On July 2, 2019 Incyte (NASDAQ:INCY) and Zai Lab Ltd. (NASDAQ:ZLAB) reported that the companies have entered into a collaboration and license agreement for the development and commercialization of INCMGA0012, an investigational anti-PD-1 monoclonal antibody, in Greater China (Press release, Incyte, JUL 2, 2019, View Source [SID1234537359]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This press release features multimedia. View the full release here: View Source

Under the terms of the agreement, Zai Lab will pay Incyte US$17.5 million up front, and Incyte is eligible to receive up to an additional US$60 million in potential development, regulatory and commercial milestones, as well as tiered royalties from the low to mid-twenties, with Incyte responsible for all royalties and pass-through payments to its licensing partner, MacroGenics, Inc.Zai Lab will receive the rights to develop and exclusively commercialize INCMGA0012 in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan. Incyte will retain an option to assist in the promotion of INCMGA0012 in Zai Lab’s licensed territories.

"The collaboration with Zai Lab further allows us to expand our potential to bring new medicines to patients with cancer around the world," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We believe Zai Lab’s experienced team will be an important strategic partner in helping to support the expansion of our research and development efforts for INCMGA0012, and if approved, provide access to an important new therapy to patients and healthcare providers in Greater China."　

"Incyte is a leading biopharmaceutical company with a world class team. We are excited to enter into this partnership with Incyte for INCMGA0012, and we look forward to working together with them to conduct more global studies and bringing this important medicine to patients in Greater China," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "Anti-PD-1 therapies have become the backbone to many current and future immuno-oncology therapies. We believe the addition of a competitive anti-PD-1 like INCMGA0012 is critical to executing on Zai Lab’s long-term strategy and unlocking the full potential of our pipeline. We intend to rapidly explore the potential of INCMGA0012 as both monotherapy and combination therapy with several of our existing pipeline products."

The transaction is effective immediately upon the execution of the collaboration and license agreement.

About INCMGA0012

INCMGA0012 is an investigational monoclonal antibody that inhibits PD-1. INCMGA0012 is currently being evaluated as monotherapy in registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer.

In 2017, Incyte entered into an exclusive global collaboration and license agreement with MacroGenics, Inc. for global rights to INCMGA0012.

On July 2, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported an update on the regulatory path for LN-145 in advanced cervical cancer (Press release, Iovance Biotherapeutics, JUL 2, 2019, View Source;p=RssLanding&cat=news&id=2402832 [SID1234537358]). Based on an End of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA), the FDA has acknowledged that the ongoing innovaTIL-04 study of TIL therapy LN-145 may be sufficient to support registration in the treatment of patients with advanced cervical cancer. The study is being enrolled with a prospective definition of objective response rate (ORR) read out by a Blinded Independent Review Committee (BIRC) as the primary endpoint. In accordance with the FDA’s recommendation, the new version of the protocol will further define the patient population. Iovance plans to include in the Biologics License Application (BLA), patients who have progressed following initial systemic therapy for recurrent or metastatic disease, which constitutes almost all of the more advanced patients enrolled to date. In addition, the company announced that the innovaTIL-04 study is expected to enroll a total of 75 to 100 patients in order to support a BLA submission.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The FDA’s agreement to consider acceptability of the ongoing study in patients with cervical cancer significantly accelerates our path to BLA submission for LN-145," said Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "This feedback is encouraging. The ability to use the current study, as well as the Breakthrough Therapy designation recently granted to LN-145, allows us to plan on a path to BLA submission in the second half of 2020."

On July 2, 2019 Oxford Vacmedix UK Limited (OVM), the UK-based biopharma company focused on the development of cancer vaccines, reported the award of an Innovate UK grant to CHAIN Biotechnology Ltd (CHAIN) and the University of Oxford to develop live biotherapeutics that support oral delivery for OVM’s recombinant overlapping peptide (ROP) cancer vaccines (Press release, Oxford Vacmedix, JUL 2, 2019, View Source/cancer-vaccine-firm-oxford-vacmedix-announces-collaboration-and-innovate-uk-grant/" target="_blank" title="View Source/cancer-vaccine-firm-oxford-vacmedix-announces-collaboration-and-innovate-uk-grant/" rel="nofollow">View Source [SID1234537356]). The research will use CHAIN’s proprietary microbiome technology and the world-class research facilities in the University’s department of Oncology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The project will initially focus on OVM-100 in a research project titled "Mucosal delivery of Clostridium spores encoding recombinant overlapping peptides (ROPs) of HPV antigen as therapeutic vaccines for cervical cancer". This will bring together University of Oxford’s expertise and CHAIN’s innovative microbial delivery platform to establish the effectiveness of delivering ROPs to the colon for the treatment of cervical cancer.

Spun out from the University of Oxford, OVM holds an exclusive licence for the ROP technology. The technology uses the novel, proprietary platform of ROPs to design and develop therapeutic cancer vaccines and diagnostics with the potential for increased efficacy, lower costs, simpler regulatory pathways and synergy when used in combination with other immune-oncology agents. OVM is developing two cancer vaccines, OVM-100 and OVM-200, focusing on unmet clinical need. OVM-100 is an HPV vaccine targeted at cervical cancer. OVM-200 represents a new type of vaccine utilising survivin, a protein inhibitor of apoptosis, to target solid tumours.

Dr Shisong Jiang, Principal Investigator in the Department of Oncology and Founder of OVM, said:

"We are delighted to have this opportunity to work with CHAIN on this exciting project. The importance of effective and controlled delivery is key to the development of new cancer vaccine and we are very pleased to have support and funding from Innovate UK for this work on our immunotherapy cancer vaccines"

Dr Edward Green, Chief Executive and Founder of CHAIN added:

"This project provides a further opportunity to exemplify our Clostridium-Assisted Drug Development (CADDTM) platform for targeted gut delivery of therapeutic peptides. We look forward to a successful collaboration with OVM and to establishing a combination approach that simplifies and accelerates the development of oral cancer vaccines providing significant patient benefits."

For more information or to arrange an interview, please contact:
William Finch, CEO, Oxford Vacmedix
T: +44 (0) 1865 742087 | M: +44(0)7769 903711 | E: [email protected]
View Source

On July 2, 2019 Sandoz reported the launch of the generic oncology medicine gefitinib indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK[1], which is recommended by ESMO (Free ESMO Whitepaper) as first-line treatment[4] (Press release, Novartis, JUL 2, 2019, View Source [SID1234537355]). The medicine will become available immediately in 13 countries across Europe on the day the reference medicine loses market exclusivity. Sandoz will continue to expand to other countries through a phased rollout.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Generics help expand access to medicine, sometimes as much as doubling the amount of patients treated without any increase in cost[5]," said Francesco Balestrieri, ad interim CEO, Sandoz. "At Sandoz, we recognize that oncology still lags behind seven other therapeutic areas that already benefit from considerable generic competition. The day one launch of generic gefitinib, seen by oncology experts as an essential treatment[8], is part of a wider Sandoz effort to change that equation."

In Europe lung cancer is the fourth most common cancer in both women and men, only exceeded by breast, prostate and colorectal cancer. Each year approximately 312,000 patients are diagnosed with lung cancer[2]. Non-small-cell lung carcinoma (NSCLC) is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC) and accounts for approximately 80% to 85% of all lung cancers cases[6].

Sandoz is the #1 provider of generic oncology medicines worldwide[7] with a broad portfolio of more than 50 products, ranging from chemotherapy, hormones and supportive care to biologics[3]. Its growing oncology portfolio covers an industry-leading 75% of molecules on the WHO’s global Oncology Essential Medicines List[8],[9]. It invests in research and development to improve the lives of cancer patients and liberate healthcare resources through increased access to high-quality, affordable medicines.

About Gefitinib
Gefitinib is a once-daily, oral, non-chemotherapy medicine indicated for monotherapy treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK[1]. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of this type of cancer[1]. The ESMO (Free ESMO Whitepaper) guidelines recommend gefitinib as a first-line treatment option for patients with EGFR-activating mutation metastatic NSCLC[4]. Gefitinib is part of the national essential medicines list for cancer[8]. European regulatory approval was received for the generic molecule in July 2018, but generic products can only be made available at loss of market exclusivity of the reference product, provided that the patent protection has already expired.

On July 1, 2019 Oncoceutics, Inc. reported a scientific publication in the journal Leukemiademonstrating selective and potent agonism of the G-protein coupled receptor (GPCR) GPR132 by ONC212, an imipridone derivative of ONC201 (Press release, Oncoceutics, JUL 1, 2019, View Source [SID1234558352]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GPR132 is an orphan GPCR previously shown to play a tumor suppressor role in acute leukemias that has not been targeted therapeutically. The article shows that ONC212 binds to and activates GPR132 at nanomolar concentrations. GPR132 expression and activation of the integrated stress response was associated with ONC212 anti-cancer effects in acute myeloid leukemia preclinical models. The preclinical efficacy was observed as a single agent and synergistic in combination with the Bcl-2 inhibitor ABT-199.

These findings are consistent with a previous publicationon ONC212 safety and efficacy in preclinical models of pancreatic cancer, which also exhibits elevated GPR132 expression. ONC212 is protected by a composition of matter patent and its future Phase I/II clinical trials in refractory AML is the subject of an alliance between MD Anderson and Oncoceutics.

"Whereas our clinical programs that are ongoing with ONC201 or will commence shortly with ONC206 focus on specific antagonistic effects on Dopamine Receptor D2, the referenced publication clearly indicates the translational potential of ONC212 as the first GPR132 agonist for oncology that is poised for clinical introduction," said Wolfgang Oster, MD, PhD, and Chief Executive Officer of Oncoceutics. "ONC212 adds another GPCR to our target list that have not been druggable so far and allows us to incorporate GPR132 as a predictive biomarker in the development program."

"ONC212 belongs to the group of orphan GPCRs that have been extremely challenging targets for drug development despite their frequent dysregulation in malignant diseases," said J. Silvio Gutkind, PhD, Associate Director of Basic Science at University of California, San Diego. "ONC212 is one of the first drug candidates discovered and developed by Oncoceutics to address this opportunity and it extends the utility of the imipridone platform into hematologic malignancies, as elegantly described in this manuscript."