On September 15, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported that other clinical experts in releasing a new commentary in Journal of Clinical Oncology Precision Oncology, underscoring the importance of universal germline testing for all patients with cancer (solid tumors) (Press release, Invitae, SEP 15, 2022, View Source [SID1234619581]). The paper reports a meta-analysis of multiple clinical publications supporting universal testing, independent of age, stage, family history or type of cancer. It reports that for cancer types such as pancreatic and ovarian where universal genetic testing is already recommended, 13% and 20% of patients (respectively) have identifiable actionable heritable gene mutations,2. In comparison, the actionable inherited gene mutation rate for patients with other cancer types is similar: breast 11%, endometrial 13%, prostate 14%, kidney 13%, bladder 14%, testicular 13%, colorectal 13%, liver 14%, and stomach 14%.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

Furthermore, it reports that between 5-13% of patients with cancer with heritable gene mutations are missed by current restrictive testing guidelines and are unable to benefit from associated precision treatment and clinical trial benefits. First, allowing all patients to receive germline testing, without restrictive guidelines, affords patients access to precision therapies, clinical trials and other risk reducing interventions that can improve outcomes, and even extend overall patient survival1. Second, genetic testing informs surveillance and risk reduction for future cancers in patients already affected by cancer. Third, cascade testing helps alert their family members of an increased risk for cancer, so they too can then take advantage of monitoring and risk reducing interventions. Consistent with the Cancer Moonshot 2.0 and the President’s Cancer Panel report 2022, the expert consensus concludes that current evidence supports the implementation of universal germline genetic testing for all patients with cancer (solid tumors).

"This consensus from nationally recognized, cancer genetics clinical experts reinforces the current guidelines that universal genetic testing be offered in all patients with ovarian and pancreatic cancer and either be offered or considered in all patients with colorectal," said Ed Esplin, MD, PhD, FACMG, FACP, clinical geneticist at Invitae. "More importantly, this is a call to all guidelines committees, insurer medical policy makers and the President’s Cancer Moonshot Cabinet to make universal genetic testing available to potentially reduce mortality and improve the lives of all patients with cancer."

The collaborative commentary included experts from the Carolina Urologic Research Center, City of Hope, Dana-Farber Cancer Institute, Mayo Clinic and Invitae.

"The PROCLAIM study demonstrates the clinical utility of universal germline genetic testing in patients with prostate cancer. Current NCCN guidelines preclude some prostate cancer patients from receiving germline testing, thus depriving these patients of the potential to receive precision-based therapies and specific clinical trial eligibility, while perpetuating healthcare disparities among historically underrepresented populations. The PROCLAIM data supports universal genetic testing for prostate cancer patients. We should expeditiously eliminate barriers to gene-based precision therapies to optimize patient outcomes and accelerate equitable access to care," said Neal Shore, MD, urologist and medical director, Carolina Urologic Research Center.

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020.

Worldwide, there were an estimated 18.1 million new cases of cancer in 2018, with one in four men and one in five women developing the disease. In addition, there were 43.8 million persons living with cancer in 2018 who were diagnosed within the last five years.

"The INTERCEPT study has shown the prevalence and clinical utility of germline genetic testing is virtually the same across 14 cancer types, even those cancers not traditionally considered hereditary. This data supports universal genetic testing not only for colorectal cancer, but patients with all cancer types, to potentially improve their treatment and future cancer prevention for them and their family members," said Jewel Samadder, MD, enterprise co-leader precision/individualized cancer medicine, Mayo Clinic Comprehensive Cancer Center.

Restrictive guidelines can lead to disparities in cancer care. Offering germline genetic testing to all patients with cancer at diagnosis may help reduce inequities in cancer care by expanding access for all patients to precision therapy or clinical treatment trials.

"The prevalence of pathogenic variants in cancer susceptibility genes for which there are management guidelines is similar among patients with all types of solid tumors, therefore, it does not makes sense that current guidelines only recommend germline genetic testing for all patients with ovarian, pancreatic, and recently, colorectal cancers. This information has the potential to affect the treatment of these individuals’ current cancers. In addition, it has the potential to allow for the prevention or early detection of future cancers in both these patients and their family members," said Heather Hampel, MS, CGC, professor, Department of Medical Oncology & Therapeutics Research, City of Hope.

On September 15, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the six months ended June 30, 2022 (Press release, Innate Pharma, SEP 15, 2022, View Source [SID1234619580]). The consolidated financial statements are attached to this press release.

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"Based on our strong financial position, we continued the momentum in our product pipeline during the second quarter of the year. We are advancing our anti-CD39 blocking monoclonal antibody IPH5201 to a Phase 2 clinical trial in lung cancer with AstraZeneca, and Sanofi selected a second asset for development, targeting BCMA, that benefits from ANKETTM, Innate’s proprietary multi-specific NK cell engager platform and Sanofi’s CROSSDILES platform. The ANKETTM technology is the engine for development of our robust pipeline of much needed novel solutions to treat cancer." said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We continue to see progress for monalizumab in the early non-small cell lung cancer setting, with the ongoing PACIFIC-9 Phase 3 study, sponsored by AstraZeneca, and recent Phase 2 data presentations. We look forward to further clinical readouts from the Phase 2 TELLOMAK trial for lacutamab and ANKETTM updates in the second half of the year."

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

The Phase 2 TELLOMAK study in Sézary syndrome and mycosis fungoides continues to progress and the Company expects to report preliminary data from both cohorts in the second half of 2022.
Preliminary results from the TELLOMAK Phase 2 study of lacutamab in patients with advanced mycosis fungoides according to KIR3DL2 expression will be presented at the EORTC-CLTG (European Organisation for Research and Treatment of Cancer – Cutaneous Lymphoma Tumours Group) 2022 meeting in Madrid on Friday 23 September.
Two clinical trials are underway evaluating lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL):
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
On the 11 September, at the ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) 2022 conference, the Company presented a poster on ongoing lacutamab Phase 1b trial design in monotherapy in PTCL.
ANKET (Antibody-based NK cell Engager Therapeutics):

The Phase 1/2 clinical trial by Sanofi continues, evaluating IPH6101/SAR’579, the first NKp46/CD16-based NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).
During the period, Sanofi informed the Company of the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies, triggering a €3 million milestone payment. IPH6401/SAR’514 is a BCMA-targeting NK cell engager using Sanofi’s proprietary CROSSODILE multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKETTM proprietary platform. IPH6401/SAR’514 has shown anti-tumor activity and promising drug properties in pre-clinical models. Sanofi will be responsible for all future development, manufacturing and commercialization of IPH6401/SAR’514.
Innate plan to provide updates on IPH65, the tetra-specific ANKETTM, throughout the year as progress is made toward IND-enabling studies in 2023.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

On April 29, Innate announced a $50 million milestone payment from AstraZeneca was triggered for dosing the first patient in the Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT).
Detailed results from the randomized AstraZeneca-sponsored Phase 2 COAST clinical trial, including monalizumab data in combination with durvalumab, were published in the Journal of Clinical Oncology on April 22. The results were initially presented during the ESMO (Free ESMO Whitepaper) Congress 2021. The results of the interim analysis showed monalizumab in combination with durvalumab improved progression-free survival (PFS) and objective response rate (ORR) compared to durvalumab alone in patients with unresectable, Stage III NSCLC who had not progressed after concurrent CRT. The Journal of Clinical Oncology publication now includes exploratory subgroup analysis.
On April 11 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, there was an oral presentation from the AstraZeneca-sponsored Phase 2 NeoCOAST randomized trial in resectable, early-stage NSCLC. The presentation highlighted improved disease responses with durvalumab in combination with monalizumab, oleclumab or danvatirsen, when compared to durvalumab alone. The follow-up randomized Phase 2 clinical trial, NeoCOAST-2, is enrolling patients with resectable, stage IIA-IIIA NSCLC to receive neoadjuvant durvalumab combined with chemotherapy and either oleclumab or monalizumab, followed by surgery and adjuvant durvalumab plus oleclumab or monalizumab.
As a post-period event, on August 1, Innate announced that a planned futility interim analysis of the INTERLINK-1 study Phase 3 sponsored by AstraZeneca did not meet a pre-defined threshold for efficacy. The company announced that, based on the result and the recommendation of an Independent Data Monitoring Committee, the study was to be discontinued. There were no new safety findings. AstraZeneca plan to share the data in due course. The INTERLINK-1 study, sponsored by AstraZeneca, evaluated monalizumab in combination with cetuximab vs. cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
On the 12 September at the ESMO (Free ESMO Whitepaper) 2022 congress, AstraZeneca presented an oral presentation on the Phase 2 NeoCOAST study assessing the safety and efficacy of neoadjuvant durvalumab in combination with chemotherapy and oleclumab or monalizumab and adjuvant treatment in patients with resectable, early-stage NSCLC.
IPH5201 (anti-CD39), partnered with AstraZeneca:

On June 3, Innate announced that IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, will advance into a Phase 2 clinical trial in lung cancer. Innate received in August 2022 a $5 million 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. AstraZeneca conducted a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab. The data are expected to be presented at an upcoming medical meeting in due course.
IPH5301 (anti-CD73):

The investigator-sponsored Phase 1 trial of IPH5301 (CHANCES), in collaboration with Institut Paoli-Calmettes is underway. The trial will be conducted in two parts, Part 1, the dose escalation, followed by a Part 2 safety expansion study cohort. Part 2 will evaluate IPH5301 in combination with chemotherapy and trastuzumab in HER2+ cancer patients.
Preclinical updates:

During the period, the Company received from AstraZeneca a notice that it will not exercise its option to license the four preclinical programs covered in the "Future Programs Option Agreement". This option agreement was part 2018 multi-term agreement between AstraZeneca and Innate. Innate has now regained full rights to further develop the four preclinical molecules.
Corporate Update:

On May 03, Innate announced the commencement of an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million American Depositary Shares ("ADS"). Each ADS representing one ordinary share of Innate. As of June 30, 2022, the balance available under our May 2022 sales agreement remains at $75 million.
Announced on 20 May 2022, as part of the resolutions voted by shareholders, Dr Sally Bennett was appointed as new member of the Supervisory Board. She was appointed as a member of the Audit Committee during the Supervisory Board Meeting of May 20, 2022. On the same day it was announced that Mr Patrick Langlois decided to resign from his mandate of Supervisory Board member of Innate Pharma.
Financial highlights for the first half of 2022:

The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2022 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €158.2 million (€m) as of June 30, 2022 (€159.7m2 as of December 31, 2021).
Revenue and other income from continuing operations3 amounted to €45.6m in the first half of 2022 (€14.7m in the first half of 2021) and mainly comprise of:
Revenue from collaboration and licensing agreements, which mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi and which are recognized on the basis of the percentage of completion of the works performed by the Company under such agreements:
(i) Revenue from collaboration and licensing agreements for monalizumab increased by €10.3m to €16.4m in the first half of 2022 (€6.1m in the first half of 2021). This change mainly results from the transaction price increase of €13.4m ($14.0m) triggered by the launch of the "PACIFIC-9" Phase 3 trial on April 28, 2022. This change in the transaction price generated a €12.5 million favorable cumulative adjustment in the revenue related to monalizumab agreements for the first half of 2022, partially offset by effects of the decrease in direct monalizumab research and development costs over the period as compared to the first half of 2021, in connection with the Phase 1 & 2 trials maturity;
(ii) Revenue related to IPH5201 for the six months ended June 30, 2022 amounted to €4.8m and results from the entire recognition in revenue of the $5.0m milestone payment received in August 2022 from AstraZeneca following the signature on June 1, 2022 of an amendment to the initial contract signed in October 2018. This amendment sets the terms of the collaboration following AstraZeneca’s decision to advance IPH5201 to a Phase 2 study;
(iii) During the period, the Company received from AstraZeneca a notice that it will not exercise its option to license the four preclinical programs covered in the "Future Programs Option Agreement". This option agreement was part of the 2018 multi-term agreement between AstraZeneca and the Company under which the Company received an upfront payment of $20.0m (€17.4m). Innate has now regained full rights to further develop the four preclinical molecules. Consequently, the entire initial payment of $20.0m, or €17.4m was recognized as revenue as of June 30, 2022.
(iv) During the period, the Company was informed of Sanofi’s decision to advance IPH6401/SAR’514 into investigational new drug (IND)-enabling studies. As such, Sanofi has selected a second multispecific antibody engaging NK cells as a drug candidate. This selection triggered a €3.0m milestone payment from Sanofi to the Company, fully recognized in revenue as of June 30, 2022. This amount was received by the Company on September 9, 2022.
Government funding for research expenditures of €4.3m in the first half of 2022 (€6.4m in the first half of 2021).

Operating expenses from continuing operations are €37.1m in the first half of 2022 (€33.9m in the first half of 2021), of which 67.3% (€25.0m) are related to R&D.
R&D expenses from continuing operations increased by €3.7m to €25.0m in the first half of 2022 (€21.2m in the first half of 2021). This change mainly results from (i) a €0.7m increase in direct R&D expenses relating to lacutamab clinical program and to non-clinical programs, notably IPH65, partially offset by the decrease in others clinical programs expenses; (ii) a €1.7m increase in personnel expenses mainly explained by the increase in share-based payments and (iii) the increase in other R&D expenses explained by the provision relating to the payment to be made to Orega Biotech SAS upon receipt of the $5.0m milestone payment from AstraZeneca under the IPH5201 collaboration and agreement following the amendment signed on June 1, 2022.
General and administrative (G&A) expenses from continuing operations decreased by €0.5m to €12.1m in the first half of 2022 (€12.6m in the first half of 2021).
A loss on the Lumoxiti discontinued operations amounting to €0.1m (€6.2m for the first half of 2021). As a reminder, the Company recorded, as of June 30, 2021, a provision for charges relating to the payment of €5.2 million ($6.2 million) to AstraZeneca under the Lumoxiti transition and termination agreement effective as of June 30, 2021. Persuant to the April 2022 underlied agreement, the amount of €5.9 million ($6.2 million) was paid by the Company.
A net financial loss of €2.1m in the first half of 2022 (net financial gain of €1.7m in the first half of 2021), principally as a result of the decrease in fair value of certain of our financial instruments due to the negative impact of the COVID-19 health crisis as well as the Ukrainian crisis on the financial markets.
A net income of €6.3m for the first half of 2022 (net loss of €23.7m for the first half of 2021).
The table below summarizes the IFRS consolidated financial statements as of and for the six months ended June 30, 2022, including 2021 comparative information.

On September 15, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or the "Company"), a clinical-stage biopharmaceutical company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported a strategic reorganization together with the appointment of Dr. Saman Maleki to the Company’s Board of Directors and promotion of Brittany Davison to Chief Accounting Officer (Press release, IMV, SEP 15, 2022, View Source [SID1234619579]).

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"We have made the decision to strategically reconfigure IMV in order to maximize shareholder value and focus resources on driving to near-term value-creating milestones," said Andrew Hall, Chief Executive Officer. "I would like to express my sincere gratitude to the affected employees. Each of them has made valuable contributions to advance MVP-S and have, by virtue of these efforts, positively affected the lives of people with cancer."

The Company reinforces focus on its ground-breaking DPX platform and the clinical advancement of its lead DPX asset, Maveropepimut-S (MVP-S)

IMV is implementing a plan to reduce its workforce by approximately one third, focusing its resources on ongoing MVP-S clinical programs in immuno-oncology (IO), most notably the Phase 2B trials VITALIZE (in relapsed/ refractory DLBCL) and AVALON (in advanced, metastatic ovarian cancer). Moreover, IMV continues to invest in its DPX platform and to leverage this novel technology to drive key strategic partnerships.

This restructuring initiative enables IMV to focus its resources on key near-term value drivers while reducing cash burn and future cash needs.

Appointment of Dr. Saman Maleki to Board of Directors

Dr. Saman Maleki has been appointed to join IMV’s Board of Directors. Dr. Maleki is an Assistant Professor of Oncology, Pathology & Laboratory Medicine, and Medical Biophysics at Western University and a seasoned international expert in the field of immuno-oncology. Dr. Maleki regularly collaborates with biotech companies in the immuno-oncology space and has helped advance oncology and immuno-oncology drug candidates from pre-clinical to phase I clinical trials. Dr. Maleki’s research is focused on disciplines that are synergistic with IMV’s research, such as understanding how to sensitize hard-to-treat cancers to immunotherapy, and his guidance is expected to help support clinical pipeline development and prioritization. Dr. Maleki will be replacing Brittany Davison on the Board of Directors.

Promotion of Brittany Davison to Chief Accounting Officer

Brittany Davison will be promoted to Chief Accounting Officer from her current role as Senior Vice President, Finance. Brittany has been instrumental to IMV’s financial and operational leadership since joining the Company in 2014, taking over full financial reporting responsibility since the departure of Pierre Labbe, the former CFO.

Clinical update to be provided on first group of patients in the VITALIZE r/r DLBCL Phase 2B trial

Later this month, IMV will provide an early clinical update on the first group of patients treated in the VITALIZE Phase 2B trial, a trial designed expressly to solidify and extend the clinical benefit seen in the Phase 2A trial, SPiReL.

On September 15, 2022 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a clinical-stage biotechnology company developing placental-derived allogeneic cell therapies, reported that it entered into a Pre-Paid Advance Agreement (the "Agreement") with YA II PN, LTD ("Yorkville"), an affiliate of Yorkville Advisors Global, LP (Press release, Celularity, SEP 15, 2022, View Source;utm_medium=rss&utm_campaign=celularity-enters-into-150-million-pre-paid-advance-agreement-with-yorkville [SID1234619576]).

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Under the Agreement, Celularity may request individual pre-paid advances from Yorkville in an amount up to $40 million each subject to certain conditions, up to $150 million over the next eighteen (18) months from time to time and as mutually agreed by the parties. Pre-paid advances are issued at a 2% discount, bear interest at a rate of 6% (increased to 15% in the event of default). If at any time during the 18-month commitment period there is an outstanding balance under a pre-paid advance, Yorkville may require the Celularity to issue and sell shares of Common Stock to Yorkville at a price per share equal to the lower of (a) 135% of the daily VWAP prior to disbursement and (b) 95% of the lowest VWAP during the three consecutive trading days immediately prior to the date on which Yorkville provides the purchase notice to Celularity, in each case subject to a floor price of $0.75 per share, and subject to certain share ownership limitations. Celularity could also be required to repay the pre-paid advance in certain circumstances by making monthly cash payments of $6.0 million, plus any accrued and unpaid interest along with a 5.0% redemption premium until such time as the daily VWAP for five consecutive trading days immediately prior to the due date of the next monthly payment is at least 10% greater than $0.75.

Celularity intends to use the proceeds for working capital and other general corporate purposes. General corporate purposes may include research and development and clinical development costs to support the development of its cellular therapy candidates and the expansion of our research and development programs, as well as costs associated with its commercial biomaterials businesses; working capital; capital expenditures; and other general corporate purposes.

The shares described above are being offered by Celularity pursuant to a shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on August 11, 2022 (File No. 333-266786), as declared effective by the SEC on August 18, 2022. A final prospectus supplement containing additional information relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 15, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients. GEN-1 is the Company’s IL-12 gene-mediated immunotherapy (Press release, Celsion, SEP 15, 2022, View Source [SID1234619575]). Topline results are expected in the second half of 2023.

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The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. The study is designed with an 80% confidence interval to show an approximate 33% improvement in progression-free survival when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT only).

IL-12 is a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 gene and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

"We are delighted to reach this important milestone of completing enrollment in our Phase I/II OVATION 2 Study with GEN-1 and are optimistic the study will show our technology’s ability to deliver the powerful immune-modulating agent IL-12," said Corinne Le Goff, Ph.D., president and chief executive officer of Celsion Corporation. "Preliminary interim data in this study are very promising, showing both safety and activity. We look forward to completing the study and reporting top line results, in the second half of 2023."

The Company announced in June 2022 that following a pre-planned interim safety review of 87 patients (46 in the experimental arm and 41 in the control arm), the Data Safety Monitoring Board (DSMB) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit. No dose-limiting toxicities were reported.

In June, the Company also announced that interim clinical data from 70 patients who underwent interval debulking surgery showed that those in the GEN-1 treatment arm had improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores versus the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on omental examination.

In February 2021, the FDA awarded fast track designation to GEN-1 in advanced ovarian cancer. Celsion plans to request FDA breakthrough therapy designation for GEN-1 based on the encouraging clinical data.

About GEN-1 Immunotherapy

Designed using Celsion’s proprietary TheraPlas platform technology, GEN-1 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. The Company previously reported positive safety and encouraging Phase I results with GEN-1 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase Ib dose-escalation trial (the OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer (EOC) is the fifth deadliest malignancy among women in the United States. There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced stages III and IV. EOC is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, stage III and IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stages III and IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.