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Cardiff Oncology Enters Agreement with PoC Capital to Fund Phase 2 Clinical Trial of Onvansertib in KRAS-Mutated Metastatic Colorectal Cancer (mCRC)

On May 13, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga-resistant prostate cancer and leukemia, reported an agreement with PoC Capital, LLC, to fund the completion of its ongoing Phase 1b/2 clinical trial in patients with KRAS-mutated metastatic Colorectal Cancer (mCRC) (Press release, Trovagene, MAY 13, 2020, View Source [SID1234557893]).

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"We are pleased to be able to support the second phase of Cardiff Oncology’s clinical study of onvansertib in patients with KRAS-mutated colorectal cancer," said Daron Evans, Managing Director of PoC Capital. "The response in patients enrolled in the first phase of this study is very encouraging and we are optimistic that patients will soon have a new therapeutic option to treat their cancer."

Cardiff Oncology’s agreement with PoC Capital follows the Company’s announcement of positive safety and efficacy data from its Phase 1b trial, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference. The data demonstrate clinical benefit in patients treated with onvansertib in combination with second line standard-of-care, FOLFIRI/Avastin. Seven out of eight (88%) evaluable patients achieved a clinical response (partial response + stable disease) and progression-free survival (PFS) of 6.5 months, which exceeds the current standard-of-care response rate of 4% and median PFS of 5.5 months. Additional trial data will be presented as a virtual oral poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on Friday, May 29, 2020.

"Our agreement with PoC Capital is an important milestone and recognition of the efficacy we are already observing in our ongoing clinical trial targeting KRAS-mutated mCRC, an indication of high unmet medical need," said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. "We are pleased to continue our partnership with PoC Capital and advance our clinical development of onvansertib and address the once considered ‘undruggable’ KRAS mutation in an effort to improve response to treatment in patients who have previously been faced with a very poor prognosis."

Colorectal cancer (CRC) is the second leading cause of cancer death in the U.S. Despite significant progress in the treatment of mCRC, the majority of patients with metastatic disease succumb to the disease. Therefore, improving the treatment options and effectiveness is critical in changing the outcomes for this patient population. The efficacy of second-line therapy in terms of survival prolongation and response remains very limited, particularly in the KRAS-mutated population, where treatment options are more restricted. The response rate in the second-line setting is 4% and the median progression-free survival is 5.5 months as reported in a large international trial.
About the Phase 1b/2 Clinical Trial of Onvansertib in mCRC
In this open-label, Phase 1b/2 trial, onvansertib in combination with standard-of-care FOLFIRI and Avastin is being evaluated for safety and efficacy in patients with KRAS-mutated mCRC. The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second‑Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation, will enroll up to 44 patients with a KRAS mutation and histologically confirmed metastatic and unresectable disease. In addition, patients must have failed treatment or be intolerant of FOLFOX (fluoropyrimidine and oxaliplatin) with or without Avastin (bevacizumab). The trial is being conducted at two prestigious cancer centers: USC Norris Comprehensive Cancer Center and The Mayo Clinic Arizona.
About Onvansertib
Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Cardiff Oncology believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.
Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Cardiff Oncology believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.
Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410; and a Phase 2 clinical trial of onvansertib in combination with decitabine in patients with relapsed or refractory AML (NCT03303339).
Cardiff Oncology licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

Veru Reports Strong Fiscal 2020 Second Quarter Results as Net Revenues Increase 43%, Gross Profit Up 61%

On May 13, 2020 Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, reported that net revenues increased 43% and gross profit rose 61% for its fiscal 2020 second quarter ended March 31, 2020 (Press release, Veru, MAY 13, 2020, View Source [SID1234557892]).

Second-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues increased 43% to $9.9 million from $7.0 million;

Gross profit of $7.4 million, up 61% from $4.6 million;

Gross margin climbed to 75% of net revenues from 66%;

FC2 US prescription net revenues grew 168% to $7.0 million from $2.6 million;

Operating loss significantly narrowed to $0.3 million from $2.1 million; and

Net loss was $ 0.8 million, or $0.01 per share, compared with $4.0 million, or $0.06 per share.

Year-to-Date Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues rose 54% to $20.5 million from $13.3 million;

Gross profit of $14.7 million, up 59% from $9.3 million; and

Gross margin climbed to 72% of net revenues from 69%.

"Substantial growth in prescription sales of FC2 was the key driver for our strong fiscal 2020 second quarter performance," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "Net revenues and gross profit grew 43% and 61%, respectively, compared with the same quarter last year. Moreover, our gross margin percentage rose to 75% of net revenues, which is significantly higher than both last year’s second quarter and our preceding quarter. Our operating loss significantly narrowed to $0.3 million. Our PREBOOST/Roman Swipes product continued its upward sales trajectory and is becoming a solid contributor to our business. Our commercial business continues to generate significant funding for our advancing clinical development of multiple prostate and oncology drug candidates which are progressing nicely. Positive clinical results have firmly positioned Veru as an oncology focused biopharmaceutical company."

Pharmaceutical Pipeline FY Q2 Highlights:

VERU-111 for Advanced Prostate Cancer

"Our drug product development continues to progress at a substantial pace," said Dr. Steiner. "Last week we announced exciting results from our Phase 1b clinical trial of VERU-111 for the treatment of metastatic castration resistant prostate cancer (mCRPC) in men who have also become resistant to novel androgen blocking agents such as abiraterone or enzalutamide. As for safety, the maximum tolerated dose (MTD) of VERU-111 was determined to be 72mg (3 of 11 men had reversible Grade 3 diarrhea). No Grade 3 diarrhea was observed at doses less than 72 mg per day. At doses of VERU-111 of 63 mg and lower per day, mild to moderate nausea, vomiting, diarrhea and fatigue were the most common adverse events. There were no reports of neurotoxicity and no neutropenia at doses 63 mg and lower oral daily dosing continuous for 21 days per cycle."

"Efficacy (antitumor activity) was assessed by serum PSA and standard local imaging with bone and CT scans. In the eight men that received at least four 21-day cycles of oral VERU-111 at any dose, based upon their 21-day cycle baseline PSA levels, 6/8 (75%) had decreases in their PSA levels, 4 patients (50%) demonstrated a ³ 30% decline, and 2 patients (25%) had a ³ 50% decline in serum PSA. Based upon PCWG3 and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, objective tumor responses were seen in 2 patients (25%) (soft tissue and bone) and 5/8 patients (63%) had stable disease. Objective tumor responses and PSA declines lasted longer than 12 weeks. The primary endpoint used in pivotal efficacy studies for the treatment of metastatic castration-resistant prostate cancer is median time to cancer progression by imaging (bone and CT scans). In the current study, median duration of response, or time to cancer progression, has not been reached since 7 out of 8 of the men are still being treated on the study with an average duration of response of 10 months (range = 6-14 months). There are an additional 3 subjects on study that have not yet completed four 21-day cycles; therefore, a total of 10 men are still on study. Based on the positive data from the Phase 1b study, we have initiated and are continuing to enroll patients in the Phase 2 portion of the study. We will meet with FDA next quarter to gain agreement on the registration Phase 3 design for this indication. We also plan to present an update of the Phase 1b/2 clinical data at the next possible upcoming major scientific meeting. We believe VERU-111, with a different mechanism of drug action, could address this significant unmet medical need as a treatment for this rapidly growing indication, metastatic castration and androgen blocking agent resistant prostate cancer prior to IV chemotherapy."

VERU-111 Possible Treatment for COVID-19

"Yesterday we received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19, the global pandemic disease caused by the novel coronavirus SARS-CoV-2. We have initiated the study and expect the first patient to be dosed within 2 weeks. We believe that VERU-111, a microtubule depolymerization agent that has broad antiviral activity, could be effective against the SARS CoV-2 virus by disrupting its intracellular transport along the microtubules. Microtubule trafficking is critical for viruses to cause infection. Furthermore, microtubule depolymerization agents that target α and ß tubulin subunits of microtubules, like VERU-111, also have strong anti-inflammatory effects, including the potential to treat the cytokine release syndrome (cytokine storm) and septic shock induced by the SARS-CoV-2 viral infection that seems to be associated with high COVID-19 mortality rates."

"Based on the strong pharmacologic rationale, as well as the preclinical and clinical studies supporting both the antiviral and anti-inflammatory effects of VERU-111 and its acceptable safety profile to date, we will proceed with this placebo-controlled Phase 2 study in patients that have been hospitalized for SARS-CoV-2 and who are at high risk for Acute Respiratory Distress Syndrome (ARDS) . The small study is designed to evaluate VERU-111’s ability to improve pulmonary symptoms and recovery and to avoid the need for mechanical ventilation."

VERU-111 COVID-19: Phase 2 Clinical Trial

The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of 18mg VERU-111 for 21 days versus placebo in 40 hospitalized patients (20 subjects will be treated with VERU-111 and 20 subjects will receive placebo) who tested positive for the SARS-CoV-2 virus and who are at high risk for ARDS. The primary efficacy endpoint will be proportion of subjects that are alive without respiratory distress at Day 29. Secondary endpoints will include measures of improvements on the WHO Disease Severity Scale (8-point ordinal scale), which captures COVID-19 disease symptoms and signs, including hospitalization to progression of pulmonary symptoms to mechanical ventilation as well as death.

"Although Veru is focused in prostate cancer and oncology, due to the urgency of the current global pandemic and the fact that VERU-111 has the potential to treat both SARS-CoV-2 infection and the associated reactive severe lung inflammation in COVID-19 patients at high risk for ARDS, the Company is duty-bound to pursue this COVID-19 indication even though it is not the primary focus of the Company. There is minimal downside to conducting this small study, and if VERU-111 has efficacy and safety, the upside is substantial for COVID-19 patients," said Dr. Steiner.

Because of this urgent need for effective and timely therapeutics to combat COVID-19, the Company has applied for significant grant funding through both The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) and The Defense Advanced Research Projects Agency of the US Department of Defense (DARPA) to expedite the clinical development program of VERU-111 for COVID-19. There can be no assurances that any such grant funding will be provided.

Event Details

Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10143040, for one week.

Oasmia announces outcome of strategic review to deliver long-term, profitable growth as a specialty pharma company

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]).

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."

China NMPA Approves Optune® for the Treatment of Newly Diagnosed and Recurrent Glioblastoma

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.

"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.

DelMar Pharmaceuticals Announces Fiscal Third Quarter 2020 Financial Results and Recent Corporate Updates

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]).

"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.