On December 4, 2019 Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation to zotiraciclib for the treatment of glioma (Press release, Adastra Pharmaceuticals, DEC 4, 2019, View Source [SID1234551941]). Zotiraciclib is currently the subject of two separate Phase 1b clinical trials in glioblastoma (GBM). Adastra expects to report results from the two studies during 2020.

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The first Phase 1b clinical trial, sponsored by the National Cancer Institute (NCI), is a multi-arm, dose-finding study examining the combination of zotiraciclib and temozolomide (TMZ) for the treatment of recurrent malignant gliomas. Having recently enrolled the Phase 1 portion, the NCI and Adastra expect to report top-line data early in 2020, expanding upon results previously reported at the 2019 ASCO (Free ASCO Whitepaper) Annual meeting and also via e-Poster at the 2019 Society of Neuro Oncology.

The second Phase 1b trial of zotiraciclib is being conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and is designed as a three-parallel cohort, open-labeled, non-randomized, multicenter study in elderly patients with IDH1R132H-non mutant and MGMT promoter-unmethylated anaplastic astrocytoma or glioblastoma. Group A consists of First-Line patients with unmethylated disease and is designed to determine the application of zotiraciclib in combination with radiation. Group B consists of First-Line patients with methylated disease and is designed to determine zotiraciclib use in combination with TMZ. Group C consists of patients with recurrent GBM and is single agent zotiraciclib intended to measure progression free survival at six months.

"We are very pleased to have been granted Orphan Drug Designation by the FDA and EMA for zotiraciclib in the treatment of glioma. These designations are important in the continued development of zotiraciclib and the ongoing clinical trials in the U.S. at the NCI and throughout Europe with the EORTC," said Scott Megaffin, Chief Executive Officer of Adastra. "Though rare, glioblastoma is one of the most devasting and difficult-to-treat cancers, urgently necessitating the development of new treatments with unique mechanisms of action. Data from the ongoing clinical trials of zotiraciclib have been encouraging and are suggestive of a therapy that is safe and capable of eliciting clinical benefit in high grade gliomas. We greatly look forward to reporting top-line data from the NCI Phase 1b study in early 2020, as well as completing enrollment in two of the EORTC study cohorts later in the year."

About Orphan Drug Designation
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. and not more than five in 10,000 in the E.U. Orphan Drug Designation provides important incentives, including marketing exclusivity upon approval and tax credits for qualified clinical testing, as well as fee exemptions and reductions.

On December 4, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis), for the treatment of various cancers including leukemia, prostate and colorectal, reported new in-vitro and in-vivo data suggesting that onvansertib may provide a new therapeutic option for patients who develop resistance to frontline treatment with venetoclax (Press release, Trovagene, DEC 4, 2019, View Source [SID1234551924]).

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The data show that onvansertib, as a single agent, inhibits tumor growth in venetoclax (Venclexta – Abbvie) resistant in-vitro and in-vivo models. Additionally, the data also demonstrate synergy with the combination of onvansertib and venetoclax, providing further support for the ability of onvansertib to rescue patients once they show signs of resistance to venetoclax. Currently, there are no viable treatment options for patients once they develop resistance to venetoclax; the median overall survival is only 1.7 to 2.3 months and prognosis is poor. Onvansertib represents a new therapeutic option to treat venetoclax-resistant AML and potentially increase progression-free and overall survival for these patients.

"We are very encouraged by the data suggesting that onvansertib will be able to rescue AML patients once they develop resistance to frontline treatment with venetoclax," said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. "In our current Phase 2 AML trial, we are targeting venetoclax-resistant patients and treating them with the combination of onvansertib plus hypomethylating agent decitabine. We are also considering plans to conduct a future clinical trial of onvansertib in combination with venetoclax in patients showing initial signs of resistance to venetoclax to provide a new therapeutic option in an indication with significant clinical need."

AML is the most common acute leukemia in adults and is most frequently diagnosed in those 65 to 74 years of age. Prognosis is generally poor and worsens with advanced age. Current first-line treatment options for AML include induction chemotherapy; however, many older patients are not candidates for this treatment option. With the introduction of venetoclax, the treatment landscape has evolved and elderly patients who are not eligible for intensive chemotherapy are receiving venetoclax in combination with a hypomethylating agent frontline. Resistance tends to develop within approximately 11 months following initiation of treatment with venetoclax and today there are no viable therapies for these patients and their prognosis is poor. Thus, there is a significant medical need for new therapeutic options to treat patients once they develop resistance to venetoclax.
About the Ongoing Phase 2 Clinical Trial of Onvansertib in AML

Trovagene Inc. | 11055 Flintkote Avenue | San Diego | CA 92121 | Tel.: USA [+1] 888-391-7992

The ongoing multi-center open label Phase 2 AML trial (NCT03303339) of onvansertib in combination with decitabine will enroll a total of 32 patients. Eligible patients are either treatment naïve and not candidates for induction therapy or have relapsed/refractory disease following treatment with one prior regimen, including patients treated with venetoclax in combination with a hypomethylating agent. Patients will receive onvansertib, administered orally, on days 1 through 5 of each 21-28-day cycle in combination with decitabine. The primary efficacy endpoint of objective response (CR + CRi) will be assessed in patients who complete at least 1 cycle of treatment.

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 December 4, 2019 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported that the Company will present at the 12th Annual LD Micro Main Event on Wednesday December 11, 2019 at 11:40 AM PT (Press release, Citius Pharmaceuticals, DEC 4, 2019, View Source [SID1234551942]). The conference is being held at the Luxe Sunset Boulevard Hotel in Bel Air, California on December 10-12, 2019.

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Presentation Date: Wednesday, December 11, 2019

Presentation Time: 11:40 AM PT – Track 3

Location: Luxe Sunset Boulevard Hotel – Bel Air, CA

Mr. Leonard Mazur, Chairman of Citius, will deliver an overview of the Company, answer questions from investors, and be available for one-on-one meetings. To arrange a meeting with the Company, please contact Mr. Andrew Scott: [email protected].

On December 4, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations (Press release, Hoffmann-La Roche, DEC 4, 2019, View Source [SID1234551906]).

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"We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Today’s approval offers another opportunity to help prolong the lives of people with this type of the disease."

This approval is based on results from the Phase III IMpower130 study, which showed Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS]=18.6 versus 13.9 months; hazard ratio [HR]=0.80; 95% CI: 0.64–0.99; p=0.0384) in the intention-to-treat wild-type (ITT-WT) population.1 The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (median PFS=7.2 versus 6.5 months; HR=0.75; 95% CI: 0.63–0.91; p=0.0024) in the ITT-WT population.1

Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving Tecentriq plus chemotherapy compared with 60.3% of people receiving chemotherapy alone.

In lung cancer, Tecentriq is also approved in the US in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for NSCLC harbouring these aberrations prior to receiving Tecentriq. Tecentriq is also approved in the US in combination with carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

Roche has an extensive development programme for Tecentriq, including nine Phase III studies underway across different types of lung cancer, and multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower130 study
IMpower130 is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with nab-paclitaxel and carboplatin versus chemotherapy (nab-paclitaxel and carboplatin) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC. The study enrolled 724 people, of whom 681 were in the ITT-WT population and were randomised (2:1) to receive:

Tecentriq plus nab-paclitaxel and carboplatin (Arm A), or
Nab-paclitaxel and carboplatin (Arm B, control arm)
During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first. People in Arm A received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.

During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People in Arm B received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover to receive Tecentriq as monotherapy until further disease progression.

The co-primary endpoints were:

PFS, as determined by the investigator using RECIST v1.1 in people without EGFR or ALK mutations (the ITT-WT population)
OS in the ITT-WT population
About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.3 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.3

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On December 4, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported the pricing of an underwritten public offering of 4,000,000 shares of its common stock, offered at a price of $58.00 per share, before underwriting discounts (Press release, Arrowhead Pharmaceuticals, DEC 4, 2019, View Source [SID1234551925]). The offering is expected to close on or about December 6, 2019, subject to customary closing conditions. In addition, Arrowhead has granted the underwriters of the offering a 30-day option to purchase up to an additional 600,000 shares of common stock at the public offering price, less the underwriting discount. Gross offering proceeds will be approximately $232 million, before deducting underwriting discounts and commissions and offering expenses.

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Goldman Sachs & Co. LLC, Jefferies LLC and Piper Jaffray & Co. are acting as bookrunning managers for the offering, Cantor Fitzgerald & Co. is acting as passive joint bookrunner for the offering and Robert W. Baird & Co. Incorporated and B. Riley FBR, Inc. are acting as co-managers for the offering. Arrowhead intends to use the net proceeds from this offering for general corporate purposes, including working capital, capital expenditures, research and development expenditures and clinical trial expenditures. A portion of the net proceeds may also be used for the acquisition of complementary businesses, products and technologies, or for other strategic purposes.

A shelf registration statement on Form S-3 (File No. 333-235324) relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and became automatically effective upon filing on December 2, 2019. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or from Piper Jaffray & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

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