlycoConnect to consistently generate ADCs that are more effective and better tolerated when compared to the three major clinical-stage ADC conjugation technologies.

On January 4, 2019 Triumvira Immunologics Inc., reported that it will present at Biotech Showcase 2019, to be held January 7–9, during the most important week for healthcare investors at the Hilton San Francisco Union Square (Press release, Triumvira Immunologics, JAN 4, 2019, View Source [SID1234532484]).

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Paul Lammers, MD, MSc, President and Chief Executive Officer, will present at Biotech Showcase as follows:

Date: Monday, January 7, 2019
Time: 1:45PM (PST)
Room: Franciscan D, Level Ballroom
Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street, San
Francisco, CA (United States)
Presentation: Triumvira Immunologics Company Overview and Progress in Key Programs/Technology

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

"We are delighted that Triumvira Immunologics will be presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is the perfect platform for life science companies to showcase their innovation and seek out their next deal. We are thrilled to, once again, be hosting what we believe will be the great strategic networking opportunity of 2019."

About Biotech Showcase
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week which sets the tone for the coming year. Now in its eleventh year, this rapidly growing conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high-quality programs that support the biotechnology and broader life sciences industry.

On January 4, 2019 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it’s needed most, reported that Chief Executive Officer David Kalergis will join investors, executives, civic leaders, and scientists to present at the 37th Annual J.P. Morgan Healthcare Conference on Monday, January 7, 2019 at 7:00pm EST/4:00pm PST (Press release, Diffusion Pharmaceuticals, JAN 4, 2019, View Source [SID1234532482]). The Conference will be held on January 7-10, 2019 at the Westin St. Francis Hotel in San Francisco, California.

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"Advancements in the biotechnology, pharmaceutical, and medical industries don’t happen in a vacuum; they require collaboration between investors, scientists, and business leaders," said David Kalergis, Chairman and CEO of Diffusion. "Diffusion was founded in that same spirit of collaboration, and at the 37th Annual J.P. Morgan Healthcare Conference, we’ll have the opportunity to share our progress with an even larger audience of leaders who can potentially work with us to fuel life and fight deadly conditions such as cancer and stroke."

The "largest and most informative healthcare investment symposium in the industry," the J.P. Morgan Healthcare Conference brings together "industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community." Over 9,000 attendees and representatives from over 450 public and private companies have had the chance at past conferences to hear from speakers including Bill Gates, Vice President Joe Biden, and CEO of 23andMe Anne Wojcicki. To listen to Mr. Kalergis’s presentation live, you can go to the Investor Relations section of the Diffusion Pharmaceuticals website at www.diffusionpharma.com. An archived webcast of the presentation will also be available on the Company’s website for a period of time.

On January 4, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported that its CEO Daniel J. Abdun-Nabi will be retiring and that its board of directors has unanimously appointed Robert G. Kramer, Sr., the company’s current president and COO, to succeed him as president and CEO, effective April 1, 2019 (Press release, Emergent BioSolutions, JAN 4, 2019, View Source;p=RssLanding&cat=news&id=2382140 [SID1234532481]). Mr. Abdun-Nabi has also indicated that he plans to step down as a member of the Emergent board of directors, and Emergent expects the board of directors to appoint Mr. Kramer to fill the board vacancy created by Mr. Abdun-Nabi’s retirement.

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Since becoming CEO in April 2012, Mr. Abdun-Nabi has forged a strong company culture of leadership, innovation, and social responsibility while expanding Emergent’s business to address some of the most critical public health threats of concern to the United States and other countries across the globe. Key accomplishments during his tenure position the company for continued near- and long-term growth and include:

Developing a compelling corporate vision and achieving a significant vision metric of protecting and enhancing 50 million lives by 2025, seven years ahead of plan;
Acquiring five revenue-generating businesses, as well as multiple platform technologies and products in development;
Expanding Emergent’s product offerings from one to 11 to include dual-market products that are marketed and procured by government and commercial customers globally;
Building a strong and diversified product development pipeline of more than 15 product candidates addressing a spectrum of public health threats;
Growing the company’s global footprint to 19 locations, eight of which are manufacturing facilities located in the United States, Canada and Europe;
Establishing a company reputation of social responsibility recognized for corporate philanthropy and contributions to local communities;
Driving strategic plans that grew total revenue by 280 percent, from $282 million in 2012 to an estimated total revenue of approximately $800 million in 2018, and expected to exceed $1 billion in 2019, one year ahead of plan; and
Realizing a market capitalization of $3 billion and shareholder return of approximately 292.29 percent(1), significantly outperforming key indices, including the S&P 500 (105.05%), Dow Jones Industrial Average (108.60%) Nasdaq Biotech (143.26%) and Russell 2000 (78.25%) among others, over that same period.
Fuad El-Hibri, founder and executive chairman of the board of directors stated, "On behalf of the board of directors, I thank Dan for his visionary leadership as CEO during a period in which the company achieved significant growth and strong financial performance. His laser focus on developing and implementing successive strategic growth plans to advance the company’s mission ― to protect and enhance life ― has transformed the company from a primarily biodefense company to a global, diversified life sciences company. The company has never been stronger ― Dan’s ability to make strategic investments to drive growth, while achieving consistent financial performance, leaves the company well-positioned for future success. We will miss Dan and wish him all the best."

Commenting on the transition, Mr. Abdun-Nabi said, "It has been my great honor to have contributed to Emergent’s 20-year history of leadership delivering products to protect those vulnerable to public health threats. And, it has been a great privilege to lead and serve a tremendously talented team of employees. I am confident that our efforts to realize our vision to be a Fortune 500 company recognized for protecting and enhancing life, driving innovation, and living our values will continue unabated under Bob’s leadership."

Regarding the appointment of Mr. Kramer, Mr. El-Hibri said, "The election of Bob is the result of our succession planning process. Bob has been a committed leader since he first joined the company in 1999 as chief financial officer. As president and COO, Bob has an extensive and thorough knowledge of all aspects of the company’s operations. The board is continually impressed with his ability to act decisively and strategically in the company’s best interests, making him uniquely qualified to step into this role. The board has every confidence in Bob’s ability to further advance growth and a flourishing culture of innovation and engagement across the business."

Mr. Kramer stated, "I am deeply honored to take the company’s helm and continue driving towards achieving Dan’s inspiring vision. Building on the tremendous momentum we have gained from executing on successive strategic growth plans, I look forward to leading an incredibly talented, experienced team as we continue to broaden our reach into the public health threats market, strengthen our portfolio of unique products, serve our customers and partners, generate shareholder value, and fulfill our mission – to protect and enhance life."