On March 28, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an early stage immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the year ended December 31, 2022 and provided a corporate update (Press release, MediGene, MAR 28, 2023, View Source [SID1234629460]).

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Full Year 2022 Financial Results

Revenues amounted to EUR 31.3 million, up 200% compared to EUR 10.5 million in 2021.The increase in revenues compared to the previous year is mainly a result of the comprehensive TCR-T and technology partnership with BioNTech as well as a milestone payment received from 2seventy bio.

General and administrative (G&A) expenses were EUR 7.7 million in 2022 compared to EUR 6.2 million in the year prior. This 25% increase was mainly due to higher personnel expenses and consulting costs. In addition, some of the expenses for Executive Board compensation were reported under G&A expenses, whereas in previous years they were reported under R&D expenses.

Research and development (R&D) expenses increased from EUR 12.8 million in 2021, to EUR 28.5 million in fiscal 2022. The significant increase is mainly due to depreciation related to the full impairment of the drug candidate RhuDex, which was out-licensed to Dr. Falk Pharma GmbH, for the amount of EUR 20.4 million. This is attributable to the results of a clinical trial for primary biliary cirrhosis, where the efficacy of the drug candidate RhuDex could not be demonstrated. In the previous year, the impairment loss on RhuDex amounted to EUR 1.5 million.

Cash and cash equivalents amounted to EUR 22.2 million at the end of 2022, compared to EUR 22.4 million at the end of 2021. Based on current planning, Medigene is financed into the fourth quarter 2024.

"2022 was a transformational year for Medigene. We announced a strategic update, that involved the shift of our pipeline focus from liquid to solid tumors, expanding our in-house pipeline and accelerating the development of our lead candidates. We were thrilled to welcome BioNTech as our global strategic partner and received a milestone payment from one of our existing partners, 2seventy bio. In addition, we continued to expand our patent portfolio, which now consists of 57 issued and 94 pending patents across both our assets and technologies in our End-to-End Platform," said Selwyn Ho, Chief Executive Officer of Medigene.

"In 2023, we continue to progress our own MDG1015 program towards a first-in-human clinical trial and look forward to selecting our first lead candidate from the MDG10xx program in the second half of this year. We expect to extend our collaborative approach to R&D, maximizing our existing partnerships and evaluating new partnerships. We will continue to innovate and expand our End-to-End Platform to generate additional value from new development optimization and product enhancement technologies. Finally, despite our current strong cash position, we will explore opportunities to extend our cash runway into 2025 and beyond."

Recent Program Development Highlights and Anticipated 2023 Milestones

MDG1015: 3rd Generation TCR-T therapy for NY-ESO-1 combined with PD1-41BB Switch Receptor technology: MDG1015 is our lead internal solid tumor program. MDG1015 is being advanced towards a phase 1 clinical trial and is currently undergoing Investigational New Drug (IND) and Clinical Trial Application (CTA) enabling experiments, with the aim of having the IND / CTA approved in the 2nd half of 2024.

The first presentation of pre-clinical data for MDG1015 has been accepted for poster presentation at the upcoming American Academy of Clinical Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.

MDG10xx: Multiple TCR-T therapies for yet undisclosed targets combined with PD1-41BB Switch Receptor technology: MDG10xx is being developed against several, as yet undisclosed targets and involving multiple human leukocyte antigens (HLAs), again in combination with the PD1-41BB Switch Receptor technology. The Company expects to announce the first lead for this program in the second half of this year.

MDG1011: TCR-T therapy in blood cancers: The successful completion of the phase 1 MDG1011 trial provides clear clinical validation of our ability to generate and manufacture TCR-T therapies. Despite the positive data generated for MDG1011, the Company made the strategic decision to focus future research and development efforts towards solid tumors indications.

Recent Corporate Development Highlights

Milestone payment from 2seventy bio: In December 2022, a strategic partnership between 2seventy bio (Nasdaq: TSVT) and JW Therapeutics (HKEX: 2126) was announced that included plans for the advancement of the MAGE-A4 TCR licensed from Medigene into a phase 1 clinical trial in China. This triggered a USD 3 million milestone payment from 2seventy bio, which the Company received in January 2023. As a reminder, our partnership with 2seventy bio concluded in June 2022 in accordance with the contract. Upon achievement of contractually defined targets, Medigene remains eligible for milestone payments and royalties from 2seventy bio as per the existing agreement.

Strengthened leadership team with new appointments of James Cornicelli, Pamela Keck and Kirsty Crame: Mr. Cornicelli is the Head of Corporate Development and Strategy. As a highly seasoned executive with over 20 years in senior corporate development and strategic advisory roles, Mr. Cornicelli brings multiple areas of expertise that will help guide the company on critical decisions about partnering and accelerate the growth strategy.

Pamela Keck is the Head of Investor Relations and Corporate Communications. Ms. Keck brings more than 15 years of experience as investor relations and corporate communications professional, and will lead Medigene’s investor relations and corporate communication actvities.

Kirsty Crame, MD, was recently appointed as Medigene’s Head of Clinical Research & Development. Kirsty brings more than 10 years of experience in drug development and clinical operations, focusing primarily in immuno-oncology and in cell therapy development. Dr. Crame will lead the Company’s clinical operations and guide the development of the MDG1015 program towards IND/CTA submissions and approval

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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"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.