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Innovation Pharmaceuticals Announces Publication of Independent Research on Kevetrin, the Company’s p53 Drug Candidate, in Oncology Reports

On September 8, 2020 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported the publication of independent research, in Oncology Reports, a leading oncology journal, supporting the therapeutic potential of Kevetrin, the Company’s p53-modulating anti-cancer drug candidate, in treating Acute Myeloid Leukemia (AML) (Press release, Innovation Pharmaceuticals, SEP 8, 2020, View Source [SID1234564737]). AML accounts for approximately one-quarter to one-third of all leukemias worldwide and has a 5-year survival rate of only 24 percent.

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In the recently published Kevetrin AML research, linked below, Kevetrin treatment was shown to arrest cell growth and cause cell death (apoptosis) in AML cells. Multiple p53 targets, several cellular processes and oncogenic pathways were also shown to be positively impacted by Kevetrin. Kevetrin was further shown to exhibit preferential cytotoxic activity against leukemia blast cells, while largely not affecting the immune microenvironment, supporting a less toxic drug profile.

The researchers concluded: "These findings suggest that Kevetrin may be a promising therapeutic option for patients with both wild-type and TP53-mutant AML."

"These compelling research findings, by independent researchers, confirm Kevetrin’s treatment potential in AML—a serious blood cancer in great need of novel treatments," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "A Phase 2a clinical trial of Kevetrin in late-stage platinum-resistant ovarian cancer revealed intra-tumor p53 modulation. The Company is planning to formulate Kevetrin for oral delivery, leveraging drug pharmacokinetics and enhancing ease of use. These new published findings provide valuable insights into Kevetrin’s anti-cancer properties."

As a gene-based therapy, should Kevetrin demonstrate efficacy in clinical testing, its regulatory pathway to approval might be expedited. The Food and Drug Administration (FDA) has signaled strong support for development of gene therapies. Two gene therapies for cancers of the blood (Kymriah and Yescarta) were approved for genetically-driven diseases based primarily on results from mid-stage, single-arm, open-label clinical trials. FDA’s efficacy determination for Kymriah was based on 92 evaluable patients, and 108 evaluable patients for Yescarta.

The Company will keep shareholders apprised of developments in our Kevetrin program. In separate news, the Company will be submitting a briefing package shortly to the FDA in preparation for our planned clinical study of Brilacidin for COVID-19.

· Napolitano R, et al. "Kevetrin Induces Apoptosis in TP53 Wild‑Type and Mutant Acute Myeloid Leukemia Cells." Oncol Rep. 2020 Oct; 44(4): 1561–1573.
View Source
View Sourcepdf/or-44-04-1561.pdf (pdf)

About Kevetrin and p53

Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by modulating p53, a protein frequently referred to as the "Guardian of the Genome" due to its critical role in controlling cell mutations. In a majority of cancers, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Kevetrin, by intravenous dosing, has successfully completed a Phase 1 clinical trial in advanced solid tumors and a Phase 2a clinical trial in late-stage ovarian cancer. The company plans on completing oral toxicology studies and changing the dosing to an oral formulation (tablet or capsule), subject to available financial resources. The Food and Drug Administration (FDA) has awarded Orphan Drug status for Kevetrin in ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and market exclusivities upon any future regulatory approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.

Selecta Biosciences to Participate in Upcoming Investor Conferences

On September 8, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform, ImmTOR, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will participate virtually in the following investor conferences in September (Press release, Selecta Biosciences, SEP 8, 2020, View Source [SID1234564735]):

H.C. Wainwright & Co. 22nd Annual Global Investment Conference 2020
Date: Monday, September 14, 2020
Presentation Time: 3 p.m. ET

Cantor Fitzgerald Virtual Global Healthcare Conference
Date: Wednesday, September 16, 2020
Presentation Time: 1:20 p.m. ET

Live webcasts will be available in the Investors & Media section of the company’s website at www.selectabio.com.

Celsion Announces Common Stock Purchase Agreement with Lincoln Park Capital and Provides Updates on OVATION 2 Study

On September 8, 2020 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported an update on the OVATION 2 Study with GEN-1 in advanced ovarian cancer patients (Press release, Celsion, SEP 8, 2020, View Source [SID1234564734]). Celsion also announced it has entered into a common stock purchase agreement for the issuance and sale, from time to time, of up to $26 million of shares of common stock with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor.

Stock Purchase Agreement

In connection with the execution of the purchase agreement, LPC made an initial purchase of $1 million of common stock at $1.00 per share, representing a significant premium to the current market price.

Under the terms of the new purchase agreement with LPC, Celsion has the right at its sole discretion, but not the obligation, to sell to LPC up to $26 million worth of shares (including the $1 million initially purchased) over the 36-month term of the agreement, subject to certain conditions. There are no upper limits to the price per share LPC may pay to purchase the shares, and the purchase price of the shares will be based on the prevailing market prices at the time of each sale to LPC. Celsion controls the timing and amount of any future sales of its stock to LPC.

There are no warrants, derivatives, financial or business covenants associated with the agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Celsion’s common stock. Celsion may terminate the purchase agreement at any time, at its discretion, without any cost or penalty. In consideration for LPC entering into the purchase agreement, Celsion issued shares of its common stock to LPC as a fee for LPC’s obligation to purchase shares at the Company’s discretion.

"The LPC financing, along with the anticipated sale of New Jersey net operating losses later this year, the repayment and restructure of our long-term debt with Horizon announced last week and our current cash position of approximately $20 million, will help us reach a number of value-rich events including full enrollment of the OVATION 2 Study," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "These funds will also allow us to complete the definitive analysis of the OPTIMA Study, our Phase III trial with ThermoDox in primary liver cancer. We continue to follow patients for overall survival, and to compile data and CT scans to submit to the National Institutes of Health for their review and perspective," Mr. Tardugno added.

Celsion intends to use any net proceeds from the sale of its common stock to LPC to advance its product pipeline and for general corporate purposes. Additional information regarding the purchase agreement with LPC is available in the Current Report on Form 8-K that Celsion will file with the Securities and Exchange Commission.

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

OPTIMA Study Update

Celsion continues to follow patients for overall survival (OS) in its Phase III study of ThermoDox for newly diagnosed hepatocellular carcinoma (HCC) patients, noting that the unexpected and marginally crossed futility boundary, suggested by the Kaplan-Meier analysis at the second interim analysis on July 9, 2020, may be associated with a data maturity issue. The Company has hired independent statisticians to further evaluate the trial data, the statistical plan, and the hypothesis generating data from the earlier HEAT Study, as well as, supplying data to the NIH for independent analysis and recommendation. The Company expects to announce its plans for the OPTIMA Study before year end.

OVATION 2 Study Update

Enrollment in the Phase II portion of the Phase I/II OVATION 2 Study has been accelerated with 22 patients enrolled thus far at 13 sites in the U.S. The Company expects 12 additional sites in the U.S. and Canada to begin enrolling patients by the end of the year, and now expects full enrollment of 118 patients to be completed by the end of the second quarter of 2021, a full quarter earlier than previously anticipated.

GEN-1 was designed using TheraPlas, Celsion’s proprietary, synthetic, non-viral nanoparticle delivery system platform. It is an interleukin-12 (IL-12) DNA plasmid vector associated with a non-viral nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.

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 cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall survival. The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (standard of care + GEN-1) with the control arm (standard of care alone). Celsion has received definite confirmation from the U.S. Food and Drug Administration (FDA) that PFS may be used as a surrogate endpoint for overall survival.

Because OVATION 2 is an open-label study, the Company intends to provide clinical updates throughout the course of treatment, including response rates and surgical resection scores.

Dr. Nicolas Borys, Celsion’s chief medical officer, said, "We are pleased with the pace of enrollment in this trial, and attribute the high level of interest among investigators and patients to the impressive data generated from prior studies. In particular, data from the Phase I portion of the OVATION 2 Study that showed successful tumor resections, with seven out of eight patients (87.5%) in the GEN-1 treatment arm 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. The NACT-only treatment arm had an R0 resection rate of 50%."

"In addition, investigators have expressed confidence in the role of IL-12 and GEN-1’s safety profile. The Data Safety Monitoring Board recommended that the Phase II portion of the OVATION 2 Study proceed with a GEN-1 dose of 100 mg/m², and with more than 17 doses over more than six-months of treatment. We look forward to providing tumor response data and surgical results as they become available throughout the course of treatment. In addition, we believe that PFS as an endpoint bodes well for study success," Dr. Borys added.

NeuBase Therapeutics to Present at Upcoming Investor Conferences in September 2020

On September 8, 2020 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of synthetic medicines, reported that Dietrich A. Stephan, Ph.D., Chief Executive Officer of NeuBase, will present a corporate overview at the virtual H.C. Wainwright 22nd Annual Global Investment Conference, as well as participate in a fireside chat at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, which are both being held in September 2020 (Press release, NeuBase Therapeutics, SEP 8, 2020, View Source [SID1234564733]).

Conference Details:
Event: H.C. Wainwright 22nd Annual Global Investment Conference (virtual)
Format: Presentation
Date: Wednesday, September 16TH
Time: 1:30 p.m. ET
Location: Webcast Link – or at the company’s website (click here)

Event: Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (virtual)
Format: Fireside Chat
Date: Wednesday, September 23RD
Time: 10:00 a.m. ET
Location: Webcast Link – or at the company’s website (click here)

Kura Oncology to Participate in Two Upcoming Investor Conferences

On September 8, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming virtual investor conferences (Press release, Kura Oncology, SEP 8, 2020, View Source [SID1234564732]):

A fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020 at 11:30 a.m. ET / 8:30 a.m. PT; and

A fireside chat at the 2020 Cantor Virtual Global Healthcare Conference on September 16, 2020 at 4:00 p.m. ET / 1:00 p.m. PT.
Live audio webcasts of the fireside chats will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the events.