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QIAGEN Announces 20-F Annual Report Filing for 2021 Results

On March 14, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that it has filed its annual report, including its audited consolidated financial statements on Form 20-F, for the year ended December 31, 2021, with the U.S. Securities and Exchange Commission (Press release, Qiagen, MAR 14, 2022, View Source [SID1234610029]). The document can be accessed on QIAGEN’s website here.

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QIAGEN will provide printed copies of the 2021 Annual Report to shareholders free of charge upon request. To obtain a printed copy of the 2021 Annual Report please use our contact form or send an email to [email protected].

Miravo Healthcare™ Announces Fourth Quarter 2021 Results Release Date and Conference Call Details

On March 14, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported it expects to release its fourth quarter 2021 financial results before markets open on Monday, March 28, 2022 (Press release, Nuvo Pharmaceuticals, MAR 14, 2022, View Source [SID1234610022]).

The Company will subsequently hold a conference call the same day, Monday, March 28, 2022 at 11:00 a.m. ET, hosted by Jesse Ledger, Miravo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.

CONFERENCE CALL DETAILS

The audio webcast and webcast replay can be accessed at:

View Source

Lantern Pharma to Present Positive Preclinical Data on the Effectiveness of LP-184 in Brain Metastases at the American Association of Cancer Research (AACR) Annual Meeting

On March 14, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will present positive preclinical data on the in vitro efficacy of its drug candidate LP-184 in brain metastases (mets) at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, April 8-13th, 2022, held in New Orleans, Louisiana (Press release, Lantern Pharma, MAR 14, 2022, View Source [SID1234610021]).

LP-184 is a small molecule drug candidate and next generation acylfulvene that preferentially damages DNA in cancer cells that overexpress certain biomarkers and is therefore lethal in tumors that harbor mutations or deficiencies in DNA repair pathways. LP-184 has already been demonstrated preclinically to have potent efficacy in several targeted central nervous system (CNS) cancer indications, including glioblastoma multiforme (GBM) and atypical teratoid rhomboid tumors (ATRT). The development promise for LP-184 in these indications is strengthened by LP-184’s favorable blood brain barrier (BBB) permeability. LP-184 has also demonstrated potent tumor cell killing capabilities in vitro and in animal xenografts of tumors such as lung, breast, melanoma and colon, many of which frequently metastasize to the brain. The tumor specificity of LP-184 is driven by expression levels of PTGR1, and Lantern’s RADR analysis indicates that such expression levels are retained in brain mets of these primary tumors.

The virtual poster will be presented by Lantern Pharma in collaboration with Johns Hopkins School of Medicine and the Kennedy Krieger Institute and will describe positive preclinical data demonstrating the effectiveness of LP-184 treatment in brain mets cell models derived from patient lung, skin, and breast cancers. The poster will also show that in an in vitro model of brain mets from lung cancer, LP-184 treatment was found to be 6 times more potent than EGFR tyrosine kinase inhibitors (a widely used type of therapy).

Brain mets are more common than primary brain tumors (cancer that starts in the brain), and studies suggest that brain mets occur in about 10%-30% of patients with cancer. In the U.S., brain mets (from all cancers combined) are estimated to account for over 100,000 diagnoses annually and generally have a very poor prognosis even after radiation therapy. There is an urgent and unmet clinical need for novel therapies for brain mets due to a current lack of novel agents that can cross the blood brain barrier. LP-184’s favorable BBB permeability paired with its observed preclinical efficacy in certain CNS cancers, underscore its potential to become a vital treatment option for patients relapsed from current standard of care treatment or for use in combination with other agents.

LP-184 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of malignant gliomas, pancreatic cancer, and ATRT, and was also granted a Rare Pediatric Disease Designation for ATRT. These designations and continued positive preclinical data will help to accelerate LP-184 towards IND submission and multiple Phase 1 clinical trials in 2022.

Details of the virtual poster presentation are listed below or can be found on the AACR (Free AACR Whitepaper) website:

Title: LP-184, a tumor site activated small molecule synthetic lethal therapeutic, is effective in central nervous system cancers
Permanent Abstract number: 5442
Date and Time: April 8, 2022, 12:00pm-1:00pm CST
Session Category: Experimental and Molecular Therapeutics
Session Title: Small Molecule Therapeutic Agents
Presenter: Aditya Kulkarni, Ph.D., Lantern Pharma

Nutcracker Therapeutics Raises $167 Million in Series C Financing to Advance its mRNA Therapeutics and First-of-its-Kind Biochip-based Manufacturing Platform

On March 14, 2022 Nutcracker Therapeutics, Inc., a biotech company developing RNA therapeutics using its proprietary biochip-based manufacturing platform, reported it has raised $167 million in Series C financing led by ARCH Venture Partners (Press release, Nutcracker Therapeutics, MAR 14, 2022, View Source [SID1234610020]). The funds will allow the company to expand and advance its pipeline of mRNA medicines for cancer, in addition to further refining its RNA manufacturing platform and the underlying technology.

"The recent success of the mRNA vaccines for COVID-19 has brought newfound energy around the use of RNA as a therapeutic tool," said Igor Khandros, Ph.D., co-founder, and CEO of Nutcracker Therapeutics. "As a consequence, we have an unparalleled opportunity to bring this emerging class of medicines to treat patients suffering from very complex diseases. With this significant milestone and the support of our top-flight investors and partners, we are well-positioned to begin the next phase of Nutcracker’s evolution: accelerating RNA therapeutics development within the company and beyond using our unique ‘GMP-in-a-box’ platform, and meet the rising demand for RNA therapies and their efficient, scalable manufacturing."

Nutcracker Therapeutics’ RNA manufacturing platform is at the core of the company’s therapeutic effort. It combines RNA biochemistry with microfluidic engineering, semiconductor-like biochips, and a proprietary nanoparticle delivery technology to create a fully automated and isolated manufacturing pathway. The platform is capable of supporting RNA therapeutic development from discovery to the clinic and commercialization, scaling up appropriately at each stage. Using this platform, the company aims to increase the speed and scale at which therapeutics can be discovered, developed, and manufactured.

Concurrent to the financing, Nutcracker Therapeutics has added Michael F. Bigham, former CEO and current executive chairman of the board of Paratek Pharmaceuticals, to its board of directors. Bigham has more than 30 years of leadership experience in the biopharmaceutical and life science industries, including as a general partner at Abingworth LLP, President and Chief Executive Officer of Coulter Pharmaceuticals, and in various roles at Gilead Sciences, such as Chief Financial Officer and Executive Vice President Operations.

"RNA has unique qualities as a therapeutic modality and could prove to be a first-line tool for many diseases," commented Bigham. "Nutcracker Therapeutics is well-positioned to develop RNA therapeutics in a scalable and efficient manner with its innovative platform. I’m excited to be a part of the team and help further its goal of advancing its pipeline into the clinic and bringing RNA therapies to patients with the greatest need."

Bristol Myers Squibb and Nektar Announce Update on Phase 3 PIVOT IO-001 Trial Evaluating Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab) in Previously Untreated Unresectable or Metastatic Melanoma

On March 14, 2022 Bristol Myers Squibb (NYSE: BMY) and Nektar Therapeutics (NASDAQ: NKTR) reported an update following the first analysis of the Phase 3 PIVOT IO-001 study evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma (Press release, Bristol-Myers Squibb, MAR 14, 2022, View Source [SID1234610019]). Following a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC), Bristol Myers Squibb and Nektar were informed that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR). The DMC notified the companies that the third primary endpoint of overall survival (OS) did not meet statistical significance at the first interim analysis.

Given there was no additional clinical benefit in the doublet therapy arm compared to the monotherapy arm for the primary endpoints of PFS and ORR, and based on the data reviewed by the DMC, the companies have decided to unblind the trial and to perform no additional analyses for the OS endpoint. Additionally, based on the results from PIVOT IO-001, the companies have also made the decision to discontinue enrollment and unblind the ongoing PIVOT-12 study in adjuvant melanoma, which is evaluating the doublet therapy of bempegaldesleukin in combination with Opdivo compared to Opdivo monotherapy in patients at high risk for recurrence after complete resection of melanoma. Patients in both studies will be counseled on their treatment options, and permitted to continue treatment if agreed to with their physician.

The companies will review the data and plan to share the results with the scientific community.

"As a leader in developing innovative therapies for patients with cancer, we have continued to explore novel strategies that may expand treatment benefits to more patients with advanced disease," said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. "We are disappointed with the results of this trial, which we had hoped would lead to a new therapeutic option to treat metastatic melanoma. We express our gratitude to the patients, caregivers and investigators who chose to participate in these trials."

The other four studies ongoing for bempegaldesleukin plus Opdivo in renal cell carcinoma and bladder cancer are continuing.

"While we are surprised and deeply disappointed in these results for the melanoma study, we will continue to await initial results from our first two ongoing studies in renal cell carcinoma and urothelial cancer, which are currently expected in the first half of 2022," said Jonathan Zalevsky, chief research and development officer of Nektar Therapeutics. "We look forward to collaborating with BMS to evaluate the data from these other studies to guide the future development of bempegaldesleukin. Nektar remains dedicated to the development of therapeutics to treat cancer and auto-immune disease."

About PIVOT IO-001

PIVOT IO-001 is a randomized Phase 3 study evaluating the combination of bempegaldesleukin in combination with Opdivo versus Opdivo alone in patients with previously untreated unresectable or metastatic melanoma. The study is sponsored and conducted by Bristol-Myers Squibb. A total of 783 patients were randomized 1:1 to receive a combination of bempegaldesleukin 0.006 mg/kg and Opdivo 360 mg or Opdivo 360 mg by intravenous infusion every three weeks in an outpatient setting. Patients were treated until disease recurrence, unacceptable toxicity or withdrawal of consent for up to 24 months.

About PIVOT-12

PIVOT-12 is a randomized Phase 3 open-label study evaluating the adjuvant immunotherapy of bempegaldesleukin combined with Opdivo versus Opdivo alone after complete resection of melanoma in patients at high risk for recurrence. The study is sponsored and conducted by Nektar Therapeutics.