On October 12, 2020 Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies, reported the publication in Nature Medicine of interim findings from its ongoing phase 1 GINAKIT2 clinical trial collaboration with Baylor College of Medicine and Texas Children’s Hospital, in high risk relapsed refractory (R/R) patients with neuroblastoma, a form of childhood cancer (Press release, Kuur Therapeutics, OCT 12, 2020, View Source [SID1234568344]).

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The interim results demonstrated that expressing the CAR with interlukin-15 (IL-15), a natural protein that supports NKT survival, enhanced the tumor-fighting capabilities and in vivo persistence of autologous NKT cells. Two of three patients studied showed tumor reduction following CAR-NKT infusion: one classified as stable disease and the other as a partial response. Imaging revealed a dramatic reduction in the size and metabolic activity of bone metastases in the patient with the partial response. CAR-NKT cells demonstrated a favorable safety profile and localized to the site of the neuroblastoma tumors.

Kuur is the first company to test CAR-NKT cell therapy in patients. The company’s revolutionary platform engineers CARs on invariant NKT cells, a subset of T lymphocytes. NKT cells represent the next generation of CAR therapy, because this innovative approach harnesses the innate tumor-homing properties of NKT cells, a specialized type of lymphocyte that eliminates tumor-supportive macrophages, activates anti-tumor NK, dendritic and CD8 T cells, and does not induce graft versus host disease when used in an allogeneic setting.

"These results validate the biology of CAR-NKT cells in that they home to tumor and marrow, expand and have tumor killing properties. They also demonstrate safety and enhanced tumor homing capabilities, offering distinct advantages over other cell types for the treatment of solid and hematological tumors," said Kurt C. Gunter, MD, CMO of Kuur. "Using our novel engineering platform, we have manufactured CAR-NKT cells with high purity and added IL-15 to the CAR construct, which further increases in vivo persistence and anti-tumor activity. We look forward to continuing our research with the experts in cellular and gene therapy at Baylor as we aim to leverage the CAR-NKT cell approach to create more precise and effective therapies for cancer patients, including allogeneic therapies."

The results published were derived from the three heavily pre-treated, R/R metastatic neuroblastoma patients in dose level 1 (3×106 CAR-NKTs/m2) of the GINAKIT2 clinical study. These data were originally presented at the 23rd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in May 2020. The trial is currently enrolling at the fourth and highest dose level.

About KUR-501

KUR-501 is an autologous product in which natural killer T (NKT) cells are engineered with a chimeric antigen receptor (CAR) targeting GD2, which is expressed on almost all neuroblastoma tumors. KUR-501 is also designed to address key limitations of current CAR immune cell therapies by secreting the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. KUR-501 is being tested in the phase 1 GINAKIT2 clinical study (NCT03294954) in patients with R/R high-risk neuroblastoma. The KUR-501 development program is also designed to provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target.

About the Licensing Agreement with Baylor College of Medicine

Kuur’s partnership with Baylor College of Medicine’s Center for Cell and Gene Therapy was first announced in March 2020 with the goal of advancing Kuur’s novel anti-cancer therapies via its innovative CAR-NKT platform. The platform was developed in the laboratory of Baylor principal investigator Dr. Leonid Metelitsa, an expert in the role of NKT cells in tumor immunity and a pioneer in applying this knowledge to NKT cell-based cancer immunotherapies. Kuur has an exclusive license to this platform and certain cell therapy candidates.

On October 12, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it will announce results for the second quarter ended September 30, 2020 on Wednesday, October 28th, 2020 after the Board Meeting (Press release, Dr Reddy’s, OCT 12, 2020, View Source [SID1234568343]).

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Summary of Events

Event

Date and Time

Medium

Release of financial results

October 28th, after the Board Meeting

Stock Exchange, Media, Company website, Business wire, Email

Press meet presentation

Will be available on the Company’s website

Company’s website www.drreddys.com

Earnings Call

October 28th, 5:30 PM IST / 8:00 AM EDT

Hosted by the Company (Details below)

Playback of Earnings Call

After the earnings call till November 4th, 2020

Details below

Transcript of the Earnings call

Will be available on the Company’s website

Company’s website www.drreddys.com

Earnings Call

Following the release, the management of the Company will host an earnings call to discuss the Company’s financial performance. (Dial In and other details given below)

Play Back

The play back will be available after the earnings call, till November 4th, 2020. For play back dial in phone No: +91 22 7194 5757 | +91 22 6663 5757, and Playback Code is 97779.

Conference Joining Information

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Pre-register with the below link and join without waiting for the operator.

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Option 2: Join through below Dial-In Numbers

No password/pin number is necessary to dial in to any of the above numbers. The operator will provide instructions on asking questions before and during the call.

On October 12, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that its data were featured in two oral presentations during the 2020 American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting, Oct. 9-11, 2020 (Press release, Castle Biosciences, OCT 12, 2020, View Source [SID1234568341]).

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DecisionDx-Melanoma: Skin Cancer and Reconstruction Session; Friday, October 9, 2020

"Cutaneous Melanoma Prognostic Model Combining 31-gene Expression Profile and Sentinel Lymph Node Biopsy" was presented by Aaron Farberg, M.D., Baylor University Medical Center, Dallas, Texas.

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.

"As most sentinel lymph node biopsies are negative, there is a need to identify which melanoma patients can forgo sentinel lymph node biopsy (SNLB)," said Dr. Farberg. "Based on the cohort described in a recent meta-analysis by Greenhaw and colleagues, we modeled the use of Castle’s DecisionDx-Melanoma test to determine whether it might alter the predictive value of SLNB alone in high-risk patients, and whether the test might identify patients who would not benefit from SLNB. In fact, we found that use of the test stratifies risk in the cohort studied, which can help focus the resources needed for SLNB on patients with genuinely higher risk, thereby reducing surgical risks for patients who can avoid SLNB."

Study methods and findings:

The study objective was to model the use of DecisionDx-Melanoma to triage cutaneous melanoma patients for SLNB, to evaluate the outcomes of low-risk patients who can forgo SLNB and to evaluate the combined accuracy of DecisionDx-Melanoma and SLNB in high-risk patients.
The model was based on use of DecisionDx-Melanoma to triage the patients from the recently published systematic review and meta-analysis (Greenhaw et al. JAAD, Sept., 2020), assuming that:
Patients with a Class 1A result who were 55 years of age or older with T1-T2 melanoma would not undergo SLNB;
The negative predictive value of DecisionDx-Melanoma for recurrence-free survival, distant metastasis free survival and ultimately melanoma specific survival would be high for patients who would not have undergone SLNB due to DecisionDx-Melanoma triage; and
The remaining patients would undergo SLNB.
Result showed that:
69% of all patients could forgo an SLNB due to a DecisionDx-Melanoma Class 1A test result, and the negative predictive value for 5-year melanoma specific survival was 98%.
For the remaining 31% of patients who would undergo an SLNB:
Sensitivity for melanoma specific death was 87% for DecisionDx-Melanoma compared with 73% for SLNB. Combining DecisionDx-Melanoma with SLNB improved sensitivity to 96%.
Negative predictive value for melanoma specific death was 95% for DecisionDx-Melanoma, compared with 94% for SLNB. Combining DecisionDx-Melanoma with SLNB improved negative predictive value to 98%.
The study concluded that use of DecisionDx-Melanoma to triage patients with a Class 1A result, who were at least 55 years old with T1-T2 melanoma, could have reduced SLNB procedures in that population by 69%. Use of DecisionDx-Melanoma for SLNB triage can focus the SLNB procedure on patient populations at higher risk for a positive sentinel lymph node, thereby reducing surgical risks and better utilizing healthcare resources.
DecisionDx-SCC: Skin Cancer and Reconstruction Session; Friday, October 9, 2020

"Clinical Validation and Incorporation of a Prognostic 40-gene Expression Profile Test into Clinicopathological Risk Assessment for Cutaneous Squamous Cell Carcinoma (cSCC)" was presented by Sherrif Ibrahim, M.D., Ph.D., associate professor, University of Rochester Medical Center.

DecisionDx-SCC is Castle’s prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) that uses a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

"Managing cutaneous squamous cell carcinoma is challenging, and deaths from SCC are now estimated to exceed those from melanoma," said Dr. Ibrahim. "Current methods of metastatic risk assessment are limited by low positive predictive values. DecisionDx-SCC was designed to accurately classify SCC patients with one or more risk factors as high, moderate or low risk for metastasis (nodal and/or distant) within three years of diagnosis. Incorporating DecisionDx-SCC test results into patient risk assessments may lead to more personalized patient management and improved outcomes."

DecisionDx-SCC has been validated as an independent predictor of metastatic risk that can complement current risk-factor staging systems for patients with SCC and one or more clinicopathologic risk factors.

Validation study findings:

DecisionDx-SCC stratifies high-risk SCC patients into three classes based on metastasis risk: Class 1 (low risk), Class 2A (moderate risk) and Class 2B (high risk).
In multivariate analyses, DecisionDx-SCC demonstrated strong independent prognostic value relative to other significant risk factors, indicating its ability to better stratify patients. Similar hazard ratios (HRs) were observed for a Class 2A result (2.33; p=0.013), poor differentiation (2.29; p=0.011), and deep invasion (2.05; p=0.039), indicative of independent and additive metastatic risk associated with each factor. A DecisionDx-SCC Class 2B result was found to have the greatest independent prognostic value (HR, 6.86; p<0.001).
Patients with a DecisionDx-SCC Class 1 result (n=212; lowest-risk group) had a 3-year metastasis-free survival rate of 93.9%, which was significantly better than the metastasis-free survival rate for patients with a moderate-risk Class 2A result (80.5%; n=185) or highest-risk Class 2B result (47.8%; n=23) (p<0.0001).
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. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 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. Through June 30, 2020, DecisionDx-Melanoma has been ordered more than 59,900 times for use in patients with cutaneous melanoma.

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

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, 2A or 2B 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.

On October 12, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that it has raised gross proceeds of approximately $54.8 million through its At-the-Market ("ATM") facility pursuant to its Open Market Sale AgreementSM dated as of September 25, 2020 with Jefferies LLC, as sales agent (the "Sale Agreement"), with participation based on interest received from multiple institutional investors (Press release, ImmunoGen, OCT 12, 2020, View Source [SID1234568340]). On October 9, 2020, the Company sold approximately 12.7 million shares of the Company’s common stock at a per share purchase price of $4.33, the market price at the time of sale.

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The additional funds raised through the ATM strengthen the Company’s balance sheet and will be used to fund the Company’s operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization and commercialization activities, capital expenditures, and working capital.

The shares of common stock described above were sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-223507), previously filed with the Securities and Exchange Commission ("SEC") on March 7, 2018, which became effective upon filing, and a prospectus supplement dated September 25, 2020 and the accompanying prospectus the Company filed with the SEC in connection with the offer and sale of the Company’s common stock pursuant to the Sale Agreement. Copies of the prospectus supplement and the accompanying prospectus may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388. Electronic copies of the prospectus supplement and the accompanying prospectus are also available on the SEC’s website at View Source

On October 12, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported the availability of a new publication on domatinostat in the Journal of Investigative Dermatology entitled "The HDAC Inhibitor Domatinostat Promotes Cell Cycle Arrest, Induces Apoptosis and Increases Immunogenicity of Merkel Cell Carcinoma Cells" (Press release, 4SC, OCT 12, 2020, View Source [SID1234568338]). The article was published by the Research Group of Professor J. C. Becker, Department of Translational Skin Cancer Research, Essen, Germany and is freely accessible via View Source(20)32074-1/fulltext or via the 4SC homepage.

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The article presents preclinical data demonstrating domatinostat´s efficacy and mode of action in Merkel Cell Carcinoma (MCC). The data shows that domatinostat not only exerts direct anti-tumoral effects, but also restores HLA class I surface expression on MCC cells – and as a result, restores surviving MCC cells’ susceptibility to recognition and elimination by cytotoxic T cells.

Frank Hermann, MD, Chief Development Officer at 4SC commented: "The preclinical results published in this article strongly support our clinical development strategy to combine domatinostat with avelumab in patients with advanced MCC – to effectively address critical escape mechanisms in this deadly cancer and synergize with immune checkpoint blockade. We acknowledge the scientific value and relevance of the work of Professor Becker and his research team, and look forward to seeing clinical data from our MERKLIN 2 and MERKLIN 1 studies."