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.

On January 12, 2022 Adagene presented the Corporate Presentation (Presentation, Adagene, JAN 12, 2022, View Source [SID1234598649]).

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On January 12, 2022  OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported results from its ongoing multicenter clinical trial, PROPHETIC (Press release, OncoHost, JAN 12, 2022, View Source [SID1234598648]). These interim results confirm that through proteomic analysis of just one blood test before treatment, OncoHost’s AI platform, PROphet, can predict response to cancer treatment for non-small cell lung cancer (NSCLC) patients with remarkably high accuracy at three months, six months and one year.

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"These results are statistically and clinically significant, giving us great hope for the future of precision oncology. The value that this validation will provide, both to cancer patients and their clinicians, is insurmountable," said Dr. Ofer Sharon, CEO of OncoHost. "With just one blood test pre-treatment, we will now be empowered with a level of knowledge that is currently non-existent. Understanding the response probability trajectory for a full twelve months before treatment initiation, combined with insights on resistance associated pathways and proteins, has the potential to allow physicians to make critical clinical decisions earlier, all based on personalized patient data."

PROphet is a first-of-its-kind diagnostic platform that combines proteomic analysis with AI to predict patient response to immunotherapy and identify resistance associated processes with just one blood test pre-treatment. The device employs high-throughput protein analysis technology, scanning approximately 7,000 proteins in a patient’s plasma using the SomaScan platform by SomaLogic (NASDAQ-GM: SLGC), combined with proprietary bioinformatic and machine learning-based algorithms, to identify proteomic patterns that are predictive of patient outcome. PROphet also identifies potential drug targets, advancing the development of novel therapeutic strategies and providing clinicians with potential combination strategies to overcome treatment resistance.

With a focus on patients diagnosed with advanced stages of melanoma or non-small cell lung cancer (NSCLC) receiving immunotherapy, OncoHost’s clinical trials have shown PROphet to have high accuracy. OncoHost continues to open additional clinical trial sites around the world and will be expanding its research to further cancer indications including ovarian cancer, head and neck cancers and urogenital cancers.

The full results of the analysis will be published later this year in a peer-reviewed paper. This announcement comes ahead of OncoHost’s official launch of PROphet in 2022.

On January 12, 2022 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the first patient had been dosed in its China phase 2 study (NCT05145907) of efineptakin alfa (also known as TJ107) in combination with pembrolizumab (Keytruda) in patients with advanced solid tumors (Press release, I-Mab Biopharma, JAN 12, 2022, View Source [SID1234598647]). The study will follow a "basket" trial design to include selected tumor types, including triple-negative breast cancer (TNBC) and squamous cell cancer of the head and neck (SCCHN).

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Efineptakin alfa, the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7) developed as a T lymphocyte-booster for cancer-related immunotherapy, has distinct advantages over other cytokines such as human IL-2. Efineptakin alfa combined with immune checkpoint inhibitors, such as PD-(L)1 therapies, has a synergistic effect as it increases the number of circulating anti-tumor T cells for tumor suppression. It has been tested as monotherapy and in combination with checkpoint inhibitors to treat advanced solid tumors in the U.S., South Korea and China, with encouraging clinical results.

"As the majority of cancer patients either do not respond or respond poorly to current PD-(L)1 therapies, there are intense attempts to identify an effective agent that can work synergistically with PD-(L)1 antibodies to increase the probability of treatment success," said Professor Ye Guo, Deputy Director of Department of Oncology at Shanghai East Hospital and the principal investigator of the study. "Studies have shown that efineptakin alfa has the potential to address this unmet need. We look forward to further validating the safety and efficacy profile of efineptakin alfa in patients with solid tumors."

"The initiation of efineptakin alfa’s phase 2 study is another example that I-Mab’s pipeline is not only innovative but also mature with a majority of clinical programs being in the advanced clinical development stage," said Dr. Andrew Zhu, President of I-Mab. "Efineptakin alfa is the world’s first rhIL-7 designed to cater to the therapeutic needs of cancer patients, so we are mindful of the importance of this therapy and are committed to expediting the clinical development of a potentially transformative solution for patients in need."

I-Mab is also evaluating efineptakin alfa in another phase 2 clinical trial (NCT04600817) in lymphopenic patients with newly diagnosed glioblastoma multiforme (GBM) who have received standard concurrent chemoradiotherapy. By leveraging the two ongoing clinical studies, the Company aims to rapidly advance the clinical development of efineptakin alfa for approval in Greater China.

About Efineptakin alfa

Efineptakin alfa, also known as TJ107/GX-I7/NT-I7, is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for the discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize efineptakin alfa in Greater China. Efineptakin alfa may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. Efineptakin alfa has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

On January 12, 2022 MYND Life Sciences Inc. ("MYND" or the "Company") (CSE: MYND) (OTC: MYNDF) a biopharmaceutical research and development company creating innovative precision medicines for patients with relentless neurological diseases, reported that it has entered into Collaborative Research Agreement (the "Agreement") with the University of British Columbia ("UBC") focussing on Novel Therapies for Neurological Diseases (Press release, University Of British Columbia, JAN 12, 2022, View Source [SID1234598646]).

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MYND is creating safe and effective precision medicines based on proprietary technologies, targeting intractable diseases affecting the Central Nervous System, aiming to improve the standard of care for patients. This research seeks to test new compounds, including Psilocybins which may modify neurological diseases. Through 38 Health Canada licenses issued under their Section J exemptions of the Food and Drug Act issued to the UBC Laboratory, MYND possesses the enviable ability to examine the unique actions of analogues of Psilocybin. The focus is to develop, validate and patent the ability of Psilocybin-based drugs to modify outcomes in disease.

"We are very excited to announce our second Collaborative Research Agreement focussing on diseases of the brain," stated Dr. Lyle Oberg, MYND’s Chief Executive Officer. "We have a unique opportunity to improve the wellness and quality of life of millions of people and families torn apart by the tragedy of dementia and other debilitating diseases of the Central Nervous System. The MYND management team has a wealth of scientific, clinical and operational experience, and is well networked within the pharmaceutical industry. The Psilocybin sector is rapidly transitioning to become a pharmaceutical industry and MYND holds a unique position within the sector in terms of building upon our unique intellectual property and a valuable portfolio of related patents","

The Company has a broad development pipeline, including advancing clinical programs, such as novel biomarkers for depression and MYND is expecting results from its pivotal trial to validate these biomarkers. Through its subsidiary MYND Diagnostics INC., this includes conducting an adaptive dose finding single phase 2b clinical trial funded by the Australian Government of the efficacy and safety of psilocybin assisted psychotherapy ("PAP") in the treatment of people diagnosed with treatment resistant depression ("TRD") in collaboration with clinical researchers at Monash University. Furthermore, MYND anticipates entering clinic trials with three additional programs in the course of 2022/2023. After progressing to clinical proof of concept, MYND will continue to have the option to enter into partnerships for late-stage development and commercialization.

"We are continuing to translate our innovative approaches, while maintaining our scientific excellence," stated Dr. Wilfred Jefferies, Chief Science Officer at MYND. "We have unique technologies with differentiating potential and access to state-of-the-art facilities. This funding will allow us to accelerate our research dramatically leading to more rapid translation of our studies. This is a really exciting time for MYND and our team."

DEPARTURE OF AN OFFICER OF THE COMPANY

MYND’s Chief Operating Officer, Jordan Cleland, is moving on from the company to pursue other professional opportunities effective the end of day, January 11, 2022. Cleland was MYND’s first hire in August of 2020 and provided operations set up and support in the formative months of the company. Cleland’s duties will be assumed by Dr. Chahaat Singh who will assume the role of Operations and Research Manager with MYND. Dr. Singh has a Ph.D. in Medical Genetics, a M. Sc. In Microbiology, and brings a wealth of research experience to the position. Singh has biotech industry experience with the firms IMTech and Panacea and recently co-authored an article in the Lancet dealing with Alzheimer’s Disease. Mynd would like to thank Mr. Cleland for his dedication to the company and wishes him well in his future endeavours.