On October 15, 2019 Genmab A/S (Nasdaq: GMAB) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 765 million in the third quarter of 2019 (Press release, Genmab, OCT 15, 2019, View Source [SID1234542250]). Net sales were USD 402 million in the U.S. and USD 363 million in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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!

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma and in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On October 15, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat age-related diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present at the 2019 BIO Investor Forum, which is being held October 22-23 at the Westin St. Francis Hotel in San Francisco, CA (Press release, CohBar, OCT 15, 2019, View Source [SID1234542268]). The BIO Investor Forum explores investment trends and opportunities in life sciences, with a focus on venture-stage growth and emerging public companies as well as those poised to join the growth "watch list" in 2020.

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!

Presentation details:
Wednesday, October 23rd 11:15 AM PT
Westin St. Francis Hotel, Yorkshire conference room

Webcast: The presentation may be accessed via webcast at the scheduled time, or after the presentation, using the following link: CohBar Presentation.

On October 15, 2019 Kleo Pharmaceuticals Inc., a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics, reported that its CEO Doug Manion, M.D., FRCP(C), will present at the 2019 BIO Investor Forum, which will be held at the Westin St. Francis Union Square in San Francisco on October 22-23rd (Press release, Kleo Pharmaceuticals, OCT 15, 2019, View Source [SID1234542287]).

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!

During his live presentation, Dr. Manion will provide an overview of Kleo’s development strategy for its pipeline of small molecule and synthetic peptide compounds that function similar to highly complex biologics, while offering multiple potential advantages. The overview will also outline Kleo’s key value drivers including the three proprietary technology platforms that drive in-house drug development and partnership opportunities, the multiple in-house and collaborative channels through which it is building its immuno-oncology pipeline and its discovery collaboration with PeptiDream. Human studies are anticipated in 2020 for Kleo’s first product candidate to move into the clinic, CD38-ARM, a CD38 targeting antibody recruiting molecule (ARM) to treat multiple myeloma.

Dr. Manion will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

Details of Kleo’s presentation are as follows:

Event:

2019 BIO Investor Forum

Date:

Tuesday, October 22, 2019

Time:

2:30 p.m. PDT

Location:

Room: Elizabeth A

Westin St. Francis Hotel

335 Powell Street

San Francisco, CA

The presentation will be webcast live and remain available for 90 days following the presentation. To access the webcast, please visit the News & Events section of Kleo’s website at kleopharmaceuticals.com/news-events/

On October 15, 2019 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it has entered into an agreement to divest a portfolio of select over-the-counter (OTC) and prescription pharmaceutical assets in a number of Near East, Middle East and Africa (NEMEA) countries within its Growth and Emerging Markets Business Unit to Acino for a total value in excess of $200 million USD (Press release, Takeda, OCT 15, 2019, View Source [SID1234542269]). This is the third transaction in FY19 that furthers Takeda’s strategy to focus on business areas core to its long-term growth and facilitate rapid deleveraging following its acquisition of Shire.

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!

"Takeda remains committed to this region, as we continue our work in accelerating access to our life-changing portfolio of innovative products to meet the needs of patients. We will do this via our commercial activities and Takeda’s Access to Medicines program"

Tweet this
"The divestment of non-core assets sold in NEMEA represents the continued execution of our strategy to optimize our portfolio, invest in the defined core business areas, and accelerate our progress toward reaching our target leverage ratio," said Costa Saroukos, Chief Financial Officer, Takeda.

While these products continue to play important roles in meeting patient needs, they are primarily outside of Takeda’s chosen business areas – Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience – core to its global long-term growth.

"Takeda remains committed to this region, as we continue our work in accelerating access to our life-changing portfolio of innovative products to meet the needs of patients. We will do this via our commercial activities and Takeda’s Access to Medicines program," said Ricardo Marek, President, Growth and Emerging Markets Business Unit, Takeda. "We are confident that Acino is best positioned to provide uninterrupted access and supply of the divested products to patients."

Takeda intends to use the proceeds from this divestiture to reduce debt and continue to deleverage towards its target of 2.0x net debt/adjusted EBITDA over the next three to five years. Takeda is committed to rapid deleveraging driven by strong cash flow and divestiture proceeds, while also simplifying its portfolio.

Transaction Details

Takeda has agreed to sell a portfolio of approximately 30 select prescription pharmaceutical and OTC products sold in the NEMEA region to Acino, a Swiss pharmaceutical company headquartered in Zurich, with a clear focus on selected markets in the Middle East, Africa, the CIS Region, and Latin America. The following key countries are included in the agreement: Egypt, Saudi Arabia, South Africa, Turkey, Ukraine and United Arab Emirates, as well as other countries.

Under the terms of the agreement, Acino will acquire the rights, title, and interest to the products in the portfolio exclusive to these countries. It is anticipated that primarily sales and marketing professionals supporting the portfolio will transition to Acino at closing of the transaction. The parties will also enter into a multi-year manufacturing and supply agreement, under which Takeda will continue to manufacture the products on behalf of Acino.

The transaction is expected to close in Q4 FY19 (January – March 2020), subject to the satisfaction of customary closing conditions including receipt of applicable antitrust approvals. Until then, these products will continue to be made available by Takeda.

Takeda is being advised by BofA Securities (financial advisor), White & Case (legal advisor), and Deloitte (financial consultant) in this transaction.

On October 15, 2019 Cyteir Therapeutics, a leader in the discovery and development of next-generation synthetic lethal therapies for cancer, reported the close of an additional $40.2 million in the company’s Series B financing, for a total of $75.2 million in this financing (Press release, Cyteir Therapeutics, OCT 15, 2019, View Source [SID1234542288]). The additional funding will be used to expand the clinical investigation of Cyteir’s first-in-class RAD51 inhibitor and lead compound, CYT-0851, and to identify new targets using the company’s novel gain-of-function synthetic lethality screening platform.

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!

Novo Holdings led the round, joined by existing investors Venrock, DROIA Oncology Ventures, Osage University Partners (OUP), Lightstone Ventures and Celgene Corporation. As part of this closing, Karen Hong, Ph.D., of Novo Ventures, which provides consulting services to Novo Holdings, will join the Cyteir Board.

"The continued support for Cyteir from highly knowledgeable investors reflects the growing excitement around our novel application of synthetic lethality," said Markus Renschler, M.D., Cyteir president and CEO. "This financing will support the recently launched first-in-human phase 1/2 study of CYT-0851 while simultaneously allowing us to continue investigating our synthetic lethality platform to find new targets that inhibit DNA damage repair. We believe this approach could lead to valuable new treatment options for cancer patients."

Cyteir’s platform is based on the discovery of a relationship between DNA-damaging enzymes known as cytidine deaminases, and RAD51, a protein that is essential for the repair of DNA breaks. These enzymes are non-damaging in healthy tissues, but gain hyperactive function in a wide range of cancers and cause elevated DNA damage. Cyteir is developing selective small-molecule inhibitors of RAD51 to reduce the ability of cancer cells to self-repair through homologous recombination. This causes the cancer cells to become overwhelmed by accumulated DNA damage and undergo cell death – resulting in the therapeutic effect known as "synthetic lethality."

In preclinical experiments, CYT-0851 demonstrated synergy with PARP inhibitors, consistent with its DNA damage-repair pathway inhibitory activity. These results suggest CYT-0851 has the potential to overcome PARP inhibitor resistance.

Researchers at Sarah Cannon Research Institute in Nashville, Tenn., recently dosed the first patient in a Phase 1/2 study of CYT-0851. This study will enroll up to 200 patients with B-cell malignancies and solid tumors.

"We are pleased to be part of this study, which will help define the potential of an entirely new class of targeted cancer therapy," said Johanna Bendell, M.D., chief development officer at Sarah Cannon Research Institute and the study’s lead investigator. "Pre-clinical evaluations of CYT-0851 have been very encouraging, and we look forward to seeing how this compound impacts patients in this trial."

In March 2019, Cyteir presented pre-clinical data at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting that validated the mechanism of action underlying the company’s synthetic lethal platform and confirmed that CYT-0851 is a potent inhibitor of RAD51-mediated homologous recombination with the potential to target multiple cancers that have high levels of cytidine deaminase-related DNA damage. The data indicated that CYT-0851 could potentially be clinically active as a monotherapy against B-cell lymphomas and multiple solid tumors, including pancreatic cancer.

About the CYT-0851 Phase 1/2 Trial

CYT-0851-01 is a phase 1/2 study of CYT-0851 in patients with relapsed, refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma, or advanced breast cancer, ovarian cancer, head and neck cancer, soft tissue sarcoma, and pancreatic cancer. The study will be conducted at leading research institutions in the United States. An initial dose-escalation phase will establish the safety and tolerability of CYT-0851 and identify the recommended phase 2 dose. This will be followed by an expansion phase to evaluate response rates among each of six disease cohorts. Cyteir is also developing a companion diagnostic assay to identify patients with tumors that overexpress certain cytidine deaminases that may make them more susceptible to RAD51 inhibition.

About CYT-0851

CYT-0851 is an experimental, oral, selective inhibitor of RAD51, a protein involved in homologous recombination. Cancer cells that overexpress certain DNA-damaging cytidine deaminases rely on RAD51 to repair DNA damage. In preclinical models, inhibition of RAD51 with CYT-0851 induces cell death in cytidine deaminase overexpressing cell lines and reduces proliferation.