Veracyte to Present at 20th Annual Needham Virtual Healthcare Conference

On April 2, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie Anderson, chairman and chief executive officer, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13, 2021 at 2:15 p.m. Eastern Time (Press release, Veracyte, APR 2, 2021, View Source [SID1234577540]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The link to the live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

Allarity Therapeutics Submits Premarket Approval Application to U.S. FDA for DRP® Companion Diagnostic for Dovitinib

On April 2, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the submission of a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for DRP-Dovitinib, the Company’s validated companion diagnostic for the drug dovitinib (Press release, Allarity Therapeutics, APR 2, 2021, View Source [SID1234577544]). Dovitinib is a small molecule, pan-tyrosine kinase inhibitor licensed from Novartis, and is Allarity’s most advanced clinical asset. This milestone marks the first time that Allarity has sought regulatory approval for one of its drug-specific DRPs used to guide patient therapy.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Allarity’s unique DRP biomarker technology makes it possible to predict whether a particular cancer patient is likely to benefit from treatment with dovitinib, in addition to a broad range of anti-cancer drugs. DRP drug response assessments of the individual patients are done based on a biopsy from the patients’ tumors. The DRP-Dovitinib is intended to be used to identify patients, suffering from renal cell carcinoma (RCC), who by the gene expression signature of their tumor are found to have a high likelihood of responding to dovitinib.

Allarity plans to file a New Drug Application ("NDA") with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021. If the FDA provides the anticipated premarket approval of the dovitinib DRP as a companion diagnostic, as well as an NDA approval for dovitinib, Allarity will be able to market dovitinib to DRP-selected RCC patients as an effective new therapy to treat their disease. The DRP for dovitinib, if approved, will be the first complex, gene expression signature approved by the U.S. FDA as a companion diagnostic to guide patient selection for cancer therapy.

Allarity’s CEO, Steve Carchedi, noted "Our current goal for dovitinib is to make it available to the group of RCC patients for whom a treatment with this particular therapeutic will be the most efficacious treatment for their disease. Today, marks a milestone for the advancement of our unique DRP biomarker technology for dovitinib, and approval of our PMA will enable oncologists to select those patients who are high likelihood responders to this drug." Mr. Carchedi further stated: "Later this year, I look forward to announcing our expected filing of a New Drug Application for dovitinib itself. Ultimately, if both of these filings are approved by the FDA, our Company will be positioned to significantly change how treatment of RCC will be conducted in the future, and help realize the promise of personalized medicine for these patients."

Steen Knudsen, Ph.D., CSO and Co-Founder of the Company, further stated, "I am extremely pleased to reach the milestone event of our first regulatory approval application for a DRP companion diagnostic, following our extensive work, over the past 15 years, developing, validating, and perfecting our DRP technology. I look forward to our Company advancing dovitinib, in combination with the Dovitinib-DRP, through approval and to market, and to similarly advancing the rest of our oncology therapeutics pipeline with DRP companion diagnostics in a true personalize medicine approach."

In October 2020 Allarity announced that the United States Patent and Trademark Office (USPTO) had issued a notice of allowance to the Company on its patent application no 16/444,881 titled "METHODS FOR PREDICTING DRUG RESPONSIVENESS IN CANCER PATIENTS" – directed to a DRP biomarker for dovitinib.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

Pfizer Invites Public to Register for Webcast of Analyst and Investor Call to Review Oncology Business on April 9, 2021

On April 2, 2021 Pfizer Inc. (NYSE: PFE) reported investors and the general public to access a live video webcast of a presentation and conference call with investment analysts at 10 a.m. EDT on Friday, April 9, 2021 (Press release, Pfizer, APR 2, 2021, View Source [SID1234577545]). Pfizer Oncology leadership will provide an update on the Oncology pipeline progress, specifically how the company is applying its capabilities to move quickly and utilize cutting-edge science to key programs such as LORBRENA (lorlatinib) in ALK-positive metastatic lung cancer, elranatamab (PF-06863135) in multiple myeloma and our next generation breast cancer portfolio.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the live webcast, including audio, video and presentation slides, visit our web site at www.pfizer.com/investors. Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance.

Participants will also have an opportunity to ask questions in a live Q&A session with speakers. Those participants who would like to ask a question can dial either (833) 741-0115 in the United States and Canada or (818) 488-5731 outside of the United States and Canada. The password is "Pfizer Oncology".

Visitors to www.pfizer.com/investors will be able to view and listen to an archived copy of the webcast following the conclusion of the event.

Alloy Therapeutics Raises $75 Million in Series C Financing to Advance Collaborative Biotechnology Ecosystem

On March 31, 2021 Alloy Therapeutics, a biotechnology ecosystem company empowering the global scientific community to make better medicines together, reported the close of a $75 million Series C financing round (Press release, Alloy Therapeutics, MAR 31, 2021, View Source [SID1234583285]). The round was led by 8VC, Presight Capital, and Peter Thiel with participation from new investors including Mubadala Capital, the asset management arm of Mubadala Investment Company, an unnamed sovereign wealth fund, Founders Fund and Gaingels, as well as Alloy’s existing investors Luma Bio-IT, Alexandria Venture Investments, and Ulysses Diversified Holdings.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The path to translate an idea into lifesaving medicine is long, challenging, and uncertain. At Alloy we are building an ecosystem of collaboration across the biopharma community to reduce the barriers of translation and make better medicines together," said Errik Anderson, CEO and founder of Alloy Therapeutics. "Alloy is a forever company, allowing us to be generous when others are in need. In joining the Alloy network, those taking the hard path of drug discovery can know that they are not alone. We are in this together."

Through partnership, Alloy Therapeutics democratizes access to tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics. Since its formation in 2017, Alloy’s community has grown to include over 70 partners of the ATX-Gx platform for human antibody discovery, and the formation of multiple new biotechnology companies, including Broadwing Bio, an ophthalmology company led by Dr. Andrew Peterson and created in partnership with Maze Therapeutics. Proceeds from the Series C financing will extend Alloy’s platforms and services into adjacent biologic modalities and further expand access to Alloy’s capabilities to more partners and geographies around the world.

"Alloy is building a true platform layer in the drug discovery industry," said Alex Kolicich, founding partner of 8VC. "We have seen firsthand how democratizing the product development process has transformed the technology industry through accelerating network effects. We are proud to support Alloy as they apply these lessons to the biopharmaceutical market. Our portfolio companies have benefited greatly from the Alloy ecosystem, and we are impressed with the team’s vision, leadership, and execution."

As part of the Series C financing, Fabian Hansen, founder and Managing Director of US venture capital fund Presight Capital, will join as a member of Alloy Therapeutics’ board of directors. In addition, Alaa Halawa, co-head of Mubadala Capital’s US Ventures business, will join as a board observer.

"Mubadala Capital partners with visionary founders building enduring life science and healthcare companies, supporting them with the global scale and longevity of Mubadala’s permanent and diversified capital base," said Halawa of Mubadala Capital. "We have deep roots in company building, particularly in healthcare. Alloy’s ambitious long-term vision is a natural fit for our partnership. We are excited to work with the Alloy team to support them in advancing the healthcare ecosystem into the new global bioeconomy."

About ATX-Gx

The ATX-Gx platform is the fastest growing in vivo human antibody discovery platform, used by over 70 discovery teams ranging from top biopharma to academic research labs. ATX-Gx is a suite of highly immunocompetent transgenic mice strains that together offer (i) full human heavy chain repertoire, (ii) human kappa and human lambda chain repertoire, (iii) haplotype diversity, and (iv) limited immunodominance. ATX-Gx is available to scientists worldwide at groundbreaking business terms including royalty free access, a simple licensing process (ability to start working with ATX-Gx in as little as two weeks), permission to design KO and bespoke genetic modifications, and expanding access to new platform innovation.

Veracyte to Present at 20th Annual Needham Virtual Healthcare Conference

On April 2, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that Bonnie Anderson, chairman and chief executive officer, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13, 2021 at 2:15 p.m. Eastern Time (Press release, Veracyte, APR 2, 2021, View Source [SID1234577546]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The link to the live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.