On October 27, 2023 Theseus Pharmaceuticals, Inc. (the "Company") reported written notice to ARIAD Pharmaceuticals, Inc. ("ARIAD") of its termination of the License Agreement, dated June 13, 2018, between the Company and ARIAD (the "ARIAD License Agreement"), which termination will be effective in accordance with the terms of the termination for convenience clause of such agreement (Filing, 8-K, Theseus Pharmaceuticals, OCT 27, 2023, View Source [SID1234636556]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company previously announced in July 2023 that it was discontinuing enrollment in the ongoing Phase 1/2 study and terminating development of THE-630 in patients with gastrointestinal stromal tumors. THE-630 is derived from intellectual property licensed to the Company under the ARIAD License Agreement and is therefore subject to the ARIAD License Agreement. In connection with the termination of development of THE-630, the Company is terminating the ARIAD License Agreement. The Company did not use any intellectual property licensed to the Company, or any biological materials provided to the Company, under the ARIAD License Agreement to develop any of the Company’s other programs.

Under the ARIAD License Agreement, the Company acquired an exclusive, transferable (subject to certain restrictions), sublicensable (subject to certain conditions), worldwide license, under certain of ARIAD’s patent rights, know-how and compounds and a certain ARIAD chemical library, to develop, use, manufacture, market and commercialize certain compounds, and products that contain such compounds, that are therapeutically useful for the treatment of diseases and disorders in humans, including with respect to KIT.

Pursuant to the terms of the ARIAD License Agreement and related stock purchase agreements, the Company issued an aggregate of 1,615,427 shares of the Company’s Series A Preferred Stock to ARIAD (which converted to shares of common stock of the Company in connection with the Company’s initial public offering in October 2021). If the Company had commercialized a product subject to the ARIAD License Agreement, the Company would have been obligated to make tiered royalty payments to ARIAD of low- to mid-single digits of the Company’s future net sales and those of the Company’s sublicensees of each product comprising a licensed ARIAD compound in each country, beginning on the first commercial sale of such product in such country and ending on the later of (1) ten years following such first commercial sale and (2) the expiry of all patents that cover the product in such country, or the royalty term.

On October 27, 2023 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with a strong unmet medical need, reported financial results for the quarter ended September 30, 2023 and provided a corporate update on recent developments (Press release, Oryzon, OCT 27, 2023, View Source [SID1234636420]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: "Oryzon continued with a strong path in its clinical programs in the third quarter. In CNS, we recently reported positive blinded aggregate safety data of 198 patients from our Phase IIb PORTICO trial with vafidemstat in BPD at the ECNP conference earlier this month. BPD is a highly unmet medical need and an enormous commercial opportunity with limited competition and a low risk of generification. PORTICO is now fully enrolled, and we remain on track to present top-line data early next year. The company has started a structured dialogue with corporate pharma to identify a suitable partner to move forward the asset to Phase III, pending positive results. Our Phase IIb trial with vafidemstat in schizophrenia, EVOLUTION, has also continued to enroll patients. We continue working for a future submission of an IND to initiate HOPE in 2024, the first randomized Phase I/II personalized medicine trial with an LSD1 inhibitor, in Kabuki Syndrome patients."

Dr Buesa continued: "In oncology, we also continued to make progress this quarter, with both iadademstat’s ongoing clinical trials, the FRIDA trial in combination with gilteritinib in relapsed/refractory FLT3-mutant AML patients, where a new cohort has been initiated, and the collaborative trial with the Fox Chase Cancer Center (FCCC) in combination with paclitaxel in neuroendocrine tumors, which is actively recruiting patients. In addition, and broadening our epigenetic pipeline, we reported positive preclinical efficacy data of ORY-4001, our selective HDAC-6 inhibitor recently nominated as a clinical development candidate, in Charcot-Marie-Tooth (CMT) at the Third Annual Global CMT Research Convention in Cambridge, U.S., and the medical team participated in several round tables."

Third Quarter and Recent Highlights

Vafidemstat in large multifactorial CNS indications:

Positive preliminary blinded aggregate safety data from PORTICO, vafidemstat’s Phase IIb clinical trial in BPD, reported at the 36th European College of Neuropsychopharmacology (ECNP) congress 2023, corresponding to the initial 198 randomized patients (data cut-off, August 23rd 2023). As of September 2023, PORTICO randomized 210 participants, and 131 of the originally planned participants (N = 150) already completed the trial. Results presented at ECNP 2023 confirm that PORTICO enrolled a representative real-world BPD population allowing common comorbidities and concomitant medications that are typically exclusionary in other BPD trials, as well as allowed subjects to receive psychotherapy during the trial. The screen failure and dropout rates were lower than in the most recent BPD clinical trial. Finally, the aggregated blinded safety data on the fully enrolled sample supports that vafidemstat has been extremely safe and well-tolerated, with a low discontinuation rate (2%) due to treatment-emergent adverse events (TEAEs) and 0% due to serious TEAEs (STEAEs). Only one serious TEAE deemed severe was reported, which fully recovered/resolved during the study. Current data of PORTICO continue to support that vafidemstat is safe and well-tolerated. Positive results from PORTICO’s interim analysis, conducted by the independent DMC in Q1 2023, were previously reported, with the trial being determined to be non-futile and to be continued with the planned enrollment number. PORTICO is a multicenter, double-blind, randomized, placebo-controlled Phase IIb conducted in the U.S. and EU to evaluate the efficacy and safety of vafidemstat in BPD patients. The trial has two independent primary objectives: reduction of aggression/agitation and overall BPD improvement. The trial is fully recruited and last patient out is expected before the end of 2023. Topline results are expected in Q1 2024, followed by a full data presentation at a psychiatric conference, as well as in a peerreviewed journal publication.
The EVOLUTION Phase IIb clinical trial with vafidemstat in patients with schizophrenia continues to enroll patients. This Phase IIb study aims to evaluate the efficacy of vafidemstat on negative symptoms and cognitive impairment in patients with schizophrenia. This project is partially financed with public funds from the Spanish Ministry of Science and Innovation and is being carried out in various Spanish hospitals.
Vafidemstat in monogenic CNS indications:

We continue the preparations of a new precision medicine trial in Kabuki Syndrome (KS). The company is in a dialogue with the regulatory agencies to refine the final design of this trial and expects to submit an IND for HOPE to the U.S. Food and Drug Administration (FDA) in 2024.
Iadademstat in oncology:

FRIDA, an open-label, multicenter Phase Ib clinical trial of iadademstat in combination with gilteritinib in patients with relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) harboring a FMS-like tyrosine kinase mutation (FLT3mut+), continues to enroll patients. The primary objectives of the trial are to evaluate the safety and tolerability of iadademstat in combination with gilteritinib in patients with FLT3mut+ R/R AML and to establish the Recommended Phase 2 Dose (RP2D) for this combination. Secondary objectives include the evaluation of the treatment efficacy, measured as the rate of complete remission and complete remission with partial hematological recovery (CR/CRh), the Duration of Responses (DoR), and the assessment of Measurable Residual Disease (MRD). The study is being conducted in the U.S. and will accrue up to approximately 45 patients. If successful, Oryzon and the FDA have agreed to hold a meeting to discuss the best plan to further develop this combination in this much-in-need AML population.
The collaborative Phase II basket trial of iadademstat in combination with paclitaxel in platinum R/R small cell lung cancer (SCLC) and extrapulmonary high-grade neuroendocrine tumors (NET trial) continues to enroll patients. This trial is being conducted in the U.S. under a collaborative clinical research agreement with the FCCC, under which the FCCC will be conducting different collaborative combination clinical trials with iadademstat, with Oryzon providing funding, the drug, and technical expertise.
Preparations for the STELLAR trial, a randomized, multicenter Phase Ib/II study of iadademstat plus a checkpoint inhibitor in first-line extensive-stage SCLC, are ongoing. The company believes that STELLAR could potentially support an application for accelerated approval.
Earlier stage programs:

Positive preclinical efficacy data in CMT with ORY-4001, a selective histone deacetylase 6 (HDAC-6) inhibitor, was presented at the Third Annual Global CMT Research Convention held in September. ORY-4001 treatment was able to reverse disease progression symptoms in a CMT mice model which reliably recapitulates many of the symptoms of this condition in humans, improving myelination and restoring axon integrity in the sciatic nerve, and improving compound muscle action potential and nerve conduction in comparison with untreated animals. The results presented are fruit of a collaboration entered in 2022 between Oryzon and the CMT Research Foundation (CMTRF), a U.S.-based patient-led, non-profit organization focused on delivering treatments and cures for CMT. ORY-4001 was recently nominated as a clinical development candidate for the treatment of certain neurological diseases as CMT, Amyotrophic Lateral Sclerosis (ALS) and others, and the compound will now enter into IND enabling studies to prepare it for clinical studies. HDAC6 inhibitors have been previously proposed as potentially effective treatments for CMT, ALS and other neurological disorders that lack effective treatments.
Financial Update: Third Quarter 2023 Financial Results

Research and development (R&D) expenses were $3.8 and $12.2 million for the quarter and nine months ended September 30, 2023, respectively, compared to $4.3 and $11.9 million for the quarter and nine months ended September 30, 2022.

General and administrative expenses were $0.7 and $2.9 million for the quarter and nine months ended September 30, 2023, respectively, compared to $0.7 and $3.3 million for the quarter and nine months ended September 30, 2022.

Net losses were $0.8 and $3.4 million for the quarter and nine months ended September 30, 2023, respectively, compared to $0.7 and $3.9 million for the quarter and nine months ended September 30, 2022. The result is as expected, given the biotechnology business model where companies in the development phase typically have a long-term maturation period for products, and do not have recurrent income.

Negative net result was $1.7 million (–$0.03 per share) for the nine months ended September 30, 2023, compared to a negative net result of $1.9 million (–$0.04 per share) for the nine months ended September 30, 2022.

Cash, cash equivalents and marketable securities totaled $8.8 million as of September 30, 2023.

On October 27, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported its financial results and business highlights for the six months ending June 30, 2023, and provides an outlook for the rest of the year (Press release, TME Pharma, OCT 27, 2023, View Source [SID1234636418]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Aram Mangasarian, CEO of TME Pharma commented: "This year has been a highly productive period for TME Pharma in which we have reported unprecedented survival rates for newly diagnosed brain cancer patients with chemotherapy resistant tumors not amenable to complete surgical removal receiving our lead asset NOX-A12 in combination with radiotherapy and VEGF inhibition. These maturing survival data not only position NOX-A12 as potentially the best available treatment for glioblastoma, but they also mean we have advanced to the point where we can now engage with the FDA on the next clinical and regulatory development steps for NOX-A12. These include an Investigational New Drug filing and potential access to expedited regulatory pathways, which we expect to achieve in early 2024. We are convinced that this will generate significant interest among investors and potential partners. This year has also seen TME Pharma take a major step forward in our commitment to our shareholders to end the use of convertible bond financing with the successful completion of a €2 million financing that included a lock-up of new shares and bond conversions for a period of six months. This innovative transaction secured new cash and investors while allowing us to remain focused on our goal of developing novel therapies for cancer and bringing them to market. We are solidly financed into 2024 and looking forward to achieving further clinical and regulatory progress in the months ahead."

Business and Clinical Highlights

GLORIA trial in first-line brain cancer (glioblastoma)

Maturing data from the ongoing GLORIA trial suggest a greater clinical benefit of NOX-A12 combination regimen with radiotherapy + VEGF inhibition over the standard of care:
67% of patients were alive 18 months after the start of their therapy vs. 5% in the standard of care reference cohort – a 13-fold improvement.
Median overall survival (mOS) exceeds 18 months and continues to improve further with three of six patients (50%) receiving treatment or follow-up care.
Maturing mOS >18 months has surpassed all relevant competitor trials conducted in the US and EU involving chemotherapy resistant (MGMT promoter unmethylated) population despite the fact that the NOX-A12 trial excluded patients with complete tumor resection (and thus a better prognosis) that were allowed into competitor trials.
50% of patients in the GLORIA trial expansion arm achieved a complete or near-complete response when treated with NOX-A12 + radiotherapy + VEGF inhibition.
Data identifying a potential predictive biomarker for glioblastoma patients treated with NOX-A12 and radiotherapy, the "EG12 score", were presented at the June 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
The EG12 score is based on histopathological assessment of tumor tissue collected during standard of care surgery before drug therapy and predicts which patients will benefit most from treatment with NOX-A12 and radiotherapy.
Patients with a high EG12 score had a significantly longer median progression-free survival than patients with a low EG12 score (6.0 months vs. 3.0 months, p=0.031) and a strong trend for longer median overall survival (15.8 months vs. 11.1 months, p=0.075).
Further in-depth analysis of how the combination of radiotherapy and NOX-A12 remodels the immune tumor microenvironment was showcased in October 2023 in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
The biomarker could help identify target populations for future clinical trials, thereby enhancing the statistical power of trials and reducing the risk of failure in further development.
First authorization for clinical trial of NOX-A12 in the US granted by US FDA
TME Pharma’s first Investigational New Drug (IND) application was approved by the US Food and Drug Administration (FDA) in May 2023 to evaluate the company’s lead asset NOX-A12 in the OPTIMUS Phase 2 clinical trial in pancreatic cancer. This represents the first comprehensive review and approval of NOX-A12 – and more broadly the first review of the Group’s class of compounds – by the FDA and will facilitate any future clinical development of NOX-A12 in the US. In addition to the US, the clinical trial protocol has been approved by regulatory authorities in France and Spain. To conduct the clinical trial, TME Pharma and MSD (Merck & Co., Inc., Kenilworth, N.J. USA) entered a clinical collaboration (it is the second clinical trial collaboration between the companies in this indication) by which MSD will provide pembrolizumab (Keytruda) and expert advice for the study protocol. TME Pharma is planning to initiate the trial when appropriate financing and drug supply are available beyond that needed for development of NOX-A12 in brain cancer.

H1 2023 Financial Highlights

For the reporting period, the Group – TME Pharma N.V., TME Pharma AG and TME Pharma Inc. – has not generated any revenues. The Group, like most pre-commercial biotech companies, does not expect any revenues to be generated from any product candidates that it develops until the Group either signs a licensing or collaboration agreement or obtains regulatory approval and commercializes its compounds.

Research and development (R&D) expenses decreased by 77% in H1 2023 over the same period last year. This significant reduction is primarily due to the GLORIA trial of NOX-A12 in brain cancer nearing completion, which required lower costs while at the same time generating more mature data. The process to bring the OPTIMUS pancreatic cancer trial Phase 2 protocol to FDA approval in the US was also successfully completed in Q2 2023, reducing ongoing costs related to this trial. As a result, TME Pharma was able to decrease drug manufacturing costs, service fees and other costs related to the clinical trials and preclinical testing, in addition to lower personnel expenses, patent costs and consulting services.

General and administrative (G&A) expenses decreased by 27% in H1 2023, mainly driven by lower personnel expenses and lower legal, consulting and audit fees. The net loss from operations for H1 2023 was €2.8 million, a 64% decrease on the prior year period. TME Pharma has focused its financial resources on achieving its primary near-term goal of generating mature overall survival data in the GLORIA trial of NOX-A12 in brain cancer. With the trial now nearing completion, TME Pharma will assess how and where to deploy the Group’s available financial resources to maximize the chances of NOX-A12 reaching the market.

In April 2023, the company raised €2 million as part of an innovatively structured transaction that involved €1.00 million in equity financing (gross) from a group of new investors and a €1.08 million convertible bond financing (nominal) under the agreement with Atlas Special Opportunities, LLC (ASO). ASO also converted €2 million convertible bonds into shares as part of the transaction at the same price per share as the new investors, thus aligning the financial interests of all investors participating in the transaction. In addition, TME Pharma has committed not to draw any further tranches from the ASO convertible bond vehicle and the agreement with ASO was terminated other than with regards to the convertible bonds held by ASO following the transaction.

This transaction thus marked the company’s commitment to end reliance on convertible bond financing. By removing the pressure of convertible bonds and introducing the six-month soft lock-up of shares, the company’s objective was to strengthen its position and valuation in the financial market. Considering cash and cash equivalents of €3 million as of June 30, 2023, TME Pharma has financial visibility into February 2024. Management is engaged in active discussions and anticipates the ability in the coming weeks to extend financial visibility beyond the planned regulatory value inflection points in 2024.

Outlook for the Remainder of 2023 and 2024

Progress of NOX-A12 program in glioblastoma
TME Pharma continues to make progress in its ongoing Phase 1/2 trial of NOX-A12 combination therapies in first-line brain cancer (glioblastoma) patients who are resistant to the current standard of care chemotherapy. The company has made the strategic decision to concentrate its available resources on advancing the development of NOX-A12 in glioblastoma since management believes that this indication offers the fastest path to regulatory approval for NOX-A12 in the solid tumor space. For the remainder of the year, the company expects to report additional clinical data as our clinical trial matures. At the Society for Neuro-Oncology (SNO) conference in November 2023, TME Pharma will provide updates on the progress of the bevacizumab expansion arm.

FDA advice and IND for NOX-A12 in glioblastoma
Based on the latest positive survival data reported on October 20, 2023, showing a landmark overall survival at 18 months (OS-18) of 67%, the Group plans to request formal advice from the FDA by the end of October 2023, with feedback expected in late December, regarding its planned clinical development approach for NOX-A12 in glioblastoma and its potential eligibility for expedited regulatory pathways, such as Fast Track Designation. TME Pharma then plans to file an Investigational New Drug (IND) application for glioblastoma with the FDA along with expedited regulatory pathway access request. Successful IND filing and feedback are targeted by end of Q1 2024.

Financial security for further development of NOX-A12 in glioblastoma
The financial environment of the last 30 months has proven to be the most demanding funding environment for public biotech companies over the last 20 years. The market has seen valuations fall across the board with the S&P Biotech Index1 down almost 60% since its peak in January 2021, with many institutional investors, including generalists and specialists, exiting the space and funding becoming increasingly challenging to source and secure. The company believes that with its lean structure and value created through its clinical performance, it is now better positioned in terms of its attractiveness to investors despite the current adverse financing conditions.

The Group will carefully monitor its available cash and calibrate additional financings through available sources in order to ensure its ability to continue to advance its clinical development plans in brain cancer and, to the extent deemed appropriate, maintain a sufficient cash runway, yet minimize shareholder dilution whenever possible.

On October 27, 2023 Intas Pharmaceuticals Limited ("Intas") reported that it has entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) for the development and commercialisation of serplulimab for Europe and India markets (Press release, Henlius Biopharmaceuticals, OCT 27, 2023, View Source;a-novel-anti-pd1-mab-in-europe–india-301970290.html [SID1234636417]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius. It has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Small Cell Lung Cancer (SCLC). Its marketing application for the first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is under review by the EMA. Serplulimab was launched in China under the trade name HANSIZHUANG in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC).

This collaboration deepens the strategic partnership between the two companies and opens new development opportunities for serplulimab’s global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing, and supply upon launch. Henlius will receive: i) a €42 million upfront payment, ii) up to €43 million in regulatory milestones, iii) up to €100 million in commercial sales milestones, and iv) double-digit royalties on net profit from Intas in the licensed territory.

Serplulimab will be commercialised by Intas in India and by its subsidiary, Accord Healthcare Ltd (Accord), in Europe. As one of the key players in the global oncology market, Accord has a longstanding commitment to oncology with proven commercial capabilities and currently supplies around one in three injectable oncology medicines in Europe.

In June 2018, Henlius and Accord entered into a license agreement, under which Henlius granted Accord exclusive commercialisation rights of HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name in Europe: Zercepac; trade names in Australia: Tuzucip/Trastucip) in certain countries and regions in Europe, the Middle East, North Africa, and the Commonwealth of Independent States. In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.

HANSIZHUANG (serplulimab) has become the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for 4 indications in China, benefiting over 40,000 Chinese patients. Its marketing application has been validated by the European Medicines Agency (EMA) in March 2023," said Jason Zhu, Executive Director, Chief Executive Officer, and Chief Financial Officer of Henlius. "By continuously partnering with Intas, we hope to accelerate serplulimab’s wider accessibility globally and contribute to the improvement of patient outcomes."

Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, "Henlius and Intas first entered into a collaboration in 2018. Over the past 5 years, we have worked closely together and expanded the internationalisation of HANQUYOU (Zercepac in Europe), which has been successfully approved in 40+ of overseas countries, benefiting patients in Europe and MENA. Building on the successful collaboration, we look forward to working with Intas to accelerate the launch of serplulimab in Europe and India, and to continue our mission to offering high-quality and affordable biologics to patients around the world."

Binish Chudgar, Vice-Chairman & Managing Director, Intas Pharmaceuticals Ltd., said, "We are excited to reinforce our long-standing partnership with Henlius. This collaboration will further bolster Intas’ global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide. The forthcoming launch of serplulimab in Europe and India will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve."

Paul Tredwell, Executive Vice President of EMENA., Accord, said, "I am delighted to strengthen our partnership with Henlius. The launch of serplulimab will further solidify Accord as a leader in providing specialty medicines. This marks our second novel launch in just two years, adding to our existing platform of supplying up to 25% of chemotherapy medicines in our region, exemplifying our commitment to innovation and growth and our mission to improve access to value-based medicines for patients."

About Serplulimab

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, non-proprietary name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. To date, four indications are approved for marketing in China, one marketing application is under review in the EU, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). Serplulimab’s marketing applications for the first-line treatment for ES-SCLC is under review by the EMA. Focusing on lung and gastrointestinal cancer, the synergy of serplulimab with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in China, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasians is over 30% in two MRCTs, making serplulimab an anti-PD-1 mAb with a significant global clinical data pool. The results of three pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, serplulimab was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. In addition, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare serplulimab to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well underway.

On October 27, 2023 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for the phase 2b study for Radspherin in patients with peritoneal carcinomatosis from colorectal cancer (Press release, Oncoinvent, OCT 27, 2023, https://www.oncoinvent.com/press-release/oncoinvent-announces-u-s-fda-clearance-of-investigational-new-drug-ind-application-for-radspherin-in-colorectal-cancer-patients/ [SID1234636416]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to announce the IND clearance for Radspherin for colorectal cancer patients following the promising indications of safety and efficacy from the RAD-18-002 Phase 1/2a clinical trial, " said Anders Månsson, Chief Executive Officer of Oncoinvent. "This is an important corporate milestone for Oncoinvent, allowing us to clinically advance Radspherin and expand to the U.S. landscape. Today’s announcement, in conjunction with the positive clinical data supporting Radspherin, continues to reinforce our belief in its transformative potential, and we look forward to advancing its clinical development."

In the ongoing phase 1/2a clinical trials with Radspherin, all dose levels have to date been well tolerated and 7MBq was selected as the recommended dose. Oncoinvent recently presented preliminary 18-month safety and efficacy data from the ongoing RAD-18-002 study in patients with peritoneal carcinomatosis from colorectal cancer at the 13th International Congress on Peritoneal Surface Malignancies (PSOGI). At 18 months, none of the 12 patients who received the recommended dose of 7 MBq experienced peritoneal recurrences.

Only 2.6% of all adverse events reported were considered to be related to Radspherin, all of which were grade 1-2.

The planned trial, for which we have now received FDA clearance, is a randomized controlled phase 2b trial, assessing efficacy and safety of Radspherin in patients with peritoneal carcinomatosis from colorectal carcinoma following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary objective for the trial, planned to start in Q2 of 2024, is to compare progression-free survival (PFS) between patients following CRS and HIPEC and Radspherin versus CRS and HIPEC.