On September 29, 2020 Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid malignancies, reported the treatment of the first patients in its ANCHOR phase 1 study of KUR-502, an allogeneic CAR-NKT therapy (Press release, Kuur Therapeutics, SEP 29, 2020, View Source [SID1234567747]).

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"This is an important day, as the initiation and dosing of the first patients in the ANCHOR phase 1 clinical study marks the first time that patients have been treated with an allogeneic engineered CAR-NKT cell therapy," said Dr. Carlos Ramos, Principal Investigator of the ANCHOR study, Professor of Medicine in the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center. "CAR-NKT cells have the potential to offer a distinct set of advantages over other lymphocytes commonly used for cell therapy, such as T cells. We are pleased to be advancing this ground-breaking first-in-human clinical study and anticipate that CAR-NKT cells could be an important treatment option for patients with both hematological and solid tumors in the future."

"With the initiation of the ANCHOR study of KUR-502 in CD19 positive hematological malignancies, we are able to turn our focus to exploring the effects of off-the-shelf CAR-NKT cells," said Kevin S. Boyle, Sr., Kuur’s Chief Executive Officer. "This study will allow us to evaluate our platform technology with a validated target in CD19 and validated indications, generating critical data to advance our allogeneic efforts. Together with the results from our proof of concept GINAKIT2 study of KUR-501 in neuroblastoma, the forthcoming data from the ANCHOR study will guide future development of our next generation platform technology."

KUR-502 is built on Kuur’s next-generation CAR-NKT platform, with novel engineering capabilities that harness and enhance the unique tumor-homing properties of NKT cells. This NKT platform technology was developed in the CAGT Lab of Dr. Leonid Metelitsa, Professor of Pediatrics-Oncology at Baylor College of Medicine and Texas Children’s Hospital and member of the Dan L Duncan Comprehensive Cancer Center, and KUR-502 was produced by the CAGT cGMP facility. One of the challenges with allogeneic therapies is that infusing a patient with donor-derived lymphocytes can induce graft versus host disease (GvHD), a potentially life-threatening condition in which the infused cells recognize the patient’s tissues as foreign. The NKT cells used in Kuur’s CAR-NKT platform have an invariant T cell receptor that does not distinguish between self- and non-self tissues, making the cells unlikely to induce GvHD when given to another person. Preclinical data generated by Baylor College of Medicine indicate that while human CAR-T cells cause severe GvHD, CAR-NKT cells from the same donor do not.

The ANCHOR (NCT03774654) study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies, including B cell lymphomas, acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). The single arm study will evaluate three dose levels, with patients receiving lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502.

Patients with R/R CD19 positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by delays to get treatment, a requirement for patient leukapheresis, and issues with inferior quality leukapheresis starting material due to prior treatment. Off-the-shelf KUR-502 is designed to overcome these limitations.

The ANCHOR study is being sponsored and conducted by Kuur’s collaborator, Baylor College of Medicine.

About KUR-502

KUR-502 is an innovative allogeneic (off-the-shelf) product in which natural killer T cells are engineered with a chimeric antigen receptor targeting CD19. KUR-502 is engineered with a CD19-specific CAR construct that is additionally designed to secrete 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. In addition, the CAR-NKT cells express short hairpin RNA (shRNA) designed to downregulate HLA class I and class II expression, which may minimize rejection by the patient’s immune system and further enhance persistence. The CAR, IL-15 and shRNAs are effectively expressed in NKT cells via a single gammaretroviral vector, allowing for one-hit generation of off-the-shelf CAR-NKT cells. In contrast to off-the-shelf CAR therapy with conventional alpha-beta T cells, gene editing to remove the TCR to prevent GvHD is not required for off-the-shelf CAR-NKT therapy. KUR-502 is manufactured from healthy donors, from whom cell therapy products can be prepared in large quantities from a single procedure and used to treat many different patients.

On September 29, 2020 Novocure (NASDAQ: NVCR) reported that it will host a virtual Research & Development Day for analysts and investors from 7:30 a.m. to 9:30 a.m. EDT on Thursday, November 12, 2020, to highlight progress across its clinical and product development pipelines and to introduce areas of internal and external focus in its translational research (Press release, NovoCure, SEP 29, 2020, View Source [SID1234567746]). The event will include presentations from various leaders of Novocure’s research and development teams as well as from key opinion leaders from across the global scientific community who are conducting research on Tumor Treating Fields.

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The event will be webcast live and can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations. The webcast will be available for replay for at least 14 days following the event. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On September 29, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the first quarter of fiscal year 2021, which ended August 31, 2020 (Press release, AngioDynamics, SEP 29, 2020, View Source [SID1234567744]).

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"We had a strong first quarter, as our customers continued to show signs of recovery from the disruption of COVID-19," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "While customer demand has not yet returned to pre-COVID levels, the team is clearly executing in this challenging environment. Our key technology platforms performed well during the quarter, including strong sales growth of our AngioVac platform and more than $1 million in sales of our Auryon platform. We’re still seeing the impact of COVID, particularly in our Oncology business, but, despite the unique challenges presented by this environment, we remain confident in our ability to efficiently manage the business while growing our key technology platforms."

First Quarter 2021 Financial Results

Net sales for the first quarter of fiscal 2021 were $70.2 million, an increase of 6.3% compared to the prior-year quarter. Net sales in the first quarter continued to be impacted by the disruption to procedure volumes resulting from the COVID-19 global pandemic. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $12.3 million, a decrease of 12.3% from $14.0 million a year ago, with growth in microwave ablation and U.S. NanoKnife probe sales more than offset by lower sales in international markets.
Vascular Interventions and Therapies ("VIT") net sales were $29.9 million, an increase of 3.3%, compared to $29.0 million a year ago. Sales of AngioVac grew 46% over the previous year and were partially offset by a decline in sales of Venous products as a result of lower elective procedure volumes. Auryon sales during the quarter were $1.1 million, and the Company announced the full commercial launch of this platform on September 21, 2020.
Vascular Access net sales were $28.1 million, an increase of 21.4% from $23.2 million a year ago, which includes the impact of a previously disclosed sale in the UK through our distributor partner to the NHS. Excluding the impact of this sale, Vascular Access sales declined approximately 1.2% year over year.
U.S. net sales in the first quarter of fiscal 2021 were $54.1 million, an increase of 2.2% from $52.9 million a year ago, and International net sales were $16.1 million, including the one-time sale to NHS, an increase of 22.9% from $13.1 million a year ago.

Gross margin for the first quarter of fiscal 2021 was 50.9%, a decline of 700 basis points compared to the first quarter of fiscal 2020. The gross margin decline was primarily attributable to the Company’s previously discussed COVID-related operating plan, which included COVID-related operating protocols designed to ensure supply-chain security and employee safety. Additionally, during the first quarter, inventory was reduced by $7.2 million when compared to inventory levels on May 31, 2020.

The Company recorded a net loss of $4.3 million, or loss per share of $0.11, in the first quarter of fiscal 2021. This compares to net loss of approximately $1.3 million, or loss per share of $0.03, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the first quarter of fiscal 2021 was $0.6 million or adjusted earnings of $0.02 per share, compared to adjusted net income of $3.2 million, or adjusted earnings per share of $0.08, in the first quarter of fiscal 2020.

Adjusted EBITDA in the first quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $4.5 million, compared to $7.3 million in the first quarter of fiscal 2020.

In the first quarter of fiscal 2021, the Company used $5.4 million in operating cash and had capital expenditures of $1.8 million. As of August 31, 2020, the Company had $47.9 million in cash and cash equivalents compared to $54.4 million in cash and cash equivalents at the end of the fourth quarter of fiscal 2020. As of August 31, 2020, the Company had $40.0 million in debt outstanding, consistent with its debt balance on May 31, 2020. Management remains focused on cash preservation amid the current environment.

Fiscal Year 2021 Financial Guidance

The Company expects fiscal year 2021 net sales to be in the range of $278 to $284 million and fiscal year 2021 adjusted earnings per share to be in the range of $0.00 to $0.05.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2021 first quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13710506.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, September 29, 2020, until 11:59 p.m. ET on Tuesday, October 6, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13710506.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

On September 29, 2020 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy, reported that President & CEO Usman "Oz" Azam is scheduled to present at two upcoming virtual investor conferences (Press release, Tmunity Therapeutics, SEP 29, 2020, View Source [SID1234567742]).​

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Chardan 4th Annual Genetic Medicines Conference

Date:

Monday, October 5, 2020

Time:

1:30 pm ET

Location:

Presentation will be via webcast

Alliance of Regenerative Medicine 2020 Virtual Cell & Gene Meeting on the Mesa

Date:

Monday, October 12 – Friday, October 16

Time:

Company presentations will be available to view on-demand throughout the entirety of the conference

Location:

Please visit www.meetingonthemesa.com for full information including registration.

On September 29, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported results of an additional secondary endpoint from the Phase 3 HERO study evaluating relugolix in men with advanced prostate cancer (Press release, Myovant Sciences, SEP 29, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-results-additional-secondary-endpoint [SID1234567739]). Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks.

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"These new data from the Phase 3 HERO study show that three out of four men with metastatic prostate cancer remained castration resistance-free through 48 weeks while on oral relugolix, in-line with leuprolide acetate injections, the current standard of care," said Dan George, M.D., a professor of medicine and surgery at the Duke University School of Medicine and HERO program steering committee member. "I continue to be excited by relugolix as a potential new and differentiated treatment option for men with prostate cancer given its robust clinical and safety data, including the lower risk of major adverse cardiovascular events compared to leuprolide acetate."

Castration-resistant prostate cancer is defined by disease progression despite achieving testosterone suppression to castrate levels (< 50 ng/dL). In the subgroup of men with metastatic disease treated with relugolix, 74% were castration-resistance free through 48 weeks compared to 75% men treated with leuprolide acetate (HR = 1.03 [95% CI: 0.68-1.57]; p = 0.84). In the secondary endpoint analysis, castration resistance-free survival was defined as the time from first dose to prostate-specific antigen (PSA) progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death from any cause. PSA progression was defined as a PSA increase ≥ 25% and ≥ 2 ng/mL above the nadir, and confirmed by a second PSA value ≥ 3 weeks later.

"We believe the totality of data – including previously reported data from the Phase 3 HERO program, published in the New England Journal of Medicine – presents compelling evidence for the potential use of relugolix in men with advanced prostate cancer," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "With our New Drug Application under Priority Review by the FDA, we look forward to our target action date in December 2020 and hope to advance our commitment to redefining care by bringing once-daily, oral relugolix to men with prostate cancer."

The incidence of adverse events in the subgroup of men with metastatic disease was consistent with that observed in primary analysis of HERO with no new safety signals observed.

Relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. In the Phase 3 HERO study, relugolix met the primary efficacy endpoint, with 96.7% of men treated with relugolix achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks versus 88.8% of men treated with leuprolide acetate. Relugolix also met six key secondary endpoints, demonstrating rapid and profound suppression of testosterone and PSA response, in addition to improved testosterone recovery after discontinuation of treatment. Men in the relugolix group had a 54% lower risk of major adverse cardiovascular events (MACE) compared to men in the leuprolide acetate group (2.9% vs. 6.2%, respectively). In men with a reported history of MACE, the relugolix group had 80% fewer MACE events reported compared to the leuprolide acetate group (3.6% vs. 17.8%, respectively). The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively).

About the Phase 3 HERO Program in Advanced Prostate Cancer
Myovant’s Phase 3 clinical program for advanced prostate cancer consisted of a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in over 900 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men in the U.S. are currently living with prostate cancer, and approximately 190,000 men are estimated to be newly diagnosed in 2020.

Advanced prostate cancer is prostate cancer that has spread or come back after treatment and may include men with biochemical recurrence (rising PSA in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels. GnRH receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, GnRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. Approximately 210,000 men are treated with androgen deprivation therapy with a GnRH agonist or antagonist each year.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.