On October 22, 2021 Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company, reported its research partners will present Phase 1 results from a study of ifabotuzumab in glioblastoma multiforme (GBM) at the Annual Congress of the European Association of Nuclear Medicine (EANM’21) and plan to initiate a follow-on Phase 1b study in non-CNS solid tumors in early 2022 (Press release, Humanigen, OCT 22, 2021, View Source [SID1234591790]). EANM is the largest organization dedicated to nuclear medicine in Europe and represents more than 9,000 specialists from 41 different countries.

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The abstract will be presented virtually by Principal Investigator Prof. Andrew Scott, Head, Tumor Targeting Laboratory, Olivia Newton-John Cancer Research Institute; Director of the Department of Molecular Imaging and Therapy, Austin Health; and Professor, School of Cancer Medicine, La Trobe University. The abstract (OP-0854) entitled: "Phase I safety and bioimaging trial of ifabotuzumab in patients with glioblastoma" has been published in the EANM‘21 abstract book and was chosen to be included in a TOP 3 trials session at EANM’21 that will take place from 3:05-4:35pm Central European Standard Time on October 22, 2021.1

"The biodistribution characteristics demonstrated in the Phase 1 GBM study indicate ifabotuzumab has ideal characteristics for a range of therapeutic options including the creation of an antibody-drug conjugate," said Prof. Scott. "Our preclinical studies with antibody-drug conjugate forms of ifabotuzumab have shown promising results. We hope to take this payload delivery approach into the clinic in the next 1-2 years."

The Olivia Newton-John Cancer Research Institute plans to conduct a Phase 1b dose-escalation and imaging study in non-CNS solid tumors that is scheduled to begin in early 2022. This will be led by Prof. Andrew Scott and Prof. Hui Gan, Clinical Research Lead, Olivia Newton-John Cancer Research Institute and Director, Cancer Clinical Trials Center, Austin Health.

"We are excited by the potential ifabotuzumab holds to create a novel cancer therapeutic that delivers cytotoxic agents to tumor cells while minimizing toxicity to normal tissue," said Cameron Durrant, Chairman and CEO of Humanigen. "We look forward to supporting our valued partners in Australia as they advance research of ifabotuzumab into solid tumors."

About Ifabotuzumab
Ifabotuzumab is a proprietary Humaneered monoclonal antibody that binds the EphA3 receptor, which plays an important role during fetal development but is not thought to be expressed nor play a significant role in healthy adults. EphA3 is a tyrosine kinase receptor, aberrantly expressed on the tumor vasculature and tumor stroma in many solid tumors including melanoma, breast cancer, lung cancer, colorectal cancer, GBM and prostate cancer, making it an attractive target for a range of cancers.

Humanigen has completed a Phase 1 study in multiple hematologic malignancies that suggest it is well tolerated with mild-to-moderate infusion reactions that can be managed by stopping infusion, or using medications to treat reactions (chills, fever, nausea, hypertension, and rapid heart rate).

In 2021, a Phase 1 safety and bioimaging study of ifabotuzumab, supported by Cure Brain Cancer Foundation, and Humanigen, showed specific and reproducible targeting of the tumor and its microenvironment, with no normal tissue uptake, in all patients. Future development plans, in conjunction with our research partners in Australia, are intended to confirm highly specific tumor uptake in non-CNS solid tumors with the intention of creating an antibody-drug conjugate by linking ifabotuzumab to a cytotoxic (cell-killing) agent.

On October 22, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), applying innovative diagnostics to transform disease management and improve patient outcomes, reported recent poster presentations on the Company’s suite of dermatologic cancer gene expression profile (GEP) tests, as well as a poster describing the study design for its inflammatory skin disease pipeline initiative at the 2021 Fall Clinical Dermatology Conference, held Oct. 21-24 (Press release, Castle Biosciences, OCT 22, 2021, View Source [SID1234591791]).

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DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s prognostic gene expression profile test for cutaneous melanoma. The Company utilizes two proprietary algorithms, i31-ROR and i31-SLNB, to produce an integrated test result designed to provide a precise, personalized prediction of risk of recurrence and likelihood of sentinel lymph node (SLN) positivity, respectively, by integrating DecisionDx-Melanoma with traditional assessment of the clinicopathologic features of a patient’s tumor.

The company presented new data on the capabilities of these independently validated algorithms through a poster titled, "Integrating the 31-gene expression profile and clinicopathologic data to determine the risk of sentinel lymph node positivity and recurrence-free survival in cutaneous melanoma." The poster can be found here.

"The risks associated with a melanoma diagnosis can lead to several different clinical procedures, including sentinel lymph node biopsy (SLNB), and many patients experience regional recurrence, distant metastasis or even death," said Bob Cook, Ph.D., senior vice president of research and development of Castle Biosciences. "The study results demonstrated that integrating the DecisionDx-Melanoma result with assessment of clinical and pathologic features improved individualized risk prediction for SLNB positivity, regional recurrence and distant metastasis, which could help clinicians make more informed and personalized risk-stratification decisions."

Study methods and findings:

The purpose of the study was to demonstrate the combined ability of two independently validated algorithms that incorporate the DecisionDx-Melanoma result with clinicopathologic features to predict individual SLNB positivity risk and recurrence-free survival (RFS).
Using artificial intelligence techniques, two algorithms were developed:
The i31-GEP-SLNB (i31-SLNB) algorithm, developed from 1398 cases and validated in an independent cohort of 1674 cases, was developed to determine the individual likelihood of SLN positivity.
The i31-GEP-outcomes (i31-ROR) algorithm, developed from 1581 cases and validated in an independent cohort of 523 cases, was developed to provide personalized survival predictions for recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and melanoma-specific survival (MSS).
The i31-SLNB algorithm identified 31.2% (135/433) of patients with a <5% likelihood of SLN positivity who could potentially forego the SLNB surgical procedure. These patients all received a low-risk i31-ROR result and had high survival rates (>98% RFS, DMFS and MSS), reinforcing the i31-ROR algorithm’s risk prediction precision.
In the SLN negative population, 20% of patients were identified as high risk by the i31-ROR algorithm and had five-year RFS rates that were like those for patients with a positive SLNB (e.g., Stage III disease) (47.7% vs. 48.7%, respectively).
Overall, using National Comprehensive Cancer Network (NCCN) treatment guidelines, the test identified 44.8% (194/433) of patients who may have been able to avoid SLNB or were re-stratified as low or high risk compared to SLN status alone.
The i31-ROR algorithm was able to stratify patients with Stage IIB-IIC melanoma according to risk of recurrence with an absolute recurrence difference of 20% at 12 months. This is of particular interest given the recent announcement of the absolute treatment effect of Pembrolizumab in patients with Stage IIB-IIC melanoma of 5.7% at 12 months.
The study data demonstrated that DecisionDx-Melanoma’s integrated test result, using both i31-ROR and i31-SLNB algorithms, identified patients who may potentially forego SLNB and provide a more precise prediction of high and low risk of recurrence for more personalized patient care decisions.
Comprehensive Diagnostic Offering:

Castle’s Comprehensive Diagnostic Offering (CDO) leverages the strengths of both myPath Melanoma and DecisionDx DiffDx-Melanoma, two GEP tests designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions.

Castle presented data validating the company’s implementation of its CDO via a poster presentation entitled "A comprehensive diagnostic offering workflow increases the rate of actionable results of the 23- and 35-gene expression profile tests for use as ancillary diagnostic tools for difficult-to-diagnose melanocytic lesions." The poster can be viewed here.

"Since Castle’s acquisition of the myPath laboratory earlier this year, we have looked forward to demonstrating the value that these two diagnostic GEP tests can offer together," said Matthew S. Goldberg, M.D., first study author and medical director at Castle Biosciences. "We are pleased to have evidence that demonstrated the complementary power of these tests, which could enable physicians to make more confident diagnoses for patients with difficult-to-diagnose melanocytic lesions and to create individualized care plans by interpreting the patient’s gene expression profile in the context of the clinical, laboratory and histopathologic information."

Study methods and findings:

This study highlighted the results of all CDO clinical cases submitted to Castle Biosciences between June 30-Aug. 31, 2021. Using the Company’s CDO workflow, all adult cases not receiving an actionable result of benign or malignant from myPath Melanoma had the opportunity to be run using DecisionDx DiffDx-Melanoma.
myPath Melanoma returned nonactionable classifications 22.3% of the time (nonactionable classifications are comprised of the combined total of intermediate risk results [12.9%] and technical failures [9.4%]).
The nonactionable cases underwent additional testing using DecisionDx DiffDx-Melanoma, at which point an additional 20.9% of originally submitted cases received an actionable result. Only 1.1% of cases received an intermediate result from both tests; the technical failure rate of both tests combined was 0.2%.
Leveraging both tests as a comprehensive diagnostic workflow substantially improved the reporting of clinically actionable results from a historic rate of 77.8% for myPath Melanoma alone to 98.7% when used in conjunction with DecisionDx DiffDx-Melanoma.
Psoriasis, Atopic Dermatitis and Related Conditions:

Inflammatory skin diseases, like psoriasis and atopic dermatitis, severely impact a patient’s quality of life. While there are many effective treatment options available for those with moderate-to-severe disease, current clinical practice relies on a costly and time-consuming trial-and-error approach to determine an individual patient’s response to systemic therapies. To answer this unmet clinical need, Castle Biosciences is developing a GEP test designed to predict response to systemic therapies for patients with moderate to severe psoriasis, atopic dermatitis and other related diseases. Personalized guidance for therapy selection and anticipated efficacy has the potential to improve patient health outcomes by enabling clinicians to select the best medication for their patients’ specific skin disease.

Castle initiated an IRB-approved clinical study to develop and validate one or more gene expression signatures to guide treatment selection in patients with psoriasis, atopic dermatitis and related conditions. The study’s design was presented via a poster titled "A study to help guide management decisions in patients with psoriasis and atopic dermatitis." The poster can be viewed here.

"Patients with psoriasis and atopic dermatitis could benefit immensely from a more straightforward path to finding an effective therapeutic treatment option for their inflammatory skin disease," said Aaron S. Farberg, M.D., the study’s first author and dermatologist at Baylor University Medical Center in Dallas. "Based on a history of success, Castle Biosciences is well positioned to potentially identify a molecular signature that could aid in finding the appropriate drug selection for a patient, based on their unique disease biology, saving patient time, money and contributing to a more effective use of healthcare resources."

Study design:

Up to 4,850 patients between two and 85 years of age diagnosed with psoriasis, atopic dermatitis or a related disorder will be prospectively enrolled in the study.
At enrollment, disease severity will be documented. Superficial layers of diseased and healthy skin will be collected from participants. Clinical data including systemic treatment type, dose, response and side effects will be logged at subsequent visits.
RNA from samples will be isolated, and an unbiased assessment of RNA expression levels using microarray will be performed.
Through this study protocol, Castle is aiming to develop a GEP test that may help guide therapeutic choice for patients with moderate-to-severe psoriasis and atopic dermatitis for whom clinical diagnosis or drug selection may be challenging, thereby potentially decreasing the amount of time and money spent on finding a successful treatment option for each patient.

DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic 40-GEP test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) having one or more risk factors.

Castle presented data on DecisionDx-SCC through a poster entitled "Real-world clinical usage data demonstrates appropriate utilization of the prognostic 40-gene expression profile test for cutaneous squamous cell carcinoma with one or more risk factors."

Study methods and findings:

The objective of the study was to demonstrate independent prognostic value of DecisionDx-SCC via analyses with existing risk assessment methods and report on the early clinical usage of DecisionDx-SCC.
Summary metrics were generated on the first 1000 samples received for DecisionDx-SCC testing that met clinical testing criteria. Metrics on early clinical usage include:
Technical reliability of DecisionDx-SCC was 96.3%.
69.0% of samples received DecisionDx-SCC Class 1 results, 26.0% received DecisionDx-SCC Class 2A results and 1.3% received DecisionDx-SCC Class 2B results.
52% of tested patients had three or more risk factors.
This study demonstrated that the intended use population (high-risk SCC patients with one or more risk factors) aligned with the cases that were submitted for clinical testing.
The study also found that DecisionDx-SCC results can be applied as an adjunct to enhance SCC risk stratification and contribute to risk-appropriate surveillance and treatment decisions.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

In addition to reporting Class results, the Company also reports results that predict risk of recurrence and likelihood of sentinel lymph node positivity. Castle utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an integrated DecisionDx-Melanoma test result.

Through June 30, 2021, DecisionDx-Melanoma has been ordered 78,277 times for use in patients with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.

About Castle Biosciences’ Comprehensive Diagnostic Offering for Difficult-to-Diagnose Melanocytic Lesions

Castle Biosciences’ comprehensive diagnostic offering leverages the strengths of myPath Melanoma and DecisionDx DiffDx-Melanoma. These gene expression profile tests are designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining highly accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, myPath Melanoma and DecisionDx DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

More information about the test and disease can be found at www.CastleTestInfo.com.

About Psoriasis, Atopic Dermatitis and Related Conditions

Inflammatory skin disease accounts for a significant number of patient visits to both primary care and dermatology clinics across the U.S. every year. Psoriasis and atopic dermatitis are among the most common inflammatory skin conditions, and patient quality of life is severely impacted by these chronic diseases. Fortunately, systemic medications developed over the past 15 years have demonstrated a significant improvement in patients’ lives. In the U.S. alone, there are about 18 million patients diagnosed with psoriasis and atopic dermatitis, and approximately 450,000 patients annually are eligible for these systemic therapies. While there are now many effective treatments options available for those with moderate to severe disease, current clinical practice relies on a trial-and-error approach for therapy selection. To answer this unmet clinical need, Castle Biosciences is developing a gene expression profile test designed to predict response to systemic therapies for patients with moderate to severe psoriasis, atopic dermatitis and other related diseases. Personalized guidance for therapy selection and anticipated efficacy has the potential to improve patient health outcomes by enabling clinicians to select the best medication for their patients’ specific skin disease.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

On October 22, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the third quarter of fiscal year 2021 (Press release, Chugai, OCT 22, 2021, View Source [SID1234591824]).

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"We achieved robust double-digit growth in both revenues and profits in the nine months under review. This was due to significant increases in both domestic and overseas sales, driven by new products and mainstay products, as well as continued growth in royalty income. As a result, we raised our full year forecast for FY2021. In terms of R&D, I am very pleased that our first mid-size molecule project, LUNA18, has entered the clinical development phase. Mid-size molecule drugs are expected to become the third modality to drive our future growth. Concerning COVID-19, we have filed Ronapreve for subcutaneous administration and the additional indications of treatment for asymptomatic patients and prophylaxis. In order to satisfy unmet medical needs through innovation, we will continue pursuing world-leading science and technology to contribute to patients awaiting treatments." said Dr. Osamu Okuda, Chugai’s President and CEO.

[Third quarter results for 2021]

Revenues and Core operating profit increased by approximately 17% and 25%, respectively, for the third quarter (nine months, Core-basis), mainly due to increases in sales and royalty and profit-sharing income.

Revenues increased by approximately 20% in total since sales, which recorded flat year-on-year growth for the first half, turned to double-digit growth. Domestic sales increased by double digits as the strong oncology field grew further with a mainstay product Tecentriq maintaining high growth despite the NHI price revision in August this year, and the contribution of a new product Polivy. In the primary field, sales increased approximately 30% after reporting a decrease by roughly 10% in the first half. The growth was driven by new products, with the supply of Ronapreve to the government and the market penetration of Enspryng, and double-digit growth of mainstay products, Actemra and Hemlibra. Overseas sales recovered growth and increased by approximately 10% as the further growth of Hemlibra outweighed the decrease in the sales of Actemra. Royalties and other operating income increased by approximately 20% mainly due to increases in royalty and profit-sharing income related to Hemlibra, despite a continued decrease in other operating income resulting from one-time income.

Cost to sales ratio improved by 1.2% points year-on-year to 41.9%, mainly due to an increase in the proportion of in-house products including Hemlibra. Operating expenses increased approximately by 10% as research and development, marketing and distribution, and general and administration expenses all increased. Research and development expenses increased by double digits, continued from the first half, associated with the progress of projects. The increases in marketing and distribution expenses were affected by last year’s decrease in activities due to the spread of the COVID-19. General and administration expenses increased owing to the enterprise tax and various expenses. As a result, core operating profit increased by approximately 25%.
The Company also made good progress in research and development. Its first mid-size molecule project, LUNA18, has entered the clinical development phase. Chugai has been focusing on mid-size molecule drugs as a new modality to constitute the mainstay for driving its medium-to long-term growth. LUNA18 is an oral cyclic peptide RAS inhibitor, and a Phase I clinical trial has been initiated for solid tumors. As for other in-house projects, Chugai has started development of Enspryng in generalized Myasthenia Gravis (gMG), initiating a Phase III clinical trial.

In the efforts to develop treatments for COVID-19, Chugai filed an application for the antibody cocktail Ronapreve, which had received Special Approval in July. The filing is to obtain approval for additional indications for prophylaxis of COVID-19 and treatment of asymptomatic COVID-19, and additional subcutaneous administration. In addition, an application for approval was filed in Europe for Actemra for an additional indication of COVID-19 pneumonia.

[Revision of Full-Year Forecast for 2021]

Chugai raised forecasts (Core-basis) for FY2021 following the strong nine-month results. Regarding domestic sales, the sales forecast attributable to the supply of Ronapreve to the government, which was not expected at the beginning of the fiscal year, has been included, and the progress and revised assumptions have been reflected for each product including Avastin and Tecentriq, which are progressing ahead of the initial forecast. The forecast for overseas sales has been revised upward reflecting that sales of Actemra and Hemlibra should exceed the original forecast. Royalties and other operating income have been also revised upward. As a result, the revenues have been raised to ¥970 billion, an increase of ¥170 billion from the initial forecast. Operating profit forecast has been revised to ¥400 billion, up ¥80 billion from the initial forecast, taking into account a higher cost to sales ratio due to a change in the product mix, and increases in some expenses including the foreign exchange effects.

In accordance with the revision of the financial forecast, year-end dividends forecast was also revised to an undecided value. Reflecting the significant changes in the profit structures, year-end dividends will be decided based on the Company’s dividend policy* after the fiscal year ends.

*Regarding income distribution, taking into account the strategic funding needs and earning prospects, Chugai aims for a consolidated dividend payout ratio of 45% on average in comparison with Core EPS to provide a stable allocation of profit to all shareholders.

On October 22, 2021 Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported the publication of a peer-reviewed article demonstrating that the Company’s novel investigational peptide-drug conjugates (PDCs) TH1902 and TH1904, derived from its SORT1+ Technology, are effective in inhibiting vasculogenic mimicry (VM) in in vitro ovarian and triple negative breast cancer (TNBC) models (Press release, Theratechnologies, OCT 22, 2021, View Source [SID1234596236]).

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The article was published in the science journal Frontiers in Oncology and is titled "New Peptide-Drug Conjugates for Precise Targeting of SORT1-Mediated Vasculogenic Mimicry in the Tumor Microenvironment of TNBC-Derived MDA-MB-231 Breast and Ovarian ES-2 Clear Cell Carcinoma Cells."

"The results published in Frontiers in Oncology showcase for the first time that the sortilin receptor plays a role in the formation of VM, which is associated with cancer progression and resistance. By targeting SORT1, TH1902 and TH1904 have the potential to inhibit VM and cancer cell growth," said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer at Theratechnologies. "This recognition by our scientific peers highlights the great potential of our PDCs as a unique and effective vehicle for the potential treatment of many types of cancers in which SORT1 receptors are overexpressed and provides additional evidence that SORT1 plays a major role in the generation of VM, particularly in TNBC and ovarian cancer."

The article is the first to report that SORT1 plays a key role in VM formation and highlights the novel results from preclinical models evaluating the efficient inhibitory properties of TH1902 and TH1904 against VM in in vitro ovarian and TNBC cell models. These results further support the expectation that TH1902 and TH1904 may alter the VM process by bringing anticancer drugs, like docetaxel and doxorubicin, into SORT1-positive cancer cells.

The article can be accessed online here.

About Vasculogenic Mimicry
The formation of microvascular channels by deregulated cancer cells leads to aggressive, metastatic and resistant cancer cells and is known as vasculogenic mimicry. VM is believed to be associated with tumor growth, resistance and poor prognosis in many types of aggressive cancers including ovarian and TNBC.

About SORT1+ Technology
Theratechnologies is currently developing a platform of new proprietary peptides for cancer drug development targeting SORT1 receptors called SORT1+ TechnologyTM. SORT1 is a receptor that plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue making it an attractive target for cancer drug development. Expression has been demonstrated in, but not limited to, ovarian, triple-negative breast, endometrial, skin, lung, colorectal and pancreatic cancers. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

The Company’s innovative peptide-drug conjugates (PDCs) generated through its SORT1+ TechnologyTM demonstrate distinct pharmacodynamic and pharmacokinetic properties that differentiate them from traditional chemotherapy. In contrast to traditional chemotherapy, Theratechnologies’ proprietary PDCs are designed to enable selective delivery of certain anticancer drugs within the tumor microenvironment, and more importantly, directly inside SORT1 cancer cells. Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to Theratechnologies’ PDC to specifically target SORT1 receptors. This could potentially improve the efficacy and safety of those agents.

In preclinical data, the Company’s SORT1+ TechnologyTM has shown to improve anti-tumor activity and reduce neutropenia and systemic toxicity compared to traditional chemotherapy. Additionally, in preclinical models, SORT1+ TechnologyTM has shown to bypass the multidrug resistance protein 1 (MDR1; also known as P-glycoprotein) and inhibit the formation of vasculogenic mimicry – two key resistance mechanisms of chemotherapy treatment.

About TH1902
TH1902 combines Theratechnologies’ proprietary peptide to the cytotoxic drug docetaxel. TH1902 is currently Theratechnologies’ lead investigational PDC candidate for the treatment of cancer derived from its SORT1+ Technology. The FDA granted fast track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. TH1902 is currently being evaluated in a Phase 1 clinical trial for the treatment of cancers where the sortilin receptor is expressed.

The Company is also evaluating TH1904 in preclinical research, a second PDC derived from its SORT1+ TechnologyTM TH1904 is conjugated to the cytotoxic drug doxorubicin.

The Canadian Cancer Society and the Government of Quebec, through the Consortium Québécois sur la découverte du médicament (CQDM), contributes a total of 1.4 million

On October 22, 2021 RaySearch Laboratories AB (publ) and Mevion Medical Systems, two companies that are leading the field of proton therapy, reported a collaboration to develop advanced treatment planning techniques for FLASH delivery with the MEVION S250i Proton Therapy System (Press release, Mevion Medical Systems, OCT 22, 2021, View Source [SID1234591792]).

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The collaboration will explore FLASH intensity modulated proton therapy (IMPT) delivery using a technique that supports the delivery of large-volume clinical FLASH fields through the combination of smaller fields, each delivered at FLASH dose rates which complements Mevion’s advanced HYPERSCAN delivery system.

Townsend Zwart, Vice President of Advanced Development, Mevion Medical Systems, says: "Mevion is pleased to continue our long partnership with RaySearch to develop ultra-high dose rate (FLASH) intensity modulated proton therapy. Optimizing FLASH delivery requires explicit consideration of the time dependent dose delivery and sequencing of proton spots. Overlapping spots or spots with multiple pulses may have complex FLASH weighting factors. Differing tissue types or tissue properties may also need to be included in an effective dose weighting model. The RaySearch development team is uniquely qualified to incorporate these features into a FLASH dose calculation module."

Kjell Eriksson, Chief Science Officer, RaySearch, says: "RayStation already supports IMPT planning for Mevion’s HYPERSCAN system with Monte Carlo dose calculation for both optimization and final dose calculation. We are now excited to explore how RayStation can create optimal FLASH plans for the HYPERSCAN system and to further deepening our partnership."

Since 2014, RaySearch and Mevion have collaborated to provide advanced treatment planning capabilities for Mevion’s HYPERSCAN pencil-beam scanning and Adaptive Aperture pMLC. Both companies will be exhibiting at the upcoming American Society for Radiation Oncology (ASTRO) annual meeting in Chicago, October 24–26. Attendees are invited to the respective booths to learn more.

* FLASH therapy is currently under preclinical research and is not yet available for commercial sale or clinical use.