On October 1, 2020 Johnson & Johnson (NYSE: JNJ) reported it has successfully completed its acquisition of Momenta Pharmaceuticals, Inc. ("Momenta"), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 billion (Press release, Johnson & Johnson, OCT 1, 2020, View Source;johnson-completes-acquisition-of-momenta-pharmaceuticals-inc-301143938.html [SID1234567937]).

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!

"We’re delighted to welcome Momenta’s talented team to the Janssen Pharmaceutical Companies of Johnson & Johnson and to begin our work together to further advance patient care in autoantibody-driven diseases," said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. "We anticipate multiple launches, many of which would be first-in-class indications in rare diseases and areas of significant unmet need."

Johnson & Johnson’s tender offer for all outstanding shares of Momenta for $52.50 per share expired at 12:00 a.m. (midnight), New York City time, at the end of the day on September 30, 2020. American Stock Transfer & Trust Company, LLC, the depositary and paying agent for the tender offer, has advised Johnson & Johnson that approximately 100,595,118 shares of Momenta’s common stock were validly tendered and not validly withdrawn in the tender offer, representing approximately 79.4% of the outstanding shares of Momenta’s common stock on a fully diluted basis. All of the conditions to the tender offer have been satisfied, and on October 1, 2020, Vigor Sub, Inc. ("Vigor"), a wholly-owned subsidiary of Johnson & Johnson, accepted for payment, and will as promptly as practicable pay for, all shares validly tendered and not properly withdrawn in the tender offer.

The acquisition was completed on October 1, 2020 through a merger of Vigor with and into Momenta in accordance with Section 251(h) of the General Corporation Law of the State of Delaware without a vote of Momenta’s stockholders. Momenta now operates as a wholly-owned subsidiary of Johnson & Johnson. In connection with the merger, shares of Momenta that were not tendered in the tender offer were acquired by Johnson & Johnson and converted into the right to receive $52.50 per share. As a result of the completion of the merger, Momenta’s common stock will be delisted from the NASDAQ Global Select Market.

"The Momenta team has made excellent progress in developing its medicines for rare diseases, and we look forward to combining our expertise and resources with theirs to increase that scope," said Mathai Mammen, M.D., Ph.D., Global Head of Janssen Research & Development, Johnson & Johnson. "Our immunology pathways strategy creates an opportunity to create a ‘pipeline in a pathway,’ with multiple potential indications across autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuroimmune disorders, rheumatology, dermatology and autoimmune hematology."

On October 1, 2020 Debiopharm (www.debiopharm.com), a Swiss biopharmaceutical company, reported the first patient dosed in their phase III clinical trial (TrilynX) with xevinapant, an orally available antagonist of IAPs (Inhibitor of apoptosis proteins) cancer therapy in combination with CRT for LA-SCCHN patients (Press release, Debiopharm, OCT 1, 2020, View Source;a-large-scale-phase-iii-clinical-trial-to-further-evaluate-xevinapant-in-the-treatment-of-head–neck-cancer-301143930.html [SID1234567935]). This prospective, randomized, double-blind, placebo-controlled, multicenter, 2-arm clinical trial is being conducted to demonstrate the superior efficacy of xevinapant vs. placebo when added to CRT in high risk head and neck patients including those affected in the throat and vocal chords (oropharynx -HPV-negative, hypopharynx and larynx). The TrilynX study is being launched worldwide in 25 countries in over 200 sites with the aim of enrolling approximately 700 patients.

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 trial launch follows the positive phase II results observed at 3-year follow-up analysis showing superior and statistically significant locoregional control, progression-free survival and overall survival vs. the placebo control group. Efficacy during phase III will be evaluated by multiple radiological and clinical variables including event-free survival, progression-free survival, and duration of response.

"The launch of the TrilynX trial follows several key 2020 milestones in the development of xevinapant including the FDA Breakthrough Designation in February and the recent presentation this fall of our clinically meaningful 3-year, phase II data at the ESMO (Free ESMO Whitepaper) (European Society of Medical Oncology) virtual congress. We expect that this large-scale trial will confirm the strong outcomes observed in phase II, bring us a step further towards positively impacting the lives of high-risk head & neck cancer patients." expressed Bertrand Ducrey, CEO of Debiopharm.

Worldwide, head and neck cancer accounts for more than 650,000 cases and 330,000 deaths annually1 making it the 6th most common cancer type worldwide. LA-SCCHN is a highly debilitating disease, gradually progressing impaired breathing, swallowing, and speech.2 Risk for the disease is linked with alcohol and tobacco abuse, largely due to exposure to carcinogens in the upper airways. Despite standard of care CRT, at least 50% of patients with LA-SCCHN develop locoregional or distant relapses, which are usually detected within the first 2 years of treatment,3,4 hence the need to identify new therapeutic solutions.

Debiopharm’s commitment to patients
Debiopharm, Swiss Biotech Award Winner 2020, develops innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

On October 1, 2020 Olema Oncology, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported the closing of a $85 million Series C financing (Press release, Olema Pharmaceuticals, OCT 1, 2020, View Source [SID1234567933]). Olema will use the financing proceeds to advance the clinical development of OP-1250, its lead product candidate in breast cancer, and expand ongoing research and development activities. OP-125 is currently being evaluated in a Phase 1/2 clinical trial in patients with recurrent, locally advanced or metastatic estrogen-receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer whose disease has progressed on endocrine therapy.

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!

Vivo Capital led the financing with participation by additional new investors, including Avoro Capital Advisors, funds and accounts managed by BlackRock, Deerfield Management Company, and OrbiMed, among other investors. All existing institutional investors – BVF Partners L.P., Logos Capital, Janus Henderson Investors, Cormorant Asset Management, Wellington Management Company, RA Capital Management, Venrock Healthcare Capital Partners, Surveyor Capital (a Citadel company), and Foresite Capital – also participated.

"We are pleased to have such strong support from our new and existing investors as we begin our next phase of growth as a clinical-stage company in pursuit of our mission to bring novel, potentially life-saving therapies to women affected by breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We recently strengthened our executive team and Board with the appointment of leading industry experts and initiated a Phase 1/2 trial of OP-1250."

Shane Kovacs, Chief Operating and Financial Officer of Olema, added, "The proceeds from this financing provide Olema with additional capital that will allow us to continue to build and execute our growth plans for OP-1250 as well as further invest in our research efforts to expand our pipeline and advance additional programs that could benefit women with breast and other hormone-positive cancers. The quality of this investor syndicate is a testament to the strength of our opportunity and the team we have been building."

Olema plans to conduct additional studies evaluating OP-1250 in combination with other targeted breast cancer therapies.

"With new treatments urgently needed for women living with breast cancer, we are thrilled to lead this Series C financing and help Olema and its experienced leadership team, now headed by biopharma veteran Sean Bohen, pursue its goal of changing the way breast cancer is treated," said Albert Cha, M.D., Ph.D., Partner at Vivo Capital. "We are impressed by OP-1250 and the opportunity it presents in women’s oncology. With its oral formulation and differentiated profile, OP-1250 is poised to potentially overcome the limitations of current endocrine therapies for metastatic ER+ breast cancer and potentially become the endocrine therapy of choice to treat women with this type of cancer."

Cowen served as exclusive placement agent for the Series C financing.

On October 1, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) reported it has entered into an amended Sponsored Research Agreement with the University of Louisville (UofL) to advance development of Qualigen’s anticancer drug candidate AS1411-GNP, also known as ALAN (Aptamer-Linked Anti-Nucleolin) (Press release, Qualigen, OCT 1, 2020, View Source [SID1234567931]).

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 work being performed under the original Sponsored Research Agreement comprises animal studies to assess antitumor efficacy and safety of different ALAN compositions designed to treat pediatric and adult acute myeloid leukemia (AML). Under the amended Sponsored Research Agreement UofL will perform preclinical studies on AML and on additional indications including glioblastoma, a malignant brain cancer that is difficult to treat because most drugs cannot pass the blood-brain membrane, and non-small cell lung cancer, which comprises approximately 85% of the 1.6 million global lung cancer cases each year.

Additionally, Qualigen and UofL will study how ALAN may inhibit metastasis of cancer cells as a potential adjuvant therapy. The recurrence of cancer after initial treatment is the cause of approximately 90% of cancer deaths and represents a pressing unmet clinical need.

"Our expanded agreement with UofL should provide Qualigen with additional data to help us achieve our goal of advancing our ALAN cancer drug candidate into clinical trials against AML next year. We are especially interested in several new applications of this drug candidate, namely the treatment of pediatric cancers such as leukemia, the treatment of glioblastoma, the deadliest form of brain cancer and as an adjuvant therapy to stop the recurrence of cancer after initial treatment. We believe these paths will become a larger part of our clinical efforts and will accelerate the expansion of our product pipeline over the coming year, as they represent high unmet needs for critically important areas of cancer treatment," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen.

ALAN is a combination of AS1411 plus a DNA-coated gold nanoparticle, which dramatically increases its potency. This cancer drug candidate has the potential to target and destroy tumor cells in a wide variety of cancer types with minimal side effects. The Company is aiming to commence Phase 1 human trials in 2021 for AML, its lead indication. Qualigen has an exclusive worldwide license agreement from the UofL for ALAN.

"We are pleased to continue our relationship with Qualigen Therapeutics to expand the development program for ALAN," added Paula Bates, PhD, Professor of Medicine at UofL, who will be leading the project at UofL in collaboration with Martin O’Toole, PhD, and Levi Beverly, PhD. "We look forward to conducting these studies, which have the potential to demonstrate ALAN’s broad applicability as an effective therapy for these difficult-to-treat cancers."

On October 1, 2020 Hologic, Inc. (Nasdaq: HOLX), an innovative medical technology company primarily focused on improving women’s health, reported a multi-year commitment to decreasing breast cancer screening disparities for Black women (Press release, Hologic, OCT 1, 2020, View Source [SID1234567923]).

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 program is in partnership with the Black Women’s Health Imperative (BWHI), the only nonprofit organization created by Black women to help protect and advance the health and wellness of Black women and girls through awareness and education, and RAD-AID, a nonprofit dedicated to ensuring equal access to radiology health services for medically underserved communities.

Research has shown that Black women are almost 40 percent more likely to die from breast cancer than non-Hispanic white women.1 Hologic’s initiative, which launched today in conjunction with the start of Breast Cancer Awareness Month, is designed to encourage all Black women to get annual mammograms beginning at age 40, and to provide women in underserved communities with access to superior breast cancer screening technology. The situation has become even more urgent due to the COVID-19 pandemic, as the National Cancer Institute recently predicted that 10,000 more people in the United States will die in the next decade from breast or colorectal cancer because of delayed screening and treatment.2

The multi-pronged initiative includes BWHI’s P.O.W.E.R. of Sure campaign, which will examine common barriers to early screening and encourage Black women to schedule and attend their annual mammograms. The campaign features Grammy award winning, Oscar and Golden Globe nominated artist Mary J. Blige and a multimedia digital hub with resources including common facts and myths about mammography, frequently asked questions regarding breast cancer and screening guidelines, a list of locations offering breast cancer screening, and information about what to expect when getting a mammogram during the COVID-19 pandemic.

"As a nonprofit laser-focused on the health and wellness of Black women and girls, we have a deep understanding of the barriers Black women face when it comes to annual breast cancer screening," said Linda Goler Blount, MPH, President and CEO, Black Women’s Health Imperative. "The P.O.W.E.R. of Sure campaign will address those barriers head-on, with the help of our spokeswoman, Mary J. Blige, whose voice resonates like no other when it comes to speaking directly to Black women in an authentic and inspiring way."

Additionally, in partnership with RAD-AID, Hologic will fund screening and diagnostic services, and ensure there is a pathway for medically disenfranchised women to receive treatment. "Our approach is evidence-based to target regions of the United States having urgent need for breast cancer screening and diagnostics, particularly where breast cancer disproportionately impacts women of color due to healthcare inequalities," said Dr. Daniel J. Mollura, MD, Founder and CEO of RAD-AID. "Our interdisciplinary solution will help patients by mobilizing RAD-AID’s 12,000+ volunteer radiologists, technologists, nurses, radiation oncologists/therapists, IT professionals, health navigators, and public health specialists for new service models that overcome racial barriers."

Hologic’s grant to RAD-AID for this initiative will support innovative care, radiology, public education, and nurse navigation at multiregional sites selected by RAD-AID as clinical partners to provide critical screening, diagnostic breast imaging, and treatment for women who may otherwise go without. Sites and facilities under development for this program are located in regions including the Bronx/Washington Heights areas of New York, the South Side of Chicago, Washington D.C., North Carolina, Georgia, Mississippi, Alabama, Arizona, Seattle/Pacific Northwest, and Colorado.

Facilities supported through this collaborative program will be equipped with Hologic’s 3D Mammography system, which features the Genius 3D Mammography exam. The Genius exam is the only mammogram FDA approved as superior to 2D mammography for all women, including those with dense breasts, which is common among Black women.3,4,5,6

"As a company committed to improving women’s health and well-being, we have always played an active role in increasing awareness and access among all women, including those who are traditionally underserved, because it’s core to our mission and our culture," said Jennifer Meade, Hologic’s Division President, Breast and Skeletal Health Solutions. "We believe this initiative will make a significant impact, as it unites our passion for women’s health with that of our nonprofit partners, BWHI and RAD-AID, who share our commitment to increasing awareness of the importance of breast cancer screening and improving access to 3D mammography, the standard of care for annual screenings."

The Genius 3D Mammography exam (also known as the Genius exam) is only available on a Hologic 3D Mammography system. It consists of a 2D and 3D image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D image set. There are more than 7,000 Hologic 3D Mammography systems in use in the United States alone, so women have convenient access to the Genius exam. To learn more, visit View Source