On May 19, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies, reported that additional data from its Phase 1/2a study of PBCAR0191, the Company’s first generation, off-the-shelf allogeneic CAR T candidate targeting CD19 will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting being held virtually June 4-8, 2021 (Press release, Precision Biosciences, MAY 19, 2021, View Source [SID1234580255]).

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Abstracts are available and can be viewed on the ASCO (Free ASCO Whitepaper) web site at www.asco.org. Additional data including updated response rates, safety, and durability will be presented at the ASCO (Free ASCO Whitepaper) meeting.

Title: Preliminary safety and efficacy of PBCAR0191, an allogeneic, off-the-shelf CD19-targeting CAR T product, in relapsed/refractory (r/r) CD19+ NHL
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia, Abstract 7516
Date/Time: Friday, June 4, 2021 at 9:00 a.m. ET
Presenting Author: Bijal Shah, M.D., Moffitt Cancer Center

By February 1, 2021, 13 patients with R/R non-Hodgkin lymphoma (NHL) met study eligibility criteria and had received PBCAR0191 dose level 3 at 3×106 or equivalent with either standard lymphodepletion (sLD) (n=6)1 or enhanced lymphodepletion (eLD) (n=7)2. Of these patients, 77% had aggressive lymphomas and 62% had four or more courses of prior treatment. PBCAR0191 continued to demonstrate an acceptable safety profile with no cases of graft versus host disease, no cases of Grade ≥ 3 cytokine release syndrome, and no cases of Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome.

"These results continue to confirm the activity of PBCAR0191 with strategies that mitigate rejection, and we look forward to sharing additional data in the poster and on our hosted conference call on June 4," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "While we continue to advance PBCAR0191 through its Phase 1/2a study, we eagerly await the clinical start of our next-generation, immune evading stealth cell technology with PBCAR19B, which includes modifications designed to enhance CAR T persistence and delay allogeneic immune rejection by T cells and natural killer cells."

Company-Hosted Conference Call and Web Cast Information
Precision will host a conference call and webcast on Friday, June 4, 2021 at 8:00 a.m. ET to review the most recent interim clinical data for PBCAR0191. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 5647916. Participants may access the live webcast and the accompanying presentation materials on Precision’s website www.precisionbiosciences.com in the Investors and Media section under Events and Presentations. An archived replay of the webcast will be available on Precision’s website.

On May 19, 2021 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that Ryan Spencer, Chief Executive Officer, will participate in a virtual fireside chat at the William Blair 41th Annual Growth Stock Conference on Tuesday, June 1, 2021 at 2:40 p.m. C.T (Press release, Dynavax Technologies, MAY 19, 2021, View Source [SID1234580254]).

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

On May 19, 2021 Novartis reported that it will present new data from its portfolio of approved and investigational targeted, radioligand, cell and gene and immunotherapies at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 2021 European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress (Press release, Novartis, MAY 19, 2021, View Source [SID1234580253]). More than 110 abstracts, including Novartis-sponsored and investigator-initiated trials, will be presented at the meetings.

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"Our bold ambition is to extend and improve the lives of those living with cancer and serious blood disorders, and ultimately find cures," said Susanne Schaffert, PhD, President, Novartis Oncology. "These exciting data from across our four therapeutic platforms illustrate how we are uniquely positioned to deliver transformative innovations that may bring renewed hope for patients."

Key highlights of data accepted by ASCO (Free ASCO Whitepaper):

Efficacy and safety results from Phase III VISION study of investigational targeted radioligand therapy 177Lu-PSMA-617
Phase 3 study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION) [Abstract #LBA4; oral presentation (plenary): Sunday, June 6, 1:00 PM EDT]

Kisqali (ribociclib)* overall survival analysis from MONALEESA-3
Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB) [Abstract #1001; oral presentation: Saturday, June 5, 1:30 PM EDT]

Piqray (alpelisib) long-term disease control data from SOLAR-1
Long-term (LT) Disease Control in Patients (pts) With Hormone Receptor-Positive (HR+), PIK3CA-Altered Advanced Breast Cancer (ABC) Treated With Alpelisib (ALP) + Fulvestrant (FUL) [Abstract #1054; poster session: Friday, June 4, 9:00 AM EDT]

Kymriah (tisagenlecleucel) updated efficacy and safety results from Phase II ELARA trial in patients with relapsed or refractory follicular lymphoma
Efficacy and Safety of Tisagenlecleucel (Tisa-cel) in Adult Patients (Pts) With Relapsed/Refractory Follicular Lymphoma (r/r FL): Primary Analysis of the Phase 2 ELARA Trial [ASCO: Abstract #7508; oral presentation: Monday, June 7, 11:30 AM EDT] / [EHA encore: Abstract #S210; oral presentation: Friday, June 11, 9:00 AM CEST]

Investigational agent tislelizumab** RATIONALE 302 pivotal data in advanced/unresectable metastatic esophageal squamous cell carcinoma and Phase II data in patients with MSI-H or dMMR solid tumors
RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma [Abstract #4012; poster discussion: Friday, June 4, 9:00 AM EDT]
A phase 2 study of tislelizumab monotherapy in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high/mismatch repair deficient solid tumors [Abstract #2569; poster discussion: Friday, June 4, 9:00 AM EDT]

Early data demonstrating innovation in solid tumors with novel assets TNO155 and NIS793; further combination studies and NIS793 Phase III planned to start later this year
Initial results from a dose finding study of TNO155, a SHP2 inhibitor, in adults with advanced solid tumors [Abstract #3005; oral abstract: Friday, June 4, 11:00 AM EDT]
Phase Ib study of the anti-TGF-β monoclonal antibody (mAb) NIS793 combined with spartalizumab (PDR001), a PD-1 inhibitor, in patients (pts) with advanced solid tumors [Abstract #2509; poster session: Friday, June 4, 9:00 AM EDT]

Analysis of pyrexia-related and efficacy outcomes with new pyrexia management algorithm in patients with stage III BRAF-mutation positive melanoma treated with adjuvant Tafinlar (dabrafenib) and Mekinist (trametinib)
Improved pyrexia-related outcomes associated with an adapted pyrexia adverse event (AE) management algorithm in patients (pts) treated with adjuvant dabrafenib + trametinib (dab + tram): Primary results of COMBI-APlus [Abstract #9525; poster session: Friday, June 4, 9:00 AM EDT]

Tabrecta (capmatinib)*** updated analysis from Phase II GEOMETRY mono-1 trial
Capmatinib in MET exon 14-mutated, advanced NSCLC: Updated results from the GEOMETRY mono-1 study [Abstract #9020; poster session: Friday, June 4, 9:00 AM EDT]

Lutathera (lutetium Lu 177 dotatate)**** final overall survival data from Phase III NETTER-1 study in adults with somatostatin receptor-positive midgut neuroendocrine tumors
Final overall survival in the phase 3 NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumors [Abstract #4112; poster session: Friday, June 4, 9:00 AM EDT]
Key highlights of data accepted by EHA (Free EHA Whitepaper):

Iptacopan (LNP023) efficacy and safety results from Phase II oral monotherapy trial as first-line treatment in patients with paroxysmal nocturnal hemoglobinuria
First-Line Treatment of PNH Patients With Iptacopan Leads to Rapid and Durable Hemoglobin Increase by Controlling Both Intra- and Extra-Vascular Hemolysis [Abstract #S173; oral presentation: Friday, June 11, 9:00 AM CEST]

Subgroup analyses of REACH2 trial evaluating Jakavi (ruxolitinib)***** in acute graft-versus-host disease
Efficacy and Safety of Ruxolitinib in Patients With Steroid-Refractory Acute Graft-Vs-Host Disease After Crossover in the Phase 3 REACH2 Study [Abstract #S236; oral presentation: Friday, June 11, 9:00 AM CEST]

Results from X2105 study of sabatolimab (MBG453), a novel immuno-myeloid therapy targeting TIM-3, in patients with a myelodysplastic syndromes and acute myeloid leukemia
Sabatolimab Plus Hypomethylating Agents (HMAs) in Patients (Pts) With High-/Very High-risk Myelodysplastic Syndrome (HR/vHR-MDS) and Acute Myeloid Leukemia (AML): Subgroup Analysis of a Phase 1 Study [Abstract #S168; oral presentation: Friday, June 11, 9:00 AM CEST]

Safety and efficacy results from the Phase II SOAR trial evaluating Promacta/Revolade (eltrombopag) in patients with severe acquired aplastic anemia who cannot use ATG
An Interventional, Phase 2, Single-Arm Study to Assess the Efficacy and Safety of Eltrombopag Combined with Cyclosporine as First-Line Therapy in Adults with Severe Acquired Aplastic Anemia (SOAR) [Abstract #S172; oral presentation: Friday, June 11, 9:00 AM CEST]
Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

On May 19, 2021 Propella Therapeutics Inc. (Propella), a biopharmaceutical company focused on developing innovative, best-in-class oncology drugs, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PRL-02 (abiraterone decanoate), a potentially best-in-class therapy for metastatic prostate cancer (Press release, Propella Therapeutics, MAY 19, 2021, View Source [SID1234580252]). Under the IND, Propella plans to initiate an open-label, phase 1/2a clinical study in June 2021. The phase 1 portion will have a dose-escalation design that will assess the safety, tolerability, pharmacokinetics, and preliminary clinical activity of PRL-02 in patients with metastatic prostate cancer.

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"We believe that abiraterone decanoate has the potential to be a more effective and convenient therapy for advanced prostate cancer than current standards of care," said Propella President and CEO, William Moore. "We have strong preclinical data, and we’re excited to be initiating a first-in-human trial. This is a key milestone for us."

PRL-02 is a novel, long-acting prodrug of abiraterone. The acetate prodrug of abiraterone is the current standard of care for advanced prostate cancer. Abiraterone acetate produces varying daily blood concentrations of the active drug, abiraterone, including high levels that may produce side effects, including liver toxicity, and low levels that may not be effective. Preclinical results showed that a single dose of PRL-02, injected into the muscle, produced the precise concentrations of abiraterone that produced clinically relevant declines in testosterone for more than 12 weeks, with a better safety profile than oral abiraterone acetate, and without liver effects.

"PRL-02 represents the first potent, long-acting androgen biosynthesis inhibitor and which has the potential to improve upon the safety and efficacy of chronic hormonal therapy for metastatic prostate cancer patients," observed Daniel George, Professor of Medicine and Surgery, Divisions of Medical Oncology and Urology at the Duke University School of Medicine. "I am personally excited to see this agent enter the clinic."

Brendan Griffin Joins Propella as CFO

Today, Propella also announced the appointment of Brendan Griffin to its leadership team as the company’s Chief Financial Officer (CFO). In this role, Mr. Griffin will lead Propella’s finance, business and corporate development, administrative and communications activities.

"I’m pleased to be joining Propella at such a pivotal time in its trajectory," explained Mr. Griffin. "I look forward to being part of this team as we work together to realize this company’s extraordinary potential."

Prior to joining Propella, Mr. Griffin served as a senior member of the biotechnology investment banking team at SVB Leerink, a leading investment bank that specializes in healthcare and the life sciences. At SVB Leerink, he completed over 100 transactions for clients across North America, Europe, and Asia, including more than 20 initial public offerings. Mr. Griffin earned a Master of Business Administration degree from the Tepper School of Business at Carnegie Mellon University, a Master of Public Policy Management degree from Heinz College of Public Policy at Carnegie Mellon University, and a Bachelor of Science degree from Elon University.

On May 19, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Jefferies Virtual Healthcare Conference (Press release, Quest Diagnostics, MAY 19, 2021, View Source [SID1234580251]). Steve Rusckowski, Chairman, CEO and President, will discuss the company’s vision, goals, and capital deployment strategies. The presentation is scheduled for Thursday, June 3, 2021 at 8:00 a.m. Eastern Time.

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The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until July 3, 2021.