On February 15, 2022 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment of cancer and fibrosis, reported that a clinical trial abstract describing the results of its Phase 1 clinical trial of AMP945 has been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting that will be held in New Orleans from April 8th to 13th 2022 (Press release, Amplia Therapeutics, FEB 15, 2022, View Source;[email protected] [SID1234608133]).

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The abstract entitled "A Phase 1 trial of AMP945, a potent and selective focal adhesion kinase inhibitor, in healthy volunteers" describes the results from Amplia’s Phase 1 clinical trial of AMP945 in healthy volunteers which completed in 2021. This trial showed that AMP945 was safe and well tolerated, could be administered orally once a day, and was able to inhibit its intended target, focal adhesion kinase (FAK), in tissue samples taken from participants in the study1. On the back of the successful data from this trial, Amplia intends to initiate a Phase 2 clinical trial in first line pancreatic cancer patients in early Q2 2022. This abstract will be presented at the AACR (Free AACR Whitepaper) Meeting in early April 2022 and also published online in the Proceedings of the AACR (Free AACR Whitepaper).

"The AACR (Free AACR Whitepaper) is one of the most recognised international forums for cancer research and we are delighted that the results of our Phase 1 trial have been selected for presentation at this prestigious meeting," said Dr. John Lambert, CEO of Amplia. "We believe the approach we are taking using AMP945 to potentially improve the current standard of care treatment for pancreatic cancer is well supported by our Phase 1 clinical trial data and the results from a number of nonclinical studies we have conducted."

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.

On February 15, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapies leveraging CRISPR-based technologies, and ONK Therapeutics Ltd., an innovative company dedicated to developing optimally engineered natural killer (NK) cell therapies to cure patients with cancer, reported a licensing and collaboration agreement (Press release, Intellia Therapeutics, FEB 15, 2022, View Source [SID1234608132]). NK cells are specialized, naturally occurring immune cells that play a critical role in immune activation against abnormal cells, including cancer cells. NK cells have gained significant attention in the field of cancer immunotherapy and various approaches are being explored to effectively develop and engineer NK cell-based cancer immunotherapy.

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The agreement grants ONK a non-exclusive license to Intellia’s proprietary ex vivo CRISPR/Cas9-based genome editing platform and its lipid nanoparticle (LNP)-based delivery technologies to develop up to five allogeneic NK cell therapies. ONK will receive exclusive rights to certain Intellia guide RNAs (gRNAs) resulting from the collaboration for use in engineering those NK cell products. ONK will be responsible for preclinical and clinical development for the engineered NK cell therapies covered under the agreement. Intellia will be eligible to receive up to $184 million per product in development and commercial milestone payments, as well as up to mid-single digit royalties on potential future sales. In addition, the agreement grants Intellia options to co-develop and co-commercialize up to two products worldwide with rights to lead commercialization in the U.S. ONK retains lead commercialization rights ex-U.S. This co-development and co-commercialization option excludes ONK’s lead product ONKT-102, which is being developed for the treatment of patients with relapsed / refractory multiple myeloma, for which ONK retains sole rights. If Intellia chooses to exercise the co-development and co-commercialization option on an investigational product, in lieu of the potential royalties and milestones, Intellia will share 50 percent of any future profit and loss generated by the product.

"We look forward to working with ONK in the development of allogeneic NK cell therapies for patients with cancer. This collaboration, which combines Intellia’s industry-leading CRISPR technology platform and ONK’s expertise in NK cell technology, offers yet another powerful example of how we’re leveraging our strategic collaborations to address life-threatening diseases for patients in need," said Intellia President and Chief Executive Officer John Leonard, M.D.

"We believe combining Intellia’s ex vivo genome editing and LNP delivery platforms with our suite of proprietary NK cell gene edits has the potential to create optimally engineered NK cells with enhanced cytotoxicity, persistence and an improved metabolic profile that hold tremendous promise to advance the treatment of both hematologic malignancies and solid tumors. We are excited to partner with Intellia and are looking forward to a collaboration that allows us to continue to deliver against our strategy, as we evolve into a clinical-stage company," said ONK Therapeutics Chief Executive Officer Chris Nowers.

On February 15, 2022 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its fourth quarter and fiscal year 2021 financial results on Tuesday, March 1, 2022 (Press release, Perrigo Company, FEB 15, 2022, View Source,-2022 [SID1234608131]). The Company will also host a conference call beginning at 8:30 A.M. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 3221228. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EST) Tuesday, March 1, until midnight Tuesday, March 8, 2022. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 1209247.

On February 15, 2022 Mirati Therapeutics, Inc. (Nasdaq:MRTX), a clinical-stage targeted oncology company reported that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy (Press release, Mirati, FEB 15, 2022, View Source [SID1234608130]). The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022.

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The adagrasib NDA is being reviewed by the FDA for Accelerated Approval (Subpart H), which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. In addition, the application is being reviewed under the FDA Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.

Pasi A. Jänne, M.D., Ph.D., an investigator participating in the KRYSTAL-1 study, and director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, commented, "KRAS mutations have been notoriously hard to target and historically have had limited therapeutic options. The KRASG12C biomarker in particular is associated with poor survival outcomes. The FDA’s review of the adagrasib NDA marks important progress toward potentially providing a new, targeted option for those living with KRASG12C-mutated non-small cell lung cancer."

"The acceptance of our NDA for adagrasib is a significant step forward in Mirati’s ongoing efforts to advance innovative, differentiated treatment options for patients with KRASG12C cancers," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "We look forward to working with the FDA during their review of our application and potentially provide a novel option for patients with non-small cell lung cancer."

The NDA is based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating adagrasib 600mg BID in patients with advanced NSCLC harboring the KRASG12C mutation following prior treatment with immunotherapy and chemotherapy, either together or sequentially. The Company reported positive topline data from this cohort in September 2021, and plans to present detailed results at a medical conference during the first half of 2022.

The Company has an ongoing confirmatory Phase 3 trial, KRYSTAL-12, evaluating adagrasib versus docetaxel in patients with second-line KRASG12C-mutated NSCLC.

Mirati Therapeutics thanks the patients and investigators who participated in this clinical study.

About Adagrasib (MRTX849)

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.

On February 15, 2022 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Adaptive Biotechnologies, FEB 15, 2022, View Source [SID1234608129]).

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"We finished the year strong with revenue increasing 57% year over year, driven by growth in both our sequencing and development revenue categories," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "As we move into 2022, I am encouraged by the momentum and the multiple shots on goal across our businesses, which could positively inflect the trajectory of the company."

Recent Highlights

Revenue of $37.9 million for the fourth quarter and $154.3 million for the full year of 2021, representing a 26% increase and 57% increase, respectively, over the corresponding periods in 2020.

clonoSEQ clinical sequencing volume increased 41% to 6,356 clinical tests delivered in the fourth quarter of 2021, compared to the fourth quarter of 2020 and ended the year with 22,516 clinical tests delivered, up 48% versus 2020.

Recognized $10.0 million in MRD regulatory milestones resulting from pharmaceutical partners who used data from our MRD assay to support their respective drug approvals.

Genentech selected TCR candidate targeting a shared cancer neoantigen to progress as a potential therapeutic product candidate.

Received Emergency Use Authorization (EUA) from FDA for T-Detect COVID to confirm recent or prior COVID-19 infection with over 30,000 tests ordered.

Confirmed T-Detect signals in Crohn’s disease and Multiple Sclerosis and identified signals in Ulcerative Colitis and Rheumatoid Arthritis.

Fourth Quarter 2021 Financial Results

Revenue was $37.9 million for the quarter ended December 31, 2021, representing a 26% increase from the fourth quarter in the prior year. Sequencing revenue was $23.1 million for the quarter, representing an 81% increase from the fourth quarter in the prior year. Development revenue was $14.9 million for the quarter, representing a 15% decrease from the fourth quarter in the prior year.

Operating expenses were $99.5 million for the fourth quarter of 2021, compared to $74.4 million in the fourth quarter of the prior year, representing an increase of 34%.

Net loss was $61.4 million for the fourth quarter of 2021, compared to $44.6 million for the same period in 2020.

Adjusted EBITDA (non-GAAP) was a loss of $44.9 million for the fourth quarter of 2021, compared to a loss of $34.6 million for the fourth quarter of the prior year.

Full Year 2021 Financial Results

Revenue was $154.3 million for the year ended December 31, 2021, representing a 57% increase from the prior year. Sequencing revenue was $78.9 million in 2021, representing a 90% increase from 2020. Development revenue was $75.4 million in 2021, representing a 32% increase from the prior year.

Operating expenses for 2021 were $363.3 million, compared to $251.2 million for 2020, representing an increase of 45%.

Net loss was $207.3 million in 2021, compared to $146.2 million in 2020.

Adjusted EBITDA (non-GAAP) was a loss of $151.7 million for 2021, compared to a loss of $119.6 million in the prior year.

Cash, cash equivalents and marketable securities was $570.2 million as of December 31, 2021.

2022 Financial Guidance

Management will provide the 2022 outlook during the conference call scheduled to discuss the 2021 financial results.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its fourth quarter and full year 2021 financial results after market close on Tuesday, February 15, 2022 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.