On April 1, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel tetracyclines to treat serious and life-threatening conditions, reported that senior management will present a corporate overview at the H. C. Wainwright and Company Global Life Sciences Conference on Monday, April 8, 2019 at 9:10 a.m. GMT at the Grosvenor House JW Marriott Hotel in London, UK and at the 18th Annual Needham Healthcare Conference on Wednesday, April 10, 2019 at 2:50 p.m. ET at the Westin Grand Central Hotel in New York City (Press release, Tetraphase, APR 1, 2019, View Source [SID1234534853]).

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Live audio webcasts of both presentations will be available on the Company’s website at View Source The archived presentation will be available for 30 days.

On April 1, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its results from the Phase 1b portion of the ProSTAR clinical trial of CPI-1205 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Atlanta (Press release, Constellation Pharmaceuticals, APR 1, 2019, View Source [SID1234534873]). Poster CT094/18, ProSTAR: A phase 1b/2 study of CPI-1205, a small molecule inhibitor of EZH2, combined with enzalutamide (E) or abiraterone/prednisone (A/P) in patients with metastatic castration-resistant prostate cancer (mCRPC), was presented at the poster session starting at 1:00 PM EDT today. The Company will present two other posters highlighting its preclinical pipeline later in the AACR (Free AACR Whitepaper) meeting.

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"We are pleased to report the ProSTAR Phase 1b results," said Adrian Senderowicz, Chief Medical Officer. "These results show clinical activity in subsets of a heterogeneous population of advanced mCRPC patients in combination with either abiraterone or enzalutamide. Activity was particularly noteworthy in patients taking CPI-1205 in combination with abiraterone, an agent where responses in second-line patients have historically been poor, and in AR-V7-negative patients. Based on the entirety of the results, we initiated the Phase 2 portion of the trial in late 2018 to better define the patient populations most likely to benefit from CPI-1205. We look forward to reporting initial Phase 2 data in the second half of 2019."

The poster presentation included the following highlights from the Phase 1b portion of ProSTAR, using a February 6, 2019, data cutoff:

Baseline Characteristics

The Phase 1b portion of ProSTAR enrolled 36 patients: 20 in the CPI-1205 + abiraterone arm and 16 in the CPI-1205 + enzalutamide arm.

Each arm studied two different dose regimens of CPI-1205 as part of the combination: 800 mg three times daily or 400 mg twice daily + cobicistat (to block CYP3A4).

The Phase 1b portion of ProSTAR was conducted in a heterogeneous patient population who had been treated with a variety of treatment regimens, including chemotherapy. As such, a significant proportion of patients had indicators of poor prognosis at baseline. Of the 36 patients enrolled, 13 (36%) were positive for Androgen Receptor Splice Variant 7, or AR-V7, isoforms (proteins with similar structures); 20 (56%) had unfavorable circulating tumor cell counts; 13 (36%) had previously received chemotherapy; and 18 (50%) had abnormal levels of lactate dehydrogenase (an enzyme in the blood that can indicate tissue damage, cancer, or some noncancerous conditions) at baseline.

Because patients without AR-V7 isoforms have tended to respond better to ARS inhibition than those with AR-V7 isoforms, and given the hypothesis that ARS inhibition acts synergistically with EZH2 inhibition, patients without AR-V7 isoforms may be more likely to benefit from the potential synergistic effect of CPI-1205 with ARS inhibitor therapy.

Clinical Activity

Clinical activity was observed in both the enzalutamide and abiraterone arms, including ³50% PSA reductions and an objective response by RECIST 1.1 criteria.

All PSA responses seen in the trial were ³80%, deeper than the ³50% reduction endpoint in the trial. All PSA responses were found in AR-V7-negative patients. Two out of 18 patients in the abiraterone arm achieved PSA reductions of more than 80%. Patients being treated with abiraterone after enzalutamide historically have been shown to achieve poor PSA responses and rapid time to disease progression. PSA responses are summarized below:

³80% PSA
Reductions in
AR-V7-Positive
Patients ³80% PSA
Reductions in
AR-V7-Negative
Patients
CPI-1205 + abiraterone**

0/8* (0%) 2/10* (20%)
CPI-1205 + enzalutamide**

0/5 (0%) 3/11 (27%)

*
2 patients not evaluable for PSA response

Includes patients treated with CPI-1205 800 mg three times daily and CPI-1205 400mg twice daily + cobicistat

The majority of patients with measurable lesions achieved durable disease control during the study, as follows:

Partial
Response Stable
Disease Disease
Control Rate of
Any Duration Disease
Control Rate
³3 Months
CPI-1205 + abiraterone

0/8 (0%) 6/8 (75%) 6/8 (75%) 4/8 (50%)
CPI-1205 + enzalutamide

1/5 (20%) 2/5 (40%) 3/5 (60%) 3/5 (60%)
Several patients achieved disease control that exceeded or was approaching six months at the data cutoff while continuing therapy.

Safety

CPI-1205 was generally well tolerated in combination with enzalutamide or abiraterone. The most common treatment-related adverse events (³20%) were fatigue, diarrhea, and nausea, which were usually mild to moderate in severity and manageable with supportive care. In combination with enzalutamide, treatment-related adverse events ³ Grade 3 included fatigue, nausea, and increased ALT (n=1; 6.3%, respectively). In combination with abiraterone, treatment-related adverse events ³ Grade 3 included fatigue and increased ALT (n=1; 5%, respectively). For more details, please see the poster here.

Pharmacokinetics/Pharmacodynamics (PK/PD)

Patients in two treatment arms were dosed with 800 mg of CPI-1205 three times daily with enzalutamide or abiraterone. Patients in the other two arms were dosed with 400 mg of CPI-1205 twice daily in combination with cobicistat, a CYP3A4 inhibitor, and enzalutamide or abiraterone. While the Company observed in the trial that cobicistat increased the exposure of CPI-1205, the Company did not observe meaningful differences in pharmacodynamics or efficacy compared to 800 mg of CPI-1205 three times daily without cobicistat. Therefore the recommended Phase 2 dose of CPI-1205 for ProSTAR Phase 2 was determined to be 800 mg three times daily.

Phase 2

The Phase 1b portion of ProSTAR was designed primarily to study the safety, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and a recommended Phase 2 dose of CPI-1205 with abiraterone and enzalutamide. Based on the Phase 1b data, the Company initiated the Phase 2 portion of ProSTAR in late 2018. The Phase 2 portion of the trial is evaluating CPI-1205 in combination with an ARS inhibitor as a second-line treatment for patients with mCRPC. The Company will collect and analyze biomarker and other translational data in Phase 2 to better define which patients may be most likely to respond to treatment with CPI-1205. Two randomized arms of Phase 2 are studying CPI-1205 in combination with enzalutamide versus enzalutamide alone.

In addition, because of the activity seen in the abiraterone arm in the Phase 1b portion of ProSTAR, the Company has also initiated a Phase 2 arm to evaluate CPI-1205 in combination with abiraterone in second-line mCRPC patients. According to a recent study by the laboratory of Dr. Kim Chi of the Vancouver Prostate Centre, few patients responded to treatment with abiraterone after experiencing disease progression on enzalutamide. For this reason, we have not instituted an additional control arm. In the Chi study, out of 101 patients receiving abiraterone after experiencing disease progression on enzalutamide, no patients achieved an 80% reduction in PSA levels and only 4% achieved a 50% PSA reduction.1 The patient population in the Chi study had baseline characteristics that are different from those in the Phase 1b portion of ProSTAR, and more similar to those that are expected to be in ProSTAR Phase 2. For example, unlike ProSTAR Phase 1b, in which patients had been previously treated with a range of therapies – including 36% who had received chemotherapy – ProSTAR Phase 2, like the Chi study, is enrolling only patients receiving second-line therapy with no prior chemotherapy in order to focus on activity in that patient population.

The Company expects to provide an initial update from the Phase 2 portion of ProSTAR in the second half of 2019.

For more information on the Phase 1b portion of ProSTAR, please see the poster here.

1
D Khalaf et al., Phase 2 randomized cross-over trial of abiraterone + prednisone (ABI) vs enzalutamide (ENZ) for patients (pts) with metastatic castration resistant prostate cancer (mCRPC): results for 2nd-line therapy, poster presented at 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting.

Discovery Pipeline

Constellation is presenting two additional posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting that speak to the depth and breadth of the Company’s product pipeline and its expertise in epigenetics. Poster 4351/11, Single-cell RNA sequencing reveals transcriptomic heterogeneity in response to epigenetic inhibitors, will be presented at the 1PM-5PM EDT poster session on April 2. Poster 4722/12, Efficacy of novel EP300/CBP histone acetyltransferase inhibitor in hormone responsive breast cancer, will be presented at the 8AM-12PM EDT poster session on April 3.

About ProSTAR

ProSTAR is an open-label Phase 1b/2 clinical trial of CPI-1205, a potent and highly selective small-molecule EZH2 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC) in the second-line setting. The ProSTAR study is evaluating CPI-1205 in combination with either enzalutamide or abiraterone / prednisone ("abiraterone"), which are androgen receptor signaling (ARS) inhibitors, in mCRPC patients who experienced disease progression while receiving the other ARS inhibitor.

About mCRPC

Metastatic castration-resistant prostate cancer (mCRPC) is an advanced form of prostate cancer and is defined by disease progression despite treatment with androgen depletion therapy (ADT). mCRPC may present as one or any combination of the following: a continuous rise in serum levels of PSA, progression of known metastases, or appearance of new metastases. Prognosis is associated with several factors, including the ability to perform certain daily activities and the presence of bone pain. Additional symptoms commonly include anemia (low levels of healthy red blood cells), weight loss,

fatigue, hypercoagulability (abnormal blood coagulation), and increased susceptibility to infection. mCRPC presents as a spectrum of disease, ranging from patients without symptoms but rising PSA levels despite ADT to patients with metastases and significant debilitation.

On April 1, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported positive interim data from the ongoing single-arm marginal zone lymphoma (MZL) cohort of its Phase 2b clinical trial known as UNITY-NHL (Press release, TG Therapeutics, APR 1, 2019, View Source [SID1234534821]). The MZL cohort of UNITY-NHL is designed to investigate umbralisib as a single agent in patients with relapsed or refractory MZL. Umbralisib is an investigational, oral, once daily PI3K delta inhibitor with unique inhibition of CK1 epsilon and is currently under development for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

The interim data were reported this morning by Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center and Study Chair of the UNITY-NHL MZL cohort, during this morning’s official 2019 Press Program at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Dr. Fowler will also present the data during an oral session this afternoon (details below).

Summary of Data Presented:

The MZL cohort of UNITY-NHL enrolled patients with relapsed or refractory MZL who had received prior treatment with one or more lines of therapy including at least one anti-CD20 regimen. In August 2018, the trial completed enrollment with 69 treated patients. The interim data reported today included safety and tolerability data on all 69 treated patients (safety population) and efficacy data on 42 patients who were enrolled at least 9 cycles (28 day cycles) prior to the data cut-off date (interim efficacy population). The primary endpoint is overall response rate (ORR) as assessed by IRC using criteria adopted from the International Working Group criteria for malignant lymphoma.

Efficacy

Analysis of the interim efficacy population (n=42) with a median follow-up of 12.5 months showed the following:

Interim Efficacy Population (n=42)
Overall Response Rate by IRC (CR + PR), %
52%
Complete Response by IRC (CR), (%)
19%
Partial Response by IRC (PR), (%)
33%
Median duration of response, months
NR (95% CI: 8.4 – NE)

CI = confidence interval; NR = not reached; NE = not estimable; SD = stable disease

Additional Efficacy Highlights:

● 88% clinical benefit rate by IRC (defined as patients obtaining Complete Response + Partial Response + Stable Disease)

● All patients achieving a Complete Response by IRC remain on study (range: 10.1+ to 15.7+ months)

● 86% of patients had a reduction in tumor burden

● Median time to initial response was 2.7 months

● Kaplan-Meier (KM) estimate of progression-free survival (PFS) at 12 months was 66%, with the median PFS not reached

Safety

Interim safety data were presented for all 69 treated patients with a median duration of exposure of 6.9 months. No unexpected toxicities were observed. The most common adverse events were diarrhea, nausea, and fatigue, with the majority of events Grade 1 in severity. The most frequent grade 3 or higher adverse events were neutropenia, diarrhea and ALT/AST increase, observed in 13%, 10% and 10% of patients, respectively.

A subgroup analysis of patients treated for greater than 6 cycles (n=41) was also conducted to evaluate long-term incidence of key toxicities of interest occurring after 6 cycles of treatment. Median duration of treatment of this subgroup was 10.1 months (range: 5.6 – 19.1 months). In this subgroup, grade 3 or higher adverse events of interest were rare, limited to 2 patients with diarrhea and 1 patient with pneumonitis, with no events of ALT/AST elevation, pneumonia, or colitis.

Key Safety Findings (n=69):

● No events of colitis were reported and only 1 event of Grade 3 pneumonitis was reported

● Grade 3 infections were limited, occurring in 3 patients (bronchitis, pneumonia, and influenza)

● Discontinuations due to umbralisib-related AEs were limited (14%) with no discontinuations after 6 months due to a treatment-related AE

● No deaths occurred on study

Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center and the Study Chair of the UNITY-NHL MZL cohort, stated, "MZL remains an incurable disease with few treatment options for patients who relapse after first-line chemoimmunotherapy. The exciting results presented today suggest that this oral targeted therapeutic has significant activity against relapsed/refractory marginal zone lymphoma and offers hope for patients." Dr. Fowler continued, "The adverse event and clinical activity data are highly encouraging at this point and we are excited to continue following patients for a longer time. With the results reported thus far, umbralisib has the potential to make a real difference for patients with relapsed/refractory marginal zone lymphoma."

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are very excited about these interim data and believe the results today demonstrate the activity and differentiated safety and tolerability profile of umbralisib at our Phase 3 dose of 800 mg once per day." Mr. Weiss continued, "As announced previously, the efficacy for the entire population has already reached our target range of 40-50% ORR and we look forward to presenting the final data from the entire MZL cohort later this year when all patients have had the opportunity to be followed for at least 9 cycles. In addition, we look forward to discussing the results with the FDA with a goal of filing for accelerated approval by year end."

CONFERENCE CALL INFORMATION

The Company will host a conference call today, Monday April 1, 2019, at 12:00pm (noon) ET. Michael S. Weiss, Chief Executive Officer of TG Therapeutics, will host the call and Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston and Study Chair of the MZL cohort, will review the UNITY-NHL interim MZL data.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics AACR (Free AACR Whitepaper) Update Call.

A live webcast and accompanying slides will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com for a period of 30 days after the call.

2019 AACR (Free AACR Whitepaper) ORAL PRESENTATION DETAILS

● Title: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open-label, registration directed Phase II study
o Session Date and Time: Monday April 1, 2019 3:00 PM – 5:00 PM ET
o Presentation Time: 4:20 PM ET
o Session Title: The Next Generation of Clinical Trials in Molecularly-driven Therapy
o Session Location: Marcus Auditorium- Bldg A-GWCC
o Presenter: Nathan Fowler, MD, Associate Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX
o Abstract Number: 7821

The full text of the abstract is now available and can be accessed via the AACR (Free AACR Whitepaper) meeting website at www.aacr.org. The slides to be presented in this afternoon’s oral presentation are available on the Company’s corporate website at www.tgtherapeutics.com/publications.cfm.

ABOUT THE UNITY-NHL PHASE 2b STUDY—Marginal Zone Lymphoma Cohort

The multicenter, open-label, UNITY-NHL Phase 2b study – Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by central Independent Review Committee (IRC) assessment.

The MZL cohort completed enrollment in August 2018 with a total of 69 patients enrolled and receiving at least one dose of umbralisib. In February of 2019, the Company announced that the MZL cohort met its primary endpoint of ORR as determined by central IRC for all treated patients (n=69). While the study has already met the Company’s target guidance of 40-50% ORR, the final analysis of ORR will be conducted when all treated patients have had at least 9 cycles (cycle = 28 days) of follow-up. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

ABOUT BREAKTHROUGH THERAPY DESIGNATION

The Company announced in January of 2019 that the U. S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for umbralisib for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20 regimen.

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.

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On April 1, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX) and 4SC AG (FSE Prime Standard: VSC) reported the combination of 4SC’s orally available class I selective HDAC inhibitor domatinostat (4SC-202) with Dynavax’s intratumoral TLR9 agonist SD-101 induced a systemic anti-tumoral immune response in tumor mouse models, resulting in the significant decrease in tumor size of both target tumors and distant site metastases (Press release, Dynavax Technologies, APR 1, 2019, View Source [SID1234534838]).

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Combination of SD-101 with domatinostat showed better results than combinations of SD-101 with competing HDAC inhibitors. The triple combination of both compounds with PD-1 blockade (checkpoint inhibition) demonstrated even higher efficacy.

Émilie Degagné, PhD, scientist at Dynavax will present the data in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting, which takes place from 29 March to 3 April 2019 in Atlanta, USA.

Combined mode of actions of SD-101 plus checkpoint inhibitor plus domatinostat

SD-101 is a TLR9 agonist, which was specifically developed for cancer based upon its ability to stimulate both IFN-α production and the maturation of plasmacytoid dendritic cells into tumor antigen presenting cells. This results in increased activation and proliferation of tumor-specific CD8+ T cells which attack distant site non-injected tumors. Domatinostat, acting via epigenetic regulation, renders tumor cells more visible to the immune system and promotes a general immune response against tumor tissue as well as infiltration of T cells into the tumor tissue.

Preclinical data demonstrate that the combination of intra-tumoral SD-101 and systemic domatinostat strongly synergize to induce substantial regression of the primary (injected) tumor, as well as distant site non-injected tumors, including lung metastases. Checkpoint inhibitors, such as anti-PD-1 antibodies further boost the anti-tumor T-cell response, leading to rejection in mice with high metastatic burden. These data indicate that the combination of these three different treatment classes result in induction of a more potent tumor-specific immune response and better recognition and elimination of tumors by immune cells, especially in cancer patients refractory to anti-PD-1 treatment.

"We believe the induction of innate immunity will be instrumental in the future treatment of cancer and are pleased to work with 4SC as they develop differentiated drug candidates to modulate the immune system," said Eddie Gray, CEO of Dynavax. "SD-101 has demonstrated significant antitumor effects by direct enhancement of innate immunity and adds meaningful clinical benefit to anti-PD-1 therapy. The addition of domatinostat to this combination shows encouraging results and we look forward to continuing to assess the potential of this combination."

Jason Loveridge, Ph.D., CEO of 4SC, added: "We thank Eddie Gray and his team at Dynavax for performing these highly promising experiments. We are very impressed by the data on the triple-combination of SD-101, domatinostat and PD-1 blockade and believe there is significant potential for novel combinations based on immunotherapeutics such as these to fight cancer, especially in patients who are resistant to or progressing on treatment with prior immunotherapies. Of particular importance to us was the clear demonstration of domatinostat’s superiority as compared to competing HDAC inhibitors."

Abstract ID 2259: Tumor abscopal responses induced by the TLR9 agonist, SD-101, are strongly potentiated by a HDAC class I inhibitor, domatinostat.

Date: 1 April 2019
Time: 1:00 PM – 5:00 PM EDT
Session: PO.CL06.05 – Combination Immunotherapies 1
Location: Exhibit Hall B, Section 19, Poster Board Number 18

Further information

About SD-101

SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

About domatinostat (4SC-202)

Domatinostat is an orally administered small molecule Class I selective HDAC inhibitor with a unique mode of action that was designed to strengthen the body’s own anti-tumor immune response. Domatinostat also influences the tumor microenvironment facilitating infiltration of immune cells into the tumor and making it more visible to the immune system.

Domatinostat has been investigated in a Phase I study with 24 heavily pretreated patients with several types of advanced hematologic cancers and was well tolerated. Positive signs of anti-tumor efficacy were also observed; with one complete remission (28 months) and one partial responder (8 months).

In addition to its therapeutic potential in cancer monotherapy, 4SC is evaluating domatinostat’s capacity as a partner in combination therapies, specifically in the immuno-oncology area. In this respect, 4SC initiated a Phase Ib/II study of domatinostat in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with advanced-stage melanoma. A second Phase II study of domatinostat in combination with the anti-PD-L1 checkpoint inhibitor avelumab in patients with advanced-stage microsatellite-stable gastrointestinal cancer is conducted by Prof. David Cunningham of The Royal Marsden NHS Foundation Trust (London, UK).

As soon as results from the aforementioned trials will be available, 4SC plans to advance domatinostat into a potentially pivotal study in combination with a checkpoint inhibitor in PD-(L)1 refractory patients with advanced Merkel-cell carcinoma (MCC).

On April 1, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune disease, asthma and allergic diseases, reported that company management will participate in two upcoming conferences (Press release, Xencor, APR 1, 2019, View Source [SID1234534854]):

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Jefferies 6th Annual IO Cell Therapy Summit
Date: Friday, April 5, 2019
Location: Boston, MA
18th Annual Needham Healthcare Conference
Date: Tuesday, April 9, 2019
Presentation Time: 2:10 p.m. ET
Location: New York, NY
A live webcast of the Needham Healthcare Conference presentation will be available under "Events & Presentations" in the Investors section of the Company’s website located at View Source A replay of the event will be posted on the Xencor website approximately one hour after the live event and will be available for 90 days following the event.