On January 5, 2022 Alkermes plc (Nasdaq: ALKS) reported that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 40th Annual J.P. Morgan Healthcare Conference (Press release, Alkermes, JAN 5, 2022, View Source [SID1234598197]). The presentation will take place virtually on Wednesday, Jan. 12, 2022 at 11:15 a.m. EST (4:15 p.m. GMT), followed by a question and answer session. The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On January 5, 2022 Akoya Biosciences, Inc., (NASDAQ: AKYA), The Spatial Biology Company, and Bio-Techne (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, reported a partnership to develop the first single-cell, spatial multiomics workflow for comprehensive, unbiased analysis of tissue samples (Press release, Akoya Biosciences, JAN 5, 2022, View Source [SID1234598196]).

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Through this agreement, the partners will bring to the market an automated, spatial multiomics workflow that can perform rapid, in situ analysis of multiple analytes, at single cell resolution, across whole slides. Akoya’s PhenoCycler-Fusion System, due to launch in early January 2022, will run the company’s well-established protein imaging assays in addition to automating Advanced Cell Diagnostics’, a Bio-Techne brand, proven and highly cited RNAScope HiPlex v2 assay for RNA imaging. The partnership exemplifies the commitment of both companies to offer researchers greater access to innovative and open access solutions for spatial biology applications.

RNA and protein expression offer complementary insights into cell states and phenotypes. Combining the PhenoCycler-Fusion workflow with the RNAScope HiPlex v2 assay has the potential to accelerate scientific understanding of human health and complex diseases like cancer. Spatial multiomics approaches can also unlock new biomarker diagnostic signatures, enabling better stratification of patients and ultimately improving treatment outcomes.

Backed by over 4,500 peer-reviewed publications, RNAScope Assays are an established standard for spatial RNA imaging. Under the terms of the agreement, Akoya and Bio-Techne will develop and co-market protocols to enable automated workflows for running RNAScope assays on Akoya’s spatial phenotyping systems.

This new combined workflow complements Akoya’s spatial transcriptomics capabilities, currently under development, serving as an important validation tool for deep spatial phenotyping applications.

"The life sciences market has long needed an approach that provides an unbiased, multiomics view of tissue biology and architecture, which is critical for understanding complex mechanisms of disease and response to therapy," said Brian McKelligon, Chief Executive Officer of Akoya Biosciences. "The partnership with Bio-Techne, which revolutionized RNA in situ hybridization methods, can further empower researchers with the spatial tools and technologies required to ignite innovation, and break barriers to advance discovery of new biomarkers and improve treatment options."

"We are excited to partner with Akoya to accelerate multiomic spatial phenotyping in translational and clinical disease research," said Kim Kelderman, President of Bio-Techne’s Diagnostics and Genomics Segment. "Akoya’s established leadership in spatial phenotyping automation and multiplex protein biomarker imaging is uniquely complementary to Bio-Techne’s proven expertise in specific and sensitive multiplex RNA detection in cells and tissues. Enabling Akoya’s large and rapidly growing installed base with an automated HiPlex RNAScope workflow provides a uniquely powerful solution to advance discovery research and diagnostic assay development across a wide range of diseases."

On January 5, 2022 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company that aspires to develop medicines to make chemotherapy safer and thereby more effective to save more patients’ lives, reported a business update and outlined the company’s strategic priorities for 2022 (Press release, Aileron Therapeutics, JAN 5, 2022, View Source [SID1234598195]).

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"All cancer patients undergoing chemotherapy – still the standard of care for most patients – experience chemotherapeutic side effects to varying degrees, from unpleasant to fatal. Utilizing a biomarker strategy, we are developing ALRN-6924 as a selective chemoprotective agent to shift the paradigm from accepting these side effects to preventing them for patients with p53-mutated cancer regardless of type of cancer or chemotherapy," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "In 2022, we expect several key milestones may propel us toward this vision, including our planned initiation of a clinical trial in breast cancer patients receiving neoadjuvant chemotherapy in the first half of the year with interim results in the fourth quarter, as well as planned interim and topline data readouts for our ongoing NSCLC trial in the second and fourth quarters, respectively."

Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone, and Aileron employs a precision medicine approach to exclusively treat those patients with p53-mutated cancers who are receiving chemotherapy. ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without protecting cancer cells. This novel concept is known as selective chemoprotection. The reduction or elimination of multiple chemotherapy-induced side effects is expected to enhance tolerability of chemotherapy, which is expected to result in fewer dose reductions and delays of chemotherapy, and that is expected to improve efficacy of chemotherapy.

2022 Strategic Priorities and Business Update

Initiate clinical trial in neoadjuvant (pre-operative) breast cancer in 1H22, with interim results in 4Q22. Aileron plans to initiate a new clinical trial in 1H22 to evaluate ALRN-6924 to protect against chemotherapy-induced bone marrow and other toxicities in ER+/HER2- breast cancer patients treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen, also known as ‘AC-D’. The Phase 1b trial will enroll up to 30 patients in a parallel group design trial with a dose expansion cohort. Aileron will provide more details on the planned neoadjuvant breast cancer trial design at the time of trial initiation.
Advance ongoing NSCLC trial to interim (20-patient) and topline (60-patient) readouts, in 2Q22 and 4Q22, respectively. Aileron is currently enrolling patients in the US and EU with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. As previously guided, Aileron anticipates reporting interim results on 20 patients in 2Q22, and topline results on 60 patients in 4Q22. Aileron has dosed the first 10 patients in the trial and plans to conduct a blinded safety evaluation on these patients after one cycle in 1Q22, as previously guided.
Continue to progress ongoing Healthy Volunteer Study. Aileron is continuing to progress its ongoing Phase 1 pharmacology study which is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. The company presented initial data from the study in 2021, confirming the drug’s novel p53 biomarker-driven mechanism of action, as well as its pharmacodynamic effects, including time to onset, magnitude and duration. The aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated cancers. Aileron anticipates reporting additional findings from the study this year.

Expanded patent portfolio in 2021 with issuance of 11 new foreign and U.S. patents. Aileron was issued 7 new international patents and 4 U.S. patents over the past 12 months, including new patent protection for ALRN-6924 in China. These newly issued patents add to Aileron’s robust intellectual property portfolio, which includes over 170 U.S. and foreign patents, with another 47 applications in prosecution. These patents and applications include ALRN-6924 methods of manufacture, methods of use, drug product formulations, and compositions of matter (COM). The COM patent in the US expires in 2033 with up to 5 additional years subject to patent term extensions. Of note, Aileron maintains exclusive rights to its proprietary peptide drug technology and ALRN-6924 worldwide.

On January 5, 2021 AbbVie (NYSE: ABBV) reported that it will announce its fourth-quarter and full-year 2021 financial results on Wednesday, February 2, 2022, before the market opens (Press release, AbbVie, JAN 5, 2022, View Source [SID1234598194]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. CT. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On January 5, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported an update on eganelisib clinical development plans and 2022 guidance (Press release, Infinity Pharmaceuticals, JAN 5, 2022, View Source [SID1234598172]).

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"Eganelisib is a unique drug for which we have presented positive results in multiple indications where checkpoint inhibitors have provided little to no patient benefit. Based on these strong data, we will be initiating a registration study in frontline TNBC in 2022 – due to the magnitude of the unmet need in this very large patient population and the magnitude of the eganelisib benefit. Eganelisb combination therapy has demonstrated tumor volume reductions of 92.8% and 85.2%, and disease control rates of 92.8% and 81.4%, in PD-L1(+) and PD-L1 (-) frontline TNBC patients, respectively, as well as improvements in progression free survival over standard of care benchmarks regardless of PD-L1 status," said Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals.

"We are aggressively advancing a registration focused study in TNBC with the goal of bringing eganelisib to patients in need as quickly as possible. We also continue to be encouraged by the overall survival benefit seen in patients with urothelial cancer, and to support the initiation of future registration trials in 2023 and beyond, we are also expanding the development of eganelisib in a platform study in additional indications where checkpoint inhibitors and other current therapies have offered little benefit," said Robert Ilaria, Jr. M.D., Chief Medical Officer, Infinity Pharmaceuticals.

Program Updates and Guidance:

The Company plans to initiate a frontline mTNBC randomized, double-blind, pivotal trial by the end of 2022 with progression free survival (PFS) and overall survival (OS) as endpoints. In the PD-L1 negative patients eganelisib will be evaluated in combination with chemotherapy and a checkpoint inhibitor (the eganelisib triplet) vs chemotherapy. In the PD-L1 positive patients the eganelisib triplet will be evaluated vs chemotherapy and a checkpoint inhibitor. Pending feedback from a MARIO-3 end-of-Phase 2 meeting with global regulatory authorities, Infinity will finalize the MARIO-4 trial design.
Infinity also plans to initiate MARIO-P, a platform study to evaluate the clinical benefit of eganelisib to support the initiation of future registration focused studies across various solid tumor indications, on a rolling basis in 3Q 2022.
The Company expects multiple data releases in 2H 2022:
MARIO-3 study in mTNBC patients
MARIO-3 study in renal cell carcinoma patients
MARIO-275 study in urothelial cancer patients
Window of Opportunity IST study in head and neck squamous cell carcinoma patients sponsored by Dr. Ezra Cohen
2022 Financial Guidance:

Infinity ended 2021 with approximately $81 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2021 financial results in March 2022. The Company expects to end 2022 with between $25 million to $35 million in cash and investments based on its current operating plans, which excludes additional financing or business activities. The company expects net loss for 2022 to range between $45 million to $55 million.