On October 12, 2023 Foundation Medicine Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx and FoundationOneLiquid CDx to be used as companion diagnostics for Pfizer’s BRAFTOVI (encorafenib) in combination with MEKTOVI (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation (Press release, Pfizer, OCT 12, 2023, View Source [SID1234635912]).

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"We are thrilled to see both tests approved simultaneously for the same indication, which will expand access to this therapy option to more NSCLC patients who harbor a BRAF V600E mutation."

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Non-small cell lung cancer is the most common form of lung cancer, accounting for 80-85% of lung cancer diagnoses.1 BRAF V600E mutations occur in approximately 2% of NSCLC cases.2 BRAFTOVI and MEKTOVI are kinase inhibitors, which are a kind of targeted therapy that work by blocking enzymes and keeping cancer cells from growing.3 This therapy combination was previously approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

These companion diagnostic approvals mark the first simultaneous approval of both Foundation Medicine’s FDA approved tests as companion diagnostics for the same therapy. Both tests can help determine if BRAFTOVI in combination with MEKTOVI is an appropriate treatment option for certain patients. Foundation Medicine is the only company with an FDA-approved portfolio with tissue and blood-based comprehensive genomic profiling tests.

Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test currently has over 30 companion diagnostic indications. From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. The test has several companion diagnostic indications across NSCLC, breast cancer, and colorectal cancer, plus a pan tumor indication specific to NTRK1/2/3 fusions.

Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.

"Foundation Medicine’s FDA-approved companion diagnostic tests offer physicians a high-quality diagnostic tool to support their personalized treatment planning," said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "We are thrilled to see both tests approved simultaneously for the same indication, which will expand access to this therapy option to more NSCLC patients who harbor a BRAF V600E mutation."

"We are grateful to see continued efforts to develop more treatment options for patients facing a non-small cell lung cancer diagnosis" said Danielle Hicks, Chief Patient Officer at GO2 for Lung Cancer. "It’s especially exciting to see that patients can be matched to this combination therapy from either a blood or tissue-based test, which expands avenues for more access to this treatment option."

On October 12, 2023 Nerviano Medical Sciences S.r.l., a part of NMS Group S.p.A. (NMS Group) and Nerviano Medical Sciences, Inc., a wholly owned subsidiary of NMS Group, focused on the discovery and early development of oncology drugs and the largest oncological R&D company in Italy, reported initial results from the dose escalation parts of two Phase I-I/II studies for NMS-03305293 (NMS-293) (Press release, Nerviano Medical Sciences, OCT 12, 2023, View Source [SID1234635911]). As an oral, brain penetrant PARP-1 selective inhibitor, NMS-293 has shown strong antitumor activity and complete tumor regression in BRCA mutated preclinical models as a single agent. NMS-293 shows remarkable selectivity towards PARP-1 and efficiently inhibits cellular PARP activity resulting in selective antiproliferative responses on BRCA mutated cell lines. Furthermore, NMS-293 is synergistic and well tolerated in combination with temozolomide (TMZ) in both MGMT methylated and MGMT unmethylated glioblastoma mouse models. For the first time, clinical data is being presented during the poster session (Abstract 37568) at the AACR (Free AACR Whitepaper)-NCI-EORTC 2023 Annual Meeting in Boston, Massachusetts. The poster will be available today on the NMS websites.

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"The data presented today shows NMS-293 is well tolerated and exhibits early signs of clinical activity, that together could provide future treatment options in areas of high unmet medical need in many non-BRCA-mutation tumors, including glioblastoma" stated Lisa Mahnke, MD, PhD, Chief Medical Officer for Nerviano Medical Sciences. NMS-293 showed encouraging clinical activity in combination with TMZ in difficult-to-treat, recurrent glioma patients. Investigator assessed clinical activity included two patients with relapsed glioma experiencing partial responses by RANO criteria as well as one patient with relapsed glioblastoma having disappearance of a non-measurable lesion.

NMS-293 is being evaluated in two Phase I-I/II dose-escalation/expansion studies assessing safety, tolerability, and preliminary antitumor activity. In PARPA-293-001 (NCT04182516), NMS-293 has been administered orally in dose escalation as a single agent, in adult patients with selected advanced/metastatic, relapsed/refractory solid tumors who have exhausted standard treatment options. An MTD has been identified at 100 mg BID for 28 days on 28-day cycle, a dose providing exposure in a meaningful, active range relative to preclinical predictions. PARPA-293-002 (NCT04910022) is a Phase I/II trial in which NMS-293 was administered in dose escalation, on days 1-7, together with TMZ for the first 5 days of each cycle, in repeated 28-day cycles in adult patients with recurrent diffuse gliomas who failed prior standard of care. The Phase II expansion will focus on glioblastoma. "I am so proud of our NMS team; NMS was the first company to crack PARP-1 biology and bring a PARP-1 selective inhibitor into the clinic. Furthermore, NMS is the first company to have a brain penetrant PARP-1 in clinical development. The initial clinical data presented in glioma is the first demonstration of our therapeutic hypothesis that a PARP-1 inhibitor can be combined with chemotherapy such as TMZ paving the way for indications outside of BRCA mutant tumors," stated Hugues Dolgos, PharmD, Chief Executive Officer for NMS Group.

To date, no DLTs in PARPA-293-002 have been characterized, and overall, NMS-293 was well tolerated with no trends of myelosuppression. The unpooled safety database at the data-cut-off includes 45 patients in PARPA-293-001 and 21 patients in PARPA-293-002. The most frequent (≥10%) any-grade treatment related adverse events (TRAEs) in PARPA-293-001 were reversible QTcF prolongation, nausea, asthenia, decreased appetite and vomiting, mainly mild/moderate. In PARPA-293-002, no TRAEs above grade 3 were reported and the most frequent (≥10%) any-grade TRAEs were: nausea, fatigue, vomiting, decreased appetite, and decreased platelet count, mainly grade 1 adverse events.

On October 12, 2023 MediLink Therapeutics ("MediLink"), reported that it has entered into a strategic research collaboration and worldwide license agreement with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, on the development of a next-generation antibody-drug conjugate candidate ("ADC"), against Human Epidermal Growth Factor Receptor 3 (HER3) (Press release, BioNTech, OCT 12, 2023, View Source [SID1234635907]).

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Under the terms of the agreement, MediLink will grant BioNTech exclusive global rights for the development, manufacturing, and commercialization of one of MediLink’s ADC assets excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region. In exchange, BioNTech will provide MediLink with an upfront payment totaling of $70 million and additional development, regulatory and commercial milestone payments potentially totaling over $1 billion. The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino ("HSR") Antitrust Improvements Act.

HER3 is a target that is overexpressed in various cancer types, such as non-small cell lung cancer and breast cancer and is closely associated with tumor metastasis and disease progression. Furthermore, HER3 expression is upregulated after frontline drug therapy, making it an adequate target for cancer treatment. MediLink’s ADC candidate has demonstrated encouraging efficacy and safety in various preclinical tumor models through the utilization of MediLink’s TMALIN technology, and preliminary clinical data further supports the conceptual validation of this candidate.

On October 12, 2023 SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, reported that the first patient was treated on October 10th, 2023 with BL-B01D1, a first-in-class bispecific antibody-drug conjugate targeting both EGFR and HER3, as part of the global, multi-center Phase 1 study, BL-B01D1-LUNG-101, that is underway to evaluate the safety, tolerability, and efficacy of BL-B01D1 in individuals with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) (Press release, SystImmune, OCT 12, 2023, View Source [SID1234635906]). The study, anticipated to enroll around 100 participants, includes two dosing schedules (Cohort A and Cohort B) and three phases (dose escalation, dose finding, and dose expansion).

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"This study underscores our commitment to advancing medical science and improving the lives of those affected by NSCLC. We look forward to the results of BL-B01D1-LUNG-101 in diverse populations and its potential impact on NSCLC care," stated Dr. Martin S. Olivo, Chief Medical Officer at SystImmune.

This registered study is titled "A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects with Metastatic or Unresectable Non-Small Cell Lung Cancer," and this research represents a significant step forward in NSCLC treatment possibilities. NCT05983432

About BL-B01D1

BL-B01D1 is a first-in-class bispecific antibody-drug conjugate (ADC) developed by SystImmune, targeting both EGFR and HER3, proteins that are highly expressed in most epithelial tumors. The tetravalent BL-B01D1 possesses two binding domains blocking each Growth Factor Receptor, which both drive cancer cell proliferation and survival. Inheriting the SI-B001 mechanisms of action, BL-B01D1 effectively blocks EGFR and HER3 signals to cancer cells, thereby reducing proliferation and survival signals. Upon antibody-mediated internalization, BL-B01D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induced genotoxic stress activating pathways leading to cancer cell death.

The two targets of BL-B01D1 are broadly expressed in epithelial tumors, including NSCLC, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal carcinoma, Gastrointestinal tumors, Gynecological tumors, and others. The therapeutic conjugated toxin of BL-B01D1 comprises SystImmune’s Ex-0115 linker-payload platform, a proprietary Top1 inhibitor conjugated to the bi-specific antibody by a stable, cleavable linker. Each BL-B01D1 carries 7-8 units of SystImmune’s proprietary ED-04 toxin.

On October 12, 2023 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported that its partner Asieris Pharmaceuticals (SSE: 688176) has today unveiled the results of its Hexvix (APL-1706) Phase III clinical trial in China (Press release, PhotoCure, OCT 12, 2023, View Source [SID1234635905]). A presentation scheduled for today at the 43rd Congress of the Société Internationale d’Urologie (SIU), confirms that, in a Chinese population, Hexvix blue light cystoscopy (BLC) outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability.

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The highly statistically significant results corroborate the findings of Photocure’s own randomized controlled trials (RCTs) that demonstrate the clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection and a favorable tolerability profile with no serious adverse events. Moreover, Asieris’ Phase III Hexvix trial is the first RCT conducted with high definition 4K blue light capital equipment.

"This randomized-controlled trial reinforces the benefits of BLC with Hexvix in tumor detection over WLC alone with clinically convincing and statistically significant results. This is on the backdrop of this Chinese trial being the first RCT conducted with 4K high definition (HD) blue light equipment, making it a valuable addition to the body of evidence already available on BLC with Hexvix. It confirms that BLC with Hexvix is additive to WL also with high quality HD imaging technology. We are pleased to see and acknowledge that our partners at Asieris are driving innovation to support unmet needs in bladder cancer", said Anders Neijber, Photocure’s Chief Medical Officer.

The trial results have been selected as a "late-breaking abstract" at the 43rd Congress of the Société Internationale d’Urologie (SIU) in Istanbul, Turkey, October 11-14. The clinical study data will be presented today, October 12, in the form of an Oral ePoster at 1:45pm local time.

The study is a prospective, self-controlled, multicenter Phase Ⅲ study intended to evaluate the safety and detection benefits of blue light cystoscopy (BLC) with Hexvix compared to white light cystoscopy (WLC) in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. The study included a total of 158 patients, of which 114 underwent BLC. Of the 97 patients diagnosed with NMIBC, a total of 42 patients (43.3%) had one or more additional lesions detected with Hexvix BLC compared to WLC (p<0.0001). Among the 114 patients, 11.4% (13/114) had CIS lesions, and among these, 11 patients (84.6%, 11/13) had additional CIS lesions detected under Hexvix BLC that were not found under WLC. The detection rates for PUNLMP, CIS, Ta, T1, and T2-T4 tumor lesions in the BLC group were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while in the WLC group, they were NA, 42.1%, 76.1%, 91.2%, and 100%, respectively.

Read Asieris’ full media release here: View Source

Asieris Pharmaceuticals is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases.

In January 2021, Asieris entered into a license agreement with Photocure ASA to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan.

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.

This press release may contain product details and information which are not valid, or a product 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 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 BC 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 today, 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.