On July 1, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it has completed the acquisition of Sanofi’s stake in Libtayo (cemiplimab), providing Regeneron with exclusive worldwide development, commercialization, and manufacturing rights to the medicine originally discovered in Regeneron’s laboratories (Press release, Regeneron, JUL 1, 2022, View Source [SID1234616436]). The intent to purchase Libtayo was announced on June 2, 2022.

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In 2015, Regeneron and Sanofi entered into the Immuno-oncology License and Collaboration Agreement whereby the companies split Libtayo’s worldwide operating profits equally and co-commercialized Libtayo in the U.S., with Sanofi solely responsible for commercialization outside the U.S. With today’s closing, Regeneron will now record 100% of global net sales and expenses for Libtayo.

Regeneron intends to update its full year 2022 financial guidance to reflect the Libtayo purchase during its second quarter 2022 earnings announcement in early August.

Anticipated Impact to Second Quarter 2022 Financial Results from Recently Completed Business Development Transactions
There is no financial or accounting impact to second quarter 2022 financial results as a result of the Libtayo transaction.

On May 31, 2022, Regeneron announced that it had successfully acquired Checkmate Pharmaceuticals, Inc. for a total equity value of approximately $250 million. As a result of the Checkmate acquisition, Regeneron expects to record in the second quarter of 2022 an acquired in-process research and development (IPR&D) charge of approximately $195 million, which would negatively impact GAAP and non-GAAP diluted earnings per share by approximately $1.70. This acquired IPR&D charge and its resultant impact on diluted earnings per share represent unaudited estimates that have not been subject to Regeneron’s quarterly financial statement closing procedures, and therefore actual amounts could differ from what the Company currently anticipates.

On June 30, 2022 Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that LG Chem Life Sciences (LG Chem), the life sciences division of the South Korean LG Group, has exercised its renewal option as part of the ongoing collaboration with Avacta, triggering a license renewal fee payment to Avacta of $2 million (Press release, LG Chem, JUN 30, 2022, View Source [SID1234616415]).

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Under the terms of the agreement, LG Chem has the exclusive rights to develop and commercialise, on a global basis, Avacta’s Affimer PD-L1 inhibitor with Affimer XT serum half-life extension for a range of indications. LG Chem has exercised its license renewal option and will progress the PD-L1/XT candidate by commencing pre-clinical studies which are intended to form the basis of an Investigational New Drug (IND) submission.

In December 2018, Avacta and LG Chem entered into a multi-target development agreement to develop Affimer therapeutics in several disease areas. In 2020 the companies agreed to expand this drug development partnership to include Avacta’s Affimer XT technology, which can be used to control the time a drug spends in the blood.

Dr Alastair Smith, Chief Executive Officer of Avacta, commented: "I am very pleased with the progress being made by our partners LG Chem with the Affimer PD-L1 checkpoint inhibitor programme, which includes the Affimer XT serum half-life extension technology. The initiation of IND enabling studies represents a significant step towards first-in-human clinical trials of the Affimer platform, which is a key value driver for the technology and for Avacta."

On June 30, 2022 Synaffix B.V. (Synaffix), a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, has expanded the license agreement with Synaffix (announced in August 2021) by adding a third ADC target to its research evaluation and development efforts under this deal (Press release, Synaffix, JUN 30, 2022, View Source [SID1234616400]). In addition it exercised its option to take exclusive development and commercialization rights for an undisclosed ADC target under the terms of this agreement.

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This follows a successful initial research collaboration between the companies whereby Kyowa Kirin has demonstrated a highly competitive preclinical therapeutic index for its lead program under this collaboration, prepared from a Kyowa Kirin antibody using Synaffix’s ADC technology.

The technology licensed from Synaffix include GlycoConnect, HydraSpace, and multiple toxSYN linker-payloads, which allow for the drug-to-antibody ratio (DAR) to be tailored to 1, 2 or 4 to optimize the therapeutic index of the ADC.

Under the terms of the amended license agreement, Synaffix will receive an immediate payment of $5 million and is eligible to receive total potential payments for the first ADC program alone of up to $171m plus royalties on commercial sales.

Floris van Delft, Ph.D., Chief Scientific Officer of Synaffix, said:

We are thrilled with the successful ADC data, expansion of this license agreement and to see a leading global pharmaceutical company like Kyowa Kirin deploying Synaffix ADC technology in order to fulfill its mission of improving the lives of patients with cancer worldwide.

On June 30, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Ildong Pharmaceutical, reported an agreement under which Ildong will license a suite of Twist VHH antibody libraries to use to discover and develop antibodies for applications in immuno-oncology (Press release, Twist Bioscience, JUN 30, 2022, View Source [SID1234616416]).

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"This collaboration with Twist moves us closer to our vision of becoming a fully global healthcare company while also continuing to drive novel therapies in South Korea through the expansion of our pipeline," said Hongseok Ban, Ph.D. of Ildong Pharmaceutical. "Access to a selection of Twist’s VHH libraries will enable us to complete discovery efforts to select antibody candidates for development as novel immuno-oncology therapies."

"We believe our VHH libraries are extremely versatile in their applications developing novel and next generation therapies. Because they are significantly smaller than a traditional human antibody, they can be combined with other technologies, or used on their own for development of effective therapies," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "This VHH library licensing agreement with Ildong is our first collaboration with a South Korea-based company and broadens our presence in the Asia-Pacific region."

Under the terms of the agreement, Ildong will license a suite of Twist’s VHH libraries for a period of three years and will use the libraries to conduct research and development activities. Twist will receive an upfront payment, annual maintenance fees and additional payments for success-based clinical and regulatory milestones as well as royalties on product sales.

VHH Antibody Libraries

Antibodies contain two variable domains, the heavy and the light chains. A VHH antibody, also known as a single domain antibody, is the antigen binding domain of the heavy chain, with three complementary determining regions (CDRs), or areas where antigens bind to the antibody. Twist’s VHH libraries use novel methods that combine synthetic and natural approaches to maximize diversity in the 10 billion antibody library, creating high quality VHH libraries for use against any protein target. The small size of the VHH antibodies allow them to access targets that traditional antibodies cannot, with tight binding affinity. The modular nature of VHH antibodies supports creation of bi- or multi-specific antibodies ideal for developing next generation therapies specific to oncology, autoimmune disease and virology.

About Ildong Pharmaceutical

Ildong Pharmaceutical
Health Research Center for sharing happier lives

As a leading pharmaceutical company in South Korea, Ildong Pharmaceutical has been dedicated and committed to the development and supply of superior pharmaceutical products that contribute to the health and well-being of people around the world. Ildong Pharmaceutical is steadfast in its vision of continuously growing with its customers as a leading global company by providing solutions for disease prevention and developing new solutions for healthier and happier lives.

Ildong Pharmaceutical has earned the trust of our customers with ethical drugs franchise for chronic disease and cancer therapies, antibiotics, and digestive and circulatory drugs, in addition to well-known OTC brands such as Biovita(probiotics product) and Aronamin(multivitamin). Ildong Pharmaceutical is on the road to reaching its vision of becoming a global total healthcare company with various new drug pipelines including Besivo(hepatitis B therapy), which is the 28th novel drug in South Korea, as well as new innovative drug pipelines and new businesses for health functional foods, medical devices, cosmetics, and beverages.

On June 30, 2022 AstraZeneca reported that Positive high-level results from a planned interim analysis of the AEGEAN Phase III trial showed treatment with it’s Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete response (pCR) compared to neoadjuvant chemotherapy alone for patients with resectable non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, JUN 30, 2022, View Source [SID1234616401]).

A statistically significant improvement in major pathologic response (MPR) was also observed. The trial will continue as planned to assess the additional primary endpoint of event-free survival (EFS) to which the Company, investigators and participants remain blinded.

The safety and tolerability of adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not decrease the number of patients able to undergo successful surgery versus chemotherapy alone.

Up to 30% of all patients globally with NSCLC are diagnosed early enough to have surgery with curative intent.1-3 However, only around 56-65% of patients with Stage II disease will survive for five-years. This decreases to 24-41% for patients with Stage III disease.4

Susan Galbraith, Executive Vice President, Oncology R&D, said: ”Treating resectable lung cancer early provides the best chance for a cure, yet lung cancer will still recur within five years for the majority of patients despite chemotherapy and successful surgery. Engaging the immune response with Imfinzi both before and after surgery is an exciting new strategy, and we hope these early findings from AEGEAN will lead to improved survival for lung cancer patients in this potentially curative setting."

These pCR data will be shared with global health authorities and presented at a forthcoming medical meeting when EFS results are available.

AstraZeneca has several ongoing registrational trials focused on testing Imfinzi in earlier stages of lung cancer, including in resectable NSCLC (ADJUVANT BR.31) and unresectable NSCLC (PACIFIC-2, 4, 5, 8 and 9), and in limited-stage small cell lung cancer (SCLC) (ADRIATIC).

Imfinzi is approved in the curative-intent setting of unresectable Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy in the US, Japan, China, across the EU and many other countries, and is the global standard of care in this setting based on the PACIFIC Phase III trial. Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial.

Notes

Lung cancer
In 2020, an estimated 2.2 million people were diagnosed with lung cancer worldwide.5 Lung cancer is the leading cause of cancer mortality among men and women and accounts for about one-fifth of all cancer-related deaths.5 Lung cancer is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC.6 The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis. 1-2 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.7-8

For patients with resectable tumours, the majority of patients eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.

AEGEAN
AEGEAN is a randomised, double-blind, multi-centre, global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage IIA-IIIB (tumours greater than or equal to 4cm or node positive) NSCLC with no EGFR or ALK genomic tumour aberrations, irrespective of PD-L1 expression. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 802 patients were randomised to receive a 1500mg fixed dose of Imfinzi every three weeks plus chemotherapy or placebo plus chemotherapy for four cycles prior to surgery, followed by Imfinzi or placebo every four weeks (for up to 12 cycles) after surgery.

In the AEGEAN trial, the primary endpoints are pCR, defined as no viable tumour following neoadjuvant therapy, and EFS, defined as the time from randomisation to an event like tumour recurrence or progression. At this interim analysis EFS was not assessed. Key secondary endpoints are MPR, defined as residual viable tumour of less than or equal to ten percent following neoadjuvant therapy, disease-free survival, overall survival, safety and quality of life. The trial is being conducted across 264 centres in more than 25 countries including in the US, Canada, Europe, South America and Asia.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

As well as global approvals in lung cancer, Imfinzi is approved for previously treated patients with advanced bladder cancer in several countries.

Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer and other solid tumours.

In the past year, Imfinzi combinations have resulted in positive Phase III trials in multiple additional cancer settings including; unresectable advanced liver cancer (HIMALAYA), biliary tract cancer (TOPAZ-1) and metastatic NSCLC (POSEIDON) and the data are under review with global health authorities.

AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab) and tremelimumab; Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s Immuno-Oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome evasion of the anti-tumour immune response. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumour types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.

In addition, the ability to combine the IO portfolio with radiation, chemotherapy, and targeted small molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

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