On January 11, 2021 Sensei Biotherapeutics, Inc., a clinical-stage cancer immunotherapy company, reported the successful closing of a $30 million Series B financing (Press release, Sensei Biotherapeutics, JAN 11, 2021, View Source [SID1234573846]). The financing was co-led by existing investor Apeiron Investment Group and new investor Catalio Capital Management. Additional investments included new investors Pura Vida Investments and several international family offices, as well as existing investors Cambrian Biopharma, Moore Strategic Ventures, Steve Jurvetson’s Future Ventures, and Presight Capital.

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"We believe Sensei’s ImmunoPhage platform represents the future of personalized cancer therapies. With our technology, once a patient’s cancer is genetically profiled we can have a personalized cocktail of ImmunoPhage delivered to that patient within a week. This is a critical improvement over the months it takes for existing personalized approaches in cancer, where every day matters for patients," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "I’m delighted to be working with this fantastic group of both new and existing investors to advance Sensei’s platform and provide life-changing therapies to more patients."

The ImmunoPhage platform uses genetically engineered viruses called bacteriophage to create robust immune responses to human cancer proteins and block key immunosuppressive pathways. ImmunoPhage are highly immunogenic and can be manufactured quickly, inexpensively, and at large scale. Sensei is expanding its proprietary Phortress library consisting of pre-manufactured, GMP-grade ImmunoPhage. Using the Phortress library, ImmunoPhage are selected and customized for each cancer patient using a personalized yet off the shelf cocktail approach to deliver a potent immunotherapy to the patient in a rapid and cost-effective manner.

Sensei’s lead ImmunoPhage product candidate, SNS‑301, is being evaluated in a Phase 1/2 trial for the treatment of locally advanced unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) in combination with pembrolizumab. Promising interim results were published in Q4 2020, and topline results from this trial are expected by the end of 2021.

Sensei is also advancing two preclinical programs generated from its platform, including SNS-401, an ImmunoPhage cocktail for the treatment of merkel cell carcinoma, and SNS‑VISTA, a monoclonal antibody targeting V-domain Ig suppressor of T cell activation (VISTA), an immune checkpoint protein that inhibits the anti-tumor T cell response.

Christian Angermayer, founder of Apeiron Investment Group, said, "Sensei’s approach has the realistic potential to overcome the prior challenges of cancer immunotherapy and make advancements we previously couldn’t dream of. If a loved one got cancer today, I would want them to have access to a treatment that is both fast and personalized to their disease. And down the road, we might even be able to develop the therapy towards a real prophylactic cancer vaccination, so that we end cancer before it even starts."

"Sensei has the right mix of proprietary technology and experienced management to advance potentially game-changing therapeutic candidates in the cancer immunotherapy field," remarked George Petrocheilos, Co-founder and Managing Partner of Catalio Capital Management. "We look forward to collaborating again with Christian and working with the Sensei leadership team, as they advance a novel pipeline of cancer immunotherapy candidates and execute on their goal of transforming the treatment of cancer."

On January 11, 2021 Resolution Bioscience, Inc. reported a companion diagnostic agreement with Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company (Press release, Mirati, JAN 11, 2021, View Source [SID1234573845]). As part of the agreement, Resolution’s ctDx liquid biopsy technology will be used to help identify non-small cell lung cancer (NSCLC) patients who may benefit from Mirati’s investigational KRAS G12C inhibitor therapy. The fast and non-invasive assay was designed to detect actionable NSCLC mutations, such as KRAS G12C.

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Cancers stemming from RAS mutations account for nearly a quarter of all human cancers and contribute to 1 million deaths per year worldwide. Among the RAS family of oncogenes, KRAS gene mutations are the most common, making up to 85% of all RAS mutations. Mirati’s investigational drug candidate adagrasib (MRTX849) is an orally available small molecule that potently and selectively inhibits the G12C substitution mutation. The Resolution assay will be used to identify patients whose cancers are driven by this KRAS variant.

"We are excited to join forces with Mirati to address this large unmet medical need and to further drive adoption of our innovative liquid biopsy diagnostic tests," said Mark Li, CEO of Resolution Bioscience. "Our mission is to provide critical, actionable information to improve care and clinical outcomes for cancer patients worldwide."

About Resolution Bioscience’s Liquid Biopsy Technology

The Resolution liquid biopsy assays are powered by the company’s patented cell-free DNA (cfDNA) analysis platform, which includes proprietary targeted capture next-generation sequencing (NGS) biochemistry and tightly coupled, cloud-based bioinformatics. The liquid biopsy assays are designed to provide rapid and accurate tumor genotyping, all without an invasive tissue procedure. Now covered by Medicare and private payors, Resolution’s technology has been recognized as novel by the FDA and cited in several important scientific publications and presentations. For example:

97% clinical response was seen for NSCLC patients who received plasma-directed therapy selection from Resolution’s assay as reported in a publication with Memorial Sloan Kettering Cancer Center and the Northern Cancer Institute of Sydney. With more than 1,000 patients enrolled, the ongoing study is the largest prospective study of stage II, III, or IV NSCLC aimed at demonstrating clinical response and outcomes based upon plasma-directed therapy selection.
A recent study by the Dana-Farber Cancer Institute found that the Resolution ctDx Lung assay identified more actionable gene fusion mutations than Guardant Health’s Guardant360 test.
Resolution was the first to demonstrate the detection of all four major types of mutations in a blinded clinical study led by scientists at Dana-Farber Cancer Institute. The team determined the assay has the potential to be implemented broadly for patient care and translational research.
Resolution was also the first company to demonstrate gene deletion detection in cfDNA in a study led by scientists at Vanderbilt University in small cell lung cancer. The team determined that cfDNA sequencing allows for improved monitoring of disease burden, depth of response to treatment, and timely warning of disease relapse in patients.
The Resolution HRD assay was granted Breakthrough Device Designation by the US Food and Drug Administration.
In a recent AstraZeneca publication, Resolution had the highest positive predictive value and the lowest false positive rate among four leading NGS liquid biopsy companies in a blinded comparison study.

On January 11, 2021 Akoya Biosciences, Inc., The Spatial Biology Company, reported that Brian McKelligon, the company’s Chief Executive Officer,reported to present at the J.P. Morgan 39th Annual Healthcare Conference on Wednesday, January 13, 2021 (Press release, Akoya Biosciences, JAN 11, 2021, View Source [SID1234573844]). Mr. McKelligon will provide a company overview of Akoya and its spatial phenotyping solutions.

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On January 11, 2021 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported a corporate update and highlighted priorities for 2021 (Press release, Scholar Rock, JAN 11, 2021, View Source [SID1234573843]).

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"2020 was a transformative year for Scholar Rock with significant progress made both clinically and operationally with positive interim data from the TOPAZ trial providing initial proof-of-concept of apitegromab’s potential in SMA and showing the potential benefit of inhibiting the latent forms of growth factors," said Tony Kingsley, President and CEO of Scholar Rock. "In 2021, we will further elucidate the potential of our product candidates through data from our TOPAZ Phase 2 trial in SMA and our DRAGON Phase 1 trial in cancer immunotherapy as well as build upon our scientific platform towards additional indications."

2021 Expected Milestones:

Apitegromab is a highly selective inhibitor of latent myostatin activation being developed as the potential first muscle-directed therapy for the treatment of spinal muscular atrophy (SMA).

Top-line Efficacy and Safety Data from TOPAZ Phase 2 Trial in SMA Anticipated in 2Q21. A total of 58 patients were enrolled across the three cohorts of the TOPAZ clinical trial with one discontinuation to date. Positive six-month interim analysis data were announced in October 2020, demonstrating apitegromab’s potential to improve motor function in patients with Type 2 and Type 3 SMA. The top-line 12-month efficacy and safety data are expected in the second quarter of 2021.
As of January 8, 2021, 56 patients have completed the 12-month study and all 56 have opted into the extension period.

Identification of Second Indication for Apitegromab Planned for 2021. With the demonstration of initial proof-of-concept from the TOPAZ interim analysis, Scholar Rock is actively evaluating multiple other disorders for which the selective inhibition of the activation of myostatin may offer therapeutic benefit.
SRK-181 is a potent and highly selective inhibitor of latent transforming growth factor beta 1 (TGFβ1) activation being developed with an aim of overcoming resistance to and increasing the number of patients who may benefit from, checkpoint inhibitor therapy.

Initial Clinical Response and Safety Data from the DRAGON Trial are Anticipated in the Second Half of 2021. SRK-181 is being evaluated in the two-part DRAGON Phase 1 trial in patients with locally advanced or metastatic solid tumors exhibiting primary resistance to anti-PD-(L)1 therapy. Dose escalation in Part A of the DRAGON trial is progressing with the highest planned dose of 2400 mg now being evaluated in Part A1 (SRK-181 as a single-agent) and the 800 mg dose being currently evaluated in Part A2 (SRK-181 in combination with an approved anti-PD-(L)1 therapy).
The DRAGON trial is anticipated to advance to Part B in the second quarter of 2021, which is expected to encompass multiple cohorts, including urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, and other solid tumors. Each cohort will enroll up to 40 patients with locally advanced or metastatic solid tumors for which they have been treated with an approved anti-PD-(L)1 therapy and have demonstrated primary resistance. Patients in Part B will be treated with SRK-181 in combination with an approved anti-PD-(L)1 therapy.

"We enter 2021 with positive momentum across our programs. We believe we’ve demonstrated the potential of our novel scientific approach to treating a wide array of disease areas for which growth factors play a critical role in disease progression," said Ted Myles, CFO and Head of Business Operations of Scholar Rock. "Our strong balance sheet, which can fund operations into 2023, provides flexibility as we continue to invest in developing important therapies for patients in need."

On January 11, 2021 Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) ("Takeda") reported that it will present virtually at the 39th Annual J.P. Morgan Healthcare Conference at 5:20 p.m. ET on Monday, January 11, 2021 / 7:20 a.m. JT on Tuesday, January 12, 2021 (Press release, Takeda, JAN 11, 2021, View Source [SID1234573842]). Investors and the general public are invited to listen to the live webcast with Christophe Weber, president and chief executive officer, here. A replay of the webcast will also be archived at the same location. A link to the webcast and slides for download will also be available on Takeda’s website at View Source

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