On March 22, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported that a notice that a Clinical Use Patent for the drug candidate arfolitixorin will be approved in Europe (Press release, Isofol Medical, MAR 22, 2021, View Source [SID1234576956]). The patent covers a dose regimen for treating solid tumors, such as colorectal, stomach, breast and liver cancer and expires in 2038.

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The patent application that will be granted , EP18150457.2, includes a dose regimen involving two or more injections of arfolitixorin in combination with 5-fluorouracil (5-FU). These two agents may also be given in combination with other anticancer drugs, such as oxaliplatin, irinotecan and bevacizumab.

"It is most gratifying that we now have strengthened our patent rights in the European market as well. This patent, which has already been approved in USA, Japan and Korea will now be granted in Europe* as well. It is a clinical patent based on data derived from an earlier study (ISO-005) of arfolitixorin and 5-FU in metastatic colorectal cancer patients. The data have demonstrated superior activity of arfolitixorin and 5-FU compared to the standard of care therapy. The patented dose regimen covers the one used in the ongoing global Phase III study AGENT, a multicenter study in patients with metastatic colorectal cancer", said Ulf Jungnelius, M.D, CEO of Isofol.

* EPO, meaning that we may select it to cover up to 38 countries in Europe.

The information was submitted for publication, through the agency of the contact person set out above, at 11.00 CET on March 22, 2021.

About the AGENT study

The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On March 22, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa" or the "Company"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co. under which the underwriter has agreed to purchase on a firm commitment basis 1,904,762 shares of common stock of the Company at a public offering price of $5.25 per share, less underwriting discounts and commissions (Press release, Anixa Biosciences, MAR 22, 2021, View Source [SID1234576955]). The Company also has granted the underwriter a 30-day option to purchase up to an additional 285,714 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about March 25, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds of the offering are expected to be approximately $10 million, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by the Company and excluding the exercise of the underwriter’s option to purchase additional shares. The Company intends to use the net proceeds from this offering for general corporate purposes, including, but not limited to, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to its technologies, and licensing activities related to current and future product candidates and working capital.

The shares of common stock are being offered pursuant to an effective registration statement on Form S-3 (File No. 333-232067) that was filed with the U.S. Securities and Exchange Commission ("SEC") on June 11, 2019 and declared effective on June 21, 2019. The shares of common stock may be offered only by means of a prospectus supplement forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when filed, may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (212) 856-5711.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 22, 2021 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, reported that on March 22, 2021, it received notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum $1.00 bid price per share requirement under Nasdaq’s Listing Rule 5550(a)(2) (Press release, AEterna Zentaris, MAR 22, 2021, View Source [SID1234576954]).

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On July 29, 2020, the Company received notice from Nasdaq that its common stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by Nasdaq. On January 26, 2021, the Company was granted an additional 180 calendar day period to regain compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market.

Now that the Company has regained compliance with Listing Rule 5550(a)(2), Nasdaq has advised the Company that this matter is now closed.

On March 22, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the full fiscal year ended December 31, 2020 (Press release, VolitionRX, MAR 22, 2021, View Source [SID1234576953]). Volition management will host a conference call tomorrow, March 23 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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An interview with Cameron Reynolds, President and Chief Executive Officer, Terig Hughes, Chief Financial Officer and Jake Micallef, Chief Scientific Officer.
An interview with Cameron Reynolds, President and Chief Executive Officer, Terig Hughes, Chief Financial Officer and Jake Micallef, Chief Scientific Officer.
"We made significant progress on many fronts throughout 2020, culminating in the launch of our first product, the Nu.Q Vet Cancer Screening Test in the fourth quarter. This was a pivotal moment for Volition, demonstrating that our platform has the reliability and reproducibility to launch in an independent laboratory," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "Despite the persistence of the COVID-19 pandemic, we kept our laboratory operational throughout the year and completed the fit out and opening of our new Silver One production facility in Namur, Belgium. I am proud of the way our team has adapted to the different world we find ourselves in and has kept working at full speed. It is their efforts and tenacity that have made possible these milestones and the many others that we achieved during 2020."

View Source

An interview with Cameron Reynolds, President and Chief Executive Officer, Terig Hughes, Chief Financial Officer and Jake Micallef, Chief Scientific Officer.

Mr. Reynolds continued, "We added to our already extensive intellectual property portfolio and at year end held 64 patents with a further 90 patents pending. We have made considerable progress in our human studies with data released in blood cancer, lung cancer, Nu.Q Capture, COVID-19 and most recently sepsis. Currently we are in our strongest-ever financial position to support the pursuit of our many milestones and look forward to providing updates throughout the year."

Company Highlights

Financial

Cash and cash equivalents as of December 31, 2020 totaled approximately $19.4 million compared with $17 million as of December 31, 2019.
Continued to manage our expenditures carefully with a burn rate of approximately $1.5 million per month throughout 2020.
During the first quarter of 2021 to date added an aggregate of approximately $20.5 million in cash mostly through an underwritten public offering of our common stock that closed in February, as well as through periodic sales of common stock under our at-the-market equity distribution program.
Secured a further $4 million in non-dilutive funding consisting of a cash grant of $1.3 million and loans totalling $2.7 million from the Walloon Regional Government and associated agencies.
Following the public offering in February, our cash and cash equivalents totaled approximately $40 million before deducting expenses incurred thus far in 2021, by far our strongest cash position ever.
Nu.Q Vet Cancer Screening Test Commercial Launch

Launched the Nu.Q Vet Cancer Screening Test in late November.
We are very happy with the sales progress to date. We received the first order from the GI lab at Texas A&M University late last year and have already received three additional orders from them in 2021.
The test is positioned for use in the annual health check of older dogs (those that are seven years and older). It may also be a complimentary test for younger dogs of breeds at high risk for developing cancer in their lifetimes such as Golden Retrievers.
This beta launch will facilitate real-world learnings and help shape the marketing mix before our planned launch nationally across the U.S. in the next few months.
The beta launch also provides us an opportunity to showcase the product to the large multinational companies we are in active discussions with, regarding the distribution and/or sales of our tests in the veterinary market.
In addition to the Texas beta launch we are finalizing beta launch planning in both Asia and Europe.
Clinical – New U.S. Regulatory Study

Engaged Diagnostic Oncology CRO LLC, the largest U.S. Contract Research Organization specializing in oncology purposed in-vitro diagnostic device clinical trials, to conduct a U.S. regulatory clinical trial for Non-Hodgkin’s Lymphoma (NHL).
The trial is designed to obtain multiple FDA-approved adjunct tests to aid in the diagnosis of the five most common and aggressive forms of NHL.
The trial will enroll up to 1,500 subjects across 10 major U.S. healthcare institutions over 22 months.
This extensive program will cost approximately $2.9 million over two years assuming the completion of numerous projects and includes not only the clinical study but also data analysis and regulatory and reimbursement submission preparation.
Existing data suggests Nu.Q technology will greatly aid physicians in distinguishing NHL from common conditions, fulfilling what we believe is a critical unmet clinical need and which represents a major market opportunity.
We expect our first FDA 510(k) submission will be possible approximately 10-12 months into the trial.
In addition, we are also conducting a proof-of-concept study for the monitoring of treatment response for the most aggressive NHL cancer, diffuse large B-cell lymphoma (DLBCL). We expect the results from this trial in the first half of 2021.
Clinical – NETosis including COVID-19

We have made great progress on a research program for the use of our Nu.Q technology in NETosis and in particular in monitoring disease progression of COVID-19 and sepsis and, as announced last week, as a potential companion diagnostic for a treatment for sepsis. We are seeking to broaden this further into influenza and potentially other diseases associated with NETosis.
Several studies have been collected, processed and are now either being analyzed or have been submitted to conferences for publication. This program has taken longer than we expected as the hospitals we are working with have, understandably, been focused on caring for the very high numbers of patients admitted during the 2nd wave of COVID-19.
We are negotiating a large FDA trial for use of our assays in diseases associated with neutrophil extracellular traps (NETs) such as sepsis, COVID-19 and influenza in the U.S. and will announce the full details once they have been finalized.
We have filed a novel patent for this application and plan to utilise results of these trials and other ongoing studies to further our aim of developing a clinically useful Nu.Q NETs product.
Clinical – Cancer

In various ways our "marquee trials" have now been affected by the continued pandemic either by slower or paused collection, or a host of other supply chain or travel and communication issues. We believe we have successfully managed those areas under our direct control (such as assay development and running samples – both of which are on track with our milestones) but many issues are not within our control.
An abstract regarding Nu.Q performance in lung cancer detection was presented at the WCLC conference in January 2021. The key message from the presentation is that, based on an interim analysis of a subset of subjects in the ongoing study with the National Taiwan University, Nu.Q assays could help identify non-cancerous nodules following a scan thereby reducing unnecessary biopsies by as much as 32%.
We hope to complete this large 1,200 subject lung cancer study and share findings at upcoming conferences later this year.
If the data continues to be encouraging, we are planning to initiate a 510(k) regulatory study in the U.S. for lung cancer, as we have for NHL.
Expansion

As we transition from a research and development company to a commercial company, we strengthened the leadership team with the appointment of a new Chief Financial Officer, Mr. Terig Hughes, Mr. Gael Forterre as Chief Commercial Officer, in addition to the promotion of Dr. Gaetan Michel as Chief Operating Officer and Dr. Mark Eccleston as Chief Technology Officer.
We completed the purchase and fit-out of "Silver One", the production hub for our products and key components located in Namur, Belgium. With this new facility we can provide a service for clinical trial purposes and produce CE-marked products for Europe and beyond.
We have also opened a small, shared laboratory at California State University in San Marcos, California where we will focus on blue-sky innovation and discovery research.
Upcoming Milestones

Volition expects to achieve the following milestones during 2021 and beyond:

Beta launches of the Nu.Q Vet Cancer Screening Test in Asia and Europe.
National launch of the Nu.Q Vet Cancer Screening Test in the U.S.
Focus on driving revenue in the coming quarters, where possible during the pandemic, in four key areas:
– Nu.Q Vet products,
– Disease monitoring tests (e.g. Nu.Q NETs for COVID-19, sepsis and other diseases),
– Reagent sales, and
– Licensing of our technology for others to commercialize in both humans and animals.

Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.
Continue to advance our previously announced large-scale blood, lung and colorectal cancer trials in Europe, Asia and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of our Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend our intellectual property portfolio.
VolitionRx Limited Full Fiscal 2020 Financial Results and Business Update

Date: Tuesday, March 23, 2021
Time: 8:00 a.m. U.S. Eastern time
U.S. & Canada Dial-in: 1-877-407-9716 (toll free)
U.K. Dial-in: 0 800 756 3429 (toll free)
Toll/International: 1-201-493-6779
Conference ID: 13717672

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer, Jake Micallef, Chief Scientific Officer and Scott Powell, Executive Vice President, Investor Relations.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source

In addition, a telephone replay of the call will be available until April 6, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13717672.

On March 22, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported the publication of results from its RUN-HN study, a Phase 2 open-label, single-arm trial of tipifarnib in patients with HRAS mutant head and neck squamous cell carcinoma (HNSCC) whose disease had progressed after prior therapy (Press release, Kura Oncology, MAR 22, 2021, View Source [SID1234576952]). The paper, titled "Tipifarnib in Head and Neck Squamous Cell Carcinoma with HRAS Mutations," was published online in the Journal of Clinical Oncology earlier today.

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As of the April 10, 2020 data cutoff, a total of 22 HNSCC patients with high HRAS mutant variant allele frequency1 were enrolled, of whom 20 were evaluable for response. Eleven of the 20 evaluable patients met RECIST v1.1 criteria for confirmed partial response (PR) and, for an objective response rate (ORR) of 55% (95% CI, 31.5 to 76.9).

Median progression-free survival (PFS) of 5.6 months (95% CI, 3.6 to 16.4) on tipifarnib was a statistically significant improvement over the median PFS of 3.6 months (95% CI, 1.3 to 5.2) on last prior therapy (p=0.0012). The median overall survival (OS) was 15.4 months (95% CI, 7.0 to 29.7). Robust activity was seen despite resistance to chemotherapy, immunotherapy and/or cetuximab.

The ORR for three FDA-approved therapies for treatment of HNSCC in the second line range from 13-16%, with median PFS of 2-3 months and median OS of 5-8 months.

"We are encouraged by the compelling efficacy and safety profile of tipifarnib in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma," said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the trial. "Importantly, these patients experienced limited benefit on prior therapies, including immunotherapies, which demonstrates the high unmet need for this disease. These data also reinforce the relevance of genomic testing for HRAS mutations to identify patients who could potentially benefit from tipifarnib treatment."

Tipifarnib was generally well-tolerated in the trial. The most common grade 3 or 4 adverse events (AEs) seen in at least 10% of patients, were anemias and lymphopenias. Patients had received a median of two prior lines of systemic therapy (range 0-6; one patient received prior radiotherapy only), with 64% receiving prior immunotherapy, 50% receiving prior cetuximab, and 23% receiving both.

"We are pleased to see our data from the Phase 2 RUN-HN trial of tipifarnib published in the Journal of Clinical Oncology for review by the broader clinical community," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "The highlighted data from the RUN-HN trial comes on the heels of our Breakthrough Therapy Designation from the FDA and we continue to advance the ongoing AIM-HN registration-directed trial in patients with HRAS mutant HNSCC, for whom there is an urgent unmet need."

The AIM-HN registration-directed trial of tipifarnib, in patients with recurrent or metastatic HRAS mutant HNSCC, is currently recruiting at more than 100 clinical sites in the U.S., Europe, Russia/Ukraine and Asia/Pacific. Patients interested in participating in this trial may talk to their doctor to have their tumor tested for the HRAS mutation for eligibility to enroll in this trial. Further details regarding the trial are available at clinicaltrials.gov (NCT03719690).

HRAS mutations occur in 4%-8% of patients with recurrent and/or metastatic HNSCC. The HRAS biomarker can be found on most commercially available genomic panels. More information about HRAS and biomarker testing is available at uncoverhras.com

About HNSCC

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 500,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory recurrent/metastatic HNSCC.

About Tipifarnib

Tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen. Previously, tipifarnib was studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets; however, no molecular mechanism of action had been determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. In addition to Breakthrough Therapy Designation, tipifarnib has been granted Fast Track designation by the FDA for the treatment of patients with HRAS mutant HNSCC. In addition to HNSCC, tipifarnib has demonstrated encouraging clinical activity in multiple additional genetically defined tumor types. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.