On March 23, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported that Exosome Diagnostics, a Bio-Techne brand, has completed its clinical validation of an in vitro diagnostic (IVD) version of the ExoDx Prostate test (EPI) kit enabling self-certification as CE-IVD as of March 22, 2021 (Press release, Bio-Techne, MAR 23, 2021, View Source [SID1234577033]). The EPI-CE test will be performed immediately in our Munich ISO 15189 accredited clinical laboratory and be made available throughout Europe through various distribution channels.

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Exosome Diagnostics is the world leader in developing exosomal liquid biopsy-based diagnostic assays. The EPI test is a non-invasive, urine-based genomic test that helps inform the prostate biopsy decision. This liquid biopsy test continues to expand its presence and usage among urologists and primary care physicians in the US. The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures. The EPI-CE test demonstrated comparable results to the US ExoDx Prostate test with high sensitivity of 92% and high negative predictive value (NPV) of 89% for ruling out clinically significant prostate cancer.

These findings can have significant implications for both clinical and economic outcomes. According to Alexander Kretschmer, M.D., Assistant Professor of Urology at Ludwig-Maximilians-University Munich, "From a clinical perspective, deferring biopsy can help a patient avoid the undesirable complications from a biopsy, such as pain, hematuria, infection and potentially hospitalization. Many patients are frightened to undergo the biopsy procedure; however, introducing an EPI test can identify which patients should proceed to biopsy, and which patients can avoid biopsy, so it’s really about performing the procedure for the right patient at the right time."

"The EPI test could have important implications from an economic perspective in Europe and the UK," commented Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Avoiding unnecessary biopsy procedures represents an estimated savings to the healthcare system in Europe of more than €1,000 per patient, in addition to added costs for treating complications. There are economic consequences to missing high grade prostate cancer as well. Risk stratification tools such as the ExoDx Prostate test can help appropriately guide clinicians to treat the highest risk patients earlier. We look forward to enabling European men to make more informed decisions on whether to proceed with an invasive, and potentially dangerous, prostate biopsy."

On March 23, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported the first patient has been dosed in the Phase 2a portion of a Phase 1b/2a clinical trial evaluating NT-I7 (efineptakin alfa), a novel T cell amplifier, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of patients with relapsed/refractory advanced solid tumors (Press release, NeoImmuneTech, MAR 23, 2021, View Source [SID1234577049]).

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The Phase 2a portion of this study will enroll up to 150 patients and will explore the preliminary anti-tumor activity of the combination therapy both in patients who have been treated with a checkpoint inhibitor (CPI) for triple-negative breast cancer, non-small cell lung cancer, or small cell lung cancer, and CPI-naïve patients with microsatellite stable colorectal cancer or pancreatic cancer.

"We are excited to quickly advance to the Phase 2a portion of this important clinical trial to further evaluate this combination treatment in patients with a variety of advanced solid tumors," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. "We have great confidence in the combination of NT-I7, as a T cell amplifier, with CPI therapies like KEYTRUDA to improve clinical outcomes and become a viable treatment option for many cancer patients, with either CPI-responsive or CPI-resistant tumors."

The results of this study will be used to guide further clinical development of this combination in select tumor types.

More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04332653

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On March 23, 2021 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development, reported that it will present new data on LP-184, a next-generation, targeted small molecule in the acylfulvene drug class, showcasing its potency across various 2D and 3D models of prostate cancer, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, taking place from April 10-15, 2021 (Press release, Lantern Pharma, MAR 23, 2021, View Source;utm_medium=rss&utm_campaign=new-data-supporting-lp-184-advancement [SID1234577018]).

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Lantern’s poster will highlight the spectrum of DNA damage repair defects, occurring in 25-30% of metastatic castration resistant prostate cancer (mCRPC) patients, against which LP-184 shows nanomolar potency. "In vitro studies of LP-184 continue to show potentially best in class efficacy in metastatic prostate cancer with a novel mechanism of action," stated Panna Sharma, CEO and President of Lantern Pharma. "Our ongoing work of LP-184 in metastatic prostate cancer in collaboration with Georgetown University has shown effectiveness in tumor models with mutations in DNA damage repair pathway components including in genes involved in Homologous Recombination and Transcription Coupled-Nucleotide Excision Repair. We look forward to sharing this new data at AACR (Free AACR Whitepaper) and developing this compound towards the clinic and for the benefit of prostate cancer patients."

Details of the abstract are as follows:

Title: LP184, a novel alkylating agent, is efficacious in prostate cancer models with DNA damage repair defects
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents
Permanent Abstract Number: 1249
The full text of the abstract is now available on the AACR (Free AACR Whitepaper) Annual Meeting 2021 website.
The accompanying poster will be available to view to registered participants during the conference via the AACR (Free AACR Whitepaper) e-poster website on April 10, 2021, and published on the company website after the conference.

On March 23, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported its financial results for the fourth quarter 2020 on Tuesday, March 30th, 2021. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CET) to report its financial results and provide a corporate update on the fourth quarter and full year 2020 (Press release, BioNTech, MAR 23, 2021, View Source [SID1234577034]).

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The slide presentation and audio of the webcast will be available via the following link: View Source

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On March 23, 2021 Selexis SA, a JSR Life Sciences company, and Tallac Therapeutics reported that they have signed both a commercial license agreement (CLA) and a service agreement (SA) to advance Tallac’s Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform, which harnesses the power of innate and adaptive immunity to treat cancer (Press release, Selexis
, MAR 23, 2021, View Source [SID1234577050]). Under the agreements, Tallac will employ Selexis’ proprietary SUREtechnology Platform to develop the research cell banks necessary to bring its immunotherapy candidates for the treatment of solid tumors to the clinic.

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"We are proud to work with Tallac Therapeutics as the company develops new medicines for cancer," said Yemi Onakunle, PhD, MBA, Selexis chief business officer. "Our work with Tallac will allow Selexis to play a role in the advancement of differentiated immunotherapies that are designed to overcome the resistance and lack of response seen in the majority of patients receiving currently available treatments."

Tallac Therapeutics is developing systemically delivered therapeutics with the potential to provide powerful innate and adaptive anti-tumor immunity. The Company’s TRAAC platform currently supports a pipeline of next-generation immunotherapies that have potential for monotherapy and combination approaches across multiple tumor indications.

"As we advance our pipeline of groundbreaking cancer immunotherapies, we chose Selexis as our cell line development partner because of their innovation and scientific expertise, and their proven commitment to the quality, speed, safety and reliability of the technology solutions they provide," said Dr. Hong I. Wan, Tallac Therapeutics president, CEO and co-founder.

Selexis’ modular SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of recombinant proteins and vaccines, providing seamless integration of the development continuum from discovery to commercialization.