On April 1, 2020 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, oncology therapeutics company developing onvansertib for the treatment of various cancers including colorectal, prostate and leukemia, reported that its Phase 1b/2 clinical trial of onvansertib in combination with standard-of-care FOLFIRI/Avastin (bevacizumab) for second-line treatment of patients with KRAS-mutated mCRC, will be featured in a presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held from May 29 – June 2 (Press release, Trovagene, APR 1, 2020, View Source [SID1234556073]).

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There is a significant, unmet medical need to develop a safe and effective second-line treatment option for patients with KRAS-mutated mCRC. Currently available treatments have limited efficacy with only a 4% response rate and a median of 5.5 months progression-free survival (PFS). Other compounds currently in clinical development that target KRAS-mutated cancers have shown minimal activity in mCRC.

Data presented at the ASCO (Free ASCO Whitepaper)-GI meeting in late January showed the effectiveness of onvansertib against all prevalent KRAS mutations associated with mCRC by quantitative decreases in the plasma KRAS mutation levels in treated patients within the first cycle of treatment. Subsequent radiographic scans performed at 8 and 16 weeks confirmed efficacy by measurable shrinkage of tumors in all patients.

"We are excited to have our abstract accepted for presentation at the prestigious ASCO (Free ASCO Whitepaper) annual meeting," said Dr. Thomas Adams, Chief Executive Officer and Chairman of Trovagene. "Despite more than 30 years of intensive efforts, anti-KRAS therapies have remained elusive, and currently there are no drugs effectively targeting a broad spectrum of KRAS mutations. We believe onvansertib has the potential to provide a substantially improved treatment option for second-line treatment of patients with KRAS-mutated mCRC."

About the Phase 1b/2 Trial of Onvansertib in Metastatic KRAS-mutated Colorectal Cancer

The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second‑Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation (NCT03829410), will evaluate the safety and efficacy of onvansertib in combination with standard-of-care FOLFIRI and Avastin (bevacizumab). Up to 44 patients, with a confirmed KRAS mutation, metastatic and unresectable disease, who have failed or are intolerant of treatment with FOLFOX (fluoropyrimidine and oxaliplatin) with or without Avastin (bevacizumab), will be enrolled. The trial is being conducted at two prestigious cancer centers: USC Norris Comprehensive Cancer Center and The Mayo Cancer Center.

About Onvansertib

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

Trovagene has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML (NCT03303339). Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.

Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

On April 1, 2020 OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) reported that the primary endpoint was met in the predefined Step-1 analysis of its Phase 3 clinical trial of investigational product Tedopi, called Atalante 1, in HLAA2 positive non-small cell lung cancer (NSCLC) patients after failure from immune checkpoint inhibitors (PD-1/PD-L1) (Press release, OSE Immunotherapeutics, APR 1, 2020, View Source [SID1234556093]).

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Considering the population of the treated patients in both trial arms randomized at least 12 months before the time of the Step-1 analysis (N=99), the primary objective of Step-1 of the Atalante 1 trial planned in the protocol was met:

In the Phase 3 Step-1 analysis, the statistically positive preliminary results show at least 12-month survival for 29 patients out of 63 patients in the Tedopi arm, corresponding to a 12-month survival rate of 46% with the lower limit (33%) of the 95% confidence interval* [33%-59%], above the pre-specified futility boundary of 25%.

The observed rate of 46% is also above the assumption of a survival rate of 40% specified for the alternative efficacy hypothesis in the protocol.

In the chemotherapy control arm the results show at least 12-month survival for 13 patients out of 36 patients, corresponding to a 12-month survival rate of 36%.

Alexis Peyroles, CEO of OSE Immunotherapeutics, said: "We are very pleased with these positive results for Tedopi in Step-1 and with a 10% absolute difference in 12-month survival rate versus chemotherapy in NSCLC patients after failure of checkpoint inhibitor treated in Atalante 1 Step-1 trial. This outcome confirms the therapeutic value of our neoepitope product in a patient population for whom there are no registered product today and who needs new therapeutic options. Based on these positive results, we are now eager to engage in discussions with regulatory authorities to evaluate Tedopi’s current clinical results and agree upon the best options for further development to maximize on the product’s positive data in terms of benefit/risk ratio. In parallel, given the significant value added by positive Step-1 results, we continue exploring potential partnership opportunities for Tedopi."

As explained in the recent press release from March 26, 2020, the Company together with the Independent Data Monitoring Committee (IDMC) and the Steering Committee of the trial have reviewed the potential impact of the COVID-19 outbreak on the Atalante 1 trial. As of today, there is ongoing concern that trial data may be markedly impacted given the current worldwide COVID19 pandemic and the increased risk for patients with NSCLC as COVID-19 can cause serious pulmonary complications in this immunocompromised patient population. In addition, recommendations from several medical societies include voluntary holds on recruitment of new patients in oncology trials for the time being, due to patient safety concerns.

Consequently, following the recommendation from both IDMC and Steering Committee of Atalante 1, OSE Immunotherapeutics voluntarily decided to terminate patient screening and accrual in the initially planned and now cancelled Step-2. Further analysis of the positive Step-1 data will commence while engaging with regulatory agencies on the best development path forward for the product given the significant unmet medical need in the NSCLC patient population post-checkpoint inhibitor therapy failure.

*The 95% confidence interval (CI) is a range of values which has a 95% chance of containing the true value of the estimated parameter. With less rigor, it can be said that the CI represents the range of values within which it is 95% certain to find the true value sought. It provides a visualization of the uncertainty of the estimate.

On March 31, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the company is entering into a financing of up to $3 million with an institutional investor, with an initial $450,000 of securities purchased at closing (Press release, Propanc, MAR 31, 2020, View Source [SID1234556039]). Funds raised will be used to undertake an engineering run and full scale GMP manufacture of PRP, the Company’s lead product candidate, as well as validation of the pharmacokinetics method to analyze the distribution of the drug in advanced cancer patients for a FIH study, which the Company intends to undertake at the Peter Mac Center in Melbourne, Australia.

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To complete the transaction, the Company entered into a Securities Purchase Agreement for the purchase of 11,250,000 shares of common stock and prefunded warrants issued at closing and 11,250,000 Series A warrants to purchase common stock at $0.20 per share. At closing, the investor was also issued 63,750,000 Series B warrants to purchase common stock at $0.04 per share (for an aggregate maximum exercise price of $2,550,000), and 63,750,000 Series C warrants to purchase common stock at $0.20 per share, which vest upon exercise of the Series B warrants on a ratable basis. Such warrants contain cashless exercise and other cashless conversion provisions. The Company has agreed to register for resale all shares of common stock issued, or underlying securities issued. The Company will provide further information regarding this financing in a Current Report on Form 8-K to be filed with the U.S. Securities and Exchange Commission.

"The completion of this transaction is at a pivotal point for the Company, as we move towards commencing a FIH study for PRP," said James Nathanielsz, Propanc’s Chief Executive Officer. "Given the unique and challenging situation for humankind due to recent global events, the need to improve our standard of healthcare is ever more urgent. During this time, I am especially thinking of cancer sufferers, who may be exposed to standard treatments like radiation or chemotherapy, having a suppressed immune system and therefore exposure to infection like COVID-19 becomes an extremely high risk. Our goal is to improve quality of life, reduce side effects compared to standard treatments and extend life meaningfully. We are grateful to have a strategic institutional investor on board with us who is willing to support our vision."

On March 31, 2020 AbbVie (NYSE: ABBV ), a global research-based biopharmaceutical company, reported that the clinical trial VIALE-A (M15-656) of VENCLEXTA (venetoclax) in combination with azacitidine versus the azacitidine combination with placebo achieved its two main primary objectives: statistically significant improvement in overall survival and compound complete remission rate for patients with prior treatment AML and ineligible for treatment with intensive chemotherapy (Press release, AbbVie, MAR 31, 2020, View Source;842586695.html [SID1234556055]). The complete results will be submitted to the United States regulatory agency, FDA ( Food and Drug Administration ), and to global health authorities, and will also be presented at medical congresses or published in specialized journals.

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"In the past three decades, few options have emerged for AML patients who cannot receive or tolerate intensive chemotherapy or bone marrow transplantation," said physician Neil Gallagher , Ph.D., AbbVie medical director and vice president of development . "The positive results of the VIALE-A study support the clinical benefit of the combination venetoclax plus azacytidine in AML patients who are not eligible for intensive chemotherapy and reflect our ongoing commitment to transforming the standards of care for patients with hematological neoplasms."

AML is one of the most aggressive and difficult to treat blood cancers, with a very low survival rate 1,2 . Despite advances in available therapies and care, the 5-year survival rate for patients diagnosed with AML is approximately 28% 3 . AML generally worsens rapidly and, due to age and existing comorbidities, not all patients are eligible for intensive chemotherapy 4 . AML is the most common acute leukemia in the world 5 .

It is estimated that 160,000 people are currently living with the disease globally, with an incidence rate of 103 new cases per 100,000 people 5

The Phase 3 VIALE-A study evaluated the efficacy and safety of venetoclax in combination with azacitidine compared to the placebo plus azacitidine combination. The study achieved its two primary outcomes of overall survival and complete composite remission (CR + CRi). The observed safety profile is generally consistent with the known safety profile of venetoclax with azacytidine, as seen in previous Phase 1/2 studies and the known safety profiles of the two drugs.

In November 2018, AbbVie received rapid US approval of VENCLEXTA in combination with azacytidine, decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in adults aged 75 years or older, or with comorbidities that prevent the use of chemotherapy. intensive induction based on Phase 1/2 studies. Approval was also granted by regulatory authorities in Mexico, Israel , Puerto Rico, Peru , Brazil, Russia, Argentina , Guatemala , Uruguay, Lebanon, Bahrain , Kazakhstan, Panama, Saudi Arabia, Taiwan , Australia, Qatar and the United Arab Emirates.

VENCLEXTA is being developed by AbbVie and Roche. It is marketed jointly by AbbVie and Genentech, a member of the Roche Group , in the USA, and by AbbVie outside the USA.

About the VIALE-A Phase 3 Study (M15-656)

A total of 443 patients with AML without prior treatment were included in the study and 433 were randomized to the Phase 3 VIALE-A, double-blind, placebo-controlled study. The study was developed to assess the efficacy and safety of venetoclax in combination with azacitidine (n = 287) compared to placebo in combination with azacitidine (n = 146). 6

About VENCLEXTA (venetoclax)

VENCLEXTA (venetoclax) is the first drug in the class to selectively inhibit BCL-2. In some types of cancer, BCL-2 prevents cancer cells from going through the natural process of death or self-destruction, called apoptosis. VENCLEXTA targets the BCL-2 protein and, through its mechanism of action, helps to restore the apoptosis process.

VENCLEXTA is being developed by AbbVie and Roche. It is marketed jointly by AbbVie and Genentech, a member of the Roche Group , in the USA and by AbbVie outside the USA. Together, the companies are committed to BCL-2 research and clinical studies of venetoclax for the treatment of various types of blood and other cancers. VENCLEXTA is approved in more than 50 countries, including the United States and Brazil.

About AbbVie in Oncology

At AbbVie, we strive to discover and develop drugs that provide transformative improvement in cancer treatment, uniquely combining our deep knowledge in key areas of biology with advanced technologies, and by working together with our partners – scientists, clinical experts, peers from industry, patient support groups and patients. We remain focused on generating these transformative advances in the treatment of some of the most complex and aggressive types of cancer. AbbVie’s oncology portfolio consists of drugs already in use and new molecules being evaluated worldwide, through more than 300 clinical studies and more than 20 different types of tumors. For more information, visit www.abbvie.com/oncology.

On March 31, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has entered into definitive agreements with several institutional investors for the purchase and sale of 1,713,064 shares of Phio’s common stock, at a purchase price of $2.335 per share, for gross proceeds of approximately $4.0 million in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Phio Pharmaceuticals, MAR 31, 2020, View Source [SID1234556040]). Phio has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 1,713,064 shares of common stock. The closing of the offering is expected to occur on or about April 2, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $2.21 per share of common stock, will be exercisable immediately following the date of issuance and will expire 5.5 years following the date of issuance.

Phio currently intends to use the net proceeds from the offering for the development of its immuno-oncology programs, other research and development activities and for general working capital needs.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Phio pursuant to a "shelf" registration statement on Form S-3 (File No. 333-224031) previously filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. The offering of the shares of common stock will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.