On July 17, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies reported that it will be conducting a conference call to discuss the Company’s previously announced proposed acquisition of Adgero BioPharmaceuticals Holdings, Inc. (Press release, DelMar Pharmaceuticals, JUL 17, 2020, https://ir.delmarpharma.com/news/detail/936/delmar-pharmaceuticals-to-host-conference-call-to-discuss-proposed-acquisition-of-adgero-pharmaceuticals [SID1234562032]). The call will be held Thursday, July 23, 2020 at 4:30PM ET.

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Conference Call Dial-In and Webcast Details
The call will include remarks by Saiid Zarrabian, president and CEO, Scott Praill, chief financial officer and Greg Johnson, senior VP of Operations. A slide presentation will accompany the call and can be accessed via the webcast link below. Please refer to the information below for conference call dial-in information and webcast registration.

Participants may dial in by calling: 1-877-270-2148 (domestic) or 1-412-902-6510 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the DelMar Pharmaceuticals Conference Call.

The conference call will also be available through a live webcast with an accompanying presentation which can be accessed through the following link: View Source

On July 17, 2020 Sunshine Guojian Pharma (Shanghai), a 3SBio subsidiary that develops antibody drugs, reported that it is planning a $248 million IPO on the Shanghai STAR Market (Press release, Sunshine Guojian Pharmaceutical, JUL 17, 2020, View Source [SID1234562030]). Founded in 2002, Sunshine Guojian has two marketed antibody products and is developing 15 more, several of which have completed Phase III trials. The company develops novel and biosimilar products. It claims to have the largest antibody production base of of any China biopharma with total capacity of more than 38,000 liters.

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On July 17, 2020 Bristol Myers Squibb (NYSE: BMY) reported that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for lisocabtagene maraleucel (liso-cel), an investigational CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two prior therapies (Press release, Bristol-Myers Squibb, JUL 17, 2020, View Source [SID1234562028]). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

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Results from TRANSCEND NHL 001, the largest trial in third-line or greater R/R large B-cell lymphoma (LBCL), and additional data from the TRANSCEND WORLD study were the basis of the liso-cel application. The studies evaluated patients with R/R LBCL and included patients with a broad range of histologies and high-risk disease as well as those who received liso-cel in the outpatient setting.

"With more than 30% of patients diagnosed with diffuse large B-cell lymphoma ultimately relapsing after initial therapy and an expected overall survival of about six months for patients who have had two or more prior therapies, there is a need for new treatments," said Stanley Frankel, M.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb.1,2 "The EMA’s validation of our application is a critical step toward bringing liso-cel to patients in Europe."

The EMA previously granted liso-cel access to the PRIME scheme for the treatment of R/R DLBCL and, more recently, Accelerated Assessment status, reducing the maximum timeframe to 150 days for the EMA’s Committee for Medicinal Products for Human Use (CHMP) to review the application.

Liso-cel is an investigational therapy that is not approved for use in any country.

About TRANSCEND NHL 001

TRANSCEND NHL 001 is an open-label, multicenter, pivotal Phase 1 study to determine the safety, antitumor activity and pharmacokinetics of liso-cel in patients with R/R B-cell NHL, including DLBCL, HGL, PMBCL and Grade 3B FL. Mantle cell lymphoma is investigated in a separate cohort. The primary outcome measures included treatment-related adverse events, dose-limiting toxicities and objective response rate. Key secondary outcome measures included complete response rate, duration of response and progression-free survival. The TRANSCEND program is a broad clinical program evaluating liso-cel in multiple indications and treatment lines.

About TRANSCEND WORLD

TRANSCEND WORLD is a single-arm, multi-cohort, multicenter, Phase 2 study to determine the efficacy and safety of liso-cel in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). The primary outcome measure was overall response rate (ORR). Secondary outcome measures included safety, complete response rate, event-free survival, progression-free survival, overall survival, duration of response, pharmacokinetics and health-related quality of life. The study was conducted in Europe and Japan.

About Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) is a rapidly growing, aggressive disease and the most common form of non-Hodgkin lymphoma (NHL), accounting for one out of every three cases diagnosed.3 More than two-thirds of patients will not respond to or will relapse following second-line treatment.3 For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.2,4

About Lisocabtagene Maraleucel (liso-cel)

Liso-cel is an investigational chimeric antigen receptor (CAR) T cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. Liso-cel aims to target CD19-expressing cells through a CAR construct that includes an anti-CD19 single-chain variable fragment (scFv) targeting domain for antigen specificity, a transmembrane domain, a 4-1BB costimulatory domain hypothesized to increase T cell proliferation and persistence, and a CD3-zeta T cell activation domain. The defined composition of CAR-positive viable T cells (consisting of CD8 and CD4 components) in liso-cel may reduce CAR T product variability; however, the clinical significance of defined composition is unknown.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

On July 17, 2020 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported Q2 2020 operational highlights, revenue and cash position for Nicox SA and its subsidiaries (the "Nicox Group"), as well as updating key expected milestones for the remainder of 2020 (Press release, NicOx, JUL 17, 2020, View Source [SID1234562025]).

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Key Expected Upcoming Milestones
NCX 470 Mont Blanc Phase 3 clinical trial: The adaptive design part of the first Phase 3 clinical trial of NCX 470 for lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension is on track to be completed in Q4 2020, facilitating both the start of the second Phase 3 "Denali" trial on schedule and the completion of the Mont Blanc trial where patients will then continue on the selected NCX 470 dose in the subsequent head-to-head 3-month safety and efficacy evaluation of NCX 470 vs. latanoprost.
NCX 470 Denali Phase 3 clinical trial: The second Phase 3 glaucoma clinical trial, jointly managed and equally funded by Nicox and Ocumension, is currently expected to start in Q4 2020. It will include clinical sites in both the U.S. and China, with the majority of the patients being in the U.S. The Denali trial was designed and is expected to be sufficient to support NDA filings in the U.S. and China.
NCX 4251 Phase 2b clinical trial: This Phase 2b trial will include both blepharitis and dry eye endpoints with the option of declaring either the blepharitis or dry eye endpoints as the primary outcome of the trial. Timing and further trial design details will be announced in due course.
ZERVIATETM China: A Phase 3 clinical trial for approval in China, to be conducted and financed by Ocumension, is currently expected to start by Q4 2
We continue to closely watch the spread of COVID-19 and its impact. We do not currently anticipate delays to our clinical timelines but we are monitoring the situation and will provide updates if there is an impact on our development projects and timelines.

Second Quarter 2020 and Recent Operational Highlights
The total number of prescriptions1 for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, in the U.S. in the second quarter of 2020 increased by 36% compared to the second quarter of 2019 and was unchanged compared to the first quarter of 2020.
ZERVIATETM (cetirizine ophthalmic solution), 0.24%, U.S. prescriptions2 totaled 1,389 in Q2 2020, the first full quarter of sales following launch in the U.S. in March 2020.
We divested our shareholding in VISUfarma, a pan-European ophthalmic specialty pharmaceutical company, to a subsidiary of the main shareholder, GHO Capital, for €5 million.
The first Phase 3 clinical trial, named Mont Blanc, evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was initiated on June 1, 2020, and currently has over 40 clinical sites initiated in the trial. NCX 470 is the company’s novel, second-generation nitric oxide (NO)-donating bimatoprost analog. The Mont Blanc trial is a multi-regional, double-masked, 3-month, parallel group, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005% in patients with open-angle glaucoma or ocular hypertension. In an adaptive portion of the trial, one NCX 470 dose will be selected to continue in the subsequent head-to-head 3-month efficacy and safety evaluation of NCX 470 vs. latanoprost. The primary efficacy evaluation is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3. The trial is expected to randomize approximately 670 patients, primarily at approximately 50 clinical sites in the U.S. and at a small number of clinical sites in China.
A successful Type C meeting with the U.S. FDA was held, with agreement on Phase 2b trial designs for NCX 4251 in both acute exacerbations of blepharitis and the reduction of signs and symptoms of dry eye disease. NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, is Nicox’s second product candidate in clinical development. The timing of the future program for NCX 4251 is subject to securing the financial resources to advance its development.
Following results from in vivo primary pharmacodynamics studies of naproxcinod in models of sickle-cell disease, U.S. partner Fera Pharmaceuticals decided to focus its development of naproxcinod on the treatment of painful vaso-occlusive crisis in sickle-cell disease. Fera plans to conduct further studies and other development activities in preparation for entering directly into a clinical efficacy trial of naproxcinod in sickle-cell patients, subject to being granted an ODD.
Second Quarter 2020 Financial Highlights
As of June 30, 2020, the Nicox Group had cash and cash equivalents of €40.4 million as compared with €28.0 million at December 31, 2019 and €45.2 million at March 31, 2020. This figure does not include the €5 million from the divestment of our VISUfarma shareholding in July. Net revenue3 for the second quarter of 2020 was €0.6 million (consisting entirely of royalties), compared to €5.2 million (including €4,7 million of milestone and upfront payments) for the second quarter of 2019.

As of June 30, 2020, the Nicox Group had financial debt of €17.7 million in the form of a bond financing agreement with Kreos Capital signed in January 2019.

Only the figure related to the cash position of the Nicox Group as of December 31, 2019 is audited; all other figures of this press release are non-audited.

Notes
1. Bloomberg data, comparing the period of the weeks ending April 3, 2020 to June 26, 2020 with the period of the weeks ending January 3, 2020 to March 27, 2020 and April 5 2019 to June 28, 2019
2. Bloomberg data for the period of the weeks ending April 3, 2020 to June 26, 2020
3. Net revenue consists of revenue from collaborations less royalty payments, which corresponds to Net profit in the consolidated statements of profit or loss

On July 16, 2020 GlyTherix Ltd (GlyTherix) reported that a consortium led by the company are the successful recipients of a competitive grant in Round 9 of the Federal Government’s Cooperative Research Centres Projects (CRC-P) program (Press release, Glytherix, JUL 16, 2020, View Source [SID1234565141]).

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The grant will use the company’s proprietary novel target, Glypican-1, and its lead antibody to this target, Miltuximab, as a flagship molecule to develop national capability in manufacturing and distribution of radioimmuno-oncology drugs.

Radioimmunotherapy (RIT) uses antibodies to selectively deliver radiation to kill cancer cells, while limiting damage to healthy cells.

Dr Brad Walsh, CEO of GlyTherix, said that widespread adoption of RIT has been traditionally limited by the complex manufacturing process and short shelf life of the radioisotope.

"The grant brings together Australian SMEs, universities and government research organisations to pioneer manufacturing of "shake-and-bake" kits that allow on-site, on-demand production of RITs in hospital radio-pharmacies. Our Miltuximab antibody will be used as a testbed for the entire production process, testing safety and efficacy in a Phase 1 clinical trial. This project not only builds out our data around the technology but will also lead the way for Australia to develop sovereign capability in antibody manufacturing and RIT kits. Ultimately, these kits will help facilitate expanding a theranostic approach to cancer treatment in many more hospitals and patients," said Dr Walsh.

In this project radiolabelled Miltuximab is being used for both imaging and immunotherapy, known as ‘theranostics’. The project partners include Australian Nuclear Science And Technology Organisation (ANSTO), Commonwealth Scientific And Industrial Research Organisation (CSIRO), Cytiva (formerly GE Healthcare Life Sciences), Auspep Pty Ltd, University Of Technology Sydney and Macquarie University.

Dr Walsh said that the combined experience and expertise of the project partners augurs well for a successful project.

"We are grateful to the Federal Government for recognising the internationally competitive potential in this application. It’s extremely exciting to be commencing our manufacturing and clinical trial program for Miltuximab with such an esteemed group of experts in their field from highly respected Australian and International companies and institutions," said Dr Walsh.

"Theranostics is one of the most exciting areas of medicine and an area where Australia is a world leader. This CRC-P enables the diverse skills required to be assembled locally to benefit from our world leading position in this field of medicine. The pairing of a precision diagnostic with a corresponding precision therapeutic that targets Glypican-1 has the potential to treat a wide range of cancers. We are excited to be part of the program and looking forward to working on the antibody manufacturing process at UTS." Stephen O’Sullivan, Business Development Manager – ANZ, Cytiva (formally GE Lifescience).

Professor Roger Chung from Macquarie University Faculty of Medicine, Health and Human Sciences said the University was excited to be collaborating with GlyTherix and other consortia partners on this exciting translational research project. "Through MQ Health, the University’s integrated academic health centre, we provide an important pathway for academic and industry-led technology to be evaluated in a healthcare setting towards clinical translation."

Chris Chandler MD Auspep commented that "GlyTherix has done a great job in putting this CRC-P together. They have brought the right mix of knowledge from the industrial, government and academic sectors which will give the program it’s best chance of a successful, commercial outcome."

Dr Andrew Groth, UTS Faculty of Science Business Development Manager stated the partnership was a globally significant development and the production of antibodies in the UTS Biologics Innovation Facility demonstrates the power of university and industry collaboration. "UTS is extremely proud to be part of what is a landmark for the Australian biopharmaceutical industry with an end-to-end project from development to clinical trials," he said.

"Radioimmuno-oncology is one of the most exciting and dynamic areas in nuclear medicine and radiochemistry, with robust research and commercial interest globally. This timely CRC-P will establish an end-to-end national capability for antibody-based theranostics in Australia, building our reputation as a global leader in nuclear medicine clinical trials. ANSTO is proud to be a participant in this project delivering to our core missions of improving the health of all Australians and supporting Australian business." Dr Nigel Lengkeek, Senior Radiochemist, ANSTO.

GlyTherix is looking for investors who would like to be involved in the company’s Series A funding round.