On June 3, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight") a pan-America (ex-USA) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Executive Officer, is scheduled to present at the Jefferies 2022 Healthcare Conference on Friday, June 10, 2022 at 10:00 AM ET in New York City (Press release, Knight Therapeutics, JUN 3, 2022, View Source [SID1234615526]). A copy of the presentation will be available at www.gud-knight.com.

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On June 3, 2022 Dxcover Limited, a clinical stage diagnostics company developing spectroscopic liquid biopsy technology for early detection of multiple cancers, reported that new data from a large-scale study on multi-cancer detection at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Dxcover, JUN 3, 2022, View Source [SID1234615542]).

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Presented by Dr. Matthew Baker, co-founder and Chief Technology Officer at Dxcover, the results showcase the need for an effective test that accurately identifies patients with non-specific symptoms who have cancer in its earliest stages, while it is still treatable. Dxcover has pioneered the early detection and identification of cancer by employing infrared spectroscopy of circulating pan-omic biomarkers. Its platform combines novel hardware with artificial intelligence algorithms to analyze a patient’s blood and detect the presence or absence of disease.

The study, which recruited 2,094 patients, set out to distinguish cancer from non-cancer, as well as differentiate organ specific detection from other forms of cancer including brain, breast, colorectal, kidney, lung, ovary, pancreas, and prostate. Results from the research, which applied the Dxcover Cancer Liquid Biopsy, proved the importance and impact of early cancer detection. At a 99% specificity the model achieved 64% sensitivity for stage I cancers. For overall cancer classification, the model achieved 90% sensitivity and 61% specificity when tuned for sensitivity. Detection rates were 93% for stage I, 84% for stage II, 92% for stage III and 95% for stage IV.

"Our mission is to lead the way in liquid biopsy detection of cancers to improve survival and overall quality of life. We have successfully completed two groundbreaking studies on earlier diagnosis of brain cancer using the Dxcover platform, and today’s study demonstrates its ability to detect multiple cancers at their earliest stages, which we know is critical in providing the necessary care and treatment while it can be most impactful to patient outcomes," said Dr. Matthew Baker, co-founder and Chief Technology Officer at Dxcover.

Additionally, Dxcover released results from its proof-of-concept study investigating the use of Dxcover’s liquid biopsy as a novel approach for pancreatic cancer, the 7th most deadly cancer worldwide. The study focused on the discrimination between both cancer and control samples, and cancer and symptomatic non-malignant control samples.

Results showed that the two groups were significantly distinguished, achieving up to a sensitivity of 91.0%, specificity of 87.6% and accuracy of 89.3% with PLS-DA, underscoring that early-stage detection of pancreatic cancer would be key in improving prognosis and survival rates of patients in combination with targeted earlier surgery and treatments.

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.