On September 5, 2022 Center for Translational Research CTR reported that it is a group of complementary life science service companies providing expert services and advice within product development (Press release, Symeres, SEP 5, 2022, View Source [SID1234618992]). The services provided by Admescope Sweden/Metasafe complements well the current offerings and will contribute to a more seamless development process bringing value for our customers.

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Metabolites in safety testing (MIST studies) is a natural component of the early clinical development program and thereby fits very well with the services provided by the CTR-group. By this transfer, the expansion of CTR continues to build on combining key competencies and technologies with the capability to cover projects from pre-clinical to market approval.

The collaboration between the CTR-group and Admescope and Symeres will further strengthen the access to key competences and techniques in pre-clinical development.

The activities will continue without interruption and with the same staff, in the same facilities, using the same instrumentation. Johanna Haglund, Business Development Scientist and Head of Safety Metabolism, will lead the team.

Karin Meyer, CEO at CTR says: "Through the transfer of Admescope Sweden/Metasafe to our group we will be able to offer a more integrated approach and develop the services for our customers using the talented staff and facilities in the human metabolite profiling and characterisation area. We look forward to the collaboration with Admescope and Symeres, aiming for a more complete solution for several projects."

Outi Kontkanen, CEO Admescope says: "Admescope, as part of Symeres, continues to focus on delivering tailored solutions in non-clinical ADME support and toxicology, with strategic investments to further expand our services in these areas globally. We look forward to continued collaborations with the CTR group and are pleased that our talented MIST-team has a new home where it fits to the clinical drug development landscape."

Symeres CEO Eelco Ebbers comments: "With this transfer we will have a very logical consolidation of our ADME services at two sites, namely Nijmegen in the Netherlands and Oulu in Finland which allows us to focus our development investments. Symeres looks forward to further collaboration with CTR which will strengthen our access to key competences and techniques in pre-clinical development."

On September 5, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a poster presentation titled: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Lung Cancer (NSCLC) (Press release, Spectrum Pharmaceuticals, SEP 5, 2022, View Source [SID1234618991]). The poster will be presented at the upcoming European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2022 that will take place in Paris from September 9-13, 2022.

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Details of the ESMO (Free ESMO Whitepaper) poster presentation are as follows:

Title: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Lung Cancer (NSCLC)
First Author: Xiuning Le, M.D., Ph.D., Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston
Location: Hall 4
Date: Monday, September 12, 2022
Presentation Number: 1172P

The poster will be available for viewing by registered participants during the conference via the ESMO (Free ESMO Whitepaper) website on September 10, 2022. It will also be available on the Investor Relations section of the company’s website at View Source

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. HER2 exon 20 insertion mutations are a rare subset accounting for approximately 2-4% in NSCLC. There is no approved therapy specifically for either treatment-naïve or previously treated NSCLC with HER2 exon 20 insertion mutations. The company holds an exclusive license from Hanmi Pharmaceutical to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.

On September 5, 2022 CVS Health (NYSE:CVS) and Signify Health (NYSE: SGFY) ("Signify") reported that they have entered into a definitive agreement under which CVS Health will acquire Signify Health for $30.50 per share in cash, representing a total transaction value of approximately $8 billion (Press release, Signify Health, SEP 5, 2022, View Source [SID1234618990]).

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Signify Health is a leader in Health Risk Assessments, value-based care and provider enablement. With a network of more than 10,000 clinicians across all 50 states and a nationwide value-based provider network, combined with its proprietary analytics and technology platforms, Signify Health is improving patient engagement, patient outcomes and care coordination for stakeholders across the health care system. Signify Health’s clinicians and providers can have an even greater impact by engaging with CVS Health’s unique collection of assets and connecting patients to care how and when they need it.

"Signify Health will play a critical role in advancing our health care services strategy and gives us a platform to accelerate our growth in value-based care," said CVS Health President and CEO, Karen S. Lynch. "This acquisition will enhance our connection to consumers in the home and enables providers to better address patient needs as we execute our vision to redefine the health care experience. In addition, this combination will strengthen our ability to expand and develop new product offerings in a multi-payor approach."

Signify Health’s network of clinicians – physicians, nurse practitioners and physician assistants – utilize home-based visits to identify a patient’s clinical and social needs, and then connect them to appropriate follow-up care and community-based resources in order for the patient to have a more connected, effective care experience. In 2022, Signify Health’s clinicians expect to connect with nearly 2.5 million unique members in the home, both in-person and virtually, and on average they spend 2.5 times longer with a patient in the home than providers spend in the average primary care office visit.

Notably, since acquiring Caravan Health in March 2022, Signify Health has further expanded its focus on value-based care and population health. Today, Caravan is already a partner to over 170 providers participating in accountable care organizations (ACOs) serving Medicare beneficiaries with a focus on improving the health of underserved communities. Signify Health recently announced that its ACOs generated more than $138 million in gross savings in 2021, and in 2023 the Caravan business is expected to serve ACOs representing over 700,000 people – rivaling many standalone platforms. As part of CVS Health, Signify Health will continue to advance its extensive primary care enablement capabilities, including turnkey analytics, network, and practice improvement solutions, to help providers transition to value-based reimbursement and improve quality of care.

"Signify Health’s mission is to build trusted relationships to make people healthier by using actionable intelligence to understand what’s really impacting outcomes and cost today," said Kyle Armbrester, CEO of Signify Health. "As we carefully considered our long-term strategic options, we determined that CVS Health is the ideal partner, given its focus on expanding access to health services and helping consumers navigate to the best sites of care. We are both building an integrated experience that supports a more proactive, preventive and holistic approach to patient care, and I look forward to executing on our shared vision for the future of care delivery."

"We formed Signify Health and recruited Kyle and the team to build a strategic innovation platform focused on leveraging technology as a catalyst for connecting key health care stakeholders to drive better patient outcomes," said Matt Holt, Chairman of the Board, Signify Health and President of Private Equity and Managing Director at New Mountain Capital, which owns a majority stake in Signify Health. "Together with CVS Health, Signify is uniquely positioned to continue to lead the transformation to value-based care. We look forward to the significant impact this transaction will make on health care for years to come."

Following the close of the transaction, Kyle Armbrester will continue to lead Signify Health as part of CVS Health. Signify Health’s extensive network of over 50 health plan clients and their members will further augment CVS Health’s longstanding and leading offering of payor-agnostic solutions for a diverse set of health plan and employer clients.

Transaction details

CVS Health will acquire Signify Health’s stock for $30.50 per share. CVS Health expects to fund the transaction with existing cash from its balance sheet and available resources and is committed to maintaining its current credit ratings. The transaction was approved by the Board of Directors at each of the respective companies. It is subject to approval by a majority of Signify Health’s stockholders, receipt of regulatory approval and satisfaction of other customary closing conditions. Private equity funds affiliated with New Mountain Capital, which owns approximately 60% of the common stock of Signify Health, have agreed to vote the shares they own in favor of the transaction, subject to customary exceptions. CVS Health and Signify Health anticipate that the transaction will close in the first half of 2023.

"This is a major step as we continue to execute on our strategy," said CVS Health Executive Vice President and Chief Financial Officer Shawn Guertin. "We expect the acquisition to be meaningfully accretive to earnings and, as a result, are increasingly confident we can achieve our long-term adjusted EPS goals as outlined at our Investor Day in December 2021."

Joint Conference Call and Webcast

CVS Health and Signify Health will hold a joint conference call for analysts and investors on September 6, 2022 at 8:30 a.m. ET. An audio webcast of the conference call will be broadcast simultaneously on the Investor Relations portion of the CVS Health website at investors.cvshealth.com where it will be archived for a period of one year.

Advisors

BofA Securities is serving as financial advisor to CVS Health. CVS Health was advised on legal matters by Fried, Frank, Harris, Shriver & Jacobson LLP, Dechert LLP, and McDermott Will & Emery LLP. Goldman Sachs & Co. LLC and Deutsche Bank Securities Inc. are serving as financial advisors to Signify Health. Ropes & Gray LLP is acting as Signify Health’s legal advisor.

On September 5, 2022 Phynova Group Ltd reported a new strategic partnership with Singapore-based Nutraconnect Pte, Ltd. to introduce its innovative, scientifically backed nutraceutical ingredient Reducose to critical markets in Asia namely Indonesia & Thailand (Press release, Phynova, SEP 5, 2022, View Source [SID1234618989]). This strategic partnership will also aim to take Reducose to certain Key marquee brands in the APAC region. Reducose turns fast sugars and other carbohydrates into slow ones. It empowers consumers to take back control of their blood sugar fluctuations in response to foods. Reducose is a patented functional ingredient, that is a water extract of white mulberry leaves. It can easily be incorporated into a wide range of foods and drinks or be used in dietary supplements. In several human clinical trials, Reducose has been studied to lower blood glucose after eating foods containing sugars and other carbohydrates. Reducose has also been shown to lower the amount of insulin our bodies need to make, and Reducose will decrease the Glycaemic Index (GI) of common carbohydrates. Blood sugar management is a major health benefit of concern for healthy people who actively seek to manage their energy, concentration, weight and lifestyle. Blood sugar management is also critical for people who live with diabetes or pre-diabetes. Diabetes is now a disease of major concern both globally and in APAC and is a leading cause of death in most countries. In 2021, the International Diabetes Federation (IDF) estimated that ∼537 million people had diabetes worldwide, and by 2030, this is predicted to rise to 643 million. Eighty percent live in low-and middle-income countries, and of the total, more than 60% live in Asia, with almost one-third in China. This strategic partnership combines the strengths of the two companies to bring a natural solution to the consumers who actively seek to live a healthier life through better control of their blood sugar. Stephane Ducroux, CEO at Phynova, said: "We are delighted to have a Strategic Partnership with Nutraconnect. Phynova’s strategy is to partner with market focused experts such as Nutraconnect who have a proven track record of introducing and developing opportunities for ingredients with a strong science like Reducose to certain key marquee brands in the APAC region. "The aim of Nutraconnect is to bring innovative, safe and science backed natural solutions to brand customers in the APAC region. We guide our clients through the regulatory, language, cultural and distribution labyrinth using our experience, reach and knowledge so that we can successfully bring products like Reducose to the market. We are proud of our association with Phynova Group Limited" adds Nikhil Sawant, CEO and Co-founder of Nutraconnect. "To develop formulations that comply to the local regulations, brand customers expect great service and rapid responses, Nutraconnect is based in Asia and in the same time zone as its customers enabling us to meet and exceed the expectations of our customers. The services provided by Nutraconnect is an added competitive advantage for our client to win in the APAC region" adds Rohit Noronha, Chief Growth Officer, and Co-founder of Nutraconnect.

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On September 5, 2022 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported that clinical trial investigator, Anthony B. El-Khoueiry, MD, Associate Director for Clinical Research and Phase I Program Director at the University of Southern California, Norris Comprehensive Cancer Center, and Associate Professor of Clinical Medicine at the Keck School of Medicine of USC, will present a Trials in Progress Poster for HFB301001 on Monday, September 12 from 12:00 to 13:00 CEST at the 2022 ESMO (Free ESMO Whitepaper) Congress held September 9 – 13, 2022, in Paris, France (Press release, HiFiBiO Therapeutics, SEP 5, 2022, View Source [SID1234618988]).

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"HFB301001 is positioned as a second generation anti-OX40 antibody that induces T cell activation and demonstrates anti-tumor activity in animal models compared to first-generation antibodies," said Anthony El-Khoueiry, MD. " USC Norris is excited to be part of this Phase I clinical study (NCT05229601), our second program working with HiFiBiO Therapeutics."

"We look forward to sharing the clinical study for HFB301001 in DIS selected indications including soft tissue sarcoma, renal cell carcinoma, hepatocellular carcinoma, and HNSCC," said Luigi Manenti, MD, Chief Medical Officer of HiFiBiO Therapeutics. "We believe HFB301001’s optimized pharmacological profile combined with our dosing strategy and with our DIS driven clinical development plan will allow us to differentiate from first generation anti-OX40 antibodies, and potentially make a difference for these patients."

Details on the poster presentation are as follows:

Title: Phase I study of HFB301001, a novel OX40 agonist monoclonal antibody, in patients with solid tumors selected via Drug Intelligence Science (DIS)
Poster Number: 783TiP
Poster Session: Investigational Immunotherapy
Location: Hall 4
Session Date and Time: Monday, September 12 9:00 – 17:00 CEST

The abstract can be viewed here. The full e-poster will be available on the virtual platform on Saturday, September 10 at 9:00 CEST.

HFB301001 (OX40)
HFB301001 is a novel fully human IgG1 class OX40 agonistic antibody with an optimized pharmacological profile. In contrast to other anti-OX40 antibodies, the agonistic activity of HFB301001 is further enhanced in the presence of the endogenous ligand OX40L and does not result in reduced expression of OX40 on T cells. HFB301001 demonstrated enhanced anti-tumor activity in a human OX40 knock-in mouse model compared to a competitor antibody and is positioned as a best-in-class differentiated molecule for enhanced clinical activity. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select indications and patients who may benefit the most from HFB301001 treatment.