On September 30, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported updated data from patients with synovial sarcoma who were treated in the ongoing Phase 1 trial with SPEAR T-cells targeting MAGE-A4 (ADP-A2M4) (Press release, Adaptimmune, SEP 30, 2019, View Source [SID1234539909]). The oral presentation by Brian Van Tine, MD, PhD of Washington University in St. Louis, occurred earlier today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, Spain.

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"These data demonstrate a clear benefit of SPEAR T-cells for this population of patients with synovial sarcoma. These results are truly meaningful in this rare and deadly disease because patients with advanced synovial sarcoma have very few treatment options," said Elliot Norry, Adaptimmune’s interim Chief Medical Officer. "These data and the recent FDA orphan drug designation for ADP-A2M4 in sarcoma are important positive steps to expedite further development. We recently started SPEARHEAD-1, our Phase 2 trial in synovial sarcoma and myxoid/round cell liposarcoma (MRCLS), with the aim to commercialize ADP-A2M4 in 2022."

Overview of data presented at ESMO (Free ESMO Whitepaper)

This is a Phase 1 dose escalation, multi-tumor trial to assess the safety, tolerability, and antitumor activity of ADP-A2M4 in HLA-A2+ patients. As of Sep. 03, 2019, data from 12 patients with synovial sarcoma treated in the expansion phase of this trial demonstrated a best overall response rate of 58% (including both confirmed and unconfirmed partial responses [PRs]). There was a disease control rate of 92%, defined as objective overall response (including confirmed and unconfirmed PRs) and stable disease.

Most adverse events were consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies. Fatal aplastic anemia was reported in 1 patient with synovial sarcoma in this trial. This event was previously described and reported to the US Food and Drug Administration.

The median age of these patients was 54 years and they had received a median of 2 prior lines of systemic therapy. The median dose received was 9.7 billion SPEAR T-cells (range 3.4 to 10 billion transduced cells).

Data from patients with synovial sarcoma treated in the expansion phase of this trial were previously reported in May of this year. At that time 8 patients had been assessed, with 6 showing a decrease in tumor size, of which 3 patients had confirmed partial responses and 1 patient had an unconfirmed partial response.

Detailed summary of response data presented at ESMO (Free ESMO Whitepaper) for ADP-A2M4 in patients with synovial sarcoma

Twelve patients received treatment in the expansion phase of this trial and had post-baseline scans to assess efficacy by time of data cutoff (Sep. 03, 2019).

·Of the 12 patients with post-baseline scans to assess efficacy:
o11/12 showed clinical benefit with best overall responses of PR (confirmed or unconfirmed; n=7) or stable disease (SD; n=4); this represents a disease control rate of 92%
o7/12 had clinical responses representing a best overall response rate of 58% with
§5 confirmed PRs (cPR) by RECIST criteria; 3 of which remain ongoing at the time of data cutoff; 2 of which developed progressive disease (PD)
§ unconfirmed PRs (ucPR) that remain ongoing at the time of data cutoff
·Higher peak SPEAR T-cell expansion was associated with decreases in target lesions from baseline

About Adaptimmune’s ADP-A2M4 program in sarcoma

Adaptimmune’s ADP-A2M4 SPEAR T-cell therapy is directed to a member of the MAGE family of cancer testis antigens (MAGE-A4) expressed in a number of solid tumor cell types. The MAGE- A4 antigen is among the most commonly expressed cancer testis antigens. Adaptimmune is evaluating ADP-A2M4 in synovial sarcoma and MRCLS in a number of trials including the recently initiated Phase 2 trial SPEARHEAD-1 in sarcoma, as well as the ongoing Phase 1 trial, which includes a radiation sub-study to enhance T-cell trafficking and antitumor activity. Both the radiation sub-study and Phase 1 trial include sarcoma as well as multiple other solid tumor indications. Adaptimmune is also evaluating a next-generation SPEAR T-cell (ADP-A2M4CD8) targeting MAGE-A4 in sarcoma as well as other solid tumor indications in the SURPASS trial.

On September 30, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), reported that Ryan Spencer, Senior Vice President, Commercial, and Interim Co-President, will present at the 2019 Cantor Global Healthcare Conference on Friday, Oct. 4, at 12 p.m. E.T (Press release, Dynavax Technologies, SEP 30, 2019, View Source [SID1234539926]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source

On September 30, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported results from a new analysis of the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, which reinforce the unique value of the Oncotype DX Breast Recurrence Score test to guide the use of adjuvant chemotherapy for women with hormone receptor-positive (HR+), HER2-negative, early-stage breast cancer and identify those patients who derive a significant benefit from treatment (Press release, Genomic Health, SEP 30, 2019, View Source [SID1234539942]). The findings, published today in JAMA Oncology1 and presented at the ESMO (Free ESMO Whitepaper) 2019 Congress2, are consistent with results from the B20 trial3 and show that, in patients with high Recurrence Score results (26-100) treated with endocrine therapy plus chemotherapy, outcomes were better compared to what would be expected with endocrine therapy alone. The analysis also provides details on the outcomes of different chemotherapy regimens for the minority of patients who benefit from chemotherapy.

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"We’re pleased to see that the landmark TAILORx trial continues to receive global recognition, as evidenced by this fourth peer-reviewed publication," said Steven Shak, M.D., chief scientific officer, Genomic Health. "TAILORx established that the Oncotype DX test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy and the important minority for whom chemotherapy can be life-saving. The additional insight from this new analysis is consistent with, and further supports, the conclusion that the Recurrence Score predicts which patients benefit from chemotherapy and which patients do not, giving them the standard of care they deserve."

The objective of this secondary analysis of TAILORx, the largest ever breast cancer treatment trial, sponsored by the National Cancer Institute (NCI) and led by the ECOG-ACRIN Cancer Research Group, was to evaluate clinical outcomes for patients with a high Recurrence Score result assigned to receive adjuvant chemotherapy plus endocrine therapy. In this group of 1,389 women, treated largely with standard of care taxane and/or anthracycline-containing adjuvant chemotherapy regimens, the estimated proportion free from distant recurrence at five years was about 93%, an outcome much better than expected with endocrine therapy alone in this population.

"Last year, TAILORx established the highest level of evidence and unprecedented precision supporting the use of the Oncotype DX Breast Recurrence Score test to guide adjuvant chemotherapy treatment for women with early-stage breast cancer," said lead author Joseph A. Sparano, M.D., associate director for clinical research at the Albert Einstein Cancer Center and Montefiore Health System in New York, and vice chair of the ECOG-ACRIN Cancer Research Group. "This new analysis provides the largest dataset on outcomes in patients with high Recurrence Score results, and confirms the importance of using the test to identify the patients who will receive a significant benefit from adding adjuvant chemotherapy."

The groundbreaking TAILORx results, presented during the Plenary Session at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine, have elevated the Oncotype DX test to a new standard of care with increasing, and more consistent, use of the test by physicians worldwide for all medically eligible patients. The study is also having an important impact on global reimbursement of the test, most recently in Germany and Italy. Following the German Institute for Quality and Efficiency in Health Care’s (IQWiG’s) positive assessment of the TAILORx results, the German Federal Joint Committee (G-BA) issued an exclusive nationwide reimbursement decision for the Oncotype DX test. In Italy, the Lombardy Regional Authority adopted a resolution to include the test in the Regional Health Service Fees List, thereby making it available as of September 1, 2019, to eligible patients living in the region.

Over the last several months, results of the TAILORx study have also influenced positive treatment guideline updates distinguishing the Oncotype DX Breast Recurrence Score test from prognostic-only tests based on clinical evidence and the critical importance of predicting chemotherapy benefit. The updates include:

The recent update to ASCO (Free ASCO Whitepaper) guidelines, which increased the proportion of women who can be effectively treated without chemotherapy based on the Recurrence Score results, highlighting the importance of testing all medically eligible early-stage breast cancer patients.

The National Comprehensive Cancer Network (NCCN), which updated its guidelines in 2018 to categorize the Breast Recurrence Score test as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative, early-stage breast cancer. NCCN also classified the Breast Recurrence Score test as the only test that is predictive of chemotherapy benefit.

The new St. Gallen International Breast Cancer Guidelines, which recommend the Oncotype DX test to guide chemotherapy treatment use for patients with hormone-receptor positive, HER-2 negative, early-stage breast cancer with and without lymph node involvement (up to three positive nodes).

The updated ESMO (Free ESMO Whitepaper) guidelines for early-stage breast cancer, which elevated the Oncotype DX test to highest 1A level of evidence and refer to TAILORx and PlanB results, which identify groups of patients – both in the node-negative and node-positive setting – for whom chemotherapy can be safely spared.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic Health. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On September 30, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that it will be attending the 2019 Cell & Gene Meeting on the Mesa being held October 2nd – October 4th in Carlsbad, CA (Press release, Actinium Pharmaceuticals, SEP 30, 2019, View Source;gene-meeting-on-the-mesa-300927503.html [SID1234539961]). Members of Actinium’s executive and R&D teams will highlight the Iomab-ACT program at the meeting. To schedule a meeting with Actinium please email Eileen Geoghegan, Ph.D., at [email protected] or through the meeting’s partnering system View Source

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Actinium is developing its Iomab-ACT program to be a universal lymphodepletion regimen to replace chemotherapy-based regimens such as Flu/Cy (Fludarabine and Cyclophosphamide) that are used in standard practice today. Actinium proposes that Iomab-ACT has a multi-modal mechanism of action that can; 1) deplete lymphocytes to create a suitable homeostatic cytokine environment; 2) deplete immune suppressive cell populations that may hinder activation of CAR-T cells; (3) deplete macrophages that may secrete cytokines implicated in CRS and neurotoxicity; and (4) potential anti-tumor effect on CD45+ blood cancer cells.

Iomab-ACT is an ARC or Antibody Radiation-Conjugate that targets the antigen CD45, which is uniquely expressed on leukemia, lymphoma and immune cells making it an ideal target for targeted condition prior to CAR-T and adoptive cell therapies. Iomab-ACT is a lower, outpatient, non-myeloablative dose of Actinium’s lead program, Iomab-B, which has been studied in over 300 patients and is currently being studied as a targeted conditioning agent prior to bone marrow transplant in a pivotal Phase 3 trial.

Actinium presented initial feasibility data for its ACT program at the Transplantation and Cellular Therapies Meeting in February 2019. The data demonstrated that a CD45 targeting antibody labeled with the radioisotope Iodine-131 effectively depleted greater than 90% of lymphocytes and other immune cells while sparing platelets, neutrophils and bone marrow stem cells in preclinical animal models (Click here for TCT poster). Additionally, in a preclinical model of adoptive cell therapy, the CD45-targeted ARC enabled improved tumor control. Actinium also presented data at the Society of Nuclear Medicine and Molecular Imaging demonstrating that the Iomab-ACT program could utilize the radioisotope Lutetium-177 with an anti-CD45 antibody to achieve targeted lymphodepletion prior to adoptive cell therapy (Click here for SNMMI poster).

About the Cell & Gene Meeting on the Mesa

The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 70+ dedicated presentations by the leading publicly traded and privately held companies in the space. Attracting over 1,150 attendees – over 20% of which are C-level executives – this conference enables key partnerships through more than 2,200 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.

On September 30, 2019, Delcath Systems, Inc (the "Company") and holders of a majority of the Company’s Series E and Series E-1 Convertible Preferred Stock entered into an amendment to those certain registration rights agreements, dated as of July 11, 2019 (effective as of July 15, 2019) (the "July Registration Rights Agreement") and August 15, 2019 (the "August Registration Rights Agreement"), between the Company and the holders signatory thereto (the "Amendment") (Filing, 8-K, Delcath Systems, SEP 30, 2019, View Source [SID1234539977]). The Amendment extends the applicable deadline for having a registration statement declared effective by the Securities and Exchange Commission (the "SEC") under certain circumstances from 75 days to 120 days following the date of the July Registration Rights Agreement.

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The foregoing description of certain terms contained in the Amendment does not purport to be complete and is qualified in its entirety by reference to: (i) the copy of the Amendment filed as Exhibit 10.1 to this Current Report on Form 8-K, (ii) the copy of the Form of Registration Rights Agreement between the Company and each other party a signatory thereto filed as Exhibit 4.2 to the Current Report on Form 8-K filed with the SEC on July 11, 2019 and (iii) the copy of the Form of Registration Rights Agreement between the Company and each other party a signatory thereto filed as Exhibit 4.2 to the Current Report on Form 8-K filed with the SEC on August 16, 2019.