A Phase I Study of Anetumab Ravtansine in Combination With Either Anti-PD-1 Antibody, or Anti-CTLA4 and Anti-PD-1 Antibodies or Anti-PD-1 Antibody and Gemcitabine in Mesothelin-Positive Advanced Pancreatic Adenocarcinoma

This phase I trial studies the side effects and best dose of anetumab ravtansine when given together with nivolumab, ipilimumab and gemcitabine hydrochloride in treating patients with mesothelin positive pancreatic cancer that has spread to other places in the body (advanced). Anetumab ravtansine is a monoclonal antibody, called anetumab ravtansine, linked to a chemotherapy drug called DM4. Anetumab attaches to mesothelin positive cancer cells in a targeted way and delivers DM4 to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving anetumab ravtansine together with nivolumab, ipilimumab, and gemcitabine hydrochloride may work better in treating patients with pancreatic cancer.

Start Date09 Dec 2019

Sponsor / Collaborator

National Cancer Institute

NCT03926143 / TerminatedPhase 2

An Open-label, Multicenter Rollover Study to Provide Continued Treatment With Anetumab Ravtansine for Participants With Solid Tumors Who Were Enrolled in Previous Bayer-sponsored Studies

The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.

Start Date03 Jun 2019

Sponsor / Collaborator

Bayer AG

NCT03587311 / Active, not recruitingPhase 2IIT

A Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian Cancer

This phase II trial studies the side effects of bevacizumab and anetumab ravtansine or paclitaxel in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that does not respond to treatment (refractory). Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Anetumab ravtansine is a drug that targets a protein in the body called mesothelin, which can be found in some ovarian, pancreatic and other tumors. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving bevacizumab and anetumab ravtansine or paclitaxel may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Start Date12 Oct 2018

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Anetumab ravtansine

100 Translational Medicine associated with Anetumab ravtansine

100 Patents (Medical) associated with Anetumab ravtansine

Literatures (Medical) associated with Anetumab ravtansine

01 Sep 2024·LUNG CANCER

Randomized trial of anetumab ravtansine and pembrolizumab compared to pembrolizumab for mesothelioma

Article

Author: Villaruz, Liza C ; Patel, Shiven ; Sharon, Elad ; Lou, Yanyan ; Rolfo, Christian ; Mikula, Elizabeth ; Kwiatkowski, David J ; Dizona, Paul ; Adjei, Alex ; Arnold, Susanne M ; Bazhenova, Lyudmila A ; Mansfield, Aaron S ; Forde, Patrick ; Chen, Li ; Smith, Katherine E R ; Bradbury, Penelope ; Xia, Bing ; Patel, Kashish ; Shapiro, Geoffrey ; Cao, Liang ; Koczywas, Marianna ; Khalil, Maya ; Kindler, Hedy L ; Moscow, Jeffrey A ; Costello, Brian A ; Zamboni, William ; Pacheco, Jose ; Hassan, Raffit ; Vivien Yin, Jun

PURPOSE:

The mesothelin-targeting antibody-drug conjugate anetumab ravtansine was evaluated in combination with the programmed cell death-1 (PD-1) inhibitor pembrolizumab based on the common expression of mesothelin and reports of activity in mesothelioma.

PATIENTS AND METHODS:

A phase 1 safety run-in of the combination of anetumab ravtansine (6.5 mg/kg iv q3weeks) and pembrolizumab (200 mg, IV q3weeks) was conducted, followed by a phase 2 randomization to the combination or pembrolizumab alone at medical centers across the United States and Canada in the National Cancer Institute's Experimental Therapeutics Clinical Trials Network. Patients with pleural mesothelioma that expressed mesothelin and had previously received platinum-based therapy were eligible.

RESULTS:

In phase 1 (n = 12) only one dose limiting toxicity was observed and the rules for dose reduction were not met. In phase 2, there was no difference in the confirmed response rates between the combination group (n = 18, 2 partial responses [PR], 11 %) and the pembrolizumab group (n = 17, 1 PR, 6 %; z = -0.5523, p = 0.29116). The median PFS was 12.2 months (95 % CI 5.1-not evaluable [NE]) for the combination, and 3.9 months for pembrolizumab (95 % CI 2.1-NE)(HR=0.55, p = 0.20). Patients with high baseline levels of soluble mesothelin who received anetumab ravtansine had a median PFS of 5 months.

CONCLUSIONS:

The numeric difference in PFS between treatment groups was not statistically significant, likely related to a smaller than planned sample size. High levels of soluble mesothelin should potentially be considered to select against the use of mesothelin-targeting therapies in development that are neutralized by soluble mesothelin.

01 Apr 2023·International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

Safety and activity of anti-mesothelin antibody–drug conjugate anetumab ravtansine in combination with pegylated-liposomal doxorubicin in platinum-resistant ovarian cancer: multicenter, phase Ib dose escalation and expansion study

Article

Author: Walter, Annette O ; Romero, Ignacio ; Copeland, Larry J ; Schulz, Anke ; Schlicker, Andreas ; Santin, Alessandro D ; Elbi, Cem ; Childs, Barrett H ; Köchert, Karl ; Herzog, Thomas J ; Coleman, Robert L ; Vergote, Ignace ; Moore, Kathleen ; Monk, Bradley J ; González-Martín, Antonio ; Oaknin, Ana ; Siegel, Jonathan ; Kasten, Linda ; Bulat, Iurie ; Diab, Sami

Objectives:

Anetumab ravtansine is an antibody-drug conjugate consisting of a fully human anti-mesothelin monoclonal antibody conjugated to cytotoxic maytansinoid tubulin inhibitor DM4. Mesothelin is highly expressed in ovarian cancer. This phase Ib study determines the safety, pharmacokinetics, and anti-tumor activity of anetumab ravtansine and pegylated liposomal doxorubicin in mesothelin-expressing platinum-resistant ovarian cancer.

Methods:

Anetumab ravtansine (5.5 or 6.5 mg/kg) and pegylated liposomal doxorubicin (30 mg/m2) were administered intravenously every 3 weeks to 65 patients with platinum-resistant epithelial ovarian cancer. Mesothelin expression was assessed by central immunohistochemistry. Adverse events, tumor response (RECIST 1.1), and progression-free survival were determined. Biomarker samples were assessed by ELISA and next-generation sequencing.

Results:

In dose escalation, nine patients received anetumab ravtansine across two doses (5.5 or 6.5 mg/kg). The maximum tolerated dose of anetumab ravtansine was 6.5 mg/kg every 3 weeks and no dose-limiting toxicities were observed. In dose expansion, 56 patients were treated at the maximum tolerated dose. The most common treatment-emergent adverse events of any grade were nausea (47.7%), decreased appetite (43.1%), fatigue (38.5%), diarrhea (32.3%), and corneal disorder (29.2%). In all treated patients the objective response rate was 27.7% (95% CI 17.3% to 40.2%), including one complete (1.5%) and 17 partial responses (26.2%), with median duration of response of 7.6 (95% CI 3.3 to 10.2) months and median progression-free survival of 5.0 (95% CI 3.2 to 6.0) months. In an exploratory analysis of a sub-set of patients (n=19) with high mesothelin expression who received ≤3 prior lines of systemic therapy, the objective response rate was 42.1% (95% CI 20.3% to 66.5%) with a median duration of response of 8.3 (95% CI 4.1 to 12.0) months and median progression-free survival of 8.5 (95% CI 4.0 to 11.4) months.

Conclusions:

Anetumab ravtansine and pegylated liposomal doxorubicin showed tolerability and promising clinical activity. These results established the dose schedule and the mesothelin-positive target population of this combination for a phase III study in platinum-resistant ovarian cancer.

Trial registration number:

NCT02751918.

01 Apr 2022·The Lancet. OncologyQ1 · MEDICINE

Anetumab ravtansine versus vinorelbine in patients with relapsed, mesothelin-positive malignant pleural mesothelioma (ARCS-M): a randomised, open-label phase 2 trial

Q1 · MEDICINE

Article

Author: Cedrés, Susana ; Siegel, Jonathan M ; Ceresoli, Giovanni L ; Bearz, Alessandra ; Calabrò, Luana ; Kindler, Hedy L ; Blumenschein, George ; Novello, Silvia ; Spicer, James ; Santoro, Armando ; Nowak, Anna K ; Elbi, Cem ; Burgers, Jacobus A ; Kasten, Linda ; Van Meerbeeck, Jan P ; Walter, Annette O ; Childs, Barrett H ; Fennell, Dean A ; Nackaerts, Kristiaan ; Köchert, Karl ; Ponce, Santiago ; Aerts, Joachim G J V ; Taylor, Paul ; Jennens, Ross ; Hassan, Raffit ; Serwatowski, Piotr ; Greystoke, Alastair

BACKGROUND:

Few treatment options exist for second-line treatment of malignant pleural mesothelioma. We aimed to assess the antibody-drug conjugate anetumab ravtansine versus vinorelbine in patients with unresectable locally advanced or metastatic disease overexpressing mesothelin who had progressed on first-line platinum-pemetrexed chemotherapy with or without bevacizumab.

METHODS:

In this phase 2, randomised, open-label study, done at 76 hospitals in 14 countries, we enrolled adults (aged ≥18 years) with unresectable locally advanced or metastatic malignant pleural mesothelioma, an Eastern Cooperative Oncology Group performance status of 0-1, and who had progressed on first-line platinum-pemetrexed chemotherapy with or without bevacizumab. Participants were prospectively screened for mesothelin overexpression (defined as 2+ or 3+ mesothelin membrane staining intensity on at least 30% of viable tumour cells by immunohistochemistry) and were randomly assigned (2:1), using an interactive voice and web response system provided by the sponsor, to receive intravenous anetumab ravtansine (6·5 mg/kg on day 1 of each 21-day cycle) or intravenous vinorelbine (30 mg/m² once every week) until progression, toxicity, or death. The primary endpoint was progression-free survival according to blinded central radiology review, assessed in the intention-to-treat population, with safety assessed in all participants who received any study treatment. This study is registered with ClinicalTrials.gov, NCT02610140, and is now completed.

FINDINGS:

Between Dec 3, 2015, and May 31, 2017, 589 patients were enrolled and 248 mesothelin-overexpressing patients were randomly allocated to the two treatment groups (166 patients were randomly assigned to receive anetumab ravtansine and 82 patients were randomly assigned to receive vinorelbine). 105 (63%) of 166 patients treated with anetumab ravtansine (median follow-up 4·0 months [IQR 1·4-5·5]) versus 43 (52%) of 82 patients treated with vinorelbine (3·9 months [1·4-5·4]) had disease progression or died (median progression-free survival 4·3 months [95% CI 4·1-5·2] vs 4·5 months [4·1-5·8]; hazard ratio 1·22 [0·85-1·74]; log-rank p=0·86). The most common grade 3 or worse adverse events were neutropenia (one [1%] of 163 patients for anetumab ravtansine vs 28 [39%] of 72 patients for vinorelbine), pneumonia (seven [4%] vs five [7%]), neutrophil count decrease (two [1%] vs 12 [17%]), and dyspnoea (nine [6%] vs three [4%]). Serious drug-related treatment-emergent adverse events occurred in 12 (7%) patients treated with anetumab ravtansine and 11 (15%) patients treated with vinorelbine. Ten (6%) treatment-emergent deaths occurred with anetumab ravtansine: pneumonia (three [2%]), dyspnoea (two [1%]), sepsis (two [1%]), atrial fibrillation (one [1%]), physical deterioration (one [1%]), hepatic failure (one [1%]), mesothelioma (one [1%]), and renal failure (one [1%]; one patient had 3 events). One (1%) treatment-emergent death occurred in the vinorelbine group (pneumonia).

INTERPRETATION:

Anetumab ravtansine showed a manageable safety profile and was not superior to vinorelbine. Further studies are needed to define active treatments in relapsed mesothelin-expressing malignant pleural mesothelioma.

FUNDING:

Bayer Healthcare Pharmaceuticals.

News (Medical) associated with Anetumab ravtansine

13 Sep 2022

·www.globenewswire.com

CytomX Therapeutics Announces Phase 1 Data Update for anti-CTLA-4 Probody® Therapeutic BMS-986249

SOUTH SAN FRANCISCO, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today announced that its collaborator, Bristol Myers Squibb, presented updated Phase 1 results with BMS-986249, a Probody® therapeutic version of ipilimumab, the anti-CTLA-4 antibody, at the ESMO Congress 2022 in Paris, France. “BMS-986249 is a conditionally activated CTLA-4-targeting antibody that has shown clinical activity in multiple tumor types, and the safety profile and disease control rate observed in the updated Phase 1 data for BMS-986249 with and without nivolumab is promising. BMS-986249 appears to be tolerated at higher doses than traditional ipilimumab dosing, and we are encouraged by the report of a complete response in melanoma and a case study of a partial response in microsatellite-stable colorectal cancer. This Phase 1 study set the stage for the ongoing randomized Phase 2 trial of BMS-986249 in melanoma evaluating the potential differentiation of the Probody from ipilimumab, and we look forward to results from this study in due course,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. About CytomX Therapeutics, Inc. CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises seven therapeutic candidates across multiple treatment modalities. Three of these candidates are in Phase 2 studies across multiple cancer types, including CX-2029 and praluzatamab ravtansine. CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie. Praluzatamab ravtansine is an investigational conditionally activated ADC directed toward CD166 and is being studied in patients with advanced breast cancer. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly-owned assets such as CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors, and CX-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has established strategic collaborations with multiple leaders in oncology, including AbbVie, Amgen, Astellas, and Bristol Myers Squibb. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and Twitter.

CollaborateAntibodyADCPhase 1Clinical Result

08 Sep 2022

·www.globenewswire.com

CytomX Therapeutics Presents Overview of Conditionally-Activated Antibody-Drug Conjugate (ADC) Programs Including Next Generation EpCAM-Targeting CX-2051

SOUTH SAN FRANCISCO, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today announced that the Company presented advances within its conditionally-activated ADC portfolio, including the next generation EpCAM-ADC, CX-2051, at the World ADC conference taking place September 6-9, 2022, in San Diego, CA. “The momentum in the field of ADC therapeutics is incredibly exciting and holds great promise for the innovation and development of novel oncology therapeutics. Our pioneering work and experience in applying our versatile Probody® platform to the ADC modality has the potential to expand the universe of addressable targets and to further increase the therapeutic window of future molecules entering the clinic,” said Marcia P. Belvin, Ph.D., senior vice president and head of research at CytomX. “CX-2051, our EpCAM-targeted, conditionally activated ADC, is strategically tailored to optimize the therapeutic index for systemic treatment of EpCAM-expressing epithelial cancers, which is an area of high unmet need where, to date, efforts have not been successful due to dose-limiting toxicities.” “Our strategy with CX-2051 is to match payload mechanism of action with tumor sensitivity, and we have selected the topoisomerase-1 inhibitor, camptothecin, as the payload for our newest ADC,” Dr. Belvin continued. “Topoisomerase-1 inhibitor-conjugated ADCs are showing impressive clinical activity, and importantly, the safety profiles of camptothecin and its derivatives have been well characterized. Additionally, two camptothecin derivatives, irinotecan and topotecan, have been approved by the U.S. Food and Drug Administration for clinical use - irinotecan for pancreatic and colorectal cancer, and topotecan for ovarian, cervical, and small cell lung cancer. We plan to pursue multiple indications with this new therapeutic candidate and look forward to progressing to an investigational new drug application submission in the second half of 2023.” Presentation highlights include: Review of clinical activity for the conditionally activated ADCs CX-2029 and praluzatamab ravtansine (CX-2009), targeting CD71 and CD166, respectively. CD71 and CD166 have historically been inaccessible targets for traditional ADCs due to their high expression levels on normal tissues. The data presented demonstrate clinical anti-cancer activity and a therapeutic window for these previously undruggable targets. The molecular structure of CX-2051, a masked, conditionally activated, EpCAM-targeting ADC with a next generation camptothecin-based linker payload. CX-2051 highlights the potential for CytomX’s Probody technology to unlock a new ADC target (EpCAM/Trop-1), which is a target that has previously yielded promising clinical results only through locally administered therapies. CX-2051 preclinical data indicating strong anti-cancer activity and tolerability with a favorable predicted therapeutic index. The full presentation is available at the following link: Tailoring the Selection of Target, Payload, & Tumor Type to Maximize the Therapeutic Index of Conditionally Activated ADCs Marcia P. Belvin, Ph.D., Senior Vice President, Head of Research, CytomX Therapeutics Presentation Link About CytomX Therapeutics, Inc. CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises seven therapeutic candidates across multiple treatment modalities. Three of these candidates are in Phase 2 studies across multiple cancer types, including CX-2029 and praluzatamab ravtansine. CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie. Praluzatamab ravtansine is an investigational conditionally activated ADC directed toward CD166 and is being studied in patients with advanced breast cancer. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly-owned assets such as CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors and CX-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has established strategic collaborations with multiple leaders in oncology, including AbbVie, Amgen, Astellas, and Bristol Myers Squibb. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and Twitter.

CollaborateAntibodyADC

05 Aug 2022

·www.globenewswire.com

Press Release: Sanofi and Innovent Biologics enter strategic collaboration to accelerate development of oncology medicines and expand presence in China

Paris, August 4, 2022. Sanofi and Innovent Biologics (HKEX: 1801.HK, “Innovent”) announced a collaboration to bring innovative medicines to patients in China with difficult-to-treat cancers. Innovent is a leading biopharmaceutical company with strong clinical development capabilities and a broad commercial footprint in China. Both companies are committed to accelerating the development and commercialization of two Sanofi key clinical stage oncology assets: Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2), combining with sintilimab, the leading checkpoint inhibitor in China. In addition to the collaboration and license agreement, Sanofi will invest €300 million in Innovent through subscription of new common shares. John Reed, M.D., Ph.D. Global Head of Research and Development at Sanofi “This strategic collaboration with Innovent will not only accelerate the development, market access and future commercialization of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China. We look forward to a successful partnership with Innovent, one of the most innovative companies in China, and to leveraging their development capabilities and market leadership in the country.” Michael Yu, Ph.D. Founder, Chairman and CEO of Innovent “This strategic collaboration with Sanofi, a leading global pharmaceutical company, opens the pathway to great synergy for accelerating the pace of innovation. This pioneering partnership will leverage the synergy between Sanofi and Innovent’s pipeline and R&D resources with the mutual aim to address major unmet medical needs for cancer patients. We hope this agreement will be a great start of the two parties’ long-term partnership, and we look forward to bringing more innovative therapies to patients.” Clinical development and commercialization of tusamitamab ravtansine SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. SAR408701 is currently in a Phase 3 study for 2L NSCLC globally including China, and global Phase 2 studies in additional indications including 1L NSCLC, gastric cancers and other solid tumors. According to the agreement, Innovent will be responsible for developing and exclusively commercializing tusamitamab in multiple oncology-based indications in China. Sanofi will be entitled to receive up to €80 million development milestone payment and royalties on the net sales of the product in China upon approval. Clinical development and commercialization of SAR444245 SAR444245 is a potential first-in-class reprogrammed, site-directed, single PEGylated, recombinant human IL-2 (rIL-2) variant with extended half-life that specifically binds to the low-affinity IL-2 receptor but lacks binding affinity for the αlpha chain of the high-affinity IL-2 receptor. SAR444245(IL-2) is currently under global Phase 2 studies for skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma. Innovent and Sanofi will jointly explore the development of SAR444245 in China in various cancer types, where Innovent will lead the clinical development. Sanofi remains the sole Marketing Authorization holder for both assets and will be fully responsible for SAR245 commercialization. Innovent will be entitled to receive up to €60 million development milestone payments and royalties on the net sales of the product in China upon approval. Sanofi’s initial strategic equity investment in Innovent for €300 million In addition to the strategic multi-product collaboration and license agreement, Sanofi, subject to conditions precedent including regulatory approval and customary closing conditions, will invest in new common shares issued by Innovent for €300 million, at a price of HK $42.42 per share, representing a 20% premium to the Innovent 30-trading-day average share price as of August 3, 2022, one day prior to the signing of the agreements. Subject to mutual agreement of both parties in the future, Sanofi will have the right to acquire additional Innovent new common shares for €300 million, at a subscription price that represents 20% premium to Innovent 30-trading-day average share price as the date of the separate agreement that may be entered into by both parties. About SAR408701 SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. Tusamitamab ravtansine is currently in a Phase 3 study for second-line NSCLC globally including China, and global Phase 2 studies in additional indications including first-line NSCLC, gastric cancers and other solid tumors. About SAR444245 SAR444245 is a potential first-in-class recombinant human IL-2 (rIL-2) variant that includes a site-directed single PEG moiety/chain that prevents it from binding to the α chain of the IL-2 receptor while retaining near-native affinity for the beta/gamma subunits. SAR444245 is currently being investigated in global Phase 2 studies for the treatment of skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma. About Sintilimab (TYVYT®) Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. In China, sintilimab has been approved for six indications including relapsed or refractory classic Hodgkin’s lymphoma, first-line treatment of non-squamous NSCLC, first-line treatment of squamous NSCLC, first-line treatment of hepatocellular carcinoma, first-line treatment of esophageal squamous cell carcinoma, and first-line treatment of gastric or gastroesophageal junction adenocarcinoma, of which the first four indications have been included in the National Reimbursement Drug List (NRDL). Note: SAR408701 and SAR444245 are not approved products in China About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 34 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

CollaborateSmall molecular drugAntibodyFinancial StatementFirst in Class

100 Deals associated with Anetumab ravtansine

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 2	US	Bayer AG	03 Jun 2019
Solid tumor	Phase 2	FR	Bayer AG	03 Jun 2019
Solid tumor	Phase 2	IT	Bayer AG	03 Jun 2019
Solid tumor	Phase 2	PL	Bayer AG	03 Jun 2019
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 1	US	Bayer AG	08 Jun 2016
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 1	BE	Bayer AG	08 Jun 2016
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 1	MD	Bayer AG	08 Jun 2016
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 1	ES	Bayer AG	08 Jun 2016
Recurrent Platinum-Resistant Ovarian Carcinoma	Phase 1	US	Bayer AG	08 Jun 2016
Recurrent Platinum-Resistant Ovarian Carcinoma	Phase 1	BE	Bayer AG	08 Jun 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03126630 (CTgov)	Phase 1/2	Malignant Pleural Mesothelioma	49	Pharmacological Study+pembrolizumab (Group I (Pembrolizumab))	icyroghhti(ufnbkbxojd) = lbpccwzhjr cifcvbyqte (aerfqvdzld, nvcxcmbvzm - ywahnvwasx) View more	-	16 Oct 2024
				Pharmacological Study+Anetumab Ravtansine+pembrolizumab (Group II (Anetumab Ravtansine, Pembrolizumab))	icyroghhti(ufnbkbxojd) = gmleerkags cifcvbyqte (aerfqvdzld, rovbqwblny - xndjbljbxs) View more
NCT03126630 (WCLC2023) Manual	Phase 1/2	Malignant Pleural Mesothelioma Mesothelin Positive	35	Anetumab ravtansine + Pembrolizumab	plvexmmxxk(ohywbqrsxc) = pdulfdhucl cpvwgaocma (xqysgoqzrt ) View more	Negative	10 Sep 2023
				Pembrolizumab	plvexmmxxk(ohywbqrsxc) = rzknokbrsr cpvwgaocma (xqysgoqzrt ) View more
NCT03926143 (CTgov)	Phase 2	Solid tumor	9	Anetumab Ravtansine	suhtasmsvj(qoknkrxnld) = jjcjkklief qegzacroan (ttoymicbpi, jnabemlyib - pnrmkfvzdq) View more	-	04 Aug 2023
NCT03587311 (NCI 10150, ASCO2022)	Phase 2	Platinum-Resistant Ovarian Carcinoma	57	Anetumab ravtansine (AR) + bevacizumab (ARB)	dkdhhvyggl(xjoipumjhl) = volrnozetr rysubafvso (zqfzrozkrc ) View more	Negative	02 Jun 2022
				Weekly paclitaxel + bevacizumab (PB)	dkdhhvyggl(xjoipumjhl) = upgveruxdw rysubafvso (zqfzrozkrc ) View more
NCT03816358 (ASCO2022)	Phase 1	Advanced Pancreatic Adenocarcinoma	33	Anetumab ravtansine + Nivolumab	umramtsbxx(tqjjejegbz) = G1/2 blurred vision in 5/33 (15%) svrsoqeoen (snnjxpeqms ) View more	-	02 Jun 2022
				Anetumab ravtansine + Nivolumab/Ipilimumab
IGCS2020	Phase 1	Platinum-Resistant Primary Peritoneal Carcinoma mesothelin-positive	65	Anetumab ravtansine	ieujbuhefh(zhupbuuyuf) = gfwnucfaka aydbotwhjm (hepargxvva, 16.0–38.5) View more	-	13 Nov 2020
				Pegylated liposomal doxorubicin	klcfaluuge(xhsweeriks) = vdtgdlzbcv msjruncave (xpncbwvfjq )
NCT01439152 (Pubmed \| J Urol) Manual	Phase 1	Solid tumor	116	Anetumab Ravtansine	gtqapkqqkf(yysgdvorvt) = exwsfkraut ipmzglrqhm (ssrdgfinwk ) View more	Positive	01 Jun 2020
NCT03455556 (CTgov)	Phase 1	Non-small cell lung cancer stage IIIA \| Non-small cell lung cancer stage IIIB \| Advanced Lung Non-Small Cell Carcinoma	1	Laboratory Biomarker Analysis+Anetumab Ravtansine+Atezolizumab	avllagtyqo(kopqrvyjfi) = emhmkqgodz jjhyfiitds (bpxcxcgidx, aciwfdypez - evjtwzdobg) View more	-	15 May 2020
NCT02839681 (CTgov)	Phase 2	Lung Cancer \| Adenocarcinoma of Lung	2	Blood test+Anetumab Ravtansine	esztxgbhoj(qdgluckpvh) = yticqqprko fwbuajybav (ycmzawjovc, zplthtmbtr - dwepfzjdda) View more	-	21 May 2019
NCT01439152 (ASCO2016)	Phase 1	Mesothelin positive Neoplasms	147	Anetumab ravtansine (AR)	rcctvoptuy(wboclpouuj) = Adverse events (AEs) were similar to the mesothelin-ADC inhibitor class, including reversible keratopathy, asymptomatic liver function test increases, and gastrointestinal disorders rwsyfwpqwl (bkbmhrdbab ) View more	Positive	20 May 2016

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