CStone received China NMPA IND approval for CS2006/NM21-1480, a PD-L1/4-1BB/HSA multi-specific antibody-based molecule, marking further expansion of its Pipeline 2.0

On September 15, 2021 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the investigational new drug (IND) application of multi-specific antibody CS2006/NM21-1480 has been approved by the National Medical Products Administration (NMPA) of China (Press release, CStone Pharmaceauticals, SEP 15, 2021, View Source [SID1234587864]). CS2006/NM21-1480 represents a leading class of next-generation anti-PD-1/PD-L1 cancer immunotherapies and a new backbone molecule for combinations.

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CS2006/NM21-1480 is a monovalent, tri-specific antibody-based molecule targeting PD-L1, 4-1BB, and human serum albumin (HSA).CS2006/NM21-1480 is designed to bind to the immune co-stimulation receptor 4-1BB and conditionally activate T cells only when engaging the checkpoint receptor ligand PD-L1 on the surface of tumor cells, potentially preventing the liver toxicities observed with previous anti-4-1BB agonistic antibodies. As a potential best-in-class drug, CS2006/NM21-1480 could be used as monotherapy or in combination with multiple treatments. The upcoming clinical study is designed to evaluate the safety, pharmacokinetics, and anti-tumor efficacy of CS2006/NM21-1480 in Chinese patients with various advanced solid tumors.

Compared to other PD-L1/4-1BB bispecific antibody candidates, CS2006/NM21-1480’s unique monovalent structure and ultra-high-affinity PD-L1-binding is designed to fully exploit the synergistic potential of tumor-localized modulation of PD-L1 and 4-1BB, to provide broader and more sustained treatment response and at the meantime, to avoid systemic toxicities. Furthermore, half-life extension via the HSA-binding motif enables convenient dosing schedules for patients. CS2006/NM21-1480 is anticipated to be effective against tumors with a wide range of PD-L1 expression levels and may overcome primary and/or acquired resistance to anti-PD-1/PD-L1 therapies.

Dr. Archie Tse, Chief Scientific Officer of CStone, said, "We are very glad that the IND application of CS2006/NM21-1480 in China has been approved by the NMPA, with the clinical trial starting soon, it marks a significant milestone in CStone’s Pipeline 2.0 strategy which focused on assets with first-in-class or best-in-class potential. Since April 2020, the first-in-human study of CS2006/NM21-1480 has been well underway in the US. Moving forward, we will step up our efforts to drive the research and development of CS2006/NM21-1480, and other pipeline assets to provide potentially more effective treatments for Chinese and global patients."

CS2006/NM21-1480 was discovered and engineered by Numab Therapeutics ("Numab"), CStone’s partner, using its proprietary λcap technology and MATCH platform. CStone and Numab signed an exclusive regional licensing agreement for the development and commercialization of the drug candidate. Pursuant to the terms of the licensing agreement, CStone will fund the research and development of CS2006/NM21-1480 up to completion of an initial Phase Ib clinical trial. In exchange, CStone obtains exclusive rights from Numab to develop and commercialize CS2006/NM21-1480 in Greater China (including Mainland China, Hong Kong, Macau and Taiwan), South Korea and Singapore. Numab retains all CS2006/NM21-1480 rights for the rest of the world. Upon completion of CStone’s funding period, no further financial obligations will be owed by either party.

Celularity Appoints Andrew L. Pecora, M.D., F.A.C.P., C.P.E., as President

On September 15, 2021 Celularity Inc. (Nasdaq: CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, reported the appointment of Andrew L. Pecora, M.D., F.A.C.P., C.P.E., as President effective today (Press release, Celularity, SEP 15, 2021, View Source [SID1234591817]). Reporting to Robert J. Hariri, M.D., Ph.D., Chairperson and Chief Executive Officer, Dr. Pecora will provide senior leadership to advance Celularity’s clinical pipeline toward U.S. Food and Drug Administration (FDA) approval, including responsibility for preclinical and clinical development and regulatory affairs.

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"It is with great pleasure that we announce Andrew’s appointment as Celularity’s President," said Dr. Hariri. "Building on our recent Nasdaq listing, Andrew’s proven track record as an executive leader in biotechnology and healthcare innovation, delivery and reimbursement will help take Celularity to the next level as we advance our clinical pipeline of next-generation placental-derived cellular therapeutic candidates. Andrew and I trained together at the Weill Cornell Medical Center and have worked in cellular medicines on parallel paths for over 30 years," Dr. Hariri continued.

Dr. Pecora commented, "I am excited to take on this new role at Celularity. I have been very impressed by the early clinical insights and underlying translational science of these novel, placental-derived, off-the-shelf cellular medicines. The potential of Celularity’s clinical pipeline, including its CYNK-101, CyCART-19 and APPL-001 programs, is tremendous. I look forward to providing leadership and strategic vision, working with Bob and his team to realize the potential of these novel allogeneic cell therapies for patients with cancer, infectious disease and degenerative disease."

Dr. Pecora is an award-winning clinician, scientist, and healthcare executive and innovator, with a track record of success leading biotechnology companies to pioneer novel cellular medicines. He is among the world’s foremost experts in blood and bone marrow stem cell transplantation, drug development, and the advancement of novel cell therapies. Dr. Pecora previously served as President of the Physician Enterprise, Chief Innovations Officer, and the Institutional Research Official of Hackensack Meridian Health. There, he oversaw more than 7,500 physicians as well as the business and clinical operations of the John Theurer Cancer Center and clinical and basic research of the Center for Discovery and Innovation. Dr. Pecora also is a Professor of Medicine and Oncology at Georgetown University.

Dr. Pecora is Founder and serves as Chairman of Cota, Inc., a real-world evidence-based data and analytics company focused on leveraging information technology and big data analytics to bridge the gap between precision medicine and population-based health outcomes and to accelerate the development of innovative medicines for patients with difficult to treat diseases.

Prior to Cota, Dr. Pecora served as Co-Founder, Chair and CEO of Progenitor Cell Therapy (PCT), an internationally recognized cellular medicine cGMP manufacturing company. He facilitated the purchase of the Dendreon, Inc., which ultimately led to the FDA approval of PROVENGE (sipuleucel-T), the first FDA approved cell therapy used to treat certain men with advanced prostate cancer. Dr. Pecora eventually led the sale of PCT to Caladrius Biosciences, and co-led multiple public and private capital raises that exceeded USD 500 million.

Earlier in his career, Dr. Pecora was Founder and Chairman of Amorcyte, Inc., a clinical-stage cell therapy company focused on developing novel treatments for cardiovascular disease. At Amorcyte, Dr. Pecora led the capital raise, preclinical and clinical development efforts for AMR-001, a cellular therapy product candidate for vascular injury, through Phase 1 development. This work led to Amorcyte’s sale to Caladrius Biosciences, where Dr. Pecora led the regulatory and clinical development efforts for Amorcyte through Phase 2 development and facilitated a Phase 3 registration trial in Japan.

Dr. Pecora has authored more than 200 peer-reviewed publications and holds over 50 patents, many involving cellular medicines. He has led numerous clinical trials in cancer and other diseases serving as principal investigator. He also has served on national and international steering committees, and contributed to international guidelines for development of cellular medicines, FDA regulatory approval and commercialization standards, including FACT-ISCT International Standards for Hematopoietic Cellular Therapy Production, Processing and Administration. An award-winning healthcare executive, he was recognized in 2019 by Modern Healthcare as one of the top 50 influential clinical healthcare executives.

Coherus and Junshi Biosciences Announce Results from Phase 3 Study of Toripalimab Published in September Issue of Nature Medicine

On September 15, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) reported publication of a cover article in the September issue of Nature Medicine featuring clinical data from the pivotal study "JUPITER-02", a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) (Press release, Coherus Biosciences, SEP 15, 2021, View Source [SID1234587736]).

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Titled Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial, the paper highlights that the addition of toripalimab to standard of care gemcitabine-cisplatin (GP) chemotherapy as a first-line treatment for patients with recurrent or metastatic NPC provided superior progression free survival (PFS) compared to GP alone [median PFS of 11.7 vs 8.0 months, hazard ratio (HR) = 0.52 (95% confidence interval (CI): 0.36–0.74), P = 0.0003], and with a manageable safety profile. The impact of the addition of toripalimab on PFS was demonstrated in patients regardless of PD-L1 expression status. Although overall survival data were not yet mature, as of February 18, 2021, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.603 (95% CI: 0.364–0.997)). The incidence of grade ≥3 treatment emergent adverse events (TEAEs) (89.0% vs 89.5%), TEAEs leading to discontinuation of toripalimab/placebo (7.5% vs 4.9%), and fatal TEAEs (2.7% vs 2.8%) was similar between both arms. Immune-related adverse events (irAEs) (39.7% vs. 18.9%) and Grade ≥3 irAEs (7.5% vs. 0.7%) were more frequent in the toripalimab arm. The full results can be found in the on-line edition of Nature Medicine.

"There are currently no PD-1 blocking antibodies approved for NPC in the United States. We are pleased that this study has been selected for cover article publication in this highly-respected journal," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "This is a strong signal that further validates the potential advance that toripalimab in combination with chemotherapy would represent as a new standard-of-care first-line therapy for patients with advanced NPC, an aggressive and difficult-to-treat cancer."

A biologics license application has been submitted to the U.S. Food and Drug Administration ("FDA") for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

About JUPITER-02
The JUPITER-02 Study (ClinicalTrials.gov identifier: NCT03581786) is a randomized, double-blind, placebo-controlled, international multi-center Phase 3 clinical trial comparing the efficacy and safety of toripalimab versus placebo in combination with Gemcitabine/Cisplatin, as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma. Professor Ruihua Xu from Sun Yat-sen University Cancer Centre is the lead principal investigator of the study. The largest Phase 3 clinical trial to date evaluating a checkpoint inhibitor plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, JUPITER-02 was conducted in mainland China, Taiwan and Singapore and enrolled a total of 289 patients.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April 2021, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and for toripalimab monotherapy in the 2nd line and subsequent treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

IntelGenx Receives U.S.$6 Million in Additional Loans from atai Life Sciences and Conditional Approval to Graduate to Toronto Stock Exchange

On September 15, 2021 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQB: IGXT) (the "Company") reported that its wholly-owned subsidiary, IntelGenx Corp. ("IntelGenx"), has entered into an amended and restated secured loan agreement (the "Loan Agreement") with atai Life Sciences ("atai") pursuant to which atai has made two additional term loans available to IntelGenx in the amount of U.S.$3,000,000 each (the "New Loans"), which will mature on January 5, 2024 (Press release, IntelGenx, SEP 15, 2021, View Source [SID1234587753]). The New Loans will be made on January 7, 2022 and January 6, 2023, respectively, subject to the satisfaction of customary conditions. The Loan Agreement also extends the maturity date for the current loans, in an aggregate amount of U.S.$2,500,000, to January 5, 2024. The obligations under the New Loans are guaranteed by the Company.

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The Company also announces that it has received conditional approval from the Toronto Stock Exchange (the "TSX") to graduate from the TSX Venture Exchange and list its shares of common stock (the "Common Shares"), its 8% convertible debentures with a maturity date of June 30, 2022, and its share purchase warrants expiring on February 11, 2023, on the TSX. Final approval of the listing is subject to the Company meeting certain requirements of the TSX. The Company will make a further announcement once the TSX has issued a bulletin confirming the date on which trading on the TSX will commence. In connection with the listing on the TSX, the Company will apply to voluntarily delist its Common Shares, debentures and warrants from the TSX Venture Exchange to be effective as of the date the Common Shares, debentures and warrants commence trading on the TSX.

"Graduating to the TSX will be a significant milestone for our Company coming as a result of, among other recent accomplishments, our transformative strategic partnership with atai," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "The TSX is Canada’s premier stock exchange and this should increase the visibility of IntelGenx to a broader and more diverse range of institutional investors, both at home and abroad."

Innate Pharma reports first half 2021 financial results and business update

On September 15, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the six months ended June 30, 2021 (Press release, Innate Pharma, SEP 15, 2021, View Source [SID1234587721]). The consolidated financial statements are attached to this press release.

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"In the first half of 2021, we had two key advancements in our portfolio – encouraging new lacutamab data in a subtype of cutaneous T-cell lymphoma, mycosis fungoides, and new data from our proprietary, multi-specific NK cell engager platform, ANKET. These progressions have set the stage for delivering both near and long-term value, while also highlighting the strength and depth of our core R&D efforts," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We look forward to the continued progress of our pipeline, including the upcoming monalizumab presentation at ESMO (Free ESMO Whitepaper) and our lacutamab clinical trial program, in addition to advancing our early-stage R&D activities. These important efforts will help to progress the next wave of innovation at Innate."

Upon registration, participants will be provided with dial-in numbers, a direct event passcode and
a unique registrant ID that they may use 10 minutes prior to the event start to access the call.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.
A replay of the webcast will be available on the Company website for 90 days following the event.
Financial highlights for the first half of 2021:

The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2021 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €159.4 million (€m) as of June 30, 2021 (€190.6m as of December 31, 2020).
Revenue and other income amounted to €15.7m in the first half of 2021 (€36.7m in the first half of 2020) and mainly comprise of:
Revenue from collaboration and licensing agreements, which mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi and which are recognized on the basis of the percentage of completion of the works performed by the Company under such agreements:
(i) Revenue from collaboration and licensing agreements for monalizumab decreased by €13.5m to €6.1m in the first half of 2021 (€19.6m in the first half of 2020), due to lower costs in connection with the collaboration works performed relating to the trials’ maturity;
(ii) Revenue from collaboration and licensing agreements for IPH5201 are nil for the first half of 2021 (€8.7m in the first half of 2020), due to the Company having fulfilled all of its commitments on preclinical work related to the start of Phase 1 of the IPH5201 program as of December 31, 2020.
Revenue from invoicing of research and development (R&D) costs for avdoralimab (IPH5401) and IPH5201 are €1.2m the first half of 2021 (€1.1m in the first half of 2020), or an increase of €0.1m, or 11%, between the first half of 2020 and the first half of 2021.
Government funding for research expenditures of €6.4m in the first half of 2021 (€6.9m in the first half of 2020).
Operating expenses are €41.1m in the first half of 2021 (€46.0m in the first half of 2020), of which 53.0% (€21.8m) are related to R&D.
R&D expenses decreased by €9.7m to €21.8m in the first half of 2021 (€31.5m in the first half of 2020). This change mainly results from a decrease in depreciation and amortization expenses allocated to R&D, and a decrease in direct R&D expenses relating to Lumoxiti following the end of the transition period with AstraZeneca in September 2020 and the return of commercialization rights in the U.S. and Europe, as well as the end of recruitment in trials evaluating avdoralimab in oncology.
Selling, general and administrative (SG&A) expenses increased by €4.8m to €19.3m in the first half of 2021 (€14.5m in the first half of 2020) primarily as a result of the provision for charges booked as of June 30, 2021 relating to the payment of $6.2m (€5.2m as of June 30,2021) to be made to AstraZeneca on April 30, 2022. In the full year results 2020 announcement2, the Company reported a contingent liability of up to $12.8m in its consolidated financial statements, which was linked to the split of certain manufacturing costs. As part of the termination and transition agreement, effective on June 30, 2021, Innate and AstraZeneca agreed to split the manufacturing costs, and Innate will pay $6.2m on April 30, 2022.
Revenue from distribution agreement are nil in the first half of 2021 (net gain of €0.9m in the first half of 2020). As of June 30, 2021, following the end of the transition period relating to the commercialization of Lumoxiti in the U.S. on September 30, 2020, the Company recognized net sales of Lumoxiti for the first half of 2021 for an amount of €1.0m.
A net financial gain of €1.7m in the first half of 2021 (net financial loss of €2.0m in the first half of 2020), principally as a result of the decrease in fair value of certain of our financial instruments due to the negative impact of the COVID-19 outbreak on the financial markets in the first half of 2020.
A net loss of €23.7m for the first half of 2021 (net loss of €10.3m for the first half of 2020).

The table below summarizes the IFRS consolidated financial statements as of and for the six months ended June 30, 2021, including 2020 comparative information.

In thousands of euros, except for data per share June 30, 2021 June 30, 2020
Revenue and other income 15,686 36,745
Research and development expenses (21,794) (31,499)
Selling, general and administrative expenses (19,321) (14,490)
Operating expenses (41,115) (45,989)
Net income / (loss) distribution agreements — 896
Operating income (loss) (25,428) (8,348)
Net financial income (loss) 1,709 (1,986)
Income tax expense — —
Net income (loss) (23,719) (10,334)
Weighted average number of shares ( in thousands) : 78,998 78,892
– Basic income (loss) per share (0.30) (0.13)
– Diluted income (loss) per share (0.30) (0.13)

June 30, 2020 December 31, 2020
Cash, cash equivalents and financial assets 159,402 190,571
Total assets 266,217 307,423
Total shareholders’ equity 133,561 155,976
Total financial debt 16,502 19,087
Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

In June 2021, the Company announced promising preliminary data from its Phase 2 TELLOMAK trial, in which lacutamab demonstrated a 35% overall global response rate in patients with mycosis fungoides (MF) that express KIR3DL2 (cohort 2). This first trial data set also established safety and demonstrated skin improvement. Lacutamab reached the pre-determined threshold to advance to stage 2 (six confirmed responses). These results were presented in an oral presentation at the 16th International Conference on Malignant Lymphoma (16-ICML).

In the second half of the year, the Company will initiate two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL):

Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.

Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) plans to initiate an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.

ANKET (Antibody-based NK cell Engager Therapeutics):

In June 2021, the Company presented new data on its next-generation NK cell engager platform, ANKET, at the Federation of Clinical Immunology Societies (FOCIS) meeting. Specifically, Innate shared data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a cytokine receptor (IL-2Rb) and a tumor antigen via a single molecule. In preclinical studies, the tetra-specific ANKET demonstrated in vitro the ability to induce human NK cell proliferation, cytokine production and cytolytic activity against cancer cells expressing the targeted antigen. The tetra-specific ANKET also demonstrated in vivo anti-tumor efficacy in several tumor models, allowing regression of established tumors as well as control of metastasis, associated with increased NK cell infiltration, cytokine and chemokine production at the tumor site. ANKET also showed a pharmacodynamic effect, low systemic cytokine release and a manageable safety profile in non-human primates.

Progress was made in the IPH6101/SAR443579 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 multi-specific antibody format (Gauthier et al. Cell 2019). The decision triggered a €7 million milestone payment from Sanofi to Innate. In addition, in January 2021, a GLP-tox study was initiated for the IPH6101/SAR443579 program.

The Company will present further ANKET data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on September 18, 2021.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

On September 17, 2021, AstraZeneca will present a late-breaker abstract on the COAST Phase 2 trial, highlighting progression-free survival (PFS) results for novel durvalumab combinations with potential new medicines, including Innate’s lead partnered asset, monalizumab, and AstraZeneca’s oleclumab, an anti-CD73 monoclonal antibody, in unresectable, Stage III non-small cell lung cancer at the ESMO (Free ESMO Whitepaper) Congress 2021.

The Company expects to publish data this year from the Phase 2 expansion cohort (‘cohort 3’), exploring the combination of monalizumab, cetuximab and durvalumab in first-line IO naïve patients with R/M SCCHN.

Avdoralimab (IPH5401, anti-C5aR antibody):

In July 2021, the Company announced that FORCE (FOR COVID-19 Elimination), the investigator-sponsored, Phase 2 clinical trial evaluating the safety and efficacy of avdoralimab, in COVID-19 patients with severe pneumonia, did not meet its primary endpoints in all three cohorts of the trial. Results from this trial, including translational data, are planned to be submitted for publication. The Company’s COVID-19 activities were covered by public funding from the French government.
Following a strategic review, the Company will now solely pursue avdoralimab in bullous pemphigoid, an inflammatory disease, through an investigator-sponsored study and stop further development in all other indications.

Corporate Update:

Bpifrance informed Innate that its permanent representative at Innate’s Supervisory Board, Ms. Maylis Ferrere will be replaced by Mr. Olivier Martinez, Senior Investment Director in the Life Sciences Investments Department of the Direction of Innovation of Bpifrance, who has been Observer of Innate’s Supervisory Board since 2010.
Announced on May 28, 2021, Novo Nordisk A/S, represented by Marcus Schindler, M.D., decided not to seek re-election to the Supervisory Board due to Dr. Schindler’s new role as Executive Vice President Research & Early Development and Chief Scientific Officer of Novo Nordisk A/S. Novo Nordisk A/S remains a shareholder in the Company but no longer has a seat on its Supervisory Board.