On May 13, 2020 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported the outcome of a strategic review assessing all aspects of the business to maximise the company’s resources, to achieve the full potential of its XR17 platform technology and to optimise Oasmia’s path towards long-term, profitable growth (Press release, Oasmia, MAY 13, 2020, View Source [SID1234557891]).

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The review was undertaken by Oasmia following the appointment of Francois Martelet as Chief Executive Officer in February 2020. In March, Oasmia announced a global strategic partnership with Elevar Therapeutics, the U.S. subsidiary of HLB Co. Ltd, to commercialise Oasmia’s anticancer product Apealea, which is based on its XR17 technology. Under the terms of the agreement, Oasmia has received an upfront payment of USD 20 million and is eligible to receive milestone payments of up to USD 678 million and double-digit royalties on future sales.

As a result of the review, Oasmia has identified a number of areas of strategic focus allowing the company to achieve its long-term goals, including:

Explore additional opportunities to apply the company’s proprietary XR17 solubility-enhancing technology platform in oncology and other therapeutic areas, including out-licensing of non-core applications
Continue to drive the development of Oasmia’s existing pipeline of XR17-based products, including Docecal (docetaxel) in breast and prostate cancers and its combination cancer therapy XR19
Leverage the company’s GMP manufacturing facilities for R&D and clinical trial production
Expand Oasmia’s pipeline through potential acquisitions or in-licensing deals with a focus on late-stage assets that will move the company towards positive cash flow.
As a consequence of this review, Oasmia will undertake a comprehensive cost control program designed to maximise resources and enable it to invest in areas which can deliver the greatest return. Key aspects of the cost control program include:

Annualised cost savings of more than SEK 100 million
A ~50% reduction in the cash burn rate to below SEK 10 million a month
Greater focus on R&D and clinical trial GMP manufacturing as opposed to commercial manufacturing
Francois Martelet, Chief Executive Officer of Oasmia, said:

"Since joining Oasmia in March, I have been impressed by the quality and potential of its technology and pipeline. With Apealea approved in Europe and becoming available to patients, Oasmia has demonstrated its ability to bring promising new products to market that meet unmet need and enhance drug safety. The transformative global agreement with Elevar has further underlined Oasmia’s clinical, regulatory and commercial strengths. We are now ideally placed to move into the next phase of growth, establishing Oasmia as a leading Sweden-based specialty pharmaceutical company, maximising the potential of our proven XR17 technology platform and leveraging our skills and expertise through the acquisition or in-licensing of promising assets. Management is now fully focused on delivering these objectives, which will provide benefits to patients and build value for shareholders."

Jörgen Olsson, resigning Chairman of the Board of Oasmia, comments:

"In the Board, we are very impressed and pleased by the sharp analysis, speed and decision-making qualities that our new CEO shows in this short time. We very much look forward to the new, commercial future for Oasmia."

On May 13, 2020 Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform therapy called Tumor Treating Fields, reported that the China National Medical Products Administration (NMPA) has approved the Marketing Authorization Application (MAA) for Optune in combination with temozolomide for the treatment of patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM (Press release, Zai Laboratory, MAY 13, 2020, View Source [SID1234557885]). GBM is the most common form of primary brain cancer, and Optune is the first treatment for glioblastoma approved in China in over 15 years.

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"The NMPA’s approval of Optune is a significant treatment advance for GBM patients in China and another important milestone for Zai," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "Optune was previously granted the Innovative Medical Device Designation, which highlights the differentiation and importance of this novel treatment for GBM patients. We appreciate the NMPA for their partnership through this rapid and thorough assessment of the Optune application, recognizing the high unmet medical need it serves. We look forward to working with Novocure to bring Tumor Treating Fields to GBM and other difficult to treat cancer indications."

"Novocure is working to extend survival in some of the most aggressive cancers through the development and commercialization of Tumor Treating Fields," said William Doyle, Novocure’s Executive Chairman. "Approval of Optune for GBM in Greater China extends the promise of Tumor Treating Fields therapy to patients in the world’s largest market. We thank Zai Lab for their commitment and hard work and congratulate them on their second product approval in six months."

Optune delivers Tumor Treating Fields therapy to the region of the tumor. Globally, more than 15,000 GBM patients have been treated with Optune, to date. Tumor Treating Fields is also approved by the U.S. FDA under the Humanitarian Device Exemption pathway for the treatment of malignant pleural mesothelioma (MPM), which is anticipated to be the next MAA filed with the NMPA. In addition to GBM and MPM, Tumor Treating Fields is under evaluation in global phase 3 pivotal trials for the treatment of brain metastases, non-small cell lung cancer, pancreatic cancer and ovarian cancer, and in phase 2 pilot trials for liver cancer and gastric cancer. Approximately 1.5 million patients a year in China are diagnosed with non-small cell lung cancer, pancreatic cancer, ovarian cancer and gastric cancer, collectively.

"In China, there are more than 45,000 patients diagnosed with GBM each year and this approval marks the first new treatment option for these patients in over 15 years," said Jiang Tao, M.D., Ph.D., Head of Beijing Neurosurgical Institute, Founder of Chinese Glioma Genome Atlas, and Professor of Beijing Tiantan Hospital. "Optune was recommended with Level 1 evidence as a treatment for newly diagnosed GBM patients in China’s Glioma Treatment Guideline in 2018, and we are excited to now have Optune available as part of the standard of care for GBM patients in China."

About Optune

Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Approved Indications (China)

Optune is intended as a treatment for adult patients (22 years of age or older) with recurrent supratentorial glioblastoma multiforme (GBM) diagnosed by histopathology or imaging, and newly diagnosed supratentorial GBM.

Newly diagnosed GBM

Optune with temozolomide (TMZ) is indicated for the treatment of adult patients with newly diagnosed GBM after surgery and radiotherapy.

Recurrent GBM

Optune is indicated for the treatment of recurrent GBM as a monotherapy.

On May 13, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported its financial results for the three and nine months ended March 31, 2020 and provided a corporate update (Press release, DelMar Pharmaceuticals, MAY 13, 2020, View Source [SID1234557884]).

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"We continue to be pleased with the rapid enrollment pace in both of our Phase 2 GBM trials," stated Saiid Zarrabian, CEO of DelMar Pharmaceuticals. "While we cannot predict the future impact of COVID-19 on our studies at MD Anderson Cancer Center in Houston and Sun Yat-sen University Cancer Center in China, we have been encouraged that COVID-19 has not negatively impacted trial enrollment and dosing to date. As previously stated, we have completed full enrollment of our first line study in China, and based on historical enrollment rates, we are optimistic that we will complete full enrollment of the remaining two patient cohorts by the end of calendar year 2020. In the meantime, we look forward to sharing updated clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program being held May 29-31 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II being held June 22-24."

RECENT CORPORATE UPDATES

·May 2020 – Announced enrollment of our 22nd patient (study over 90% enrolled) in the adjuvant arm of our ongoing Phase 2 clinical study investigating adjuvant treatment (pre-temozolomide — or TMZ – maintenance therapy) of MGMT-unmethylated glioblastoma multiforme (GBM) with VAL-083. The adjuvant arm of the Phase 2 study of VAL-083 is being conducted at the MD Anderson Cancer Center (MDACC) and is designed to enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy.

·May 2020 – Provided an enrollment update for the recurrent arm of the study, which is also being conducted at MDACC, where 72 patients out of a planned 83 patients have been enrolled.

·February 2020 – Announced we had enrolled the final patient in our ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated GBM being conducted at Sun Yat-sen University Cancer Center in China.

SUMMARY OF FINANCIAL RESULTS FOR THE QUARTER ENDED MARCH 31, 2020

For the three months ended March 31, 2020, the Company reported a net loss of approximately $1.96 million, or $0.17 per share, compared to a net loss of approximately $1.7 million, or $0.67 per share, for the same period of 2019.

For the nine months ended March 31, 2020, the Company reported a net loss of approximately $5.3 million, or $0.52 per share, compared to a net loss of approximately $5.5 million, or $2.27 per share, for the same period of 2019.

On May 13, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that its chief executive officer, Jeff Goater, will present at the upcoming UBS Virtual Global Healthcare Conference, discussing Surface Oncology’s lead programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27) (Press release, Surface Oncology, MAY 13, 2020, View Source [SID1234557883]).

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The presentation will take place virtually on Wednesday, May 20, 2020 at 10 a.m. EDT. The live audio and subsequent archived webcasts of the Company’s presentations will be accessible from the Company’s investor relations website: investors.surfaceoncology.com.

On May 13, 2020 Alector, Inc. (Nasdaq: ALEC), a clinical- stage biotechnology company pioneering immuno-neurology, reported business highlights and financial results for the first quarter ended March 31, 2020 (Press release, Alector, MAY 13, 2020, View Source [SID1234557882]).

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"At Alector we are committed to developing transformative treatments for neurodegeneration. We believe that our mission could benefit millions of patients and families affected by neurodegenerative diseases, and even with the current COVID-19 health crisis, we remain focused on advancing our portfolio of immuno-neurology programs," said Arnon Rosenthal, Ph.D., Co-founder, and Chief Executive Officer of Alector. "Our COVID-19 task force and the entire Alector team continues to focus on initiating a pivotal Phase 3 study of AL001 in FTD-GRN patients and a Phase 2 study of AL002 in Alzheimer’s disease patients in 2020."

Business Highlights

COVID-19 Response

Alector is actively monitoring the evolving impact of COVID-19 on its operations and clinical trials, with a primary focus on the health and safety of employees, clinical trial participants, and clinical trial site teams. The Company is complying with regulatory, institutional, and governmental guidance for conducting its business worldwide. As the COVID-19 pandemic continues to evolve, it could impact Alector’s programs in the future.

The Company is also continuing with its efforts to complete enrollment across ongoing clinical trials. Currently, certain clinical trial sites have delayed enrollment of new patients and paused clinical trial visits across clinical development programs. Alector is aware that some participants in ongoing trials have not been able to receive scheduled doses on time due to site closures or various state and local shelter-in-place directives. However, the Company is continuing to collect data from all existing clinical trial participants enrolled to date.

The Company remains on track with previously stated guidance to initiate a pivotal Phase 3 study of AL001 in FTD-GRN patients in 2020. Alector also intends to initiate a Phase 2 study of AL002 in Alzheimer’s disease patients in 2020. Ongoing activities for AL003, AL101, and AL014 programs are continuing as planned. The Company believes that its cash and investments as of March 31, 2020 will be sufficient to fund its anticipated operations through 2022.

Progranulin Portfolio: AL001, AL101

The Company remains on track to advance AL001 into a pivotal Phase 3 study in FTD-GRN patients in 2020.
Alector expects to present preliminary Phase 2 data of AL001 in FTD-GRN patients at medical meetings in 2020. The number of patients with available data for presentation may be impacted by the COVID-19 pandemic.
Initial Phase 1a data of AL101 in healthy volunteers are also expected during in 2020.
Alzheimer’s Disease Portfolio: AL002, AL003, AL014

Following the completion of the Phase 1a study with AL002 and based on the safety and biomarker data collected in preclinical studies and in healthy volunteers, and in agreement with its partner AbbVie, Alector has closed enrollment for the Phase 1b study of AL002 and will proceed with initiating a Phase 2 trial in Alzheimer’s disease patients in 2020.
The Company continues to advance the Phase 1b trial of AL003 in Alzheimer’s disease. AL003 is being developed by Alector in collaboration with its partner AbbVie.
Alector plans to initiate Phase 1 development for AL014 within the next 12 months. AL014 is the Company’s latest prioritized candidate that targets MS4A4A, a transmembrane receptor protein that is expressed selectively in microglia in the brain and is associated with control of microglia functionality and potential viability.
Immuno-oncology Portfolio

In March, Alector entered into a regional licensing agreement with Innovent Biologics for the development and commercialization of AL008 in oncology indications in China. AL008 is a potentially best-in-class SIRP-alpha inhibitor with a unique dual mechanism of action that non-competitively antagonizes the CD47-SIRP-alpha pathway by inducing the internalization and degradation of the inhibitory receptor on macrophages to relieve immune suppression (a "don’t eat me signal") while also engaging Fc gamma receptors to promote immuno-stimulatory pathways that drive anti-tumor immunity. Alector retains the global rights for AL008 outside of China.
First Quarter 2020 Financial Results

Revenue. Collaboration revenue for the quarter ended March 31, 2020 was $7.2 million compared to $5.6 million for the same period in 2019. This increase was primarily due to an increase in expenses for the AL002 and AL003 programs compared to the same period last year.

R&D Expenses. Total research and development expenses for the quarter ended March 31, 2020 were $34.6 million compared to $20.6 million for the same period in 2019. This increase was driven by an increase in personnel-related expenses as headcount grew to support the advancement of the clinical and pre-clinical programs. Additionally, expenses increased due to timing of manufacturing runs and continued progression through clinical trials for several programs. Expenses for AL014 increased as well as for other early stage programs as investment in research and clinical pipeline continues.

G&A Expenses. Total general and administrative expenses for the quarter ended March 31, 2020 were $14.6 million compared to $5.8 million for the same period in 2019. This increase was primarily due to an increase in personnel-related expenses due to increased headcount to support the advancement of the clinical and pre-clinical programs and an increase in legal costs associated with our ongoing arbitration proceedings for certain intellectual property matters.

Net Loss. For the quarter ended March 31, 2020, Alector reported a net loss of $40.0 million, compared to a net loss of $18.6 million for the same period in 2019.

Cash Position. Cash, cash equivalents, and marketable securities were $548.5 million as of March 31, 2020.