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Nanopharmaceutics, Inc. Announces the End of Patient Recruitment for the National Cancer Institute (NCI) Sponsored Phase 3 Clinical Study in Advanced-Stage Cervical and Vaginal Cancers with Cisplatin During Radiation Therapy with and without Triapine®

On November 2, 2022 Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, reported completion of patient enrollment in the 450 patient Phase 3 clinical study sponsored by the NCI, part of the National Institutes of Health, and led by NCI funded network group, NRG Oncology, with participation of the NCI National Clinical Trials Network (NCTN), "A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal," (NRG-GY006, ClinicalTrials.gov Identifier: NCT02466971) (Press release, Nanopharmaceutics, NOV 2, 2022, View Source;301666297.html [SID1234622847]). The randomized phase 3 trial is evaluating radiation therapy and cisplatin with Nanopharmaceutics’ proprietary formulation of Triapine compared to the standard radiation therapy and cisplatin, alone, in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors.

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Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with Triapine Injection in treating cervical or vaginal cancer. 450 patients were enrolled in the study, which was performed under a Cooperative Research and Development Agreement (CRADA) between NCI and Nanopharmaceutics.

About Triapine

Triapine is a synthetic heterocyclic carboxaldehyde thiosemicarbazone with potential antineoplastic activity being studied in the treatment of cancer. It is a type of ribonucleotide reductase inhibitor. Also called 3-aminopyridine-2-carboxaldehyde thiosemicarbazone and 3-AP, Triapine inhibits the enzyme ribonucleotide reductase, resulting in the inhibition of the conversion of ribonucleoside diphosphates to deoxyribonucleotides necessary for DNA synthesis.

Memorial Sloan Kettering Cancer Center Partners with Curbside Health to Advance Clinical Pathways in Oncology

On November 2, 2022 Curbside Health reported an official partnership with Memorial Sloan Kettering Cancer Center (MSK), with a plan to fully deploy its proprietary and scalable, clinical pathway platform in multiple aspects of MSK’s day-to-day clinical practice (Press release, Memorial Sloan-Kettering Cancer Center, NOV 2, 2022, View Source [SID1234622846]).

MSK is among the highest-regarded, leading cancer centers in the world, and as such, the Curbside team is delighted to deliver industry-leading tools and resources to support MSK’s gold-standard.

Curbside is currently offering tailored consultations to qualified hospital groups and institutions.
Curbside is currently offering tailored consultations to qualified hospital groups and institutions.
For MSK, Curbside enhances digital tools and resources available to the clinical staff, while providing detailed clinical information and decision support. Based on similar instances, the Curbside team expects the usability goes up since Curbside is integrated inside of the Electronic Health Records (EHR), allowing the latest available, and approved pathways are delivered right at the point of care.

At a very granular level, Curbside will help MSK disseminate case-specific content to other sites so that a patient with a challenging cancer diagnosis, as an example, could still significantly benefit from world-class decision-making even if they’re not at MSK.

Regarding the complete solution from Curbside, Co-Founder Eric Leroux, MD MBA states, "The platform solution for MSK is all-inclusive, incorporating all of the content creation, maintenance, management access, analytics, reporting, it’s all in a single place. Curbside is where you go for any sort of clinical content you need to get pathways, guidelines, protocols, clinical calculators, and so on," he continues, "we see the usability go way up for an organization such as MSK".

Among Curbside’s core value propositions is that it provides a robust ecosystem helping to ensure patients are not limited in the quality of care they receive based on where they have to live or receive care — it’s a democratization of clinical pathways on all fronts.

Dr. Leroux adds, "It really starts to break down barriers to highest quality of care and that’s an important theme for Curbside and actually the reason for the company’s name — Curbside Health."

Photocure ASA: Results for the third quarter of 2022

On November 2, 2022 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 96.9 million in the third quarter of 2022, up 12% compared to Q3 2021 (NOK 86.7 million), and positive EBITDA of NOK 4.7 million (NOK -0.2 million) for the Company (Press release, PhotoCure, NOV 2, 2022, View Source [SID1234622845]). With the launch of Karl Storz’s new high-definition blue light system in the U.S., Photocure expects that placements of new blue light rigid towers will begin to accelerate in the fourth quarter of this year. A recent ruling by the Centers for Medicare and Medicaid Services (CMS) improves U.S. reimbursement for Cysview, expanding access in the Ambulatory Surgery Center (ASC) segment.

"Photocure delivered Hexvix/Cysview revenue growth of 12%, driven by higher unit sales in both North America and Europe in addition to the net favorable effect of foreign exchange. I am very pleased to report that our North American business segment achieved the highest quarterly unit sales volume in our history, and we are now in a strong position to significantly expand the installed base of blue light capital equipment in the U.S. and get back to the high growth trajectory that we were achieving before the pandemic," says Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 106.8 million in the third quarter of 2022 (NOK 87.4 million), and EBITDA* of NOK 4.7 million (NOK -0.2 million), driven by the increase in product revenue and a milestone payment from Asieris. Hexvix/Cysview revenues ended at NOK 96.9 million in the quarter (Q3 2021: NOK 86.7 million), due to higher unit sales in both North America and Europe, and net favorable foreign exchange. EBIT was NOK -1.4 million (-6.3 million) and the cash balance at the end of Q3 2022 was NOK 283.9 million.

Photocure announced the commercial availability of Karl Storz’s new high-definition blue light rigid system in the United States late in the quarter. The Company reports that 10 new blue light towers were installed during the period; 6 new Saphira cystoscopes and 4 flexible units. The installed base of blue light cystoscopes in the U.S. was 339 (302) at the end of the third quarter, a 12% increase from the same period last year. This includes 62 flexible cystoscopes, an increase of 38%.

"The pipeline for new blue light cystoscopy towers remains stronger than ever. With the new system now officially launched, we are currently assisting Karl Storz with the placement and activation of towers for accounts that participated in the obsolescence protection program to replace the old standard definition system. We anticipate broader installations of rigid BLC equipment in new accounts this quarter," Schneider adds.

With the launch of Karl Storz’s new high-definition blue light system in the U.S. at the end of the third quarter 2022, Photocure expects that placements of new blue light rigid towers will accelerate in the fourth quarter of this year and beyond. Additionally, the post-period ruling by CMS to improve Medicare reimbursement is anticipated to help increase sales in the Hospital-Based Outpatient Department (HOPD) setting and enable Photocure’s U.S. commercial team to penetrate accounts in the ASC site of care.

"With account access now open in our major markets, Karl Storz’s new blue light system launching, and an improvement in Medicare access and reimbursement expected to take effect January 1 of next year, I believe that Photocure’s business is at an inflection point. We remain focused on positioning the Hexvix/Cysview franchise as the standard of care in the management of bladder cancer," Schneider concludes.

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 third quarter 2022 financial report on page 22.

The quarterly report and presentation will be published at 08:00 CET and will be publicly available at www.photocure.com. Daniel 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/hegnarmedia/#!/hegnarmedia/20221102_7

Omega Therapeutics Receives Orphan Drug Designation for OTX-2002 for the Treatment of Hepatocellular Carcinoma

On November 2, 2022 Omega Therapeutics, Inc. ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OTX-2002, the company’s first-in-class epigenomic controller engineered to downregulate c-Myc (MYC), for the treatment of hepatocellular carcinoma (HCC) (Press release, Omega Therapeutics, NOV 2, 2022, View Source [SID1234622844]).

The company recently announced that the first patient had been dosed in its Phase 1/2 MYCHELANGELO I clinical trial investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a monotherapy and in combination with standard of care therapies in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene.

"HCC is a devastating illness that often develops resistance to current standard of care therapeutics. The FDA’s decision to grant orphan drug designation for OTX-2002 underscores the need for novel therapies to address HCC and the potential of epigenomic programming to transform the treatment landscape," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We look forward to continuing to work with clinical investigators, patients and the FDA as we advance our MYCHELANGELO clinical program and evaluate the potential of OTX-2002 to bring a new treatment option to the liver cancer patient community."

About Orphan Drug Designation
The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths worldwide and represents an unmet clinical need with few therapeutic options. Tyrosine kinase inhibitors (TKIs) have been used as a systemic therapy for HCC, but patients frequently develop resistance with oncogenic MYC identified as a correlating prognostic factor. The MYC oncogene is associated with aggressive disease in up to 70% of patients with HCC.

About OTX-2002
OTX-2002 is a first-in-class Omega Epigenomic Controller in development for the treatment of hepatocellular carcinoma (HCC). OTX-2002 is an mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. MYC is a master transcription factor that regulates cell proliferation, differentiation and apoptosis and plays a significant role in more than 50% of all human cancers. OTX-2002 is currently being evaluated in the Phase 1/2 MYCHELANGELO I trial in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene; visit clinicaltrials.gov (NCT05497453) for more details.

Aadi Bioscience to Report Third Quarter 2022 Results and Corporate Update

On November 2, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that it will host a conference call and live webcast on Wednesday, November 9, 2022 at 8:30 am ET (5:30 am PT) to report third quarter 2022 financial results and provide recent corporate updates (Press release, Aadi Bioscience, NOV 2, 2022, View Source [SID1234622843]).

Conference Call Information

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this Conference Registration (vevent.com). Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the website for at least 30 days.