On April 26, 2023 Blueprint Medicines Corporation (NASDAQ: BPMC) reported the acceptance of clinical abstracts for multiple programs across its precision therapy portfolio at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2 to 6 (Press release, Blueprint Medicines, APR 26, 2023, View Source [SID1234630553]). The presentations showcase Blueprint Medicines’ next wave of therapeutic candidates in its robust clinical pipeline, and highlight ongoing progress as the company seeks to pioneer innovative combination strategies and advance development of its programs into earlier lines of treatment.

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The datasets to be reported at the ASCO (Free ASCO Whitepaper) Annual Meeting include:

Results from the ongoing dose escalation part of the VELA trial of BLU-222 in breast cancer and other cancers vulnerable to CDK2 inhibition, showing evidence of monotherapy safety and pathway modulation.

Updated results from the dose escalation part of the SYMPHONY trial showing the safety and tolerability of BLU-945 as a monotherapy and in combination with osimertinib in patients with late-line, EGFR-mutant non-small cell lung cancer (NSCLC).

Results from the ongoing dose escalation part of the CONCERTO trial of BLU-451 in EGFR exon 20 insertion-positive NSCLC showing early safety and clinical activity.
"These upcoming presentations reflect important clinical progress toward realizing the promise of our innovative precision therapies to help address complex medical needs in lung and breast cancer, leveraging our scientific and development expertise with the goal of overcoming traditional limitations of targeted therapy," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "Collectively, the datasets represent another step toward achieving our 2027 Blueprint for Precision at Scale – our five-year growth strategy to reach broad patient populations through the development of transformative precision therapies."

The accepted abstracts are listed below, and abstract titles are available today on the ASCO (Free ASCO Whitepaper) conference website: meetings.asco.org.

Data Presentations

Poster Presentation Title: BLU-222, an oral, potent and selective CDK2 inhibitor, in patients with advanced solid tumors: phase 1 monotherapy dose escalation
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date & Time: Saturday, June 3, 2023 from 8:00 a.m. — 11:00 a.m. CT (9:00 a.m. — 12:00 p.m. ET)
Abstract Number: 3095
Location: Hall A

Poster Presentation Title: Emerging phase 1 data of BLU-451 in advanced NSCLC with EGFR exon 20 insertions
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date & Time: Sunday, June 4, 2023 from 8:00 a.m. — 11:00 a.m. CT (9:00 a.m. — 12:00 p.m. ET)
Abstract Number: 9064
Location: Hall A

Short Oral Presentation Title: BLU-945 monotherapy and in combination with osimertinib (OSI) in previously treated patients with advanced EGFR-mutant (EGFRm) NSCLC in the phase 1/2 SYMPHONY study
Session Title: Rapid Abstract Session: Lung Cancer
Session Date & Time: Monday, June 5, 2023 from 11:30 a.m. — 12:30 p.m. CT (12:30 p.m. — 1:30 p.m. ET)
Abstract Number: 9011
Location: S406

On April 26, 2023 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that two abstracts with its innate cell engager (ICE) AFM24 have been accepted for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2 – 6, 2023 in Chicago, IL (Press release, Affimed, APR 26, 2023, View Source [SID1234630552]).

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NSCLC Abstract and Presentation Details:
Title: Leveraging innate immunity with AFM24, a novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager: Interim results for the non-small cell lung cancer (NSCLC) cohort
Authors: Anthony B. El-Khoueiry, Delcia Rivas, Se Hoon Lee, Jacob Stephen Thomas, Yu Jung Kim, Andrés Cervantes, Omar Saavedra Santa Gadea, Byoung Yong Shim, Laura Kohlhas, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada
Poster presentation session: Developmental Therapeutics—Immunotherapy, June 3, 2023, 8:00 – 11:00 a.m. CDT
Abstract Number for Publication: 2533

CRC Abstract Details:
Title: Investigating the novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager, AFM24, to leverage the innate immune system: Interim results from the colorectal cancer (CRC) cohort
Authors: Andrés Cervantes, Delcia Rivas, Se Hoon Lee, Jacob Stephen Thomas, Yu Jung Kim, Omar Saavedra Santa Gadea, Byoung-Yong Shim, Laura Kohlhas, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada, Anthony B. El-Khoueiry Abstract Number for Publication: e14508

The full abstracts will become public at 5:00 p.m. EDT on Thursday, May 25. More details about the programs for the ASCO (Free ASCO Whitepaper) Annual Meetings are available online at www.asco.com.

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
Affimed is evaluating AFM24 as monotherapy and in combinations with other cancer treatments in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450. AFM24 is also being evaluated in a phase 1/2a study in combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442). Furthermore, Affimed and NKGen Biotech initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with NKGen Biotech’s NK cell SNK01 (NCT05099549).

On April 26, 2023 XOMA Corporation (NASDAQ: XOMA), the Biotech Royalty Aggregator, reported that Owen Hughes, Executive Chairman, and Brad Sitko, Chief Investment Officer, will be featured in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on Tuesday, May 2, 2023, at 10:30 AM ET (Press release, Xoma, APR 26, 2023, View Source [SID1234630551]).

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The fireside chat can be accessed at https://bit.ly/403aHUp or by visiting the investor relations section of the Company’s website at www.xoma.com. A replay of the conversation will be available and archived on the site for 90 days after the event.

On April 26, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported a data update from the AUTO1/22 study (CARPALL) in Pediatric B-cell Acute Lymphoblastic Leukemia in an oral presentation at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), which is being held in Paris from April 23 to 26, 2023 (Press release, Autolus, APR 26, 2023, View Source [SID1234630550]).

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CD19 negative relapse is a major cause of treatment failure after CD19 CAR T cell therapy for pediatric B-ALL. To address this, AUTO1/22 is designed to target both CD19 and CD22 using the fast-off rate CD19 CAR from obe-cel combined with a novel CD22 CAR capable of effective signaling in response to low antigen density1.

Twelve patients with advanced pediatric B-ALL were treated in a study. AUTO1/22 maintained the safety profile of obe-cel alone, with no cases of severe cytokine release syndrome. AUTO1/22 induced MRD (minimal residual disease) negative CR in 83% (10 of 12) patients. This includes 2 (of 3) patients who had CD19 negative disease, demonstrating the efficacy of the CD22 CAR.

Notably, remissions were induced despite the high-risk nature of this cohort (including 4 patients who had failed prior CD19 CAR therapy, 3 patients with a CD19-negative disease component, 3 patients with non-CNS extramedullary disease and 6 patients who had received prior blinatumomab). The 12-month OS and EFS in this study were comparable to the ELIANA study2. Crucially, amongst the 10 responding patients, with a median follow up of 8.7 months, there have been no cases of leukemic relapse or emergence of MRD related to antigen escape.

"We are pleased to see the updated data for AUTO1/22 in pediatric B-ALL," said Dr. Christian Itin, Chief Executive Officer of Autolus. "AUTO1/22 demonstrated a favorable safety profile and good efficacy in a heavily pre-treated cohort of patients and, importantly, we have not observed antigen negative relapse indicating that the combining of our optimized CD22 CAR design with the CD19 CAR used in obe-cel may be effective in preventing antigen-loss driven relapse in pediatric B-ALL."

Title: Dual Antigen Targeting with Co-Transduced CD19/22 CAR T cells may Prevent Antigen-Negative Relapse after CAR T Cell Therapy for Relapsed/Refractory ALL

Link to Abstract
Session date and time: Wednesday, April 26, 2023, 11:57 to 12.06 BST
Presenting Author: Dr Giovanna Lucchini, Consultant BMT, Great Ormond Street Hospital, London

On April 26, 2023 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported that it will present positive clinical data from its Phase 1b trial investigating azenosertib in combination with chemotherapy in patients with advanced platinum-resistant ovarian cancer in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting in Chicago, June 2-6, 2023 (Press release, Zentalis Pharmaceuticals, APR 26, 2023, View Source [SID1234630548]). Azenosertib is the Company’s potentially first-in-class Wee1 inhibitor currently being investigated in multiple clinical trials as a monotherapy and in combination.

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The poster, entitled "Correlation of Cyclin E1 expression and clinical outcomes in a Phase 1b dose- escalation study of Azenosertib (ZN-c3), a Wee1 inhibitor, in combination with chemotherapy in patients with platinum-resistant or refractory (R/R) epithelial ovarian, peritoneal, or fallopian tube cancer", will be presented on June 5, 2023, from 1:15 PM-4:15 PM CT and the poster discussion session will be on June 5, 2023, from 4:30 PM-6:00 PM CT.

"We are pleased to have the opportunity to share these exciting clinical data from our chemotherapy combination trial at ASCO (Free ASCO Whitepaper) this year. These encouraging clinical data, together with the preclinical data we recently presented at the 2023 AACR (Free AACR Whitepaper) Annual Meeting, provide clear support for the use of Cyclin E1 expression as a predictive marker to identify patients who may significantly benefit from treatment with azenosertib," said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "Importantly, these findings offer robust evidence that azenosertib restores chemotherapy sensitivity in Cyclin E1 positive cancers, which are known to be chemotherapy resistant."

The Company also announced today separate agreements with Foundation Medicine, Inc., an independent affiliate of the Roche Group, and with Roche Diagnostics. The current Foundation Medicine partnership involves global prospective genomic profiling for potential patient enrollment in Zentalis’ Phase 2 clinical trial of azenosertib in Cyclin E1 driven high-grade serous ovarian cancer. The companies are also exploring opportunities to develop Foundation Medicine’s tissue based next generation sequencing assay as a companion diagnostic for azenosertib. The Roche Diagnostics agreement is focused on the development of an immunohistochemistry-based clinical trial assay that evaluates Cyclin E1 protein levels and that can potentially identify a broader patient population with high protein expression in the absence of amplification.

"There continues to be a need for predictive markers for targeted therapeutics in difficult to treat malignancies such as platinum-resistant ovarian cancer," said Mark Lackner, Ph.D., Chief Translational Officer of Zentalis. "We are extremely happy to announce our partnerships with Foundation Medicine

and Roche Diagnostics to identify patients likely to benefit from treatment with azenosertib, our potentially first-in-class Wee1 inhibitor currently in clinical trials across a range of cancers."

About Azenosertib

Zentalis’ azenosertib (ZN-c3) has been designed to be a highly potent and selective Wee1 inhibitor.
Azenosertib is currently being evaluated in the clinic for advanced solid tumors and hematological malignancies in the following three therapeutic settings of high unmet medical need: (1) as a monotherapy, (2) in combination with traditional chemotherapy and DNA damaging agents, and (3) in combination with molecularly targeted agents. As a monotherapy, azenosertib is currently being evaluated in a Phase 2 clinical trial in adult women with uterine serous carcinoma (USC), an aggressive form of endometrial cancer that accounts for approximately 10-15% of all endometrial cancers. We are also evaluating azenosertib as a monotherapy in a Phase 2 clinical trial in patients with Cyclin E1 driven high-grade serous ovarian cancer (HGSOC). The Company is evaluating azenosertib as a monotherapy in a Phase 1 dose optimization clinical trial in patients with advanced solid tumors, and plans to declare the recommended Phase 2 monotherapy dose and provide an update on dose optimization activities in the first half of 2023. In chemotherapy combinations, azenosertib is currently being evaluated in combination with each of paclitaxel, carboplatin, pegylated liposomal doxorubicin (PLD) and gemcitabine in four cohorts in a Phase 1b clinical trial in patients with advanced platinum-resistant ovarian, peritoneal or fallopian tube cancer. The Company plans to disclose results from this study in the first half of 2023, in advance of original guidance. Azenosertib is also currently being evaluated in combination with gemcitabine in a Phase 1/2 clinical trial in adult and pediatric patients with relapsed or refractory osteosarcoma. In combination with molecularly targeted agents, the Company is studying azenosertib in combination with GlaxoSmithKline plc’s (GSK’s) PARP inhibitor, niraparib (ZEJULA), in a Phase 1/2 clinical trial in platinum-resistant ovarian cancer patients who have failed PARP inhibitor maintenance treatment as part of a clinical collaboration with GSK. The Company is also collaborating with Pfizer Inc. to evaluate azenosertib in combination with encorafenib and cetuximab, an FDA-approved standard of care known as the BEACON regimen, in patients with BRAF V600E mutant metastatic colorectal cancer in a Phase 1/2 clinical trial.