On March 18, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and provided a corporate update for the fourth quarter and full year 2020 (Press release, Hookipa Pharma, MAR 18, 2021, View Source [SID1234576847]).

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"Despite the global pandemic, 2020 was a break-out year for HOOKIPA, a testament to the strength of our novel scientific platform and our dedicated team. We reported compelling, early clinical data with both our replicating and non-replicating technologies in oncology and infectious diseases, respectively, and advanced the HBV and HIV cures towards the clinic in our strategic collaboration with Gilead Sciences. With the appointment of Jean-Charles Soria, M.D., Ph.D., we added a globally recognized oncology expert to our board to help guide our clinical development progress," said Joern Aldag, Chief Executive Officer at HOOKIPA. "Our strong year-end cash balance of $143 million positions us well to advance our CMV and HPV16+ cancer programs and to expand our pipeline. Given the strength of the interim data reported in 2020, we are excited about the further potential of our platform and additional read-outs this year, particularly from our HB-201/HB-202 two-vector alternating immunotherapy, which has the potential to deliver even greater immune response than HB-201 alone."

R&D Pipeline Update and Clinical Progress

Oncology Portfolio (HB-201 and HB-202)

Clinical proof of concept achieved with HB-201. In December, interim Phase 1 data on HB-201 for the treatment of advanced HPV16+ cancers showed promising anti-tumor activity and favorable tolerability as a monotherapy, i.e. without any additional combination product. Data demonstrated responses and stable disease in head and neck cancer patients who failed prior standard of care therapy, platinum therapy, PD(L)1 inhibitor, or both. By targeting an antigen common to HPV16+, HB-201 has the potential to be a tumor-agnostic therapy for all HPV16+ cancers. These early-stage data establish proof of concept for HOOKIPA’s replicating single-vector immunotherapy in oncology. Dose escalation and dose frequency continue to be evaluated in the ongoing Phase 1/2 trial, with the next data read-out anticipated by mid-2021. HPV is estimated to cause 5% of the worldwide cancer burden, the majority of which is HPV16+.
First patient dosed with HB-202. HOOKIPA expanded its Phase 1/2 HB-201 clinical trial to include evaluation of HB-201/HB-202, an alternating two-vector therapy. Following clearance of the IND by the Food and Drug Administration in June 2020, the first patient was dosed with HB-202 in October 2020. Preclinical data show that adding an additional arenaviral vector to achieve alternating two-vector therapy can enhance the immune response. Initial data read-out is anticipated by mid-2021.
OncoImmunology published HB-201 pre-clinical data demonstrating high immunogenicity. In September, pre-clinical data on HB-201 in HPV16+ models were published in OncoImmunology. Specifically, intravenous administration of HB-201 elicited a robust expansion of antigen-specific CD8+ T cell responses. In the HPV16+ tumor model, HB-201 showed significantly delayed tumor growth or complete tumor clearance with prolonged survival.
Pre-clinical data highlighting the potential of alternating two-vector cancer therapeutics published in Cell Reports Medicine. The March 2021 issue of Cell Reports Medicine featured pre-clinical data showing that alternating, intravenous administration of two replicating arenaviral vectors induced tumor-specific responses exceeding 50% of circulating CD8 T cells. In addition, the two-vector approach resulted in tumor cures and long-term immunity in a pre-clinical setting. HOOKIPA is currently evaluating the alternating two-vector therapy in its ongoing HB-201/HB-202 clinical trial, with initial data read-out anticipated by mid-2021.
Infectious Disease Portfolio (HB-101)

Clinical proof of concept achieved with HB-101. In November, interim Phase 2 data were released for patients who received a three-dose CMV vaccination with HB-101 prior to a kidney organ transplantation. These interim results showed a reduction in CMV viremia, reduction in antiviral use, and no CMV disease in the CMV-negative kidney transplant recipients as compared to placebo. Strong CMV-neutralizing antibody responses and a favorable tolerability profile were also observed. HOOKIPA believes that these interim data establish proof of concept for HB-101, a potential first-in-class vaccine candidate, which uses HOOKIPA’s non-replicating technology. HOOKIPA expects to conclude enrollment of the ongoing Phase 2 trial in mid-2021 and to report additional data in the second half of 2021.
Scientific validation with Phase 1 HB-101 data publication in The Journal of Infectious Diseases. In April, Phase 1 safety and immunogenicity data on HB-101 were published in The Journal of Infectious Diseases. The trial concluded that the CMV vaccine candidate was well-tolerated and induced strong neutralizing antibody and T cell immune responses against CMV in healthy adult volunteers.
Strategic Collaborations

Gilead Sciences collaboration for Hepatitis B Virus and HIV therapeutic vaccines advances. HOOKIPA’s collaboration with Gilead aims to develop immunotherapy candidates for functional cures of Hepatitis B Virus and HIV in combination therapies. Significant progress was made in the collaboration during 2020. In the fourth quarter, another pre-clinical milestone was triggered in the HIV program, bringing the total revenue recorded from the Gilead collaboration in 2020 to $19.6 million. Gilead agreed to reserve manufacturing capacity and expanded resources to support future clinical trials.
Corporate Highlights

Balance sheet strengthened with $80.9m financing. Following the positive data read-outs in both the oncology and infectious disease programs, HOOKIPA completed a successful follow-on offering to close the year with a cash balance of $143.2 million. Funding will support advancement of the HPV16+ and CMV programs and an expansion of the overall pipeline.
Board of Directors adds expertise in late-stage oncology clinical development. In October, HOOKIPA welcomed Professor Jean-Charles Soria, M.D., Ph.D., Director General of the Gustave Roussy Cancer Center in Paris, as a Board Director. Dr. Soria is a globally recognized physician-scientist who brings deep oncology, immunotherapy and clinical development expertise to the Board.
Strong management through COVID-19 uncertainty. Despite the challenges of the pandemic, HOOKIPA’s team was able to continue to deliver effectively on our corporate goals. HOOKIPA quickly pivoted early on to maintain its laboratory and manufacturing operations with appropriate safety precautions, while other employees were able to maintain productivity via remote work. HOOKIPA continues to monitor the impact of the ongoing pandemic on its overall operations.
Upcoming Milestones

Translational data from the HB-201 program in Q2 2021
Additional HB-201 and initial HB-201/HB-202 Phase 1/2 efficacy data in HPV16+ cancers in mid-2021
Additional HB-101 CMV Phase 2 efficacy data in H2 2021
Advancing HB-300 towards IND for the treatment of metastatic prostate cancer
HBV and HIV collaboration with Gilead Sciences advancing towards clinical studies
Fourth Quarter and Full Year 2020 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of December 31, 2020 was $143.2 million compared to $113.6 million as of December 31, 2019. The increase was primarily attributable to $75.0 million in net proceeds from the issuance of common stock and convertible preferred stock in a follow-on financing in December 2020, offset by cash used in operating activities.

Revenue was $5.2 million for the three months ended December 31, 2020, and $19.6 million for the year ended December 31, 2020 compared to $3.6 million for the three months ended December 31, 2019 and $11.9 million for the year ended December 31, 2019. The increase was primarily due to higher cost reimbursements received under the collaboration agreement with Gilead and the partial recognition of a milestone payment we received from Gilead in February 2020.

Research and Development Expenses: HOOKIPA’s research and development expenses were $15.7 million for the three months ended December 31, 2020, and $54.8 million for the year ended December 31, 2020 compared to $11.2 million for the three months ended December 31, 2019, and $46.3 million for the year ended December 31, 2019.

The primary driver of the increase in research and development expenses by $8.5 million compared to 2019 was an increase in internal research and development expenses, partially offset by a decrease in direct research and development expenses.

Internal research and development expenses increased primarily due to higher personnel expenses, including stock based compensation and an increase in facility related expenses. The decrease in direct expenses was primarily due to a decrease in research and development service expenses, along with a decrease in manufacturing and quality control expenses and a decrease of other direct research and development expenses, partially offset by an increase in clinical trial expenses and an increase in laboratory expenses.

General and Administrative Expenses: General and administrative expenses amounted to $4.7 million for the three months ended December 31, 2020 and $18.1 million for the for the year ended December 31, 2020 compared to $5.7 million for the three months ended December 31, 2019, and $16.7 million for the year ended December 31, 2019. The increase was mainly due to the growth in personnel related expenses as well as costs associated with ongoing business activities and costs to operate as a public company, partially offset by a decrease in professional and consulting fees.

Net Loss: HOOKIPA’s net loss was $12.5 million for the three months ended December 31, 2020 and $44.1 million for the year ended December 31, 2020 compared to a net loss of $10.2 million for the three months ended December 31, 2019 and $43.0 million for the year ended December 31, 2019. This increase was due to an increase in research and development expenses, mainly driven by the progression of HOOKIPA’s oncology programs, and an increase in general and administrative expenses to operate as a public company.

Conference call: HOOKIPA will host a conference call and live webcast at 8:30 am EDT to discuss its financial results. Please register here to access the conference call. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

On March 18, 2021 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA; the "Company") reported that ILLUMINATE-301, the Company’s pivotal registration trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, did not meet its primary endpoint of objective response rate (ORR) (Press release, Idera Pharmaceuticals, MAR 18, 2021, View Source [SID1234576870]). Idera is evaluating its next steps regarding continuation of the trial toward its overall survival (OS) endpoint, which includes evaluating the full data set when it is available. The Company also plans to continue its ILLUMINATE-206 Phase 2 study of tilsotolimod in combination with ipilimumab and nivolumab in patients with microsatellite stable colorectal cancer (MSS-CRC).

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ILLUMINATE-301 is a randomized, global, multi-center, open label Phase 3 trial comparing the efficacy of 8 mg intratumoral tilsotolimod in combination with 3 mg/kg ipilimumab versus 3 mg/kg ipilimumab alone in 481 patients with anti-PD-1 refractory advanced melanoma. The trial has a primary endpoint family of ORR per RECIST v1.1 and OS. Although the primary endpoint of ORR was not met, if the study continues and reaches a positive OS outcome, the Company would expect to discuss with regulatory authorities a potential path forward in this indication.

ILLUMINATE-301 Key Findings:
Patients in the study were randomized and treated either with 8 mg of tilsotolimod in combination with ipilimumab or with ipilimumab alone. Topline results include:

ORR of 8.8% for the combination arm and 8.6% for ipilimumab alone.
Disease control rate (DCR, defined as stable disease or better) of 34.5% for the combination and 27.2% for ipilimumab alone.
Treatment-emergent adverse events (TEAEs) (Grade 3 and above) occurred in 61.1% of patients who received the combination vs. 55.1% of patients who received ipilimumab alone. Immune-related TEAEs (Grade 3 and above) were reported in 37.6% vs. 30.1%, respectively.
More detailed results from ILLUMINATE-301 may be submitted for future publication or presentation.

"We are surprised and disappointed that the response data from ILLUMINATE-301 do not lead us to an accelerated path to a new and much-needed treatment option for these patients," stated Vincent Milano, Idera’s Chief Executive Officer. "We would like to extend our deepest gratitude to everyone involved in this study, especially the many courageous patients who participated and continue in follow up."

Continued Mr. Milano, "Despite today’s news, we are continuing to explore tilsotolimod via our ongoing ILLUMINATE-206 study in order to understand its potential to lead to better outcomes for patients with MSS-CRC."

About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to checkpoint inhibitors (CPIs) than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.

About Anti-PD-1 Refractory Advanced Melanoma
Melanoma is a cancer that begins in a type of skin cell called melanocytes. While melanoma is the least common type of skin cancer, it has a poor prognosis when not detected and treated early. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread, or metastasized, beyond the skin to other parts of the body. According to the American Cancer Society, approximately 100,000 people in the US will be diagnosed with invasive melanoma this year. In recent years, immunotherapies known as CPIs have changed the treatment of advanced melanoma, with anti-PD-1 agents, alone or in combination with anti-CTLA-4, being the most commonly used immunotherapy in the first-line setting. These agents work by increasing the ability of the body’s immune system to help detect and fight cancer cells. However, due to primary or acquired resistance mechanisms that exclude or inhibit anti-tumor immune cells, as many as 60% of patients may not benefit from this type of therapy when used as monotherapy, and up to one-third of initial responders may develop resistance to the therapy and ultimately experience disease progression. Today, these refractory patients are left with few options for further treatment, paving the way for novel investigational therapies such as tilsotolimod.

About MSS-CRC
Colorectal cancer involves the abnormal growth of cells in the colon or rectum. This type of cancer is typically tested to determine its "MSI" status, which will inform treatment approach and prognosis. MSI stands for "microsatellite instable." MSI-High (MSI-H) means that there is a high amount of instability in a tumor, whereas MSS tumors are "microsatellite stable." The American Cancer Society estimates that, annually in the United States, approximately 140,000 people are diagnosed with CRC, of which 85% are MSS, and approximately 50,000 people die due to CRC. MSS-CRC has been shown to be highly immunosuppressive; there are no approved immunotherapy options, and a prior trial of ipilimumab plus nivolumab (Bristol Myers Squibb’s CheckMate 142) yielded overall response rates of 0-10%. Given tilsotolimod’s mechanism of action of activating dendritic cells and therefore triggering innate and adaptive immune responses, it may serve a complementary function to ipilimumab and nivolumab within the immunosuppressive tumor microenvironment of MSS-CRC patients.

On March 18, 2021 Aktis Oncology, a biotechnology company discovering and developing a novel class of targeted radiopharmaceuticals to treat a broad range of solid tumor cancers, reported completion of a $72 million Series A financing (Press release, Aktis Oncology, MAR 18, 2021, View Source [SID1234576886]). The company was founded and incubated by MPM Capital, which co-led the financing with EcoR1 Capital and Vida Ventures, with participation from Octagon Capital, TCG Crossover, Novartis and Bristol Myers Squibb.

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"Aktis Oncology is building on recent successes in the radiopharmaceutical field, using a novel approach to extend the efficacy of targeted radiopharmaceuticals into a wide range of solid tumors," said Todd Foley, Chairman of Aktis Oncology, and Managing Director of MPM Capital. "We’re incredibly excited by the science, the team and a world class syndicate of institutional and strategic investors that share in our vision to realize the potential of targeted radiotherapy to become a mainstream anti-cancer modality."

Aktis Oncology is developing novel alpha radiotherapies to improve upon the efficacy of conventional solid tumor therapies, while limiting toxicity. The company has developed proprietary platforms to discover best-in-class tumor targeting agents designed with optimal pharmacology for delivering alpha radiotherapy. Aktis Oncology targeting agents are highly tumor penetrant but clear from other areas of the body quickly, to maximize tumor elimination while minimizing potential side effects of treatment.

"Alpha radiotherapy is the future of radiopharmaceuticals," said Matthew Roden, PhD, President and Chief Executive Officer of Aktis Oncology. "By harnessing the power of alpha particles – with nearly 1000 times the potency of beta particles – we believe our approach has the potential to deliver game-changing results for patients."

Aktis Oncology’s theranostic approach would also enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes, allowing for better selection of patients most likely to benefit from therapy. The company plans to produce multiple development candidates with potential for efficacy against well-validated cancer targets.

Aktis Oncology was founded by Brian Goodman, PhD, Patrick Baeuerle, PhD, and Todd Foley, of MPM Capital. The company is led by:

Matthew Roden, PhD, President and Chief Executive Officer of Aktis Oncology. He is an Executive Partner of MPM Capital, and serves as Chairman of Turmeric Acquisition Corporation, and is a member of the boards of iTeos Therapeutics and NextPoint Therapeutics. Prior to joining MPM, Dr. Roden held senior leadership positions in the biopharma industry, most recently as Senior Vice President and Head of Enterprise Strategy at Bristol Myers Squibb; he held senior roles in the capital markets, including serving as head of biotechnology equity research at UBS and as a senior biotechnology equity analyst at J.P. Morgan; and has scientific training in immunology, structural biology, and cancer biology.
Paul Feldman, PhD, Chief Scientific Officer of Aktis Oncology. Prior to joining Aktis Oncology Dr. Feldman was the Head of Discovery and Translational Medicine at Intarcia Therapeutics. An accomplished drug discoverer and executive in the biopharmaceutical industry, he previously served as Senior Vice President at GlaxoSmithKline, leading the Enteroendocrine Discovery Performance Unit and GSK’S enterprise Chemistry Council, before retiring to co-found Phoundry Pharmaceuticals, a peptide hormone therapeutic company.
Brian Goodman, PhD, Head of Operations and Corporate Development of Aktis Oncology. As part of the Investment and Operations Team at MPM Capital, he is responsible for investment identification, due diligence, business development, and new company creation at a number of MPM portfolio companies. He serves as a board observer for Orna Therapeutics and Triplet Therapeutics. Prior to joining MPM Capital, Dr. Goodman co-founded and served as Head of Technology and Innovation at Evelo Biosciences, a company focused on the pharmacology of microbial drugs across multiple therapeutic areas; and was a Senior Associate at Flagship Pioneering.
Aktis Oncology is headquartered in Cambridge, Mass. with laboratory operations in Research Triangle Park, NC.

On March 18, 2021 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196.SH; 02196.HK) reported that its subsidiary YaoPharma Co., Ltd. ("YaoPharma") had recently received the approval from the NMPA regarding the clinical trial for the YP01001 capsules (the "Investigational New Drug") for the treatment of advanced solid tumors (Press release, Fosun Pharma, MAR 18, 2021, View Source [SID1234626451]).

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The Investigational New Drug is an innovative small molecule chemical drug intended for the treatment of advanced solid tumors (including, among others, liver cancer and gastric cancer). YaoPharma plans to conduct Phase I clinical trial for the Investigational New Drug in China (excluding Hong Kong, Macao and Taiwan) recently after the conditions are available.

As of February 2021, Fosun Pharma has invested about RMB 33.66 million (unaudited) in the R&D of the Investigational New Drug at this stage.

Driven by innovation and R&D, Fosun Pharma continuously improves its drug R&D system based on the combination of generic and innovator drugs and builds international R&D platforms for small molecule innovator drugs, high-cost generic drugs, biologics and new technology-based therapies, etc.

In the future, the Company will continue to focus on clinical demands, increase its investment in R&D and improve innovation efficiency, so as to bring high-quality and affordable innovator drugs to patients.

On March 18, 2021 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2020 (Press release, Innate Pharma, MAR 18, 2021, View Source [SID1234576848]). The consolidated financial statements are attached to this press release.

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"In 2020, we made the strategic decision to re-prioritize our investments in our R&D portfolio, enabling us to concentrate our resources and further strengthen our clinical pipeline," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Our priority going forward is to advance the clinical development of our lead proprietary candidate, lacutamab, as well as leverage our multispecific NKCE antibody platform, to create potential innovative therapeutics for patients and provide long-term value to our shareholders."

Pipeline highlights:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

The TELLOMAK Phase 2 clinical trial, which is evaluating the efficacy and safety of lacutamab in patients with advanced cutaneous T-cell lymphomas, is now fully open to enrollment in countries that had a partial regulatory hold following the successful resolution of Good Manufacturing Practice issues.
In November, the Company announced that the European Medicines Agency (EMA) granted PRIME designation to lacutamab for the treatment of patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies. This is the first time PRIME designation has been granted for a potential treatment of any sub-type of T-cell lymphoma. This follows the Fast Track designation that was awarded to lacutamab by the U.S. Food and Drug Administration in 2019.
In February 2021, the Company announced lacutamab demonstrated a positive early signal in cohort 2 of KIR3DL2-expressing mycosis fungoides patients in the TELLOMAK clinical trial earlier than anticipated. This cohort reached the pre-determined number of responses needed to advance to stage 2. The Company plans to present this preliminary data at a scientific meeting in 2021.
The Company will initiate two parallel clinical trials to study lacutamab in KIR3DL2-expressing patients with relapsed/refractory peripheral t-cell lymphoma (PTCL):
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in KIR3DL2-expressing patients with relapsed PTCL.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) will launch an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in KIR3DL2-expressing relapsed/refractory patients.
IPH6101 (NKp46-based NK cell engager), partnered with Sanofi:

Progress was made in the NKCE collaboration with Sanofi, resulting in the decision announced in January 2021 that Sanofi will transition IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. IPH6101 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. Cell 2019). The decision triggered a €7 million milestone payment from Sanofi to Innate.
In January 2021, a GLP-tox study was initiated for the IPH6101/SAR443579 program.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

In October 2020, AstraZeneca (LES/STO/Nasdaq: AZN) dosed the first patient in its randomized Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab vs. placebo and cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. Dosing of the first patient in this trial triggered a $50 million milestone payment from AstraZeneca to Innate. Innate is eligible to receive an additional $50 million milestone payment after the interim analysis demonstrates the combination meets a pre-defined threshold of clinical activity. To date, the Company has received a total of $400 million from the AstraZeneca partnership for monalizumab.
The Company presented efficacy data on the Phase 2 expansion cohort investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Conference held in May 2020. This data showed an overall response rate in line with previously reported data and a manageable safety profile. The Company presented updated results at the ESMO (Free ESMO Whitepaper) Immuno-oncology Virtual Congress in December 2020.
In 2020, the Company expanded a Phase 2 expansion cohort ("cohort 3"), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with R/M SCCHN, from 20 to 40 patients. Recruitment for cohort 3 is complete, and the Company expects to publish data in 2021.
Avdoralimab in Inflammation (anti-C5aR1 antibody):

• In November 2020, the first patient was dosed in the investigator-sponsored Phase 2 clinical trial in bullous pemphigoid (BP) where the C5aR1 pathway has been shown to be involved in the physiopathology of the disease. The trial is investigating the clinical efficacy of avdoralimab in addition to topical steroids compared to topical steroids alone in BP patients.

Avdoralimab in COVID-19:

The investigator-sponsored Phase 2 clinical trial, FORCE (FOR COVID-19 Elimination), has completed enrollment and is ongoing for patient follow-up and data analysis. More information on this study can be found at clinical trials.gov.
Results from the exploratory translational EXPLORE study supporting this trial were published online in Nature on July 29, 2020.
The investigator-sponsored Phase 2 clinical trial, ImmunONCOVID-20, has resumed, and is currently recruiting. This study is exploring the potential efficacy of monalizumab and avdoralimab amongst other treatment arms, against COVID-19 in cancer patients with mild symptoms and pneumonia respectively.
In August 2020, the Company announced it obtained €6.8 million in public funding from the French government for its COVID-19 R&D activities. This funding is part of the government’s PSPC COVID call for COVID-19 related projects and will enable the Company to cover the development of its current COVID-19 activities, which began in March 2020, including the EXPLORE COVID-19 translational research study and its two Phase 2 clinical trials, FORCE and ImmunONCOVID-20.
Avdoralimab in Oncology:

• In September 2020, the Company announced the decision to stop enrollment in STELLAR‑001, a Phase 1 dose escalation and expansion study in combination with durvalumab in three expansion cohorts: 1) NSCLC patients with secondary resistance to prior immuno-oncology (IO) treatment; 2) IO-naïve HCC patients; and 3) IO-pretreated HCC patients. The decision was made based on the data from the Company’s cohort expansions in NSCLC and IO-naïve HCC.

IPH5201 (anti-CD39 antibody), partnered with AstraZeneca:

• In February 2020, the AstraZeneca sponsored, multicenter, open-label, dose-escalation Phase I trial evaluating IPH5201 as monotherapy or in combination with durvalumab (anti-PD-L1) with or without oleclumab (anti-CD73) in advanced solid tumors started. Following the dosing of the first patient in the trial on March 9, 2020, AstraZeneca made a $5 million milestone payment to Innate under the companies’ October 2018 multi-product oncology development collaboration. Innate made a €2.7 million milestone payment to Orega Biotech SAS pursuant to Innate’s exclusive licensing agreement.

Lumoxiti (CD22-directed immunotoxin):

In December 2020, the Company announced that it will return the US and EU commercialization rights of Lumoxiti (moxetumomab pasudotox-tdfk) to AstraZeneca3. Innate licensed the US and EU rights to AstraZeneca’s FDA-approved Lumoxiti for certain patients with relapsed or refractory hairy cell leukemia in October 2018.
Innate and AstraZeneca are currently in discussions regarding the transition plan for the transfer of the US marketing authorization and distribution of Lumoxiti to AstraZeneca, including timing and costs (see Contingent liabilities).
Corporate Update:

In July 2020, Dr. Joyson Karakunnel was appointed as Executive Vice President and Chief Medical Officer (CMO). Dr. Pierre Dodion, CMO since 2014, retired from this position. Dr. Karakunnel comes to the Company with deep experience in immuno-oncology, and a proven track record in drug development. Most recently, Dr. Karakunnel served as CMO and Senior Vice President at Tizona Therapeutics, where he led the development of the company’s biotherapeutics pipeline.
Laure-Helene Mercier, Executive Vice President, Chief Financial Officer and member of the Executive Board, has decided to step down from her position, after leading the Company through more than 14 years of growth, including an initial public offering in the US. Frederic Lombard will join the company as CFO on April 1, 2021. Mr. Lombard will be joining Innate with more than 20 years of financial experience in the pharmaceutical industry, holding senior finance roles at Ipsen, AstraZeneca and Novartis. Ms. Mercier will remain at the Company until the end of the year to ensure a smooth transition of responsibilities.

Financial highlights for 2020:

The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2020 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €190.6 million (€m) as of December 31, 2020 (€255.9m as of December 31, 2019), including non-current financial instruments amounting to €38.9m (€37.0m as of December 31, 2019).
Cash and cash equivalents include the milestone payment of $50.0m (€41.2m) following the inclusion by AstraZeneca of the first patient in its Phase 3 randomized clinical trial evaluating monalizumab, INTERLINK-1. It doesn’t include the milestone payment of €7.0m from Sanofi relating to the progress of IPH6101/SAR443579 into new drug (IND)-enabling studies, received in February 2021.
As of December 31, 2020, financial liabilities amount to €19.1m (€18.7m as of December 31, 2019). This change is partly linked to the receipt, in August 2020, of €1.4m in repayable advance in connection with the financing contract signed with BPI Financement (COVID-19).
Revenue and other income amounted to €70.5m in 2020 (2019: €85.8m, -17.9%). It mainly comprises revenue from collaboration and licensing agreements (€56.2m in 2020 vs €69.0m in 2019, -18.6%), and research tax credit (€13.1m in 2020 vs €16.7m in 2019, -21.8%):
Revenue from collaboration and licensing agreement with AstraZeneca amounted to €49.0m in 2020 (€69.0m in 2019, -29.0%) and mainly resulted from (i) the spreading of the upfront and opt-in payments received from AstraZeneca and (ii) the invoicing to AstraZeneca of certain fees for the work performed by Innate for the partnered programs. The variation between the two periods is notably explained by the completion of (i) the recruitment of the Cohort 2 in the monalizumab Phase 2 trials performed by Innate in 2019, and (ii) the preclinical work related to the Phase 1 program of IPH5201, which started in 2020.
Revenue of €7.0m from Sanofi for the progress of IPH6101/SAR443579 into investigational new drug (IND)-enabling studies.
The variation in the research tax credit mainly results from a decrease in the amortization for the intangible assets related to acquired licenses (monalizumab, IPH5201).
Operating expenses of €89.9m in 2020 (2019: €104.6m, -14.1%):
Selling, general and administrative (SG&A) expenses amounted to €31.2m in 2020 (2019: €25.8m, +21.1%). This increase mainly results from the full-year effect of personnel costs related to our US subsidiary, including personnel assigned to Lumoxiti commercial activities.
R&D expenses amounted to €58.6m in 2020 (2019: €78.8m, -25.7%). This variation mainly results from a decrease in direct R&D expenses (mainly related to Lumoxiti, IPH5201 and IPH5301) and in depreciation and amortization of intangible assets acquired by the Company (IPH5201 and monalizumab).
Lumoxiti intangible asset full impairment of €43.5m, following the Company’s decision to return the US and EU commercialization rights of Lumoxiti to AstraZeneca.
The Lumoxiti distribution agreement generated a net income of €0.9m in the first three quarters of 2020 (a net loss of €8.2m in 2019). During the 2020 fourth quarter, the Company recognized net sales from Lumoxiti of €0.7m.
A net loss of €64.0m in 2020 (2019: net loss of €20.8m).