On December 12, 2022 Arcellx presented its corporate presentation (Presentation, Arcellx, DEC 12, 2022, View Source [SID1234625084]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On December 12, 2022 Onchilles Pharma, a private biotech company developing new cancer therapeutics to modulate myeloid biology, reported the nomination of its first drug development candidate, N17350, a first-in-class biologic therapeutic that is designed to leverage the immunobiology of neutrophils, a key part in the innate immune system, against a wide range of cancer types (Press release, Onchilles Pharma, DEC 12, 2022, View Source [SID1234625083]). The company is targeting to start first-in-human clinical trials in 2024. Onchilles also disclosed the expansion of its technology platform to design new therapeutics modulating the M2-like TAMs found in multiple solid tumor indications.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Alain P. Algazi, M.D., member of Onchilles’ Scientific Advisory Board, said, "I am extremely excited about N17350 as preclinical data shows it maintains the immune compartment while generating tumor cytotoxicity. The tumor-killing capability of N17350 yields an immunological cell death, which is a key attribute that could enhance most immunotherapies and lead to global responses."

Research published last year in Cell from Co-Founder Lev Becker’s Lab first described a pathway where human neutrophils release catalytically active neutrophil elastase, called ELANE, to selectively kill many cancer cell types while sparing non-cancer cells. ELANE consistently activated this cancer-killing program in more than 40 different cancer cell lines but not in any non-cancer cells tested. Research shows that ELANE initiates a complex killing mechanism that culminates in cancer cell apoptosis at the initial tumor site as well as increases adaptive immunity that attacks distant metastases.

To advance this research into a therapeutic, Onchilles generated the N17350 molecule to mobilize the ELANE-mediated cancer-killing pathway. As part of innate immunity, neutrophils have broad efficacy and specificity to eliminate genetically diverse cellular threats. The company completed preclinical studies showing N17350 has better anti-cancer efficacy than standard of care chemotherapy in select cancer mouse models and synergy with checkpoint inhibitors in tumor models non-responsive to checkpoint blockade. Further studies have shown N17350 has an encouraging safety profile and a lack of resistance with repeated exposure.

"The team at Onchilles translated a ground-breaking scientific discovery of ELANE, the inherent cancer-killing pathway in neutrophils, into a proprietary set of molecules that have the potential to treat a wide variety of tumor types with an optimal safety and efficacy profile," Court R. Turner J.D., Co-Founder & Executive Chair of Onchilles. "With our expanded technology platform, we are interrogating myeloid biology and generating additional molecules to leverage neutrophil biology, as well as tumor-associated macrophages, with a novel and highly differentiated approach."

Onchilles has discovered a novel mechanism by which TAMs help tumors evade an effective adaptive immune response. Onchilles has developed proprietary antibodies for TAM targets validated on human patient samples, and these antibodies generated a more robust adaptive immune response in preclinical cancer models.

On December 12, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in PCR-based DNA technologies, reported that it plans to release its fiscal 2022 fourth quarter and year-end financial results after the market close on Wednesday, December 14, 2022 (Press release, Applied DNA Sciences, DEC 12, 2022, View Source [SID1234625081]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company’s management will host a conference call with investors and covering analysts starting at 4:30 pm ET that same day. On the call, Chief Financial Officer Beth Jantzen and President and CEO Dr. James A. Hayward will discuss the Company’s quarterly financial performance and recent accomplishments, followed by a question-and-answer session.

To access the conference call:

U.S. callers should dial 1-844-887-9402, and international callers should dial +1-412-317-6798 approximately five minutes before the call begins.
Participants should ask to be connected to the Applied DNA Financial Results conference call.
You can listen to the call and view the accompanying exhibits on Applied DNA’s investor relations website at View Source at the scheduled time. A webcast replay of the call will also be available on the investor relations website approximately one hour after the end of the call.

On December 12, 2022 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community following the announced acquisition of Horizon Therapeutics at 8:00 a.m. ET on Monday, December 12, 2022 (Press release, Amgen, DEC 12, 2022, View Source [SID1234625080]). Robert A. Bradway, chairman and chief executive officer, along with members of the executive team, will participate.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

The directors of Amgen accept responsibility for the information contained in this press release. To the best of the knowledge and belief of the directors (who have taken all reasonable care to ensure that such is the case), the information contained in this press release is in accordance with the facts and does not omit anything likely to affect the import of such information.

On December 12, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, reported the presentation of clinical data from the Phase 1a dose escalation part of the ASPEN-05 trial evaluating evorpacept in combination with azacitidine and venetoclax for the treatment of patients with relapsed or refractory ("r/r") or newly diagnosed ("ND") acute myeloid leukemia ("AML") (Press release, ALX Oncology, DEC 12, 2022, View Source [SID1234625079]). The new results, shared in a poster at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting [Abstract #4076], show that the combination of evorpacept with azacitidine and venetoclax is active and generally well tolerated. As of October 3, 2022, 14 patients with either r/r or ND AML have been treated with evorpacept in the Phase 1 dose escalation part of the study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks ("Q2W") or 60 mg/kg once every 4 weeks ("Q4W") together with standard dosing of azacitidine and venetoclax.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Evorpacept in combination with azacitidine and venetoclax was generally well tolerated (N=14) with no maximum tolerated dose identified and a maximum administered dose of 60 mg/kg Q4W.

In 10 relapsed or refractory AML response-evaluable patients, including 8 that had progressed after prior venetoclax treatment, all experienced a reduction in bone marrow blasts, and 4 achieved a response.

In 3 newly diagnosed AML response-evaluable patients, all 3 achieved a response, including 1 complete response ("CR"), 1 CR with incomplete hematologic recovery ("CRi"), and 1 morphologic leukemia free state ("MLFS").
"It is extremely encouraging to observe evorpacept’s preliminary clinical activity in a population of difficult to treat AML patients with primarily relapsed or refractory disease after prior venetoclax therapy, as well as TP53 mutation and adverse risk genetics," said Harry Erba M.D., Director of the Leukemia Program in the Division of Hematologic Malignancies and Cellular Therapy at Duke University, Durham, NC. "Additionally, evorpacept’s favorable initial tolerability profile in combination with azacitidine and venetoclax suggests it may be safely added to this AML backbone therapy without worsening cytopenias, which is particularly important for this patient population."

"The initial data from this early part of the ASPEN-05 study support the tolerability and activity of evorpacept in patients with AML, and provide further validation for adding our CD47 myeloid checkpoint blocker to established backbone regimens in patients with cancer," said Sophia Randolph M.D., Ph.D., Chief Medical Officer, ALX Oncology. "We are pleased to see this initial data as part of our ongoing studies of evorpacept in both solid tumor indications and hematologic malignancies, which support the emerging role of CD47-blockade in enhancing the innate immune anti-cancer response."

Conference Call on December 13th at 7:30 a.m. EST

ALX Oncology will host a conference call on Tuesday, December 13, 2022 at 7:30 a.m. EST to further discuss the initial AML data from ASPEN-05. In addition to ALX Oncology’s executive management team, Harry Erba M.D., Director of the Leukemia Program in the Division of Hematologic Malignancies and Cellular Therapy at Duke University, Durham, NC will be featured on the call to discuss the results.

To access the conference call, please dial (800) 715-9871 (U.S./Canada) or (646) 307-1963 (international) at least 10 minutes prior to the start time and refer to conference ID 1300143. Presentation slides will be available to download under "News & Events (see "Events") in the Investors section of the ALX Oncology website at www.alxoncology.com.