On March 8, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported the details of its poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, being held from April 8-13 in New Orleans, Louisiana (Press release, Gracell Biotechnologies, MAR 8, 2022, View Source [SID1234609730]).

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Gracell will present early clinical results of a first-in-human investigator-initiated trial (IIT) on GC502, an allogeneic CD19/CD7 dual-directed CAR-T cell therapy currently under development for multiple B-cell malignancy indications including B-cell acute lymphoblastic leukemia (B-ALL). GC502 is currently being studied in an open-label single-arm Phase 1 IIT in China for patients with B-ALL. This product candidate leverages the novel dual-directed CAR design of Gracell’s proprietary TruUCAR platform, which allows the CD19 CAR to target malignant cells, while the CD7 CAR is designed to suppress host-versus-graft rejection response.

Details of the presentation are as follows:

Presentation Title: Early results of a safety and efficacy study of allogeneic TruUCAR GC502 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
Session Title: Phase I Clinical Trials 2
Session Date and Time: Tuesday, April 12, from 9:00AM – 12:30PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 33
Poster Board Number: 21
Permanent Abstract Number: CT196
The full text of the abstract will be published to the AACR (Free AACR Whitepaper) Online Itinerary Planner at 1:00PM ET on Friday, April 8. The e-poster will be viewable to registered attendees on the AACR (Free AACR Whitepaper)’s e-poster website from Friday, April 8, through Wednesday, July 13. Additional meeting information is available on the AACR (Free AACR Whitepaper) website.

About GC502

GC502 is a TruUCAR-enabled CD19/CD7 dual-directed, off-the-shelf allogeneic CAR-T product candidate that is being studied for the treatment of B-cell malignancies. GC502 is manufactured using T cells from non-human leukocyte antigen (HLA) matched healthy donors. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells. Optimized for CD19/CD7 dual-CAR functionality and in vivo durability, GC502 has demonstrated robust anti-tumor efficacy with promising potential to suppress host versus graft (HvG) rejection in preclinical models.

About B-ALL

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with approximately 6,000 diagnosed in the United States, and approximately 7,400 diagnosed in China in 2020[1]. B-ALL accounts for 85%-88% of ALL diagnosed.

About TruUCAR

TruUCAR is Gracell’s proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host versus graft rejection (HvG) as well as graft versus host disease (GvHD) without the need for being co-administered with immunosuppressive drugs. The novel dual-directed CAR design allows tumor antigen-CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress HvG response.

On March 8, 2022 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that it will present preclinical data for its first generation of androgen receptor (AR) N-terminal domain degraders at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, ESSA, MAR 8, 2022, View Source [SID1234609729]). The ANITen bAsed Chimera (ANITAC) degraders suppressed AR transcriptional activity and decreased the viability of prostate cancer cells in castration-resistant prostate cancer (CRPC) preclinical models. ANITAC degraders degraded full length, mutant and splice variant forms of AR that are expressed in CRPC patients.

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Poster presentation details are as follows:

Title: Androgen receptor (AR) N-Terminal Domain degraders can degrade AR full length and AR splice variants in CRPC preclinical models
Authors: Nan Hyung Hong, et al.
Abstract Number: 429
Session Title: Protein Degraders and Proteasome Inhibitors
Session Date and Time: Sunday, April 10, 2022 | 1:30 p.m. – 5:00 p.m. ET
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 26

The e-poster will be available to 2022 AACR (Free AACR Whitepaper) Annual Meeting attendees and on the Company’s website at www.essapharma.com on April 8, 2022, at 1:00 p.m. ET.

On March 8, 2022 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the Company will present the updated data of PMC-309, one of the Company’s first immuno-oncology drug candidates, at AACR (Free AACR Whitepaper) (American Association for Cancer Research) 2022 (Press release, PharmAbcine, MAR 8, 2022, View Source [SID1234609728]). The event will take place both onsite (New Orleans, Louisiana) and online over April 8-13, 2022.

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Presentation Details
Title: PMC-309, a highly selective anti-VISTA antibody reverses immunosuppressive TME to immune-supportive TME
Session category/title: Preclinical/Immunotherapy
Presentation Type: Online (E-poster)
Date: April 8, 2022

PMC-309 is a novel anti-VISTA (V-domain Ig Suppressor of T cell Activation) antagonizing antibody in the development to treat various tumor types. VISTA is an immune checkpoint receptor that is mainly expressed on MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). It is known to play a pivotal role in maintaining the immunosuppressive environment around the tumor cells. Due to this unique mode of action, PMC-309 can provide a promising immunotherapeutic strategy and help address unmet medical needs.

"We are delighted to share the newly updated data of PMC-309 at this important annual event," said Dr. Jin-San Yoo, CEO of PharmAbcine. "Last year at both AACR (Free AACR Whitepaper) 2021 and KSMO (Korean Society of Medical Oncology) 2021, the Company presented PMC-309’s nonclinical data as of early-2021. The presentations highlighted that PMC-309 inhibits VISTA pathways on immunosuppressive cells, such as MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells) which resulted in T cell proliferation in in vitro settings and encouraging anti-tumor effects in in vivo studies. This year’s presentation will include PMC-309’s effect on monocyte activation, which is one of key immune-supportive factors. The Company is preparing an IND submission for a global clinical trial in 2022."

The abstract of the presentation is currently available on the AACR (Free AACR Whitepaper) website, and the e-poster will be accessible during the poster session at 1:00 p.m. ET on April 8 and be available for viewing through July 13.

On March 8, 2022 Blueprint Medicines Corporation (NASDAQ: BPMC) reported plans to present new clinical and preclinical data for multiple programs across its precision therapy portfolio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans, April 8 to 13 (Press release, Blueprint Medicines, MAR 8, 2022, View Source [SID1234609727]). The presentations highlight Blueprint Medicines’ next wave of therapeutic candidates in its growing pipeline. These investigational treatments could bring the promise of precision medicine to broad patient populations with genomically defined cancers, including lung, ovarian and breast cancers.

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"At AACR (Free AACR Whitepaper), we plan to unveil a constellation of data highlighting our scientific leadership in precision therapy, and reflecting our commitment to rapidly translate research into transformative medicines for patients," said Fouad Namouni, M.D., President of Research and Development at Blueprint Medicines. "With multiple drug candidates entering clinical trials, our AACR (Free AACR Whitepaper) presentations feature initial results from the Phase 1/2 SYMPHONY study of BLU-945 in EGFR-driven non-small cell lung cancer, as well as data reinforcing our programs’ differentiated preclinical profiles and significant potential to advance patient care."

The accepted abstracts are listed below and available on the AACR (Free AACR Whitepaper) conference website: View Source

Clinical Trial and Late-Breaking Poster Presentations

Presentation Title: Emerging evidence of activity of BLU-945 in patients with advanced EGFR-mutant NSCLC utilizing circulating tumor DNA (ctDNA) in the phase 1/2 SYMPHONY study
Session Title: Phase I Clinical Trials 2
Session Date & Time: Tuesday, April 12, 2022 from 9:00 a.m. – 12:30 p.m. CT (10:00 a.m. – 1:30 p.m. ET)
Abstract Number: CT184
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 33

Presentation Title: Efficacy of a highly potent and selective KIT V654A inhibitor for treatment of imatinib resistant GIST
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Session Date & Time: Wednesday, April 13, 2022 from 9:00 a.m. – 12:30 p.m. CT (10:00 a.m. – 1:30 p.m. ET)
Abstract Number: LB205
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 16

Poster Presentations

Presentation Title: LNG-451,* a potent inhibitor of EGFR exon 20 insertion mutations with high CNS exposure
Session Title: Epigenetic Targets
Session Date & Time: Tuesday, April 12, 2022 from 1:30 p.m. – 5:00 p.m. CT (2:30 p.m. – 6:00 p.m. ET)
Abstract Number: 3261
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 23

Presentation Title: LNG-451* is a potent, CNS-penetrant, wild-type EGFR sparing inhibitor of EGFR exon 20 insertion mutations
Session Title: Tyrosine Kinase and Phosphatase Inhibitors
Session Date & Time: Tuesday, April 12, 2022 from 1:30 p.m. – 5:00 p.m. CT (2:30 p.m. – 6:00 p.m. ET)
Abstract Number: 3332
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 26

Presentation Title: BLU-222, an investigational, potent, and selective CDK2 inhibitor, demonstrated robust antitumor activity in CCNE1-amplified ovarian cancer models
Session Title: Cell Cycle Control and Cell Cycle Regulators as Therapeutic Targets
Session Date & Time: Tuesday, April 12, 2022 from 9:00 a.m. – 12:30 p.m. CT (10:00 a.m. – 1:30 p.m. ET)
Abstract Number: 2306
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 5

Presentation Title: Antitumor activity of BLU-945 and BLU-701 as single agents and in combination in EGFR L858R-driven models of NSCLC
Session Title: Tyrosine Kinase and Phosphatase Inhibitors
Session Date & Time: Tuesday, April 12, 2022 from 1:30 p.m. – 5:00 p.m. CT (2:30 p.m. – 6:00 p.m. ET)
Abstract Number: 3328
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 26

* LNG-451 is now known as BLU-451.

Investor Conference Call Information

Blueprint Medicines will host a live webcast on Friday, April 8, 2022 beginning at 2:00 p.m. ET to discuss the data reported at AACR (Free AACR Whitepaper). On the day of the webcast, poster presentations will be made available on the AACR (Free AACR Whitepaper) conference website at 1:00 p.m. ET. To access the live call, please dial 844-200-6205 (domestic) or 929-526-1599 (international), and refer to conference ID 084402. A webcast of the conference call will be available in the Investors & Media section of Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On March 8, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that pre-clinical data on JZP815, an investigational, next-generation pan-RAF kinase inhibitor, will be presented as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting from April 8-13, 2022 (Press release, Jazz Pharmaceuticals, MAR 8, 2022, View Source [SID1234609726]).

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"Together with our pre-clinical collaboration partner, Redx Pharma, we look forward to presenting at AACR (Free AACR Whitepaper) our first pre-clinical data on JZP815, which demonstrated that it selectively and potently inhibits mutant A, B and CRAF kinases, and demonstrated anti-tumor activity in RAS- and RAF-mutant xenograft models," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "The pan-RAF inhibitor program is part of a novel class of next generation precision oncology therapies that has the potential to benefit cancer patients with high unmet needs in multiple different solid tumors. We look forward to progressing JZP815 to the clinic to further evaluate the benefit it may have for appropriate patients."

The Jazz presentation abstract – titled, "JZP815, a potent and selective pan-RAF inhibitor, demonstrates efficacy in RAF and RAS mutant tumor pre-clinical models" – and the AACR (Free AACR Whitepaper) 2022 Annual Meeting details are available here.

Activation of the mitogen-activated protein kinase (MAPK) pathway by oncogenic mutations in RAS and RAF is a frequent driver of cancer. Targeting specific components of the pathway can be a precise and rational route to deliver benefits to cancer patients with high unmet needs. The RAF kinase proteins (ARAF, BRAF, CRAF) are core pathway components that mediate MAPK signaling. Mutations in these critical signaling proteins leads to constitutive activation of the MAPK pathway and tumor growth.

JZP815 is an investigational, pre-clinical stage, next-generation pan-RAF kinase inhibitor that was discovered and developed using state-of-the-art screening methodologies and medicinal chemistry. JZP815 is not currently approved for use anywhere in the world.

Jazz acquired JZP815 from Redx Pharma, and the two companies are collaborating on this pre-clinical research. Jazz plans to submit an IND for JZP815 this year. JZP815 is part of Jazz’s growing early-stage R&D pipeline focused on precision oncology in solid tumors.