On August 29, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has filed with the Food and Drug Administration (FDA) an Investigational New Drug (IND) application to study Annamycin in the treatment of relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, AUG 29, 2017, View Source [SID1234520328]).

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Submitting this revised IND marks a significant milestone for Moleculin. FDA allowing the IND to go into effect — which is the anticipated next step and normally would occur within 30 days — will allow the Company to begin additional clinical trials as part of demonstrating the safety and effectiveness of Annamycin. The current plan is to seek approval for treating relapsed or refractory acute myeloid leukemia. If the IND goes into effect as planned, the Company expects to begin clinical trials during the fourth quarter of this year. There can be no assurance, however, that the IND will go into effect within in expected time frame, or at all.

"It took considerable time to produce the additional CMC data requested by the FDA," commented Walter Klemp, Chairman and CEO of Moleculin, "but now that we have all of what the FDA requested, we are pleased to submit a revised IND. We have seen considerable interest from Principle Investigators who are eager to enroll AML patients in an Annamycin clinical trial, so this is a critical step for us."

The Company previously filed an IND, in response to which the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls (CMC). The Company withdrew its original application in order to develop the additional information and CMC data and revise the protocol, with the goal of resubmitting the application when that was accomplished. The current IND submission represents the completion of that process.

On August 29, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN) reported that Seattle Genetics, Inc. has exercised its option to co-develop tisotumab vedotin (Press release, Genmab, AUG 29, 2017, View Source [SID1234520327]). The companies originally entered into a commercial license and collaboration agreement in October 2011 under which Seattle Genetics had the right to exercise a co-development option for tisotumab vedotin at the end of Phase I clinical development. Tisotumab vedotin, an antibody-drug conjugate (ADC) targeting tissue factor, is currently being evaluated in Phase I/II clinical studies in solid tumors. Going forward, Genmab and Seattle Genetics will co-develop and share all future costs and profits for tisotumab vedotin on a 50:50 basis.

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"The combination of Genmab’s differentiated HuMax-TF antibody and Seattle Genetics’ clinically-validated antibody-drug conjugate (ADC) technology has resulted in encouraging preliminary data for tisotumab vedotin in selected solid tumors. We very much look forward to working with Seattle Genetics to further develop this exciting first-in-class ADC product," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

"Our ADC partnership with Genmab has generated promising Phase I/II data for tisotumab vedotin in patients with recurrent cervical cancer. As Seattle Genetics opts into co-development of this clinical program, we add another potential product to our strong pipeline," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Together with Genmab, we look forward to advancing tisotumab vedotin for the treatment of solid tumors."

Preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701) were announced in June 2017, demonstrating antitumor activity and manageable safety in recurrent cervical cancer patients. This announcement can be found here. Updated preliminary data from the Phase I/II study will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid (Spain), September 8-12, 2017.

Today’s news does not impact the 2017 financial guidance issued by Genmab on May 10, 2017.

About the collaboration
In October 2011, Genmab and Seattle Genetics, Inc. entered into a commercial license and collaboration agreement for ADCs. Under the agreement, Genmab was granted rights to utilize Seattle Genetics ADC technology with its HuMax-TF antibody. Seattle Genetics was granted rights to exercise a co-development and co-commercialization option at the end of Phase I clinical development for tisotumab vedotin. With today’s news Seattle Genetics exercises its option to co-develop tisotumab vedotin and the companies will share all future costs and profits for the product on a 50:50 basis. Seattle Genetics will be responsible for commercialization activities in the US, Canada, and Mexico, while Genmab will be responsible for commercialization activities in all other territories. Each party has the option to co-promote by employing up to 40 percent of the sales effort in the other party’s territories.
About tisotumab vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of a human antibody that binds to tissue factor (TF) and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). TF is a protein involved in tumor signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for an ADC approach. Tisotumab vedotin is in Phase I/II clinical studies for solid tumors.

On August 29, 2017 Eli Lilly and Company (NYSE: LLY) reported it will showcase new data across six different tumor types at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain, September 8-12, 2017 (Press release, Eli Lilly, AUG 29, 2017, View Source [SID1234520326]). Notably, results from Phase 3 studies of abemaciclib and ramucirumab have been selected for oral presentation during a Presidential Symposium, which features groundbreaking research that is potentially practice-changing, on September 10.

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"In line with this year’s theme of ‘integrating science into oncology for a better patient outcome,’ the data being presented at ESMO (Free ESMO Whitepaper) demonstrate how we are further developing our foundational medicines – each rooted in the biology of cancer – to deliver innovative breakthrough medicines that will make a meaningful difference to patients and doctors," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "We are excited to share new data that shows our progress on bringing forward abemaciclib as a potential new treatment option for advanced breast cancer and investigating the use of ramucirumab in additional tumor types such as advanced or metastatic urothelial carcinoma."

For the first time, two Lilly molecules will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium, with data from its MONARCH 3 and RANGE studies in advanced breast cancer and platinum-refractory urothelial cancer, respectively. MONARCH 3 is a global Phase 3, double-blind, placebo-controlled study, which evaluated the efficacy and safety of abemaciclib in combination with a nonsteroidal aromatase inhibitor (letrozole or anastrozole) as initial endocrine-based therapy for postmenopausal women with advanced breast cancer who have had no prior systemic treatment for advanced disease. RANGE is a global Phase 3 randomized, double-blind study evaluating the safety and efficacy of ramucirumab and docetaxel compared to placebo and docetaxel in patients with advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.

All key studies, along with the times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract Title: MONARCH 3: Abemaciclib as initial therapy for patients with HR+/HER2- advanced breast cancer
Abstract #236O_PR; Presidential Symposium II: Sunday, September 10, 2017; 16:30-16:45 CEST
Author/Speaker: Angelo Di Leo, M.D., Hospital of Prato, Instituto Toscano Tumori
Location: Madrid Auditorium

Abstract Title: Efficacy and Safety of Abemaciclib Combined with LY3023414 or Pembrolizumab in Stage IV NSCLC
Abstract #1363P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST
Author/Speaker: Pilar Garrido Lopez, M.D., Hospital Universitario Ramón y Cajal
Location: Hall 8

Abstract Title: Analysis of overall survival by tumor response in MONARCH 1, a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, in women with HR+/HER2- metastatic breast cancer (MBC) after chemotherapy for advanced disease
Abstract #249P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST
Author/Speaker: Javier Cortés, M.D., Vall d’Hebron University Hospital
Location: Hall 8

Abstract Title: Abemaciclib plus fulvestrant in patients (pts) with HR+/HER2- endocrine therapy naïve (EN) advanced breast cancer – an exploratory analysis of MONARCH 2
Abstract #253P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST
Author/Speaker: Peter Kaufman, M.D., Dartmouth-Hitchcock Medical Center
Location: Hall 8
Ramucirumab

Abstract Title: RANGE: a randomized, double-blind, placebo-controlled phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma
Abstract #LBA4; Presidential Symposium II: Sunday, September 10, 2017; 17:30-17:45 CEST
Author/Speaker: Daniel Petrylak, M.D., Yale Cancer Center
Location: Madrid Auditorium

Abstract Title: Meta-analysis of individual patient safety data from six randomized, placebo-controlled trials with the antiangiogenic VEGFR2-binding monoclonal antibody ramucirumab
Abstract #1592P; Poster Session: Sunday, September 10, 2017; 13:15-14:15 CEST
Author/Speaker: Dirk Arnold, M.D., Klinik für Tumorbiologie
Location: Hall 8

Abstract Title: A Dose-Response Study of Ramucirumab Treatment in Patients with Gastric Cancer/Gastroesophageal Junction Adenocarcinoma: Primary Results of 4 Dosing Regimens in the Phase 2 Trial I4T-MC-JVDB
Abstract #698P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST
Author/Speaker: Jaffer Ajani, M.D., MD Anderson Cancer Center
Location: Hall 8

Abstract Title: Analysis of Angiogenesis Biomarkers for Ramucirumab (RAM) Efficacy in Patients with Metastatic Colorectal Cancer (mCRC) from RAISE, a Global, Randomized, Double-Blind, Phase 3 Study
Abstract #555P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST
Author/Speaker: Josep Tabernero, M.D., Vall d’Hebron University Hospital
Location: Hall 8
Sarcoma

Abstract Title: The Sarcoma Policy Checklist – focusing policy efforts on sarcoma
Abstract #1493P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST
Author/Speaker: Bernd Kasper, M.D., Universitätsmedizin Mannheim
Location: Hall 8

On August 29, 2017 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and ImmunoGen, Inc. (Nasdaq: IMGN) reported that the companies have entered into a collaboration and option agreement granting Jazz Pharmaceuticals exclusive, worldwide rights to opt into development and commercialization of two early-stage, hematology-related antibody-drug conjugate (ADC) programs, as well as an additional program to be designated during the term of the agreement (Press release, ImmunoGen, AUG 29, 2017, View SourceJazz-Pharmaceuticals-ImmunoGen-Announce-Strategic-Collaboration-Option/?feedref=JjAwJuNHiystnCoBq_hl-Q2avtREEUtW02Sy35VP1Jgh2AeBni2PXJ_Baqm56MONnkvYMqDDYxFrLs-oQ2BHQ2rAcstzsNUxXKGrEYTNy5oMAQjA1BPjLiRY4AHvKLse85mKl9fT46bVvfOgDdqKag==" target="_blank" title="View SourceJazz-Pharmaceuticals-ImmunoGen-Announce-Strategic-Collaboration-Option/?feedref=JjAwJuNHiystnCoBq_hl-Q2avtREEUtW02Sy35VP1Jgh2AeBni2PXJ_Baqm56MONnkvYMqDDYxFrLs-oQ2BHQ2rAcstzsNUxXKGrEYTNy5oMAQjA1BPjLiRY4AHvKLse85mKl9fT46bVvfOgDdqKag==" rel="nofollow">View Source [SID1234520325]). The programs covered under the agreement include IMGN779, a CD33-targeted ADC for the treatment of acute myeloid leukemia (AML) in Phase 1 testing, and IMGN632, a CD123-targeted ADC for hematological malignancies expected to enter clinical testing before the end of the year.

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This Smart News Release features multimedia. View the full release here: View Source

Under the terms of the agreement, ImmunoGen will be responsible for the development of the three ADC programs prior to any potential opt-in by Jazz. Following any opt-in, Jazz would be responsible for any further development as well as for potential regulatory submissions and commercialization.

As part of the agreement, Jazz will pay ImmunoGen an upfront payment of $75 million. Additionally, Jazz will pay ImmunoGen up to $100 million in development funding over seven years to support the three ADC programs. For each program, Jazz may exercise its opt-in right at any time prior to a pivotal study or any time prior to a biologics license application (BLA) upon payment of an option exercise fee of mid-double digit millions or low triple digit millions, respectively. For each program to which Jazz elects to opt-in, ImmunoGen would be eligible to receive milestone payments based on receiving regulatory approval of the applicable product, plus tiered royalties as a percentage of commercial sales by Jazz, which depending upon sales levels and the stage of development at the time of opt-in, range from mid- to high single digits in the lowest tier to low 10’s to low 20’s in the highest tier. After opt-in, Jazz and ImmunoGen would share costs associated with developing and obtaining regulatory approvals of the applicable product in the United States (U.S.) and the European Union. ImmunoGen has the right to co-commercialize in the U.S. one product (or two products, under certain limited circumstances) with U.S. profit sharing in lieu of Jazz’s payment of the U.S. milestone and royalties to ImmunoGen.

"We are pleased to enter into this collaboration with ImmunoGen, a well-known leader in the field of ADC technology, with demonstrated success in creating ADC molecules, including the only FDA-approved ADC product to treat metastatic breast cancer. This investment supports our long-term commitment to expand our hematology/oncology portfolio with the potential addition of multiple innovative antibody drug conjugates," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We look forward to the advancement of these ADC programs and the potential synergy of these compounds with our current products and pipeline, as new therapeutic options for cancer patients are urgently needed."

"This strategic partnership with Jazz significantly advances our goal of accelerating the development of our early-stage novel ADC assets. This deal joins us with a global partner, provides us with substantial funding to support these programs, and preserves the right to co-commercialize one of these assets," said Mark Enyedy, president and chief executive officer of ImmunoGen. "Jazz has demonstrated the ability to bring innovative compounds to patients and will make an ideal partner to help develop and commercialize our novel ADC assets targeting AML, and more broadly, in the area of hematology/oncology. In addition, this partnership significantly strengthens our financial position and moves us closer to delivering upon our mission of bringing ADC therapies to patients."

IMGN779 is a novel ADC that combines a high-affinity, humanized anti-CD33 antibody, a cleavable disulfide linker, and one of ImmunoGen’s novel indolino-benzodiazepine payloads, called IGNs, which alkylate DNA without crosslinking, resulting in potent preclinical anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells1,2. IMGN779 is in Phase 1 clinical testing for the treatment of AML. IMGN632 is a preclinical stage humanized anti-CD123 antibody-based ADC that is a potential treatment for AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN), myelodysplastic syndrome, B-cell acute lymphocytic leukemia, and other CD123-positive malignancies. IMGN632 uses a novel payload, linker, and antibody technology and in AML xenograft models has demonstrated a large therapeutic index3. ImmunoGen expects to file an investigational new drug application (IND) for IMGN632 this quarter and enroll the first patient in a Phase 1 study before the end of the year.