On July 19, 2021 Cytokinetics, Incorporated (Nasdaq:CYTK) reported plans to offer, subject to market and other conditions, $200,000,000 of shares of its common stock in an underwritten public offering (Press release, Cytokinetics, JUL 19, 2021, View Source [SID1234584979]). There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Cytokinetics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. All of the shares of common stock in the offering will be sold by Cytokinetics.

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J.P. Morgan and Morgan Stanley are acting as joint book-running managers for the offering. Mizuho Securities and JMP Securities are acting as passive book-runners.

The securities described above are being offered by Cytokinetics pursuant to a shelf registration statement (including a prospectus) filed on November 6, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone: 1-866-803-9204, or by email at [email protected]; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at 866-718-1649 or by email at [email protected].

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

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.