On February 10, 2022 Innovent Biologics reported that The U.S. Food and Drug Administration (FDA) held a public Oncology Drug Advisory Committee (ODAC) for sintilimab, which is under review for the first-line treatment of people with non-squamous non-small cell lung cancer (nsqNSCLC) based on the ORIENT-11 trial conducted exclusively in China (Press release, Innovent Biologics, FEB 10, 2022, View Source [SID1234608050]). On the single voting question, the advisory committee voted that additional clinical trial(s) should be required to demonstrate applicability to the U.S. population and U.S. medical practice prior to a final regulatory decision. Sintilimab is a novel PD-1 inhibitor being developed and commercialized under a collaboration agreement between Innovent and Lilly.

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"We appreciate this opportunity to share our data of ORIENT-11 with FDA and the advisory committee. While conducted in China, ORIENT-11 was well designed and conducted in compliance with ICH GCP standards. The data of sintilimab generated from ORIENT-11 has suggested a positive risk and benefit profile, with no safety issue identified by the FDA." said Dr. Yongjun Liu, President of Innovent. "While we are disappointed by the ODAC outcome, we together with Lilly will continue to work with FDA as the agency completes its review of our BLA application. We remain confident in the value of sintilimab, and the interaction with FDA will help us to pave the way to advance our exciting pipeline and globally develop innovative medicines for patients around the world."

"While we are disappointed with the outcome of today’s ODAC as it relates to the investigational product sintilimab, we appreciated the opportunity to publicly discuss the application and broader issues related to single-country clinical trials," said Jacob Van Naarden, President, Lilly Oncology. "Along with Innovent, we will continue to work with the FDA as it completes its review of the sintilimab application."

The ODAC provides the FDA with independent advice and recommendations from outside experts on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the vote as it reviews the application and is not bound by the committee’s guidance. Innovent and Lilly will continue to work closely with the agency as they complete their review of the application.

About the ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial conducted in China assessing the efficacy and safety of sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with advanced or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC), with no sensitizing EGFR mutations or ALK rearrangements. The primary endpoint is progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1., and secondary endpoints include overall survival (OS), ORR and safety profile.

A total of 397 patients were enrolled and randomized 2:1 to receive either sintilimab injection 200mg or placebo in combination with pemetrexed and platinum chemotherapy every three weeks for up to four cycles, followed by either sintilimab injection or placebo plus pemetrexed maintenance therapy. Patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that required treatment discontinuation. Conditional crossover was permitted. The results of the ORIENT-11 study were published in 2020.

About Lung Cancer

Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year.[i] In the U.S., lung cancer is the second most common cancer (not counting skin cancer) and the leading cause of cancer death, responsible for nearly 25 percent of all cancer deaths – more than those from colorectal, breast and prostate cancers combined.[ii] Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers, and about 70 percent of those with NSCLC have the nonsquamous subtype.[iii] Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.[iv]

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer;
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer;
In combination with bevacizumab biosimilar for the first-line treatment of unresectable or advanced hepatocellular carcinoma.
Additionally, Innovent currently has three regulatory submissions under review in China’s NMPAfor sintilimab:

In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma;
In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
In combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.
Additionally, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.

On February 10, 2022, Twist Bioscience Corporation (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, and Cowen and Company LLC, as the representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell an aggregate of 5,227,272 shares of its common stock, including 681,818 shares pursuant to an option granted to the Underwriters to purchase such additional shares that was exercised in full (collectively, the "Shares"), to the Underwriters (the "Offering") (Filing, 8-K, Twist Bioscience, FEB 10, 2022, View Source [SID1234608109]). The Shares will be sold to the Underwriters at a public offering price of $55.00 per share, less the underwriting discount and commissions. The Underwriting Agreement contains customary representations and warranties, conditions to closing, market standoff provisions, termination provisions and indemnification obligations, including for liabilities under the Securities Act of 1933, as amended.

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The Offering is being made pursuant to the Company’s registration statement on Form S-3 (Registration No. 333-238906), which was filed with the Securities and Exchange Commission (the "SEC") on June 3, 2020, and the prospectus supplement dated February 10, 2022 filed by the Company with the SEC. The Offering is scheduled to close on or about February 15, 2022, subject to customary closing conditions.

On February 10, 2022 AstraZeneca reported on its strong growth trajectory in 2021, with industry-leading R&D productivity, five of our medicines crossing new blockbuster thresholds, and the acquisition and integration of Alexion (Press release, AstraZeneca, FEB 10, 2022, View Source [SID1234607947]). We also delivered on our promise of broad and equitable access to our COVID-19 vaccine with 2.5 billion doses released for supply around the world, and we made good progress on reducing our greenhouse gas emissions.

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Growth was well balanced across our strategic areas of focus, and we saw double-digit growth in all major regions, including Emerging Markets despite some headwinds in China. The positive news from our pipeline, including approvals for Evusheld and Tezspire, supports the outlook for 2022. This, along with the transformative acquisition of Alexion, means that we are confident in our long term growth and profitability. After a landmark year in 2021, we are increasing the dividend for our shareholders.

The differences between Reported and Core measures are primarily due to items related to the acquisition of Alexion, amortisation of intangibles, as well as impairments and restructuring charges, of which $1,030m in the year related to the Group Review detailed below. A full reconciliation between Reported EPS and Core EPS is provided in Tables 17 and 18 in the Financial performance section of this document. The differences between Actual Change and CER Change are due to foreign exchange movements between corresponding periods in 2021 vs 2020.

Key elements of Total Revenue performance in FY 2021
-An increase in Product Sales of 41% (38% at CER) to $36,541m-Among AstraZeneca’s thirteen7 blockbuster medicines in 2021, five medicines crossed new thresholds: Tagrisso ($5bn+), Farxiga ($3bn+), Lynparza ($2bn+), Calquence ($1bn+) and Fasenra ($1bn+)Following completion of the Alexion acquisition on 21 July 2021, Rare Disease medicines generated 8% of AstraZeneca’s FY 2021 Total Revenue, growing 8% (9% CER) on a pro-rata basis to $3,071m
-Growth of 19% (17% at CER) in Oncology to $13,663m, 13% (9% at CER) in CVRM8 to $8,034m, and 13% (9% at CER) in R&I9 to $6,049m-In the US, Total Revenue increased by 38% to $12,228m. In Europe, Total Revenue increased by 45% (40% at CER) to $8,050m including Vaxzevria10 revenue of $1,035m
-An increase in Emerging Markets revenue of 41% (36% at CER) to $12,281m, including Vaxzevria revenue of $2,304m.

In China, Total Revenue increased by 12% (4% CER) in the year to $6,011m. Pricing pressure associated with NRDL11 and VBP12 programmes led to a decline in growth in the second half of the year, and in Q4 2021 China Total Revenue was 4% lower (8% at CER) than in Q4 2020-Excluding vaccine revenue, Total Revenue in ex-China Emerging Markets increased by 19% in the year (21% at CER) to $3,977m and by 36% (38% at CER) in the quarter to $1,197m, driven by Oncology medicines and Farxiga Post Alexion Acquisition Group Review In conjunction with the acquisition of Alexion, the enlarged Group initiated a comprehensive review across the organisation, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments.

These activities are expected to be substantially complete by the end of 2025, with a number of planned activities having commenced in late 2021. The identified activities, including those previously announced regarding the integration of Alexion, are anticipated to incur one-time restructuring costs of approximately $2.1bn, of which approximately $1.4bn are cash costs and $0.7bn are non-cash costs, and capital investments of approximately $0.2bn. The activities are anticipated to realise run-rate pre-tax benefits, before reinvestment, of approximately $1.2bn, including previously-announced Alexion synergies, by the end of 2025.

In line with established practice, restructuring costs will be excluded from our Core (non-GAAP) financial measures. Guidance The Company provides FY 2022 guidance at CER. 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 vaccine revenue in 2022 is expected to come from initial contracts. The Gross Profit Margin from the COVID-19 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 the heightened risks and uncertainties from the effects of COVID-19. 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 average foreign-exchange rates for January 2022 were seen over the full year, it is anticipated that there would be a low single-digit adverse impact on actual Total Revenue and Core EPS versus the financials at CER.

The Company’s foreign-exchange rate sensitivity analysis is shown in the Operating and financial review.

On February 10, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported that it has dosed the first participant in a Phase 1 study of its seasonal influenza second-generation mRNA vaccine candidate, CVSQIV, developed in collaboration with GSK (Press release, CureVac, FEB 10, 2022, View Source [SID1234607965]). The differentiated multivalent vaccine candidate features multiple non-chemically modified mRNA constructs to induce immune responses against relevant targets of four different influenza strains. The use of customizable and rapidly produced mRNAs to address influenza could enable faster development and delivery of potentially improved vaccine candidates, featuring even short-term strain updates for the approaching influenza season.

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"Providing seasonally updated yet highly effective influenza vaccines has historically been challenging. The successful implementation of mRNA technology to address the global COVID-19 pandemic has demonstrated a tremendous opportunity for this platform," said Dr. Klaus Edvardsen, Chief Development Officer of CureVac. "Leveraging the inherent flexibility of our mRNA platform together with our fast manufacturing, we have successfully combined multiple different mRNAs in a single candidate with the goal to develop a potentially improved vaccine for seasonal influenza. We believe this represents an important advancement of this key technology."

The Phase 1 dose-escalation study is being conducted in Panama and is expected to enroll up to 240 healthy adult participants to evaluate the safety, reactogenicity and immunogenicity of CVSQIV. In line with the mRNA development strategy in collaboration with GSK, both companies are also working on chemically modified mRNA technologies with clinical programs for influenza and COVID-19 expected to start later this year.

The CureVac-GSK infectious disease collaboration was first announced in July 2020 and focuses on the development of new products based on CureVac’s mRNA technology for different targets in the field of infectious diseases.

About CVSQIV

CVSQIV is the first seasonal influenza vaccine candidate in clinical development based on an advanced mRNA backbone developed by CureVac and is one of the second-generation mRNA vaccine candidates from the infectious disease program developed in collaboration with GSK. The differentiated candidate combines multiple separate non-chemically modified mRNA constructs encoding for antigens that address four different influenza strains. The Phase 1, open-label, dose-escalation study will assess the safety, reactogenicity and immunogenicity of CVSQIV in the dose range of 3 to 28µg in the predefined age groups of 18-55 years and 65 years and above. The study is expected to enroll up to 240 healthy participants and is being conducted in Panama. A clinical study to test the use of chemically modified mRNA is expected to begin later this year.

On February 10, 2022 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its fourth quarter and full year 2021 financial results on Thursday, February 24, 2022, and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, FEB 10, 2022, View Source [SID1234607981]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To access the conference call, please register at the link below:
View Source

Upon registering, each participant will be provided with call details and a conference ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.