On August 26, 2021 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) reported the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) for distribution within Latin America (Press release, BioNTech, AUG 26, 2021, View Source [SID1234586907]).

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Eurofarma will perform manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities. To facilitate Eurofarma’s involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately. Per the agreement, Eurofarma will obtain drug product from facilities in the U.S., and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production is expected to exceed 100 million finished doses annually. All doses will exclusively be distributed within Latin America.

"Everyone – regardless of financial condition, race, religion or geography – deserves access to lifesaving COVID-19 vaccines," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Our new collaboration with Eurofarma expands our global supply chain network to another region – helping us continue to provide fair and equitable access to our COVID-19 vaccine. We will continue to explore and pursue opportunities such as this to help ensure that vaccines are available to all who are in need."

"We have been continuously increasing the manufacturing capacity of our own facilities and included dozens of manufacturing partners into our global network. Together with Pfizer, we have delivered more than 1.3 billion doses and we plan to deliver 3 billion doses in total by the end of the year. Today’s partnership is an important step to broaden the access to vaccines in Latin America and beyond by expanding our global manufacturing network," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "We will continue to enable people worldwide to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses."

"At such a difficult time as this one, being able to share this news fills us with pride and hope. Eurofarma is about to turn 50 years old and signing this collaboration in the production of the COVID-19 vaccine represents another milestone in our trajectory. We are making available our best resources in terms of industrial capacity, technology and quality to this project, so that we can meet the contract with excellence and contribute to supplying the Latin American market," said Maurízio Billi, President, Eurofarma.

Pfizer and BioNTech select contract manufacturers using a rigorous process based on several factors: quality, compliance, safety track record, technical capability, capacity availability, highly trained workforce, project management abilities, prior working relationship, and commitment to working with flexibility through a fast-paced program.

To date, Pfizer and BioNTech have shipped more than 1.3 billion COVID-19 vaccine doses to more than 120 countries and territories in every region of the world. The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments and global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year. This includes direct supply agreements with individual country governments; an agreement to supply 500 million doses to the U.S. Government at a not-for-profit price, which the government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment (AMC) countries; and a direct supply agreement with COVAX for 40 million doses in 2021.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use
COMIRNATY (COVID-19 vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
prevent COVID-19 in individuals 12 through 15 years, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The Pfizer-BioNTech COVID-19 vaccine has received EUA from FDA to:

prevent COVID-19 in individuals 12 years of age and older, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY (COVID-19 vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY (COVID-19 vaccine, mRNA) or the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

EUA Statement
This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Important Safety Information
Individuals should not get the Pfizer-BioNTech COVID-19 vaccine if they:

had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:

have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone.

Side effects reported with the vaccine include:

There is a remote chance that the vaccine could cause a severe allergic reaction
A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported with the vaccine include:
severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The vaccine is still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away
There is no information on the use of the vaccine with other vaccines.

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit View Source or call 1‐800‐822‐7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age).

On August 26, 2021 BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (or "Hengrui") reported an exclusive commercialization and co-development agreement in Greater China ("the Territory") for BeyondSpring’s investigational drug candidate plinabulin, a first-in-class, selective immunomodulating microtubule-binding agent (SIMBA). Plinabulin in combination with G-CSF is currently under NDA Priority Review by the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) for the prevention of chemotherapy-induced neutropenia (CIN) (Press release, BeyondSpring Pharmaceuticals, AUG 26, 2021, View Source [SID1234586906]). BeyondSpring recently announced positive topline Phase 3 results from its DUBLIN-3 study of plinabulin in combination with docetaxel for the treatment of 2nd and 3rd line, EGFR wild-type non-small cell lung cancer (NSCLC). BeyondSpring will still retain 100% of the global plinabulin rights outside of Greater China.

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"We are thrilled to continue executing on our global commercialization plans by entering into this partnership with Hengrui, a world-class leader in pharmaceuticals with substantial expertise in oncology research and development and deep experience in marketing in China. This landmark partnership serves as a validation from a well-respected, leading pharma for plinabulin as a ‘pipeline in a drug’," said Dr. Lan Huang, co-founder, Chair and Chief Executive Officer of BeyondSpring. "Over the past 40 years, Hengrui has successfully grown to become the largest oncology drug sales company in China, with the top-selling PD-1 inhibitor and docetaxel product, and one of the top three G-CSF products in China. With plinabulin’s potential for combination use with these agents, we believe there are significant synergies in this partnership and believe it positions plinabulin to be developed for additional indications and to accelerate and increase peak sales in China."

Dr. Lianshan Zhang, President of Global R&D and Member of the Board of Directors of Hengrui, commented, "Treatment and prevention of chemotherapy-induced hematological toxicities still represent a huge unmet medical need. We are impressed by the clear benefit brought by plinabulin for the prevention of CIN. We also are very excited about plinabulin’s positive anti-cancer benefit that was demonstrated in the DUBLIN-3 study, and the potential for plinabulin to enhance immune responses to tumors. We look forward to working with BeyondSpring to prepare the NDA filing for the NSCLC indication in China and to explore additional anti-cancer indications to benefit cancer patients in need."

Under the terms of the agreement, Wanchunbulin will grant Hengrui exclusive rights to commercialize and co-develop plinabulin in the Greater China markets, including mainland China, Hong Kong, Macau and Taiwan. Wanchunbulin will retain the manufacturing rights of plinabulin in the Territory and will book all plinabulin revenue in the Territory. Hengrui will receive a pre-determined percentage of the net sales in each quarter. Wanchunbulin will receive the equivalent of up to 1.3B RMB (est. $200M USD), including an upfront payment of 200M RMB (est. $30M USD) and regulatory and sales milestones of up to 1.1 B RMB (est. $170M USD). Hengrui will be responsible for all costs associated with commercialization of plinabulin in the Territory.

Pursuant to the terms, Wanchunbulin will be responsible for 100% of the clinical and regulatory costs for the first two indications for plinabulin: prevention of CIN and 2nd/3rd line treatment of NSCLC (EGFR wild type). Hengrui will fund 50% of the clinical development costs for additional indications for plinabulin in the Territory, with a Joint Steering Committee overseeing the clinical strategy and priorities. With deep understanding of plinabulin and its potential, Wanchunbulin will lead the protocol design and development for additional indications.

In connection with the signing of the collaboration, Hengrui will make an equity investment at 100M RMB (est. $15M USD) into the Wanchunbulin subsidiary at a pre-money valuation of 3.6B RMB (est. $560M USD).

Dr. Huang concluded, "This partnership accomplishes important strategic goals and represents a tremendous potential for optimizing the value of the plinabulin franchise. The near-term financial terms, with the upfront and milestone payments and the equity investment in our China subsidiary, strengthen our balance sheet. In addition, this creative business partnership allows us to book revenue while creating long-term value in participating in the future revenue growth of plinabulin, backed by Hengrui’s strong infrastructure with proven successful commercial track record in China. Importantly, it positions us well to continue on our path to becoming a global biopharmaceutical company, while preserving our strategic optionality in other key markets worldwide to enhance shareholder value."

About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation from both U.S. and China FDA for the CIN prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.

On August 26, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:13) has initiated a Phase Ib/II study of fruquintinib in combination with BeiGene’s tislelizumab in patients with advanced triple negative breast cancer ("TNBC") or advanced endometrial cancer ("EC") in the U.S. The first patient was dosed on August 24, 2021 (Press release, Global Virus Network, AUG 26, 2021, View Source [SID1234586904]). This trial is to explore the potential for the addition of a highly selective vascular endothelial growth factor receptor ("VEGFR") inhibitor, fruquintinib, to anti-programmed death-1 ("PD-1") antibody tislelizumab in inducing activity to immune checkpoint inhibitors.

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This is an open-label, multi-center, non-randomized study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic TNBC or advanced EC. This study will be conducted in two parts; a safety lead-in phase (Part 1) and a dose expansion phase (Part 2). The safety lead-in phase will determine safety and tolerability and the recommended Phase II dose ("RP2D") of the combination. In the dose expansion phase, the RP2D will be administered to two cohorts of patients: Cohort A – Patients with TNBC who have received prior therapy with an immune checkpoint inhibitor; and Cohort B – Patients with TNBC who have not received prior therapy with an immune checkpoint inhibitor. A cohort evaluating the combination in second line advanced EC is anticipated to open in 3Q2021. Additional details may be found at clinicaltrials.gov, using identifier NCT04577963.

About TNBC and EC

Breast cancer is a common type of cancer in the U.S., estimated to be diagnosed in over 281,000 women during 2021.1 TNBC is one of several subtypes of breast cancer, accounting for approximately 10% of newly diagnosed breast cancer cases.2 The number of women living with TNBC in the U.S. was estimated to be over 150,000 in 2018.3 PD-L1 expression is estimated to be present in approximately 20% of TNBC.4 TNBC is distinguished from the other subtypes of breast cancer in that the cancer cells do not have receptors for the hormones estrogen or progesterone (hormone receptor negative) and do not make excessive amount of the protein human epidermal growth factor receptor 2 (HER2). TNBC is more aggressive and has a worse prognosis compared to other types of breast cancer.

EC is the fourth most common type of cancer among women in the U.S., estimated to be diagnosed in over 66,000 women during 2021.5 The number of women living with EC in the U.S. was estimated to be over 800,000 in 2018. Options are limited beyond front line chemotherapy treatment for the 20-30% of women who are diagnosed at an advanced stage of the disease, as well as those who develop advanced disease that are not curable with surgery. Among patients with EC, an estimated 14% of advanced stage tumors express PD-L1, and approximately 20-30% of EC are microsatellite instability-high (MSI-H).6,7,8,9

Immune checkpoint inhibitors ("ICIs") have improved clinical outcomes in TNBC and EC, but a large proportion of patients do not respond to ICIs and initial responders eventually develop resistance. Combination therapy including VEGFR inhibition may improve the clinical efficacy of ICIs by promoting inhibition of angiogenesis in the tumor region, which can suppress tumor growth and reduce metastasis.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

About Fruquintinib Development

Metastatic colorectal cancer in China: Fruquintinib was approved for marketing by the China National Medical Products Administration ("NMPA") in September 2018 and commercially launched in China in late November 2018 under the brand name Elunate. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Elunate is for the treatment of patients with metastatic colorectal cancer ("CRC") who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

Metastatic CRC in the U.S., Europe, and Japan: The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020. A Phase III registration study of fruquintinib for the treatment of patients with metastatic CRC, FRESCO-2, is currently underway in the U.S., Europe, Japan and Australia. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539. The U.S. FDA has acknowledged that the totality of the fruquintinib clinical data, including the FRESCO-2 study (if positive), the prior positive Phase III FRESCO study demonstrating improvement in overall survival that led to fruquintinib approval for metastatic CRC in China in 2018, and additional completed and ongoing supporting studies in metastatic CRC, could potentially support a New Drug Application (NDA) for the treatment of patients with advanced metastatic CRC (third-line and above). The FRESCO-2 study design was also reviewed and endorsed by The European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

Gastric Cancer in China: In October 2017, HUTCHMED initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients are randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored (clinicaltrials.gov identifier: NCT03223376). In June 2020, HUTCHMED completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.

Metastatic breast cancer: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced, refractory TNBC. This study is being conducted to investigate if the addition of fruquintinib can potentially induce activity to ICIs therapy in TNBC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib were demonstrated in advanced solid tumors, including TNBC, in a phase I study conducted in China (NCT01645215) and a phase 1/1b study is ongoing in the United States (NCT03251378).

Other Immunotherapy combinations: HUTCHMED has entered into other collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with Tyvyt (sintilimab, IBI308, developed by Innovent Biologics, Inc.).

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The NMPA has granted tislelizumab approval in five indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer ("NSCLC") in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy; and conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, four supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy, and for first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).
BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase III trials and four pivotal Phase II trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

On August 26, 2021 Vaccibody reported its interim report for the second quarter of 2021 (Press release, Vaccibody, AUG 26, 2021, View Source [SID1234586903])

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HIGHLIGHTS:

• Vaccibody plans to initiate a Phase 1/2 trial to evaluate two next generation SARS-CoV-2 virus vaccine candidates to address emerging variants of concern
• The VB C-02 clinical trial with the therapeutic HPV cancer vaccine VB10.16 and immune checkpoint inhibitor atezolizumab (Tecentriq) is on track to finalize enrollment during fourth quarter 2021. Per protocol interim safety analysis was conducted with no safety concerns and a recommendation to continue the trial as planned
• Vaccibody appointed Mikkel Wandahl Pedersen as new Chief Scientific Officer and Agnete B. Fredriksen as Chief Innovation & Strategy Officer
• Vaccibody appointed Harald Gurvin as new Chief Financial Officer
• Dr. Birgitte Volck, M.D., Ph.D. appointed as new member of the Board of Directors, providing extensive global drug development and Nasdaq experience Highlights after June 30, 2021:
• Vaccibody entered into worldwide, exclusive license agreement with Adaptive Biotechnologies to access clinically validated SARS-CoV-2 T cell epitopes
• VB10.NEO – approval of the first US site initiation for the VB N-02, Phase 1b trial in collaboration with Genentech
• Vaccibody reached a headcount of more than 80 people Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 3 Michael Engsig, Chief Executive Officer at Vaccibody, comments: "Second quarter 2021 was yet another quarter with great advancement in our activities, in particular with our COVID vaccines.

We will initiate a Phase 1/2 trial with two COVID vaccine candidates and expect the first subject to be dosed in early Q4 2021. The two vaccines are a 2nd generation RBD vaccine and a 3rd generation T cell focused vaccine, respectively." Michael Engsig continues: "The RBD vaccine candidate retains strong neutralization across variants of concern in preclinical tests. The T cell focused vaccine is based on the clinically validated SARS-CoV-2 T cell epitopes that comes out of the exclusive collaboration and licensing agreement with Adaptive Biotechnologies, which was announced mid-July. The partnership is directly in line with our strategic pillar of seeking complimentary partnerships.

It is truly a unique fit of technologies, and we are excited to have used Adaptive’s data to inform the design and development of our T cell-based SARS-CoV-2 vaccine. This 3rd generation T cell focused vaccine candidate elicits T cell responses against conserved and immunogenic regions across a broad set of SARS-CoV-2 antigens and can be used as a universal booster."

R&D UPDATE Please find below an update on Vaccibody’s research and development activities. Oncology VB10.16 VB10.16 is a therapeutic HPV vaccine directed against HPV16+ induced malignancies:

• Clinical trial VB C-02: o Clinical stage: Phase 2 o Indication: HPV16+ advanced, non-resectable cervical cancer o ClinicalTrials.gov Identifier: NCT04405349 Status and highlights Investigational sites in six European countries are screening and enrolling patients. Per protocol interim safety analysis was conducted with no safety concerns and a recommendation to continue the trial as planned. The trial has enrolled more than half of the patients and is on track to have completed enrolment in Q4 2021. The trial plans to report interim clinical data in Q1 2022. VB10.NEO VB10.NEO is an individualized neoantigen cancer vaccine, exclusively licensed to Genentech:

• Clinical trial VB N-01: o Clinical stage: Phase 1/2a o Cancer indications: Melanoma, non-small cell lung cancer, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck o ClinicalTrials.gov Identifier: NCT03548467

• Clinical trial VB N-02: o Clinical stage: Phase 1b o Cancer indications: Locally advanced and metastatic tumors o ClinicalTrials.gov Identifier: NCT05018273 Status and highlights In collaboration with Genentech, the site initiation for VB N-02 has started in the USA to support enrollment of 40 patients at 10 sites across three countries: USA, Germany and Spain. Approval has been achieved for the first US site and CTA (Clinical Trial Applications) were done for Germany and Spain where approvals are expected in the 2nd half of 2021.

Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 5 Infectious Diseases Vaccibody’s infectious disease initiative continues to generate supportive data and explore and evaluate a diverse set of pathogens as potential next future clinical vaccine targets. VB10.COV2 Vaccibody has chosen a 2-arm strategy for its VB10.COV2 project to fight SARS-CoV2 variants of concern (VoC*). VB10.2129 and VB10.2210 are two vaccines designed using Vaccibody’s modular and Antigen Presenting Cell (APC) targeted technology. :

• Clinical trial VB-D-01, investigating the two vaccine candidates, VB10.2129 and VB10.2210, in both naïve as well as previously vaccinated healthy volunteers o Clinical stage: Phase 1/2 o Pathogen: SARS-CoV-2 o ClinicalTrials.gov Identifier: TBD VB10.2129 – 2nd generation vaccine addressing novel variants of concern* VB10.2129 contains the RBD domain of the Beta (i.e. South African) variant of concern B1.351. Importantly, preclinical data demonstrate induction of rapid, strong and persistent neutralizing antibody responses in animal models by VB10.2129 not only against the South African variant, but also across several other major variants of concern. Vaccibody’s RBD vaccine has the potential to induce rapid and strong levels of neutralizing antibody responses addressing both existing and emerging variants of concern VB10.2210 – 3rd generation universal broadly protective T cell vaccine Increasing evidence highlight the importance of broad T cell responses in providing rapid as well as long-term memory responses against COVID-19 with limited sensitivity to viral mutations. In July, Vaccibody and Adaptive Biotechnologies entered into an exclusive agreement for use of Adaptive’s validated SARS-CoV-2 T cell epitopes. Adaptive is our partner of choice and has applied its immune medicine platform to identify and validate immuno-dominant

T cell epitopes across the viral genome using sequence information from more than 6,500 patients impacted by COVID-19. Further, it has launched T-Detect COVID, which is the first-in-class T cell based clinical test for COVID-19 with FDA Emergency Use Authorization. Vaccibody will use a selected set of these SARS-CoV-2 T cell epitopes in its VB10.2210 vaccine. Vaccibody aims to boost and broaden the most clinically relevant and conserved T cell responses against a broad set of SARS-CoV-2 epitopes identified by Adaptive. Preclinical data confirm induction of strong T cell responses against multiple SARS-CoV-2 antigens in several mouse models.

The aim is to induce long-lasting protective immunity across all population groups and across current and future variants. Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 6 VB-D-01 trial The VB-D-01 trial is a Phase 1/2, open label, dose escalation trial to determine safety and immunogenicity of two SARS-CoV-2 vaccine candidates. The clinical trial application is planned for Q3 2021 and first subject dosed is planned for early Q4 2021. The trial will enroll up to 200 patients in Norway.

*Note: All viruses, including SARS-CoV-2, mutate and change over time. Most changes have limited impact on the virus’ properties. However, some changes may affect the virus’ properties, e.g. as how easily it spreads, the associated disease severity, or the performance of vaccines, diagnostic tools and so forth. The emergence of variants that poses an increased risk to global public health has prompted the characterization of specific variants of concern, in order to prioritize global monitoring and research, and ultimately to inform the ongoing response to the COVID-19 pandemic. Source: Tracking SARS-CoV-2 variants (who.int) Autoimmune disorders Autoimmune disorders are caused by unwanted immunogenicity to autoantigens. Vaccibody has initiated research to take advantage of the platform’s unique APC targeting approach to induce antigen-specific immune tolerance.

Initial focus is screening and identifying the constructs that induce the optimal immune response profile for future product development in the field.

FINANCIAL REVIEW
Income statement The net result for the 2nd quarter of 2021 was a net loss of USD 6.2 million compared to a net loss of USD 6.6 million in the 2nd quarter of 2020. The reduced net loss is mainly due to increased revenue and movement in deferred tax. The operating loss in the 2nd quarter of 2021 was USD 7.7 million compared to a loss of USD 6.4 million in the same period in 2020, driven by increased R&D and operating activities and planned increase in headcount.

The net result for the 1st half of 2021 was a loss of USD 12.8 million compared to a loss of USD 9.4 million in the 1st half of 2020, driven by the increase in R&D and operating activities, planned headcount and finance costs, offset by movement in deferred tax. Revenue and other income Total revenue and other income amounted to USD 1.9 million in the 2nd quarter of 2021 (Q2 2020: USD 0.1 million) and USD 2.7 million for the 1st half of 2021 (1H 2020: USD 0.3 million). Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 7 The Group recognized revenues of USD 1.6 million in the 2nd quarter of 2021 and USD 2.1 million for the 1st half of 2021 according to the development of underlying research activities related to the Genentech agreement announced in October 2020.

The Group also had other income of USD 0.3 million in the 2nd quarter (Q2 2020: USD 0.1 million) and USD 0.6 million in the 1st half (1H 2020: USD 0.3 million), primarily government grants. Operating expenses Total operating expenses amounted to USD 9.6 million in the 2nd quarter of 2021 (Q2 2020: USD 6.5 million) and USD 17.8 million for the 1st half 2021 (1H 2020: USD 10.6 million). Employee benefit expenses were USD 2.7 million in the 2nd quarter (Q2 2020: USD 2.5 million) and USD 6.6 million for the 1st half (1H 2020: USD 3.0 million).

The increase in employee benefit expenses in 2021 is primarily due to the planned increase in headcount, expenses related to the Group’s share option program and recruitment. Employee benefit expenses in the 2nd quarter 2020 were impacted by accrued social security tax on the share option program. Other operating expenses amounted to USD 6.8 million in the 2nd quarter (Q2 2020: USD 3.9 million) and USD 11.1 million for the 1st half (1H 2020: USD 7.5 million). The increase in 2021 was driven by the N-02 Phase 1b study initiation as well as consulting and legal services. Net financial income and expenses Net financial income and expenses were USD 0.1 million in the 2nd quarter of 2021 (Q2 2020: USD 0.2 million loss) and a net loss of USD 0.6 million in the 1st half 2021 (1H 2020: USD 1.0 million gain).

Finance income and finance costs mainly relate to movements in foreign currency exchange rates and fair value adjustments of financial instruments. Income tax expenses The Group recognized tax income of USD 1.3 million in the 2nd quarter of 2021 and USD 3.0 million in the 1st half of 2021, which primarily relates to movement in deferred tax. There was no income tax in the same periods of 2020. Statement of financial position Cash At June 30, 2021, Vaccibody had a cash position of USD 174.4 million compared to USD 183.9 million at December 31, 2020. The decrease in cash is mainly a result from operating activities. Equity At June 30, 2021, total equity amounted to USD 168.5 million, compared to USD 178.9 million at December 31, 2020.

The change mainly reflects the net loss of the period of USD 12.8 million, the exercise of warrants and recognition of share-based payments. Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 8 Trade receivables At June 30, 2021, trade receivables amounted to USD 3.8 million, compared to USD 3.8 million at December 31, 2020. The amount is related to the partial invoiced amount payable under the Genentech agreement. Trade and other payables At June 30, 2021, trade and other payables amounted to USD 5.6 million, compared to USD 9.2 million at December 31, 2020. The decrease is mainly from the outstanding one-off advisory cost related to the Genentech agreement in 2020, offset with increase in accrued expenses related to the N-02 Phase 1b study initiation. Contract assets At June 30, 2021, total contract assets amounted to USD 9.6 million, compared to USD 15.0 million at December 31, 2020.

The contract assets relate to earned revenue not invoiced under the Genentech agreement. The changes in the period are related to fulfilling the performance obligations under the Genentech agreement and transferring to trade receivables. Other current financial assets At June 30, 2021, total other current financial assets amounted to USD 20.8 million compared to USD 24.9 million at December 31, 2020.

The decrease primarily relates to the sales of market based financial instruments and fair value adjustments. Cash flow Net change in cash and cash equivalents was negative USD 5.4 million in the 2nd quarter of 2021 (Q2 2020: USD 2.9 million negative) and negative USD 9.4 million in the 1st half of 2021 (1H 2020: USD 1.7 million negative). Cash and cash equivalents decreased to USD 174.4 million at the end of the period, compared to USD 183.9 million at the end of 2020. Cash flow from operating activities Net cash flow from operating activities was negative USD 9.4 million in the 2nd quarter of 2021 (Q2 2020: USD 5.1 million negative) and negative USD 14.4 million in the 1st half 2021 (1H 2020: USD 7.9 million negative).

This was primarily driven by the increase in research and development expenses and employee benefit expenses due to the planned increase in headcount. Cash flow from investing activities Cash flow from investing activities was USD 3.7 million in the 2nd quarter of 2021 (Q2 2020: USD 2.3 million) and USD 4.3 million for the 1st half 2021 (1H 2020: USD 5.4 million). The amounts mainly relate to the proceeds from sales of market based financial instruments. Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 9 Cash flow from financing activities Cash flow from financing activities was USD 0.3 million in the 2nd quarter of 2021 (Q2 2020: USD 0.06 million negative) and USD 0.7 million for the 1st half 2021 (1H 2020: USD 0.7 million). The amounts primarily relate to the proceeds from equity issuance, offset by payment of lease liabilities.

On August 26, 2021 Herantis Pharma Plc ("Herantis"), focusing on disease modifying therapies for debilitating neurodegenerative diseases, reported its half yearly financial report for the period January 1 – June 30, 2021 (Press release, Herantis Pharma, AUG 26, 2021, View Source;results-for-the-first-half-year-january-1—june-30–2021,c3403498 [SID1234586902]). It is available on Herantis’ website (Financial information). Investors, analysts and media are invited to a webcasted live call today at 10:30 EEST / 9:30 CEST.

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Register Here: Herantis’ 1H 2021 Financial Report Live Call

Webinar ID: 235-655-763

Questions can be submitted throughout the webcast event.

Following the webcast of the live call, a recording will be available on Herantis Pharma’s website (www.herantis.com).

Herantis transformed into a pure play CNS biotech company –

Highlights January – June 2021:

Strategic data drive decision taken to fully focus all company resources on Herantis’ CDNF and xCDNF assets, thus becoming a pure play CNS (central nervous system) biotech company.
Selected HER-096 as the xCDNF candidate to take forward into further development for the treatment of Parkinson’s Disease (PD) and other neurodegenerative diseases, an important milestone for the company. HER-096 was selected based on clear and compelling preclinical data including that it:
Effectively penetrates the Blood-Brain-Barrier (BBB)
Potently protects neurons and restores their functional phenotype
Significantly reduces aggregation of the toxic protein alpha-synuclein and the associated neuroinflammation
Restores proteostasis
A study showing CDNF’s therapeutic effects in alpha-synuclein-based animal models was published in Molecular Therapy, a leading scientific journal. This study provides new insight in how CDNF affects alpha-synuclein pathology on the molecular and cellular level.
Entered into an agreement with Nanoform Finland Plc. The collaboration provides for formulation proof-of- concept studies to combine Herantis’ CDNF therapy for Parkinson’s disease, with Nanoform nanoparticle technology.
Two presentations summarizing the results from the Phase I-II First-In-Man Clinical Trial of CDNF in PD were presented at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases, AD/PD 2021.
The clinical trial results from Phase II study investigating Herantis’ patented gene therapy Lymfactin, for the treatment of Breast Cancer Related Lymphedema (BCRL), were inconclusive. The primary purpose of the trial was to determine whether there was an additional benefit of Lymfactin treatment in combination with lymph node transfer surgery, compared to surgery alone. While both treatment groups experienced clear clinical benefits, the trial did not establish additional treatment benefit for Lymfactin in combination with surgery, compared to surgery alone. Strategic decision taken to seek out-licensing partners for the Lymfactin program.
Hilde Furberg was elected to the Board of Directors
Hilde brings 35+ years of global leadership experience both as a Board member and through her years in global sales, marketing, strategy and management in the international Pharma/Biotech industries
Former European Head of Rare Disease Europe/GM and Senior VP Rare Diseases EMEA at Genzyme/Sanofi Genzyme
Successful R&D investor day held in June. Link to the event: Herantis’ Virtual R&D Investor Day 2021
Presented novel evidence of biological and biomarker impact in humans from the CDNF Phase 1 clinical study

Summary and outlook for 2021:

The new Herantis is a pure play CNS company, and the programs are fully focused on disease modifying therapeutics to address the unmet need in Parkinson’s disease and other neurological illnesses. During the remainder of 2021 we will continue executing our roadmap as we aim to complete formulation activities for the new CDNF administrations routes, and continue strengthening the preclinical proof of concept data for HER-096 (xCDNF).