On January 17, 2023 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported the first patient has been dosed in VIRAGE, the Phase 2b randomized, open-label, placebo-controlled, multicenter clinical trial of systemically administered VCN-01 in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Theriva Biologics, JAN 17, 2023, View Source [SID1234626305]).

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"The dosing of the first patient in our Phase 2b PDAC trial represents an important step in our pursuit to address unmet needs for patients with difficult-to-treat cancers," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "The incidence of PDAC continues to rise and while it continues to have one of the lowest survival rates among all cancer types, efforts to improve upon the standard of care treatment have largely stalled. In contrast, we are encouraged by the growing clinical data that underscore VCN-01’s differentiated mechanism of action, as well as the biological activity and synergistic clinical benefit observed in combination with SoC chemotherapy for patients with PDAC and other solid tumors. With regulatory clearance from the FDA and AEMPS, we look forward to the continued progress of this program and more broadly, the advancement of our novel OV platform."

About VIRAGE
VIRAGE is a two-arm Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. VIRAGE is expected to enroll up to 92 adult participants at up to 25 sites across the US, Spain, and Germany. In both the control and treatment arms, patients will receive gemcitabine/nab-paclitaxel standard of care chemotherapy over 28-day cycles. In the treatment arm only, patients will also receive systemically administered VCN-01 seven-days prior to the first and fourth cycles of gemcitabine/nab-paclitaxel treatment. Primary endpoints for the trial include overall survival and VCN-01 safety/tolerability. Additional endpoints include progression free survival, objective response rate, and measures of biodistribution, VCN-01 replication, and immune response. Since this is an open label trial, progress will be monitored very closely and steps to accelerate the clinical program may be implemented if supported by the emerging data. More information about the trial is available here and through the Spanish Clinical Trials Registry (EudraCT Number: 2022-000897-24).

On January 17, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that the Company’s management team will participate in a fireside chat on Thursday, January 19, 2023 at 10:30 AM EST at the 3rd Annual B. Riley Securities Oncology Conference (Press release, Actinium Pharmaceuticals, JAN 17, 2023, View Source [SID1234626304]). The webcast of the presentation will be accessible on the event’s website at View Source and on the investor relations page of Actinium’s website View Source A replay of the presentation will be available on the day of the fireside chat through the same links.

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B. Riley Securities 3rd Annual Oncology Conference

B. Riley Securities 3rd Annual Oncology Conference, January 18-19, will feature over 30 SMiD cap healthcare companies focused on the development and commercialization of new medicines and key enabling technologies, cutting across multiple next-generation therapeutic modalities. The conference will feature KOL panel discussions with academic and industry leaders at the forefront of translational and clinical research underway with novel immunotherapy, cell therapy, and targeted oncology approaches, as well as imaging and radiation oncology initiatives, aimed at driving meaningful improvements to current standard of care for cancer patients.

On January 17, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported it has received guidance from the United States Food and Drug Administration (FDA) on Lantern’s clinical development plans for its LP-184 program (Press release, Lantern Pharma, JAN 17, 2023, View Source [SID1234626303]). LP-184 has shown nanomolar potency across a range of cancers including several solid tumors and multiple adult and pediatric central nervous system (CNS) cancers. The FDA feedback clears Lantern’s path for an IND submission and the targeted initiation of a first-in-human clinical trial in Q2 2023.

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During Q4 2022, Lantern requested a pre-investigational new drug (pre-IND) meeting with the FDA, requesting agency feedback in connection with its planned LP-184 IND application. The FDA’s responses and guidance have been aligned with the company’s clinical, CMC, and preclinical development plans and solidifies Lantern’s timeline for an IND submission and clinical trial initiation in Q2 2023. The upcoming LP-184 Phase 1 trial is expected to enroll patients with pancreatic cancer, select solid tumors with DNA damage repair deficiency, and malignant gliomas-including glioblastoma (GBM). The FDA previously granted Lantern Orphan Drug Designations (ODD) for LP-184 in both pancreatic cancer and malignant gliomas.

The upcoming LP-184 first-in-human Phase 1 trial is expected to include patients across a range of solid tumor types, including adult brain and central nervous system (CNS) cancers. CNS cancer patients have some of the lowest 5-year cancer survival rates and have had little to no meaningful treatment progress in nearly two decades. LP-184’s anti-tumor synthetic lethality mechanism of action, favorable blood brain permeability, and compelling pre-clinical efficacy for CNS cancers give it the potential to become the next generation standard-of-care agent for CNS cancer patients.

"We expect to have multiple cancer indications and sub-types in this upcoming LP-184 trial that have been identified with the help of our A.I. platform, RADR. The identification and preclinical validation of these indications has been accomplished in timelines that are typically unheard of in oncology drug development. This gives us a unique advantage of generating multiple meaningful and clinically needed programs that we can develop, partner, and monetize for the benefit of our shareholders and for cancer patients," stated Panna Sharma, Lantern’s President and CEO. "Our team has been very focused on aligning multiple workstreams to make for an impactful launch of our LP-184 Phase 1 program later this year across multiple cancer types that have the molecular characteristics for sensitivity to this exciting new drug candidate," continued Sharma.

Lantern’s LP-184 program has benefitted from involvement and collaboration with top academic centers including the Kennedy Krieger Institute at Johns Hopkins, Fox Chase Cancer Center, The Danish Cancer Society Research Center, and the Greehey Children’s Cancer Research Institute at University of Texas Health Science Center, San Antonio. These collaborations have been a key component of further validating and focusing the clinical potential of LP-184 for patient groups with high unmet need.

On January 17 2023 QIAGEN N.V. (NYSE: QGEN) (Frankfurt Stock Exchange: QIA) reported its plans to release results for the fourth quarter and full-year 2022 (Press release, Qiagen, JAN 17, 2023, View Source [SID1234626302]).

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Press release date / time: Tuesday, February 7, shortly after 22:05Frankfurt time / 21:05 London time / 16:05 New York time.

Conference call date / time: Wednesday, February 8, at15:00 Frankfurt time / 14:00 London time / 09:00 New York time.

On January 17, 2023 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of EZ2 Connect MDx for use in diagnostic laboratories, making the IVD platform for automated sample processing available for widescale use 18 months after being made available for research (Press release, Qiagen, JAN 17, 2023, View Source [SID1234626301]).

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With a high degree of automation, the EZ2 Connect MDx enables labs to purify DNA and RNA from 24 samples in parallel in as little as 30 minutes1. The device now carries the EU’s CE-IVD compliance marking for in-vitro devices (IVD) for the European Union and other countries that accept this designation. It is also available in the United States, Canada and other countries.

"EZ2 Connect MDx puts standardized and efficient nucleic acid purification in reach of any clinical lab," said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. "It solves the challenges of many clinical diagnostics labs that have to provide diagnostics results quickly, that have to deal with fluctuating sample numbers as well as a large variety of sample types and quality."

EZ2 Connect MDx can extract nucleic acids from blood plasma, serum, stool and other sample types using magnetic-bead technology. High process safety is ensured with prefilled and sealed reagent cartridges, as well as load checking through integrated cameras. Other features include UV decontamination, onboard pipetting and heating as well as automated piercing of the sealed cartridge. The resulting analyte is compatible with a variety of downstream technologies such as real-time PCR, digital PCR and next-generation sequencing.

EZ2 Connect MDx complements QIAGEN’s leading offering of automated IVD nucleic extraction platforms, which includes QIAcube Connect MDx and QIAsymphony.

EZ2 Connect MDx is designed to handle a wide range of sample material thanks to QIAGEN’s elaborate kit portfolio and customizable protocols. It can be used in research mode with research kits (MBA) or in dedicated IVD mode with EZ1 DSP kits as well as protocols for diagnostic workflows. Another key feature is the ability to use the QIAsphere digital laboratory ecosystem, which enables full integration into the digital infrastructure of a lab that allows for remote instrument management.

The new platform builds on QIAGEN’s EZ1 family of devices, which set new standards in sample-prep automation and sample-data management. The EZ2 combines the ease of use, process safety and robustness of the EZ1 with improved throughput and digital features. More than 5,000 EZ1 and EZ2 instruments have been placed worldwide through the end of 2022.