On January 12, 2022 Nirogy Therapeutics ("Nirogy" or "the Company"), a privately-held biotechnology company developing novel small molecules to target cellular transporters, reported that it has appointed life science veteran Simon Pedder, Ph.D., as Chief Executive Officer (CEO) and to the Company’s Board of Directors (Press release, Nirogy Therapeutics, JAN 12, 2022, View Source [SID1234598625]). Dr. Pedder takes over the position from the founding CEO, Vincent Sandanayaka, Ph.D., who will be transitioning to the role of President and Chief Scientific Officer (CSO). Dr. Pedder brings over 30 years of drug development and commercialization experience to Nirogy.

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"We are delighted to have Simon join us as CEO and on the Board. He brings considerable development know-how to the team at a pivotal time in the Company’s growth, as we prepare to file our first IND for our lead oncology candidate in the next 12 months," said Dennis McWilliams, a Partner at Santé Ventures and member of Nirogy’s Board of Directors. "Simon’s guidance and expertise in clinical development, regulatory processes, and the commercialization of products in the oncology and autoimmune spaces will be critical as we advance our pipeline and grow the company."

"I am thrilled to join Nirogy as it pioneers a new approach to drug development by targeting cellular transporters. The breadth of targets that Nirogy’s platform has the potential to reach is exciting as we look to develop new potential medicines to address significant unmet medical needs for people suffering from cancer and autoimmune diseases," said Dr. Pedder.

"It has been a pleasure to lead Nirogy since its inception. I look forward to focusing on the science as CSO and working with Simon to advance our new potential modality of treating cancer and autoimmune diseases," said Vincent Sandanayaka, Founder, President and CSO of Nirogy. "Simon brings a wealth of team-building and development experience that will help shepherd our company into clinical development and beyond."

Dr. Pedder joins Nirogy from Athenex Pharmaceuticals, where he served as served as Chief Business and Strategy Officer. Prior to Athenex, he was President and CEO of Cellectar Biosciences and of CEO of Chelsea Therapeutics before that. Earlier in his career, Dr. Pedder held senior leadership roles of increasing responsibility at Hoffmann-LaRoche, including as an Officer of the Company, Vice President of Oncology Pharma Business, Life Cycle Leader and Global Project Leader of Pegasys/IFN, and as global Head of the Hepatitis Franchise. Under Dr. Pedder’s leadership, he oversaw the development and commercialization of numerous global brands, such as Tasmar, Copegus, Northera, and Kliseryi and Pegasys, which became the standard of care for Hepatitis B and C for over a decade.

Dr. Pedder began his career as a faculty member in the Department of Pharmacology in College of Medicine in the University of Saskatchewan, where he obtained his Ph.D. in Clinical Pharmacology. In addition to his Ph.D. in Pharmacology, Simon obtained a Master of Science in Toxicology from Concordia University, a Joint Honors Bachelor of Science in Environmental Studies/Biology from the University of Waterloo and completed the Roche-sponsored Pharmaceutical Executive Management Program at Columbia Business School.

On January 12, 2022 Deep Lens and Hematology-Oncology Associates of Central New York (HOA CNY) reported that they have entered into a collaboration to expand the clinical trial program and improve trial matching capabilities for the upstate New York-based practice (Press release, Deep Lens, JAN 12, 2022, View Source [SID1234598642]). Deep Lens is a digital healthcare company that utilizes proprietary artificial intelligence-based technology solutions and other services to help improve efficiencies related to clinical trial recruitment and enrollment. Hematology-Oncology Associates of CNY (HOA CNY) is a private comprehensive cancer center that has been serving patients in four locations across Central New York since 1982. This partnership will expand HOA CNY’s clinical research program by increasing the breadth of trials available to patients and it will accelerate the trial matching process, enabling patients the ability to get into trials faster.

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"Clinical research has been a number one priority for our practice since our doors opened almost 40 years ago. We’ve worked hard to build and expand our clinical trial program so that all of our patients have every possible option to receive access to the newest therapies in development," said Steven Duffy, MD at HOA CNY. "We’re delighted to partner with Deep Lens – the adoption of their progressive technology and other support services will help improve the speed and accuracy of matching patients to trials and will allow our staff the ability to focus more of their time on patient care."

It is estimated that more than 15,000 oncology clinical trials are actively recruiting patients; however, fewer than 1 in 30 patients participate in a clinical trial. Limited trial site resources make it time-consuming to identify eligible patients, especially as trial protocols increase in complexity. The Deep Lens technology and other services support care teams by automating the identification of potentially eligible patients at the time of diagnosis and matching them to relevant trials in real-time.

"HOA CNY is an exceptional community-based oncology practice that already has deep relationships with leading institutions and organizations that provide them the ability to conduct and participate in clinical research," said Tyrone Richardson, vice president, provider sales for Deep Lens. "Deep Lens’ technology will add to the already-robust HOA CNY research program by bringing more trials to the practice and improving efficiencies related to the matching and enrollment process. We are thrilled to help HOA CNY support its patient community by improving access to new therapies."

Deep Lens’ VIPER will pre-screen all patients from HOA CNY’s EMR (OncoEMR) and integrate molecular data feeds from Caris Life Sciences, Guardant Health, Foundation Medicine as well as all pathology feeds to automatically identify qualified patients for clinical trials. Deep Lens’ pre-screening and clinical trial matching solution is provided at no cost to oncology practices.

Deep Lens is working with a significant number of community oncology practices representing every region in the U.S. It is estimated that approximately 85 percent of cancer patients are diagnosed and treated at local, community-based oncology practices. Deep Lens is committed to expanding important oncology research by making trials more accessible to a larger and more diverse population within these local community settings.

On January 12, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported a first patient dosed in the VITALIZE Phase 2B clinical trial (Press release, IMV, JAN 12, 2022, View Source [SID1234598626]). VITALIZE will further evaluate the clinical benefit of IMV’s lead compound, maveropepimut-S (MVP-S), in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with relapsed/refractory diffuse large B cell lymphoma (r/r DLBCL). The contribution of low dose cyclophosphamide (CPA) as an immune modulator will also be evaluated in this trial.

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"The VITALIZE study represents a critical step in advancing MVP-S toward registration," said Jeremy Graff, PhD, Chief Scientific Officer at IMV. "We believe this study should help affirm and extend our understanding of the clinical benefit previously seen in r/r DLBCL patients in the SPiReL trial and may support the use of PD-L1 as a biomarker for MVP-S in combination with KEYTRUDA. Importantly, this is an open label study, so we expect to review early data in the summer 2022."

In December 2020, results of the SPiReL study were presented at the ASH (Free ASH Whitepaper) annual meeting. In his presentation, Dr. Neil Berinstein, Principal Investigator of the SPiReL study and hematologist at Sunnybrook Health Sciences Center, describes that MVP-S in combination with KEYTRUDA induced durable clinical benefit and grade 1 or 2 adverse events. PD-L1+ patients demonstrated an objective response rate (ORR) of 75%.

About the VITALIZE Study

The VITALIZE Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess MVP-S in combination with KEYTRUDA with or without CPA. Across the arms of this study, the combination will be evaluated in up to 150 subjects with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy.

The primary endpoint is Objective Response Rate (ORR), centrally evaluated per Lugano (2014) and measured by the number of subjects per arm achieving a best response of Partial or Complete Response (PR+CR) during the 2-year treatment period. All subjects will be evaluated for their baseline PD-L1 expression. Exploratory endpoints include cell mediated immune response, tumor immune cell infiltration, and biomarker analysis.

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

On January 12, 2022 Samsung Biologics (KRX: 207940.KS) reported its sustainable growth plan for this year at the 2022 Annual JP Morgan Healthcare Conference, which is held virtually from January 10th to 13th with leaders from major pharmaceutical and biopharmaceutical companies and key investors (Press release, Samsung BioLogics, JAN 12, 2022, View Source [SID1234598643]). During the main track presentation today, John Rim, President and CEO of Samsung Biologics, addressed the company’s vision for 2022 and business goals including three core pillars of multidimensional growth plan, encompassing expanded manufacturing capacity, continued advancements in business portfolio, and greater global footprint.

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"For Samsung Biologics, 2022 will be a year where we will be able to take a great leap forward for sustainable growth and endeavor to maximize our capabilities as a leading CDMO," said John Rim, CEO of Samsung Biologics during his presentation at the conference. "Through proactive investment in increasing our manufacturing capacity, enhancing portfolio diversification, and expanding facilities in overseas, Samsung Biologics will be able to accelerate the build-up of its core success drivers as the next growth engine of the industry."

As part of its growth plan, Samsung Biologics is planning to start the construction of a new facility, Plant 5 this year where it will offer multi-modal products including cell & gene therapies and next-gen vaccines utilizing mRNA, pDNA and viral vectors, all at a single site. This will be additional to the mRNA vaccine drug substance (DS) manufacturing suite the company is currently adding to its existing facility in Songdo, which is expected to be ready for cGMP operations within the earlier part of this year.

The company is further venturing into securing additional sites within Songdo for the construction of Plant 6 and Open Innovation Center, and also overseas in multiple locations to maximize both its manufacturing capacity to produce large-scale biologics and be in close proximity to its global clients.

Samsung Biologics’ Plant 4 is currently under stable construction to be partially operational by the end of this year and the company is steadily securing pre-sales of clients. Upon the full completion of Plant 4 in 2023, the company is expected to hold a total of 620,000L of capacity, reaffirming its position as the world’s largest CDMO.

Samsung Biologics demonstrated strong operational excellence and business agility in 2021 with all Plants 1, 2, and 3 in stable operations, marking record-high financial results in two consecutive quarters. The company successfully laid a robust foundation in the mRNA business area through signing strategic partnership agreements for the manufacturing of mRNA vaccines. Samsung Biologics also launched its newest CDO process platform, S-CellerateTM, which offers an expedited process for the development and commercialization of monoclonal antibodies.

In light of the increasing importance of actions towards sustainability, Samsung Biologics issued its first annual sustainability report, consolidating the company’s policies for an enhanced ESG management system. The company was recently added to the DOW Jones Sustainability World Index (DJSI) in recognition of its commitment to ESG matters.

"The strategic roadmap and milestones outlined today illustrate the key success drivers for our growth this year as well as lay a strong groundwork for sustainable growth opportunities ahead of us," Rim added. "With our continued investment in capacity, portfolio, and global footprint, we will evolve as the top biopharmaceutical company and offer diversified services as the next growth engine of the industry."

On January 12, 2022 ICON plc, (NASDAQ: ICLR), a world-leading clinical research organisation powered by healthcare intelligence, reported its financial guidance for the year ended December 31, 2022 (Press release, ICON, JAN 12, 2022, View Source [SID1234605455]). For the full year 2022, revenue is expected to be in the range of $7,770 – $8,050 million, representing growth of 43 – 46% and adjusted earnings per share is expected to be in the range of $11.55 – $11.95, representing growth of 21 – 23%, over Full Year 2021 revenue and adjusted earnings per share guidance, respectively x. Adjusted earnings per share to exclude amortization, stock compensation, foreign exchange and transaction-related / integration-related adjustments.

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CEO Steve Cutler commented, "As the world’s largest and most comprehensive CRO, ICON is well positioned to lead the market as the healthcare intelligence partner of choice in clinical development. We saw strong demand from customers that resulted in a trailing twelve month book to bill of 1.3x and total backlog of $18.6 billion at the end of the third quarter 2021. With our solid performance in 2021 coupled with continued strength in the broader industry environment, we expect growth of 43 – 46% in revenue to a range of $7,770 – $8,050 million and adjusted earnings per share to increase by 21 – 23% to a range of $11.55 – $11.95 for the full year 2022."

The full year 2022 financial guidance assumes:

US dollar to Euro exchange rate of $1.15.
An effective tax rate of circa 16.5%.
Days Sales Outstanding of circa 25 – 30 days.
Circa $1bn free cash flow and capital expenditures of circa $150 million.
No share repurchase or M&A activity included in the above guidance.
With respect to 2021, the company reaffirmed its current guidance of revenue in the range of $5,430 – $5,530 million and adjusted earnings per share in the range of $9.55 – $9.75.