On May 18, 2022 The companies Atonco (Nantes-Saint Herblain, France) and IONETIX Corporation (Lansing, MI) reported that they have signed a partnership agreement to ensure the radioisotope production and supply of the radiopharmaceutical necessary for the success of Atonco’s clinical studies and commercialization in the United States (Press release, IONETIX, MAY 18, 2022, View Source [SID1234614839]).

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!

Atonco, a radiopharmaceutical company at the clinical stage, aims to demonstrate through its clinical research program the relevance of a breakthrough therapeutic treatment, alpha immunotherapy, targeting superficial bladder cancer.

IONETIX Corporation operates a North American good manufacturing practice ("GMP") manufacturing and supply chain of positron and alpha-emitting radiopharmaceuticals. Ionetix through this agreement will produce astatine-211 and manufacture patient doses for clinical use, according to CGMP regulations. The agreement includes the supply of the radioisotope, astatine-211, the GMP manufacturing of the injectable doses and specifies the terms of the U.S. FDA agent agreement signed in August 2021.

IONETIX is leading the way by establishing the first North American commercial scale supply of astatine-211, from its new cyclotron facility in Lansing, MI that is dedicated to the production and distribution of alpha-emitting radioisotopes. "We are very excited about the partnership with Atonco which will enable us to fully support their clinical development program and commercialization in the United States, subject to FDA approval of Atonco’s drug candidates", declared David Eve, Vice President of Medical Affairs.

"This partnership agreement is a key step in the development of Atonco", declared Sylvain Fanier, President of Atonco. "We are convinced that Ionetix is the most reliable and advanced partner to ensure optimal sourcing for our clinical development and commercialization in North America. Thanks to their expertise and experience in the manufacture of radiopharmaceuticals and in discussions with the FDA, Ionetix will greatly contribute to our common success, in order to offer patients suffering from bladder cancer a very promising therapeutic alternative".

On May 18, 2022 Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) reported that it is launching Luzsana Biotechnology (Luzsana), a global, purpose-driven innovative medicines company committed to delivering medicines that are available, accessible and affordable to more people around the world (Press release, Jiangsu Hengrui Medicine, MAY 18, 2022, View Source [SID1234614838]). Luzsana, a wholly owned subsidiary of Hengrui Pharma, is a global development and commercialization biotechnology organization. Luzsana has developed a strategic plan with Hengrui Pharma that provides the company access to a world-class pipeline of more than 250 clinical studies in areas of high unmet medical need, such as oncology, cardiovascular, metabolic/diabetes, pain management, immunology and liver and renal disease.

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

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

                  Schedule Your 30 min Free Demo!

The origin of the Luzsana name is rooted in "la luz," which is Spanish for light, and "sana," which is Latin for heal. Luzsana is a healthcare company that aspires to become a "healing light" across the biotech sector by prioritizing the well-being of all stakeholders it encounters while operating its business. With locations in Princeton, New Jersey, Basel, Switzerland, and Tokyo, Japan, Luzsana is being led by a highly skilled team of industry veterans who average more than 25 years of experience with success delivering global execution excellence and building, leading and commercializing products at scale.

"There are more innovative medicines than ever being developed across the globe, yet many people continue to face barriers in terms of availability, accessibility and affordability. For example, while the World Health Organization notes that there are 25 essential cancer medications, only 10% of countries have made all 25 available to patients.1 We refer to this as the healthcare paradox," said Scott Filosi, chief executive officer of Luzsana.

"We believe the most effective medicines are ones that people can use. That’s why we won’t rest until we get our medicines into the hands of those who need them most—no matter their geography or socioeconomic status," said Filosi. "We’re confident the Luzsana mission can be brought to life because our unique partnership model has the potential to quantifiably reduce development costs thereby allowing us to invest in proven solutions that will drive innovative medicine availability, accessibility and affordability."

Through their unique relationship, Luzsana can partner with Hengrui Pharma to assess and hand select assets from Hengrui Pharma’s robust pipeline of more than 250 clinical studies across multiple therapeutic areas for global co-development and commercialization. Luzsana also will have access to 16 Hengrui Pharma research and development centers with more than 5,400 research staff. Luzsana has initially selected 11 high-potential oncology and non-oncology programs that span all phases of development, from preclinical to phase 3 for co-development. While the company’s initial pipeline is weighted heavily toward oncology with 8 out of 11 programs, Luzsana intends to further diversify its pipeline over time.

"Combining Hengrui Pharma’s established discovery and manufacturing capabilities with our robust global clinical trials network provides Luzsana with the potential to bring medicines to market quickly and at a competitive cost following regulatory approval without needing to make significant investments in high-risk, early discovery and infrastructure," said Jeff Crowther, president, commercial strategy and global operations at Luzsana.

Luzsana will share more details about its oncology pipeline at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7 in Chicago (Exhibit Booth #27155). The company also plans to attend the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, September 9-13 in Paris, France.

On May 18, 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 the uses of XPOVIO(selinexor) for Multiple Myeloma (MM) patients with first relapse or multiple relapses were incorporated into the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) (Press release, Antengene, MAY 18, 2022, View Source [SID1234614836]). This is the first time that selinexor has been included in the guidelines.

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

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

                  Schedule Your 30 min Free Demo!

The Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) was jointly developed and revised by the Chinese Hematology Association of the Chinese Medical Doctor Association (CMDA) and the Chinese Society of Hematology of the Chinese Medical Association (CMA), and was published in the Chinese Journal of Internal Medicine in May 2022.

The 2022 Guidelines for MM incorporated four selinexor combination therapy regimens comprised of selinexor and other biological and/or chemotherapy agents. Recommendations for the treatment of relapsed/refractory MM (R/R MM) are based on the multiple sources of medical evidence including patients’ response to prior treatment. As one of the most recognized guidelines in China, the guidelines are widely adopted among Chinese oncologists in their clinical practice.

Prof. Jin Lu, at Peking University People’s Hospital, commented, "MM is a malignancy that arises from plasma cells in the bone marrow, commonly occurring in middle-aged and elderly populations. As a result of an aging population, the incidence of MM has been rising sharply in China in recent years. Despite the medical advances in MM in the past two decades, R/R MM still remains a major clinical challenge faced by clinicians in day-to-day practices. Selinexor, the world’s first oral inhibitor of the nuclear export protein, was jointly recommended by the CMDA and CMA in the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision), which indicates strong recognition of selinexor’s therapeutic utility in Myeloma. Meanwhile, we hope that other on-going studies will generate additional data supporting even wider clinical adoption of selinexor."

Dr. Jay Mei, Antengene’s Founder, Chairman and CEO said, "Antengene is pleased to fulfill our mission of treating cancer patients with relapsed/refractory disease by bringing selinexor to the market in China and other Asia Pacific geographies. Inclusion in the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) is important because it highlights the robust clinical evidence that supports the use of selinexor in patients with R/R MM from first relapse through the full spectrum of disease progression. We believe that the combination of strong clinical data and inclusion into the guidelines for MM will make it easier for practitioners to incorporate selinexor into patient care and pave the way for patients with R/R MM to benefit from this novel therapy."

Dr. Kevin Lynch, Antengene’s Chief Medical Officer added, "Antengene is especially pleased for the use of selinexor to be recommended from the first relapse or multiple relapses. We understand that cancer care is complex and that having effective treatment options for the first relapse that offers the potential for durable disease control is especially important to patients and their families. We look forward to bringing this important therapy to patients in China and other Asia Pacific geographies."

Practice Guidelines for the treatment of relapsed myeloma

The patient’s response to prior treatment

Recommended Regimens

Lenalidomide-sensitive

XDd, XPd, XKd

Lenalidomide-resistant

XDd, XVd, XPd, XKd

Bortezomib-sensitive

XVd, XPd, XKd

Bortezomib-resistant

XDd, XPd, XKd

Resistant to both lenalidomide and bortezomib

XDd, XPd, XKd

*XDd, selinexor plus daratumumab plus dexamethasone; XPd, selinexor plus pomalidomide plus
dexamethasone; XKd, selinexor plus carfilzomib plus dexamethasone; XVd; selinexor plus
bortezomib plus dexamethasone

About Multiple Myeloma (MM)

MM is caused by the dysregulated proliferation of plasma cells. It is the second most common hematologic malignancy in many countries. Despite availability of a number of treatments for relapsed patients, MM is prone to relapse and most patients still succumb to their disease. MM is the second most common hematological malignancy in China, with an estimated about 15,000 to 20,000 new MM patients and 10,300 deaths per year.[1]

About XPOVIO (selinexor)

Selinexor is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. Due to its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens to improve treatment efficacy.

Antengene secured approval of selinexor in China in December 2021 for R/R MM and plans to launch the product in the second quarter of 2022. Antengene has also secured approval for selinexor in South Korea for use in R/R MM and R/R DLBCL in July 2021, in Singapore for use in R/R MM and R/R DLBCL and in Australia for use in R/R MM in March 2022. Antengene is conducting 10 clinical studies in mainland China (3 are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]) for relapsed/refractory hematological malignancies and advanced solid tumors.

On May 18, 2022 Laekna Therapeutics ("Laekna"), a clinical-stage global biotechnology company dedicated to developing next generation medicines to treat cancer and liver diseases, reported that it has raised $61 million in Series D financing led by CS Capital with support from Worldstar, and Infinity Capital (Press release, Laekna Therapeutics, MAY 18, 2022, View Source [SID1234614835]). Yanchuang Capital as the existing investor continued to support the company with additional funding.

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!

Laekna’s robust infrastructure has enabled the rapid development of 14 innovative drug candidates. The company has initiated six clinical programs, three of which are multi-regional clinical trials (including one pivotal trial) to address urgent, unmet medical needs in the standard of care-resistant cancers.

In the four rounds of financing to date, Laekna has been supported by leading healthcare-focused institutional investment firms. In addition to CS Capital, most recently, SCGC led the company’s $61 Series C financing in October 2020, after GP Healthcare Capital and OrbiMed Healthcare Fund Management led the Series B and Series A financing rounds, respectively.

Proceeds from the Series D financing will be used to accelerate the clinical development of Laekna’s two core product candidates, AKT kinase inhibitor afuresertib (LAE002) and the world’s first clinical-stage CYP17/CYP11B2 dual inhibitor (LAE001). Both product candidates cover three differentiated key mechanisms, namely targeted therapy, hormonal therapy, and immuno-oncology therapy. Laekna’s most advanced clinical trial is an open-label, randomized, multi-regional Phase 2 PROFECTA-II clinical trial of afuresertib, the world’s first registration-directed clinical trial of an AKT kinase inhibitor to treat platinum-resistant ovarian cancer.

"As Laekna celebrates its fifth anniversary in April, I would like to thank our new and existing investors. Over the past five years, it has been our honor to be recognized and supported by all of our partners. I believe that the time has come for Laekna as we work together with like-minded partners towards a better future," said Dr. Chris Lu, Chairman and CEO of Laekna. "We have arrived at a critical stage, and we understand that drug discovery and development is a long and often arduous journey. We remain committed to our vision to cure for a better future."

CS Capital life science investment team said, "The global biopharmaceutical industry is booming and has a myriad of thriving players. We decided to invest in Laekna as its R&D pipeline, innovation capabilities and management team deeply impressed us. We will work together with Laekna to help it become a partner and a leader in the industry to benefit patients worldwide."

On May 18, 2022 Cytovia Therapeutics, LLC ("Cytovia Therapeutics"), a global biotechnology company focused on harnessing the power of natural killer (NK) cells to fight cancer through multispecific antibodies and stem cell engineering, reported that it will be presenting at the the Annual European Hematology Association (EHA) (Free EHA Whitepaper)’s (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, taking place June 9 – 12, 2022 at the Messe Wien Exhibition and Congress Center in Vienna, Austria, and online (Press release, Cytovia Therapeutics, MAY 18, 2022, View Source [SID1234614834]).

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

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

                  Schedule Your 30 min Free Demo!

The abstract was released on May 12, 2022. The e-poster presentation will be published on the virtual congress platform on Friday, June 10.

Details of Cytovia’s poster presentation:
Title: NOVEL MULTIFUNCTIONAL TETRAVALENT CD38 NKP46 FLEX-NK ENGAGERS ACTIVELY TARGET AND KILL MULTIPLE MYELOMA CELLS
Session Title: Poster session
Session date and time: Friday, June 10, 2022 – 16:30 – 17:45 CEST
Final Abstract Code: P842
Presenting Author: Jean Christophe Bories
Summary: CYT-338 is a tetravalent IgG1-like multifunctional NK cell engager antibody with a novel FLEX-linker that simultaneously binds CD38-expressing cells and NK cells via the activation receptor NKp46. The in vitro and in vivo activity of CYT-338 was studied in myeloma models. CYT-338 showed specific dose-dependent binding to CD38 expressing MM cells with ~ 2-fold higher mean fluorescence intensity than daratumumab. Epitope mapping studies suggest binding of CYT-338 to a CD38 epitope distinct from daratumumab. CYT-338 showed greater dose dependent NK cell redirected cytolysis, degranulation, and cytokine production against MM1S cells compared to daratumumab. CYT-338 combined with peripheral blood NK cells inhibited tumor growth in a MM1S-NSG mouse model. CYT-338 showed minimal immune subset depletion, NK cell fratricide, and cytokine release compared to daratumumab in human PBMCs in-vitro. These results suggest that the CYT-338 engager has a favorable NK cell engager profile for targeting CD38-expressing multiple myeloma distinct from daratumumab.