On February 21, 2024 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 114.2 million in the fourth quarter of 2023, an increase of 20% over the prior-year period (Q4 2022: NOK 94.9 million), and EBITDA of NOK 29.9 million (NOK -16.9 million) following solid business development for the Company (Press release, PhotoCure, FEB 21, 2024, View Source [SID1234640349]). Total revenues increased 37% in the fourth quarter of 2023 compared to Q4 2022, including a milestone payment from Asieris related to the license agreement for Cevira. Photocure has an ambition to deliver 40-70 new and upgraded Saphira tower installations in 2024, consolidated product revenue growth of 6% to 9% (constant currency), and positive EBITDA excluding business development expenses.

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"Hexvix/Cysview revenue increased 20% year-over-year in the fourth quarter, and we delivered EBITDA of NOK 29.9 million. Our U.S. business grew despite the ongoing phase down of flexible BLC. In Europe, we continued to see positive developments with sales growth in Germany and strong signs of traction in high-potential underpenetrated territories, known as our Priority Growth Markets. Additionally, our partner Asieris announced acceptance of their new drug application for Hexvix in China, and that they plan to present the positive Phase III results for Cevira at the EUROGIN 2024 HPV Congress in March," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 142.5 million in the fourth quarter of 2023 (NOK 104.2 million), and EBITDA* of NOK 29.9 million (NOK -16.9 million), driven by a combination of unit volume growth, price increases and a benefit from foreign exchange. Hexvix/Cysview revenues ended at NOK 114.2 million in the quarter (Q4 2022: NOK 94.9 million). EBIT was NOK 22.5 million (NOK -23.1 million) and the cash balance at the end of the period was NOK 259.5 million.

At the end of the fourth quarter of 2023, the installed base of rigid blue light cystoscopy (BLC) systems in the U.S. was 352, an increase of 17% or 51 towers since the fourth quarter of 2022. 2023 marked the highest number of rigid cystoscopes placed during any year since Photocure launched BLC in the U.S. Saphira blue light towers now represent 39% of the installed base of U.S. rigid towers.

"We continue to expect a large order of new rigid towers to come through, however, timing of the order is now anticipated in the second quarter of this year. We believe deployment of these towers has potential to significantly expand access to blue light cystoscopy for more physicians and patients in the U.S. In addition, our commercial team in North America remains focused on increasing Cysview kit usage in existing accounts, accelerating adoption in accounts using Saphira for the first time, reactivating low users or inactive accounts, and expanding BLC usage by leveraging the positive clinical results from studies reported in 2023," Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. For 2024, the Company anticipates new and upgraded Saphira blue light tower installations in the U.S. in the range of 40 to 70, consolidated product revenue growth of 6% to 9% in constant currency, and positive EBITDA excluding business development expenses.

"This year, we are planning for further growth and are well-positioned for new opportunities. We expect that the installed base of rigid towers in the U.S. will continue to expand, augmented by a large potential order anticipated next quarter. The technology upgrade cycle in blue light cystoscopy is expected to continue with the anticipated launch of Olympus’ new HD blue light system later this year. Also key to long term success is our strategy to reintroduce flexible BLC in high definition so that we can further develop the large surveillance market worldwide," Schneider continues, and concludes:

"The Citizen’s Petition to reclassify BLC equipment from Class 3 to Class 2 in the U.S. is a potential regulatory action that could change the game by creating an accelerated approval process that would enable equipment manufacturers to access the U.S. market quickly and expand BLC use by meeting the demands of the market. Our partner Asieris continues to advance its licensed and partnered programs: Cevira and Hexvix in China, respectively, which are both expected to generate significant additional revenue through regulatory and future sales milestones. With these initiatives and more, we look forward to the coming year. We remain focused on driving value for patients, our customers and our shareholders."

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the fourth quarter 2023 financial report on page 24.

The quarterly report and presentation will be published at 08:00 CET and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CET.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20240221_5/

The presentation is scheduled to conclude at 14:45 CET.

On February 21, 2024 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, reported the publication of data from its phase 1/2 trial of lead compound, LUT014, a topically applied, novel B-Raf inhibitor, for the treatment of radiation-induced dermatitis (RD) in patients with breast cancer (Press release, Lutris Pharma, FEB 21, 2024, View Source [SID1234640348]). The data were published in the peer-reviewed, JAAD International, in an article entitled, "A Topical BRAF Inhibitor (LUT014) For Treatment of Radiodermatitis Among Women with Breast Cancer."

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"Our data suggest that LUT014 can be safely administered, with no serious adverse events (AEs) observed in either the open-label or randomized parts of the study," stated Benjamin W. Corn, M.D., Chief Medical Officer of Lutris Pharma. "In part 1 of the trial, by day 28, 6 of 8 (75%) of enrolled patients who developed grade 2 dermatitis at baseline, achieved complete resolution. Additionally, all 8 women in part 2 achieved treatment success, compared to 73% in the placebo arm, illustrating that a positive efficacy signal may be associated with this compound. Importantly, the results support the need for further study of LUT014 in this radiation-induced dermatitis indication, especially since several expert professional bodies such as the Oncologic Nursing Society (ONS), the American Society of Radiation Oncology (ASTRO) and the Multinational Association of Supportive Care in Cancer (MASCC) recently concluded that there is currently no standard treatment for radiation dermatitis."

"Publication of the impressive results from our phase 1/2 trial in breast cancer patients with RD in such a highly regarded peer reviewed journal, one of the main scientific/educational arms of the American Academy of Dermatology; the largest and most influential professional organization of dermatologists in the U.S. & Canada, is a testament to the potential of LUT014 to improve patients’ quality of life while accelerating their recovery from RD," added Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "Given that the majority of women with breast cancer will develop some form of RD, and that there remains a clinically meaningful, unmet medical need, with no current, effective treatment options, we believe LUT014 may be able to effectively treat this patient population."

The phase 1/2 trial included an open-label part 1, followed by a double-blind placebo-controlled part 2. Part 1 results showed that, of the eight enrolled patients who developed grade 2 RD at baseline, 75% (6/8) had complete resolution, improving to grade 0 dermatitis, and 100% of patients had RD of 1 or 0 as assessed by the Common Terminology Criteria for Adverse Events (CTAE) after 28 days of daily, topically applied LUT014 gel. All of the patients derived benefit in quality of life by day 28 as assessed by the validated, self-reporting Dermatology Life Quality Index (DLQI) questionnaire, with seven of eight patients experiencing no or small effect of the dermatitis on their respective quality of life after the treatment course. The primary endpoint of the open-label part 1 was the incidence of Treatment-Emergent Adverse Events as assessed by CTAE at 12 weeks and the data showed that LUT014 was well tolerated, no severe or serious adverse events occurred, and no adverse events were associated with discontinuation of the study drug. These data were deemed to be sufficiently intriguing to trigger the randomized part of this phase 1/2 trial.

The randomized, double-blind, placebo-controlled part two of the phase 1/2 study enrolled a total of 20 patients and was designed to evaluate the efficacy of topically administered LUT014 in breast cancer patients with RD. Patients were randomized in a 1:1 ratio to receive either topically administered LUT014 or placebo for 28 days, followed by a 2-month follow-up period.

The primary endpoint of the double blinded part 2 of the phase 1/2 trial was the change in severity of radiation dermatitis, based on a validated self-reporting DLQI questionnaire at 14 days, as measured by improvement of at least 5 points on the DLQI at day 14, and was achieved by all eight women treated with LUT014, in comparison to 73% of the placebo arm at the same juncture. Improvement in the DLQI score at day 7 was 30%. Furthermore, 75% of patients in the intervention-arm showed improvement from grade 2 to grade 1 as early as day 7, in comparison to 55% of those assigned to the control arm. Moreover, 50% of the women assigned to the treatment arm experienced complete recovery at Day 21, versus 27% of those receiving only placebo (p=0.3765). Overall, four out of eight (50%) subjects had recovered completely in the LUT014 Gel group while four out of 11 (36%) subjects had recovered completely in the placebo group by the end of the study (Day 28) (p=0.6577). None of these differences reached conventional levels of statistical significance, however, this small study was not powered to show such differences. The mean and the median of the time to recovery were shorter in the LUT014 Gel group than in the placebo group: 30.5 vs. 46.6 days and 21.0 vs. 54.0 days, respectively.

For more information about this clinical trial, please visit: www.clinicaltrials.gov, NCT04261387.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma cancer, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.

About Radiation Dermatitis
Radiation therapy results in ionization events that lead to damage of cellular macromolecules, including double-stranded DNA breaks. Within the epidermis, this DNA damage disrupts the normal proliferation and differentiation of basal keratinocytes, depleting the differentiated epidermal keratinocytes and ultimately resulting in the loss of the protective barrier provided by the skin. This, combined with DNA damage disruption within the dermis, which results in a complex sequence of effects including an immune response cascade, leads to the symptomology associated with radiation dermatitis, which can dramatically diminish a patient’s quality of life.

There is currently no FDA-approved drug whose labelled indication is for the prevention or treatment of radiation-induced dermatitis. Rather, patients are merely treated with supportive cutaneous care. The current treatment options – which have a weak evidence base — have included topical steroids, non-steroidal anti-inflammatory topicals, and hyaluronic acid derivatives. To date, none has been definitively proved efficacious.

On February 21, 2024 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that it has recently published the phase III study results of denosumab biosimilar (MW032) online in the international top journal of JAMA Oncology (Press release, Mabwell Biotech, FEB 21, 2024, View Source [SID1234640347]). This is the first recorded trial to systematically compare the efficacy, population pharmacokinetics, and safety profile of MW032 and reference denosumab in patients with solid tumors with bone metastasis through a 53-week, multicenter, randomized, double-blind, phase 3 equivalence trial.

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708 eligible patients were enrolled and randomly assigned (1:1) to receive MW032 or reference denosumab subcutaneously every 4 weeks until week 49. The primary end point was percentage change from baseline to week 13 of natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr). Secondary end points were percentage change in uNTx/uCr and bone-specific alkaline phosphatase (s-BALP) from baseline to weeks 5, 13, 25, 37, and 53, and the incidence of SREs.

The results showed that the mean change of uNTx/uCr from baseline to week 13 was −72.0% in the MW032 group and −72.7% in the control group. After adjusting for stratification factors, the LSM (least squares mean) difference of these logarithmic transformed percent changes was 0.02. The 90% CI for the difference (−0.04 to 0.09) was within the equivalence margin. Sensitivity analyses of the primary end point, subgroup analysis, and secondary end points analysis demonstrated similarity in efficacy between the two treatment groups.

705 patients receiving at least 1 dose of investigational therapy were included in the safety analyses. The incidence of adverse events (AE), treatment related AEs, and AEs leading to discontinuation were similar in the MW032 and control groups. Treatment related AEs with the highest incidence were hypocalcemia, hypophosphatemia, and hyperuricemia, which occurred at similar rates in both treatment groups. Similarity study of immunogenicity and population pharmacokinetics have been conducted in the study.

The study systematically demonstrated that MW032 and denosumab were biosimilar in efficacy, safety profile and population pharmacokinetics. Launch of MW032 will broaden patient access to denosumab, reduce financial burden on patients, and finally benefit more patients with advanced tumors.

Find paper at: View Source

On February 21, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") reported that it has completed the acquisition of the entire portfolio of discovery, preclinical and clinical development stage assets of former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., and IMV USA ("IMV") (Press release, BioVaxys Technology, FEB 21, 2024, View Source [SID1234640346]). On February 11th, 2024, the Company executed the definitive Asset Purchase Agreement for the extensive technology portfolio from HIMV, LLC, an acquisition vehicle formed by Horizon Technology Finance Corporation (NASDAQ: HRZN) and IMV’s other secured creditors for the purpose of acquiring IMV’s intellectual property through a secured party credit bid in the proceedings commenced in Canada by IMV under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended (the "CCAA").

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At the closing, BioVaxys delivered to HIMV a one-time payment of both US$750,000 in cash and 5,034,701 common shares of BioVaxys at a deemed price of CAD$0.067.

With the transaction now complete, BioVaxys is working on integrating the acquired assets into the Company. BioVaxys President and Chief Operating Officer Kenneth Kovan stated "We now have massive opportunities in oncology, infectious disease, allergy desensitization, and autoimmune diseases. Adding several clinical-stage programs was critical for us becoming a product-centric company, but there are always inherent risks with clinical programs, and they require significant investment. Maveropepimut-S has incredible potential and is a very important addition to our oncology pipeline." Kovan further stated "Over the upcoming months our plan is to drive more organic growth by pursuing multiple licensing and partnership opportunities with the DPX and HapTenix© platforms. We will be identifying target partners where our solutions can address specific needs or gaps, making BioVaxys an attractive ‘go-to’ partner for targeted immunotherapies."

The Company has identified potential for DPX in improved mRNA vaccines, multivalent viral vaccines, vaccines for desensitizing immune response for peanut allergies, and immune system diseases. Prior clinical studies by IMV have supported proof of concept and a superior immune response with a DPX-RSV formulation, DPX-rHA/DPX-FLU influenza vaccine, DPX-packaged survivin/MAGE-Ag for advanced metastatic bladder cancer, and certain other infectious diseases.

On February 21, 2024 Processa Pharmaceuticals presented its corporate presentation (Presentation, Processa Pharmaceuticals, FEB 21, 2024, View Source [SID1234640344]).

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