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Xencor and UCLA Enter Collaboration to Discover and Develop Novel XmAb® Therapeutics

On February 25, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, and UCLA Technology Development Group (UCLA TDG) reported an agreement to develop novel therapeutic antibodies, pairing novel targets proposed by scientists at UCLA and utilizing Xencor’s modular suite of XmAb technology platforms (Press release, Xencor, FEB 25, 2021, View Source [SID1234575679]). Xencor and UCLA have established a streamlined framework to select promising biology, perform collaborative research and license intellectual property.

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Xencor’s XmAb platforms are precisely engineered antibody Fc domains, which enable the creation of stable new protein structures, such as bispecific antibodies and engineered cytokines, or amplification of natural immune functions, such as extending circulating half-life or enhancing immune cell cytotoxicity. Xencor and its pharmaceutical partners are now advancing 20 clinical-stage XmAb-engineered drug candidates for the treatment of patients with life-threatening and debilitating diseases. Two of these antibodies have been approved by the U.S. FDA, one for the treatment of patients with rare blood disorders and the other for an aggressive form of non-Hodgkin lymphoma.

"The creation of exciting new therapeutic modalities requires advancing innovative biological concepts together with state-of-the-art molecular platforms to build best-in-class biologics," said John Desjarlais, Ph.D., senior vice president and chief scientific officer at Xencor. "The inherent modularity and stability provided by our XmAb platforms, and our ability to precisely tune a molecule’s target-binding capability, opens the door to evaluate the clinical potential of biology that was previously considered intractable. We look forward to collaborating with UCLA’s investigators to translate their biological insights into potential medicines."

The UCLA Technology Development Group, the campus’ gateway to innovation, research and entrepreneurship, will work with faculty to propose potential antibody drug candidates. For selected candidates, the collaborators will use a framework with predefined terms to enter sponsored research agreements and potential license agreements.

"Many revolutionary medical breakthroughs discovered by UCLA’s world-class investigators have vastly improved the care of patients, including engineered T cells, therapeutic antibodies and small molecules that are now approved to treat many types of cancer," said Amir Naiberg, Associate Vice Chancellor, Chief Executive Officer and President of the UCLA Technology Development Group.

"With this collaboration, we aim to accelerate the development of potential new biologic medicines, leveraging Xencor’s protein engineering technologies and expertise and the ongoing scientific discoveries and insights into disease biology made at UCLA, with the ultimate goal to improve patient outcomes and quality of life," added Mark A. Wisniewski, Senior Director of Biopharmaceuticals at UCLA TDG.

Theratechnologies Announces Fourth-Quarter And Fiscal-Year 2020 Financial Results

On February 25, 2021 Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported its financial results for the fourth quarter and its fiscal year ended November 30, 2020 (Fiscal 2020) (Press release, Theratechnologies, FEB 25, 2021, View Source [SID1234575677]).

"2020 marked a transformative year for Theratechnologies that included significant and swift advancements to our pipeline and growing revenues. Despite the global pandemic, we filed two investigational new drug applications for our oncology and NASH programs and recognized record sales for our HIV business. Entering 2021, this momentum has continued as we received "study-may-proceed" letters for both pipeline programs and a fast track designation for our lead peptide-drug conjugate TH1902 for treatment of all sortilin-expressing cancers. Following our accomplishments in 2020 and continued expected progress through 2021, we believe we are well-positioned to reach our key business targets and milestones," said Paul Lévesque, President and Chief Executive Officer, Theratechnologies.

Fiscal 2020 Financial Results

The financial results presented in this press release are taken from the Company’s Management’s Discussion and Analysis, or MD&A, and audited consolidated financial statements, or Audited Financial Statements, for the twelve-month period ended November 30, 2020, or Fiscal 2020, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. The MD&A and the Audited Financial Statements can be found at www.sedar.com, on EDGAR at www.sec.gov and at www.theratech.com. Unless specified otherwise, all amounts in this press release are in U.S. dollars and all capitalized terms have the meaning ascribed thereto in our MD&A.

ADC Therapeutics to Participate in Cowen 41st Annual Health Care Conference

On February 25, 2021 ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that Chris Martin, Chief Executive Officer, will participate in a fireside chat at the Cowen 41st Annual Health Care Conference on Thursday, March 4, 2021, at 12:50 p.m. ET (Press release, ADC Therapeutics, FEB 25, 2021, View Source [SID1234575676]).

A live webcast of the fireside chat will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

Radius Health, Inc.: Fourth Quarter and Full Year Results

On February 25, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the fourth quarter ended December 31, 2020 as well as full year 2020 results (Press release, Radius, FEB 25, 2021, View Source [SID1234575675]). In addition, a number of brief business updates are included.

Q4 2020 FINANCIAL AND BUSINESS HIGHLIGHTS:

Q4 2020 U.S. net sales of TYMLOS were $60 million, an 8% year-over-year increase vs. Q4 2019
TYMLOS U.S. new patient starts increased by 26% in Q4 2020 vs. Q3 2020
FY 2020 FINANCIAL AND BUSINESS HIGHLIGHTS:

FY 2020 U.S. TYMLOS net product revenue was $208 million vs. FY 2019 net product revenue of $173 million – year-over-year growth of 20%
Balance sheet: approx. $115 million of cash, cash equivalents, and marketable securities at year end
Reduced actual total company headcount by 25+% vs. full year 2020 budget
Reduced real estate footprint and infrastructure by approximately 50%
Pivoted U.S. commercial effort to focus on post-menopausal high risk fracture patients
Increased U.S. commercial productivity (net rev. per sales person) by approximately 50%
Completed elacestrant business development out-licensing transaction with the Menarini Group
Completed RAD140 business development out-licensing transaction with Ellipses Pharma Limited
Completed abaloparatide business development out-licensing transction with Paladin Labs in Canada
Completed RAD011 business development acquisition transaction for global rights
OTHER BUSINESS HIGHLIGHTS:

Abaloparatide

ATOM phase 3 study, evaluating abaloparatide for use in osteoporotic men at high risk for fracture, remains on track for 2H 2021 read-out
wearABLe phase 3 study, evaluating the effects on bone mineral density of abaloparatide delivered via a novel transdermal system, remains on track for 2H 2021 read-out
In Japan, our partner Teijin continues to make progress within the Japan regulatory and market processes
Our partner in Canada – Paladin Labs – is advancing with plans to progress the abaloparatide molecule through the regulatory process
In the EU, we continue to advance meetings and dialogue regarding a possible re-submission of abaloparatide
RAD011

A dedicated and experienced team has been created to advance the molecule and asset
Our initial focus: Prader Willi Syndrome (PWS) for the U.S. and other global markets
Assessing additional product pathways with focus on other orphan metabolic, endocrine indications
Elacestrant

EMERALD phase 3 Study, with partner Menarini Group, remains on track for a 2H 2021 read-out
Fourth Quarter 2020 Financial Results

Three Months Ended December 31, 2020

Net Loss
For the three months ended December 31, 2020, Radius reported a net loss of $21.4 million, or $0.46 per share, compared to a net loss of $24.7 million, or $0.54 per share, for the three months ended December 31, 2019.

For the three months ended December 31, 2020, non-GAAP adjusted net income, was $10.8 million, or $0.23 per share, compared to non-GAAP adjusted net loss of $13.3 million, or $0.29 per share, for the three months ended December 31, 2019.

Revenue
For the three months ended December 31, 2020, TYMLOS net product revenues were $59.9 million compared to approximately $55.7 million for the three months ended December 31, 2019.

Costs and Expenses
For the three months ended December 31, 2020, research and development expense was $36.4 million compared to $34.5 million for the three months ended December 31, 2019, an increase of $1.9 million, or 5%. This increase was primarily driven by a $16.0 million increase in RAD011 program expenses, a $3.4 million increase in abaloparatide transdermal system program costs, which was partially offset by a $18.4 million decrease in elacestrant program costs.

Twelve Months Ended December 31, 2020

Net Loss
For the twelve months ended December 31, 2020, Radius reported a net loss of $109.2 million, or $2.35 per share, compared to a net loss of $133.0 million, or $2.89 per share, for the twelve months ended December 31, 2019.

For the twelve months ended December 31, 2020, non-GAAP adjusted net loss was $62.3 million, or $1.34 per share, compared to non-GAAP adjusted net loss of $90.9 million, or $1.98 per share, for the twelve months ended December 31, 2019.

Revenue
For the twelve months ended December 31, 2020, TYMLOS net product revenues were $208.4 million compared to approximately $173.3 million for the twelve months ended December 31, 2019.

Costs and Expenses
For the twelve months ended December 31, 2020, research and development expense was $159.7 million compared to $116.8 million for the twelve months ended December 31, 2019, an increase of $43.0 million, or 37%. This increase was primarily a result of an increase of $39.9 million in program spending for the abaloparatide transdermal system project costs and an increase of $16.0 million in other costs due to the Benuvia licensing expense. These increases were partially offset by a $11.9 million decrease in program spending for elacestrant research which is a result of $39.3 million of reimbursable expenses offsetting year to date expenses.

For the twelve months ended December 31, 2020, selling, general and administrative expenses were $144.2 million compared to $152.7 million for the twelve months ended December 31, 2019, a decrease of $8.6 million, or 6%. This decrease was primarily the result of a $6.3 million decrease in professional fees, a $4.0 million decrease compensation related expenses. These decreases were offset by a $1.7 million increase in other costs.

As of December 31, 2020, Radius had $115.3 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of December 31, 2020, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.

Webcast and Conference Call

In connection with today’s reporting of Fourth Quarter 2020 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, February 25, 2021, to review the commercial, research and development, and financial highlights and provide a Company update.

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

For those unable to participate in the conference call or webcast, a replay will be available on Thursday, February 25th at 11:30 a.m. ET and will be archived on the Company’s website for 90 days. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International, using conference ID number 8266586.

Compugen Announces Data Update from
COM701 Phase 1 Clinical Trial

On February 25, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported data from its Phase 1 dose escalation and expansion study of COM701 as a monotherapy, and in a dose escalation combination study with Opdivo (nivolumab) (Press release, Compugen, FEB 25, 2021, View Source [SID1234575674]). COM701 is a first-in-class investigational therapeutic antibody targeting PVRIG, a novel immune checkpoint discovered computationally by Compugen.

"The data generated to date across our COM701 clinical program suggest that PVRIG may be an important immune checkpoint in patients who are unresponsive or refractory to currently available immunotherapies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We are highly encouraged by our updated results from the COM701 plus Opdivo combination dose escalation, which now include a confirmed complete response in a patient with prior progression on Opdivo and a previously reported patient with a durable confirmed partial response for almost a year. Combined with a disease control rate of 66.7% and ongoing durable signals of activity beyond or approaching one year in multiple patients and across indications, these results leave us increasingly confident that dual blockade of PVRIG and PD-1 may be key to driving anti-tumor immune responses in certain patient populations. Based on these encouraging results, we will be further evaluating this dual combination regimen in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers with the initiation of the COM701 and Opdivo cohort expansion study in the second quarter of 2021, as part of our collaboration with Bristol Myers Squibb."

Dr. Cohen-Dayag continued, "Our monotherapy cohort expansion study was an important milestone in our COM701 monotherapy evaluation. This data, together with data from our previously reported dose escalation study, which includes a confirmed partial response with treatment ongoing for over one year as of our new data cutoff date, demonstrate durable signals of antitumor activity in tumor types typically unresponsive to immune checkpoint inhibitors, including patients with prior progression on these treatments. We will leverage these data, along with future data from our ongoing correlative assessments of biological samples from patients, to inform our clinical approach and next steps as we execute across our broad combination strategy, which includes dual and triple blockade regimens of COM701 with TIGIT and PD-1. Importantly, as the only company with wholly owned clinical candidates targeting both PVRIG and TIGIT, we are uniquely capable and on track to conduct this comprehensive evaluation of the synergistic blockade of the DNAM axis with PD-1, and we look forward to continued progress in potentially expanding the reach of immunotherapy."

Data highlights from the Phase 1 dose escalation studies as of the data cutoff of December 14, 2020 include:

COM701 and Opdivo combination dose escalation arm:

In 15 patients with a median of five prior anticancer therapies (range of 2-10), COM701 in combination with Opdivo was well-tolerated with no reported dose-limiting toxicities up to the fifth and final dose cohort of COM701 20 mg/kg and Opdivo 480 mg, both IV Q4 weeks.
The disease control rate (DCR) was 66.7% (N=10) with best responses of complete response (CR) 6.7% (N=1), partial response (PR) 6.7% (N=1) and stable disease (SD) 53.3% (N=8).
A patient with anal squamous cell carcinoma with confirmed SD as reported at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020, now with confirmed CR and remains on treatment at 79 weeks. This patient progressed on Opdivo prior to enrolling in our study.
A patient with microsatellite stable (MSS)-colorectal cancer with durable confirmed partial response previously reported at AACR (Free AACR Whitepaper) 2020 remained on study treatment at 44 weeks.
Durable responses of confirmed SD of six months or more in three patients. One patient with renal cell carcinoma remains on treatment at 58 weeks, and one patient with non-small cell lung cancer (NSCLC) (squamous) who failed prior treatment with immune checkpoint inhibitors remained on treatment at 36 weeks, and one patient with endometrial cancer remained on treatment at 46 weeks.
COM701 monotherapy arm dose escalation update since AACR (Free AACR Whitepaper) 2020:

The patient with primary peritoneal cancer (platinum resistant, MSS) with durable confirmed partial response remains on study treatment at 62 weeks.
The patient with pancreatic cancer, refractory to all three prior lines of standard of care (SOC) therapy with durable confirmed SD was on study treatment for 31 weeks.
Data highlights from the monotherapy expansion cohort as of the data cutoff of December 14, 2020 include:

20 patients enrolled in biomarker and data informed indications; four patients of each: endometrial cancer, NSCLC, ovarian cancer, breast cancer and colorectal cancer.
Six of the 20 patients (30%) had best responses of SD, one patient with endometrial cancer, three patients with NSCLC and two patients with ovarian cancer.
Two patients with SD remain on treatment as of the data cutoff date; one patient with NSCLC who had >3 prior lines of SOC therapy; including prior treatment with immune checkpoint inhibitors with treatment ongoing at 26 weeks, and one patient with ovarian cancer with treatment ongoing at 20 weeks.
Two additional patients remain on treatment as of the data cutoff date.
No new safety findings were observed.
Additional clinical data and initial correlative assessments of biological samples from patients are planned to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 annual meeting, to which an abstract was submitted.

Opdivo is a registered trademark of Bristol Myers Squibb.