On May 19, 2020 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX) reported the closing on May 13, 2020 of the final tranche of a previously announced private placement. With this closing, MedX has raised gross proceeds totalling $3,112,753 since January 30, 2020 (Press release, MedX Health, MAY 19, 2020, View Source [SID1234558288]). "This marks the successful achievement, indeed over-achievement of the target, set in January 2020 to raise $3.0 million to finance the development and expansion of MedX’s complete end-to-end telehealth solution focused on Dermatology. The funding will allow MedX to hire key sales and operational personnel required to expand into new marketplaces, in particular in Latin America and the USA where the Company is anticipating rapid growth," stated Scott Spearn, CEO of MedX.

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MedX announced that further to the Conditional Approval from the TSX Venture Exchange for a non-brokered Private Placement to accredited investors of up to 25,000,000 units at $0.12 per unit ("Unit"), to raise up to $3,000,000 that was announced on March 6, 2020, the closing of a final tranche of that placement has taken place on May 13, 2020, for a total of 4,887,466 units, raising a total of $586,496. Each Unit is comprised of One (1) fully paid common share and One (1) Share Purchase Warrant, exercisable to purchase One (1) further Common Share at the price of $0.20, exercisable for a period of two years from the date of issue. The securities issued will be restricted from trading for four months from their respective dates of issue.

In connection with this non-brokered private placement, 324,000 agent’s warrants ("Agent’s Warrant(s)"), as described below, were also issued. Each Agent’s Warrant, which is non-transferable, is exercisable to acquire one Unit at $0.12 per Unit, at any time during the period of two years following the date of issue. In connection with the May 13, 2020 Closing, total cash commissions of $78,640 were paid.

On May 19, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an intended use survey for DecisionDx-SCC, its prognostic test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) (Press release, Castle Biosciences, MAY 19, 2020, View Source [SID1234558287]). The test is expected to be launched commercially in the third quarter of 2020.

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The article titled, "Impact of a prognostic 40-gene expression profiling test on clinical management decisions for high-risk cutaneous squamous cell carcinoma," was published in the peer-reviewed journal, Current Medical Research and Opinion (CMRO).

Results of the study demonstrate that integration of DecisionDx-SCC (40-gene expression profile test) results impacted management decisions in a significant and risk-appropriate manner for high-risk SCC patient scenarios, while remaining aligned with national guidelines for patient management.

"It is critical that management and follow-up recommendations for patients diagnosed with high-risk cutaneous squamous cell carcinoma are tailored to individual risk, yet current staging methods are often unable to precisely stratify different risk groups that may have markedly different outcomes," said principal investigator Darrell Rigel, M.D., M.S., Clinical Professor at New York University School of Medicine. "These results demonstrate that information on tumor biology can impact clinical decisions in a significant, risk-appropriate manner."

Disease and Study Background

Approximately 1 million patients are diagnosed with SCC of the skin in the U.S. each year, and the incidence continues to grow; while the majority of patients have a favorable prognosis, approximately 200,000 patients are identified as high risk.
National Comprehensive Cancer Network (NCCN) guidelines for SCC define treatment pathways based on risk of local recurrence or metastasis. For SCC, there are two clinicopathologically defined categories: low risk and high risk. NCCN defines high risk as SCC patients with one or more of several high-risk clinicopathologic features.
DecisionDx-SCC stratifies patients into three categories based on risk of metastasis: Class 1 (low-risk), Class 2A (high-risk) and Class 2B (highest-risk).The study objective was to determine the impact of DecisionDx-SCC test results on clinician management decisions and how their choices would align with an NCCN compliant, risk-directed management plan for high-risk SCC.
162 clinicians attending a national dermatology conference were presented with DecisionDx-SCC test validation data. They were then asked to rate clinicopathological features and DecisionDx-SCC test results to assess their opinion of how concerning each is to SCC prognosis. When presented with vignettes describing patients with NCCN-defined high-risk features, clinicians were asked to document their treatment plan pre-test (without DecisionDx-SCC results), then, post-test (with DecisionDx-SCC Class 1, 2A, or 2B results) methodology along with corresponding metastasis rates for each test group. Assessed treatment plan modalities included follow-up schedule, sentinel lymph node biopsy, nodal imaging, adjuvant radiation and adjuvant chemotherapy.
Study Findings

When comparing DecisionDx-SCC risk classes with clinicopathologic risk factors, Class 2B DecisionDx-SCC result, perineural invasion, immunosuppression, invasion beyond subcutaneous fat, and tumor diameter >1cm on the scalp were identified as the features most highly associated with risk of metastasis.
Adding a DecisionDx-SCC low-risk Class 1 result to clinicopathologic information led to an overall reduction in treatment plan modality intensity by more than 60% when compared to clinicopathological features alone.
Adding a Decision-SCC Class 2B test result to clinicopathologic information led to an overall escalation in treatment plan modality intensity by more than 90% when compared to clinicopathological features alone.
More than 95% of the management recommendations were in a risk appropriate direction compared to the DecisionDx-SCC class result, and all changes were within established NCCN-guidelines for patient management.
DecisionDx-SCC is the second skin cancer test discovered, developed and validated by Castle Biosciences.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (SCC) is one of the most common cancers. Approximately 1 million patients are diagnosed with SCC each year in the U.S. While the majority of patients have a favorable prognosis, approximately 200,000 patients are identified as high risk. National guidelines provide for broad, aggressive treatment plan recommendations relative to low-risk patients. Traditional clinicopathologic based risk-factor staging systems suffer from low positive predictive value; meaning many more patients are classified as high risk than actually develop metastatic disease. This may lead to over- and under-treatment of a substantial number of cutaneous SCC patients. To address this clinical need, Castle Biosciences has developed a gene expression profile test designed to improve upon current staging systems and identify patients with cutaneous SCC at high risk for metastasis, in order to enable more informed, objective clinical decisions regarding adjuvant therapy and other management options.

On May 19, 2020 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported the pricing of its underwritten public offering of 9,433,963 shares of its common stock at a price to the public of $13.25 per share and the pricing of $200.0 million aggregate principal amount of its 5.00% convertible senior notes due 2027 (Press release, Gossamer Bio, MAY 19, 2020, View Source [SID1234558286]). The aggregate gross proceeds to Gossamer from the offerings, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $325.0 million.

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Gossamer also granted to the underwriters in the common stock offering a 30-day option to purchase up to an additional 1,415,094 shares of its common stock on the same terms and conditions and to the underwriters in the convertible senior notes offering a 13-day option to purchase up to an additional $30.0 million aggregate principal amount of the notes on the same terms and conditions solely to cover over-allotments.

The notes will be senior, unsecured obligations of Gossamer and will accrue interest at a rate of 5.00% per annum, payable semi-annually in arrears on June 1 and December 1 of each year. The notes will mature on June 1, 2027 unless earlier repurchased, redeemed or converted. Before March 1, 2027, noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after March 1, 2027, noteholders may convert their notes at any time at their election until the close of business on the scheduled trading day immediately before the maturity date. Gossamer will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Gossamer’s election. The initial conversion rate is 61.6095 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $16.23 per share of common stock. The initial conversion price represents a premium of approximately 22.50% over the public offering price per share of common stock in the common stock offering. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events.

The notes will be redeemable, in whole or in part, for cash at Gossamer’s option at any time, and from time to time, on or after June 6, 2024 and on or before the 50th scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of Gossamer’s common stock exceeds 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading date immediately preceding the date on which Gossamer provides notice of redemption, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date on which Gossamer provides the related notice of redemption.

If a "fundamental change" (as defined in the indenture for the notes) occurs, then noteholders may require Gossamer to repurchase their notes for cash. The repurchase price will be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

The offerings are expected to close on May 21, 2020, subject to customary closing conditions. The closing of each offering is not contingent on the closing of the other offering.

Gossamer intends to use the combined net proceeds from the offerings to fund research and development of its product candidates and development programs and for working capital and general corporate purposes.

BofA Securities and SVB Leerink are acting as joint book-running managers for the common stock offering. Evercore ISI, Barclays and Cantor are also acting as book-running managers for the common stock offering.

BofA Securities, SVB Leerink and Piper Sandler are acting as joint book-running managers for the convertible senior notes offering. SMBC is acting as co-manager for the convertible senior notes offering.

The securities described above are being offered by Gossamer pursuant to a shelf registration statement filed by Gossamer with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. Each offering is being made only by means of a separate prospectus supplement and the related prospectus relating to such offering that will be filed with the SEC. Copies of the applicable prospectus supplement and related prospectus relating to each offering may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected] or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; or, with respect to the convertible senior notes offering, from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 1-800-747-3924 or by email at [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will 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 May 19, 2020 Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that it has appointed Douglas E. Feltner, M.D. as its Chief Medical Officer effective May 18th, 2020 (Press release, Exicure, MAY 19, 2020, View Source [SID1234558285]). Dr. Feltner joins Exicure from AveXis (now part of Novartis) where he was the Vice President of Clinical Development, focusing on developing gene therapies for neurodegenerative and neurodevelopmental disorders, including the recent approval of Zolgensma for patients with Spinal Muscular Atrophy.

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"Doug brings deep experience in all phases of drug development, starting with translational and early strategic decision making all the way to phase 3 registration trials. Exicure is committed to building a growing pipeline of neurological drug candidates and we are very pleased to have Doug bring his expertise and experience to this important initiative," stated Dr. David Giljohann, CEO of Exicure.

Dr. Feltner is a physician-scientist, with over 20 years of experience in clinical drug development and in translational medicine, primarily focused on neurology, psychiatry and neuroscience. Prior to AveXis, Dr. Feltner, served as Vice President, Neuroscience Development, for AbbVie, Inc. and Vice President, Global Head of Translational Medicine for Pfizer, Inc. Dr. Feltner earned his M.D., with distinction in research, from the University of Michigan Medical School, did his residency in psychiatry at George Washington University, and was a postdoctoral fellow in the Lab of Mammalian Genes and Development at The National Institute of Child Health and Human Development.

Dr. Feltner commented, "I have watched with great interest the development of Exicure’s spherical nucleic acid technology. I see many compelling opportunities for addressing unmet neurological conditions with Exicure’s SNA platform technology and am thrilled to join their growing team."

On May 19, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported updated interim clinical data from the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial, in which cirmtuzumab, an investigational anti-ROR1 monoclonal antibody, is being evaluated in combination with ibrutinib in patients with mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) (Press release, Oncternal Therapeutics, MAY 19, 2020, View Source [SID1234558284]). The data will be presented as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Annual Meeting, and a copy of the poster presentation will be available online at www.oncternal.com on May 29, 2020:

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Abstract Title: Clinical activity of cirmtuzumab, an anti-ROR1 antibody, in combination with ibrutinib: Interim results of a phase 1/2 study in mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) (abstract # 8036)
Session Title: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: May 29, 2020, 8:00 – 11:00 CDT
"The reported 58% complete response rate for patients with relapsed/refractory MCL treated with cirmtuzumab and ibrutinib is highly encouraging and is higher than previously reported for ibrutinib alone in a similar patient population. Patients with relapsed MCL remain in dire need of well-tolerated treatment options that provide deeper and more durable responses," said Hun Ju Lee, M.D., Associate Professor of Medicine in the Department of Lymphoma & Myeloma at the University of Texas MD Anderson Cancer Center, who is an investigator on the CIRLL clinical trial and the first author on the ASCO (Free ASCO Whitepaper) poster presentation.

"We are particularly encouraged by the improvement in the complete response rate for patients with relapsed/refractory MCL treated with the combination of cirmtuzumab and ibrutinib in our clinical trial, which is now 58%, as compared to the 25% complete response rate that we reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We continue to be excited about cirmtuzumab’s potential for the treatment of patients with ROR1-expressing cancers, including MCL, CLL, Her2-negative breast cancer, and other solid tumors."

As of the data cut-off date of April 30, 2020, 15 patients with relapsed/refractory MCL were enrolled in the dose-finding and dose-confirming cohorts of this clinical trial, 12 of whom were evaluable for efficacy:

Seven of the 12 evaluable patients achieved a complete response, for a complete response (CR) rate of 58%, determined by Cheson criteria. One of the seven patients had a complete metabolic response (CMR) by PET scan, with an indeterminant bone marrow biopsy. Responses developed rapidly in most patients, with four of the seven CRs documented after approximately three months on the combination of cirmtuzumab and ibrutinib. All seven CRs were ongoing, including one patient who has remained in CR at over 23 months on study.
The overall best objective response rate (ORR) was 83%, including patients who achieved a CR and three patients (25%) who achieved a partial response (PR). In addition, two patients had stable disease (SD), for a total best clinical benefit rate (including CR, PR and SD) of 100%.
Median progression-free survival (PFS) was 17.5 months, with a median follow-up of 8.3 months.
Patients had received an average of 2.8 prior therapies (range 1-5) before participating in this clinical trial, including four patients who had received prior treatment with ibrutinib. Seven of the 12 evaluable patients had high or intermediate Mantle Cell Lymphoma International Prognostic Index (MIPI) risk score at study entry.
Historical data published for single-agent ibrutinib for patients with MCL, who had received more than one prior therapy, reported an ORR of 63%, CR rate of 23% and median PFS of 10.3 months (Rule 2019 Haematologica).
As of the data cut-off date on April 30, 2020, 34 patients with CLL were enrolled in the dose-finding and dose-confirming cohorts of this clinical trial, all of whom were evaluable for efficacy:

Thirty of the 34 evaluable patients achieved a clinical response, for an overall best objective response rate of 88%, including one patient (3%) who achieved a CR, and 29 patients (85%) who achieved a PR. In addition, four patients had stable disease, for a total clinical benefit rate (including CR, PR, SD) of 100%.
No patients progressed while in the study, and PFS was 100%, with a median follow-up of 12.8 months.
Twelve patients were treatment-naïve and 22 had relapsed/refractory CLL. Patients with relapsed/refractory CLL had received an average of 2.6 prior therapies (range 1-9) before participating in this clinical trial.
Cirmtuzumab as a single agent has been well tolerated in this study. The combination of cirmtuzumab plus ibrutinib has also been well tolerated, with adverse events consistent with those reported for ibrutinib alone. There have been no dose-limiting toxicities and no serious adverse events attributed to cirmtuzumab alone. Neutropenia of any grade occurred in six subjects (8.6%).

About the CIRLL Clinical Trial

The CIRLL clinical trial (CIRM-0001) is a Phase 1/2 trial evaluating cirmtuzumab in combination with ibrutinib in separate groups of patients with CLL or MCL. Enrollment of the dose-finding cohorts in CLL and MCL and dose-expansion cohort in CLL has been completed. Enrollment of the dose-expansion cohort in MCL and randomized Phase 2 cohort in CLL is ongoing. Based on the data from the dose-finding cohorts, the recommended dosing regimen was determined to be 600 mg of cirmtuzumab administered intravenously every two weeks for three doses, followed by dosing every four weeks, in combination with 420 mg of ibrutinib administered once daily for patients with CLL, or 560 mg of ibrutinib once daily for patients with MCL, which are the FDA-approved doses of ibrutinib in these indications. Additional information about the CIRM-0001 clinical trial and other clinical trials of cirmtuzumab may be accessed at ClinicalTrials.gov.

About Cirmtuzumab

Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL or MCL, in a collaboration with the UC San Diego School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine.

ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. Cirmtuzumab is in clinical development and has not been approved by the U.S. Food and Drug Administration for any indication.