On May 12, 2021 Ryvu Therapeutics (WSE: RVU) reported its first quarter 2021 financial results and provided a corporate update (Press release, Ryvu Therapeutics, MAY 12, 2021, View Source [SID1234579833]).

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"Q1 2021 was an eventful quarter for Ryvu and developments around RVU120 played a key role in it" – commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu. "We have submitted a clinical trial application to conduct a Phase I/II study of RVU120 in patients with solid tumors, and shortly after that we received an approval to expand the ongoing Phase I of RVU120 in AML and high risk MDS from US sites to Poland. We have also secured a non-dilutive grant to finance the RVU120 solid tumor study. Despite the recent partial clinical hold imposed on RVU120 Phase Ib study, we have achieved meaningful research progress in our clinical and pre-clinical pipeline in these first months of 2021. Patient safety is Ryvu’s priority, and we are working diligently to answer the FDA questions and expect to resume study enrollment as soon as possible. At the same time we believe that RVU120 continues to be a promising treatment option for cancer patients and we hope to soon resume investigating the therapeutic potential which this compound holds" – adds Przewiezlikowski.

Recent Achievements

RVU120 Solid Tumor CTA submission
On January 04, Ryvu submitted a new Clinical Trial Application (CTA), seeking approval to commence a Phase I/II trial, investigating the safety and efficacy of RVU120 (SEL120), a first-in-class, selective oral CDK8/19 inhibitor, in patients with relapsed/refractory metastatic or advanced solid tumors. The CTA has been submitted to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and to the study Central Ethics Committee. Following the approval of the CTA, expected in H1 2021, Ryvu Therapeutics will be able to activate the selected clinical sites in Poland and start enrolling patients.

RVU120 AML CTA approval
On January 07, Ryvu announced that its Clinical Trial Application (CTA) to commence the first-in-human (FIH), Phase I trial investigating RVU120, in patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (HRMDS), who have failed the prior standard treatment, has been fully approved by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the respective Central Ethics Committee. Following these approvals, Ryvu can expand the clinical trial ongoing in the United States to Poland, aiming to assess the safety and tolerability of RVU120 and to determine the recommended Phase II dose (RP2D) of the study drug, in participants with AML or HRMDS.

USD 5 million non-dilutive grant financing secured
On January 18, Ryvu announced that its project titled "Clinical development of an innovative drug candidate in solid tumors", which focuses on Phase I/II evaluation of RVU120 in patients with solid tumors, has been approved for financing by the National Center for Research and Development (NCBiR). This grant provides Ryvu with $5.0 million of non-dilutive financing. The total net value of the project amounts to $11.1 million and the anticipated project duration is until December 2023.

Distinction in Warsaw Stock Exchange Company of the Year competition
On March 16, Ryvu was awarded third place in the "Products and Services Innovation" category in the Warsaw Stock Exchange Company of the Year competition. The Stock Exchange Company of the Year competition is organized by "Puls Biznesu" – one of the largest business daily publications in Poland. It was the 22nd edition of the competition, the oldest and the most prestigious ranking in the Polish capital market. Every year the best publicly traded companies on the Warsaw stock exchange are awarded by a jury comprised of market analysts, investment advisers and managers, institutional investors, and securities house representatives.

Important milestones in 2021, before the report date

On April 10-15, Ryvu presented recent data from multiple oncology programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting 2021. Data presented included results from the RVU120, a CDK8/CDK19 inhibitor program, as well as data from small-molecule STING agonists and HPK1 inhibitor projects. Presented posters can be downloaded from Ryvu’s website: View Source
On April 08, Ryvu announced the U.S. Food and Drug Administration placed a partial clinical hold on the first-in-human Phase Ib, dose escalation clinical trial of RVU120 in patients with relapsed/refractory (R/R) AML and high-risk MDS, being conducted in the United States. Patients who are currently taking RVU120 may continue treatment in the study, but no new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA.
The partial clinical hold was initiated following Ryvu’s recent report to the FDA of a Serious Adverse Event involving a patient death, classified as possibly related to RVU120. One of the two patients enrolled in Cohort 5, 110 mg dose level, of RVU120 experienced a fatal incidence of "Worsening Pancreatitis". The other patient in the same dose cohort, completed the 1st treatment cycle without any serious adverse events (SAE) reported by the investigational site and entered Cycle 2. There are currently two patients continuing to receive treatment with RVU120 in the study.
On April 26, Ryvu announced the appointment of Vatnak Vat-Ho to the role of Chief Business Officer. As CBO, Mr. Vat-Ho will be responsible for a wide scope of corporate and business development activities at Ryvu including strategic positioning, partnering discussions, alliance management as well as investor interactions.
In Q1 2021, Ryvu Therapeutics participated and presented at several investor conferences, including Solebury Trout 1×1 Management Access Event, HCW Bioconnect Conference, IPOPEMA & Sova Capital: EM Medical/Healthcare Day, BIO-Europe Spring 2021 and AACR (Free AACR Whitepaper) Virtual Annual Meeting 2021.

Ryvu First Quarter 2021, Financial Results

In the past quarter, Ryvu Therapeutics noted a 51% decrease in its revenues, down to PLN 6.6 million ($1.8 million). Revenues from subsidies have slightly increased from PLN 5.7 million ($1.5 million) in Q1 2020, up to PLN 6.1 million ($1.6 million) in Q1 2021, however, there were no significant partnering revenues in Q1 2021 compared to Q1 2020, when milestone from SEL24 / MEN1703 was recognized.

Operational costs related in majority to the research and development expenditures, increased by 20% to PLN 22.3 million ($5.9 million), as compared to PLN 18.6 million ($4.7 million) in first quarter last year. Operational loss has increased and amounted to PLN 15.7 million ($4.1 million), compared to PLN 5.0 million ($1.3 million) in Q1 2020.

On May 5, 2021, Ryvu Therapeutics held PLN 129.3 million ($32.6 million) in cash, cash equivalents, and short-term investments.

On May 12, 2021 Sosei Group Corporation ("the Company") (TSE: 4565) provides an update on operational activities and reported its consolidated results for the first quarter ended 31 March 2021 (Press release, Sosei, MAY 12, 2021, View Source [SID1234579832]). The full report can be accessed by clicking here.

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Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented: "We continue to make good progress expanding our drug discovery business and remain well positioned to capitalize on a range of growth opportunities. We have initiated several exciting new technology collaborations designed to enhance our world-leading discovery platform and extend the reach of its application, including beyond GPCRs for the first time. We have made good progress with our partnered programs, which have delivered multiple milestones and generated important revenues since the start of the year. Meanwhile, our inhouse programs provide us with a rich source of future partnering opportunities that we are exploring. We have ambitious plans and expect 2021 to be a year of increased investment in strategic growth initiatives, both organic and inorganic, and believe we have the right strategy to deliver continued success and value creation for all stakeholders."

Operational Highlights for Q1 2021

New strategic technology collaboration with PharmEnable for AI-driven drug discovery – aim to identify new leads against a challenging "peptidergic" GPCR target
First strategic collaboration to explore SBDD approaches beyond GPCRs with Metrion Biosciences – collaboration targeting ion channels, a large, under-exploited target class where structural input to drug discovery has been limited. Drug discovery program to identify novel, highly specific leads for further development against a single ion channel associated with neurological diseases.
Worldwide rights to out-licensed muscarinic agonist programs regained from AbbVie/Allergan – independent review of programs has completed, with increased investment allocated to advance the HTL0016878 selective muscarinic M4 agonist through clinical studies and build value ahead of future partnering. HTL0016878 represents a unique opportunity to develop a novel therapeutic with a new mechanism of action for neurological disorders including schizophrenia. Negotiations for collaborations on this and other muscarinic programs are now in progress.
Two milestone payments totalling US$4 million received from Genentech during Q1 2021 – milestones achieved from the delivery of StaR proteins based on nominated targets under the 2019 multi-target agreement.
Spin-off company Orexia Therapeutics merged into Centessa Pharmaceuticals, a new asset-centric company – Orexia became one of ten private companies merged into Centessa, which launched in February 2021 and raised US$250 million. Sosei Heptares’ equity holding in Orexia was converted into a proportional shareholding in Centessa, which filed for an Initial Public Offering on Nasdaq in April 2021.
US$2.5 million milestone received from Formosa Pharmaceuticals – based on progression of APP13007, a divested asset, into Phase 3 trials as a new potential treatment for pain and inflammation following cataract surgery.
Financial Highlights for the Three-month Period ended 31 March 2021

Revenue totalled JPY 1,207 million (US$11.4 million*), an increase of JPY 45 million (US$0.7 million) vs. the prior corresponding period. The increase was due to (i) the achievement of two milestones totalling US$4.0 million in Q1 2021 relating to the delivery of StaR proteins provided to Genentech (in respect of which US$2.1 million has been recognised) vs. the achievement of one US$1.5 million milestone in Q1 2020, and (ii) larger releases of deferred revenue in Q1 2021 due to there being an additional contract in the current quarter in respect of which revenue had been deferred in the past (AbbVie).
Cash R&D expenses totalled JPY 1,102 million (US$10.4 million), an increase of JPY 545 million (US$5.3 million) vs. the prior corresponding period. The increase relates primarily to (i) spend on new innovative research collaborations, including Metrion, PharmEnable and Captor; (ii) an expansion in R&D headcount to support the growth of the business; (iii) a low level of spend in the comparative period, which included some non-recurring credits, including the successful resolution of disputed costs charged by one supplier; and (iv) a stronger GBP vs. JPY.
Cash G&A expenses totalled JPY 641 million (US$6.0 million), an increase of JPY 204 million (US$2.0 million) vs. the prior corresponding period. The increase is primarily due to an increase in personnel related expenses. In the prior corresponding period, personnel related expenses were lower as a result of a reduction in the UK share based payment related National Insurance liability, which was driven by share price movements in that particular quarter.
Cash earnings net loss** totalled JPY 683 million (US$6.4 million), vs. a cash profit of JPY 12 million (US$0.1 million) in the prior corresponding period. The main reason for the increase in the operating loss is that the increase in Cash R&D and G&A costs exceeded the increase in revenue.
Operating loss totalled JPY 1,238 million (US$11.7 million) (vs. an operating loss of JPY 445 million (US$4.1 million in the prior corresponding period). The main reason for the increase in the operating loss is that the increase in operating expenses exceeded the increase in revenue.
Net loss totalled JPY 1,153 million (US$10.9 million) vs. a net loss of JPY 746 million (US$6.9 million) in the prior corresponding period. The main reason for the net loss is the increase in operating loss (for the reasons stated above).
Cash and cash equivalents as at March 31, 2021 increased by JPY 388 million (US$3.7 million) from the beginning of the year and amounted to JPY 40,396 million (US$364.8 million).
*Convenience conversion to US$ at the following rates: 2021: 1US$ =106.092 JPY; 2020: 1US$ =108.907 JPY

On May 12, 2021 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science product development across several market segments, reported that it will release its financial results for the first quarter of 2021 on Wednesday, May 26th, 2021 (Press release, Evogene, MAY 12, 2021, View Source [SID1234579831]). Mr. Ido Dor, Chief Executive Officer of Evogene’s subsidiary, Lavie Bio Ltd., will join the conference call to discuss Lavie Bio’s recent activity.

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On the day of the announcement, the Company’s management will host a conference call to discuss the results at 09:00 AM Eastern time, 16:00 Israel time. To access the conference call, please dial +1-888-281-1167 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

A replay of the conference call will be available approximately two hours following the completion of the call. To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5901 internationally. The replay will be accessible through May 28th, and an archive of the webcast will be available on the webcast link for the following twelve months.

On May 12, 2021 BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported financial results for the first quarter of 2021 and provided an update on its business (Press release, BioAtla, MAY 12, 2021, View Source [SID1234579829]).

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"BioAtla is rapidly advancing potentially registration-enabling Phase 2 clinical trials for our two lead CAB product candidates. With strong financial resources, we are also broadening our development pipeline to include several additional ADC and bispecific CAB candidates," stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. "Our clinical objectives in 2021 include providing Phase 2 interim data readouts by year-end for CAB-AXL-ADC and CAB-ROR2-ADC. Our Phase 1 trials for these product candidates demonstrated encouraging results in hard to treat cancer indications, particularly in patients with late-stage disease refractory to other lines of therapy," added Scott Smith, President of BioAtla.

Advancing clinical trials for lead candidates

BA3011
We are developing BA3011, CAB-AXL-ADC, a conditionally activated antibody drug conjugate targeting the receptor tyrosine kinase AXL, as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future. On March 1, 2021 the Office of Orphan Drug Products (OOPD) at FDA granted Orphan Drug Designation to BA3011 for the treatment of soft tissue sarcoma. In Phase 1, five partial responses (PR) were observed, four in sarcoma patients and one in a PD-1 refractory NSCLC patient. These responses occured in stage IV refractory patients with high AXL tumor membrane expression and at our recommended phase 2 dose (RP2D). We have initiated a potentially registration-enabling Phase 2 clinical trial of BA3011 given as monotherapy or in combination with a PD-1 inhibitor in soft tissue and primary bone sarcoma patients 12 years and older that are high AXL tumor membrane expressors (AXL high), and a Phase 2 study in AXL high NSCLC patients that have previously progressed on PD-1/L1 or EGFR inhibitor therapy. We expect to submit Phase 1 results in sarcoma patients for presentation at the Connective Tissue Oncology Society (CTOS) 2021 Annual Meeting in November. Interim analyses in the sarcoma and NSCLC trials are anticipated this year. In addition, a multi-center investigator-initiated Phase 2 clinical trial for BA3011 in platinum-resistant ovarian cancer in combination with a PD-1 inhibitor is currently under review by Health Canada and is expected to commence in the first half of this year in Canada and the United States.

BA3021
BA3021, CAB-ROR2-ADC, is a CAB antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are developing BA3021 as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, squamous cell cancer of the head and neck (SSCHN), and ovarian cancer. We completed a Phase 1 dose-escalation trial with BA3021 in which we observed one complete response (CR) and 3 PRs. The CR was observed in the only ROR2-positive melanoma patient enrolled in the trial. This stage IV melanoma patient had experienced prior therapy failures with nivolumab (PD-1 inhibitor), and with nivolumab in combination with ipilimumab (CTLA-4 inhibitor). A PR was observed in the only SSCHN patient enrolled in the study. This patient was ROR2 positive and was refractory to four lines of prior therapy including with cetuximab and with pembrolizumab. Additionally, PRs were observed in two stage IV ROR2-positive NSCLC patients, both of whom had failed prior PD-1 therapy. All responses occurred at exposure levels equivalent to the BA3021 RP2D. We believe BA3021 has broad potential as a cancer therapy for patients with advanced solid tumors that have previously progressed on a PD-1 inhibitor. We are presently enrolling a Phase 2 trial of BA3021 monotherapy or in combination with a PD-1 inhibitor in ROR2 high NSCLC and melanoma patients that have previously progressed on PD-1/L1 inhibitor. A Phase 2 study in ROR2 high SSCHN patients that have previously progressed on a PD-1/L1 inhibitor is anticipated to initiate in second half of 2021. A BA3021 in combination with a PD-1 inhibitor Phase 2 clinical trial for platinum-resistant ovarian cancer is also under review by Health Canada.

BA3071
BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody, ipilimumab, but with lower toxicities due to the CAB’s tumor microenvironment-restricted activation. In a global collaboration with BeiGene, we are developing BA3071 as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer. BeiGene is responsible for all costs of development, manufacturing and commercialization globally. BioAtla is eligible to receive milestone payments and royalties on product sales upon regulatory approvals and commercialization by BeiGene. A Phase 1 dose-escalation trial of BA3071 as monotherapy and in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, are planned to commence in 2021.

Plans to advance development of several bispecific CAB candidates
We have also leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor-specific antigen and a T cell receptor (CD3) using CAB antigen-binding domains. With this design, bispecific antibodies can induce potent T cell responses against tumors expressing the tumor target antigen. We have shown in preclinical experiments that our CAB bispecific molecules meet or exceed the activity of conventional bispecifics and reduce systemic activation of potentially fatal immune responses. We advanced two CAB bispecific antibody product candidates, EpCAM/CD3 and B7-H3/CD3, into IND-enabling studies in the second half of 2020. We also are evaluating additional candidates including EGFR and Nectin-4 for CAB CD3 bispecific modalities. Nectin-4 is also progressing as a CAB ADC candidate. Overall, we are advancing multiple pre-clinical assets with the potential to submit up to four US INDs by the end of 2022 for our CAB bispecific or ADC molecules.

First quarter 2021 financial results
Cash and cash equivalents as of March 31, 2021 were $221.2 million. In July 2020, BioAtla completed a successful private placement offering with institutional investors, for net proceeds of approximately $68.2 million. In December 2020, we received net proceeds of approximately $198.4 million from our initial public offering. We expect current cash and cash equivalents will be sufficient to fund planned operations into 2023.

Research and development (R&D) expenses were $10.4 million for the quarter ended March 31, 2021 compared to $1.7 million for the same quarter in 2020. We expect our R&D expenses to increase substantially for the foreseeable future as we continue to invest in R&D activities to advance our product candidates, and our clinical programs and expand our product candidate pipeline.

General and administrative (G&A) expenses were $8.4 million for the quarter ended March 31, 2021 compared to $(0.5) million for the same quarter in 2020. We expect our G&A expenses to increase as a result of operating as a public company. In addition, we expect our intellectual property expenses to increase as we expand our intellectual property portfolio.

Net loss for the first quarter ended March 31, 2021 was $18.7 million compared to a net loss of $1.6 million for the same quarter in 2020.

On May 12, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase III clinical trial designed to evaluate the safety and efficacy of selinexor (XPOVIO) in the treatment of advanced or recurrent endometrial cancer (the SIENDO trial) (Press release, Antengene, MAY 12, 2021, View Source [SID1234579828]).

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Endometrial cancer is a common gynecologic malignancy which frequently occurs in women of reproductive age. With a high incidence rate that has continued to rise in recent years, endometrial cancer has become the most prevalent malignancy of the female reproductive tract. Pregnancy, obesity, diabetes and reproductive system diseases are the main risk factors for endometrial cancer[1]. There is a lack of treatment options and curative care for patients with advanced or recurrent endometrial cancer, so effective novel treatments are increasingly important.

Selinexor (XPOVIO) is an US Food and Drug Administration (FDA) approved oral selective inhibitor of nuclear export that has been included in five regimens recommended by the National Comprehensive Cancer Network (NCCN) Guidelines and multiple regimens recommended by the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines, for the treatment of multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL). Selinexor inhibits XPO1, the only clinically proven nuclear export protein target. Based on its unique mechanism of action, selinexor can be combined with various other drugs in order to potentially enhance efficacy. The SIENDO trial is a global trial being conducted at over 80 centers across North America, Europe and Asia.

"This IND approval for selinexor in China marks a major milestone in achieving our mission to transform patients’ lives," said Dr. Jay Mei, founder, Chairman and CEO of Antengene. "The successful initiation of the SIENDO trial is a further step in helping us to explore additional solid tumor indications for the drug candidate. We believe that selinexor has the potential to play an important role in improving treatment options for patients with endometrial cancer. We look forward to working with sites and our partners to execute this trial. If data are positive, we will soon make this innovative therapy available to patients in China and around the world."

[1] Reference: Qingliang ZENG, China Maternal and Child Health,2021,36(08),1723-1725 DOI:10.19829/j.zgfybj.issn.1001-4411.2021.08.006

About Selinexor (XPOVIO)

Selinexor, a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with rrMM or rrDLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with rrMM.

Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

Antengene is currently conducting five late-stage clinical trials of selinexor for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma. Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore, and was granted the Priority Review status by China’s NMPA and an Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS).