On May 16, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported the presentation of new data on AFM24 and AFM28 in two posters at the 19th Meeting of the Society for Natural Immunity (NK2022) (Press release, Affimed, MAY 16, 2022, View Source [SID1234614667]).

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The AFM24 presentation showed correlative science data of the exposure and pharmacodynamic effects of the compound in patients with epidermal growth factor receptor (EGFR)-expressing solid tumors from the ongoing phase 1/2a study. The poster featured an analysis of the longitudinal effects of AFM24, a CD16A/EGFR‑targeting bispecific innate cell engager (ICE), in patients treated in the AFM24-101 phase 1/2a clinical study, confirming the mechanism of action of AFM24 on the innate immune system.

The correlative science data further supports the rationale for combining different therapeutic approaches in patients with EGFR-expressing solid tumors. AFM24 engages CD16A on natural killer (NK) cells and macrophages with higher affinity than monoclonal antibodies, and triggers antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively, directed at EGFR-expressing cancer cells. Preclinical data have shown that AFM24 can induce NK cell-mediated killing of EGFR-positive solid tumor cell lines, independent of EGFR mutational status.

The analysis also showed activation of cytotoxic T cells in the periphery, and infiltration of T cells into the tumor bed, suggesting stimulation of anti-cancer immunity beyond the innate immune system and the possible engagement of the adaptive immune system. These data support the rationale for AFM24 as monotherapy and the two combinations that are currently under way in separate phase 1/2a studies – with autologous NK cell therapy and with immune checkpoint inhibition.

The AFM28 poster featured preclinical data on the anti-leukemic activity of the compound when pre-complexed and co-administered with allogeneic NK cells.

AFM28 is a novel ICE binding to CD16A on NK cells, and CD123 on acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) tumor cells. The novel bispecific engager binds with high affinity to NK cells stimulating them to destroy CD123-positive tumor cells via ADCC. In addition, AFM28 exhibits greater cell surface retention than conventional monoclonal antibodies, including Fc-enhanced IgG1.

Furthermore, the data presented at the conference demonstrate that AFM28 stimulates lysis of CD123-positive tumor cells in both formats, pre-complexed or when co-administered with NK cells. The poster also demonstrated the feasibility of cryopreserving AFM28 pre-complexed with NK cells whilst maintaining anti-tumor activity suggesting the promise for an off-the-shelf therapy targeting leukemic blasts and leukemic stem cells in patients with AML and MDS.

Poster details:
Title: Analysis of the Longitudinal Effects of AFM24, a CD16A/Epidermal Growth Factor Receptor Targeting (EGFR) Bispecific Innate Cell Engager, Confirms the Mechanism of Action and Supports the Rationale for Combination Approaches in Patients with EGFR-Expressing Solid Tumors
Authors: Gabriele Hintzen, Susanne Wingert, Michael Emig, Kerstin Pietzko, Uwe Reusch, Melissa M. Berrien‐Elliott, Todd A. Fehniger, Mark Foster, Paolo Nuciforo, Tyler Burns, Paulien Ravenstijn, Stefan Knackmuss, Bettina Rehbein, Joachim Koch, Arndt Schottelius, and Erich Rajkovic

Title: Novel Bispecific Innate Cell Engager AFM28 in Combination with Allogeneic NK Cells for the Treatment of CD123+ Acute Myeloid Leukemia and Myelodysplastic Syndrome
Authors: Jens Pahl, Jana-Julia Siegler, Armin Beez, Rebecca Hussong, Sabrina Purr, Lena Wagner, Nicole Schulze, Tatjana Kosbar, Uwe Reusch, Joachim Koch, Arndt Schottelius, Thorsten Ross, Christian Merz and Sheena Pinto

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
Affimed is evaluating AFM24 in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies as monotherapy and in combinations with other cancer treatments. AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450. Furthermore, AFM24 is being evaluated in a phase 1/2a study in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442). Affimed and NKGen Biotech have initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with SNK01, NKGen Biotech’s NK cell product (NCT05099549).

About AFM28
AFM28 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and CD123-positive cells on myeloid malignancies. Developed on Affimed’s ROCK platform, it is designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndrome (MDS). AFM28 engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), and binds CD123-positive cancer cells even at low expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123-positive leukemias.

On May 16, 2022 Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis in the knee and potentially other articular joints, reported financial results for the first quarter ended March 31, 2022 (Press release, Ampio, MAY 16, 2022, View Source [SID1234614683]).

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First Quarter Financial Results

Net Loss: Net loss was $5.6 million for the first quarter of 2022 compared to net loss of $3.7 million for the first quarter of 2021. Further details on these variances are below.
R&D Expenses: Research and development expenses were $3.7 million for the first quarter of 2022 compared to $2.3 million for the first quarter of 2021. The primary drivers of the increase were increases in (i) clinical trial and sponsored research expenses and (ii) salaries and professional fees.
G&A Expenses: General and administrative expenses were $3.3 million for the first quarter of 2022 compared to $1.5 million for the first quarter of 2021. The primary drivers of the increase were increases in (i) salaries and professional fees and (ii) non-cash stock-based compensation expense.
Cash Position / Liquidity: Cash and cash equivalents on March 31, 2022, totaled $28.8 million, compared to $33.9 million as of December 31, 2021. The decrease of $5.1 million is primarily attributable to cash required to fund business operations. Based on our current cash position and projection of operating expenses and capital expenditures, we believe that we will have sufficient liquidity to fund operations into the second half of 2023.

On May 16, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on advanced therapies for autoimmune and inflammatory diseases, reported financial results for the full year ended December 31, 2021, as well as recent pipeline progress (Press release, Akari Therapeutics, MAY 16, 2022, View Source [SID1234614778]).

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"During the last twelve months, Akari has advanced nomacopan pre-clinical and clinical development programs, including three focus areas of autoimmune skin diseases, thrombotic microangiopathies, and progressive retinal diseases," said Rachelle Jacques, President and CEO of Akari Therapeutics. "Broad and deep research and development work is producing compelling science in diseases with complex pathologies and is providing the foundation for next steps in the development of bispecific recombinant nomacopan. Late-stage programs in pediatric HSCT-TMA and BP are active and advancing in Part A clinical studies, which will inform the pivotal Part B studies that will be the basis for potential regulatory submissions in the U.S. and Europe."

Full Year 2021 and Recent Clinical Highlights

Late-Stage Program Studying Investigational Nomacopan in Pediatric HSCT-TMA

Phase III Part A clinical trial sites are open and recruiting in the U.S. and Europe for investigation of nomacopan in pediatric HSCT-TMA.
Urgent unmet need exists in pediatric HSCT-TMA with no approved treatment options in the U.S. or Europe; currently the subset of patients Akari is studying are facing a mortality rate of ~80%
Nomacopan was granted Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for pediatric HSCT-TMA
Patient dosing is underway in the Part A study that has a recruitment goal of approximately seven patients, with a minimum of two patients in each of three age cohorts
Late-Stage Program Studying Investigational Nomacopan in Bullous Pemphigoid (BP)

FDA and European Medicines Agency (EMA) registration-directed Phase III Part A study of nomacopan in moderate and severe BP patients is open for enrollment following resolution of third-party supply chain partner issues that resulted in delays. Data from the Part A study will inform the pivotal Part B study that will be the basis for potential regulatory submissions in the U.S. and Europe
There are no approved therapies; superpotent topical steroid and high dose oral corticosteroid (OCS) are the current standards of care
The mortality rate in BP is approximately three-fold higher than the general population due to the disease itself, and infections and cardiovascular conditions that are more common in older patients and are exacerbated by treatment with high dose OCS.1
There is significant unmet need for an effective steroid-sparing therapy.
Nomacopan was granted Orphan Drug and Fast Track designations by the FDA and Orphan Drug designation from the EMA for the treatment of BP
Results from the completed Phase II study of subcutaneous nomacopan in patients with mild to moderate BP were published online in JAMA Dermatology in May 2022
The Phase II study advanced understanding of the nomacopan safety profile and informed duration of treatment in the ARREST-BP Phase III Part A clinical trial, which is currently open for enrollment
The multi-center, single arm nonrandomized controlled Phase II study included nine patients newly diagnosed or recurrent patients with mild to moderate active BP
Patients received subcutaneous nomacopan (30 mg once daily) with lesional mometasone from Day 1 to 21 of treatment and nomacopan only from Day 21 to Day 42
Seven of nine patients responded to nomacopan with three, regarded as complete responders, showing >80% reduction in BPDAI (BP disease activity index) activity and four patients showing >70% reduction in pruritis by Day 42; two of nine patients were non-responders
None of the nine patients reported Common Terminology Criteria for Adverse Events (CTCAE) grade three, four or five treatment-related adverse events
A poster outlining the design of the Phase III study of nomacopan in patients with moderate to severe BP was presented at the 2021 International Pemphigus & Pemphigoid Foundation (IPPF) Scientific Symposium
Pre-Clinical Program Studying Investigational Long-Acting PAS-Nomacopan for Geographic Atrophy/Dry Age-Related Macular Degeneration (GA/dAMD)

Akari has conducted pre-clinical studies that explore the importance of the leukotriene B4 (LTB4)-VEGF axis and the potential role of nomacopan’s bispecific inhibition of both C5 and LTB4 in treating GA/dAMD
Studies have indicated that while certain complement inhibitors slow the progression of GA, they may also promote choroidal neovascularization (CNV), which can harm the macula, damage vision,2,3 and require VEGF rescue therapy
LTB4 is a potent leukotactic agent that can increase retinal vascular endothelial growth factor (VEGF) a key driver of CNV. Inhibition of LTB4 may decrease the risk of CNV.4
Akari has conducted pre-clinical studies that explore the importance of the LTB4-VEGF axis and the potential role of nomacopan’s bispecific inhibition of both C5 and LTB4 in treating GA/dAMD
In a non-infectious allergic uveitis animal model, PAS-nomacopan reduced VEGF by more than 50% compared to saline control, equivalent to the inhibition caused by an anti-VEGF antibody. In addition, PAS-nomacopan was significantly more effective in reducing retinal inflammation than the anti-VEGF antibody.
A pre-clinical study presented at ARVO 2022 used an industry standard model of laser induced CNV. Intravitreal (IVT) PAS-nomacopan injected once during a 16-day treatment period was compared to an FDA-approved VEGF inhibitor for impact on neovascularization. The IVT single dose of PAS-nomacopan significantly reduced CNV (p=0.022) as compared to saline and was as effective as multiple IVT injections of the VEGF inhibitor (p=0.019.) Single IVT injection of PAS-nomacopan showed a trend towards reduced leakage on Day 14 (p = 0.097).
Currently approved therapies for retinal diseases injected directly into the vitreous cavity are typically administered monthly. Studies have shown that due to adverse effects (such as an increase in intraocular pressure [IOP]), discomfort and anxiety, IVT injection presents a heavy burden on patients
PASylation of nomacopan has the potential to make it long-lasting in the back of the eye and may provide a dosing interval that is more attractive to patients
Akari is continuing pharmacokinetic (PK) and pharmacodynamic (PD) work to optimize PAS-nomacopan with the aim of achieving safety and efficacy in GA, and meeting patient preferences for less frequent injections
Studies of Investigational Nomacopan in Inflammation-Implicated Lung Conditions

Advanced the study of investigational nomacopan in the treatment of inflammation-implicated lung conditions
The CORONET study evaluated compassionate use of investigational nomacopan in the treatment of hospitalized COVID-19 pneumonia patients in the U.S.
The CASCADE study in the U.K. explored correlations between biomarkers and risk stratification categories to help predict the subsets of COVID-19 pneumonia patients who have a higher propensity to deteriorate clinically to more severe disease
Nomacopan Manufacturing

Significantly increased the total yield of nomacopan (more than five-fold) with a new manufacturing process
References:

Tedbirt B, et al., JAMA Dermatol. 2021 Apr 1;157(4)
Liao DS, et al. Ophthalmology. 2020 Feb;127(2)
Jaffe GJ et al. Ophthalmology. 2021 Apr;128(4)
Sasaki F et al. JCI Insight. 2018 Sep 20;3(18)
Full Year 2021 Financial Results

At December 31, 2021, the Company had cash of approximately $9.4 million, compared to cash of approximately $14.1 million at December 31, 2020.
In March 2022, Akari entered into an agreement with Paulson Investment Company, LLC to serve as placement agent in connection with a registered direct offering and sold approximately 7.4 million of the Company’s ADSs for gross proceeds of approximately $8.9 million.
In December 2021, Akari entered into an agreement with Paulson Investment Company, LLC to serve as placement agent in connection with a registered direct offering and sold approximately 4.3 million of the Company’s ADSs for gross proceeds of approximately $6.0 million.
In July 2021, Akari closed a private placement of approximately $12.3 million in gross proceeds by issuing approximately 7.9 million of the Company’s ADSs.
Research and development (R&D) expenses for full year 2021 were approximately $9.1 million, as compared to approximately $8.8 million for full year 2020.
General and administrative expenses for full year 2021 were approximately $8.1 million, as compared to approximately $9.2 million for full year 2020. This decrease was primarily due to a one-time non-cash financing expense of approximately $900,000 in 2020 related to the 2020 Purchase Agreement with Aspire Capital.
For full year 2021, total other loss was approximately $210,000 as compared to total other income of approximately $899,000 for full year 2020. This change was primarily due to the accounting reclassification of warrant liabilities to shareholders’ equity as of December 2020.
Net loss for the full year 2021 was approximately $17.4 million, as compared to net loss of approximately $17.1 million for full year 2020.
A copy of the Company’s Annual Report on Form 20-F for the year ended December 31, 2021 will be filed with the Securities and Exchange Commission and posted on the Company’s website at View Source

On May 15, 2022 Sanofi reported that Latest results from the Phase 3 IKEMA clinical trial evaluating Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd) demonstrated a median progression free survival (mPFS) of 35.7 months (Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 25.8 to 44.0; n=179), compared to 19.2 months in patients treated with Kd alone (95% CI: 15.8 to 25.1; n=123), as evaluated by an Independent Review Committee (Press release, Sanofi, MAY 15, 2022, View Source [SID1234614557]). These results, presented at the Controversies in Multiple Myeloma World Congress, represent the longest mPFS among studies investigating a proteasome inhibitor backbone in the second-line setting for the treatment of relapsed multiple myeloma (MM). These data will also be presented at the European Society for Medical Oncology on May 19.

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Philippe Moreau, MD
Head of the Department of Hematology, University Hospital of Nantes, France
"The increase in progression free survival, observed consistently across all subgroups, when adding Sarclisa to carfilzomib and dexamethasone is remarkable in patients with relapsed multiple myeloma in a proteasome inhibitor combination. Relapse is common in multiple myeloma, creating the need for differentiated second-line treatments that provide patients a longer period of time without disease progression. This updated analysis reinforces the potential for Sarclisa to become a new standard of care for patients with relapsed multiple myeloma."

A PFS analysis following the U.S. Food and Drug Administration recommendations on censoring rules, as applied in the approved U.S. prescribing information, showed an mPFS of 41.7 months for Sarclisa added to Kd (Sarclisa combination therapy) compared to 20.8 months in patients treated with Kd alone (HR 0.59; 95% CI: 27.1 to Not Calculable [NC]).

Time to next treatment for patients treated with Sarclisa combination therapy was 44.9 months (HR 0.55; 95% CI: 31.6 to NC) versus those treated with Kd alone at 25 months (95% CI: 17.9 to 31.3). Time to next treatment measured the interval from the date of randomization1 to the date of commencement of the next line of therapy, thereby allowing for measurement of the period of therapeutic benefit.2

Peter C. Adamson, MD
Global Head of Oncology Clinical Development and Pediatric Innovation at Sanofi
"To observe progression free survival of more than three years in patients with relapsed multiple myeloma when Sarclisa was added to a proteasome inhibitor backbone of therapy is unprecedented and reinforces our confidence in Sarclisa as a potential best in class anti-CD38 antibody."

The safety and tolerability of Sarclisa observed in this analysis were consistent with the safety profile of Sarclisa in other clinical trials, with no new safety signals observed. For the Sarclisa combination therapy and Kd groups, the most common adverse events were infusion related reaction (45.8%, 3.3%), diarrhea (39.5%, 32%), hypertension (37.9%, 35.2%), upper respiratory tract infection (37.3%, 27%), fatigue (31.6%, 20.5%), dyspnoea (30.5%, 22.1%), pneumonia (27.1%, 21.3%), back pain (25.4%, 21.3%), insomnia (25.4%, 24.6%), and bronchitis (24.3%, 12.3%). Treatment exposure in the Sarclisa combination therapy arm was 30 weeks longer than in the control arm. Treatment emergent adverse events (TEAEs) of ≥ Grade 3 were reported in 83.6% of patients treated with Sarclisa combination therapy and in 73% of those treated with Kd alone. Serious TEAEs were higher in the Sarclisa combination therapy arm versus Kd alone (70.1% versus 59.8%). No difference was observed after exposure adjustment."

These results will be discussed with regulatory authorities at a future date.

About the IKEMA trial

The randomized, multi-center, open label Phase 3 IKEMA clinical trial enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries. All study participants had received one to three prior anti-myeloma therapies. During the trial, Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with carfilzomib twice weekly at the 20/56mg/m2 dose and dexamethasone at the standard dose for the duration of treatment. The primary endpoint of IKEMA was progression free survival. Secondary endpoints included overall response rate, the rate of complete response or better, the rate of very good partial response or better, rate of minimal residual disease-negativity, overall survival and safety.3

About Sarclisa

Sarclisa is a monoclonal antibody that targets a specific epitope on the CD38 receptor on multiple myeloma (MM) cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

Based on the Phase 3 ICARIA-MM study, Sarclisa is approved in a number of countries, including the U.S. and EU, in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor. Based on the Phase 3 IKEMA study, Sarclisa is also approved in multiple countries in combination with carfilzomib and dexamethasone, including in the U.S. for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the European Union for patients with MM who have received at least 1 prior therapy. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA).

Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been reviewed by any regulatory authority worldwide.

For more information on Sarclisa clinical trials, please visit www.clinicaltrials.gov.

About multiple myeloma

MM is the second most common hematologic malignancy,4 with more than 130,000 new diagnoses of MM worldwide yearly.5 Despite available treatments, MM remains an incurable malignancy and is associated with significant patient burden. Since MM does not have a cure, most patients will relapse. Relapsed MM is the term for when the cancer returns after treatment or a period of remission. Refractory MM refers to when the cancer does not respond or no longer responds to therapy.

On May 15, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that its first commercialized product, the oral XPO1 inhibitor XPOVIO (selinexor) approved for the treatment of relapsed/refractory multiple myeloma (R/R MM), has officially entered multiple hospitals, online-hospitals, and direct-to-patient (DTP) pharmacies in mainland China and widely prescribed in the country for the first time at Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai Jiaotong University School of Medicine Renji Hospital, Tongji Hospital of Tongji University, Shanghai Sixth People’s Hospital, Shanghai Jiaotong School of Medicine St. Luke’s Hospital, and the PLA Naval Medical Center (Press release, Antengene, MAY 15, 2022, View Source [SID1234614559]). By the end of May, selinexor will be expeditiously rolled out to approximately 600 hospitals and 105 DTPs in over 30 provinces, autonomous regions, and municipalities including Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang, Henan, and Shandong, providing Chinese MM patients across the country with an easy to access to this new treatment option.

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Expeditious Launch of Novel Targeted Therapy for Unmet Cancer Need

Multiple myeloma (MM) is the second most common hematologic malignancy in China, accounting for approximately 10% of all hematologic malignancy incidences. The number of new diagnoses of MM has been rising year after year, thus presenting a rapidly growing medical need.[1] Strikingly, more patients are diagnosed at younger ages.

The prior standard of care for MM has been based on treatment with a combination of therapies including dexamethasone, proteosome inhibitors, immunomodulatory agents and an anti-CD38 monoclonal antibody. Despite the availability of these therapies, MM remains a hard-to-treat cancer. Most patients with MM experience at least one relapse,[2][3] with each relapse resulting in a shorter duration of response. In particular, those patients relapsed after third- or forth-line treatments have a poor prognosis and limited treatment options,[4][5] with a median progression-free survival (PFS) of only 3-6 months and an overall survival (OS) of about 6 months.

In July 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application (NDA) for XPOVIO , the world’s first oral selective inhibitor of nuclear export protein-1 (XPO1) approved for combination use with low-dose dexamethasone for the treatment of patients with R/R MM who have received at least four prior therapies and whose disease is refractory to at least two proteosome inhibitors, at least two immunomodulatory agents and an anti-CD38 monoclonal antibody. Less than a year after that, the FDA granted approval for another indication for XPOVIO, as a monotherapy for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). In December 2020, XPOVIO obtained its third FDA-approved indication, for combination use with bortezomib and dexamethasone in treatment of adult patients with MM who previously received at least one prior therapy.

To address the urgent medical need of MM patients in China, Antengene raced against time and dedicated significant resources to bringing this novel drug to the country. On December 14, 2021, selinexor was approved through a priority review process by the China National Medical Products Administration (NMPA), for the treatment of adults with R/R MM who previously received treatment with at least three agents including a proteosome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Prof. Xiaojun Huang, at Peking University People’s Hospital, commented, "R/R MM remains a major clinical challenge with limited treatment options for relapsed patients. I am glad that selinexor is available in China and can start benefiting Chinese patients right away. The introduction of this novel therapy represents a clinical breakthrough bringing the country one step closer to advanced targeted therapies that are already available to patients in developed countries."

Prof. Jianxiang Wang, at the Hematology Institute of the Chinese Academy of Medical Sciences, noted, "I am pleased that selinexor has entered clinical application and now being prescribed to Chinese patients in need. This innovative drug has demonstrated an impressive clinical profile in the MARCH study, including favourable safety and tolerability, and clear efficacy with an overall response rate (ORR) of 29.3% and a median OS of 13.2 months.[6] Moreover, this novel drug offers fast onset of actions and the convenience of once-weekly oral administration that simplifies the treatment regimen and spares patients from the ordeal of frequent injections."

Prof. Depei Wu, at the First Affiliated Hospital of Soochow University, said, "MM poses a growing threat to people’s health in China. To effectively treat this condition, it requires early diagnosis, early treatment and timely adjusted treatment plans. I am thrilled that selinexor is now available to patients in China. I believe this new therapy will offer multiple myeloma patients significantly deeper responses, longer survival, and improved prognosis."

Prof. Jun Ma, at the Harbin Institute of Hematology&Oncology, added, "selinexor has a novel mechanism of action that delivers synergistic effects in combination with a number of readily available agents indicated for multiple myeloma. I am confident that we will be able to gain deeper insight from our clinical experience with selinexor-based combination therapies, thus bringing greater clinical benefit to patients."

Prof. Yu Hu, at the Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, remarked, "I am thrilled that selinexor can now be prescribed to patients in China. I believe this novel therapeutic offers a much-needed strategy that will bring renewed hope and improved health to many patients. I hope to see more novel medicines like selinexor, utilizing innovative mechanisms to bring new treatment options and potential curative care to patients, become available in China."

Integrated Distribution Channels, Coordinated Efforts to Fast Track Adoption

To make selinexor available to Chinese patients as swiftly as possible, Antengene has built world-class operations and commercial teams and established extensive strategic collaborations with Shanghai Pharmaceutical Lin-Gang Special Area Co., Ltd, the exclusive importer and national distributor of selinexor in China, and the provincial subsidiaries of Shanghai Pharmaceutical Co., Ltd, a Tier I distributor of selinexor in China, as well as a few other leaders in the across the product supply chain, such as DTP pharmacies under SPH Health Commerce Co., Ltd, the headquarters and provincial subsidiaries of SinoPharm Distribution Co., Ltd, China Resources Hunan Ruige Pharmaceutical Co., Ltd, Medbanks, LinkDoc, and Zhejiang INTYN Pharmacy Franchise Co., Ltd. Upon approval, Antengene promptly mobilized an internal team and external partners to secure supply chain readiness covering customs clearance, warehousing, quality assurance, distribution, and transportation. This coordinated effort paved the way for the rapid clinical application of selinexor across mainland China, hence benefiting many patients in need.

"Honoring our mission of Treating Patients Beyond Borders, we aim to leverage our global presence and extensive network of partners to commercialize practice-changing innovative therapies, and rapidly build out our distribution network to introduce high-quality innovative drugs to Chinese patients." said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "To have selinexor entering clinical practice and widely prescribed and utilized in mainland China vastly expands the drug’s accessibility for patients. Committed to serving patients in need, our overseas teams are racing against time to secure the accessibility of this life-saving drug for patients in South Korea, Singapore and Australia, where selinexor was also granted approvals. Moving forward, we will continue to expand our distribution network to allow more patients to benefit from the important therapy."

Novel Mechanism with Broad Potential to be Combined with Other Therapies

Selinexor is the world’s first orally-available, selective inhibitor of the nuclear export protein XPO1. Selinexor promotes the intra-nuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, down-regulating the levels of multiple oncogenic proteins, and activating the glucocorticoid receptors (GR) pathway, ultimately resulting in antitumor effects.

Utilizing this innovative mechanism of action, selinexor has demonstrated combinatory potential with multiple therapeutic agents including dexamethasone, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), daratumumab, cyclophosphamide, adriamycin, and melphalan. To date, six selinexor-based regimens have received a total of 11 recommendations by numerous leading medical societies, including the National Cancer Care Network (NCCN) Guidelines, the Guidelines for the Diagnosis and Danagement of Multiple Myeloma in China, and the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Guidelines.

At present, Antengene is conducting a total of 10 clinical studies of selinexor in mainland China (3 are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]), including several late-stage clinical trials, for the treatment of a range of relapsed/refractory hematologic malignancies and advanced solid tumors such as relapsed/refractory multiple myeloma, relapsed/refractory diffused large B-cell lymphoma and indolent lymphoma, relapsed/refractory T and NK-cell lymphoma, and recurrent/metastatic cervical/endometrial/ovarian cancers.

Note: XPOVIO is a prescription drug that should only be used under doctors’ instructions. Should you need any advice on the use of this drug, please consult your local hospitals or pharmacies.