On March 28, 2023 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported Helen Sabzevari, PhD, President and CEO of Precigen, will participate in a virtual fireside chat on April 4, 2023 from 10:45 AM to 11:15 AM ET at Cantor’s "The Future of Oncology" Virtual Symposium (Press release, Precigen, MAR 28, 2023, View Source [SID1234629459]).

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Details can be found on Precigen’s website in the Events & Presentations section at investors.precigen.com/events-presentations.

On March 28, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, reported that the first patient was dosed this month with its investigational drug onvansertib in its Phase 2 ONSEMBLE trial (NCT05593328) (Press release, Cardiff Oncology, MAR 28, 2023, View Source [SID1234629458]). The trial is designed to demonstrate a clinically meaningful difference in response and onvansertib’s contribution to standard of care (SoC) FOLFIRI/bevacizumab for the second line treatment of patients with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC).

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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

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"We are excited to be underway with our ONSEMBLE trial that builds on the promising efficacy and tolerability results demonstrated in our phase 1b/2 trial in mCRC," said Fairooz Kabbinavar, MD, Chief Medical Officer of Cardiff Oncology. "mCRC is a difficult-to-treat cancer and patients in the second line setting need novel therapeutic options to improve clinical outcomes. Based on our open-label phase 1b/2 trial, we believe the combination of onvansertib with FOLFIRI/bevacizumab could positively impact patients’ responses to treatment and the durability of the responses. Nearly half of our planned 40 sites in the US are open to enroll patients and we’ve seen great enthusiasm from participating investigators."

The Phase 2 ONSEMBLE trial includes patients with mCRC who have a documented KRAS or NRAS mutation and have previously received one prior chemotherapy regimen with or without bevacizumab in the first line metastatic setting. Patients are being randomized to onvansertib plus FOLFIRI/bevacizumab versus FOLFIRI/bevacizumab (standard of care). The primary endpoint is objective response rate determined by the Response Evaluation Criteria in Solid Tumors via an independent central review. The secondary endpoints include progression-free survival, overall survival, duration of response and safety. The trial is being led by Heinz-Josef Lenz, MD, USC Norris Comprehensive Cancer Center, who has experience with the Company’s mCRC clinical program, having served as the principal investigator for the Phase 1b/2 trial.

The Company recently introduced the members of its Scientific Advisory Board, which will continue to provide insight and guidance related to the ONSEMBLE trial and its strategy to advance onvansertib through later-stage clinical development.

On March 28, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported the dosing of the first patient in the Phase 2 Harmonic clinical trial evaluating Lantern’s investigational new drug LP-300 in combination with chemotherapy for never smokers with advanced non-small cell lung cancer (NSCLC) (Press release, Lantern Pharma, MAR 28, 2023, View Source [SID1234629457]).

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"Never-smokers with non-small cell lung cancer face limited choices in therapy options after treatment with targeted therapies, and we believe there is a great opportunity to introduce a therapeutic regimen designed specifically for this subgroup of cancer patients," stated Reggie Ewesuedo, M.D., M.Sc., MBA, Lantern Pharma’s VP of Clinical Development. "These patients show tremendous bravery and resolve in helping to establish signals of efficacy including potential increased survival in this Phase 2 trial that combines LP-300 with standard-of-care treatment. Our team continues to watch and monitor additional patients that are being screened and who, after guidance from their clinicians, may potentially enroll in the Harmonic trial," continued Dr. Ewesuedo.

The Harmonic trial (NCT05456256) is a Phase 2 clinical trial that is assessing the effect of Lantern’s investigational new drug LP-300 in combination with standard-of-care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smoker patients with advanced NSCLC. The study has been designed as a 90 patient trial with approximately 2/3rds of the patients receiving LP-300 with chemotherapy and the remaining 1/3rd receiving chemotherapy alone. Lantern has activated 5 clinical trial sites, across 12 locations in the US including Gabrail Cancer Center, Northwest Oncology, New York Cancer and Blood Specialists, Texas Oncology, and Cancer and Blood Specialty Clinic. Across the 5 Harmonic clinical trial sites, there is 1 dosed patient and 14 additional potential patients that have been pre-screened and are being monitored for possible enrollment. Multiple additional trial sites across the US are expected to be activated in the 1st half of 2023 and will bolster patient recruitment and enrollment.

In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated. Additional information on the Harmonic trial can be found at the Harmonic clinical trial website, on ClinicalTrials.gov, or on the first-of-its-kind Harmonic trial iPhone app, which is focused on education & awareness for never smoker NSCLC patients and the NSCLC community.

About Lung Cancer in Never Smokers:

NSCLC presents differently in never smokers, which are defined by the CDC as a person who has smoked 100 cigarettes or less in their life, compared to smokers. These differences are believed to be due to a higher percentage of genetic mutations in a family of cancer-promoting genes called Tyrosine Kinases (TK). Changes in TK genes, such as EGFR, ALK, ROS and MET, can contribute to the development of healthy cells into cancer cells, leading to tumor formation and growth. LP-300’s intended mechanism is to work together with chemotherapy by strongly interacting in the TK gene pathways, interrupting their activity to slow or prevent tumor growth and spread.

According to the American Cancer Society, lung cancer is the second leading cause of cancer in the US, with over 200,000 patients diagnosed annually. Historically, never smokers with NSCLC make up about 15-20% of all lung cancer patients, representing an approximate annual market potential of $1.5 to $2.0 billion.

On March 28, 2023 Allarity Therapeutics, Inc. (NASDAQ: ALLR) ("Allarity" or "the Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported updates to its ongoing phase 2 clinical programs evaluating IXEMPRA and stenoparib as monotherapies (Press release, Allarity Therapeutics, MAR 28, 2023, View Source [SID1234629454]).

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For both IXEMPRA and stenoparib monotherapy trials, Allarity is taking steps to accelerate patient recruitment to support the goals for interim data readouts by the end of 2023. Due to slower than anticipated patient enrollment in both studies, owing in part to impacts of the COVID pandemic on trial site staffing, Allarity has expanded its collaboration with multiple contract research organizations (CROs) to substantially increase the number of active trial sites. The Company has also made changes to the clinical trial protocols to increase the availability of eligible participants for both monotherapy studies.

"Patient recruitment in oncology clinical trials is an ongoing challenge and has delayed target date readouts across our sector. I am optimistic that our ongoing efforts to address this challenge will make a positive impact on our goal of providing interim data readouts in our ongoing Phase 2 studies by year’s end," said James G. Cullem, Chief Executive Officer of Allarity Therapeutics. "Similarly, our trial protocol amendments reflect Allarity’s adaptability and commitment to seek optimal patient benefit in our clinical studies, guided by our unique DRP companion diagnostics, to select and treat most likely-to-respond patients."

Allarity is sponsoring an ongoing DRP-guided Phase 2 clinical trial evaluating IXEMPRA as a monotherapy in metastatic breast cancer in Europe. In addition to expanding its CRO partnerships, Allarity has implemented a trial protocol amendment that will lower the IXEMPRA-DRP companion diagnostic cut-off score, for enrollment, from 67% to 33%. As a result, Allarity anticipates that it will have sufficient DRP-positive patient enrollment to support an interim data readout from this study in late 2023.

The Company is also evaluating stenoparib as a monotherapy in ovarian cancer in an ongoing DRP-guided Phase 2 clinical trial. Based on early data (unpublished) from this study and in consultation with trial investigators and the Company’s Scientific Advisory Board (SAB), Allarity has implemented a trial protocol amendment to change patient dosing from once daily dose to a BID regimen (twice daily). The aim is to improve therapeutic benefit by providing a consistent level of the drug in the patient throughout the treatment period. As a result of these efforts, Allarity anticipates that it will have sufficient DRP-positive patient enrollment to support an interim data readout from this study in late 2023.

The dosing-related protocol amendment in the Phase 2 stenoparib monotherapy trial also aligns with the BID dosing strategy for Allarity’s recently initiated Phase 1b combination study of stenoparib and dovitinib for the treatment of advanced solid tumors.

On March 28, 2023 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a corporate update (Press release, Vincerx Pharma, MAR 28, 2023, View Source [SID1234629453]).

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"Vincerx made great progress in 2022, advancing multiple programs while moving closer towards achieving our mission of improving outcomes for patients with cancer," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "We are particularly excited with the advancements we have made with our bioconjugation platform. This quarter, we started dosing the first cohort in our Phase 1 dose-escalation study in advanced solid tumors for VIP236, our first-in-class, front-runner αvβ3 SMDC with a tailored design to efficiently target aggressive and metastatic cancers. To date, we have generated robust preclinical results demonstrating how VIP236 can deliver up to 40 times more drug to the cancer, while sparing the surrounding tissues and normal organs. We look forward to sharing preclinical data at the upcoming AACR (Free AACR Whitepaper) meeting, highlighting how VIP236 showed monotherapy efficacy in non-small cell lung cancer (NSCLC), gastric cancer, triple negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer (CRC), and metastatic TNBC in vivo cancer models. Additionally, we will share exciting preclinical data in gastric cancer, where VIP236 showed improved efficacy in vivo compared with ENHERTU, an approved ADC."

"There have been some exciting developments in the ADC space recently, and our team has done great work positioning Vincerx to be a key player through the development and advancement of our next-generation, modular bioconjugation platform. Our lead ADC is VIP943, a novel anti-CD123 antibody that combines a unique payload class of kinesin spindle protein inhibitors (KSPi), a proprietary legumain-cleavable linker, and our CellTrapper modification of the KSPi, which allows for intracellular accumulation. CD123 is a validated target in myeloid malignancies, including higher-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), which are the first indications we are pursuing. MDS and AML are aggressive and heterogeneous in their genetic makeup, and current treatments are quite toxic with high rates of relapse. This past ASH (Free ASH Whitepaper), we presented exciting preclinical data where, for the first time, we showed that our KSPi payload, linker and CellTrapper technology had a significant improvement in safety over Mylotarg, an approved ADC for the treatment of AML. We also showed that VIP943 did not cause cytokine release in human blood cells. This indicates a potential reduced risk in the clinic for cytokine release syndrome, which is a common side effect of other CD123 targeting dugs (eg, ADCs and bispecifics). We believe these preclinical results, especially the improved safety over Mylotarg, demonstrate the benefit of our technology, which was designed to address some of the well-known challenges of existing ADCs. We remain on track to file the IND for VIP943 by mid-2023 and expect to get VIP943 into the clinic in the second half of this year," added Dr. Hamdy.

"We also remain excited about enitociclib, our CDK9 inhibitor, and anticipate dosing the first patient in our Phase 1b enitociclib combination study with an approved BTK inhibitor in CLL next quarter. While great progress has been made in the treatment of CLL, limiting patients’ exposures to toxicities, preventing resistance, and minimizing risk of relapse and death following prolonged BTK inhibition monotherapy remain unmet needs. Our objective in the Phase 1b study is to put patients on a time-limited treatment, thus reducing their exposure to toxicities and preventing resistance to the BTK inhibitor," concluded Dr. Hamdy.

FOURTH QUARTER AND FULL YEAR 2022 CORPORATE HIGHLIGHTS

Bioconjugation Platform

VIP236, an αvβ3 integrin binder linked to an optCPT payload SMDC:
Company published preclinical data in the Journal Cancers:
Compelling proof-of-concept data demonstrated that VIP236 can direct a potent cancer chemotherapy drug to tumors while sparing healthy tissues.
Compared with commonly used chemotherapeutics, VIP236 showed effective tumor targeting, better tumor regression, and better tolerability in mouse models of TNBC, SCLC, and CRC.
In December, the Company received U.S. Food and Drug Administration (FDA) safe-to-proceed letter for Investigational New Drug (IND) application for VIP236 for the treatment of advanced solid tumors; initiated dosing the first cohort of the Phase 1 first-in-human dose-escalation study with VIP236 monotherapy in the first quarter 2023 (ClinicalTrials.gov NCT05712889).

VIP943, CD123-KSPi ADC:

Company presented preclinical data on VIP943 in AML models at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating superiority with significantly improved safety in monkeys when compared with Mylotarg (gemtuzumab ozogamicin), AML ex vivo and in vivo monotherapy activity, no signs of cytokine release in human blood cells, and significant tumor regression in combination with venetoclax and azacytidine in a patient-derived AML model.
IND-enabling studies continue to advance, with IND filing expected mid-2023.

VIP924, CXCR5-KSPi ADC:

IND-enabling studies continue to advance, with IND filing on track for mid-2024.
Enitociclib, Positive Transcription Elongation Factor b (P-TEFb)/CDK9 inhibitor

Orphan Drug Designation was granted by the FDA for the treatment of high-grade B-cell lymphoma characterized by translocations of MYC and BCL2/BCL6 (double-hit lymphoma).
Phase 1b study of enitociclib in combination with an approved BTK inhibitor in patients with high-risk CLL expected to start after assessing the safety of enitociclib monotherapy in patients with high-risk CLL (NCT04978779) at the once-weekly 30mg dose. Anticipate dosing first patient in Phase 1b study in second quarter 2023.
Company presented preclinical and preliminary clinical data on enitociclib in gynecologic malignancies at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. In a preliminary monotherapy clinical study in patients refractory to multiple lines of prior therapy, treatment with enitociclib showed an early signal with stable disease in 3 out of 3 patients with gynecologic cancer as well as 1 out of 4 patients with ovarian cancer unselected for MYC.
Company presented preclinical and clinical data on enitociclib in multiple tumor types at the 2022 ASH (Free ASH Whitepaper) Annual Meeting. In a multiple myeloma (MM) preclinical study, potent monotherapy and combination antitumor efficacy was observed with enitociclib.
National Institutes of Health collaboration Phase 1 combination study with venetoclax and prednisone (VVIP) in peripheral T-cell lymphoma (NTC05371054) ongoing.
A recent publication from Dr. Steven Johnsen’s lab at the Robert Bosch Center of Tumor Diseases, Germany, identified that epigenetic reprogramming and transcriptional changes in metastatic pancreatic ductal adenocarcinoma (PDAC) are factors in therapy resistance and can be targeted by enitociclib.
These data along with our phase 1 clinical data, where we observed 2 patients with pancreatic cancer treated for 3 and 14 cycles achieve stable disease, support a potential clinical trial in metastatic PDAC in combination with chemotherapy.
Additional Corporate Highlights:

Company announced receipt of a one-year extension of Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency’s (EMA) Micro, Small and Medium-Sized Enterprise, enabling Vincerx to become eligible for EMA fee reductions and waiver and other financial incentives.
In June, Company announced key strategic update with realignment of resources to support key indications and programs, advancement of the bioconjugation platform, and extension of cash runway.
Company invited to talk on "ADCs with KSP-Inhibitor Payloads and a Tailored Design of Linker and Metabolite Profile," at the Festival of Biologics meeting.
In the first quarter 2023, Company announced upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.
VIP236: A small molecule drug conjugate with an optimized camptothecin payload has significant activity in patient-derived and metastatic cancer models.
Targeting CDK9 via the small-molecule inhibitor enitociclib as a therapeutic strategy to treat MYCN-amplified rhabdomyosarcoma and neuroblastoma in children.
Synthesis and characterization of novel small molecule drug conjugates with different payloads designed to be released in tumor microenvironment by neutrophil elastase.
CXCR5 is a very promising drug target for the development of antibody-drug conjugates to treat patients with lymphoma.
Expected cash runway into late 2024.
FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

Vincerx had $52.5 million in cash, cash equivalents and marketable securities as of December 31, 2022, as compared to $111.5 million as of December 31, 2021. Based on its current business plans and assumptions, Vincerx believes its available capital will be sufficient to meet its operating requirements into late 2024.

Research and development (R&D) expenses for the fourth quarter and full year 2022 were $11.4 million and $52.2 million, respectively, as compared to $12.3 million and $40.1 million, respectively, for each of the same periods in 2021. The annual increase was primarily driven by increases in manufacturing services, including the ongoing services associated with our ADC program, third party research and preclinical work, new employee salaries, and clinical services in connection with our preclinical studies and clinical trials, partially offset by a decline in stock-based compensation expense.

General and administrative (G&A) expenses for the fourth quarter and full year 2022 were $4.1 million and $19.0 million, respectively, as compared to $5.4 million and $22.6 million for the same periods in 2021. The quarterly and annual decreases were primarily driven by decreases in stock-based compensation expense.

For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.6 million, or $0.65 per share, and a net loss of $65.4 million, or $3.11 per share, respectively. For the fourth quarter and full year 2021, Vincerx reported a net loss of $6.5 million, or $0.31 per share, and a net loss of $39.3 million, or $2.29 per share, respectively.