On January 26, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported new data to be presented at the 2018 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO GU) taking place on February 8-10 in San Francisco (Press release, Astellas, 26 26, 2018, View Source [SID1234523593]). Among the data being presented are findings for men with non-metastatic Castration-Resistant Prostate Cancer (CRPC) taking enzalutamide*; and for patients with locally advanced or metastatic urothelial cancer taking enfortumab vedotin**, an investigational antibodydrug conjugate (ADC).

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"We are poised to announce our largest presence to date at this year’s ASCO (Free ASCO Whitepaper) GU meeting," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "We’re pleased to showcase additional work in our oncology franchise, investigating new indications and uses where possible for patients through expanded indications and tumor types in areas of high unmet need."

The following abstract will be featured during an oral presentation session for enzalutamide:

Title: PROSPER: A phase 3, randomized, double-blind, placebo (PBO)- controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC)

Presenter: Maha Hussain, M.D.

Oral Presentation Abstract Session A: Prostate Cancer; Abstract Number: 3
Session Date/Time: Thursday, February 8, 1:00 p.m.- 2:30 p.m. PST
In addition to the oral presentation, the following six abstracts will be presented during the poster sessions for enzalutamide:

Title: Hepatic effects assessed by review of safety data in enzalutamide castration-resistant prostate cancer (CRPC) trials

Lead Author: Tomasz M. Beer, M.D.

Poster Session A: Prostate Cancer; Abstract Number: 199
Session Date/Time: Thursday, February 8, 11:30 a.m.-1:00 p.m.; 5:15 p.m.- 6:15 p.m. PST
Title: Impact of enzalutamide (ENZA) vs. bicalutamide (BIC) on healthrelated quality of life (HRQoL) of patients (pts) with castration-resistant prostate cancer (CRPC): STRIVE study

Lead Author: Raoul Concepcion, M.D.

Poster Session A: Prostate Cancer; Abstract Number: 234
Session Date/Time: Thursday, February 8, 11:30 a.m.-1:00 p.m.; 5:15 p.m. – 6:15 p.m. PST
Title: Comparison of enzalutamide and bicalutamide in patients with nonmetastatic castration resistant prostate cancer: Number needed to treat to achieve one additional patient free of clinical progression events

Lead Author: Lawrence Ivan Karsh, M.D.

Poster Session A: Prostate Cancer Abstract Number: 228
Session Date/Time: Thursday, February 8, 11:30 a.m.-1:00 p.m.; 5:15 p.m.- 6:15 p.m. PST
Title: Treatment duration and utilization patterns in metastatic castrationresistant prostate cancer patients receiving enzalutamide or abiraterone acetate

Lead Author: Vahan Kassabian, M.D.

Poster Session A: Prostate Cancer; Abstract Number: 229
Session Date/Time: Thursday, February 8, 11:30 a.m.-1:00 p.m.; 5:15 p.m.- 6:15 p.m. PST
Title: Health care resource utilization and costs in metastatic castrationresistant prostate cancer patients treated with enzalutamide or abiraterone acetate

Lead Author: Vahan Kassabian, M.D.

Poster Session A: Prostate Cancer; Abstract Number: 232
Session Date/Time: Thursday, February 8, 11:30 a.m.-1:00 p.m.; 5:15 p.m.- 6:15 p.m. PST
Title: Safety of continued administration of enzalutamide in patients with prostate cancer who showed benefit from prior exposure: A Phase 2 openlabel extension study

Lead Author: Elaine Tat Lam, M.D.

Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, and Testicular Cancers; Abstract Number: 303
Session Date/Time: Friday, February 9, 12:15 p.m.-1:45 p.m.; 6 p.m. – 7 p.m. PST
Astellas will present the following three abstracts during poster sessions for enfortumab vedotin, which include updated Phase 1 data in metastatic urothelial cancer patients with prior CPI treatment and trials in progress (TIP) for the EV-201 and EV-103 studies.

Title: Enfortumab vedotin (EV) in patients (Pts) with metastatic urothelial carcinoma (mUC) with prior checkpoint inhibitor (CPI) failure: A prospective cohort of an ongoing phase 1 study

Lead Author: Daniel P. Petrylak, M.D.

Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, and Testicular Cancers; Abstract Number 431
Session Date/Time: Friday, February 9, 12:15 p.m.-1:45 p.m.; 6:00 p.m.-7:00 p.m. PST
Title: EV-201 study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy

Lead Author: Jonathan E. Rosenberg, M.D.

Trials in Progress Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, and Testicular Cancers; Abstract Number TPS542
Session Date/Time: Friday, February 9, 12:15 p.m.-1:45 p.m.; 6:00 p.m.-7:00 p.m. PST
Title: EV-103 study: A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer

Lead Author: Christopher J. Hoimes, D.O.

Trials in Progress Poster Session B: Prostate Cancer, Urothelial Carcinoma, and Penile, Urethral, and Testicular Cancers; Abstract Number TPS532
Session Date/Time: Friday, February 9, 12:15 p.m.-1:45 p.m.; 6:00 p.m.-7:00 p.m. PST
*Enzalutamide is developed through a collaboration between Pfizer and Astellas and commercialized under the brand name XTANDI.

**Enfortumab vedotin is developed through a collaboration between Seattle Genetics and Astellas.

About Enfortumab Vedotin

Enfortumab vedotin is an investigational Antibody-Drug Conjugate (ADC), composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary, industryleading linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.

About XTANDI (enzalutamide) capsules
XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

Important Safety Information

Contraindications
XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy.

Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In a study of patients with predisposing factors, seizures were reported in 2.2% of patients. See section 5.1 of the Prescribing Information for the list of predisposing factors. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES)
In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Adverse Reactions
The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy-naïve patients, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss.

In the placebo-controlled study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients.

Lab Abnormalities: In the two placebo-controlled trials, Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).

Infections: In the study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death.

Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.

Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions
Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.

Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

Please see Full Prescribing Information for additional safety information.

On January 26, 2018 Novartis AG (NYSE: NVS) reported that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults (Press release, Novartis, JAN 26, 2018, View Source [SID1234523586]). Lutathera, which received orphan drug designation from the FDA, is a first-in-class drug and the first available FDA-approved Peptide Receptor Radionuclide Therapy (PRRT), a form of treatment comprising of a targeting molecule that carries a radioactive component. The approval was based on a Phase 3 study which demonstrated a 79% reduction in the risk of disease progression or death within the Lutathera plus best standard of care arm (octreotide LAR 30mg every four weeks) compared to 60 mg of octreotide LAR alone (hazard ratio 0.21, 95% CI; 0.13-0.32; p<00.001). Novartis recently completed a successful tender offer for Advanced Accelerator Applications to become a subsidiary within the Novartis Group.

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"The approval of Lutathera marks an important achievement and an innovation greatly needed for the NET cancer community," said Susanne Schaffert, Ph.D., Chairperson and President, Advanced Accelerator Applications. "For 30 years, Novartis has supported the NET community with the development of therapeutics in NET and carcinoid syndrome. I cannot think of a better way to commemorate the joining of two organizations and our future together as we advance new nuclear medicine therapeutics in NET as well as across other tumor types."

NETs are rare tumors originating in the neuroendocrine cells of numerous organs, including the gastrointestinal tract, pancreas and lung. Some patients develop symptoms arising from the excessive production of hormones by neuroendocrine tumor cells, while others remain clinically silent for years. The estimated incidence, or rate of new cases, of NETs in the United States is approximately 6.98/100,000 per year, while the estimated prevalence for 2014, based on the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database, was 171,321.[1] Patient survival with advanced GEP-NETs depends on stage and histology. Patients with well- and moderately-differentiated tumors and distant metastases have a 5-year survival probability of 35%.[2]

The approval of Lutathera is based on results of a randomized pivotal Phase 3 study, NETTER-1 that compared treatment using Lutathera plus best standard of care (octreotide LAR 30mg every four weeks) to 60 mg of octreotide LAR, also dosed every four weeks, in patients with inoperable midgut NETs progressing under standard dose octreotide LAR treatment and overexpressing somatostatin receptors, as well as a subset of efficacy and safety data from an international, single-institution, single-arm, open-label trial conducted by Erasmus Medical Center in Rotterdam, Netherlands in more than 1,200 patients with somatostatin receptor positive tumors.

The NETTER-1 study met its primary endpoint, showing a 79% reduction in risk of disease progression or death using Lutathera compared to 60 mg octreotide LAR (hazard ratio 0.21, 95% CI: 0.13-0.32; p<0.0001).[3] Median PFS was not reached in the Lutathera arm compared to 8.5 months for the 60 mg octreotide LAR arm.[3] A pre-planned interim overall survival analysis determined that Lutathera treatment lead to a 48% reduction in the estimated risk of death (hazard ratio 0.52, 95% CI: 0.32-0.84) compared to treatment with 60 mg octreotide LAR.[3] The objective response rate, composed of complete and partial responses, was 13% for the Lutathera arm compared to 4% in the Octreotide LAR 60mg arm (p<0.0148).[3]

The most common Grade 3-4 adverse reactions occurring with a greater frequency among patients in the NETTER-1 study receiving Lutathera with octreotide compared to patients receiving high-dose octreotide include: lymphopenia (44%), increased gamma-glutamyl transferase (20%), vomiting (7%), nausea and elevated aspartate aminotransferase (5% each), and increased alanine aminotransferase, hyperglycemia and hypokalemia (4% each).[3]

Lutathera (lutetium Lu 177 dotatate) Important Safety information[3]

INDICATION
Lutathera is a radiolabeled somatostatin analog indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors in adults.

WARNINGS AND PRECAUTIONS
Radiation exposure: Treatment with Lutathera contributes to a patient’s overall long-term radiation exposure and is associated with an increased risk for cancer. Radiation can be detected in the urine for up to 30 days following Lutathera administration. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with Lutathera consistent with institutional good radiation safety practices and patient management procedures.

Myelosuppression: Due to potential hematological adverse reactions such as anemia, thrombocytopenia, leukopenia, lymphopenia, and neutropenia, blood cell counts must be monitored prior to, during, and after treatment. Dose modification or cessation of treatment may be necessary.
Secondary Myelodysplastic Syndrome and Leukemia: With a median follow-up time of 24 months, myelodysplastic syndrome (MDS) was reported in 2.7% of patients receiving Lutathera with long-acting octreotide compared to no patients receiving high-dose long-acting octreotide. In a Phase I/II clinical study, 15 patients (1.8%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to the development of MDS was 28 months (9 to 41 months) and 55 months (32 to 155 months) for acute leukemia.

Renal toxicity: Treatment with Lutathera will expose kidneys to radiation, which may impair renal function. Monitor serum creatinine and creatinine clearance to assess changes in renal function. A concomitant intravenous infusion of amino acids during Lutathera administration is mandatory for renal protection. Patients with baseline renal impairment may be at greater risk of toxicity. Perform more frequent assessments of renal function in patients with mild or moderate impairment. Withhold, reduce dose, or permanently discontinue based on severity of reaction.

Hepatotoxicity: In Lutathera clinical trials, <1% of patients were reported to have hepatic tumor hemorrhage, edema, or necrosis, with one patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure. Monitor transaminases, bilirubin, and serum albumin during treatment. Withhold, reduce dose, or permanently discontinue based on severity of reaction.
Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm and hypotension, occurred in 1% of patients and typically occurred during or within 24 hours following the initial Lutathera dose. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.

Embryo-Fetal Toxicity: Lutathera can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment and after. Verify pregnancy status of females of reproductive potential prior to initiating Lutathera.
Temporary Infertility: Radiation absorbed by testis and ovaries from the recommended cumulative Lutathera dose falls within the range in which temporary or permanent infertility can be expected following external beam radiotherapy.

ADVERSE REACTIONS
The most common Grade 3-4 adverse reactions observed in Lutathera clinical trials were lymphopenia (44%), increased GGT (20%), vomiting (7%), nausea (5%), elevated AST (5%), increased ALT (4%), hyperglycemia (4%), and hypokalemia (4%).

The following serious adverse reactions are rare but have been observed with a median follow-up time of more than 4 years after treatment with Lutathera: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%). Patients should be counseled and monitored in accordance with the Lutathera prescribing information.

DRUG INTERACTIONS
Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of Lutathera. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each Lutathera dose. Administer short- and long-acting octreotide during Lutathera treatment as recommended.

Please see full Prescribing Information at: View Source

To report SUSPECTED ADVERSE REACTIONS, contact Advanced Accelerator Applications USA, Inc. at 1-844-863-1930, or [email protected], or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On January 25, 2018 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) reported that it will issue a press release on its fourth quarter and full year 2017 financial results on Thursday, February 8, 2018 at 7:00 a.m. ET (Press release, Teva, JAN 25, 2018, View Source;p=RssLanding&cat=news&id=2328502 [SID1234523581]). Following the release, Teva will conduct a conference call and live webcast on the same day, at 8:00 a.m. ET.

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In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time): United States 1-866-869-2321; Canada 1-866-766-8269 or International +44(0) 203 0095710; passcode: 5279244. For a list of other international toll-free numbers, click here.

A live webcast of the call will also be available on Teva’s website at: www.ir.tevapharm.com. Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until March 8, 2018, 9:00 a.m. ET by calling United States 1-866-247-4222; Canada 1-866-878-9237 or International +44(0) 1452550000; passcode: 5279244.

On January 25, 2018 Cotinga Pharmaceuticals Inc. (formerly Critical Outcome Technologies Inc.) (TSX VENTURE:COT)(OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported the publication of positive data from a preclinical study demonstrating that combining COTI-2 with commonly used chemotherapeutic agents improves efficacy and exhibits a favorable drug resistance and toxicity profile in human cancer cell lines (Press release, Cotinga, JAN 25, 2018, View Source [SID1234533159]). These results were published in PLOS ONE under the title, Novel anti-cancer drug COTI-2 synergizes with therapeutic agents and does not induce resistance or exhibit cross-resistance in human cancer cell lines. The article may be found at the following link: View Source

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"These data support our rationale to evaluate COTI-2 as a combination therapy, and we are encouraged that these results specifically suggest that COTI-2 may be safe and efficacious in a variety of oncology indications when administered alongside the standard of care" said Richard Ho, Chief Scientific Officer. "In addition to data indicating synergistic activity against multiple cancer cell lines, the favorable drug resistance and toxicity profiles elucidated in this study are key findings that support the continued development of COTI-2 as part of a combination cancer therapy regimen. We look forward to building on these positive preclinical results as we advance combination treatment with COTI-2 into the clinic later this year."

The preclinical study, performed by Cotinga researchers and academic collaborators, evaluated COTI-2 in combination with commonly used chemotherapeutic agents through in vivo and in vitro experiments using human cancer cell lines. The study found that combining COTI-2 with commonly used chemotherapeutic agents, particularly taxanes and platins, demonstrated enhanced cytotoxic activity and tumor growth inhibition in a variety of human cancer cell lines. Combination treatment with COTI-2 did not induce drug resistance, and drug-resistant cancer cell lines showed little or no cross-resistance to COTI-2. The various combination treatment regimens evaluated did not result in any overt signs of toxicity.

Subject to sufficient financing, Cotinga plans to initiate basket, combination, and expansion studies in multiple oncology indications in 2018.

The Company is also continuing to analyze results from the gynecological arm of its Phase 1 trial of COTI-2 and expects to provide an update when further data are available in the first quarter of 2018. In addition, Cotinga is currently enrolling patients in the head and neck squamous cell carcinoma (HNSCC) dose-escalation arm of its Phase 1 trial of COTI-2, and expects to report initial safety data in the second quarter of 2018.

On January 25, 2018 Generon Corporation, an innovative biotech company in China developing novel biological therapeutics, reported that the first pivotal phase III study in the U.S. for F-627 to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients met the primary endpoint (Press release, Generon (Shanghai), JAN 25, 2018, View Source [SID1234523559]). F-627 (Benegrastim / BineutaTM) is a recombinant human granulocyte colony-stimulating factor (rhG-CSF) dimer with a best-in-class potential to manage CIN in in cancer patients. The primary endpoint was to shorten the duration in days of grade 4 (severe) neutropenia in the first chemotherapy cycle. Patients treated with F-627 demonstrated significantly reduced duration of severe neutropenia compared to patents in placebo group (P<0.0001).

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"We are delighted to announce the significant results seen in this study. This is an important step toward completing the F-627 regulatory package for BLA (biological licensee application) submission" said Dr. David Lacey, Generon’s Chairman of Scientific Advisor board. "We are in the process of further analysis of the data, and plan to submit the results for presentation at an upcoming major medical meeting. " said Dr. Xiaoqiang Yan, Generon’s Chairman and CEO, adding, "Meeting the primary end point of the first pivotal study is an important milestone for Generon, demonstrating our ability to be an innovative biotech company on a global level."

This Phase III trial is a randomized, multi-center, double-blind, placebo controlled Phase III study of the efficacy and safety of a once-per-cycle dose of F-627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) + Adriamycin (doxorubicin)). Subjects were randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects received either 20 mg fixed dose F-627 or Placebo. The subjects’ absolute neutrophil count (ANC) was measured each day post chemotherapy administration until ANC levels exceeded 2.0 x 109/L, then the ANC value was determined every three days until the next chemotherapy cycle. This is one of two pivotal Phase III studies required for BLA submission in the US. The second Phase III study is under an SPA with the FDA and currently ongoing.

The management executives of Yifan Pharmaceuticals congratulated Generon’s team on this achievement and emphasized their continued confidence in Generon’s ability to pursue F-627’s clinical development toward a successful BLA submission, and to bring the best-in-class rhG-CSF to patients worldwide.

Chemotherapy-induced Neutropenia (CIN)

CIN occurs commonly during current cancer treatments involving cytotoxic chemotherapy. In the U.S. alone, it is estimated that approximately 1.7 million cancer patients receive chemotherapy treatment, which amounts to a total of 7.5 million chemotherapy cycles performed annually with approximately 5.0 million chemotherapy cycles involving CIN. The global CIN market is estimated to be at $7.0 billion with about >85% of patients still on first-generation of rhG-CSFs, and less than 15% of patients using second-generation rhG-CSFs, the pegylated rhG-CSF.

About F-627

F-627 (benegrastim) is under development for the treatment of CIN in cancer patients. F-627 is a recombinant fusion protein containing G-CSF and human IgG2-Fc and is expressed in Chinese Hamster Ovary (CHO) cells. F-627 has an immunoglobulin-like structure. It consists of two G-CSF molecules at the N-terminal of Fc fragments (a G-CSF dimer). G-CSF is a growth factor acting on the neutrophilic lineage in the hematopoietic system. G-CSF binds to specific G-CSF receptors (G-CSFR) on the cell surface and stimulates differentiation, proliferation, and activation of neutrophilic granulocytes. F-627 has showed stronger bioactivities than the monomeric rhG-CSFs in vitro and in vivo.