On October 5, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported the acceptance of two Trials in Progress abstracts related to ASPEN-03 and ASPEN-04, the Company’s Phase 2 head and neck cancer studies in collaboration with Merck (known as MSD outside the US and Canada), at the SITC (Free SITC Whitepaper) 37th Annual Meeting in Boston, MA, from November 8–12, 2022 (Press release, ALX Oncology, OCT 5, 2022, View Source [SID1234621703]).

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On October 5, 2022 Photocure ASA, The Bladder Cancer Company, reported the presentation of clinical data and its breakout session in the scientific program at the International Bladder Cancer Network Meeting held September 29th-October 2nd in Barcelona, Spain (Press release, PhotoCure, OCT 5, 2022, View Source [SID1234621702]). Dr. Steven Williams, of University of Texas-Medical Branch, Galveston, presented the study abstract "The Impact of Blue Light Cystoscopy Use Among Non-Muscle Invasive Bladder Cancer Patients in an Equal Access Setting: Implications on Recurrence and Time to Recurrence Stratified by Race". In addition, Photocure sponsored an industry breakout entitled "Photodynamic Detection (PDD) and Photodynamic Therapy (PDT): Applications in non-muscle invasive bladder cancer (NMIBC)."

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The IBCN meeting brings together international Bladder Cancer Experts and scientists, with the mission to improve the diagnosis, prevention, and treatment of bladder cancer.

The abstract "The Impact of Blue Light Cystoscopy Use Among Non-Muscle Invasive Bladder Cancer Patients in an Equal Access Setting: Implications on Recurrence and Time to Recurrence Stratified by Race"* was presented by Dr. Williams on September 30th. The study was conducted with support from Photocure and aims at describing bladder cancer outcomes and the impact of blue light cystoscopy (BLC) among non-muscle invasive bladder cancer (NMIBC) patients in an equal access setting, i.e., the Veterans Affairs Healthcare System (VA).

NMIBC patients within the VA receiving BLC were assessed to determine overall recurrence rates as well as the association between race and recurrence, progression, and overall survival outcomes.

A total of 378 patients were included in the analysis, of which 43 (11%) and 300 (79%) were African American and Caucasian, respectively. The results showed that the median time to first recurrence following BLC vs. white light cystoscopy (WLC) was significantly longer overall (40 vs. 26 months, p<0.001) and across all time points, respectively, in the cohort. A significant decrease in risk of recurrence following BLC utilization compared to WLC alone (HR, 0.70, p=0.005) was also determined. With regard to race stratification, the analysis showed no significant difference between African American and Caucasian patients for recurrence, progression and overall survival.

"In the present study, we found a significant decrease in risk of recurrence following BLC utilization compared to WLC alone and longer time interval to recurrence. There was no difference by race. Our findings demonstrate increased support for BLC’s clinical role in reducing bladder cancer recurrence, and that equal access to health care can achieve equitable outcomes by race," Dr. Steven Williams, Professor and Chief of the Division of Urology, at the University of Texas-Medical Branch, one of the study authors, concluded.

*Read about the abstract: View Source

Note to editors

Hexvix/Cysview and BLC are registered trademarks of Photocure ASA.

This press release may contain product details and information which are not valid, or a product that is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information, which may not comply with any legal process, regulation, registration, or usage in the country of your origin.

About Bladder Cancer

Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – 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 up to 61% in year one and up to 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, New Zealand and Israel. Please refer to View Source for further information on our commercial partners.

On October 4, 2022 Araris Biotech AG ("Araris" or "the Company"), a company pioneering a proprietary antibody-drug conjugate (ADC)-linker technology, reported the closing of a $24 million financing round, bringing the total funds raised to $40 million to date (Press release, Araris Biotech, OCT 4, 2022, View Source [SID1234651279]).

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The round was co-led by 4BIO Capital and Pureos Bioventures, with participation from new investors, including Wille AG and the Institute for Follicular Lymphoma Innovation. The round also included participation from existing investors VI Partners, Schroders Capital, btov Partners and Redalpine. Damir Illich, Ph.D. from Wille AG and Sophie Allauzen, Ph.D. from the Institute for Follicular Lymphoma Innovation will also be joining the Araris team as board observers.

Proceeds from the financing will be used to support the further development and advancement of Araris’ antibody-drug conjugate (ADC) candidates, created using the Company’s proprietary linker technology, as Araris moves closer towards clinical development.

"We’re thrilled to have support from this group of investors who recognize the potential of our linker technology in this exciting and growing ADC field and look forward to using these proceeds to support our efforts in advancing our ADC candidates toward the clinic," said Philipp Spycher, Ph.D., chief executive officer at Araris Biotech. "Our linker technology has enabled us to create ADCs in a single conjugation step. The resulting ADCs have shown a significantly improved therapeutic index and favorable biophysical properties in preclinical studies to date, and an ability to address the limitations of current ADCs on the market. This fundraising will allow us to move closer to our goal of bringing these therapies to patients in need of better treatment options."

Dmitry Kuzmin, Ph.D., managing partner at 4BIO Capital, added, "Araris continues to make waves in the industry with its pioneering linker technology, enabling fast and precise production of ADCs. Having invested in Araris’ seed round, we are now delighted to co-lead the latest round to ensure that Araris can unlock the potential of its differentiated technology and bring highly effective therapies to patients across the world."

Dominik Escher, Ph.D., founding partner at Pureos Bioventures stated, "We are pleased to continue our support for Araris in this financing round as the company advances the next generation of antibody-drug conjugates with the potential to help cancer patients in the future."

On October 4, 2022 Sibylla Biotech reported the successful close of its €23 million Series A financing round to fund the further development of its Pharmacological Protein Inactivation by Folding Intermediate Targeting (PPI-FIT) approach, which provides access to a new class of pharmacological targets that transiently appear during the process of protein folding, and to advance its proprietary pipeline programs through preclinical evaluation (Press release, Sibylla Biotech, OCT 4, 2022, View Source [SID1234641501]). The financing from an international syndicate of specialized life science investors was led by V-Bio Ventures with participation from Seroba Life Sciences, 3B Future Health Fund, Claris Ventures, CDP Venture Capital with Evolution Fund, VI Partners, Indaco Venture Partners, as well as the company’s seed investor, Vertis SGR. Concurrent with the close of the fundraising, Ward Capoen from V-Bio, Bruno Montanari from Seroba, Ciro Spedaliere from Claris Ventures, and Marianne Bjordal from 3B Future Health Fund will join Sibylla’s Board of Directors.

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"Sibylla Biotech is developing small molecule degraders designed to interfere with the folding process of a selected protein by binding to the folding intermediate states, bringing a highly differentiated approach to the protein degradation field that can access a range of targets previously considered undruggable," commented Lidia Pieri, PhD, Co-Founder and Chief Executive Officer of Sibylla Biotech.

"We have gained the support of a strong group of expert investors and the capital to advance our small molecule pipeline, expand our protein folding simulation technology platform and bring additional expertise to our team. I would like to thank all Sibylla employees, founders, and supporters for enabling our achievements so far."

Through the PPI-FIT approach, Sibylla Biotech designs Folding Interfering Degraders (FIDs), classical small molecules that target specific proteins, including proteins that lack druggable pockets in their native state. The company’s lead candidate degrades Cyclin D1, a protein that is amplified and overexpressed in a range of cancers and which is currently considered an undruggable target. The proceeds of the Series A will allow the company to build out its pipeline of therapeutics by exploiting the protein folding simulation platform, as well as to further expand the potentiality of its technology.

"Sibylla’s novel approach has already demonstrated that it can unlock a new category of targets with the potential to translate these into a robust pipeline of small molecule candidates for an unlimited range of indications. We are excited to support Sibylla Biotech’s vision to transform the protein degradation landscape," added Ward Capoen, PhD, Partner at V-Bio Ventures.

"Lidia and her team came together from a group of cross-disciplinary experts with the goal of developing the PPI-FIT technology. Sibylla Biotech has distinguished itself by applying ground-breaking science to solve therapeutic challenges and now they have the further validation from a group of highly experienced investors. Vertis congratulates the team on achieving this next step in their development," said Roberto Della Marina, PhD, Operating Partner at Vertis SGR.

On October 4, 2022 Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, reported receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019 (Press release, Cidara Therapeutics, OCT 4, 2022, View Source [SID1234636985]). The payment was made in association with the European Medicines Agency (EMA) acceptance of the marketing authorization application (MAA) for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients.

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"With the $11 million milestone payment from Mundipharma, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $108 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next two years," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. "If received, these payments have the potential to significantly bolster the Company’s financial position to more rapidly advance our key Cloudbreak programs and complete the ongoing Phase 3 ReSPECT trial and are in addition to any commercial milestones or royalties that Cidara is eligible to receive from these partnerships over the same time period."

Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.

About Rezafungin
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin has been designated a QIDP with Fast Track status by the FDA, and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.