On July 19, 2021 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that following a pre-planned interim safety review of 55 as treated patients randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2 (Press release, Celsion, JUL 19, 2021, View Source [SID1234584949]). The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose-limiting toxicities were reported.

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The OVATION 2 Study combines GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer 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 OVATION 2 Study is designed with an 80% confidence interval for an observed Progression Free Survival (PFS) Hazard Ratio of 0.75, which would mean an approximate 33% improvement in risk for cancer progression when comparing the treatment arm (NACT + GEN-1) with the control arm (NACT only). GEN-1 is an immunotherapy that produces safe and durable local levels of IL-12, 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.

The Company also announced that more than 50% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from the first 36 patients who have undergone interval debulking surgery are as follows:

Of the 36 patients who have undergone interval debulking surgery in the OVATION 2 Study:
20 patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT, with 16 out of 20 patients (80%) having a complete tumor resection (R0), which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed; and
16 patients were treated with NACT only, with 9 out of 16 patients (56%) having R0 resections.

When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to NACT:
% Patients with R0 Resections
0, 36, 47 mg/m² of GEN-1 plus NACT n=22 50 %
61, 79, 100 mg/m² of GEN-1 plus NACT n=28 82 %

The objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 16 patients treated with NACT only were comparable, as expected, to the 20 patients treated with GEN-1 at a dose of 100 mg/m² plus NACT, with both groups demonstrating an approximate 80% ORR.
"These findings show a consistent dose-dependent clinical response in both surgical outcome and tumor response, which is further supported by translational data of the tumor microenvironment," noted Nicholas Borys, M.D., Celsion’s executive vice president and chief medical officer. "Continuing our clinical research program at the 100 mg/m2 dose in patients with advanced-stage ovarian cancer holds promise and is strongly encouraged by our study investigators and medical advisors."

"We thank the DSMB members for their work and advice," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We are encouraged by the current rate of patient recruitment and expect to complete enrollment around the end of this year. FDA Fast Track and Orphan Drug Designations for GEN-1 in advanced ovarian cancer are important for our future commercialization efforts. In addition, under the Biologics Price Competition and Innovation Act of 2009, sponsors of new, licensed biological products like GEN-1 that are approved through a Biologics License Application receive 12 years of market exclusivity. The FDA cannot license any 351(k) application for a biosimilar or interchangeable product that relies on the previously approved product as a reference for biosimilarity during this 12-year period."

In February 2021, the Company announced that GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. Celsion plans to request FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data announced today.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which 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 (NK) cell proliferation. The Company previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy or a combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and recently completed a Phase Ib dose-escalation trial (OVATION 1 Study) of GEN-1 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

On July 19, 2021 SUNY Upstate reported that Cancer patients undergoing treatment frequently require assistance getting to and from facilities, often creating a financial and logistical burden (Press release, SUNY Upstate, JUL 19, 2021, View Source [SID1234584963]). That’s why the American Cancer Society has awarded a $10,000 transportation grant to the Upstate Cancer Center. These funds will be used to address the transportation needs of cancer patients in Central New York.

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To help patients get the critical care they need, American Cancer Society community transportation grants are awarded at a local level to health systems, treatment centers and community organizations. These grants are available in select communities through an application process and focus on addressing unmet transportation needs of cancer patients, particularly vulnerable populations experiencing an unequal burden of cancer.

"Disparities predominantly arise from inequities in work, wealth, income, education, housing and overall standard of living, as well as social barriers to high-quality cancer prevention, early detection and treatment services," said Joanie Richter of the American Cancer Society. "The Society collaborates with community health partners to reach individuals in areas with higher burdens of cancer and limited or no access to transportation because even the best treatment can’t work if a patient can’t get there."

The Upstate Cancer Center received a $10,000 transportation grant.

"The goal of this project is to remove transportation as a barrier to receiving cancer treatment," said Richard Kilburg, associate administrator of the Upstate Cancer Center. "We hope to ensure that no Upstate Cancer Center patient misses an appointment due to lack of transportation or lack of transportation resources."

"On behalf of our patients, we thank the American Cancer Society for their generous support," Kilburg said.

Caption: From left: Amy Williams, social worker; Joni Richter, American Cancer Society manager, Strategic Partnerships, Cancer Control Northeast Region; Dick Kilburg, associate administrator of the Upstate Cancer Center; and Linda Naples, financial counselor.

On July 19, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its second quarter financial results on Thursday, August 5, 2021 (Press release, Iovance Biotherapeutics, JUL 19, 2021, View Source [SID1234584962]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 1489438. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will also be available for one year in the Investors section at www.iovance.com.

On July 19, 2021 PEP-Therapy, a biotechnology company developing cell penetrating peptides as targeted therapies for the treatment of cancers, reported that it raised an additional €2.6 million ($3 million) in an extension of its Series A financing round, bringing the total raised in this round to €5.4 million ($6.4 million) (Press release, PEP-Therapy, JUL 19, 2021, View Source;301335760.html [SID1234584956]). This new funding comprises €1.6 million in equity from Anaxago, i&i Prague and BADGE as well as a €1 million loan from Bpifrance. This increased financial support highlights the potential of PEP-010, as well as PEP-Therapy’s Cell Penetrating & Interfering Peptide (CP&IP) technology platform, which was first developed at Sorbonne University and Institut Curie.

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PEP-010 is the first of a new class of therapeutic peptides based on PEP-Therapy’s innovative Cell Penetrating & Interfering Peptide (CP&IP) technology. These innovative molecules penetrate cells and specifically block relevant intracellular protein-protein interactions, leading to the inhibition of key pathological mechanisms, without altering physiological mechanisms.

PEP-Therapy will use the funds to finance the Phase I a/b clinical trial of PEP-010, PEP-Therapy’s lead candidate, for the treatment of advanced solid tumors. The first part of the Series A, which closed in April 2021, will finance the Phase Ia dose escalation part of the study, with the additional funds being used for the development of PEP-010 until the end of the expansion cohorts, Phase Ib.

PEP-Therapy expects to generate promising clinical data from this study, particularly in two indications: metastatic triple negative breast cancer and platinum resistant ovarian cancer. Patients with these two types of solid tumors have a poor prognosis and limited therapeutic alternatives.

Antoine Prestat, CEO and co-founder of PEP-Therapy, said: "We are delighted to have completed this financing round via an attractive balance of dilutive and non-dilutive funds from new high quality and diversified investors who will bring expertise and new insights to support our development."

Jaromír Zahrádka, PhD, CEO of i&i, commented: "PEP-Therapy has developed an extensive knowledge of targeted peptides and the promising preclinical data the company has generated show great potential. We are looking forward to seeing the confirmation of the positive results seen in preclinical data in the upcoming Phase I study."

Gaston Vasseur, Investment Manager at Anaxago, added "This extended financing highlights PEP-Therapy’s capacity to attract highly specialized as well as diversified investors. The Company has managed to rapidly secure the funding for the Phase I trial with PEP-010, a very important milestone for the company. We are happy to contribute to this financing round in conjunction with a number of experienced life science investors."

In addition, PEP-Therapy and its clinical partners, Institut Curie and Gustave Roussy, previously received a €2.9 million grant from the French state innovation fund – Fonds Unique Interministériel (FUI) – to finance nonclinical and early clinical development of PEP-010.

On July 19, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in the cohort expansion arm of the Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, with Opdivo (nivolumab) and Bristol Myers Squibb’s investigational anti-TIGIT antibody, BMS-986207 (Press release, Compugen, JUL 19, 2021, View Source [SID1234584955]).

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"We continue to push forward as leaders in the DNAM axis space and as the only company evaluating a potential synergistic triple blockade of PVRIG, TIGIT and PD-1 in the clinic," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe that the future of immuno-oncology will be driven by combination therapy and this study examining our three-pathway hypothesis is an important component of our overall strategy and a key differentiator for Compugen in the TIGIT space. The study is designed to evaluate simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1 and test the hypothesis that blockade of both PVRIG and TIGIT, parallel DNAM pathways, may be required in certain tumor types to generate or enhance an anti-tumor immune response. The initiation of the cohort expansion phase of the study, allowing us to focus with the selected dose for expansion on specific patient populations where we believe the DNAM axis is dominant, is an important step to examine the potential benefit of this unique immunotherapy combination in a broader range of patients. We are on track to report preliminary data from the triple combination dose escalation arm of the study in the fourth quarter of this year."

Dr. Cohen-Dayag added, "We are delighted to have Bristol Myers Squibb as our partner in this study and are pleased to have their continued support and commitment to the collaboration."

The open-label Phase 1/2 trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of COM701 in combination with Opdivo and BMS-986207. Additional information is available at www.clinicaltrials.gov (NCT04570839).

Opdivo is a trademark of Bristol-Myers Squibb Company.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated in preclinical studies potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. Compugen has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM axis, which also intersect with the well-established PD-1 pathway. Research from Compugen suggests that these three pathways have different dominance in different tumor types and patients, implying that to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. To test this hypothesis, Compugen has established a science-driven, biomarker informed clinical program, which evaluates different combinations of these axis members across tumor types. Compugen is the only company with clinical assets targeting both PVRIG and TIGIT in its portfolio allowing it to more fully exploit the potential of blocking these parallel and complementary members of the DNAM axis to drive robust immune responses.