On July 13, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the second quarter 2021 after market close on Thursday, August 5, 2021 (Press release, Guardant Health, JUL 13, 2021, View Source [SID1234584820]). Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

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Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

On July 13, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that Ionis Pharmaceuticals has exercised its option and entered into an exclusive worldwide license and collaboration agreement for tissue-targeted delivery of oligonucleotide therapeutics using Bicycles with high affinity to the transferrin receptor (TfR1) (Press release, Bicycle Therapeutics, JUL 13, 2021, View Source [SID1234584803]).

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Ionis had an option for an exclusive license under the terms of a December 2020 evaluation and option agreement. The agreement granted Ionis the right to evaluate tissue-targeting TfR1 binding Bicycles as vehicles to deliver oligonucleotide therapeutics to specific organ systems and an option to obtain an exclusive license at the end of the evaluation period.

Bicycle receives a total of $45 million upfront, which includes a license fee, an option fee, and an $11 million equity investment. Bicycle is also eligible to receive development, regulatory and commercial milestone payments and royalties for each program developed under the collaboration.

"This agreement stems from a highly successful collaboration with Ionis that began earlier in the year, during which Bicycles were shown to selectively deliver oligonucleotide payloads into TfR1-expressing tissue," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "These data build upon our own work, and that of our partners, which have shown Bicycles targeted to tumor antigens can rapidly and selectively deliver a variety of payloads into solid tumors. This tissue-targeting payload-delivery capability is facilitated by the unique nature of Bicycles that inherently enables the conjugation of a diverse range of molecular cargos without impacting the pharmacology of the target. We believe Bicycles have the potential to become the targeting technology of choice for the development of precision medicines."

Bicycle has identified binders that it believes to be the first small molecules to target TfR1 with high specificity without modifying TfR1’s natural function. These binders present broad conjugation potential across multiple payloads, thereby resulting in the potential to treat diseases in multiple therapeutic areas, including those of the skeletal and cardiac muscles and of the central nervous system. Bicycle is currently also collaborating with the Dementia Discovery Fund (DDF) to advance potential TfR1 Bicycles for treating dementia.

Under the terms of the license and collaboration agreement, Ionis and Bicycle will collaborate to develop a pipeline of oligonucleotide therapeutic product candidates delivered using the tissue-targeting TfR1 Bicycle technology, while Bicycle retains the rights to use TfR1 Bicycles for all non-oligonucleotide therapeutic purposes, including within its existing collaboration with DDF targeting dementia.

On July 13, 2021 NeuroLogica Corp. reported that its state-of-the-art, OmniTom Elite with Photon Counting Detector (PCD) technology will be piloted by Massachusetts General Hospital, bringing multi-energy computed tomography (CT) imaging to the patient’s point-of-care (Press release, Massachusetts General Hospital, JUL 13, 2021, View Source [SID1234584821]).

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OmniTom Elite CT system is intended to be used for CT applications. We have added the ability to upgrade the OmniTom Elite system with PCD.

Photon counting is a next generation CT technology that sorts the different energies of X-rays after they have passed through the scan field. The multiple sets of CT data are acquired at the same time with configurable energy thresholds. This could potentially mean more accurate visualization and segmentation of bone, blood clots, plaque, hemorrhage, and intracranial tumor in critical intensive care unit (ICU) patients when in use with the OmniTom Elite scanner. As well, PCD has the potential to fundamentally change the use of injected contrast agents that highlight blood vessels by collecting high signal even at low contrast agent dosage. PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The OmniTom Elite with PCD is an important advancement in CT technology and was designed in house by the NeuroLogica research and development team in Danvers, Massachusetts, in collaboration with Samsung.

"Since the advent of point-of-care CT in 2004 by NeuroLogica, we have always known that point-of-care imaging can improve patient outcomes and increase the likelihood of a better post-traumatic quality of life," said David Webster, Chief Operating Officer of NeuroLogica. "With the introduction of Photon Counting to the OmniTom Elite platform, we hope to expand the diagnostic possibilities of computed tomography at the patient’s bedside."

Pending FDA 510(k) clearance of this technology, Massachusetts General Hospital will pilot test the OmniTom Elite with PCD to monitor post-trauma and post-surgical patients.

"We are excited about our collaboration with NeuroLogica," said Raj Gupta, MD, PhD, Director, Ultra-High-Resolution Volume CT Lab, Massachusetts General Hospital. "This will be the first time where multi-spectral imaging will be used inside of the intensive care unit. We are particularly interested in how this technology can help guide patient care decisions through quantitative image analysis."

The OmniTom Elite’s ability to provide versatile, real-time mobile imaging enables healthcare providers to administer point-of-care CT to critical patients without the need to transport them to a separate department. The mobile unit will decrease the time it takes to diagnose and initiate treatment for patients in the ICU. During the pilot of the OmniTom Elite with PCD, Massachusetts General Hospital will guide best practices and evaluate use cases for the novel system.

On July 13, 2021 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported the dosing of the first patient in its TiTAN study, a Phase 1/2a clinical trial testing its GEN-011 therapy. GEN-011 represents a new category of autologous solid tumor cell therapy: neoantigen-targeted peripheral T cells ("NPTs") (Press release, Genocea Biosciences, JUL 13, 2021, View Source [SID1234584804]).

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"Dosing the first patient with GEN-011 represents an exciting milestone for Genocea and the field of neoantigen-targeted T cell therapy," said Thomas Davis, M.D., the company’s Chief Medical Officer. "We believe our GEN-011 therapy employs better targeting – using our ATLASTM platform to select optimal neoantigen targets that drive anti-tumor immune responses and avoid immunosuppressive InhibigensTM – and better T cells, derived from easily accessible peripheral blood as opposed to the tumor itself. We are grateful to the patients eager to participate in our trial, to our investigators, and to our colleagues here at Genocea for their great dedication to improve patients’ outcomes. We look forward to reporting top-line results from this study on a subset of patients late in the fourth quarter of 2021 or the first quarter of 2022."

About GEN-011
GEN-011 is a next-generation solid tumor therapy comprised of NPTs CD4+ and CD8+ which are specific for up to 30 antigens to limit tumor escape. NPTs have minimal bystander, non-tumor-specific cells, and are devoid of Inhibigen-specific cells which may be detrimental to clinical response.

About the GEN-011 TiTAN clinical trial
TiTAN is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. The TiTAN clinical trial is testing two dosing regimens, a repeated lower dose regimen of GEN-011 without lymphodepletion and a single high dose administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells. Initial data from the TiTAN trial is expected in late Q4 2021 or Q1 2022.

On July 13, 2021 AVM Biotechnology, a clinical-stage company, reported that FDA permission to modify its ongoing clinical study, AVM0703-001, entitled "The WWRD Study: AVM0703 for Treatment of Leukemia or Lymphoma" (Press release, AVM Biotechnology, JUL 13, 2021, View Source [SID1234584822]). The initial protocol, a 3 x 3-based design, called for dose escalation of 3 mg/kg for each of the six cohorts, ranging from 6 mg/kg to 21 mg/kg, with a minimum of three patients per cohort as part of an adaptive-design/expansion cohort trial.

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The approved protocol modification involves the elimination of three of the cohorts and reduction of the interval between cohorts. Eliminating the 9, 12 and 15 mg/kg dose requirements and moving directly to the anticipated effective clinical dose of 18 mg/kg is important for this study. Preclinical research and compassionate use data indicate 18-21 mg/kg will be the target effective dose for the expansion phase of the study. Bypassing the intermediate dose levels should accelerate completion of the dose-escalation part of the study, enabling the efficacy portion to commence immediately thereafter, much sooner than planned.

"We are pleased that the FDA agreed with our proposal, which leveraged the safety data amassed from the ongoing study and Expanded Access (Compassionate Use) patient data obtained to date," remarked Janet R Rea, MSPH, Chief Regulatory Officer. "This accelerates our clinical development program and propels it toward an earlier NDA submission."

Clinical experience has shown the drug to be well tolerated with mild and self-limiting side effects. Patients have reported feeling "great." The emerging safety profile is promising, to treat these seriously ill patients.

A single dose of AVM0703 triggers the rapid activation and mobilization of novel gamma delta positive Natural Killer T (NKT) cells. NKT cells exhibit properties of both innate and adaptive immunity. AVM-NKT cells home to abnormal cells including cancer and autoreactive lymphocytes sparing platelets, red blood cells and stem cells. These unique AVM-NKT cells could play a significant role in addressing several serious conditions, including various types of cancer and autoimmune diseases such as type 1 diabetes. Preclinical data also indicate AVM0703 can be synergistic with chemotherapy, allowing total cycles of chemotherapy to be reduced while maintaining patient response, thus significantly impacting patient quality of life, treatment compliance, and secondary complications from cancer treatment.

"AVM has developed an entirely new drug that demonstrates a novel mechanism of action related to tissue-bound gamma delta NKT cells. We believe this drug will have great benefit to patients in a wide variety of disease settings," stated AVM Chief Business Officer, Joe Luminiello.

AVM Biotechnology is a clinical-stage company advancing AVM0703 in Non-Hodgkin’s Lymphoma/Leukemia as an initial indication as well as autoimmune diseases and other indications. While planning for a direct commercial launch of AVM0703, the company is also developing the AVM-NKT as an ‘off-the-shelf’ cell therapy product with broad applications. Strategic partnerships are being explored.

AVM Biotechnology’s mission is to develop and deliver treatments that save lives and improve outcomes by unlocking the untapped potential of the body’s own immune system.