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."

On January 4, 2019 Evelo Biosciences, Inc. (NASDAQ:EVLO) ("Evelo") a biotechnology company developing monoclonal microbials, a new modality of oral biologic medicines, reported that it has dosed the first patient in its Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Evelo Biosciences, JAN 4, 2019, View Source [SID1234532478]). EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.

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This open-label clinical trial will evaluate the safety, tolerability, immune response markers, and overall response rates achieved with EDP1503 in combination with KEYTRUDA in up to 120 patients across three groups: microsatellite stable colorectal cancer; triple-negative breast cancer; and patients across multiple tumor types who have relapsed on prior PD-1/L1 inhibitor treatment.

Patients will receive daily EDP1503 monotherapy for two weeks followed by treatment with daily EDP1503 in combination with KEYTRUDA. The study will evaluate biomarkers identified from paired biopsies taken before and after the two-week run-in, as well as clinical outcomes observed over the course of the trial. Evelo expects to report initial clinical data from the trial in the first half of 2020.

"This clinical trial of EDP1503 will allow us to explore the potential synergies between EDP1503 and KEYTRUDA and offers the potential to treat multiple cancer types that are otherwise poorly responsive to checkpoint inhibitors," said Humphrey Gardner, M.D., FCAP, chief of medical oncology at Evelo.

In preclinical studies orally delivered EDP1503 shows activation of multiple clinically validated systemic immune pathways which are complementary to and potentially synergistic with checkpoint inhibitors. Effects include increased CXCL9 and CXCL10 production in the tumor microenvironment, augmentation of NK and T cell infiltration to the tumor site as well as upregulation of MHC Class I expression in tumors.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On January 4, 2019 Mersana Therapeutics, Inc., (NASDAQ:MRSN) 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, reported that after a strategic evaluation the Company will prioritize its resources to focus on the advancement of XMT-1536, a first-in-class ADC candidate targeting NaPi2b. As a result, Mersana and its partner, Takeda, plan to terminate the co-development collaboration for XMT-1522. Mersana will work with investigators to ensure that patients benefitting from XMT-1522 will continue to have access to the therapy as needed.

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"While still in early clinical development, we are encouraged with the safety, tolerability, and activity of XMT-1536 as well as the pace at which the current study is advancing. For this reason, we have decided to focus our resources on advancing XMT-1536, our first-in-class ADC candidate targeting NaPi2b, a clinically validated ADC target broadly expressed in ovarian and non-small cell lung cancer (NSCLC) adenocarcinoma, for which there remains a significant unmet medical need," said Anna Protopapas, President and CEO, Mersana Therapeutics. "We have made the difficult decision to terminate the further development of XMT-1522 despite a favorable emerging profile of efficacy and tolerability due to the competitive environment for HER2-targeted therapies."

"Looking forward, we’re very enthusiastic about our clinical progress with XMT-1536 and the expansion of our clinical pipeline," said Dirk Huebner, M.D., Chief Medical Officer, Mersana Therapeutics. "On behalf of the Company and our partner Takeda we want to thank the patients and their families for their participation in the study, as well as the investigators and our team for their diligent work on the clinical development of XMT-1522. We are committed to leveraging our proprietary ADC platforms to generate a differentiated pipeline of ADCs."

Update on XMT-1536

· XMT-1536 is a first-in-class ADC against a clinically validated target. Ovarian and non-small cell lung cancer (NSCLC) adenocarcinoma express NaPi2b and remain areas of significant unmet need. XMT-1536 has the potential to play a significant role in the treatment of these diseases.

· The data to date from the ongoing XMT-1536 dose escalation study indicate that the trial has reached clinically relevant dose levels but has not yet reached a maximum tolerated dose. The once-every-three-week regimen has been fully explored. The once-every-four-week schedule is currently being evaluated. The 20 mg/m2 dose cohort has been shown to be well tolerated and the 30 mg/m2 is currently being evaluated.

· As of December 31, 2018, the dose escalation study of XMT-1536, in multiple tumor types, includes eight heavily pretreated and evaluable ovarian cancer patients treated at clinically relevant doses. These patients are unselected for NaPi2b expression and had 3 to 11 (median 6) prior regimens in the platinum resistant or refractory setting. Of these eight patients, two achieved a partial response and the remaining six achieved stable disease. The higher dose levels currently being evaluated, as well as additional patient enrollment, provide the opportunity to further define and optimize the profile of XMT-1536.

Mersana Therapeutics 2019 Corporate Goals

XMT-1536

· The Company expects to select a dose for use in its Phase 1 expansion studies and to initiate enrollment of patients in the expansion cohorts in the first half of 2019. The expansion cohorts will focus on platinum-resistant ovarian cancer and NSCLC adenocarcinoma. The Company also plans to utilize its proprietary and validated immunohistochemistry assay to retrospectively determine NaPi2b expression to determine whether a companion diagnostic would facilitate the clinical development of XMT-1536.

· The Company plans to report Phase 1 dose escalation data in the first half of 2019.

Pipeline Expansion

· The Company expects to disclose its next clinical candidate in the second half of 2019 and is targeting the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2020.

Research and Discovery

· Mersana continues to build a pipeline of promising ADCs across a variety of tumor types with significant unmet need, leveraging its three proprietary ADC platforms (Dolaflexin, Dolasynthen, and Alkymer).

· The Company is applying its expertise in ADCs to optimize and validate Immunosynthen, a new platform designed to allow systemic delivery of a potent immunostimulatory molecule to provide optimal efficacy and tolerability.

· Mersana plans to disclose the progress of these research and discovery efforts at scientific meetings throughout the year.

Corporate Developments

· The Company is proactively evaluating the potential for strategic collaborations that maximize the value of each of its pipeline candidates and platforms.

· Mersana is focused on the continued recruitment and retention of top talent, while maintaining a culture of scientific excellence, focused execution, and patient needs.

Upcoming Events

· The Company will provide further details during its presentation at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 9, 2019 at 3:00 pm PT.

On January 4, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for ARV-110, an oral androgen receptor (AR) PROTAC protein degrader, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Arvinas, JAN 4, 2019, View Source [SID1234532476]). Arvinas expects to begin enrollment of a Phase 1 clinical trial for ARV-110 in the first quarter of this year.

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"This IND clearance is a key step forward for Arvinas and for the field of protein degradation," said John Houston, Ph.D., President and CEO of Arvinas. "Our PROTAC platform has demonstrated exciting promise in preclinical studies and represents an entirely new approach to treating patients with mCRPC and many other diseases. We hope ARV-110 will deliver a much-needed new therapeutic option for patients, and we expect to dose our first patient in the first quarter of 2019."

ARV-110 was developed using Arvinas’ proprietary technology platform – PROTAC (proteolysis-targeting chimera) protein degraders – that uses small molecules to harness the body’s own natural protein recycling system (the ubiquitin proteasome system) to selectively and efficiently remove disease-causing proteins. ARV-110 is a PROTAC protein degrader specifically designed to target and degrade AR, and has demonstrated activity in preclinical models of AR overexpression and AR mutations, which are both common resistance mechanisms to current standard-of-care agents in men with prostate cancer. The Phase 1 study will investigate the safety and tolerability of ARV-110 in patients with mCRPC who have progressed on at least two standard of care treatment regimens and includes exploratory measures of efficacy.