On February 23, 2021 "BioInvent reported it has started 2021 with significant positive momentum We reported promising interim efficacy data from the ongoing Phase I/IIa trial of our lead drug candidate BI-1206 (Press release, BioInvent, FEB 23, 2021, View Source;december-31–2020,c3293713 [SID1234575415]).The company also closed a successful SEK 962 million financing round, expanding our institutional shareholder base. Furthermore, we announced the expansion of our clinical pipeline to include two further drug candidates for the treatment of solid tumors." – Martin Welschof, CEO BioInvent

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!

BI-1206 was out-licensed to CASI Pharmaceuticals for the Greater China region. The collaboration accelerates and expands BioInvent’s global development plans for BI-1206. BioInvent received $12 million upfront in combination of cash and equity investment and is eligible to receive up to $83 million in milestone payments, plus tiered royalties. The equity investment was approved at an EGM held on November 27, 2020. (R)
BioInvent received a $3 million milestone payment related to selection of antibodies under its collaboration with Pfizer. (R)
Approval of a CTA was received in Denmark for the Phase I/IIa study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL).
BioInvent and Transgene received CTA approval for Phase l/lla trial of oncolytic virus BT-001 in solid tumors.
New preclinical data was presented on BI-1808 and BT-001 at the SITC (Free SITC Whitepaper) 35th Anniversary Annual Meeting. New promising clinical and preclinical data on BI-1206 was also presented at the ASH (Free ASH Whitepaper) Annual Meeting.
BioInvent received a €2 million milestone payment under its collaboration with Daiichi Sankyo related to the initiation of a global Phase I clinical trial with a GARP directed antibody. (R)
BioInvent and Cantargia signed a manufacturing agreement, which may generate revenue for BioInvent of up to SEK 30 million.
BioInvent announced the appointment of Cecilia Hofvander as Senior Director Investor Relations, a new position at BioInvent starting mid-February 2021.
The EGM held on November 27, 2020 approved the proposal on a reverse share split 1:25, a reduction of the share capital to adjust the share capital to the Company’s operations, and an updated authorization for the Board to decide on a new issue of shares comprising 4,375,121 shares (after the reverse share split). (R)
Events after the reporting period

In January 2021, BioInvent announced that Phase I/IIa data suggest that BI-1206 restores activity of rituximab in relapsed non-Hodgkin’s lymphoma patients. Responses in 6 out of 9 patients evaluated provide exciting evidence that BI-1206 has the potential to restore activity of rituximab in non-Hodgkin’s lymphoma patients who have relapsed after treatment with rituximab. Long-lasting complete responses observed in two patients beyond 12 months. (R)
On February 23, 2021, BioInvent successfully completed a directed share issue of approximately SEK 962 million before transaction costs. Investors in the directed share issue are a range of international and Swedish investors, including Redmile Group, LLC., Invus, HBM Healthcare Investments, The Fourth National Swedish Pension Fund, Swedbank Robur Fonder and Van Herk Investments. 2,834,399 new shares were issued based on the authorization granted by the EGM on November 27, 2020, and 16,260,601 new shares were issued subject to the approval of an EGM to be held on 23 March 2021. (R)
In January 2021, BioInvent announced that it had restructured a clinical development agreement with Cancer Research UK (CRUK) for BI-1206. In exchange for a one-time payment of £2.5 million, the revised deal simplifies and reduces Bioinvent’s obligations to CRUK. (R)
BioInvent announced in January 2021, enrollment of the first patient in a Phase I/IIa study of BI-1808.
In January 2021, BioInvent announced that An van Es Johansson should resign as a director of the board effective as of 15 February 2021, due to personal reasons. (R)
(R)= Regulatory event

Comments from the CEO

BioInvent has started 2021 with significant positive momentum. Promising interim efficacy data from the ongoing Phase I/IIa trial of our lead drug candidate BI-1206 was followed by a successful financing round, adding another specialized institutional owner to the company. Furthermore, we announced the expansion of our clinical pipeline to include two further drug candidates.

The data from the study of BI-1206, in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL), are very encouraging. The responses in these severely ill patients suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. Furthermore, the duration of complete response in two patients are particularly impressive and indicate that BI-1206 has the potential to significantly improve the lives of NHL patients who have progressed after previous lines of treatment.

We were proud to host a key opinion leader (KOL) event on these results with renowned lymphoma expert Professor Mats Jerkeman, MD, of Lund University. Based on these results, we will now move to identify the recommended dose for the Phase IIa part of the study. We also presented new data on BI-1206 at the ASH (Free ASH Whitepaper) Annual Meeting in December and are excited to further evaluate its potential to bring much needed innovation to lymphoma patients.

This progress is reinforced by our partnership with CASI Pharmaceuticals for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau. Under this agreement for both liquid and solid cancers, BioInvent received $12 million upfront in combination of cash and equity investment and is eligible to receive up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales. CASI is a proven leader in China and their clinical development and regulatory expertise will be important in generating additional data on BI-1206.

We have simplified and reduced our obligations to CRUK related to BI-1206 by restructuring our clinical development agreement with CRUK (Cancer Research UK) for BI-1206, in exchange for a one-time payment. This provides us with further flexibility to carry out development and partnering activities with BI-1206.

Our innovative pipeline is expanding beyond BI-1206. We now have three products in clinical development, underlining the ability of our n-CoDeR/F.I.R.S.T platforms to produce novel, differentiating drug candidates.

In January, we enrolled the first patient in a Phase I/IIa, first-in-human study of BI-1808, a first-in-class anti-TNFR2 antibody, as monotherapy and in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of solid tumors and CTCL. This is based on a solid preclinical data set for BI-1808, including the new data presented at the 35th Annual Meeting of SITC (Free SITC Whitepaper) in November.

We have now received CTA approval to start a Phase I/IIa clinical trial of the novel oncolytic vaccinia virus BT-001 in solid tumors, through our collaboration with Transgene. BT-001 combines multiple mechanisms of action and has outstanding potential in a wide range of indications due to its combination of multiple anti-cancer properties. We also presented new data on BT-001 at SITC (Free SITC Whitepaper).

On February 23, we further reinforced our financial position with a directed share issue that raised approximately SEK 962 million before transaction costs. These proceeds intend to fund the continued transformation of BioInvent and expansion of our clinical programs. Assuming continued generation of positive data, we plan to in particular use the funds to prepare a pivotal clinical trial of BI-1206 for the treatment of NHL, with the aim of receiving an accelerated regulatory pathway. We also expect to expand the clinical programs of BI-1206 in combination with Keytruda and BI-1808 as monotherapy and in combination with Keytruda.

Our partner Pfizer has selected antibodies, directed at a previously selected target, under our agreement covering developing antibodies from the F.I.R.S.TTM drug discovery platform targeting tumor-associated myeloid cells. This is an impressive example of the productivity of our platform and further strengthens our financial position by $3 million. We may now move forward to develop other antibodies internally or with other partners.

We also generated important revenue from a €2 million milestone payment under a collaboration with Daiichi Sankyo and we signed a new manufacturing agreement with Cantargia, under which BioInvent may generate revenue of up to SEK 30 million.

As previously communicated, BioInvent has taken all the necessary precautions with regards to managing the impact of Covid-19. Although we still observe viral spread throughout the community, which is of course terrible for all those affected and their families, we remain on track with our clinical trials and results. As the situation is still evolving, timelines may be impacted in geographic areas most severely affected. We will provide updates as necessary.

The company has made significant progress in delivering on our strategy in 2020 and this has set us up for a number of important milestones as we progress our portfolio through clinical development. 2021 promises to be a very exciting year for BioInvent.

On February 23, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter and year ended December 31, 2020, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for 2021 (Press release, Clovis Oncology, FEB 23, 2021, View Source [SID1234575437]).

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!

"Despite the evident COVID-related challenges of 2020, we are pleased with our overall sales performance and pipeline progress," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Most importantly, we advanced our development programs in 2020, positioning them for important potential achievements in 2021, including the initiation of clinical development for FAP-2286 in the first half of the year, top-line ATHENA monotherapy data in the second half of the year and initial efficacy data for the LIO-1 lucitanib and Opdivo combination trial at medical meetings later this year. While early, we are increasingly enthusiastic about FAP-2286 and our commitment to becoming a leader in the emerging field of targeted radionuclide therapy."

Fourth Quarter and Year-End 2020 Financial Results

Clovis reported global net product revenues for Rubraca of $43.3 million for the fourth quarter of 2020, which included U.S. product revenues of $36.4 million and ex-U.S. product revenues of $6.9 million, respectively. This represents a 10 percent increase year-over-year compared to Q4 2019 net product revenues of $39.3 million, which included U.S. net product revenues of $36.1 million and ex-U.S. net product revenues of $3.2 million.

Rubraca global net product revenues for 2020 were $164.5 million, which included $146.3 million in the U.S. and $18.2 million in ex-U.S. product revenues, respectively. This represents a 15 percent increase year-over-year compared to 2020 net product revenues of $143.0 million, which included $137.2 million in the U.S. and ex-U.S. net product revenues of $5.8 million.

Research and development expenses totaled $56.7 million for Q4 2020 and $257.7 million for FY 2020, down 22 percent and 9 percent, respectively, compared to $72.5 million and $283.1 million for the comparable periods in 2019. Research and development expenses decreased for the quarter and year compared to the same periods in the prior year due primarily to lower spending on Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to 2020.

Selling, general and administrative expenses totaled $40.8 million for Q4 2020 and $163.9 million for FY 2020, both down 10 percent compared to $45.2 million and $182.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the quarter and year compared to the same periods in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts. We expect selling, general and administrative expenses to decrease in the full year 2021 compared to 2020.

Clovis reported a net loss for the fourth quarter of 2020 of $99.0 million, or ($1.02) per share, and a net loss of $369.2 million, or ($4.38) per share, for FY 2020. Net loss for Q4 2019 was $99.5 million, or ($1.81) per share, and $400.4 million, or a net loss of ($7.43) per share, for FY 2019. Net loss for Q4 and FY 2020 included share-based compensation expense of $12.0 million and $50.8 million, compared to $12.6 million and $54.3 million for the comparable periods of 2019.

Clovis had $240.2 million in cash and cash equivalents as of December 31, 2020, which is expected to fund the Company’s operating plan into early 2023 based on current revenue and expense forecasts.

As of December 31, 2020, the Company had drawn approximately $100 million under the Sixth Street Partners, LLC ATHENA clinical trial financing and had up to $75 million available to draw under the agreement to fund the expenses of the ATHENA trial.

Net cash used in operating activities was $56.1 million for the fourth quarter of 2020, down from $70.1 million reported in the fourth quarter of 2019. Similarly, net cash used in operating activities for FY 2020 was $252.7 million, compared with $323.6 million for FY 2019. Cash burn in Q4 2020 was $40.9 million, down 27 percent from the Q4 2019 quarter cash burn of $56.3 million. Cash burn for the twelve months ended December 31, 2020 was $195.6M million, down 36 percent from the twelve months ended 2019 cash burn of $304.7 million. We expect this trend of lower cash burn to continue in 2021.

Clovis Oncology Pipeline Highlights

Rubraca ARIEL4 Study Met Primary Endpoint of Improved PFS Compared to Chemotherapy

In December, Clovis announced the top line results of the ARIEL4 randomized Phase 3 study of Rubraca versus standard-of-care chemotherapy, in which Rubraca met the primary endpoint of significantly improving progression-free survival (PFS) in later-line ovarian cancer patients with a BRCA mutation. The safety observed in the study was highly consistent with both the U.S. and European labels. These results were submitted as a late-breaking abstract and accepted as an oral presentation at the upcoming Society for Gynecologic Oncology Virtual Annual Meeting in March. Completion of ARIEL4 is a post-marketing commitment in the U.S. and Europe.

Anticipated Rubraca Pipeline Events in 2021

Top-line data from the ATHENA Phase 3 study in first-line maintenance treatment ovarian cancer setting evaluating Rubraca monotherapy versus placebo are expected in the second-half of 2021, contingent on achieving sufficient PFS events. Data from the combination arm of Rubraca plus Opdivo versus Rubraca monotherapy are expected a year or more later.

LODESTAR, the Company’s Phase 2 trial of Rubraca in patients with solid tumors with deleterious mutations in homologous recombination repair (HRR) genes is currently enrolling. This study may be registration-enabling with a potential regulatory filing by the end of 2021 or first-half 2022.

LuMIERE Phase 1/2 Study of FAP-2286 Expected to Begin 1H 2021

FAP-2286 is Clovis Oncology’s peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) and represents its lead candidate in the PTRT development program. Clovis intends to initiate the Phase 1/2 LuMIERE clinical study of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286) to determine the dose and tolerability of the FAP-targeting therapeutic agent (Phase 1), with expansion cohorts planned in multiple tumor types (Phase 2). FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) will be utilized as a diagnostic to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. The LuMIERE study is expected to begin in the first half of 2021, pending acceptance by the FDA of gallium-68 CMC data from clinical sites.Other studies of FAP-2286 linked to an alpha-particle emitting radionuclide and combination studies are also being planned.

Interim LIO-1 data of Lucitanib and Opdivo in Combination Expected in 2021

The Phase 2 part of the LIO-1 study of lucitanib in combination with Opdivo continues to enroll patients with gynecologic cancers, and Clovis Oncology intends to present initial data at 2021 medical meetings, which are expected to include interim results from the ovarian and endometrial cancer expansion cohorts.

Conference Call Details

Clovis will hold a conference call to discuss Q4/FY 2020 results this morning, February 23, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 5869256.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Peptide-Targeted Radionuclide Therapy

Peptide-targeted radionuclide therapy (PTRT) is a form of targeted radiotherapy that is emerging as a new treatment option for patients with cancer.These therapies consist of a small amount of a radioactive isotope, known as a radionuclide, linked to a cell-targeting peptide that binds to a cancer specific protein which selectively directs the radionuclide to tumors.Following binding, the radionuclide warhead emits ionizing radiation causing DNA damage and cell death to neighboring tumor cells.

On February 23, 2021 Propella Therapeutics Inc. (Propella), a leader in the development of innovative, best-in-class prescription products, and the National Cancer Institute (NCI), part of the National Institutes of Health, reported that have entered into a Cooperative Research and Development Agreement (CRADA) (Press release, Propella Therapeutics, FEB 23, 2021, View Source [SID1234575457]). Under this new partnership, Propella and NCI will conduct a multi-center clinical trial to evaluate abiraterone decanoate, as a new therapy for metastatic prostate cancer.

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!

Propella holds U.S. Patent 10,792,292, which protects multiple new long-acting, injectable, prodrugs of abiraterone, and includes composition of matter, method of manufacturing, and method of treatment claims. The acetate prodrug of abiraterone, which is given by mouth daily, is a current standard of care for advanced prostate cancer. Abiraterone acetate produces varying blood concentrations of abiraterone metabolites, including high levels that may produce side effects and low levels that may not be effective. Preclinical data indicate that a single injection of Propella’s novel intramuscular (IM) formulation of abiraterone decanoate can deliver more precise drug levels that may prove effective for up to 3 months, potentially providing patients with both greater drug effectiveness and assurance of increased safety.

Propella presented select preclinical findings on Feb. 11, 2021, at the (virtual) annual meeting of The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Genitourinary Division (GU ASCO (Free ASCO Whitepaper)) that confirmed large and continuous 3-month reductions in testosterone following a single IM injection. The presentation may now be viewed on the Propella website at: View Source

"We’re gratified to have had the opportunity to present compelling preclinical program results at the prestigious GU ASCO (Free ASCO Whitepaper) conference, and to work collaboratively with the scientists at the National Cancer Institute," said Propella President and CEO William Moore, PhD. "The upcoming clinical trial has the potential for abiraterone decanoate to improve the standard of care for patients with advanced prostate cancer."

Under the CRADA, Propella will file and hold the Investigational New Drug application (IND) while NCI will provide clinical research and development expertise along with pharmacokinetic and clinical pharmacology insights and analyses.

According to Dr. William Douglas Figg, Sr., Senior Investigator and Head of the Clinical Pharmacology Program at the NCI, "Propella’s intramuscular formulation of abiraterone, abiraterone decanoate, is an interesting new agent and we look forward to investigating its potential as a therapy choice for men with prostate cancer."

On February 23, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported two presentations, one oral and one eposter, at the upcoming European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 (Press release, Spectrum Pharmaceuticals, FEB 23, 2021, View Source [SID1234575473]). The oral presentation will provide some initial safety and efficacy data for poziotinib from the twice daily dosing cohort. The meeting takes place on March 1 – 2, 2021. Details of the presentations are as follows:

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!

Title: IGN002 (antiCD20-IFNα2b) intravenously administered tumor targeted delivery of IFNα2b and its effects in non-Hodgkin lymphoma
Speaker: Sribalaji Lakshmikanthan, Ph.D.
Session: Immunotherapy (ID 361)
Date and Time: March 1, 2021, 9:41 a.m. CET / 3:41 a.m. ET
Presentation Number: #20P (poster)

Title: Safety, tolerability and preliminary efficacy of poziotinib with twice daily strategy in EGFR/HER2 Exon 20 mutant non-small cell lung cancer
Speaker: Adrian Sacher, M.D.
Session: Mini Oral Session (ID 17) Channel 1
Date and Time: March 2, 2021, 17:25 CET / 11:25 a.m. ET
Presentation Number: 36MO (mini-oral)

Access to the presentations is available to members of ESMO (Free ESMO Whitepaper) and can be found here: View Source;module=attendee#signin

On February 23, 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 granted priority review to the New Drug Application (NDA) for ATG-010 (selinexor, XPOVIO), a first-in-class selective inhibitor of nuclear export (SINE) compound, for the treatment of patients with relapsed/refractory multiple myeloma (rrMM) (Press release, Antengene, FEB 23, 2021, View Source [SID1234575489]).

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!

ATG-010 is the first approved SINE compound in the world. It induces the apoptosis of cancer cells in vitro and in vivo by causing the nuclear storage and activation of tumor suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins while normal cells are not affected. The US Food and Drug Administration (FDA) has approved ATG-010 (selinexor) as a novel treatment in three indications within eighteen months. Five ATG-010 regimens for patients with multiple myeloma or diffuse large B-cell lymphoma have also been added to the National Comprehensive Cancer Network (NCCN) Guidelines. Antengene has completed patient enrollment for the registrational clinical trial in rrMM in mainland China and has submitted NDAs for ATG-010 in five APAC markets including Australia, South Korea and Singapore over the past six months.

"ATG-010 is a novel option for the treatment of rrMM and we are pleased that it has been granted priority review by the NMPA. The target of ATG-010, XPO1, is the only proven nuclear export protein target in clinical development and we believe that ATG-010 has potential to meet the huge unmet medical needs in hematological malignancies and solid tumors." said Dr. Jay Mei, M.D., PhD., Founder, Chairman and CEO of Antengene. "rrMM still remains an incurable disease and we are excited that more patients may have access to ATG-010 earlier in the course of their treatment. We look forward to working closely with the regulatory authority to move this important indication for ATG-010 towards approval."

"Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim)" has been issued by the NMPA on July 7, 2020 to expedite the development and registration of drugs that provide significant clinical value. With the effective implementation of these procedures, the regulatory authority will expedite the evaluation and approval of novel drugs through a priority review pathway and facilitate earlier access of these drugs to patients in China.

About ATG-010 (selinexor, XPOVIO)

ATG-010 (selinexor, XPOVIO), 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 (XPOVIO) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor (XPOVIO) also received FDA approval as a combination treatment for multiple myeloma after at least one prior therapy. A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same rrMM indication. Selinexor (XPOVIO) 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 (XPOVIO) 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 3 randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor (XPOVIO) versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase 3 SIENDO trial of selinexor (XPOVIO) 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.