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Oasmia acquires global development and commercialization rights for Cantrixil, a clinical stage, ovarian cancer program

On March 1, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that it signed an agreement with Kazia Therapeutics, an Australian oncology-focused biotechnology company, to acquire exclusive global development rights for Cantrixil, a product candidate in development intended for the treatment of ovarian cancer (Press release, Oasmia, MAR 1, 2021, View Source [SID1234575806]). The agreement is the first in a series of planned in-licensing deals and acquisitions to expand Oasmia’s oncology portfolio, leveraging its proven development and regulatory capabilities.

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Oasmia will acquire the license for an upfront cash consideration of $4m, development milestones worth up to $42m and cumulative sales-based royalties. In addition to its promise as stand-alone therapy, Cantrixil has the potential to complement Oasmia’s lead product for ovarian cancer, Apealea, through treatment protocols to be developed. It may also offer synergies with Oasmia’s XR-17 technology platform, which could enhance solubility in various routes of administration.

François Martelet, M.D., CEO of Oasmia, commented: "This agreement is the first step in our transformative ‘string of pearls’ strategy designed to achieve critical mass in Oasmia’s oncology portfolio. Cantrixil is an exciting addition and builds on our development expertise in ovarian cancer. Acquiring rights to Cantrixil, which has established clinical proof of concept, is a major step forward in executing our strategy, and we will continue to leverage our development and partnering expertise to expand our oncology pipeline."

Cantrixil consists of the active molecule, a potent and selective third generation benzopyran SMETI inhibitor named TRXE-002-01, encapsulated in a cyclodextrin. It is believed to target a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse. In December 2020, Kazia released the top-line results of a Phase I open-label study (NCT02903771) conducted at sites in the USA and Australia. The Phase I study met its primary endpoints, establishing clinical proof of concept, subject to further clinical evaluation and confirmation.

A Phase II study with Cantrixil is expected to be initiated in 2022.

James Garner, CEO and Managing Director at Kazia Therapeutics added: "We are excited by the potential of this novel candidate to target and kill tumor-initiating cells responsible for cancers originating, metastasizing, and relapsing. These slower-growing tumor-initiating cells are often resistant to other types of chemotherapies. Cantrixil has the potential to become a standard front-line agent, complementing the use of platinum therapy in Ovarian cancer patients. Oasmia’s expertise and track record in developing oncology drugs through to approval makes them ideally placed to continue the development of Cantrixil forward to benefit patients who currently have limited treatment options."

Conference call
The company will hold a conference call and an online presentation on March 1, 2021 at 14.00 CET. The call will be hosted by CEO Francois Martelet, and Acting CSO Reinhard Koenig. The presentation will be in English.

Nicox Announces 2020 Financial Results and 2021 Key Milestones

On March 1, 2021 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported the financial and operating results for Nicox and its subsidiaries (the "Nicox Group") for the year ended December 31, 2020, as approved by the Board of Directors on February 26, 2021, and provided upcoming 2021 key milestones (Press release, NicOx, MAR 1, 2021, View Source [SID1234575805]).

2020 Financial Summary
Net revenue[1] for the full year 2020 was €12.9 million (€2.4 million in net royalties, €10.5 million in license payments), compared to €6.9 million (€2.1 million in net royalties, €4.8 million in upfront and milestone payments) for the full year 2019. Net revenue has been revised upwards from that reported in the Q4 2020 business update due to an accounting adjustment reflecting a non-cash item of deferred income received from Ocumension in March 2020.

Operating expenses for the year 2020 decreased to €19.5 million from €25.5 million for the 12 months to December 31, 2019. Research and development expenses decreased by €5.0 million while administrative and other expenses decreased by €1.0 million. Nicox’s research and development efforts remained strong in 2020, mainly concentrated in the second part of the year with 3 clinical trials initiated since June.

Net loss of the Nicox Group for the full year 2020 was €18.1 million against €18.9 million for the full year 2019.

As of December 31, 2020, the Nicox Group had cash and cash equivalents of €47.2 million as compared with €28.1 million at December 31, 2019.

As of December 31, 2020, the Nicox Group had financial debt of €17.9 million consisting of €15.9 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2.0 million credit agreement with Société Générale and LCL, guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic. The position includes the prepayment to Kreos of the January 2021 period.

Events after the Reporting Period
VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, was launched by Nicox’s global partner Bausch + Lomb in Mexico. It is already commercialized in U.S. (2017), Canada (2019), Argentina (2020) and Hong Kong (2020), and approved in 4 other territories, Colombia, South Korea, Taiwan and Ukraine. Bausch + Lomb is planning to launch VYZULTA in Taiwan in 2021 and in South Korea in 2022.
Nicox amended its bond financing agreement with Kreos Capital, introducing an additional one-year period of interest-only payments on the outstanding principal starting on February 1, 2021, and an extension of the overall period of the loan by 6 months to July 2024. The new one-year interest-only period is expected to provide approximately €5.5 million of additional flexibility for investment in development activities in 2021. The interest rate of the bonds remains unchanged as a result of this amendment.
Pre-clinical intraocular pressure (IOP)-lowering results on a new class of non-prostaglandin analog, nitric oxide (NO)-donating compounds, was published in the Journal of Ocular Pharmacology and Therapeutics, a leading scientific journal. Increased IOP is one of the principal risk factors of open-angle glaucoma. The NO-mediated IOP-lowering effect in this new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 inhibition within the same molecule.
Key Expected Upcoming Milestones
NCX 470 first Phase 3 clinical trial, Mont Blanc: Nicox’s lead clinical product candidate, NCX 470 is a novel NO-donating prostaglandin analog. Mont Blanc is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%, for lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Top-line results are currently expected in H1 2022.
NCX 4251 Phase 2b clinical trial, Mississippi: NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. Mississippi is evaluating once-daily dosing NCX 4251 0.1% versus placebo for the treatment of acute exacerbations of blepharitis. Top-line results are currently expected in Q4 2021.
We expect to enter into additional agreements for ZERVIATE (cetirizine ophthalmic solution), 0.24%, further enlarging the licensed territories and increasing potential future revenue.
We continue to closely watch the spread and impact of the COVID-19 pandemic and we will provide an update of any delays.

[1] Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss

BioInvent and Transgene has enrolled first patient in Phase I/IIa trial of novel oncolytic virus BT-001 in solid tumors

On March 1, 2021 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that the first patient in a Phase I/IIa clinical trial of the novel dual mechanism-of-action oncolytic vaccinia virus BT-001 has been enrolled at Institut Bergonié (Bordeaux, France) (Press release, BioInvent, MAR 1, 2021, View Source,c3297110 [SID1234575803]).

BT-001 has been generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine.

By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. In addition, delivering the anti-CTLA-4 antibody directly to the tumor microenvironment aims to induce local Treg depletion and strong therapeutic activity. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody will be greatly improved. BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene.

"The inclusion of the first patient in this Phase I/IIa trial marks a further broadening of our clinical pipeline, which now comprises three candidate products and four clinical studies. BT-001 is a unique oncolytic virus, combining multiple mechanisms-of-action, and has outstanding potential in a wide range of indications thanks to its combination of multiple anti-cancer properties," said Martin Welschof, CEO of BioInvent.

Hedi Ben Brahim, Chairman and CEO of Transgene, said: "We are excited to start this clinical trial with BT-001, which is the result of a very productive collaboration between Transgene and BioInvent. This first Invir.IO based oncolytic virus entering the clinic has been shown to induce long-lasting antitumor immune responses and abscopal effects in several preclinical tumor models; in these experiments, the activity of BT-001 was further enhanced through combination with an anti-PD-1 antibody treatment. It has a unique mode of action and the outstanding results so far indicate it could make a significant difference to cancer patients."

This multicenter, open-label, dose-escalation Phase l/lla trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment) will first be including patients in several countries in Europe. An IND submission will follow in the USA.

The Phase I will be divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors. Patients will receive single agent, intra-tumoral administrations of BT-001, in cutaneous or palpable subcutaneous lesions or easily injectable lymph nodes. Part B will explore the combination of intra-tumoral injections of BT-001 with pembrolizumab in 12 patients. The Phase lla will evaluate the combination regimen in several patient cohorts with different tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

The trial (NCT04725331) will first be conducted at the UCL Saint Luc (Brussels, Belgium), the Bergonié Institute (Bordeaux, France), the Gustave Roussy Institute (Paris area, France), the Centre Léon Bérard (Lyon, France) and the Hôpital Saint-Louis (Paris, France).

About BT-001
BT-001 is a best-in-class oncolytic virus developed with Transgene’s Invir.IO platform. Invir.IO’s viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR-. This optimization enhances the safety profile of the virus. From this, BT-001 is engineered to encode both a highly differentiated Treg depleting anti-CTLA-4 antibody and the human GM-CSF cytokine. The recombinant antibody recognizing human CTLA-4 was generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms. The use of an oncolytic virus to deliver the anti-CTLA-4 locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both transgenes eliciting a stronger and more effective antitumor response. By reducing systemic exposure to a very low level, this local therapeutic activity furthermore allows to increase the safety and tolerability profile of the anti-CTLA-4 antibody. Preclinical data have shown that BT-001 has potential for broad single agent activity, and that selective tumor-localized delivery of anti-CTLA4 may allow for a better tolerated, sustained and more effective combination therapy with antibodies targeting the PD-1/PDL1 axis.

The scientific and clinical development of the oncolytic virus candidate BT-001 is a 50/50 collaboration between BioInvent and Transgene.

Innovent Announces First Patient Outside China Dosed in the Phase 1 Clinical Trial of Anti-CD47/PD-L1 Bispecific Antibody

On February 28, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient outside China has been successfully dosed in a Phase 1 clinical trial of the potentially first-in-class recombinant anti-CD47/PD-L1 bispecific antibody (IBI322) (Press release, Innovent Biologics, FEB 28, 2021, View Source [SID1234575801]).

This is a Phase 1a clinical study conducted in the United States to evaluate IBI322 in the treatment of patients with advanced malignancies. The primary objective of the study is to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI322 in patients with advanced malignancies who have failed standard therapy.

IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody that blocks both the PD-1/PD-L1 and CD47/ SIRP-α pathways. Pre-clinical studies showed that IBI322 can effectively block CD47–SIRP-α interactions and induce macrophages to phagocytize CD47 expressed tumor cells, which is equivalent to anti-CD47 monoclonal antibody. IBI322, on the other way, effectively blocks the binding of PD-1 to PD-L1 and activates CD4+T lymphocyte, which is comparable to anti-PD-L1 monoclonal antibody. Because of PD-L1 expression on tumor cells, IBI322 can selectively binds to tumor cells more potent than anti-CD47 monoclonal antibody, thus reducing the possibility of bind to CD47 on red blood cells, which could ultimately reduce the toxicity associated with anti-CD47 antibodies. Therefore, IBI322 has better antitumor activity and higher safety profile.

Although immune checkpoint inhibitors have shown promising results in the treatment of a wide range of tumors, there still remains many new challenges. A part of patients has developed drugs resistance and the efficacy of immune checkpoint inhibitors needs to be further enhanced. Therefore, it is of great value to develop the next generation of anti-tumor immune bispecific antibodies. CD47 is one of the most promising targets among cancer immunotherapy, combining innovative techniques for bispecific monoclonal antibody, we look forward to the results of IBI322 clinical trials.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: " By targeting effector cells directly to tumor cells, bispecific monoclonal antibody enhances cytotoxicity, antibody selectivity and functional affinity. The preliminary results showed that IBI322 had higher efficacy in vivo, tumor-rich distribution and better safety than the single-specific anti-CD47 antibody. Bispecific monoclonal antibody could bring a lower-cost solution to patients compared with a combination of monoclonal antibody therapies. Therefore, the development of the anti-CD47/PD-L1 bispecific antibody will provide patients with a novel, comprehensive, effective and cost-saving treatment regimen. We hope IBI322 could potentially benefit more patients in need."

About IBI322

IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody developed by Innovent. As a class 1 innovative drug and a potentially first-in-class molecule, IBI322 can effectively induce the phagocytosis of tumor cells and stimulate the activation of T lymphocytes to exert anti-tumor activity. IBI322 is of more affinity to tumor cells, thus reducing the toxicity to normal tissue, providing more effective treatment to cancer patients. IBI322 has received an IND approval from both the NMPA and the U.S. FDA. Innovent is actively preparing to develop it globally.

Antengene (6996.HK) Selected as a Constituent Stock of Nine Benchmark and Thematic Indexes Including the Hang Seng Composite Index

On February 28, 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 the company has been selected as a constituent stock of the Hang Seng Composite Index (HSCI), the Hang Seng Stock Connect Hong Kong Index (HSHKI), the Hang Seng Stock Connect Hong Kong MidCap & SmallCap Index (HSHKMS), the Hang Seng Stock Connect Hong Kong SmallCap Index (HSHKS), the Hang Seng SCHK Mainland China Companies Index (HSSCMLC), the Hang Seng SCHK ex-AH Companies Index (HSSCNAH), the Hang Seng Healthcare Index (HSHCI), the Hang Seng Hong Kong-Listed Biotech Index (HSHKBIO) and the Hang Seng Small Cap (Investable) Index (HSSIV), according to the quarterly review results of the Hang Seng Family of Indexes, effective on March 15, 2021 (Press release, Antengene, FEB 28, 2021, View Source [SID1234575800]).

The Hang Seng Composite Index offers a comprehensive Hong Kong market benchmark that covers about the top 95th percentile of the total market capitalization of companies listed on the Main Board of the Stock Exchange of Hong Kong (SEHK). Adopting the free float-adjusted market capitalization methodology, the HSCI can be used as a basis for index funds, mutual funds as well as performance benchmarks. The Hang Seng Stock Connect Hong Kong Index serves as a benchmark to reflect the overall performance of the securities listed in Hong Kong that are eligible for trading via the southbound trading link of Stock Connect; the Hang Seng Healthcare Index aims to reflect the overall performance of stocks listed in Hong Kong that are related to healthcare businesses; and the Hang Seng Hong Kong-Listed Biotech Index reflects the overall performance of the biotech companies that are listed in Hong Kong including stocks listed through the Listing Rules Chapter 18A of Hong Kong Exchange.

Antengene has the world’s only commercialized selective inhibitor of nuclear export (SINE), ATG-010 (selinexor), and with its successful IPO in November 2020, is one of the fastest growing Hong Kong-listed biopharmaceutical companies. In the past half a year, Antengene has achieved multiple milestones in clinical and business developments, and has submitted New Drug Applications (NDAs) in five APAC markets including China. Moreover, ATG-010 was granted Priority Review status by the China National Medical Products Administration (NMPA) and an Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS). These progress have taken the company one step closer to providing a novel therapeutic option to cancer patients.

"It is our great pleasure to see Antengene being included into nine indexes in the Hang Seng Family of Indexes. These inclusions will give Antengene greater exposure in the capital markets and further improve our visibility among the broader investor community," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "Our innovative products that are on the brink of commercialization, our fast-growing commercial team, and our clinical team possessing strong track record in the field of hematological malignancy are the source of our confidence in Antengene’s future growth. We will remain committed to our founding mission of ‘treating patients beyond borders’, and steadfastly pursue long-term growth in the field of innovative anti-tumor therapies."