On August 26, 2019 PharmaMar (MSE:PHM) has reported that it entered into a new Licensing Agreement with Janssen Products, LP (Janssen) for Yondelis (trabectedin), which replaces the 2001 Licensing Agreement entered into by both parties (Press release, PharmaMar, AUG 26, 2019, View Source [SID1234538972]).

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Under this new Licensing Agreement, Janssen will retain the right to sell and distribute, on an exclusive basis, Yondelis and any other product containing its active substance in the United States (U.S.). Both companies may agree to share new product research. The milestones and royalties on Janssen’s U.S. net sales of the product remain the same as in the 2001 Licensing Agreement.

PharmaMar will maintain the exclusive production rights of active ingredient trabectedin, which will be supplied to Janssen for clinical and commercial use.

Simultaneously, PharmaMar and Janssen have entered into a Master Product Transfer Agreement (MPTA), under which Janssen will transfer to PharmaMar all of Janssen’s rights to the compound in the rest of the countries previously licensed to Janssen. This includes all countries of the world with the exception of U.S., Europe and Japan, the last being licensed and marketed by Taiho Pharmaceuticals Co. Ltd.

The implementation of this transfer agreement will take place gradually depending on the specific regulatory requirements of each country. PharmaMar, together with Janssen, is committed to ensuring the supply of Yondelis during the transfer. Janssen will continue to sell the product until the transfer of the marketing authorizations to PharmaMar are complete.

This MPTA will enable PharmaMar to distribute Yondelis in more than 40 additional countries where the product has already been approved. PharmaMar plans to market Yondelis through local partners and does not rule out the possibility of new applications, and health regulatory submissions and approvals in more countries where the product is not currently approved.

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This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On August 26, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in the 2019 Wells Fargo Healthcare Conference in Boston, MA (Press release, Halozyme, AUG 26, 2019, View Source [SID1234538971]). Dr. Helen Torley, president and chief executive officer, will provide an overview of the company on Wednesday, September 4 at 10:50 a.m. ET / 7:50 a.m. PT.

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A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

On August 26, 2019 The Ivy Brain Tumor Center at the Barrow Neurological Institute and Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), reported a collaborative partnership to test Salarius’ therapeutic candidate, Seclidemstat, for the treatment of glioblastoma (Press release, The Ivy Brain Tumor Center, AUG 26, 2019, View Source [SID1234538970]). The organizations will launch what they believe is the most comprehensive pre-clinical study to date, evaluating the effect of targeting LSD1 (lysine-specific histone demethylase 1A), a key enzyme that has increased expression in tumors of brain cancer patients.

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Seclidemstat is a reversible LSD1 inhibitor that works by inhibiting LSD1’s enzymatic and protein-scaffolding functions. It is currently being tested by Salarius in a Phase 1 study for refractory or relapsed Ewing’s sarcoma and a Phase 1 study for Advanced Solid Tumors. Seclidemstat is among the most clinically advanced reversible LSD1 inhibitors in development, and its potential effect on glioblastoma represents a promising new therapeutic treatment option.

"Seclidemstat is highly differentiated LSD1 inhibitor with unique properties that may enable efficacy in a broader range of cancer types. Seclidemstat and/or its analogs have shown the potential for synergies with chemotherapies and other targeted agents. This gives us hope that Seclidemstat may be effective in treating a number of aggressive cancers, including glioblastoma," said Dr. Nader Sanai, director of the Ivy Brain Tumor Center. "Our shared goal with Salarius is to address the lag in new drug development for malignant brain tumors by accelerating early-phase clinical trials for first-in-class agents like Seclidemstat."

The Ivy Brain Tumor Center’s advanced pre-clinical capabilities include well-characterized patient-derived xenograft animal models and state-of-the-art pharmacokinetics and pharmacodynamics core facilities. A key component to this latest endeavor will be to leverage the Ivy Center’s core capabilities in collaboration with Salarius to perform in-house survival studies, advanced animal imaging, toxicology assessment, and in vivo pharmaco-metabolic analyses.

Should the pre-clinical phase provide sufficient evidence for positive drug effects, the program will move to the subsequent clinical evaluation of Seclidemstat. This will take place within the context of a Phase 0 clinical trial, in which researchers will quickly learn if the new regimen is having the desired impact on a patient’s individual tumor.

"Salarius is well positioned and highly-motivated to provide a new therapeutic option for a number of cancers with high unmet medical need," said David Arthur, President and Chief Executive Officer of Salarius Pharmaceuticals. "We are inspired by the Ivy Brain Tumor Center’s unwavering commitment to pursuing advances in glioblastoma treatment and look forward to this creative and vital research partnership."

For more information about the Ivy Brain Tumor Center and the drug development partnership, please visit, www.ivybraintumorcenter.org.

On August 25, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported that the first patient in China has been dosed in the Phase I/II bridging study of avapritinib, which was discovered by CStone’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, AUG 25, 2019, View Source [SID1234538983]). This stand-alone registrational bridging study in China includes a Phase I dose-escalation study and Phase II dose-expansion study, with the aim of evaluating the safety, pharmacokinetics and efficacy of avapritinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). This study consists of patients with PDGFRA D842V-driven GIST, as well as second- and third-line or later GIST patients.

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GIST is a sarcoma most commonly found in the stomach wall or small intestine. Most GIST patients are diagnosed between the ages of 50 to 80. Approximately 90% of GIST cases are associated with dysregulation of cell growth due to mutations of KIT and PDGFRA tyrosine kinases. Currently, there are no effective therapies for patients with PDGFRA D842V-driven GIST.

Avapritinib is an orally available, potent and highly selective inhibitor of KIT and PDGFRA. Previously published preclinical results have shown that avapritinib has potent activity against KIT and PDGFRA mutant kinases associated with GIST.

In June 2018, CStone entered into an exclusive collaboration and license agreement with Blueprint Medicines to develop and commercialize three therapeutic candidates, including avapritinib, in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for the three therapeutic candidates in the rest of the world.

Dr. Frank Jiang, Chairman and CEO of CStone, commented: "GIST is a rare disease with rising incidence rates in recent years, and PDGFRA D842V-mutant GIST patients still lack effective treatments. CStone is committed to the development of innovative therapies to meet urgent clinical needs. Our partner Blueprint Medicines has submitted an NDA for avapritinib in the U.S. and a marketing authorization application in the European Union. We are following their footsteps in seeking to make this novel precision therapy accessible to patients in Greater China as soon as possible. "

CStone’s Chief Medical Officer Dr. Jason Yang noted: "Early symptoms of GIST are relatively unpronounced; as a result, some GIST patients are undiagnosed until advanced stages. Data presented at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting demonstrated an objective response rate (ORR) of 86% and favorable tolerability in patients with PDGFRA Exon 18 mutant GIST in the global Phase I NAVIGATOR study of avapritinib. We have already initiated two registrational studies on avapritinib in China, both of which have enrolled their first patients. We will do our best to accelerate the development of this drug candidate and successfully bring it to the market in Greater China."

About Avapritinib

Avapritinib is an investigational, oral precision therapy that selectively and potently inhibits KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with GIST, including potent activity against activation loop mutations that are associated with resistance to currently approved therapies.

Blueprint Medicines is initially developing avapritinib for the treatment of advanced GIST, advanced systemic mastocytosis (SM), and indolent and smoldering SM. The U.S. FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRA D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

Data presented at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting from the global Phase I NAVIGATOR study of avapritinib are based on a data cutoff date of November 16, 2018.

On August 23, 2019 Cantargia AB and BioWa Inc. reported that it have signed an extension of the license agreement around the BioWa proprietary POTELLIGENT Technology for production of Cantargia’s antibody drug candidate CAN04, which gives Cantargia broader rights to use the technology (Press release, Kyowa Hakko Kirin, AUG 23, 2019, View Source [SID1234539061]). Since the original agreement allowing use of POTELLIGENT Technology was signed in 2015, Cantargia has advanced CAN04 to phase IIa clinical development for potential use in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC).

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Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). The POTELLIGENT technology generates antibodies with enhanced antibody dependent cellular cytotoxicity (ADCC). The investigational antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of interleukin 1 signaling. CAN04 is currently produced in a Chinese Hamster Ovary (CHO) cell line provided by BioWa which has been engineered using POTELLIGENT Technology. The extended agreement enables Cantargia to create and use additional CHO cell lines engineered using POTELLIGENT Technology and develop and commercialize CAN04 made through such CHO cell line.

With CAN04 having reached phase IIa clinical development, the next step in the production development is to further reduce production costs using various process improvements as well as scaling up, and Cantargia and BioWa have agreed to extend the current license to include additional opportunities.

"We are extremely pleased with our collaboration with BioWa and the amended agreement is a logical step in our long-term relationship. Given the successful advances of CAN04, optimization of the production process to reduce cost is part of the CAN04 development plan", Göran Forsberg, Cantargia’s CEO says.

"We believe that this extension of the license agreement would add benefits into the fruitful collaboration between Cantargia and BioWa." said Takeshi Masuda, BioWa’s President and CEO. "We are very pleased that this amended agreement could support the innovative program going forward".

For further information, please contact
Cantargia:
Göran Forsberg
CEO
Telephone: +46(0)46-275-62-60
E-mail: [email protected]

BioWa:
Shintaro Hasegawa
Director, Business Development
Telephone: +1-609-580-7340
E-mail: [email protected]

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on August 23, 2019.