On December 13, 2018 XBiotech Inc. (NASDAQ: XBIT) reported the publication of findings on key biomarker analysis of colorectal cancer patients treated with bermekimab in its European Phase III study (Press release, XBiotech, DEC 13, 2018, View Source;p=RssLanding&cat=news&id=2380559 [SID1234532049]). The manuscript, entitled, "Interleukin-1 Receptor Antagonist (IL-1ra) Levels Predict Favorable Outcome after Bermekimab, a First-in-Class True Human Interleukin-1α Antibody, in a Phase III Randomized Study of Advanced Colorectal Cancer", has been published online in the journal OncoImmunology.

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The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—which tend to worsen with advanced cancer, to assess whether these symptoms stabilized or improved with treatment. Patients that achieved the primary endpoint in the Phase III study had one-fifth as many serious adverse events, were twice as likely to have no tumor growth, improved significantly with all life quality measures, and had almost three-fold increase in survival compared to failures.

Results from Dr. Razelle Kurzrock’s analysis found that for patients with relatively low IL-1ra levels at the start, 41% of those treated with bermekimab achieved the primary endpoint, compared to only 33% of patients for the entire bermekimab treatment group (19% of placebo patients achieved the primary endpoint). However, in the publication it is reported that for those with relatively low pretreatment levels of both IL-1ra and IL-6, 46% of patients in the bermekimab group versus only 17% in placebo achieved the primary endpoint (p<0.01). About 28% of patients in the study met the criteria of low IL-1ra and low IL-6.

Dr. Razelle Kurzrock, lead author of the publication, is Chief, Division of Hematology and Oncology, and Director, Center of Personalized Cancer Therapy at Moores Cancer Center UC San Diego. Dr. Kurzrock commented, "These findings help us better identify patients with advanced cancer who can benefit from a targeted therapy that interrupts the inflammatory process, thereby decreasing tumor growth and cancer-related morbidity. We hope that these results will help lead us to the effective use of bermekimab in cancer therapy."

About Razelle Kurzrock, M.D.
Dr. Kurzrock is a medical oncologist and a renowned expert in precision medicine. She is a thought leader in the use of anti-cytokine therapies for the treatment of cancer and one of the first to recognize the importance of the interleukin-1 pathway in cancer. While at the University of Texas MD Anderson Cancer Center, Dr. Kurzrock built one of the most successful Phase 1 clinical trials programs in the nation, and was the senior author in the pioneering study for XBiotech’s colorectal cancer study. Dr. Kurzrock currently serves as: Senior Deputy Director for Clinical Science, Murray Professor of Medicine, Director for the Center for Personalized Cancer Therapy and Clinical Trials Office, and a Team Leader for Experimental Therapeutics at the Moores Cancer Center at UC San Diego. Dr. Kurzrock is also Chief of the Hematology & Oncology Division in the UC San Diego School of Medicine. Dr. Kurzrock serves on XBiotech’s Scientific Advisory Board.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On December 13, 2018 Veru Inc. (NASDAQ: VERU) reported its financial results for the fiscal (FY) 2018 fourth-quarter and full-year ended September 30, 2018 (Press release, Veru, DEC 13, 2018, View Source [SID1234532047]).

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"Our fiscal 2018 fourth-quarter and full-year financial results improved significantly driven by increased US demand for the FC2 Female Condom / FC2 Internal Condom (FC2) and improving gross profit," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. For the fiscal 2018 fourth quarter, net revenues increased 41% to $5.2 million and gross profit grew by 78% to $3.2 million over the prior-year period."

"We continue to see increasing US Rx demand and related improving gross profit for our FC2 product through the first two months of the current fiscal quarter as well. For example, US FC2 Rx net revenues were 15% of total global FC2 net revenues in all channels for FY 2018. Q4 FY 2018 US FC2 Rx net revenues were 67% of total US FC2 Rx net revenues for the full FY 2018. Already through the first two months of the current fiscal year 2019, US FC2 Rx net revenues are at 120% of Q4 FY 2018 US FC2 Rx net revenues.

The Company also was granted a significant tender award for FC2 from the Republic of South Africa, which could generate approximately $30 million of future net revenues spread over a three-year period. No orders from this new South African tender are reflected in the FY 2018 financial results.

"Importantly, Veru is rapidly transforming into a biopharmaceutical company with a strong focus on prostate cancer with several drugs under development to provide a continuum of care for these cancer patients. To that end, earlier this quarter we announced that we have begun enrolling patients for our zuclomiphene citrate Phase 2 clinical trial for the treatment of hot flashes caused by androgen deprivation therapy for men with advanced prostate cancer with "top line" results, or general summary data, expected in the first half of FY 2019.

"In addition, in November, we submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for VERU-111 (bisindole), a first-in-class, next generation, proprietary, oral tubulin inhibitor for the treatment of metastatic prostate cancer. We expect this drug to advance into an open label Phase 1b/2 clinical trial by no later than early January 2019. We also announced earlier this month that the first patient was dosed in our bioequivalence study of Tadalafil (Cialis) and Finasteride (PROSCAR) combination tablet for benign prostatic hyperplasia (BPH). This combination tablet is designed to improve patient compliance and convenience with bioequivalency results expected in January 2019.

"Regarding our existing portfolio of commercial products, we have expanded our FC2 presence in the US market by partnering with a leading telemedicine marketing and sales channel, as well as utilizing a contracted independent sales force. For PREBOOST we recently entered into a US distributor agreement with a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the internet."

"In early October, just after the close of our fiscal year, we strengthened our balance sheet, completing an underwritten public stock offering that generated $9.2 million of net proceeds. We intend to use the proceeds for working capital and general corporate purposes, including research and development, clinical trials and marketing expenditures."

"In summary, our accomplishments over the past year further solidify our foundation and position Veru for future success. In the coming year, we look to build on these achievements with the planned submission to the FDA of New Drug Applications for Tadalafil and Finasteride combination tablets and Tamsulosin XR capsules and sprinkles. We look to continue our transformation into a biopharmaceutical company with a strong focus on prostate cancer treatment and prostate cancer supportive care with several drugs to provide a continuum of care for these patients."

Fiscal 2018 Fourth-Quarter Results

For the fiscal 2018 fourth-quarter, net revenues, which were primarily derived from sales of FC2, rose 41% to $5.2 million from $3.7 million for the fourth-quarter of fiscal 2017. Gross profit increased by 78% to $3.2 million, or 61% of net revenues, compared with $1.8 million, or 49% of net revenues, for the fourth-quarter of fiscal 2017. Operating expenses were $7.0 million compared with $4.6 million for the fourth-quarter of fiscal 2017. Non-operating income was $63 thousand compared with non-operating expenses of $32 thousand for the fourth-quarter of fiscal 2017. Income tax expense was $4.2 million compared with an income tax benefit of $0.1 million in the fourth-quarter of fiscal 2017. Net loss was $7.9 million, or $0.14 per share, compared with net loss attributable to common stockholders of $4.7 million, or $0.10 per share, for the fourth-quarter of fiscal 2017.

Fiscal 2018 Full-Year Results

For the fiscal 2018 full-year, net revenues, which were primarily derived from sales of FC2, climbed 16% to $15.9 million from $13.7 million for fiscal 2017. Gross profit increased 23% to $8.8 million, or 55% of net revenues, compared with $7.0 million, or 51% of net revenues, for fiscal 2017. Operating expenses were $29.7 million compared with $15.5 million for fiscal 2017. Non-operating expenses were $2.2 million compared with $0.1 million for fiscal 2017. Income tax expense was $0.9 million compared with an income tax benefit of $2.0 million in fiscal 2017. Net loss was $23.9 million, or $0.44 per share, compared with net loss attributable to common stockholders of $8.6 million, or $0.25 per share, for fiscal 2017.

As of September 30, 2018, cash (including restricted cash) was $3.8 million. Subsequent to September 30, 2018, the Company completed a stock offering that generated net proceeds of approximately $9.2 million after deducting underwriting discounts and commissions and expenses payable by the Company.

Conference Call 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, and asking to be joined into the call.

In addition, investors may access a replay of the conference call the same day beginning at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for US callers, or 412-317-0088 from outside the U.S., passcode 10126693. The replay will be available for one week, after which, the recording will be available via the company’s website at View Source

On December 12, 2018 NETRIS Pharma, a clinical-stage company developing novel anticancer therapies targeting dependence receptors, reported successful completion of the first-in-human study on the effects of netrin-1 inhibition in patients with advanced solid tumors (Press release, Netris Pharma, DEC 12, 2018, View Source [SID1234611180]). The Phase 1 dose-escalation study showed that NP137, a first-in-class monoclonal anti-netrin-1 blocking antibody, was safe and well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT), meeting the primary objective. In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective response.

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"We are very pleased with the safety and tolerability profile of NP137 in this study, which enabled evaluation of netrin-1 inhibition in advanced solid tumors," said Philippe Cassier, MD, PhD, Head of Phase 1 unit at Centre Léon Bérard and Principal Investigator of the NP137 study.

"I am really impressed by the preliminary anti-tumor activity observed in this study with patients showing objective response and prolonged one-year disease control," added Professor Jean Yves Blay, MD, Ph.D. General Director of the Centre Léon Bérard and past president of EORTC.

The Phase 1 study was designed to evaluate the maximum tolerated dose, pharmacokinetics and pharmacodynamics, and establish the recommended dose for the Phase 1b/2 expansion study. NP137 was dosed every other week starting from 1 mg/kg up to 20mg/kg in heavily pre-treated patients with advanced solid tumors. Additional study objectives were to evaluate the adverse events (AE), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of NP137. The study enrolled a total of 19 patients in three French centers, the Centre Léon Bérard in Lyon, the Institut Claudius Régaud in Toulouse and the Institut de Cancérologie de l’Ouest in Nantes. A Phase 1 extension study with an additional 24 patients is ongoing to confirm the safety and tolerability of NP137, collect biopsies before and after treatment to allow measurement of potential biomarkers and confirm the preliminary clinical activity seen during dose escalation. The final phase 1a data will be submitted for presentation at an upcoming international medical conference.

"Meeting the primary objective of the dose-escalation part of this study and generating preliminary positive efficacy data, particularly in such chemotherapy-resistant patients, provide an important confirmation of our dependence receptor science and lay the groundwork for larger clinical studies with NP137 as a targeted approach to treat solid tumors in combination with chemotherapy, immune checkpoint inhibitors and tyrosine kinase inhibitors," said Prof. Patrick Mehlen, Chief Executive Officer of NETRIS Pharma. "Additionally, we would like to thank the investigators, patients and caregivers for their participation in this study, and for contributing to our understanding of NP137 as we work to address a significant medical need."

About NP137
Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers. Expression of netrin-1 often correlates with disease severity and no therapy has ever been tested against this new pathway.

NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. NP137 prevents the binding of netrin-1 on its dependence receptors, thereby re-inducing cancer cell death and impacting tumor cell plasticity. Pre-clinical studies show NP137 to have an anti-cancer effect as a monotherapy as well as synergistic effects in combination with chemotherapy, immune checkpoint inhibitors or tyrosine kinase inhibitors.

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On December 12, 2018 BerGenBio ASA (OSE:BGBIO) presented DNB Healthcare Conference 2018 (Presentation, BerGenBio, DEC 12, 2018, View Source [SID1234532110]).

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