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SciTech’s Oncology Drug Granted Orphan Status

On February 1, 2018 SciTech Development reported that the U.S. Food & Drug Administration (FDA) has recently granted its lead drug product ST-001 Orphan Drug Status for the treatment of T-cell lymphoma (Press release, SciTech Development, FEB 1, 2018, View Source [SID1234523786]).

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SciTech’s lead drug product (ST-001) is comprised of the active pharmaceutical ingredient (API) fenretinide, a proven anti-cancer drug, and a specifically selected mixture of bioavailability enhancing phospholipids combined in a proprietary nano formulation. Fenretinide has previously demonstrated human efficacy in the treatment of neuroblastoma and leukemia as well as for lymphoma. ST-001 may be utilized as a standalone drug or in combination with other drugs and immunotherapy agents.

"The granting of orphan drug status by the FDA is a significant milestone in the development of our ST-001 drug program" said Earle Holsapple, President of SciTech Development. "We intend to make use of other FDA expedited programs including fast track designation, priority review and expedited new drug application (NDA) approval in bringing ST001 to market."

The FDA confers orphan status to drugs and biologics that treat rare diseases and disorders that affect fewer than 200,000 people in the United States. Benefits to companies receiving orphan drug status include tax credits and seven years of additional market exclusivity.

Puma Biotechnology and CANbridge Life Sciences Enter into Exclusive Licensing Agreement to Commercialize NERLYNX® (neratinib) in Greater China

On February 1, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that they have entered into an exclusive agreement under which CANbridge will develop and commercialize NERLYNX (neratinib) in mainland China, Taiwan, Hong Kong, and Macau (greater China) (Press release, Puma Biotechnology, FEB 1, 2018, http://investor.pumabiotechnology.com/press-release/puma-biotechnology-and-canbridge-life-sciences-enter-exclusive-licensing-agreement-com [SID1234523716]).

NERLYNX is not approved currently for commercialization outside of the United States. CANbridge will be responsible for seeking the requisite regulatory approval and, once approved, for commercializing NERLYNX in greater China. Puma will receive an upfront payment of $30 million and potential milestone payments totaling up to $40 million upon achievement of certain regulatory milestones. In addition, Puma will receive significant double-digit royalties on NERLYNX sales in greater China and potential milestone payments upon the achievement of certain sales-based milestones.

"Puma is committed to providing access to NERLYNX to patients around the world, and greater China represents a very large market opportunity," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "While we continue to focus our commercial resources on the U.S. market, we believe this new partnership with CANbridge will help patients in greater China to access NERLYNX at the earliest opportunity."

"We are excited about the opportunity to provide this therapy to patients with HER2-positive cancer in our region," said James Xue, Ph.D., Chief Executive Officer and President of CANbridge Life Sciences. "We plan to engage our local regulatory authorities in greater China to expedite commercial access to NERLYNX, which we expect to provide in parts of greater China by mid-2019. We are honored to have been selected by Puma to develop and commercialize this important therapy, which we believe has significant commercial potential in greater China in HER2-positive cancers, including gastric cancer, where CANbridge will be leading the clinical development in greater China."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DRUG INTERACTIONS:

Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid dosing.
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:

Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

OncoBioPharm Ltd is rebranded as aTen Therapeutics Ltd

On February 1, 2018 Scottish biotechnology company OncoBioPharm has reported that from this date it will operate as aTen Therapeutics Ltd (Press release, OncoBioPharm, FEB 1, 2018, View Source [SID1234526010]).

aTen (pronounced ‘atten’) refers to the angiotensin pathway, which plays a key role in several major diseases, and is the target of the company’s lead antibody candidate, Tensinomab.

The new name reflects the company’s commitment to exploring the full potential of its innovative technology platform, not only within oncology but across other major disease areas.

Whilst the company’s main development programme continues to explore Tensinomab’s potential to treat primary cancers and protect against developing metastases, in parallel the development team is researching angiotensin pathway modulation in the context of other serious conditions.

Managing Director, Dr Tina Flatau, said: "Although the vast therapeutic potential of Tensinomab was first demonstrated in cancer models, there is mounting evidence to suggest that angiotensin pathway-modulation could also have major benefits in the treatment of other diseases, beyond oncology. The new aTen Therapeutics brand reflects our commitment to exploring the potential of our technology fully, not just for the treatment of cancer but also within the context of other serious and life-limiting diseases."

aTen Therapeutics Ltd (registered in Scotland no 547221) is a wholly-owned subsidiary of OncoBioPharm Limited (registered in Scotland 29/7/05 no. SC288225).

IMMUTEP LIMITED ANNOUNCES MILESTONE PAYMENT FROM CHINESE PARTNER EOC PHARMA

On February 1, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) reported that it has received a milestone payment from the Company’s Chinese partner for eftilagimod alpha (IMP321), EOC Pharma, an oncology focused affiliate of Eddingpharm (Press release, Immutep, FEB 1, 2018, View Source [SID1234523710]).

The milestone payment of US$1 million relates to the clinical development of eftilagimod alpha in China and follows the granting of EOC Pharma’s Investigational New Drug (IND) application in China, as outlined in Immutep’s December 12, 2017 Operational Update.

Immutep CEO, Marc Voigt, commented, "We are very pleased with the recent progress EOC Pharma has made in China. Given the recent regulatory reform, we are optimistic about eftilagimod’s navigation of the Chinese Food and Drug Administration’s regulatory pathway and its clinical development. We look forward to supporting our partner EOC Pharma."

EOC’s CEO Xiaoming Zou, added, "We have been encouraged by the CFDA approval of the IND. Eftilagimod alpha showed impressive activity in a European Phase 1 clinical trial as well as in the safety run in phase of AIPAC in metastatic breast cancer, and we are confident Chinese patients will experience similar clinical benefit. We also look forward to entering a new phase of collaboration with our partner Immutep."

In May 2013, Immutep and Eddingpharm entered into a licensing agreement whereby Immutep granted Eddingpharm exclusive development rights for eftilagimod in China, including Hong Kong, Macau, and Taiwan. In January 2015, the license was transferred from Eddingpharm to EOC Pharma upon the consent of Immutep. In exchange for these rights, EOC Pharma agreed to pay for the manufacturing of certain drug supply for Immutep and will be required to make milestone payments to Immutep if eftilagimod achieves specified development milestones. EOC Pharma will also pay Immutep a royalty on net sales of eftilagimod in China, if approved.

Affimed Reports New Data for AFM13 from Two Separate Clinical Trials in Hodgkin and CD30-Positive Lymphomas

On February 1, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported additional preliminary patient data from two separate clinical studies of its lead NK cell engager candidate AFM13 (Press release, Affimed, FEB 1, 2018, View Source [SID1234523696]). The data demonstrate that AFM13 was well-tolerated and showed promising therapeutic efficacy both in combination with the anti-PD-1 antibody Keytruda (pembrolizumab) in Hodgkin lymphoma (HL) and as monotherapy in CD30-positive lymphoma.

"We are extremely encouraged by these new data which indicate that the first-in-class NK cell engager AFM13 has achieved clinically meaningful responses both as single agent and in combination with a checkpoint inhibitor" said Dr. Adi Hoess, CEO of Affimed. "In particular, in our combination trial with Keytruda, we are excited to have increased both overall and complete metabolic response rates."

AFM13 in combination with Keytruda in relapsed/refractory HL

Best response preliminary assessment data from 9 patients treated at the highest AFM13 dose level (7 mg/kg) as reported by central read, showed an objective response rate (ORR) of 89% (8/9), including complete metabolic responses (CmR) in 44% (4/9) and partial metabolic responses

(PmRs) in 44% (4/9) of patients. One patient experienced stable disease (SD). This ORR of 89% compared favorably to the historical ORR of Keytruda (58-63%) as monotherapy in a similar patient population. Namely, these patients were R/R HL and post autologous stem cell transplantation (ASCT) or ineligible for ASCT and had failed brentuximab vedotin (BV). Importantly, the reported CR rate of 44% represents a doubled CR rate compared to previously reported anti-PD1 studies (9-22%).

The combination was well-tolerated with most of the adverse events observed mild to moderate in nature and manageable with standard of care.

The data shown here comprise six previously reported patients, including one patient evaluated as a PmR at the three-month assessment and who was converted into CmR at the six-month assessment, as well as three additional patients. In total, the extension cohort includes 21 patients and enrollment has recently been completed.

AFM13 as monotherapy in relapsed/refractory CD30-positive cutaneous lymphoma

In an ongoing investigator-sponsored Phase 1b/2a trial of AFM13 in CD30-positive lymphoma with cutaneous manifestation led by Columbia University Medical Center, an analysis of the first dose cohort (3 patients dosed at 1.5 mg/kg) has been completed. The data demonstrated that AFM13 could be safely administered and showed therapeutic activity as a single agent, with an ORR of 66% (2/3). In detail, one complete response (CR), one partial response (PR) and one stable disease (SD) were observed, as determined by global response score (GRS).

"AFM13 is a truly novel immuno-therapeutic that recruits NK cells and targets CD30-expressing lymphomas. Our early clinical experience has been impressive", said Dr. Ahmed Sawas, Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital and Principal Investigator of the study. "The treatment was well-tolerated and, importantly, it could provide a new treatment for relapsed/refractory CD30-positive lymphoma patients, who currently have limited to no options."

The data shown here comprise one previously reported patient as well as two additional patients. In total, the trial includes three cohorts of three patients each and enrollment is currently ongoing into the third dose cohort.

These data further highlight the clinical utility of NK cell engagement in CD30-positive lymphoma, an indication with high unmet medical need, providing an opportunity for AFM13 beyond classical HL.

About AFM13

AFM13 is a first-in-class tetravalent, bispecific NK cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells. AFM13 is being developed in Hodgkin lymphoma (HL) and in other CD30-positive lymphomas. AFM13 has shown a favorable safety profile and signs of therapeutic efficacy in a monotherapy setting in studies in HL and CD30+ lymphoma with cutaneous manifestation. In addition, data from a combination study of AFM13 with Merck’s anti-PD1 antibody Keytruda (pembrolizumab) supports proof of principle for the combination of NK cell engagement with checkpoint inhibition.

About Affimed’s Phase 1b study of AFM13 in combination with Keytruda (pembrolizumab) (NCT02665650)

Ongoing Phase 1b study to evaluate the safety and tolerability of the combination of the Affimed’s lead product candidate AFM13 with pembrolizumab (Keytruda) as salvage therapy after failure of standard therapies including brentuximab vedotin (BV) in relapsed or refractory (R/R) Hodgkin lymphoma (HL). Patients received escalating doses of AFM13 in combination with pembrolizumab at a flat dose of 200 mg administered every 3 weeks following the classical 3+3 design. Recruitment has been completed into an extension cohort at the highest dose level explored during dose escalation. Response assessment is performed every 12 weeks by PET/CT according to the Lugano Classification Revised Staging System for malignant lymphoma.

About Columbia University’s Phase 1b/2a study of AFM13 in CD30-positive lymphoma (NCT03192202)

Ongoing investigator-sponsored translational Phase 1b/2a study of Affimed’s lead product candidate AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by the Columbia University Medical Center. Primary objective of this study is to investigate the biologic and immunologic effects induced by the administration of various doses of AFM13, when given as a single agent in a broad spectrum of CD30-positive lymphomas with cutaneous presentation. The study is designed to allow for serial biopsies, thereby enabling assessment of NK cell biology and tumor cell killing within the tumor microenvironment.