On August 20, 2019 NuCana plc (NASDAQ: NCNA) reported that it has been informed by the Clatterbridge Cancer Centre, the sponsor of the ongoing Phase III ACELARATE study, that the enrollment of new patients has been suspended on the advice of the Independent Safety and Data Monitoring Committee (ISDMC) following completion of a prespecified futility analysis (Press release, Nucana BioPharmaceuticals, AUG 20, 2019, View Source [SID1234538887]). This study has enrolled 200 patients with metastatic pancreatic cancer who were not considered suitable for combination chemotherapy and is designed to evaluate the efficacy and safety of Acelarin monotherapy compared to gemcitabine, with further exploration of patient sub-groups that may derive additional benefit from Acelarin.

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A futility analysis was included in the ACELARATE study design to assess the likelihood of the study achieving its primary objective of Acelarin monotherapy demonstrating at least a 42% reduction in risk of death compared to gemcitabine. This analysis indicated that this efficacy objective was unlikely to be met in this difficult to treat patient population. Upon review of the interim data by the ISDMC, the sponsor decided to suspend recruitment, allow the data to mature and conduct additional sub-group analyses. Patients who are deriving benefit can continue treatment with Acelarin. There are 25 patients who are receiving or have received Acelarin monotherapy and who will continue to be followed by the study sponsor.

Professor Daniel Palmer, Director of the Liverpool CRUK/NIHR Experimental Cancer Medicine Centre and Chief Investigator of the ACELARATE study said: "Metastatic pancreatic cancer remains an area of high unmet need and the population included in ACELARATE have particularly poor outcomes and very limited treatment options. Importantly, there were imbalances in unfavorable prognostic factors for the patients in the Acelarin arm which may have impacted the futility analysis. In particular, 54% of the patients in the Acelarin arm were diagnosed at the most advanced stage T4, compared to 36% of patients in the gemcitabine arm. We need to allow the data to mature and conduct additional analyses, including biomarker assessment, in order to determine the most appropriate course of action."

Professor Palmer continued: "Although this futility analysis indicated that the study was unlikely to achieve its overall survival objective, I am encouraged by the positive survival trends observed in patient sub-groups receiving Acelarin. Furthermore, there were no new safety signals."

Hugh Griffith, NuCana’s Founder and Chief Executive Officer said: "When we agreed to provide Acelarin for this investigator-sponsored study, we were well aware of the challenges of treating patients with metastatic pancreatic cancer. We are encouraged by the positive survival trends in the various sub-group analyses and are committed to working with Professor Palmer and the wider study team to determine the optimal path forward for this study. We also look forward to assessing the data from this monotherapy study and remain excited about our ongoing efforts to develop Acelarin in additional indications and, in particular, our plans to develop Acelarin in combination with platinum-containing agents."

Professor Palmer was also a principal investigator for NuCana’s Phase Ib clinical study (ABC-08) that investigated Acelarin in combination with cisplatin in biliary tract cancer and said: "We look forward to participating in the Phase III NuTide:121 study that will investigate Acelarin plus cisplatin in biliary tract cancer. The data from ABC-08 were very encouraging and we are excited about investigating this combination in a registrational study."

On August 19, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported that an abstract on the company’s ongoing CS1001-101 Phase Ib clinical study has been accepted for poster presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress (Press release, CStone Pharmaceauticals, AUG 19, 2019, View Source [SID1234538871]).

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CS1001 is an investigational anti-PD-L1 monoclonal antibody developed by CStone, and one of the company’s three backbone immunotherapy assets. CS1001 is currently being evaluated in a number of clinical trials in China, including one multi-arm Phase I study, two registrational Phase II studies, and three Phase III clinical studies.

CS1001-101 is a Phase Ia/Ib open-label, multiple-dose, dose-escalation and expansion study assessing the safety, tolerability, pharmacokinetics and anti-tumor efficacy of CS1001 in patients with advanced solid tumors or lymphomas. The study has already completed its dose-escalations. According to data released at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting, as of the data cut-off of November 30, 2018, 7 of the 29 enrolled patients showed partial response, with an overall response rate (ORR) of 24% (6 patients are still on treatment). This data demonstrates CS1001’s durable anti-tumor activities in a variety of solid tumors and lymphomas.

The updated data to be presented at the ESMO (Free ESMO Whitepaper) 2019 Annual Congress includes the safety data from the CS1001 Phase Ia/Ib study, and efficacy data of CS1001 in gastric cancer, esophageal cancer, MSI-H cancer and cholangiocarcinoma from the Phase Ib study. It is worth mentioning that, based on previously released data, CS1001 has shown good overall safety and tolerability, and durable anti-tumor activities across different tumor types.

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerability and produced sustained clinical benefits during the Phase Ia stage of the study.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase I bridging study in the U.S. In China, its clinical program includes one multi-arm Phase Ib study, two pivotal Phase II studies, and three Phase III studies for several tumor types.

On August 19, 2019 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it has launched Versavo (bevacizumab), a biosimilar of Roche’s Avastin in India, indicated for the treatment of several types of cancers (metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer) (Press release, Dr Reddy’s, AUG 19, 2019, View Source [SID1234538855]).

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Dr. Reddy’s Versavo is available in strengths of 100mg and 400mg single use vials.

Commenting on the launch, MV Ramana, CEO – India and Emerging Markets, Dr. Reddy’s Laboratories, said, "We regard the good health of our patients as our responsibility and are committed to ensure that they always have access to the medicines they need. The launch of Versavo is another step in that journey and helps strengthen our Oncology portfolio."

Dr. Raymond De Vré, Global Head, Biologics, Dr. Reddy’s Laboratories added "Versavo will help improve access to high quality therapy at an affordable cost, addressing the needs of patients with different cancers in India."

Avastin and its biosimilars had India sales of approximately INR 223 Crore MAT for the most recent twelve months ending in December 2018, according to Ipsos*.

Dr. Reddy’s now has six biosimilar products commercialized in India and various emerging markets and an active development pipeline of several biosimilar products in the oncology and immunology space.

*Ipsos India Tandem Oncology Monitor 2018

About Biosimilars

Biosimilarity means1:

That the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and,

There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

On August 19, 2019 On Target Laboratories, Inc., a privately held biotechnology company that is developing tumor-targeted fluorescent imaging agents to improve cancer surgery, reported that it has completed its Phase 2, multi-center, open-label clinical trial for OTL38 in the detection of lung cancer nodules in lung cancer patients during surgery (Press release, On Target Laboratories, AUG 19, 2019, https://www.prnewswire.com/news-releases/on-target-completes-otl38-phase-2-clinical-trial-in-lung-cancer-300903646.html [SID1234538872]). Top-line data from the trial are expected to be reported in the first half of 2020.

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The Phase 2 study assessed the efficacy, safety and tolerability of OTL38 used intraoperatively in patients with suspected lung cancer. OTL38 is an imaging agent consisting of a folate receptor targeting ligand linked to a highly fluorescent near-infrared dye, which specifically targets folate receptors overexpressed in multiple cancers, including non-small cell lung cancers. For more information on the trial refer to www.clinicaltrials.gov, using the NCT identifier NCT02872701.

"Completing the OTL38 Phase 2 trial in lung cancer is a major milestone for On Target Laboratories," said Chris Barys, newly appointed CEO of On Target Laboratories, who recently succeeded outgoing CEO Martin Low. "The completion of this study propels us one step closer to FDA approval and commercialization which will bring a much-needed advancement in imaging for patients undergoing image-guided surgery for lung cancer."

About OTL38

OTL38, which is being evaluated in clinical trials in ovarian cancer and lung cancer, is a novel compound consisting of a folate receptor targeting ligand, linked to a near-infrared dye which specifically targets folate receptors overexpressed in multiple cancer types.

On August 19, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the closing of its previously announced registered underwritten public offering (Press release, Deciphera Pharmaceuticals, AUG 19, 2019, View Source [SID1234538857]). 10,810,810 shares of the Company’s common stock at a price to the public of $37.00 per share were issued and sold in the offering. The gross proceeds to Deciphera from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $400.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 1,621,621 additional shares of its common stock.

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J.P. Morgan, Piper Jaffray and Jefferies acted as joint book-running managers for the offering. Guggenheim Securities acted as lead manager for the offering. SunTrust Robinson Humphrey acted as co-manager for the offering.

Deciphera intends to use the net proceeds of the offering to fund: clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trials, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material; Investigational New Drug-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; and working capital purposes, including general operating expenses.

The offering was made only by means of a prospectus supplement and accompanying prospectus forming part of a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on October 12, 2018. The final prospectus supplement and the accompanying prospectus was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and 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].

This press release does 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.