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.

On January 17, 2023 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it has scheduled its fourth quarter and year-end 2022 financial results conference call and webcast for 5:00 a.m. Pacific Time (8:00 a.m. Eastern Time) on February 6, 2023 (Press release, Neurocrine Biosciences, JAN 17, 2023, View Source [SID1234626299]).

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The schedule for the press release and conference call / webcast is as follows:

• Q4 & Year-End 2022 Press Release:

February 6, 2023 at 4:30 a.m. PT / 7:30 a.m. ET

• Q4 & Year-End 2022 Conference Call:

February 6, 2023 at 5:00 a.m. PT / 8:00 a.m. ET

• Domestic Dial-In Number:

866-952-8559

• International Dial-In Number:

785-424-1743

• Conference ID:

NBIX

The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On January 17, 2023 Ad hoc announcement pursuant to Art. 53 LR Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that the first patient has been treated in a Phase 1 first-in-human study evaluating the safety, tolerability, and efficacy of MP0533, the company’s candidate for acute myeloid leukemia (AML). MP0533 is designed to focus an immune attack against AML in a new way that preferentially spares healthy cells, which has been a historic challenge for CD3-targeting therapeutics (Press release, Molecular Partners, JAN 17, 2023, View Source [SID1234626298]).

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"AML is a notoriously difficult cancer to treat, largely due to the overlapping targets expressed on both healthy and leukemic cells. Our team has worked relentlessly over the past three years to develop a molecule intended to target these cancerous cells while avoiding healthy cells. MP0533’s mechanism represents a new level of precision targeting in complex cancers that may permit greater use of the cytotoxic power of engaging CD3," said Nicolas Leupin, M.D., Ph.D., Chief Medical Officer of Molecular Partners. "We are grateful to our team and our collaborators for reaching this milestone and look forward to learning more about the potential of MP0533 to help these patients."

MP0533 simultaneously targets three surface proteins, CD33, CD123, and CD70, that are vastly more likely to be expressed together on AML blast cells and leukemic stem cells over healthy cells. It also targets CD3 on cytotoxic T cells, which will preferentially activate when at least two of the surface proteins are bound. This novel mechanism is intended to greatly favor CD3 activation in leukemic stem cells rather than the systemic activation seen in previous CD3-based T cell engagers.

The Phase 1 open-label dose escalation study will enroll patients with relapsed/refractory AML and higher-risk myelodysplastic syndromes (MDS). It is designed to assess the safety, tolerability, and efficacy of MP0533 in addition to a range of secondary endpoints, such as the effect on LSCs, pharmacokinetics, T-cell activation, and cytokine release. Between 20-45 patients are expected to be enrolled across five sites in Switzerland and the Netherlands in collaboration with select sites within the HOVON cooperative group. Additional clinical sites are planned as well.

MP0533 preclinical data demonstrates it induces preferential T cell mediated killing of cells expressing two or three of the tumor associated antigens (TAAs) compared to cells expressing a single TAA. MP0533 also demonstrated an ability to induce T cell activation and killing of AML cells in samples from newly diagnosed and previously treated patients. The research also showed that MP0533 was able to directly target and kill LSCs while sparing a variety of healthy cells including hematopoietic stem cells, endothelial cells, and T cells.

About Molecular Partners’ Oncology Product Candidates

Molecular Partners is developing several candidates designed to activate the immune system to fight cancer while reducing damage to healthy cells. These candidates use multiple novel DARPin technologies potentially applicable against a wide range of tumor types, including DARPin candidates with the ability to restrict immune activation to the tumor microenvironment, the ability to target intracellular disease-associated proteins, and multiple novel control mechanisms for immune activation designed to direct immune attack to the right cells, at the right place, and at the right time. These capabilities can be combined during candidate design through the inherent modularity of the DARPin platform, to provide precise control over immune activation and potentially enable more effective cancer therapies.