On November 14, 2018 Genmab reported Interim Report for the First Nine Months Ended September 30, 2018 (Press release, Genmab, NOV 14, 2018, View Source [SID1234531309]).

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Highlights

USD 1,441 million in net sales of DARZALEX (daratumumab), resulting in royalty income of DKK 1,111 million
DARZALEX approved in Europe in combination with bortezomib, melphalan and prednisone (VMP) for frontline multiple myeloma, triggering USD 13 million milestone payment from Janssen
Entered strategic collaboration with Immatics to discover and develop next-generation bispecific cancer immunotherapies
"During the third quarter, Genmab continued to push ahead towards completing our goals for 2018. This quarter’s highlights included the European approval of DARZALEX in combination with other standard therapies for the treatment of frontline multiple myeloma and the strategic collaboration we signed with Immatics to fuel the growth of Genmab’s innovative immunotherapy pipeline in the future," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months of 2018

Revenue was DKK 1,789 million in the first nine months of 2018 compared to DKK 1,348 million in the first nine months of 2017. The increase of DKK 441 million, or 33%, was mainly driven by higher DARZALEX royalties, the payment from Novartis of USD 50 million and reimbursement income from our collaborations with Seattle Genetics and BioNTech, partly offset by a decrease in DARZALEX milestones.
Operating expenses were DKK 1,130 million in the first nine months of 2018 compared to DKK 707 million in the first nine months of 2017. The increase of DKK 423 million, or 60%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
Operating income was DKK 659 million in the first nine months of 2018 compared to DKK 641 million in the first nine months of 2017. The increase of DKK 18 million, or 3%, was driven by higher revenue, which was offset by increased operating expenses.
Subsequent Events

October: The Phase III CASSIOPEIA study (MMY3006) of daratumumab in combination with bortezomib, thalidomide and dexamethasone (VTD) versus VTD alone as frontline treatment for multiple myeloma patients who are candidates for autologous stem cell transplant (ASCT) met its primary endpoint of number of patients that achieved a stringent Complete Response (sCR), which was reported in 28.9% of patients treated with daratumumab in combination with VTD, compared to 20.3% of patients who received VTD alone with an odds ratio of 1.60 (95% CI: 1.21 – 2.12, p ≤ 0.001). The safety profile of daratumumab in combination with VTD is consistent with the known safety profile of the VTD regimen used in patients receiving ASCT and the known safety profile for daratumumab.
October: The Phase III MAIA study (MMY3008) of daratumumab in combination with lenalidomide and dexamethasone (DRd) versus Rd alone as treatment for newly diagnosed multiple myeloma patients who are not candidates for high dose chemotherapy and ASCT met its primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.55 (95% CI 0.43 – 0.72), p < 0.0001), resulting in a 45% reduction in the risk of progression or death in patients treated with DRd. The median PFS for patients treated with DRd has not been reached, compared to an estimated median PFS of 31.9 months for patients who received Rd alone. Overall, the safety profile of daratumumab in combination with Rd is consistent with both the known safety profiles of the Rd regimen and daratumumab.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2018 today, Wednesday, November 14, at 6.00 pm CET, 5.00 pm GMT or 12.00 pm EST. To join the call dial
+1 646 828 8193 (US participants) or +44 330 336 9411 (international participants) and provide conference code 4314747.

On November 14, 2018 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported financial results for the third quarter ended September 30, 2018, and provided a business update (Press release, CohBar, NOV 14, 2018, View Source [SID1234531310]).

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"As we previously discussed, we are moving forward with our plan to address the mild but persistent injection site reactions observed in our Phase 1 clinical trial of CB4211, under development for NASH and obesity," said Simon Allen, Chief Executive Officer of CohBar. "We will be sharing this plan shortly with the FDA, and look forward to the agency’s timely feedback and resuming clinical activities as expeditiously as possible."

"This first groundbreaking study of a mitochondria based therapeutic in humans will help inform us not only for the development of CB4211, but also for the development of other potential therapeutics from our large portfolio of novel peptides. We continue to believe in the potential of MBTs to treat a broad range of age-related diseases with large-population indications, including type 2 diabetes, cancer, neurodegenerative disease and cardiovascular disease," Mr. Allen concluded.

Third Quarter and Recent Business Highlights:

Clinical Study Update for CB4211. On November 5, 2018, the company announced the temporary suspension of its ongoing Phase 1 clinical study of CB4211, its lead MBT candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity, in order to address mild injection site reactions that have been unexpectedly persistent. The company has a plan to address the persistent reactions and is seeking feedback from the FDA before resuming the clinical study.

Partnership with LifeSci Advisors. CohBar engaged LifeSci Advisors LLC ("LifeSci"), a leading New York-based investor relations consultancy serving life science companies, to implement a comprehensive investor outreach program that will include analyst and investor targeting/outreach, non-deal roadshows, corporate communications, and Key Opinion Leader (KOL) events in the field of mitochondria based therapeutics and age-related diseases.

Investment and Scientific Community Outreach. During the third quarter, CohBar’s CEO Simon Allen presented an overview of the Company and its clinical development program at the Bio Investor Forum. Additionally, company management met with investors during the H.C. Wainwright 20th Annual Global Investment Conference.
During the third quarter, CohBar’s founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, continued to be recognized as international leaders in the study of aging, age-related diseases and mitochondrial science.

Dr. Cohen co-authored a number of papers published in scientific journals during the quarter including "Humanin Prevents Age-Related Cognitive Decline in Mice and is Associated with Improved Cognitive Age in Humans," in Nature Scientific Reports; "Chronic Treatment with the Mitochondrial Peptide Humanin Prevents Age-related Myocardial Fibrosis in Mice," in American Journal of Heart Circulation Physiology; "Characterizing the Protective Effects of SHLP2, a Mitochondrial-Derived Peptide, in Macular Degeneration," in Nature Scientific Reports; and "Mitochondrial biology and prostate cancer ethnic disparity," Carcinogenesis. Dr. Cohen also received a major grant from the National Institutes of Health recognizing his ground-breaking work in the field of mitochondrial science entitled, "Humanin is an AD resilience factor through its interaction with APOE4."

Dr. Barzilai delivered a keynote speech at the Aging Cell Conference in Sitges, Spain and co-authored a number of scientific papers published during the quarter including: "Aging as a Biological Target for Prevention and Therapy," in JAMA; "A framework for selection of blood-based biomarkers for geroscience-guided clinical trials: Report from the TAME Biomarkers Workgroup," in Geroscience; "Targeting Senescence," in Nature Medicine; "APOE Alleles and Extreme Human Longevity," Journals of Gerontology; "40 Years of IGF1: The Jekyll and Hyde of the Aging Brain," in Journal of Molecular Endocrinology; "Late-Life Targeting of the IGF1 Receptor Improves Healthspan and Lifespan in Female Mice," in National Communications.
Third Quarter 2018 Financial Highlights

Cash and Investments. CohBar had cash and investments of $24,223,712 on September 30, 2018, compared to $8,452,459 on December 31, 2017.

R&D Expenses. Research and development expenses were $3,435,509 in the three months ended September 30, 2018, compared to $2,316,454 in the prior year quarter. The increase was primarily due to the costs of our clinical activities and a net increase in stock-based compensation related to performance equity grants that vested within the current year quarter, offset by a decrease in costs related to the timing of IND-enabling activities incurred in the prior year period.

G&A Expenses. General and administrative expenses were $1,061,709 for the three months ended September 30, 2018, compared to $549,505 in the prior year quarter. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation related to performance equity grants that vested within the current year quarter, the costs associated with new grants made since the prior year period and an increase in directors fees in the current quarter.

Net Loss. For the three months ended September 30, 2018, net loss was $4,613,042, or $0.11 per basic and diluted share, compared to a net loss of $2,861,107, or $0.07 per basic and diluted share, for the three months ended September 30, 2017.

Details for Conference Call

Date: November 14, 2018
Time: 5:00 p.m. Eastern Time

- Dial-in U.S. and Canada: (888) 394-8218
- Dial-in International: (323) 701-0225
- Conference ID Number: 1659879

We kindly request that you call into the conference audio approximately 10 minutes before the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 14, 2018, through 11:59 p.m. Eastern Time on December 5, 2018. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 1659879. The audio replay will also be available at www.cohbar.com from November 14 through December 5, 2018.

About CB4211
CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

On November 14, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of two Type II variation applications to the European Medicines Agency (EMA) seeking approval for the expanded use of IMBRUVICA (ibrutinib) (Press release, Johnson & Johnson, NOV 14, 2018, View Source [SID1234531468]). One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia (CLL) and to add long-term follow-up data from the existing label studies RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115). The second is for use of ibrutinib plus rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenström’s macroglobulinemia (WM).

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"Today’s news brings us one step closer to potentially offering ibrutinib in new combinations for patients where unmet needs still persist," said Dr. Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "Ibrutinib continues to demonstrate clinical benefit over the long term for a broad
group of patients living with blood cancer, and we look forward to working with relevant authorities to secure approval of these new combinations."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company. The CLL submission is supported by positive results from the Phase 3 iLLUMINATE (PCYC1130) study which investigated ibrutinib in combination with obinutuzumab versus
chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.

1 Study findings from iLLUMINATE will also be featured as an oral presentation (abstract #691), whilst further analysis of RESONATETM and RESONATETM-2 results in comparison with real-world evidence databases (abstract #4427) will be included at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place in San Diego next month.1,2 A supplemental New Drug Application (sNDA) which was also recently submitted to the U.S. Food and Drug Administration (FDA) received Priority Review.

2 In WM, the submission is supported by data from the Phase 3 iNNOVATE (PCYC-1127) study evaluating ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.

3 Follow-up efficacy and safety findings from the iNNOVATE study will also be presented at ASH (Free ASH Whitepaper) 2018 (abstract
#149).

4 In August 2018, the FDA approved ibrutinib in combination with rituximab for the treatment of WM based on the data from iNNOVATE.

5 Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).
6,7
#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.8 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.9 Ibrutinib is currently approved in Europe for the following uses:10

 Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.

 Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.

 Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemoimmunotherapy.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.10

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About CLL
CLL is typically a slow-growing blood cancer of the white blood cells.11 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year with rates amongst men and women approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.

12 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.13
CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years, according to the stage of disease.14 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
3
About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).15 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.
16 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.17 The causes of WM are unknown, with it typically affecting older adults and being slightly more
common in men than women.15,17

On November 14, 2018 Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule technologies, reported its financial results for the third quarter ended September 30, 2018 (Press release, Neuralstem, NOV 14, 2018, View Source [SID1234531311]).

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"During the third quarter of 2018 we have made progress with our programs, have taken steps to strengthen the balance sheet, and, perhaps most importantly, have determined how we will focus our efforts moving forward," said Jim Scully, Interim Chief Executive Officer of Neuralstem. "We believe that proceeds from our recent offering, combined with our efforts to reduce cash burn, will allow us to pursue key development initiatives that will be detailed in the coming weeks."

Clinical Highlights

In August, NSI-189 received from FDA the orphan designation for treatment of Angelman Syndrome. Angelman Syndrome (AS) is a rare congenital genetic disorder caused by a lack of function in the UBE3A gene on the maternal 15th chromosome. It affects approximately one in 15,000 people – about 500,000 individuals globally. Symptoms of AS include developmental delay, lack of speech, seizures, and walking and balance disorders. Patients with AS may never walk or speak and require life-long care. Life expectancy is normal which places a significant burden on patients and caregivers. There are currently no FDA-approved therapies for the treatment of Angelman syndrome.

In July, the company announced initiation of a Phase 2 clinical trial to further evaluate NSI-566 in ischemic stroke. This follows the positive results of the open-label Phase 1 stroke study disclosed in a 2018 ISSCR (International Society for Stem Cell Research) abstract on June 23, 2018. The Phase 2 study is a randomized, double-blind, sham-surgery controlled study. It is intended to further test the safety and efficacy of NSI-566 to reverse paralysis in stroke patients with half of their body partially paralyzed. The trial is taking place at BaYi Brain Hospital in Beijing, China, and commenced on August 1, 2018.

In October, the company announced publication of a manuscript in Scientific Reports showing that transplantation of NSI-532.IGF1 mitigates disease pathology and improves cognition in a mouse model of Alzheimer’s Disease. The study was performed at the University of Michigan by a team led by Dr. Eva Feldman, Director of the Program for Neurology Research and Discovery, and Research Director of the University of Michigan ALS Center of Excellence. NSI-532.IGF1 is the first candidate from the NSI-532 program, a second-generation cell therapy program which combines neural stem cells with neuroprotective proteins.
Corporate Highlights

In October, the company completed a registered direct offering of its securities which resulted in gross proceeds to Neuralstem of $2.1 million. Neuralstem intends to use the proceeds from this offering to further its clinical and preclinical programs, and for general working capital.
Financial Results for the Quarter Ended September 30, 2018

Cash Position and Liquidity: At September 30, 2018, cash and investments was $5.7 million as compared to $7.1 million at June 30, 2018. The $1.4 million decrease reflects a loss for the period, which was somewhat ameliorated by management’s cost reduction efforts. The company expects its existing cash, cash equivalents and short-term investments to fund its operations, based on its current operating plans, into the second quarter of 2019.

Operating Loss: Operating loss for the third quarter ended September 30, 2018 was $2.1 million compared to a loss of $2.6 million for the comparable period of 2017. The reduction in loss is attributed to reduced clinical development activity and management efforts to reduce overall expenses.

Net Loss: Net loss for the third quarter ended September 30, 2018 was $1.8 million, or $0.12 per share (basic), compared to a loss of $0.1 million, or $0.01 per share (basic), for the comparable period of 2017. The increase in net loss was primarily due to the non-cash gains related to the change in the fair value of our liability classified warrants in 2017, partially offset by a decrease in our operating loss.

Research and Development Expenses: The $0.9 million of research and development expenses for the quarter ended September 30, 2018 represents a 35% decrease over the comparable period of 2017. This decrease was primarily attributable to a decrease in personnel and facility expenses, and a decrease in clinical trial and related costs due to the completion of our NSI-189 Phase 2 clinical trial.

General and Administrative Expenses: The $1.2 million of general and administrative expenses for the third quarter ended September 30, 2018 represents a 2% decrease over the comparable period of 2017. This decrease was primarily attributable to lower payroll and related expenses due to corporate restructuring and cost reduction efforts coupled with a decrease in non-cash share-based compensation expense which was offset by an increase in tax and insurance expenses and consulting and professional fees.

On November 14, 2018 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported the acceptance of three posters for presentation at the 2018 San Antonio Breast Cancer Symposium (SABCS) (Press release, Sermonix Pharmaceuticals, NOV 14, 2018, View Source [SID1234532257]). The accepted presentations demonstrate Sermonix’s continued momentum toward realizing the potential of its lead investigational drug, lasofoxifene, as an oral targeted treatment for women with ESR1 mutations in metastatic breast cancer.

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The Dec. 4-8 meeting at the Henry B. Gonzalez Convention Center in San Antonio will include the following posters:

An open-label, randomized, multi-center Phase 2 study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2 – breast cancer (MBC) with an ESR1 mutation
Presenting author Matthew Goetz, M.D., Mayo Clinic
Poster Session OT (OT1-01-02); Wed., Dec. 5, 5pm-7pm
A preliminary assessment of knowledge, attitudes, and awareness surrounding ESR1 mutations and biomarker testing amongst medical oncologists
Presenting author Shari Goldfarb, M.D., Memorial Sloan Kettering Cancer Center
Poster Session 5 (PD5-11-11); Fri. Dec. 7, 5pm-7pm

Spotlight Session

Lasofoxifene decreases breast cancer lung and liver metastasis in a mammary intraductal (MIND) xenograft model of mutant ER-alpha+ breast cancer
Presenting author Muriel Lainé, Ph.D., University of Chicago
Poster Session 7 (PD7-09); Fri., Dec. 7, 7am-9am
One poster introduces a Phase 2 trial of oral lasofoxifene, evaluating its activity versus intramuscular fulvestrant for the treatment of postmenopausal women who have locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 (estrogen receptor gene) mutation. Another poster, selected for a spotlight session on endocrine resistance, is Sermonix-sponsored research from the University of Chicago Ben May Department for Cancer Research in a MIND xenograft model of mutant ER+ breast cancer. The third poster will share results of a study on medical oncologists’ knowledge, awareness and perceptions of precision medicine and liquid biopsy biomarker testing specific to breast cancer and ESR1 mutations.

"Lasofoxifene’s potency and newly discovered activity in ESR1 mutations may hold promise for patients who have acquired resistance in an area of significant unmet medical need," said David Portman, M.D., Sermonix founder and chief executive officer. "We look forward to presenting exciting data at this year’s San Antonio Breast Cancer Symposium as we move lasofoxifene forward as a targeted therapy for women with advanced breast cancer."

"Clinical data have shown a significant reduction in the incidence of ER+ breast cancer in postmenopausal women with osteoporosis who were treated with lasofoxifene," said Paul Plourde, M.D., Sermonix vice president of clinical development. "Further non-clinical and clinical study results provide a strong rationale for pursuing a Phase 2 clinical trial comparing lasofoxifene to fulvestrant, a current widely used injectable medication for advanced breast cancer."

"Lasofoxifene’s ability to reduce primary tumor weights and inhibit metastasis of ER-mutated breast cancer xenografts in a mouse mammary intraductal (MIND) model was reported at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June this year," said Geoffrey Greene, Ph.D., chair of the Ben May Department for Cancer Research and co-director of the Ludwig Center for Metastasis Research at the University of Chicago. "We look forward to sharing new data on lasofoxifene’s impact on lung and liver metastases in breast cancer xenografts that express mutant ER."

Muriel Lainé, a senior research professional in Greene’s lab, will serve as presenting author for the Spotlight Session in San Antonio.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 women worldwide.

Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.