On April 29, 2022 AstraZeneca reported that First quarter 2022 results (Press release, AstraZeneca, APR 29, 2022, View Source [SID1234613203])

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Financial performance (growth numbers at CER)
‒ Total Revenue increased 60% to $11,390m, reflecting growth across the Company, the contribution of the Alexion medicines and several Vaxzevria contracts that are expected to complete delivery by half year 2022
‒ Total Revenue from Oncology increased 25%7, including a milestone payment; Product Sales from Oncology increased 18%. Total Revenue from CVRM8 increased 18%, R&I9 increased 4% and Rare Disease increased 7%10 ‒ Operating Margin in the quarter benefitted from phasing of costs
‒ Core EPS increased 20% to $1.89
‒ FY 2022 guidance at CER reiterated Key milestones achieved since the prior results
‒ Key data: Enhertu11 in HER212-low breast cancer (DESTINY-Breast04), AZD8233 in hypercholesterolaemia (ETESIAN, Phase IIb) and publication of data for Lynparza in prostate cancer (PROpel) and nirsevimab in RSV13 (MELODY/MEDLEY)
‒ Key approvals: Saphnelo and Evusheld in the EU, Ondexxya in Japan, and in the US, approvals of Ultomiris for gMG14 and Lynparza15 for early breast cancer (OlympiA)
‒ Other key milestones: US FDA16 Breakthrough Therapy Designation for Enhertu in HER2-low breast cancer (DESTINY-Breast04), Priority Reviews for Enhertu in HER2-mutant metastatic non-small cell lung cancer (DESTINY-Lung01), and Imfinzi and tremelimumab in advanced liver cancer (HIMALAYA), and EMA17 accelerated assessment for nirsevimab in RSV (MELODY/MEDLEY) Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "2022 has started strongly for AstraZeneca.

Farxiga achieved $1bn revenue in the quarter and our Oncology medicines delivered Product Sales growth of 18%, despite COVID-19 continuing to impact cancer diagnosis and treatment. High-level results from the DESTINY-Breast04 trial pointed to Enhertu’s potential to redefine treatment of HER2-low metastatic breast cancer, and Ultomiris became the first and only long-acting C5 inhibitor approved for generalised myasthenia gravis in the US. Today we have unveiled plans for a new strategic research and development centre in the heart of Cambridge, Massachusetts’ scientific hub. In line with our sustainability commitments, it will be designed to the highest environmental standards.

Our investments in pioneering science give us confidence of further advances in the years to come." 2 Guidance The Company reiterates FY 2022 guidance at CER. Total Revenue is expected to increase by a high teens percentage Core EPS is expected to increase by a mid-to-high twenties percentage

‒ The CER growth rates include the full-year contribution of Vaxzevria in both FY 2021 and FY 2022
‒ Total Revenue from COVID-19 medicines is anticipated to decline by a low-to-mid twenties percentage, with an expected decline in sales of Vaxzevria being partially offset by growth in Evusheld sales. The majority of Vaxzevria revenue in 2022 is expected to come from initial contracts. The Gross Margin from the COVID19 medicines is expected to be lower than the Company average
‒ Core Operating Expenses are expected to increase by a low-to-mid teens percentage, driven in substantial part by the full year integration of Alexion expenses
‒ Emerging Markets Total Revenue, including China, is expected to grow mid-single-digits in FY 2022. China Total Revenue is expected to decline by a mid-single-digit percentage in FY 2022, primarily due to continued NRDL and VBP programme impacting various medicines.

The Company remains confident in the longer term outlook for Emerging Markets, driven by a large market opportunity, broader patient access and an increased mix of new medicines

‒ A Core Tax Rate between 18-22% AstraZeneca continues to recognise and actively manage the heightened risks from COVID-19 and geopolitical and supply chain uncertainties on overall business performance. Variations in performance between quarters can be expected to continue.

The Company is unable to provide guidance on a Reported basis because AstraZeneca cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal-settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If foreign-exchange rates for April to December 2022 were to remain at the average of rates seen in Q1 2022, it is anticipated that there would be a low single-digit adverse impact on Total Revenue and a mid single-digit adverse impact on Core EPS versus the financials at CER.

The Company’s foreign-exchange rate sensitivity analysis is contained in Table 15. Corporate and business development In April 2022, AstraZeneca and Harbour BioMed (HBM) committed to a global out-license agreement for HBM7022, a pre-clinical bispecific antibody targeting Claudin18.2 and CD3. AstraZeneca will be granted an exclusive global license for research, development, registration, manufacturing, and commercialisation of HBM7022. HBM shall receive an upfront payment of $25m with the potential for additional payments up to $325m pending achievement of certain development, regulatory and commercial milestones. HBM is also eligible to receive tiered royalties on net sales. Sustainability summary AstraZeneca published its eighth annual Sustainability Report and Sustainability Data summary, released in conjunction with the 2021 Annual Report. The report outlines progress on strategic priorities, material focus areas, challenges and aims for the future.

AstraZeneca continues to provide urgent humanitarian support in Ukraine and neighbouring countries. To date, AstraZeneca has committed over $7m to response efforts, including donations of:

‒ Medicines to the Company’s humanitarian relief partner Direct Relief, which is working directly with the Ukrainian Ministry of Health
‒ Medicines via The Red Cross affiliates in neighbouring countries
‒ $2m to support relief agencies working in Ukraine, Poland and surrounding areas with a focus on providing healthcare and humanitarian assistance.

Funding is being provided to Project HOPE, working with and through the World Health Organization, and International Medical Corps
‒ More than $1m to UNICEF and The Red Cross Reporting changes for Q1 2022 AstraZeneca’s Total Revenue and Product Sales tables in FY 2022 include a new disease area: BioPharmaceuticals: Vaccines & Immune Therapies (V&I). This incorporates revenues from Vaxzevria, Evusheld, FluMist, Synagis and nirsevimab.

In the FY 2021 quarterly and annual reports, Vaxzevria and Evusheld revenues were shown under COVID-19, and FluMist, Synagis and nirsevimab revenues were shown under Other Medicines. In addition, revenue from Koselugo have moved from Oncology to Rare Disease, and revenue from Andexxa has moved from Rare Disease to BioPharmaceuticals: CVRM.

The growth rate for each disease area has been calculated as though these changes had been implemented in FY 2021. Conference call A conference call and webcast for investors and analysts will begin today (29 April 2022) at 11:45 BST. Details can be accessed via astrazeneca.com.

On April 29, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that AstraZeneca (LSE/STO/Nasdaq: AZN) has now dosed the first patient in its Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (PD-L1) in combination with monalizumab (NKG2A) or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) (Press release, Innate Pharma, APR 29, 2022, View Source [SID1234613181]).

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The purpose of the study, which is sponsored by AstraZeneca, is to determine if the addition of monalizumab or oleclumab to standard-of-care durvalumab improves outcomes for patients in this setting.

Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

"We are very pleased that our key late-stage asset, monalizumab, has progressed into a second Phase 3 trial with our partner, AstraZeneca. The launch of PACIFIC-9 represents an important financial milestone for Innate, as it triggers a $50 million milestone payment that reinforces our cash position," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Based on the recent COAST clinical trial results, we are excited about the potential of extending the clinical benefit of durvalumab with the addition of monalizumab in patients with unresectable, Stage III NSCLC."

Detailed results from the randomized COAST Phase 2 trial were published in the Journal of Clinical Oncology on April 22, 2022. AstraZeneca initially presented the results during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 in September 2021 (see AstraZeneca press release). The results of the interim analysis showed monalizumab in combination with durvalumab increased objective response rate (ORR) and prolonged progression-free survival (PFS) versus durvalumab alone in patients with unresectable, Stage III NSCLC who had not progressed after CRT. The Journal of Clinical Oncology publication now includes exploratory subgroup analysis.

"Durvalumab has transformed the treatment of patients with unresectable, Stage III NSCLC, and we’re excited by the promise of extending its benefit through novel combinations with two potential first-in-class monoclonal antibodies demonstrating strong clinical activity. Based on the stand-out results from COAST, we are pleased that the Phase 3 trial is underway, which we hope will bring new treatment options to patients and further increase the potential for long-term survival benefit in this setting," said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.

About PACIFIC-9:

PACIFIC-9 is a Phase 3, randomised, double-blind, multicenter global study to determine the efficacy and safety of durvalumab alone or in combination with oleclumab or monalizumab+ in patients with unresectable, Stage III NSCLC who have not progressed on definitive, platinum-based CRT.​

The first patient has been dosed in April 2022. The PACIFIC-9 Phase 3 trial is now looking to recruit patients across more than 200 centers in the coming months. ​

Stage III NSCLC:

In 2020, an estimated 2.2 million people were diagnosed with lung cancer worldwide1. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.2,3,4 Stage III NSCLC represents approximately one quarter of NSCLC incidence5.

Stage III (locally advanced) NSCLC is commonly divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally. In contrast to Stage IV, when cancer has spread (metastasised), the majority of Stage III patients are currently treated with curative intent2,6.

The majority of Stage III NSCLC patients are diagnosed with unresectable tumours2,5.

About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies7.

The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies, including the Phase 2 NeoCOAST trial in the neoadjuvant early-stage setting.

About the Innate-AstraZeneca monalizumab agreement:

In October 2018, AstraZeneca obtained full oncology rights to monalizumab by exercising its option under the co-development and commercialization agreement initiated in 2015.

The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma. Including the $50 million payment triggered by dosing the first patient in the Phase 3 PACIFIC-9 clinical trial, Innate Pharma has received $450 million to date.

For any commercialized oncology indication, AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

On April 29, 2022 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that it will host a conference call and audio webcast on Thursday, May 5, 2022 at 2:30 pm CET (8:30 am ET) to discuss its first quarter 2022 financial results and provide a business update (Press release, argenx, APR 29, 2022, View Source [SID1234613160]). A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the call.

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On April 28, 2022 Kelonia Therapeutics, a biotech company revolutionizing in vivo gene delivery, launched with a $50 million Series A financing to usher in a new era of genetic medicines for a wide range of diseases (Press release, Kelonia Therapeutics, APR 28, 2022, Kelonia Therapeutics Launches with $50 Million Series A Financing to Pioneer Precision Targeted Genetic Medicines [SID1234640176]). Kelonia’s platform overcomes the central challenge that has prevented the full realization of gene therapy for patients. Despite life-changing responses, existing gene therapies are highly complex, costly, and limited by complicated treatment paradigms, tractable therapeutic applications, and dose-limiting toxicities. By enabling precisely targeted, highly efficient, manufacturable "off-the-shelf" in vivo gene delivery, Kelonia’s technology has the potential to dramatically expand the impact and reach of genetic medicines to every patient in need.

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Kelonia is backed by a strong syndicate of investors with a track record of successfully launching and building disruptive biotech companies. Alta Partners, Horizons Ventures, Venrock and other investors participated in the Series A round. The company will use the funding to redefine what’s possible for genetic medicines starting with an "off-the-shelf" chimeric antigen receptor (CAR) to treat hematologic cancer that may enable the unrivalled clinical benefit of CAR T without the typical toxicities and with the ease of access of conventional medicines. Additionally, the company will advance other programs for oncology and non-oncology indications, and further expand its gene delivery platform and capabilities.

"The cell and gene therapy field has been searching for solutions to durable in vivo genetic modifications regardless of whether applying gene editing, RNA expression or viral-mediated gene integration," said Kevin Friedman, Ph.D., President and Chief Scientific Officer of Kelonia. "At Kelonia, we believe we have found an in vivo gene delivery solution that is safe, effective, and manufacturable for broad therapeutic application. With our Series A funding and key strategic collaborations, we will advance our lead product candidate toward clinical studies and further optimize our technology to explore treating diseases never thought possible with genetic medicines."

Based on discoveries made in the lab of Massachusetts Institute of Technology’s Michael Birnbaum, Ph.D., and leveraging pioneering research from leading scientists at the French National Centre for Scientific Research (CNRS), Kelonia’s in vivo gene delivery technology enables a few potent lentiviral vector-like particles armed with an adjustable targeting system to precisely, efficiently, and safely deliver payloads exactly where needed to treat a broad range of diseases. The company’s early applications combine oncology-targeted therapeutics, such as CAR and T cell receptor molecules, with Kelonia’s precision in vivo targeting technology. When used in concert, this combination enables potent and precise tumor targeting with limited "off-tumor" toxicity, which would otherwise be a concern. Administered directly in vivo as an "off-the-shelf" medicine, Kelonia’s transformational therapies in development for solid and hematologic tumors have the potential to democratize patient access to genetic medicines. Beyond oncology, the company will advance its technology to unlock delivery to previously hard-to-reach tissues, such as neurological, muscular or renal, to deliver different types of genetic cargo with the goal of radically transforming the treatment of diseases in these areas.

"It turns out, a relatively simple and elegant idea to de-target and redirect lentivirus-like particles based on recently published research from my lab can potentially provide a solution to in vivo gene delivery," said Dr. Birnbaum, Ph.D., Co-Founder of Kelonia. "I’m incredibly excited about the potential of Kelonia’s platform and team to vastly expand the utility of gene therapies to treat oncology, autoimmune disease, rare monogenic or other diseases currently intractable to gene therapies."

"Kelonia is combining the two crucial elements required to develop truly novel medicines: breakthrough biology and an exceptional team," said Bryan Roberts, Partner at Venrock. "Michael Birnbaum’s industrially robust platform affords a targeting specificity log orders better than anything else out there and the team has a stellar track record for translating groundbreaking scientific gene therapy discoveries into viable products that are transformative for patients."

Strategic Collaborations

In addition to the completion of its Series A, Kelonia has established strategic collaborations with Adimab and ElevateBio. With both collaborations already successfully underway, each of these outstanding partners brings differentiating capabilities that enable and accelerate the company’s vision to bring breakthrough genetic medicines to patients.

Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. Kelonia will leverage Adimab’s expertise and proprietary technologies, across a range of applications, to access tissue-specific antibodies that enable unlocking precise in vivo gene delivery to different tissues as well as antibodies that can be leveraged within the therapeutic genetic cargo.

ElevateBio is a technology-driven company focused on powering transformative cell and gene therapies with multiple next-generation technology platforms and a fully integrated R&D and manufacturing facility. Through an expanding partnership, Kelonia will utilize ElevateBio’s lentiviral vector platform, process and analytical development expertise, and cGMP manufacturing capabilities to develop and advance novel manufacturing processes for Kelonia and manufacture of Kelonia’s products.

On April 28, 2022 Aadi Bioscience, Inc. (Nasdaq: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that it will report results for the first quarter 2022 before market open on Thursday, May 12, 2022 (Press release, Aadi Bioscience, APR 28, 2022, View Source [SID1234614203]). Aadi management will then host a conference call and webcast at 8:30 am EDT (5:30 am PDT) to discuss the results as well as provide a corporate update.

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Individuals may join the webcast online by clicking here or may participate in the live call via telephone by dialing (877) 407-9716 (domestic) or (201) 493-6779 (international) and using conference ID 13729259. A replay of the call will also be available through Aadi’s website within the "Investors & News/Event Calendar" section.