Servier Announces FDA Filing Acceptance and Priority Review for TIBSOVO® (ivosidenib tablets) in IDH1-mutated Cholangiocarcinoma

On May 5, 2021 Servier Pharmaceuticals, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO (ivosidenib tablets) as a potential treatment for patients with previously treated IDH1-mutated cholangiocarcinoma (Press release, Servier, MAY 5, 2021, View Source [SID1234579238]).

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The sNDA was granted Priority Review, which accelerates the review time from 10 months to a goal of 6 months from the day of filing acceptance. Priority Review is typically given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.

"While today is a significant milestone in our company’s history, it is also a beacon of hope for the cholangiocarcinoma patient community," said David K. Lee, CEO, Servier Pharmaceuticals. "As we continue to expand our oncology leadership presence in the U.S. into the solid tumor space, we remain committed to addressing the critical unmet needs of patients with difficult-to-treat cancers including cholangiocarcinoma."

The sNDA acceptance is supported by data from the ClarIDHy study, the first and only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma. An encore presentation of the data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 4-8, 2021.

"Currently, there are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available for patients with advanced disease," said Susan Pandya, M.D., Vice President, Clinical Development, Head of Cancer Metabolism Global Development, Servier Pharmaceuticals. "The FDA’s Priority Review is a major milestone for patients. I’d like to acknowledge and thank all the patients, their families and the investigators and research teams who took part in the ClarIDHy study."

TIBSOVO (ivosidenib tablets) is currently approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

In an effort to meet more patient needs than ever before, Servier Pharmaceuticals has grown by nearly 20% in the past two years. The company will continue to grow its oncology portfolio through new and existing research and development collaborations, potential acquisitions and a new lab opening in 2022.

About Cholangiocarcinoma

Cholangiocarcinoma is a rare, aggressive cancer of the bile ducts within and outside of the liver. IDH1 mutations occur in approximately 13% of cholangiocarcinoma cases and are not associated with prognosis. There are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available in the advanced setting. Gemcitabine-based chemotherapy is often recommended for newly diagnosed advanced or metastatic disease.

About TIBSOVO (ivosidenib tablets)

TIBSOVO is indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:

Adult patients with newly-diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Adult patients with relapsed or refractory AML.
IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: See Boxed WARNING. In the clinical trial, 25% (7/28) of patients with newly diagnosed AML and 19% (34/179) of patients with relapsed or refractory AML treated with TIBSOVO experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and creatinine increased. Of the 7 patients with newly diagnosed AML who experienced differentiation syndrome, 6 (86%) patients recovered. Of the 34 patients with relapsed or refractory AML who experienced differentiation syndrome, 27 (79%) patients recovered after treatment or after dose interruption of TIBSOVO. Differentiation syndrome occurred as early as 1 day and up to 3 months after TIBSOVO initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe.

QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. One patient developed ventricular fibrillation attributed to TIBSOVO. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, or electrolyte abnormalities, or in those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary.

Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Guillain-Barré Syndrome: Guillain-Barré syndrome occurred in <1% (2/258) of AML patients treated with TIBSOVO in the clinical study. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome.

ADVERSE REACTIONS

The most common adverse reactions including laboratory abnormalities (≥20%) were hemoglobin decreased (60%), fatigue (43%), arthralgia (39%), calcium decreased (39%), sodium decreased (39%), leukocytosis (38%), diarrhea (37%), magnesium decreased (36%), edema (34%), nausea (33%), dyspnea (32%), uric acid increased (32%), potassium decreased (32%), alkaline phosphatase increased (30%), mucositis (28%), aspartate aminotransferase increased (27%), phosphatase decreased (25%), electrocardiogram QT prolonged (24%), rash (24%), creatinine increased (24%), cough (23%), decreased appetite (22%), myalgia (21%), constipation (20%), and pyrexia (20%).
In patients with newly diagnosed AML, the most frequently reported Grade ≥3 adverse reactions (≥5%) were fatigue (14%), differentiation syndrome (11%), electrocardiogram QT prolonged (11%), diarrhea (7%), nausea (7%), and leukocytosis (7%). Serious adverse reactions (≥5%) were differentiation syndrome (18%), electrocardiogram QT prolonged (7%), and fatigue (7%). There was one case of posterior reversible encephalopathy syndrome (PRES).
In patients with relapsed or refractory AML, the most frequently reported Grade ≥3 adverse reactions (≥5%) were differentiation syndrome (13%), electrocardiogram QT prolonged (10%), dyspnea (9%), leukocytosis (8%), and tumor lysis syndrome (6%). Serious adverse reactions (≥5%) were differentiation syndrome (10%), leukocytosis (10%), and electrocardiogram QT prolonged (7%). There was one case of progressive multifocal leukoencephalopathy (PML).
DRUG INTERACTIONS

Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation.
Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO.
Sensitive CYP3A4 Substrates: Avoid concomitant use with TIBSOVO.
QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation.

LACTATION
Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with TIBSOVO and for at least 1 month after the last dose.

TRACON Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Corporate Update

On May 20, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the first quarter ended March 31, 2021 (Press release, Tracon Pharmaceuticals, MAY 5, 2021, View Source [SID1234579186]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We continue to be pleased with the pace of enrollment in the pivotal ENVASARC trial and remain on track to deliver interim data in the 2nd half of this year and final data in 2022," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We have now initiated 22 sites and have enrolled more than 20 patients which has triggered the initial Data Monitoring Committee review of safety data from each cohort, which we expect later this quarter."

Recent Corporate Highlights

Envafolimab

In April, we resubmitted our Orphan Drug Designation application to the FDA in response to a request for preclinical or clinical evidence of activity for envafolimab in sarcoma. We expect correspondence from the FDA this quarter based on the amended application.

As of May 5, we have initiated 22 U.S. clinical sites and enrolled more than 20 patients in the pivotal ENVASARC trial of single agent envafolimab and envafolimab combined with Yervoy, which has triggered the initial Data Monitoring Committee review of safety data from each cohort.
Expected Key Upcoming Milestones

Orphan Drug Designation for envafolimab in soft tissue sarcoma from FDA in 1H 2021.

Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021.

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) presentation of ENVASARC pivotal trial design in 1H 2021.

ASCO presentation of TJ004309 Phase 1 data in 1H 2021.

Interim ENVASARC efficacy and safety data in 2H 2021.

Request FDA breakthrough therapy designation or Fast Track designation for envafolimab in 2H 2021.

Decision on the envafolimab New Drug Application (NDA) in MSI-H/dMMR cancer that is under priority review by the Chinese National Medical Products Administration (NMPA).
First Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments were $30.4 million at March 31, 2021, compared to $36.1 million at December 31, 2020. The Company expects that its current cash, cash equivalents and short-term investments will fund operations into the second half of 2022.

Research and development expenses for the first quarter of 2021 were $2.3 million, compared to $2.0 million for the first quarter of 2020.

General and administrative expenses for the first quarter of 2021 were $2.7 million, compared to $1.9 million for the first quarter of 2020.

Net loss for the first quarter of 2021 was $5.1 million, compared to $4.0 million for the first quarter of 2020.
Conference Call Details

Wednesday, May 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 8852857
A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by 3D Medicines. TRACON’s partners Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of the KEYNOTE-164 clinical trial.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the U.S. FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

Race Placement closes oversubscribed & Bonus Option Issue launched for shareholders

On May 5, 2021 Race Oncology Limited (ASX: RAC) reported that it has received binding commitments to raise $5.4m (before associated costs) in an oversubscribed equity placement to new and existing institutional and sophisticated investors (Placement), and the commencement of a bonus issue of options to existing eligible shareholders of Race (Bonus Option Issue) (Press release, Race Oncology, MAY 5, 2021, View Source [SID1234580021]).

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"This new funding supports efforts to deliver outsized returns to shareholders via our Three Pillar strategy, where we are investigating Bisantrene as both a potential precision oncology agent, and as a heart-friendlier chemotherapeutic. We appreciate the amount of interest shown in both Race and Bisantrene through this process and thank all those who participated in the Placement."

Race’s CEO and Managing Director, Phil Lynch
"We thank our new and existing shareholders for their continuing support. We believe that this raise will accelerate our plans and rewards our loyal shareholders. Race remains efficient with our capital usage and will always be focused on achieving the best outcome for our shareholders and the patients who may be helped by Bisantrene."

Dr Daniel Tillett, Race’s CSO and Executive Director
About the Placement
Race will raise $5.4m (before associated costs) under the Placement by the issue of approximately 1.8m new fully paid ordinary shares (New Shares) at an issue price of $3.00 per share. The issue price represents a 2.3% discount to the last traded price and an 7.8% discount to the 10-day volume weighted average price of $3.25.

Participants in the Placement will receive 1 free attaching option (exercisable at $4.50 and expiring 16 May 2022) (Placement Option) for every 20 New Shares subscribed for and issued under the Placement. The Placement, including the Placement Options, is not subject to shareholder approval.

The cornerstone investor to the Placement was existing Race shareholder, Merchant Opportunities Fund. Merchant Opportunities Fund is a boutique fund with a number of long-term, strategic investments in the Australian biotechnology industry. Race accepted bids above $5m to cover all costs in managing the Placement leaving approximately $5m for planned activities.

Merchant Capital Partners Pty Ltd and MST Financial Services Pty Ltd acted as Joint Lead Managers and bookrunners to the Placement. IR Department provided investor relations support.

The New Shares and Placement Options are expected to be allotted and issued by 14 May 2021 and New Shares will rank equally with the existing ordinary shares on issue. The New Shares and Placement Options will be issued pursuant to the Company’s existing placement capacity under ASX listing rule 7.1.

Use of Funds
The Placement provides Race with additional capital to be primarily deployed toward its Three Pillar strategy and supporting plans:

Pillar 1: Phase 1 dose escalation trial to determine optimal FTO-targeted Phase II dosage
Pillar 2: Preclinical study to determine the molecular mechanism of action of Bisantrene’s heart safety
Pillar 3: Initiation of studies in Europe and the United States to support extramedullary Acute Myeloid Leukaemia clinical trials
Corporate: scaled manufacturing of Bisantrene to support Phase II/III trials
About the Bonus Option Issue
Race is also pleased to announce a pro-rata non-renounceable Bonus Option Issue (exercisable at $4.50 and expiring 16 May 2022) (Bonus Options) to existing eligible shareholders on the basis of 1 Bonus Option for every 20 shares held on the record date.

The primary purpose of the Bonus Option Issue is to reward loyal shareholders in Race, while efficiently growing the Company.

The Bonus Option Issue is being extended to eligible shareholders who have a registered address in Australia or New Zealand at 7:00 pm AEST on 13 May 2021.

The Bonus Options and the Placement Options will be in the same class and will not be listed. The details of the offer are contained in the Bonus Option Prospectus below.

Allogene Therapeutics Reports First Quarter 2021 Financial Results

On May 5, 2021 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported financial results for the quarter ended March 31, 2021 (Press release, Allogene, MAY 5, 2021, View Source [SID1234579206]).

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"We’ve had a strong start to the year as evidenced by the significant clinical and regulatory progress made across our growing AlloCAR T portfolio, including the start of our first solid tumors study," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We believe our progress demonstrates our ability to advance the field of allogeneic CAR T cell therapy and we look forward to sharing data from our CD19 program on May 19th during our virtual forum event."

Pipeline Highlights

Anti-CD19 Program

Updated data from the dose escalation Phase 1 ALPHA study of ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) will be jointly presented with initial data from the ALPHA2 study of ALLO-501A at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The presentation will include longer-term follow-up from the initial cohort of patients reported at ASCO (Free ASCO Whitepaper) 2020, additional data on patients treated subsequent to ASCO (Free ASCO Whitepaper) 2020, dose escalation data from ALPHA2, and initial results from patients treated with consolidation dosing of ALLO-501 and ALLO-501A. A separate poster presentation will detail safety and biomarker findings from ALLO-647, Allogene’s wholly owned antibody used for lymphodepletion with fludarabine (Flu)/cyclophosphamide (Cy) in patients with relapsed/refractory NHL and multiple myeloma.
Subject to further study progress and data, the Company plans to initiate a potentially pivotal Phase 2 trial of ALLO-501A by the end of 2021.
On May 19, 2021, the Company will host a virtual CD19 Forum focused on clinical data being presented at ASCO (Free ASCO Whitepaper), along with the Company’s vision for the future of CAR T therapy. In addition to presentations from Company management, the Forum will include a discussion with clinical investigators.
Anti-BCMA Program
The Company continues to execute on its portfolio of anti-B cell maturation antigen (BCMA) therapies in patients with multiple myeloma (MM).

ALLO-715 UNIVERSAL Trial
The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715, Allogene’s most advanced AlloCAR T candidate for relapsed/refractory MM. The designation follows proof-of-concept data from the Phase 1 UNIVERSAL trial in heavily pretreated, relapsed/refractory MM patients, which demonstrated for the first time that an allogeneic CAR T therapy directed at BCMA can achieve clinical responses while eliminating the need for bridging therapy or delays in treatment associated with manufacturing.

Patient dosing has begun in the portion of the UNIVERSAL trial investigating ALLO-715 in combination with nirogacestat in patients with relapsed/refractory MM. Nirogacestat is an investigational gamma secretase inhibitor being developed by SpringWorks Therapeutics.

ALLO-605 TurboCAR IGNITE Trial
The FDA cleared the Investigational New Drug (IND) application to evaluate ALLO-605, the first TurboCAR T cell therapy, for use in relapsed/refractory MM. TurboCAR technology allows cytokine activation signaling to be engineered selectively into CAR T cells to potentially improve efficacy, overcome exhaustion, and reduce cell dose requirements. The Phase 1 IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021.
Solid Tumor Program

ALLO-316 TRAVERSE Trial
Patient dosing has begun in the Phase 1 TRAVERSE trial examining safety, tolerability, anti-tumor efficacy, pharmacokinetics and pharmacodynamics of ALLO-316, Allogene’s first CAR T candidate for solid tumors, in patients with advanced or metastatic clear cell renal cell carcinoma.

Expanded TurboCAR Platform
In April 2021, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the Company reported on pre-clinical data that expands the TurboCAR technology platform to address the biology of solid tumor oncology. TurboCARs were engineered to confer cytokine signaling that is inducible upon binding to PDL1 in the tumor microenvironment or when stimulated with an anti-PD1 antibody while acting as a dominant negative for PDL1 and PDL2 immunosuppressive signaling. These TurboCARs are designed to overcome the challenges in solid tumors associated with an immuno-suppressive tumor microenvironment (TME) by turning negative signals into positive signals.
First Quarter Financial Results

Research and development expenses were $55.2 million for the first quarter of 2021, which includes $7.9 million of non-cash stock-based compensation expense.
General and administrative expenses were $16.4 million for the first quarter of 2021, which includes $8.9 million of non-cash stock-based compensation expense.
Net loss for the first quarter of 2021 was $33.0 million, or $0.25 per share, including non-cash stock-based compensation expense of $16.8 million.
The Company had $964.2 million in cash, cash equivalents, and investments as of March 31, 2021.
2021 Financial Guidance
Allogene continues to expect full year GAAP Operating Expenses to be between $300 million and $330 million including estimated non-cash stock-based compensation expense of $80 million to $90 million and excluding any impact from potential new business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 9435559. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Virtual CD19 Forum
Additional information on the Company’s May 19 Virtual CD19 Forum will be made available in a separate press release and on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Materials presented will be available on the Allogene website prior to the start of the event.

Poseida Therapeutics to Present at BofA Securities 2021 Virtual Health Care Conference

On May 5, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported that the Company’s CEO, Eric Ostertag, MD, PhD, will present at the BofA Securities 2021 Virtual Health Care Conference on Wednesday, May 12, 2021 at 2:45pm ET (Press release, Poseida Therapeutics, MAY 5, 2021, View Source [SID1234579222]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A webcast of the presentation will be available on the Investors & Media Section of the Poseida website, www.poseida.com. An archived replay of the webcast will be available for approximately 30 days following each presentation.