On December 2, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it has entered into a worldwide OmniAb license agreement with Sanofi (Press release, Ligand, DEC 2, 2019, View Source [SID1234551812]). Under the agreement, Sanofi will be able to use Ligand’s full OmniAb antibody discovery platform which includes OmniRat, OmniFlic, OmniMouse, OmniChicken and OmniClic in addition to Ligand’s patented antigen technology. OmniAb is licensed to over 40 corporate partners globally, and this deal with Sanofi adds to a growing portfolio of OmniAb discovery and clinical development programs with global fully-integrated pharmaceutical companies. Sanofi will pay Ligand an up-front platform access fee, development and regulatory milestone payments and potential royalties on sales of marketed products.

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"This agreement provides Sanofi with access to the industry’s only human immunoglobulin transgenic rats and chickens for efficient generation of mono- and bispecific antibody therapeutics," said John Higgins, Chief Executive Officer of Ligand. "We are pleased to collaborate with a company committed to antibody therapeutics for many years and add OmniAb’s in vivo platform to Sanofi’s outstanding antibody development capabilities."

About OmniAb

OmniAb is a three-species transgenic-animal platform consisting of five different technologies used for producing mono- and bispecific human therapeutic antibodies. OmniRat animals comprise the industry’s first human monoclonal antibody technology based on rats. Because they have a complete immune system with a diverse antibody repertoire, OmniRat animals generate antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. OmniChicken animals comprise the industry’s first human monoclonal antibody technology based on chickens. The OmniClic chicken is specifically developed to facilitate the generation of bispecific antibodies and retains the ability to generate diverse, high quality affinity matured antibodies. All five types of OmniAb therapeutic human antibody platform, OmniRat, OmniFlic, OmniMouse, OmniChicken and OmniClic, use patented technology, have broad freedom to operate, produce highly diversified, fully human antibody repertoires optimized in vivo for immunogenicity, manufacturability, and therapeutic efficacy, and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability – Naturally Optimized Human Antibodies.

On December 2, 2019 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the second quarter of fiscal year 2020 on December 9, 2019 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, DEC 2, 2019, View Source [SID1234551811]). Members of Avid’s senior management will discuss financial results for the second quarter and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.

On December 2, 2019 Novartis reported to presenting data from the company’s expansive hematology portfolio at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (ASH) (Free ASH Whitepaper), taking place December 7-10 in Orlando, Florida (Press release, Novartis, DEC 2, 2019, View Source [SID1234551810]). More than 140 abstracts will be presented, demonstrating our growing pipeline of differentiated immunotherapies and our bold ambition to research and develop medicines that transform the standard of care for patients.

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"Our data at ASH (Free ASH Whitepaper) are evidence of the hard work, dedication and pioneering mindset of our teams. Novartis is deeply committed to build on its deep legacy in hematology to provide new innovative treatments and solutions that help people with malignant and benign blood disorders live longer, better lives," said Susanne Schaffert, PhD, President, Novartis Oncology.

Data at the 2019 ASH (Free ASH Whitepaper) will focus on a range of disease areas, including:

Phase Ib data from the first anti-TIM-3 antibody in hematology, MBG453
Phase Ib study of the anti-TIM-3 antibody MBG453 in combination with decitabine in patients with high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) [Abstract #570; oral presentation: Monday, December 9, 8:15 AM ET]

Data will show real-world Kymriah results as a therapy for adults with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and children and young adults with r/r acute lymphoblastic leukemia (ALL)
Tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy for adults with diffuse large B-cell lymphoma (DLBCL): real world experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) Cellular Therapy (CT) Registry [Abstract #766; oral presentation: Monday, December 9, 3:30 PM ET]
Tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory children and young adults acute lymphoblastic leukemia (ALL): real world experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) Cellular Therapy (CT) Registry [Abstract #2619; poster presentation: Sunday, December 8, 6:00 PM ET]

Post hoc data from the SUSTAIN study, highlighting reductions in hospitalization for patients with sickle cell disease (SCD) treated with Adakveo (crizanlizumab) 5mg/kg; as well as international Sickle Cell World Assessment Survey (SWAY) insights on the impact of SCD
Crizanlizumab treatment is associated with clinically significant reductions in hospitalization in patients with sickle cell disease: results from the SUSTAIN study [Abstract # 2289; poster presentation: Sunday, December 8, 6:00 PM ET]
Impact of sickle cell disease symptoms on patients’ daily lives: interim results from the International Sickle Cell World Assessment Survey (SWAY) [Abstract #2297; poster presentation: Sunday, December 8, 6:00 PM ET]
Management strategies and satisfaction levels in patients with sickle cell disease: interim results from the International Sickle Cell World Assessment Survey (SWAY) [Abstract #1017; poster presentation: Saturday, December 7, 5:30 PM ET]

Evaluating new immune thrombocytopenia (ITP) quality of life index
The psychometric properties of the ITP Life Quality Index assessed in a large multinational "real-world" cohort of immune thrombocytopaenia patients [Abstract #386; oral presentation: Sunday, December 8, 7:45 AM ET]
Novartis plans to provide updates around the 2019 ASH (Free ASH Whitepaper) Annual Meeting on Novartis.com, Twitter, Facebook and LinkedIn, delving into the core of our commitment to reimagining medicine, including interviews with the scientists, people and principles behind our innovation; insights on new findings and developments, and breaking news.

Product Information

Approved indications for products vary by country and not all indications are available in every country. Safety and efficacy profiles have not been established for investigational compounds or are outside the approved indications for marketed products. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available or receive additional indications if already marketed.

For full prescribing information including important safety information about marketed products, please visit View Source

On December 2, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), reported a clinical collaboration agreement with Merck, known as MSD outside the United States and Canada through a subsidiary, to evaluate the combination of Seattle Genetics’ and Astellas’ antibody-drug conjugate (ADC) enfortumab vedotin and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with previously untreated metastatic urothelial cancer (Press release, Astellas, DEC 2, 2019, View Source [SID1234551809]).

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Under the terms of the agreement, the three companies will conduct and fund a global, registrational phase 3 clinical trial to be led by Seattle Genetics. The trial will be designed to evaluate the efficacy of the combination of enfortumab vedotin and pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer. The companies are working in consultation with regulatory authorities to finalize the trial design and currently plan to initiate the trial in the first half of 2020.

"We look forward to initiating a randomized phase 3 trial in patients with previously untreated locally advanced or metastatic urothelial cancer," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Recent data from a phase 1b trial of enfortumab vedotin in combination with pembrolizumab showed evidence of clinical activity leading to the development of this phase 3 trial."

"An unmet medical need exists for previously untreated patients with metastatic urothelial cancer, and we are committed to studying enfortumab vedotin in combination with other agents in different stages of urothelial cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas. "We look forward to further evaluating enfortumab vedotin and pembrolizumab in this high unmet need patient population."

Enfortumab vedotin is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. The PDUFA action date is March 15, 2020.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90 percent of cases).1 In 2019, more than 80,000 people will be diagnosed with bladder cancer in the United States. Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide.2

About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule that is expressed on many solid tumors, and that has been identified as an ADC target by Astellas.

The safety and efficacy of enfortumab vedotin are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval or become commercially available for the uses being investigated.

On December 2, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, and Pierre Fabre reported that they have agreed to extend the terms of the license agreement in which Puma granted Pierre Fabre exclusive rights to develop and commercialize NERLYNX (neratinib) within Europe and part of Africa (Press release, Puma Biotechnology, DEC 2, 2019, View Source [SID1234551808]). The amended agreement extends Pierre Fabre’s commercial rights for NERLYNX to the Middle East, South Africa, Sudan and Turkey.

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Under the terms of the agreement, Puma will receive an upfront payment of $4 million, as well as additional regulatory and sales-based milestone payments totaling up to $3 million. Net sales of NERLYNX from the countries in this extension territory will be included in the calculation of payments related to sales milestones and royalties from the original license agreement signed earlier this year.

"The expansion of our license agreement with Pierre Fabre is indicative of our belief in their robust commercial infrastructure across these additional territories," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "Puma remains committed to providing access to NERLYNX to patients around the world. By expanding Pierre Fabre’s commercial territory, we believe HER-2 positive breast cancer patients in these territories will have access to this much-needed therapy."

"We are pleased to confirm this expanded partnership with Puma Biotechnology," stated Jean-Luc Lowinski, Chief Executive Officer, Pierre Fabre Pharmaceuticals. "It will bring NERLYNX to patients seeking adjuvant treatment options for breast cancer in these new countries where Pierre Fabre is committed to making a difference in the long term."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent 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.