On January 8, 2024 Recursion Pharmaceuticals presented its corporate presentation (Presentation, Recursion Pharmaceuticals, JAN 8, 2024, View Source [SID1234639103]).

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On January 8, 2024 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, reported that it has entered into a collaboration with Alliance Foundation Trials, LLC (AFT) for research use of Haystack Oncology’s personalized MRD technology (Haystack MRD) to analyze therapeutic response and provide molecular insights for AFT’s interventional, randomized phase II clinical trial (AFT-57) in patients with unresectable stage III non-small cell lung cancer (NSCLC) (Press release, Quest Diagnostics, JAN 8, 2024, View Source [SID1234639102]). The AFT-57 clinical study is supported by Genentech, a member of the Roche Group, and will explore the efficacy and safety of an anti-PD-L1 atezolizumab (Tecentriq) with or without tiragolumab (anti-TIGIT) in conjunction with chemoradiotherapy.

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Quest Diagnostics Incorporated logo. (PRNewsFoto/Quest Diagnostics Incorporated)

"This research collaboration with AFT is a great opportunity to further explore the benefits of using highly sensitive and specific ctDNA analysis as a means to evaluate the efficacy of novel therapeutic approaches," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "Haystack MRD was purpose-built to detect ctDNA with unparalleled sensitivity, making it well-positioned to support the innovation of new treatment regimens."

"AFT is excited to work with Haystack Oncology to investigate promising new immunotherapy-based treatments in nationwide randomized cancer clinical trials," said David Kozono, MD, PhD, AFT Executive Officer and Alliance Immuno-Oncology Committee Co-Chair. "The new MRD technology, in conjunction with these novel therapies, offers a unique opportunity to significantly impact the lives of patients with inoperable locally advanced non-small cell lung cancer."

On January 8, 2024 Prime Medicine presented its corporate presentation (Presentation, Prime Medicine, JAN 8, 2024, View Source [SID1234639101]).

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On January 8, 2024 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported highlights of pipeline updates to be presented at the 42nd Annual J.P. Morgan Healthcare Conference on January 10, 2024 at 5:15 PM PST in San Francisco, California (Press release, Precigen, JAN 8, 2024, View Source [SID1234639100]).

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AdenoVerse Immunotherapies

"In the second quarter of this year, we anticipate presenting Phase 2 pivotal study data for our lead asset, PRGN-2012, in recurrent respiratory papillomatosis, RRP, and submitting the Company’s first BLA under an accelerated approval pathway in the second half of this year. In anticipation of a potential launch in 2025, we are actively preparing for commercial readiness. This is an exciting time for Precigen as we prepare to transition from a clinical to commercial stage biotechnology company. I am incredibly proud of the Precigen team for achieving the first breakthrough therapy designation and accelerated approval pathway so rapidly for an RRP treatment and for the life-changing potential that PRGN-2012 has for RRP patients," said Helen Sabzevari, PhD, President and CEO of Precigen.

· PRGN-2012 in RRP: PRGN-2012 is an investigational off-the-shelf AdenoVerse immunotherapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of RRP. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation and Orphan Drug Designation for PRGN-2012 for the treatment of RRP.

· PRGN-2012 is currently under investigation in a Phase 1/2 pivotal single-arm study in adult patients with RRP (clinical trial identifier: NCT04724980).

· PRGN-2012 demonstrated strong efficacy and favorable safety profile in the Phase 1 portion of the study with 50% of patients (N=12) in durable and ongoing Complete Response more than two years after PRGN-2012 treatment.

· A Phase 2 data presentation is anticipated in the second quarter of 2024.

· A planned Biologics License Application (BLA) submission under an accelerated approval pathway is anticipated in the second half of 2024.

· Commercial readiness preparations are underway for a potential launch in 2025.

· PRGN-2009 in OPSCC and Cervical Cancer: PRGN-2009 is an investigational off-the-shelf AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.

· The Phase 2 study of PRGN-2009 in combination with pembrolizumab in newly diagnosed patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) is currently enrolling patients (clinical trial identifier: NCT05996523).

· The Phase 2 randomized, open-label study of PRGN-2009 in combination with pembrolizumab in patients with recurrent/metastatic cervical cancer is anticipated to initiate in the first quarter of 2024 (clinical trial identifier: NCT06157151).

UltraCAR-T Cell Therapies

"We continue to advance our UltraCAR-T clinical programs and remain enthusiastic about the data we are seeing in our Phase 1b expansion studies. Precigen’s UltraCAR-T cell therapies are engineered to specifically address the limitations of conventional CAR-T therapies by improving in vivo CAR-T expansion and persistence, adding a safety/kill switch to reduce the risk of toxicity and malignancy, utilizing a non-viral design to reduce the risk of malignant transformation associated with lentivirus and retrovirus vectors, eliminating long turnaround times for manufacturing and reducing the high cost of treatment," adds Sabzevari. "We look forward to sharing new results for these assets during the planned presentations for our PRGN-3006 and PRGN-3007 UltraCAR-T programs in 2024. In addition to ongoing clinical trials, we are excited by the preclinical data for a new and differentiated CD19 targeted UltraCAR-T, which has best-in-class potential for this validated target capitalizing on the unique advantages of the UltraCAR-T platform over conventional CAR-T."

· PRGN-3006 in AML/MDS: PRGN-3006 is an investigational multigenic, autologous chimeric antigen receptor T cell (CAR-T) therapy engineered to simultaneously express a CAR specifically targeting CD33, membrane bound IL-15 (mbIL15), and a safety/kill switch. PRGN-3006 has been granted Orphan Drug Designation in patients with acute myeloid leukemia (AML) and Fast Track Designation in patients with relapsed/refractory (r/r) AML by the FDA.

· PRGN-3006 is currently under evaluation in a Phase 1b clinical trial (clinical trial identifier: NCT03927261) for the treatment of patients with r/r AML or higher-risk myelodysplastic syndromes (MDS).

· The first-in-human, Phase 1 dose escalation portion of the study with lymphodepletion was completed in r/r AML and higher-risk MDS patients.

· Phase 1 dose escalation data showed that PRGN-3006 was well-tolerated with no dose-limiting toxicities (DLTs) and a 27% objective response rate (ORR) in heavily pre-treated r/r AML patients infused following lymphodepletion.

· An interim Phase 1b dose expansion data presentation is anticipated in the second half of 2024.

· PRGN-3005 in Ovarian Cancer: PRGN-3005 is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR specifically targeting the unshed portion of MUC16, mbIL15, and a safety/kill switch.

· The Phase 1b dose expansion portion of the Phase 1/1b study is ongoing (clinical trial identifier: NCT03907527).

· PRGN-3007 in Advanced ROR1+ Hematological and Solid Tumors: PRGN-3007 is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), mbIL15, a safety/kill switch, and a novel mechanism for the intrinsic blockade of PD-1 gene expression.

· The Phase 1 dose escalation portion of the Phase 1/1b study is ongoing (clinical trial identifier: NCT05694364).

· A preliminary Phase 1 dose escalation data presentation is anticipated by the end of 2024.

· UltraCAR-T Targeting CD19: Preclinical data for the Company’s UltraCAR-T targeting CD19 (a validated target) have demonstrated significant potential and the Company is preparing to initiate a Phase 1 study to support a potential best-in-class CD19 CAR-T leveraging the unique advantages of the UltraCAR-T platform.

Precigen’s 42nd Annual J.P. Morgan Healthcare Conference presentation will be available on the Company website in the Events & Presentations section following the presentation.

On January 8, 2024 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported initial data for its PRC2 inhibitor ORIC-944, operational highlights for 2023, and anticipated upcoming milestones (Press release, ORIC Pharmaceuticals, JAN 8, 2024, View Source [SID1234639099]).

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"2023 was a landmark year for ORIC with both ORIC-114 and ORIC-944 generating clinical proof of concept data that position them as potential best-in-class therapies for NSCLC and prostate cancer, respectively. Additionally, with the completion of an $85 million PIPE financing from top tier new and existing funds, we extended our cash runway into 2026," said Jacob M. Chacko, M.D., president and chief executive officer. "In 2024, we are focused on initiating multiple dose expansion cohorts for ORIC-114 in NSCLC as well as combination studies with one or more AR inhibitors in prostate cancer for ORIC-944, all in anticipation of both programs potentially entering pivotal studies in 2025."

Initial Phase 1b Data for ORIC-944

As of December 10, 2023, the initial Phase 1b monotherapy data for ORIC-944, a potent and selective allosteric inhibitor of PRC2, in patients with metastatic prostate cancer demonstrated:
Potential best-in-class drug properties, including clinical half-life consistent with preclinical prediction of >10 hours, which is superior to other PRC2 inhibitors and supports QD dosing;
No signs of CYP autoinduction that is seen with first-generation PRC2 inhibitors;
Robust target engagement with maximal decrease (≥75%) in H3K27me3 in monocytes from peripheral blood samples at doses as low as 200 mg QD, with low inter-patient variability; and
Favorable safety with only grade 1 and 2 treatment-related adverse events at dose levels corresponding with strong target engagement.
Emerging profile with superior drug properties support advancement into combination development in prostate cancer with AR inhibitor(s).
2023 Key Accomplishments

ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor

Presented initial data from the ongoing Phase 1b dose escalation trial for patients with EGFR or HER2 exon 20 mutated non-small cell lung cancer (NSCLC) at the ESMO (Free ESMO Whitepaper) Congress 2023. Initial data demonstrated potential best-in-class profile, with favorable safety and both systemic and CNS activity in heavily pretreated patients, with 81% of patients having received prior EGFR exon 20 targeted agents and 86% having CNS metastases at baseline.
Presented preclinical data for ORIC-114 at ESMO (Free ESMO Whitepaper) Congress 2023, demonstrating potent activity across atypical mutations in EGFR, thus expanding the potential patient population.
ORIC-944: a potent and selective allosteric inhibitor of PRC2

Presented preclinical data highlighting a comprehensive biomarker strategy for the ongoing Phase 1b trial in metastatic prostate cancer at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.
Demonstrated via preclinical studies the potential for ORIC-944 to synergize with enzalutamide and other AR inhibitors in prostate cancer.
ORIC-533: a highly potent, orally bioavailable small molecule inhibitor of CD73

Presented initial data from Phase 1b trial of ORIC-533 in patients with relapsed/refractory multiple myeloma at the 2023 ASH (Free ASH Whitepaper) Annual Meeting. Initial data demonstrated preliminary evidence of clinical antimyeloma activity and immune effects, as well as a clean safety profile, with only grade 1 and 2 treatment-related events in heavily pre-treated patients.
Expect to complete dose escalation for the Phase 1b trial of ORIC-533 in the first quarter of 2024, and company plans to pursue strategic partnership for combination studies.
Discovery Pipeline:

Presented preclinical data confirming the therapeutic potential of highly selective PLK4 inhibitors as a synthetic lethal therapy for TRIM37 amplified breast cancers at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.
Advanced ORIC-613, a novel, highly selective PLK4 inhibitor, through IND enabling studies.
Corporate Highlights:

Strengthened cash position with $85 million private placement financing from new and existing healthcare specialist funds in the second quarter of 2023.
Anticipated Program Milestones

ORIC-944 initiation of combination study with AR inhibitor(s): 1H 2024
ORIC-944 program update: mid-2024
ORIC-114 initiation of dose expansion in multiple cohorts: 1H 2024
ORIC-114 updated Phase 1b data: 1H 2025
Financial Guidance

As of September 30, 2023, cash, cash equivalents and investments totaled $256.2 million, which the company expects will be sufficient to fund its operating plan into 2026.

Presentation and Webcast
Jacob M. Chacko, M.D., president and chief executive officer, will present a company overview at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 11:15 a.m. PT. A live webcast will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.