On April 14, 2023 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of an abstract for a poster presentation of early clinical data on the bispecific antibody petosemtamab in advanced gastric/esophageal adenocarcinoma (GEA) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place in Orlando, Florida April 14-19, 2023 (Press release, Merus, APR 14, 2023, View Source [SID1234630099]).

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Petosemtamab, or MCLA-158, is a human IgG1 Biclonics designed to bind to cancer cells expressing epidermal growth factor receptor (EGFR) and leucine-rich repeat-containing G protein-coupled receptor 5 (LGR5).

Petosemtamab is in clinical development in the expansion part of a phase 1/2 open-label, multicenter trial in advanced solid tumors, including advanced GEA.

Although petosemtamab has demonstrated promising clinical activity among pretreated gastric/esophageal adenocarcinoma (GEA) patients having EGFR gene amplification and/or overexpression, the Company has decided to pause further clinical exploration of the GEA cancer cohort at this time. The Company plans to prioritize investigating petosemtamab in head and neck squamous cell carcinoma, in view of the strong clinical activity observed in this cohort.

Information and observations from the cohort of GEA patients treated in the phase 1/2 trial include:

As of an October 24, 2022 data cutoff date, 14 previously treated GEA patients (pts) were treated with petosemtamab 1500 mg (IV) every two weeks
Patient Population:
Median age was 63 (range of 40-80); 79% were male
Median prior lines of systemic therapy was 3 (range 1-4); including platinum-based chemotherapy (36% of pts) and checkpoint inhibitors (14%)
14 pts were evaluable for efficacy, receiving ≥2 treatment cycles (≥8 weeks) with ≥1 post-baseline tumor assessment or experiencing early progressive disease
Antitumor activity among the 14 pts:
1 pt with tumor EGFR protein overexpression and gene copy number amplification (CNA) showed a confirmed sustained partial response (67% tumor reduction; response ongoing after 24 cycles);
3 pts had stable disease (1 with EGFR overexpression and gene CNA; 2 not evaluable for IHC), with tumor reductions of 2%, 17%, and 40%.
Petosemtamab continues to demonstrate a manageable safety profile:
Of 78 pts treated at the recommended phase 2 dose of 1500 mg every two weeks (escalation and all expansion cohorts), the most frequent AEs regardless of causality (all grades/G3-4) were rash (33%/0%), hypotension (26%/6%), dyspnea (26%/4%), nausea (26%/1%), dermatitis acneiform (24%/1%), blood magnesium decreased (19%/5%), erythema (19%/0%), diarrhea (19%/0%); IRRs (composite term) were reported in 74%/21% of pts, mostly at the first infusion, and all resolved. 5 pts (6%) discontinued treatment due to IRRs on Day 1.
Presentation Details:
Title: MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced gastric/esophageal adenocarcinoma (GEA)
Session: Phase II Clinical Trials 1
Date: Monday, April 17, 2023
Time: 1:30 – 5:30 p.m. ET
Poster #: 18
Abstract #: CT156

The abstract can be found on the conference website.

About Petosemtamab 
Petosemtamab, or MCLA-158, is a bispecific Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

On April 14, 2023 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the publication of an abstract for a plenary session oral presentation of interim clinical data on the bispecific antibody petosemtamab in previously treated head and neck squamous cell carcinoma (HNSCC) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place in Orlando, Florida April 14-19, 2023 (Press release, Merus, APR 14, 2023, View Source [SID1234630098]).

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Petosemtamab, or MCLA-158, is a human IgG1 Biclonics designed to bind to cancer cells expressing epidermal growth factor receptor (EGFR) and leucine-rich repeat-containing G protein-coupled receptor 5 (LGR5).

"We are excited by these data demonstrating clinically meaningful efficacy and durability of petosemtamab in previously treated head and neck cancer. We are looking forward to sharing additional details at the AACR (Free AACR Whitepaper) clinical trials plenary session and on our upcoming investor call," said Dr. Andrew Joe, Chief Medical Officer at Merus.

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics): Solid Tumors
Enrollment continues in dose expansion in the phase 1/2 trial, including in combination with Keytruda (pembrolizumab)

Petosemtamab is in clinical development in the expansion part of a phase 1/2 open-label, multicenter trial in advanced solid tumors, including previously treated head and neck squamous cell carcinoma (HNSCC). The Company also initiated a cohort investigating petosemtamab in combination with Keytruda in patients with untreated HNSCC, designed to evaluate safety and clinical activity in this population.

Plenary Session Oral Presentation: Clinical activity of MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced head and neck squamous cell cancer (HNSCC)

The oral presentation will include updated interim data from the ongoing phase 1/2 clinical trial and will be presented by the Principal Investigator, Dr. Ezra EW Cohen, Moores Cancer Center, UC San Diego Health.

The abstract provides information and observations from the ongoing phase 1/2 trial, including:

As of a November 28, 2022 data cutoff date, 49 previously treated HNSCC patients (pts) were treated with petosemtamab 1500 mg IV every two weeks
Patient Population:
Median age was 63 (range of 31-77); 78% were male
Median prior lines of systemic therapy was 2 (range 1-4); including anti-PD-1/PD-L1 in 96% of pts, platinum-based chemotherapy in 92% of pts; 2 pts received prior cetuximab
Most frequent primary tumor locations were oropharynx (35%), oral cavity (31%), and larynx (16%)
42 pts were evaluable for efficacy, receiving ≥2 treatment cycles (≥8 weeks) with ≥1 post-baseline tumor assessment or experiencing early progressive disease:
Antitumor activity among the 42 pts:
Overall responses rate (ORR) was 35.7% (15/42), by RECIST 1.1 per investigator assessment including 1 complete response (ongoing after 18 months), 12 partial responses (PRs), and 2 unconfirmed PRs with treatment ongoing at the data cutoff
Median duration of response (DOR) was 6.0 months (95%CI=3.3-not calculable) and median progression-free survival was 5.0 months (95%CI=3.2-6.8) with 17 pts continuing on therapy at the data cutoff
Petosemtamab continued to demonstrate a manageable safety profile:
Of 78 pts treated at the recommended phase 2 dose of 1500 mg every two weeks (escalation and all expansion cohorts), the most frequent AEs regardless of causality (all grades/G3-4) were rash (33%/0%), hypotension (26%/6%), dyspnea (26%/4%), nausea (26%/1%), dermatitis acneiform (24%/1%), blood magnesium decreased (19%/5%), erythema (19%/0%), diarrhea (19%/0%); IRRs (composite term) were reported in 74%/21% of pts, mostly at the first infusion, and all resolved. 5 pts (6%) discontinued treatment due to IRRs on Day 1.
Presentation Details:
Title: Clinical activity of MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced head and neck squamous cell cancer (HNSCC)
Session Category: Clinical Trials Plenary Session
Session: Promising Novel Antitumor Strategies in Early Phase Clinical Trials
Date: Monday, April 17, 2023
Time: 10:15 a.m. – 12:15 p.m. ET
Presentation #: CT012

Regulatory Update

Merus met with the U.S. Food and Drug Administration (FDA) in an end-of-phase meeting to discuss interim results from the previously treated HNSCC cohort of the petosemtamab phase 1/2 trial. The FDA recognized recurrent or metastatic HNSCC represents an area of unmet medical need, and provided clear recommendations for the path to potential registration.

Based on the strong clinical data and discussions with the FDA, Merus believes a randomized clinical trial in previously treated (2L/3L) or untreated (front-line) HNSCC may support a possible registration. Additionally, Merus believes a randomized registration trial in HNSCC with an overall response rate endpoint could potentially support accelerated approval and the overall survival results from the same study could potentially verify its clinical benefit to support regular approval. The Company plans to continue to acquire data to confirm a suitable dose for future randomized clinical trials.

"Based on our end-of-phase meeting with the FDA, we believe we have optionality in our development path for petosemtamab in head and neck squamous cell carcinoma and are excited to continue investigation of this important new potential therapy for patients," said Bill Lundberg, M.D., President, Chief Executive Officer at Merus. "I’m proud of the progress we are making towards our ambition to become a fully integrated US product company."

The abstract can be found on the conference website.

Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on April 17, 2023 at 6:30 p.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.

Date & Time: April 17, 2023 at 6:30 p.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: 1 (800) 715-9871 / International: 1 (646) 307-19631
Conference ID: 4032258

About Petosemtamab
Petosemtamab, or MCLA-158, is a bispecific Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

On April 14, 2023 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) ("TransCode" or the "Company"), the RNA Oncology Company committed to more effectively treating cancer using RNA therapeutics, reported that it has entered into a Common Stock Purchase Agreement (the "Agreement") with White Lion Capital, LLC ("White Lion Capital") an investor in the glioblastomas / oncology sector (Press release, TransCode Therapeutics, APR 14, 2023, View Source [SID1234630095]). The Agreement provides the Company with the right to sell White Lion Capital up to approximately $1.08 million of its common stock until May 31, 2023, subject to certain limitations and conditions. The Company intends to use the net proceeds from the transaction for working capital and general corporate purposes.

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The shares of common stock described above will be offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-268764) previously filed with the Securities and Exchange Commission (the "SEC") on December 13, 2022, and declared effective by the SEC on December 16, 2022. The offering of the shares of common stock will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. Electronic copies of the final prospectus supplement and accompanying prospectus were filed with the SEC and may be obtained on the SEC’s website at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On April 14, 2023 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that the Company convened a Type A Meeting with the United States (U.S.) Food and Drug Administration (FDA) (Press release, Soligenix, APR 14, 2023, View Source [SID1234630094]). During the Type A Meeting, representatives of the Company and the FDA discussed the contents of a refusal to file (RTF) letter previously issued by the FDA regarding the Company’s new drug application (NDA) for HyBryte (synthetic hypericin sodium) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer, where it successfully demonstrated statistically significant results in a Phase 3 clinical trial (Study HPN-CTCL-01; also referred to as the FLASH study).

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In order to accept an NDA filing for HyBryte, the FDA is requiring positive results from a second clinical study in addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan indication. The FDA indicated that it is open to engaging in protocol discussions regarding the second clinical study. Based on the feedback, the Company has decided to collaboratively engage in discussions with the FDA in order to define the protocol and evaluate the feasibility of conducting the additional clinical trial.

"While we are very disappointed by this delay, Soligenix and its clinical investigators remain committed to working with the FDA and advancing HyBryte to market for patients suffering with CTCL," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The Phase 3 FLASH study was the largest double-blind, randomized, placebo-controlled clinical trial ever conducted in the CTCL population. While we are surprised that the FDA did not accept our submitted NDA for filing and review, it was very clear that the FDA’s thinking has evolved in evaluating CTCL therapies since our initial protocol discussions on Study HPN-CTCL-01 and that another Phase 3 study will be required to support an NDA for HyBryte. During the Type A meeting, we discussed elements of protocol design for the additional confirmatory study and look forward to collaborating with the FDA to advance these discussions as quickly as possible to have a reasonable study design to meet the FDA’s requirements."

About HyBryte

HyBryte (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin sodium, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The recently published Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in the first cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc. In addition, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to a prestigious academic institution that was a leading enroller in the Phase 3 FLASH study.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.

On April 14, 2023 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of QIAseq Targeted cfDNA Ultra Panels that will enable researchers studying cancer and other diseases to turn cell-free DNA (cfDNA) liquid-biopsy samples into libraries ready for next-generation sequencing (NGS) in less than eight hours (Press release, Qiagen, APR 14, 2023, View Source [SID1234630093]).

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The new kit adds another innovation to the QIAseq Targeted DNA product portfolio. It will be one of the central features of QIAGEN’s life-science offering at the 2023 annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Orlando, Florida, from April 14 to 19, 2023.

Liquid biopsy centered on cfDNA has become a vital tool in the diagnosis, outcome prognosis and treatment monitoring of cancer and other diseases. Carried by blood and other body fluids, cfDNA eliminates the need for surgery to take tissue samples. But it often carries disease-relevant variants in low concentrations, which means researchers demand extremely sensitive and reliable tools.

The QIAseq Targeted cfDNA Ultra Panels meet this requirement as they enable reliable detection of somatic genetic variants in challenging detection scenarios as low as 0.1% variant allele frequency (VAF) by enhanced chemistry, reduced enzymatic error rates, and an optimized bioinformatics pipeline.

"QIAGEN is dedicated to driving innovation in liquid biopsy technology to enhance cancer research and improve patient outcomes. With the launch of our QIAseq Targeted cfDNA Ultra Panels, researchers can now rapidly and accurately detect somatic genetic variants at low concentrations, providing a valuable tool for investigation of cancer and other diseases," said Dr. Thomas Schweins, Senior Vice President and Head of QIAGEN’s Life Sciences Business Area. "We are delighted to engage with experts at AACR (Free AACR Whitepaper) 2023 and demonstrate our many contributions to fighting cancer."

The proven ability of QIAGEN technology to detect tiny traces cfDNA variants will feature in the AACR (Free AACR Whitepaper)’s Spotlight Theater Talks from 10-11 a.m. on April 17. Marzia Del Re from the University of Pisa, Italy, will present her study of QIAGEN’s QIAcuity nanoplate-based digital PCR and other systems. "Our data show QIAcuity has a higher sensitivity than droplet digital PCR," she said. "This allows the detection of a larger number of mutated patients, even with low cfDNA abundance."

The QIAcuity digital PCR system enables researchers to detect and quantify DNA and RNA targets with high precision and sensitivity, allowing for reliable analysis of rare and difficult-to-detect targets for a wide range of applications. The instruments integrate partitioning, thermocycling and imaging into one workflow, cutting processing times to only two hours.

QIAGEN will also add new pan-cancer panels to its digital PCR portfolio. These panels offer a cutting-edge solution for the investigation of the most important cancer-related genes and will be available to customers starting in fall 2023. With a focus on hallmark mutations within specific genes, these assays enable researchers to investigate samples in multiplex reactions, allowing for faster and more efficient analysis. The panels are suitable for a range of applications, including biomarker validation, orthogonal validation of next-generation sequencing, resistance monitoring, drug monitoring, and tumor characterization.

QIAcuity’s extremely reliable mutation detection can be coupled with the easy sample processing of QIAGEN’s EZ2 Connect system. The platform for fully automated and convenient sample processing purifies DNA and RNA from various sample types using prefilled reagent-cartridges, contributing to optimized workflows and greater lab productivity. QIAcuity ensures fast and sensitive ultra-low mutation detection – a ground-breaking end-to-end combination for cancer researchers.

QIAGEN is looking forward to hosting AACR (Free AACR Whitepaper) attendees at booth #753 in Orlando’s Orange County Convention Center. It will here unveil QIAcube Connect Red, a limited edition of QIAGEN’s gold-standard automated device for DNA, RNA and protein sample processing. Over 10,000 QIAcube instruments with blue trims have been installed – but there will always only be 100 devices with a red door-trim.

Learn more about QIAGEN’s commitment to fighting cancer at www.qiagen.com/conquer-cancer.