On June 3, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported clinical program updates for its lead program, evorpacept, a next generation CD47 blocker (Press release, ALX Oncology, JUN 3, 2022, View Source [SID1234615494]).

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Introducing ASPEN-07, a Phase 1 Trial of Evorpacept for the Treatment of Patients with Urothelial Carcinoma ("UC")

ALX Oncology will initiate a new clinical study, ASPEN-07, to investigate evorpacept in combination with an antibody-drug conjugate ("ADC"), PADCEV (enfortumab vedotin-ejfv), for the treatment of patients with urothelial carcinoma ("UC") in the fourth quarter of 2022.
Enfortumab vedotin-ejfv is an ADC directed to Nectin-4, a protein located on the surface of cells that is highly expressed in UC.
In April 2022, ALX Oncology successfully completed a pre-IND consultation with the U.S. Food and Drug Administration ("FDA") for a Phase 1 study of evorpacept in combination with enfortumab vedotin-ejfv in patients with previously treated locally advanced or metastatic UC.
The IND application for ASPEN-07 was submitted to the FDA in May 2022.
"We continue to pursue strategies to expand the potential value of evorpacept as a cornerstone therapy for the treatment of patients with cancer," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "ASPEN-07 further expands our solid tumor investigations and will be the first combination study of evorpacept with an ADC. The addition of evorpacept is expected to enhance the antibody-dependent cellular phagocytosis mediated by enfortumab vedotin-ejfv to improve efficacy in patients with UC without increasing toxicity. Our currently enrolling randomized Phase 2 studies remain a key priority for us in order to maintain ALX Oncology’s leadership position in solid tumors in the CD47 space."

Update of ASPEN-05, a Phase 1 / 2 Clinical Trial of Evorpacept in Combination with Venetoclax and Azacitidine in Acute Myeloid Leukemia ("AML"), and ASPEN-02, a Phase 1/2 Study of Evorpacept in Combination with Azacitidine in Myelodysplastic Syndrome ("MDS")

The Phase 1 dose escalation portion of ASPEN-05 has successfully completed enrollment with no safety concerns to date up to the highest protocol defined dose level of 60 mg/kg evorpacept once every four weeks. This portion of the study is designed to characterize the initial safety of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with relapsed/refractory AML and previously untreated AML who are not candidates for intensive induction therapy.
Patient enrollment will be paused before proceeding into the Phase 1 dose optimization portion of ASPEN-05 pending completion of the Phase 1 portion of ASPEN-02, a Phase 1/2 study of evorpacept in combination with azacitidine in patients with MDS. Data from ASPEN-02 will be used to inform the optimal dose(s) of evorpacept to be studied in the ASPEN-05 study in combination with venetoclax and azacitidine. Ongoing patients in ASPEN-05 will continue to be treated and followed per protocol.
"The decision to pause ASPEN-05 is based on the desire to leverage upcoming dose optimization data from the ASPEN-02 MDS study to effectively inform dose optimization in ASPEN-05," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology. "MDS and AML are indications where evorpacept possesses a similar mechanism of action, and this strategy allows us to evaluate evorpacept in a cost-efficient manner in patients with AML while maintaining our focus in our solid tumor programs. We anticipate preliminary dose escalation data from ASPEN-05 to be presented at a scientific conference in 2022, and initial dose optimization data from ASPEN-02 to be presented at a scientific conference in mid-2023."

Update of ASPEN-03 and ASPEN-04, which are two distinct randomized Phase 2 studies for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC")

ALX Oncology continues to advance evorpacept in two randomized Phase 2 studies in patients with HNSCC in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, with or without chemotherapy. Both studies are being conducted in collaboration with Merck, known as MSD outside the United States and Canada. The first study, ASPEN-03, is evaluating the efficacy of evorpacept in combination with pembrolizumab for the first-line ("1L") treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC with a Combined Positive Score ("CPS") ≥ 1. The second study, ASPEN-04, is investigating evorpacept in combination with pembrolizumab and standard chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC (any CPS value).
Patient enrollment for ASPEN-03 and ASPEN-04 continues as planned with results expected to be presented by mid-2024.
Update of ASPEN-06, a Phase 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction ("GEJ") Cancer

ASPEN-06 is a randomized Phase 2 (open-label) / Phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept and CYRAMZA (ramucirumab) added to trastuzumab and paclitaxel for the treatment of patients with HER-positive gastric/GEJ cancer whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. ASPEN-06 is being conducted in collaboration with Eli Lilly and Company.
In March 2022, the first patient was dosed in the Phase 2/3 ASPEN-06 study.
Patient enrollment continues to progress and results from the Phase 2 portion of ASPEN-06 are expected to be presented in 2023.

On June 3, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN), will advance into a Phase 2 clinical trial in lung cancer (Press release, Innate Pharma, JUN 3, 2022, View Source [SID1234615511]). Innate will receive a $5M milestone payment from AstraZeneca and will be responsible for conducting the study. AstraZeneca and Innate will share study costs and AstraZeneca will supply clinical trial drugs.

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"We are very pleased that our collaboration with AstraZeneca continues to advance with this Phase 2 trial of our anti-CD39, IPH5201. We are particularly excited about the progress of our assets targeting the adenosine pathway, which is increasingly recognized as critical in tumor immunosuppression. In addition to IPH5201, Innate’s anti-CD73 program, IPH5301 is in a Phase 1 study," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "The decision to advance IPH5201 illustrates our growing late stage pipeline and progress in building a sustainable business, as well as the positive collaboration we have with AstraZeneca, which also includes two Phase 3 trials with monalizumab in non-small cell lung cancer and head and neck cancer."

AstraZeneca conducted a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab (PD-L1). The data are expected to be presented at an upcoming medical meeting in due course.

About IPH5201:

IPH5201 is a blocking antibody targeting the CD39 immunosuppressive pathway. CD39 is an extracellular enzyme that is expressed in the tumor microenvironment, on both tumor infiltrating cells and stromal cells in several cancer types. CD39 inhibits the immune system by degrading adenosine triphosphate (ATP) into adenosine monophosphate (AMP), that is then further degraded into adenosine by CD73. By promoting the accumulation of immune-stimulating ATP and preventing the production of immune-suppressive adenosine, the blockade of CD39 may stimulate anti-tumor activity.

About the Innate Pharma-AstraZeneca Multi-Term Agreement:

In October 2018, Innate Pharma and AstraZeneca entered into a development collaboration that included an option agreement for IPH5201, an anti-CD39 blocking monoclonal antibody. As part of the option agreement AstraZeneca paid Innate a $50m upfront payment for the option to the exclusive license to co-develop and co-commercialize IPH5201 and up to $825m in opt-in payments, development and commercial milestones and high-single to double-digit tiered royalties. Innate retains the right to receive profit sharing within the EU.

On June 3, 2022 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a fireside chat at the Jefferies Healthcare Conference on Friday, June 10 at 12:45 p.m. ET (Press release, Merus, JUN 3, 2022, View Source [SID1234615527]).

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The webcast of the fireside chat will be contemporaneously available on the Investors page of the Company’s website. The archived presentation will also be available there for a limited time after the event.

On June 3, 2022 Parker Institute for Cancer Immunotherapy reported that Researchers have identified certain patients with pancreatic cancer who may be more likely to benefit from combination treatment regimens consisting of immunotherapy and chemotherapy (Press release, Parker Institute for Cancer Immunotherapy, JUN 3, 2022, View Source [SID1234615543]). These new data, stemming from a long-term collaboration between academia, biotech, pharma and nonprofits within the Parker Institute for Cancer Immunotherapy (PICI) network, were shared with the medical community at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago today . The comprehensive clinical and immunologic findings of the Phase II clinical trial, known as the PRINCE study, were published simultaneously in the peer-reviewed journal Nature Medicine.

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Approximately 60,000 people are diagnosed with pancreatic cancer every year in the U.S., and the prognosis is typically poor. For the subset of patients diagnosed with advanced metastatic pancreatic ductal adenocarcinoma (mPDAC), the disease studied in PRINCE, the five-year survival rate is less than 5%1.

The findings are part of a recent analysis of data from the PRINCE trial, sponsored by PICI, and designed on the basis of decades of research by lead Principal Investigator Robert Vonderheide, M.D., D.Phil., and others at the University of Pennsylvania. The trial involved seven PICI network institutions, and uncovered various predictive biomarkers associated with longer overall survival for a subset of mPDAC patients.

The PRINCE trial evaluated the combination of standard-of-care chemotherapy (gemcitabine + nab-paclitaxel) and nivolumab, a PD-1 inhibitor, and/or sotigalimab, an experimental antibody that is an agonist of the CD40 protein. As part of exploratory analyses, PICI researchers discovered distinct biosignatures associated with survival for the nivolumab-chemotherapy and sotigalimab-chemotherapy treatment arms, which reflect each immunotherapy’s distinct mechanisms of action. Few biomarkers predicted survival in patients receiving the sotigalimab-nivolumab-chemotherapy regimen.

"While the data from the trial suggest that these treatment regimens may not be appropriate for all PDAC patients, we uncovered various predictive biomarkers from the circulation and tumor that may correlate with longer survival and warrant further study," said Lacey Padron, Ph.D., Vice President, Informatics at PICI and lead study author. "We are encouraged by the data and believe chemoimmunotherapy combinations may improve outcomes for some patients with metastatic PDAC. Following up on these results, the scientific community can work to better understand who is most likely to benefit and why."

The PRINCE trial was conducted in collaboration with:

Bristol Myers Squibb, which provided nivolumab
Apexigen, which provided sotigalimab
Cancer Research Institute
In addition to the University of Pennsylvania, participating research sites from the PICI network include the Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Stanford Medicine, University of California, Los Angeles, University of California, San Francisco and The University of Texas MD Anderson Cancer Center.

"The PRINCE trial illustrates how this groundbreaking clinical research fostered collaboration between clinicians, researchers, nonprofits and industry, with the goal of bringing innovative treatments to patients faster," said Ute Dugan, M.D., Ph.D., Chief Medical Officer of PICI. "We look forward to building on these interesting results."

PDAC remains one of the most intractable challenges in oncology. Pancreatic cancer, the third-leading cause of cancer death in the U.S. in 2020, is predicted to become the No. 2 cause of cancer death in the U.S. by 20402. In the metastatic setting, while combination chemotherapy reliably offers tumor control and clinical stabilization, both standard regimens of gemcitabine plus nab-paclitaxel and FOLFIRINOX (oxaliplatin, irinotecan, fluorouracil and leucovorin) are limited in response durability and incur toxicity. Thus, new treatment strategies for this disease are urgently needed.

"The identification of signals that may help predict clinical outcomes for pancreatic cancer patients receiving combination treatment with chemotherapy and immunotherapy has significant potential to save more lives, as oncologists will be better equipped to design optimal treatment plans for their patients based on the presence or absence of these signals," said Jill O’Donnell-Tormey, Ph.D., Chief Executive Officer and Director of Scientific Affairs at the Cancer Research Institute.

The PRINCE trial is a collaborative research effort designed to work towards advancing more efficacious therapies that can create durable response, and ultimately remission, in patients. The translational work highlighted at ASCO (Free ASCO Whitepaper) and in Nature Medicine has identified biological signals in the blood and tumor that may uncover which patients have longer survival after these combination treatment regimens. The goal of this research is to one day predict via a simple test ahead of time whether a patient stands to benefit from a particular chemoimmunotherapy regimen.

"While scientific and medical advances in immunotherapy are helping to turn cancer into a curable disease for many patients, pancreatic cancer presents unique challenges that deserve the attention of the greatest scientific minds," said William Hoos, cancer research and collaboration lead at 1440 Foundation, a nonprofit that funds innovative pancreatic cancer research and collaboration, including support for the REVOLUTION study of novel immunotherapy combinations in pancreatic cancer, at PICI. "The potential for a biomarker selection strategy to identify the right immunotherapy combination for each patient holds potential for progress in pancreatic cancer. These new findings suggest next steps for researchers, and hope for pancreatic cancer patients and their families. We look forward to continued progress in this promising field."

More Information about the ASCO (Free ASCO Whitepaper) Presentation

Title: Distinct biosignatures associate with survival after chemoimmunotherapy in a randomized, three-arm phase II study in patients with metastatic pancreatic cancer
Abstract No.: 4010
Session: Clinical Science Symposium: Can We Begin to Predict Responders to Targeted Therapy in Gastrointestinal Cancer?
Location: McCormick Place, Hall D1 (in person and via livestream)
Date and Time: Friday, June 3, 2022, 5:30-7 p.m. ET/4:30-6 p.m. CT/2:30-4 p.m. PT
Lead Author and Presenter: Lacey Padron, Ph.D., Vice President, Informatics at PICI

The study’s comprehensive clinical and immunologic findings, "Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: Clinical and immunologic analyses from the randomized Phase 2 PRINCE trial," were published in the peer-reviewed journal Nature Medicine. The study authors conclude the Phase Ib/II study is a first step toward characterizing which patients may derive clinical benefit from these chemoimmunotherapy regimens by having identified potential biomarkers that can now be validated prospectively to determine if this allows for minimally invasive biomarker-enrichment designs for chemoimmunotherapy treatment in metastatic PDAC.

"The presentation and publication of these results in pancreatic cancer underscore PICI’s commitment to advancing our understanding of the toughest tumor types," said John Connolly, Ph.D., Chief Scientific Officer of PICI. "This shared knowledge can help patients, clinicians and researchers, alike, combat this deadly disease."

About Pancreatic Cancer

Pancreatic cancer is one of the deadliest types of tumors, and the number of diagnosed cases continues to rise each year. The disease is often difficult to catch early, such that by the time most people are diagnosed, their cancer is advanced and may have already spread. In addition, the tumors usually contain a variety of mutations, which often means a single targeted therapy isn’t enough to stop the disease by itself. For patients diagnosed with advanced metastatic pancreatic ductal adenocarcinoma (mPDAC), the five-year survival rate is less than 5%.

On June 3, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that the Company will share an update on its allogeneic CAR T programs during a company-hosted webcast and conference call on June 8, 2022 at 8:00 AM ET (Press release, Precision Biosciences, JUN 3, 2022, View Source [SID1234615495]).

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"We look forward to sharing the recent developments on our CAR T programs, including the latest clinical data on our potential first-in-class allogeneic CAR T program, PBCAR0191, in patients who relapsed following CAR T treatment," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "The CAR T relapse setting is a rapidly growing area with dire unmet medical need that is not adequately addressed by current treatment options."

Company-Hosted Webcast and Conference Call Information

Precision will host a conference call and webcast on Wednesday, June 8, 2022 at 8:00 AM ET to review its ongoing allogeneic CAR T programs. 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 5754683. Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: View Source