On February 28, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update (Press release, Olema Oncology, FEB 28, 2022, View Source [SID1234609200]).

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"2021 was a transformative year for Olema. Our team made important progress against our strategic goals, culminating in the presentation of strong proof-of-concept data for OP-1250 in ER+ / HER2- breast cancer. The initial data, demonstrating OP-1250’s attractive pharmacokinetics, favorable tolerability and encouraging anti-tumor activity in a heavily pretreated patient population, validate OP-1250’s potential to become the endocrine therapy of choice for ER+ breast cancer. We are now actively expanding our clinical study enrollment and expect to be in a position to present more data later this year," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Importantly, we entered 2022 with a strong balance sheet, and as we continue to build our team and grow our capabilities, we are well positioned to advance our clinical development program and discovery efforts."

Recent Corporate Highlights

●Presented interim Phase 1a dose escalation data for OP-1250 from the ongoing Phase 1/2 clinical study. The initial data provide strong proof-of-concept supporting OP-1250’s potential as a once-daily oral monotherapy in women with recurrent, locally advanced, or metastatic ER+ / HER2- breast cancer, with OP-1250
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demonstrating highly attractive pharmacokinetics, favorable tolerability, and clear efficacy signals in a heavily pretreated patient population.
●Initiated monotherapy dose expansion at 60 mg and 120 mg dose levels. Each cohort will enroll approximately 15 patients with measurable disease, and findings will help inform the selection of a recommended Phase 2 dose (RP2D). Enrollment remains on track to complete in the first quarter of 2022.
●Initiated Phase 1b combination study with palbociclib, a CDK4/6 inhibitor. The dose escalation portion of the combination trial includes a starting dose of 30 mg OP-1250 once-daily and follows a standard 3+3 design.
●Presented nonclinical data on OP-1250 in a poster session at the San Antonio Breast Cancer Symposium (SABCS), held December 7-10, 2021. Data presented showed that the addition of OP-1250 to anti-HER2 agents, trastuzumab and tucatinib, improved the inhibition of tumor growth in nonclinical models of ER+ / HER2+ breast cancer.
●Appointed Naseem Zojwalla, M.D., as Olema’s new Chief Medical Officer. Dr. Zojwalla joins Olema from Turning Point Therapeutics and brings significant leadership in clinical development, operations and regulatory experience. Former CMO Pamela Klein, M.D., continues to work with Olema in a strategic advisory capacity and as a newly appointed member of the company’s Scientific Advisory Board.
●In December 2021, Olema was added to the NASDAQ Biotechnology Index (Nasdaq: NBI).
Anticipated Milestones

●Select the Recommended Phase 2 Dose (RP2D) for OP-1250 and initiate Phase 2 in the first half of 2022. The Phase 2 study includes enrollment across three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15).
●Initiate additional Phase 1b combination studies with CDK4/6 and PI3Kα inhibitors in 2022.
●Initiate Phase 1b study of OP-1250 in patients with ER+/HER2+ breast cancer and CNS metastases in the second half of 2022.
●Present updated monotherapy and initial combination data for OP-1250 in 2022.
●Sean Bohen, M.D., Ph.D., President and CEO of Olema Oncology, is scheduled to present at the 42nd Annual Cowen Healthcare Conference on Monday, March 7, 2022 at 2:50 PM ET.
Fourth Quarter and Full Year 2021 Financial Results

●Cash, cash equivalents and marketable securities as of December 31, 2021 were $287.3 million. Olema anticipates that this balance of cash will be sufficient to fund operations into 2024.
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●Net loss was $21.6 million and $71.1 million for the quarter and year ended December 31, 2021, respectively, as compared to $10.1 million and $22.1 million for the quarter and year ended December 31, 2020, respectively. The increase in net loss related primarily to Olema’s continued investment in OP-1250, and an increase in general and administrative (G&A) infrastructure costs.
●GAAP research and development (R&D) expenses were $16.0 million and $51.1 million for the quarter and year ended December 31, 2021, respectively, as compared to $6.3 million and $13.7 million for the quarter and year ended December 31, 2020, respectively. The increase in R&D expenses was primarily related to the advancement of the ongoing Phase 1/2 clinical trial of OP-1250, increase in nonclinical development activities, higher personnel-related expenses and higher non-cash stock-based compensation expenses. Non-GAAP R&D expenses were $13.1 million and $41.8 million for the quarter and year ended December 31, 2021, respectively, excluding $2.9 million and $9.3 million non-cash stock-based compensation expense respectively. Non-GAAP R&D expenses were $4.8 million and $11.7 million for the quarter and year ended December 31, 2020, respectively, excluding $1.5 million and $2.0 million non-cash stock-based compensation expense respectively. The increase in R&D expenses was primarily related to the advancement of the ongoing Phase 1/2 clinical trial of OP-1250, increase in nonclinical development activities, higher personnel-related expenses and higher non-cash stock-based compensation expenses. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this news release.
●GAAP G&A expenses were $5.8 million and $20.4 million for the quarter and year ended December 31, 2021, respectively, as compared to $3.8 million and $7.8 million for the quarter and year ended December 31, 2020, respectively. Non-GAAP G&A expenses were $4.1 million and $13.8 million for the quarter and year ended December 31, 2021, respectively, excluding $1.7 million and $6.6 million non-cash stock-based compensation expense respectively. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses. Non-GAAP G&A expenses were $3.0 million and $6.7 million for the quarter and year ended December 31, 2020, excluding $0.9 million and $1.1 million non-cash stock-based compensation expense respectively. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses.

On February 28, 2022 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, reported its cash position as of December 31, 2021 and revenues for 2021[1] (Press release, Genfit, FEB 28, 2022, https://ir.genfit.com/news-releases/news-release-details/genfit-announces-solid-revenues-and-cash-position-december-31 [SID1234609199]).

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Financials

As of December 31, 2021, the Company’s cash and cash equivalents amounted to €258.8 million compared with €171.0 million, as of December 31, 2020. This amount includes:

A €120 million non-refundable upfront payment from Ipsen received in December 2021, as well as €24 million in VAT collected on that amount
A €28 million equity investment from Ipsen in December 2021
A €7.9 million Research Tax Credit 2020 reimbursement received in October 2021
A €2.25 million subsidized loan from Bpifrance in November 2021 in addition to the State Guaranteed Loans received in June and July 2021

As of June 30, 2021, cash and cash equivalents amounted to €104.4 million.

The solid cash position as of December 31, 2021 takes into account the collaboration and license agreement signed with Ipsen in December 2021 which gives Ipsen exclusive worldwide[2] license to develop, manufacture and commercialize GENFIT’s investigational treatment elafibranor for people living with Primary Biliary Cholangitis (PBC), in return for a €120 million upfront payment. In addition to the upfront payment GENFIT is eligible to receive up to €360 million in milestone payments as well as tiered double-digit royalties of up to 20%. To underscore the long-term commitment represented by this partnership, Ipsen also purchased newly issued GENFIT equity representing 8% post-issuance through a €28 million investment in GENFIT, becoming one of the largest shareholders.

Pascal Prigent, CEO of GENFIT, commented: "This breakthrough strategic partnership with Ipsen marks the beginning of a new chapter for GENFIT. With a considerably improved financial situation, we’re now in a good position to accelerate our development."

Revenues [3]

Revenues for 2021 were €80.06 million compared to €0.76 million for 2020. This mainly results from the receipt of the €120 million upfront payment from Ipsen, out of which €80 million is recognized as 2021 revenue, after deduction of €40 million deferred revenue, which will gradually be recognized as revenue following the completion of the ELATIVE double-blind study, in accordance with the IFRS 15 norms.

As a comparison, revenues for 2020 mainly resulted from the licensing agreements with Labcorp to roll out the NIS4 diagnostic technology in NASH and the sale of goods and services provided pursuant to the collaboration and license agreement with Terns Pharmaceuticals.

A note about the COVID-19 pandemic and its potential consequences on our business

During this evolving crisis, our priorities continue to be to ensure the safety and well-being of our employees, of the patients and healthcare professionals involved in our clinical trials, as well as the integrity of our ongoing clinical trials. We remain committed to ensuring business continuity and have been monitoring the situation closely.

We have worked with our contract research organizations (CRO), trial sites and investigators to regularly revise our program execution estimations to take into account the evolution of the pandemic situation and its impact on our activities.

As a result of measures implemented in consultation with our CRO we were able to minimize disruption to our ELATIVE Phase 3 clinical trial of elafibranor in PBC, which enrolled its first patient in September 2020. At the start of the trial, and considering the pandemic situation, we had estimated that enrollment in the ELATIVE study would take approximately 18 months and so far, we have been broadly in-line with this estimate. However, the recent rapid expansion of the highly contagious Omicron strain of COVID has created additional complications for us in enrolling patients and in clinical trial operations generally. The rate of infection, as well as the containment measures put in place to control its growth have led to patients postponing site visits or having to be re-screened because they had fallen outside the screening window. This recent worsening of the COVID pandemic has also created significant additional administrative backlogs at sites and regulatory agencies, due to the combination of continued high volume of trials and staffing shortages. This has disproportionately impacted regions where there were already significant delays, such as Latin America. Although we currently do not anticipate these recent complexities to substantially change the guidance related to availability of the ELATIVE top line results, we are currently assessing with our CRO the extent of impact on enrollment timelines. We will provide an update during our next webcast scheduled for April 7, 2022.

Upcoming Financial Communications

The Company will release its full-year 2021 financial results on April 7, 2022. The 2021 Universal Registration Document, the 2021 Annual Financial Report (included in the 2021 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2022.

On February 28, 2022 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Celldex Therapeutics, FEB 28, 2022, View Source [SID1234609198]).

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"Celldex made significant progress over the past year in advancing our pipeline, as marked by successful clinical results from our Phase 1b study with CDX-0159 demonstrating a 95% complete response rate in chronic inducible urticaria, and we remain excited to report data from our chronic spontaneous urticaria Phase 1b study early this summer," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "In July 2021, we raised $287 million in gross proceeds from a public offering which provides us with a very strong foundation to further develop our scientific and clinical programs. After successfully completing key readiness activities, including the development of a CDX-0159 subcutaneous formulation, we remain on track to initiate our Phase 2 urticaria programs in the second quarter of 2022."

Mr. Marucci continued, "With encouraging results and multiple ongoing studies across all our programs, we are focused on executing our development plan and are well positioned for a transformational year."

Program Highlights

CDX-0159 – KIT Inhibitor Program

CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

Celldex is currently completing enrollment in the Phase 1b multi-center, randomized, double-blind, placebo-controlled study of CDX-0159 in chronic spontaneous urticaria (CSU). This study is designed to assess the safety and treatment effects of multiple ascending doses of CDX-0159 in up to 40 patients with chronic spontaneous urticaria who remain symptomatic despite treatment with antihistamines. Data from this study (0.5, 1.5 and 3 mg/kg cohorts) are planned to be submitted for a late breaking presentation at EAACI 2022.

Celldex remains on track to initiate Phase 2 studies in chronic spontaneous urticaria and chronic inducible urticaria (cold urticaria and symptomatic dermographism) in the second quarter of 2022. In the fourth quarter of 2021 and first quarter of this year, Celldex successfully advanced important activities to support the initiation of these studies.

A randomized, double-blind, placebo-controlled, Phase 1 study designed to evaluate the safety of single ascending doses of the subcutaneous formulation of CDX-0159 has been conducted in healthy volunteers. Subcutaneous administration of CDX-0159 demonstrated a well tolerated safety profile; no injection site reactions were reported. Multiple dose levels have been identified that possess promising pharmacokinetic and pharmacodynamic properties. Importantly, subcutaneous delivery of CDX-0159 resulted in dose-dependent, rapid and sustained decreases in serum tryptase compared with placebo and achieved sufficient exposure to produce tryptase suppression levels comparable with the levels that generated impressive clinical activity observed in the Phase 1 chronic inducible urticaria IV study. Celldex anticipates the upcoming Phase 2 multi-dose studies in urticaria will evaluate 75mg and 150mg administered q4weeks and 300mg administered q8weeks. The planned doses support a 0.5 to 2 ml injection volume, allowing for a single injection as CDX-0159 advances towards potential commercialization.

The in-life dosing portion of the six month chronic toxicology study has also been completed; a subset of the animals will continue to be followed beyond clearance of the CDX-0159 antibody to study completion. As expected and consistent with other KIT-targeting agents, impact on spermatogenesis was observed which is anticipated to be fully reversible upon clearance of the antibody. There were no other clinically adverse findings reported in the study. Celldex believes these data strongly support the Company’s planned Phase 2 programs in urticaria later this year and future indications.

Celldex believes there is broad development opportunity for CDX-0159 and continues to assess potential opportunities for CDX-0159 in other diseases where mast cells play an important role, such as dermatologic, respiratory, allergic, gastrointestinal and ophthalmic conditions. In 2022, Celldex plans to expand development into eosinophilic esophagitis (EoE), the most common type of eosinophilic gastrointestinal disease. Several studies have suggested that mast cells may be an important driver in the disease, demonstrating that the number and activation state of mast cells are greatly increased in EoE biopsies and that mast cell signatures correlate with markers of inflammation, fibrosis, pain and disease severity. Given the lack of effective therapies for EoE and CDX-0159’s potential as a mast cell depleting agent, Celldex believes EoE is an important indication for future study and plans to initiate a Phase 2 trial in the fourth quarter of 2022.

In December 2021, Celldex announced the first patient was dosed in the Phase 1b multi-center, randomized, double-blind, placebo-controlled study of CDX-0159 in patients with prurigo nodularis (PN), a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin. This study is designed to assess the safety and treatment effects across multiple dose levels of CDX-0159 in up to 30 patients with PN.

In 2021, Celldex presented interim data from the CDX-0159 single dose (3 mg/kg) Phase 1b open label study in inducible urticaria (cold contact and symptomatic dermographism) across multiple medical meetings. CDX-0159 demonstrated a compelling 95% complete response rate to provocation testing; responses occurred rapidly after dosing and were durable. Clinical benefit was also supported across patient reported outcomes measuring symptom control and quality of life. Rapid, marked and durable suppression of serum tryptase and depletion of skin mast cells (87% depletion) as measured through biopsy were also observed. CDX-0159 was generally well tolerated. In March and June 2021, respectively, we added a third cohort (single dose, 3 mg/kg) in patients with cholinergic urticaria (n=10) and a fourth cohort at a lower dose (single dose, 1.5 mg/kg) in cold urticaria. Enrollment to these cohorts is ongoing.
CDX-1140 – CD40 Agonist Program

CDX-1140 is a potent CD40 human agonist antibody developed by Celldex that the Company believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

In the Phase 1 study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas, the monotherapy cohort, the combination cohort with CDX-301 and the safety run-in combination cohort with gemcitabine/nab-paclitaxel have been completed. Expansion cohorts including CDX-1140 with KEYTRUDA (pembrolizumab) in patients with squamous cell head and neck cancer and non-small cell lung cancer who have progressed on checkpoint therapy are ongoing.
CDX-527 – Bispecific Antibody Program

CDX-527 is the first candidate developed by Celldex from its bispecific platform which utilizes the Company’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway.

In the Phase 1 dose-escalation study of CDX-527 in patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy, enrollment to the dose escalation portion of the study has been completed and an expansion cohort in ovarian cancer is currently enrolling patients.
Corporate Highlights

In July 2021, Celldex closed an underwritten public offering of common stock, including the full exercise of the underwriters’ option to purchase additional shares, for gross proceeds of $287.5 million. Celldex believes that the proceeds from this offering, together with current reserves, provide the cash runway to fund key clinical, regulatory and operational activities through 2025.

In September 2021, Marc Rothenberg, MD, PhD was appointed to the Celldex Scientific Advisory Board. Dr. Rothenberg is currently Director of the Allergy and Immunology Division and Director of the Cincinnati Center for Eosinophilic Disorders at Cincinnati Children’s Hospital Medical Center. His clinical and research interests have focused on developing innovative therapies for allergic inflammatory diseases, with a focus on eosinophilic gastrointestinal disorders (EGIDs).
Fourth Quarter and Twelve Months 2021 Financial Highlights and 2022 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2021 were $408.3 million compared to $423.1 million as of September 30, 2021. The decrease was primarily driven by cash used in operating activities of $14.5 million. At December 31, 2021, Celldex had 46.7 million shares outstanding.

Revenues: Total revenue was $0.3 million in the fourth quarter of 2021 and $4.7 million for the year ended December 31, 2021, compared to $3.8 million and $7.4 million for the comparable periods in 2020. The decrease in revenue was primarily due to a decrease in revenue from product development and licensing agreements as a result of the $1.8 million milestone payment received from Rockefeller University in the first quarter of 2020 related to Celldex’s manufacturing and development services agreement and a decrease in services performed under our contract manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.

R&D Expenses: Research and development (R&D) expenses were $14.7 million in the fourth quarter of 2021 and $53.3 million for the year ended December 31, 2021, compared to $10.4 million and $42.5 million for the comparable periods in 2020. The increase in R&D expenses was primarily due to an increase in clinical trial, contract research, and personnel expenses.

G&A Expenses: General and administrative (G&A) expenses were $6.2 million in the fourth quarter of 2021 and $20.5 million for the year ended December 31, 2021, compared to $3.6 million and $14.5 million for the comparable periods in 2020. The increase in G&A expenses was primarily due to higher stock-based compensation and legal expenses.

Intangible Asset Impairment: The Company recorded a non-cash impairment charge of $3.5 million related to the TAM program IPR&D asset in the third quarter of 2021 as a result of a lack of interest in the program from third parties. The Company recorded a non-cash impairment charge of $14.5 million related to the TAM IPR&D asset in the fourth quarter of 2020 as a result of changes in the projected development and regulatory timelines for the program. The Company recorded a non-cash impairment charge of $3.5 million during the second quarter of 2020 due to the discontinuation of the CDX-3379 program.

Changes in Fair Value Remeasurement of Contingent Consideration: During the year ended December 31, 2021, the Company recorded a $1.4 million gain on fair value remeasurement of contingent consideration primarily due to updated assumptions for the TAM program, partially offset by losses related to changes in discount rates and the passage of time.

Net Loss: Net loss was $20.1 million, or ($0.43) per share, for the fourth quarter of 2021, and $70.5 million, or ($1.64) per share, for the year ended December 31, 2021, compared to a net loss of $21.9 million, or ($0.55) per share, for the fourth quarter of 2020 and $59.8 million, or ($2.02) per share, for the year ended December 31, 2020.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2021 are sufficient to meet estimated working capital requirements and fund planned operations through 2025.

Webcast and Conference Call
Celldex executives will host a conference call at 4:30 p.m. ET today to discuss business and financial results and to provide an update on key 2022 objectives. The conference call will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 2177774.

A replay of the call will be available approximately two hours after the live call concludes. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 217774. The webcast will also be archived on the Company’s website.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.

On February 28, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported an update regarding the Company’s negotiations with China Grand Pharmaceutical and Healthcare Holdings Limited (China Grand) (Press release, Clarity Pharmaceuticals, FEB 28, 2022, View Source [SID1234609197]).

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As noted in the Company’s Prospectus, Clarity and China Grand agreed to enter exclusive discussions for the grant of a licence to permit China Grand to develop, manufacture and commercialise one or more of the Company’s products in the Greater China territory. In connection with those discussions, and in consideration for exclusivity, the Company and China Grand entered into an Option Deed on 1 July 2021, with an expiration date on the earlier of a number of events including a period of six months from the date of the Company listing on the ASX.

Under the Deed, the Company issued 25,543,912 options to China Grand to acquire shares at an exercise price of A$1.75. Those options lapsed and were cancelled at 5pm on 25 February 2022 (Expiry Date), being six months from Clarity’s listing date, and the exclusivity period for the licencing negotiations also expired at that time. Clarity continues to progress strategic discussions in relation to its pipeline and technology globally and is now clear to negotiate the Greater China territory on a non-exclusive basis.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We consider China Grand to be a quality pharmaceutical group who could be a potential future partner. We welcome the interest they have shown in our entire platform, products and technology as well as the opportunity to discuss collaborative opportunities in the Greater China territory. The Clarity Board of Directors is committed to ensuring that any collaborative agreement provides maximum value for Clarity shareholders and reflects the long-term potential returns to all parties.

"Clarity has rapidly expanded its clinical program and manufacturing and supply capabilities in the past 12 months, clearly differentiating itself as an effective and sustainable player in the radiopharmaceutical market, a market that is undergoing rapid growth. The Company is currently recruiting in four clinical trials in the US and Australia with plans to open a number of additional trials across all our products over the next 12 months. This provides a broad range of strategic partnering opportunities globally, which we continue to explore.

"With our continued clinical momentum in a range of products in rare and large indications, it is an exciting time for the Company as we look to create substantial value for shareholders while we progress towards our ultimate goal of better treating children and adults with cancer."

This announcement has been authorised for release by the Executive Chairman.

On February 28, 2022 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported the publication of new results from its exploratory research program in the journal Biomedicines, entitled "Antitumor Effect and Induced Immune Response Following Exposure of Hexaminolevulinate (HAL) and Blue Light in an Orthotopic Model of Rat Bladder Cancer" (Press release, PhotoCure, FEB 28, 2022, View Source [SID1234609186]). These results support initial pre-clinical data on the potential anti-tumor effect of HAL, which were presented at the BLADDR 2019 congress [View Source

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The study objective was based on the hypothesis that the positive impact on long-term outcomes in NMIBC patients who had undergone Blue Light Cystoscopy (BLC) prior to cystectomy could be caused by a direct anti-tumor effect and/or activation of the immune system indicating an additional effect of Blue Light with HAL beyond pure detection. Therefore, as an exploratory preclinical study, the authors investigated whether intravesical administration of HAL followed by a diagnostic blue-light illumination-regime, aiming to mimic the one used currently in Photodynamic Diagnosis (PDD), could have anti-tumor and/or immune modulating effects as seen with Photodynamic therapy (PDT). In addition, it was explored if co-administration of a checkpoint inhibitor would increase the susceptibility to the PD-1/PD-L1 pathway inhibition thus increasing the anti-tumor effect. Over the years, Photocure has conducted a number of experiments on "mechanisms of actions" effects of HAL, as well as to see if there potentially are similar anti-tumor and immune modulating effects of PDD with blue light as reported with PDT. For this study, rats were treated with HAL and blue light in an orthotopic model of bladder cancer, and then subjected to histopathological analysis of the bladder samples and additional assessment of immune markers. Co-administration of HAL and blue light with a checkpoint inhibitor was further evaluated in this model aiming to assess for potentiation of anti-tumor effects when combined with an immunotherapy.

Results of the study demonstrated an anti-tumor effect of HAL and blue light when aiming to mimic the dosing regimen of a photodynamic diagnostic procedure (PDD) in an orthotopic bladder cancer model in rats.

The authors conclude "The anti-tumor effect is most probably pertaining to stimulation of the immune system as evident by tumor infiltration of CD3+ and CD8+ T-cells. These results support our hypothesis that the positive impact on patient outcomes observed in patients who had undergone BLC prior to cystectomy could be explained by systemic immune activation induced by HAL and blue light. Combination of HAL and blue light with intravesical anti-PD-L1 resulted in increased anti-tumor effects. Further studies are warranted to explore the long-term effects of HAL and blue light alone or in combination with checkpoint inhibitors which should extend to investigate any systemic (abscopal) effects. Intriguingly is also the idea that local treatment with HAL and blue light can prime an immune response with potential additional effect of checkpoint inhibitors."

"The intriguing results from this pre-clinical study are encouraging and might explain an effect of HAL+BL beyond pure detection. The results motivate further research to evaluate the potential of HAL as a photodynamic therapy (PDT), which may be an innovative technique for treatment of non-muscle invasive bladder cancer.", said Anders Neijber, Vice President, Global Medical Affairs and Clinical Development at Photocure.

Read the full article here: View Source

Note to editors

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About Bladder Cancer

Bladder cancer ranks as the seventh most common cancer worldwide, with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate, with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all cases and include the subtypes Ta, carcinoma in situ (CIS), and T1 lesions. In MIBC, the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3, and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [January 2022].

2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

3 Sievert KD et al. World J Urol 2009;27:295–300

4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, and New Zealand. Please refer to View Source for further information on our commercial partners.