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Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

– FDA Action Date is October 10, 2021 –

– BLA Submission Supported by Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 –

BOTHELL, Wash. & COPENHAGEN, Denmark–(BUSINESS WIRE)–Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of October 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prognosis.¹

“The FDA’s filing of the tisotumab vedotin BLA with Priority Review marks an important step forward for this ADC as a potential treatment for patients with recurrent or metastatic cervical cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We are collaborating closely with the FDA throughout the review process to make this important therapy available to patients.”

“We are pleased that the tisotumab vedotin BLA has been accepted with Priority Review by the FDA as there is an unmet need for effective therapies for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “This is an important milestone for Genmab as it brings us closer to our goal of bringing differentiated therapies to patients and transforming cancer treatment.”

The BLA for tisotumab vedotin was submitted in February 2021. The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent or metastatic cervical cancer. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

About Cervical Cancer

Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with invasive cervical cancer in the U.S. in 2020, with approximately 4,200 deaths.² Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women being in the developing world.³ Routine medical examinations and human papillomavirus (HPV) vaccines have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic. Current therapies for previously treated recurrent or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months.^4-10

About the innovaTV 204 Trial

The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the recurrent or metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.

The study was conducted by Genmab in collaboration with Seagen, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG) Foundation. For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About Tisotumab Vedotin

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a cell-surface protein and associated with tumor growth, angiogenesis, metastasis and poor prognosis.¹ Based on its elevated expression in multiple solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

Tisotumab vedotin is being evaluated in a global phase 3, randomized clinical trial called innovaTV 301 versus investigator’s choice of chemotherapy in recurrent or metastatic cervical cancer. The primary endpoint is overall survival and secondary endpoints include progression-free survival, duration of response, objective response rate, safety and tolerability. Enrollment is ongoing and the study is intended to support global registrations. In addition, tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in recurrent or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule. More information about the innovaTV 301 clinical trial, including enrolling sites, as well as other ongoing clinical trials is available at www.clinicaltrials.gov.

About Seagen

Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmab’s proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

Seagen Forward Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy based on the results of the innovaTV 204 trial, the timing of any potential FDA approval and the therapeutic potential of tisotumab vedotin. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include without limitation the possibility that the Biologics License Application submission based on the innovaTV 204 trial may not be ultimately approved by the FDA in a timely manner or at all or with the requested label; that subsequent clinical trials may fail to establish sufficient efficacy; that adverse events or safety signals may occur; and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Genmab Forward Looking Statements

This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® and Kesimpta® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO® are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc.

References:

¹ Rondon et al. Semin Thromb Hemost 2019;45:396–412.

² National Cancer Institute SEER. “Cancer Stat Facts: Cervix Uteri Cancer.” Available at https://seer.cancer.gov/statfacts/html/cervix.html. Last accessed April 2020.

³ Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 countries https://www.iarc.fr/news-events/global-cancer-statistics-2018-globocan-estimates-of-incidence-and-mortality-worldwide-for-36-cancers-in-185-countries/.

⁴ Miller et al., Gynecol Oncol 2008; 110:65.

⁵ Bookman et al., Gynecol Oncol 2000; 77:446.

⁶ Garcia et al., Am J Clin Oncol 2007; 30:428.

⁷ Monk et al., J Clin Oncol 2009; 27:1069.

⁸ Santin et al., Gynecol Oncol 2011; 122:495.

⁹ Schilder et al., Gynecol Oncol 2005; 96:103

¹⁰ Chung HC et al. J Clin Oncol 2019; 37:1470.

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Seagen

Media and Investors:

Peggy Pinkston, Senior Vice President, Investor Relations

(425) 527-4160

[email protected]

Genmab A/S

Media:

Marisol Peron, Senior Vice President, Global Investor Relations & Communications

+1 609 524 0065

[email protected]

Investors:

Andrew Carlsen, Vice President, Head of Investor Relations

+45 3377 9558

[email protected]

KEYWORDS: Denmark Europe

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Oncology Health FDA Clinical Trials

MEDIA:

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CBRE Clarion Global Real Estate Income Fund (NYSE: IGR) Declares Monthly Distribution for April

PHILADELPHIA–(BUSINESS WIRE)–
The Board of Trustees of the CBRE Clarion Global Real Estate Income Fund (NYSE: IGR) (the “Fund”) has declared a monthly distribution of $0.05 per share for the month of April 2021. The following dates apply:

	Declaration Date	Ex-Dividend Date	Record Date	Payable Date
April 2021	04-09-2021	04-19-2021	04-20-2021	04-30-2021

IGR’s current annualized distribution rate is 7.6% based on the closing market price of $7.92 on April 7, 2021, and 6.9% based on a closing NAV of $8.74 as of the same date.

Future earnings of the Fund cannot be guaranteed, and the Fund’s distribution policy is subject to change. For more information on the Fund, please visit www.cbreclarion.com.

The Fund’s monthly distribution is set by its Board of Trustees. The Board reviews the Fund’s distribution on a quarterly basis in view of its net investment income, realized and unrealized gains, and other net unrealized appreciation or income expected during the remainder of the year. The Fund strives to establish a level monthly distribution that, over the course of the year, will serve to distribute an amount closely approximating the Fund’s net investment income and net realized capital gains during the year.

CBRE Clarion Global Real Estate Income Fund is a closed-end fund, which is traded on the New York Stock Exchange and invests primarily in real estate securities. Holdings are subject to change. Past performance is no guarantee of future results.

For the current fiscal year (January 1, 2021 to April 30, 2021), the Fund has made or declared four (4) regular monthly distributions totaling $0.20 per share. The source of the distribution declared for the current month and fiscal year to date is estimated as follows:

Estimated Source of Distributions:
		Estimated Allocations
Distribution		Net Investment Income	Net Realized Short- Term Capital Gains	Net Realized Long- Term Capital Gains	Return of Capital
Current	$0.05	$0.015 (30%)	— (0%)	— (0%)	$0.035 (70%)
YTD	$0.20	$0.060 (30%)	— (0%)	— (0%)	$0.140 (70%)

The allocations reported in this notice are only estimates and are not provided for tax reporting purposes. The actual allocations will depend on the Fund’s investment experience during the remainder of its fiscal year and will not be finalized until after year-end. In addition, the allocations reported to shareholders for tax reporting purposes will also reflect adjustments required under applicable tax regulations. Some of these tax adjustments are significant, and amounts reported to you for tax reporting may be substantially different than those presented in this notice. SHAREHOLDERS WILL BE SENT A FORM 1099-DIV FOR THE CALENDAR YEAR INDICATING HOW TO REPORT FUND DISTRIBUTIONS FOR FEDERAL INCOME TAX PURPOSES.

The estimated allocations presented above are based on the Fund’s monthly calculation of its year-to-date net investment income, capital gains and returns of capital. The Fund’s investment income is mainly comprised of distributions received from the real estate investment trusts (REITs) and other companies in which it invests. “Net investment income” refers to the Fund’s investment income offset by its expenditures, which include the fees paid to the investment adviser and other service providers. “Net realized capital gains” represents the aggregation of the capital gains and losses realized by the Fund from its purchase and sale of investment securities during the year-to-date period. Short-term capital gains are those arising from the sale of securities held by the Fund for less than one year. Long-term capital gains are those arising from the sale of securities held by the Fund for a year or more. The amount of net realized capital gains is also offset by capital losses realized in prior years. Adjustments to net investment income are made based on the character of distributions received by the Fund. A portion of the distributions the Fund receives from REITs will be characterized by the REITs as capital gains or returns of capital. Because REITs often reclassify the distributions they make, the Fund does not know the ultimate character of these distributions at the time they are received, so the Fund estimates the character based on historical information. The Fund’s net investment income is reduced by the amounts characterized by the REITs as capital gains and returns of capital. Amounts characterized by the REITs as capital gains are added to the Fund’s net realized capital gains. Amounts characterized by the REITs as return of capital are classified as such by the Fund.

The Fund estimates that it has distributed more than its net investment income and net realized capital gains; therefore, a portion of your distribution may be a return of capital. A return of capital may occur, for example, when some or all of the money that you invested in the Fund is paid back to you. A return of capital distribution does not necessarily reflect the Fund’s investment performance and should not be confused with “yield” or “income”.

Shareholders should not draw any conclusions about the Fund’s investment performance from the amount of this distribution or from the terms of the Fund’s managed distribution policy. The performance and distribution rate information disclosed in the table below is based on the Fund’s net asset value (“NAV”). The Fund’s NAV is calculated as the total market value of all the securities and other assets held by the Fund minus the total value of its liabilities. Performance figures are not meant to represent individual shareholder performance. The value of a shareholder’s investment in the Fund is determined by the market price of the Fund’s shares.

The Fund’s Cumulative Total Return for fiscal year 2021 (January 1, 2021 through March 31, 2021) is set forth below. Shareholders should take note of the relationship between the Cumulative Total Return and the Fund’s Cumulative Distribution Rate for 2021, as well as its Current Annualized Distribution Rate. Moreover, the Fund’s Average Annual Total Return for the preceding five-year period (April 1, 2016 through March 31, 2021) is set forth below. Shareholders should take note of the relationship between the Fund’s Average Annual Total Return and its Average Annual Distribution Rate for the preceding five-year period.

Fund Performance and Distribution Rate Information:

Full Year 01/01/2021 to 03/31/2021
	Cumulative Total Return1	6.36%
	Cumulative Distribution Rate2	1.77%
Preceding Five-Year Period 04/01/2016 to 03/31/2021
	Average Annual Total Return3	7.75%
	Average Annual Distribution Rate4	7.14%
Current Annualized Distribution Rate5		7.08%

1		Cumulative Total Return is the percentage change in the Fund’s NAV over the year-to-date time period including distributions paid and assuming reinvestment of those distributions.
2		Cumulative Distribution Rate for fiscal year to date 2021 (January 1, 2021 through March 31, 2021) is determined by dividing the dollar value of distributions in the period by the Fund’s NAV as of March 31, 2021.
3		Average Annual Total Return represents the simple arithmetic average of the Annual Total Returns of the Fund for the preceding five-year period. Annual Total Return is the percentage change in the Fund’s NAV over a year including distributions paid and assuming reinvestment of those distributions.
4		Average Annual Distribution Rate is the simple arithmetic average of the Annual Distribution Rates for the preceding five-year period. The Annual Distribution Rates are calculated by taking the tota distributions paid during the period divided by average daily NAV for the period.
5		The Current Annualized Distribution Rate is the current monthly distribution rate annualized as a percentage of the Fund’s NAV as of March 31, 2021.

Please refer to the chart below for information about the Fund’s historical NAVs, change in NAVs, total returns, and distributions paid.

	Average Daily NAV for Period		End of Period NAV Per Share		Change in NAV		Annualized Total Returns		Distribution Rate4		Level Distributions Paid		Special Distributions Paid		Total Distributions Paid
IPO			$	15.00
20041	$	14.39	$	17.46	16.40	%	28.20	%	5.77	%	$	0.75	$	0.08	$	0.83
2005	$	16.81	$	17.23	-1.32	%	8.13	%	8.75	%	$	1.29	$	0.18	$	1.47
2006	$	20.27	$	22.78	32.21	%	53.42	%	16.13	%	$	1.38	$	1.89	$	3.27
2007	$	21.67	$	16.16	-29.06	%	-15.82	%	14.86	%	$	1.38	$	1.84	$	3.22
2008	$	11.97	$	5.63	-65.16	%	-61.14	%	10.36	%	$	1.24	$	–	$	1.24
2009	$	5.82	$	7.51	33.39	%	46.79	%	9.28	%	$	0.54	$	–	$	0.54
2010	$	7.82	$	8.58	14.25	%	22.41	%	6.91	%	$	0.54	$	–	$	0.54
2011	$	8.60	$	8.14	-5.13	%	0.94	%	6.28	%	$	0.54	$	–	$	0.54
2012	$	8.99	$	9.48	16.46	%	24.15	%	6.47	%	$	0.54	$	0.042	$	0.582
2013	$	9.57	$	9.04	-4.64	%	0.91	%	5.64	%	$	0.54	$	–	$	0.54
2014	$	9.77	$	10.16	12.39	%	18.73	%	5.52	%	$	0.54	$	–	$	0.54
2015	$	9.67	$	9.04	-11.02	%	-5.57	%	5.89	%	$	0.57	$	–	$	0.57
2016	$	9.11	$	8.65	-4.31	%	2.17	%	6.58	%	$	0.60	$	–	$	0.60
2017	$	8.75	$	8.99	3.93	%	11.29	%	6.85	%	$	0.60	$	–	$	0.60
2018	$	8.36	$	7.55	-16.02	%	-9.75	%	7.18	%	$	0.60	$	–	$	0.60
2019	$	8.62	$	8.86	17.35	%	25.79	%	6.96	%	$	0.60	$	–	$	0.60
2020	$	7.51	$	8.11	-8.47	%	-0.60	%	7.99	%	$	0.60	$	–	$	0.60
20212	$	8.19	$	8.47	4.44	%	6.36	%	1.83	%	$	0.15	$	–	$	0.15
Average3							9.15	%	8.15	%

Since Inception Annualized Total Return 5.31%

1		Figures for 2004 are from February 24, 2004, the Fund’s inception date.
2		2021 figures are for year to date through March 31, 2021.
3		Average calculated on number of months and years since inception. The Fund’s inception date was February 24, 2004.
4		Distribution rate calculated by taking the total distributions paid within the period divided by average daily NAV for the period.

Sources: NAV per share amounts and annualized total returns are published in the Fund’s audited annual reports for the respective year.

About CBRE Clarion Securities:

CBRE Clarion Securities is a registered investment advisory firm specializing in the management of global real asset securities for institutional investors. Headquartered near Philadelphia, the firm has personnel located in the United States, United Kingdom, Hong Kong, Japan, and Australia. For more information about CBRE Clarion Securities, please visit www.cbreclarion.com.

CBRE Clarion Securities is the listed equity management arm of CBRE Global Investors. CBRE Global Investors is a global real assets investment management firm with $122.7 billion in assets under management* as of December 31, 2020. The firm sponsors investment programs across the risk/return spectrum for investors worldwide.

CBRE Global Investors is an independently operated affiliate of CBRE Group, Inc. (NYSE:CBRE). It harnesses the research, investment sourcing and other resources of the world’s largest commercial real estate services and investment firm (based on 2020 revenue) for the benefit of its investors. CBRE Group, Inc. has more than 100,000 employees serving clients in more than 100 countries. For more information about CBRE Global Investors, please visit www.cbreglobalinvestors.com

*Assets under management (AUM) refers to the fair market value of real assets-related investments with respect to which CBRE Global Investors provides, on a global basis, oversight, investment management services and other advice and which generally consist of investments in real assets; equity in funds and joint ventures; securities portfolios; operating companies and real assets-related loans. This AUM is intended principally to reflect the extent of CBRE Global Investors’ presence in the global real assets market, and its calculation of AUM may differ from the calculations of other asset managers.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210409005390/en/

Analyst and Press Inquiries:

David Leggette, Principal

610.995.2500

Investor Relations:

888.711.4272

www.cbreclarion.com

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

Posted on April 9, 2021 4:03 pm

Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

 Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

• FDA action date is Oct 10, 2021
• BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020

COPENHAGEN, Denmark & BOTHELL, Wash.–(BUSINESS WIRE)–Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of Oct 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prognosis.¹

“We are pleased that the tisotumab vedotin BLA has been accepted with Priority Review by the FDA as there is an unmet need for effective therapies for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “This is an important milestone for Genmab as it brings us closer to our goal of bringing differentiated therapies to patients and transforming cancer treatment.”

The FDA’s filing of the tisotumab vedotin BLA with Priority Review marks an important step forward for this ADC as a potential treatment for patients with recurrent or metastatic cervical cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We are collaborating closely with the FDA throughout the review process to make this important therapy available to patients.”

The BLA for tisotumab vedotin was submitted in February 2021. The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent or metastatic cervical cancer. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

About Cervical Cancer

Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with invasive cervical cancer in the U.S. in 2020, with approximately 4,200 deaths.² Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women being in the developing world.³ Routine medical examinations and human papillomavirus (HPV) vaccines have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic. Current therapies for previously treated recurrent or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months.^4-10

About the innovaTV 204 Trial

The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the recurrent or metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.

The study was conducted by Genmab in collaboration with Seagen, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG) Foundation. For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About Tisotumab Vedotin

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a cell-surface protein and associated with tumor growth, angiogenesis, metastasis and poor prognosis.¹ Based on its elevated expression in multiple solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

Tisotumab vedotin is being evaluated in a global phase 3, randomized clinical trial called innovaTV 301 versus investigator’s choice of chemotherapy in recurrent or metastatic cervical cancer. The primary endpoint is overall survival and secondary endpoints include progression-free survival, duration of response, objective response rate, safety and tolerability. Enrollment is ongoing and the study is intended to support global registrations. In addition, tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in recurrent or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule. More information about the innovaTV 301 clinical trial, including enrolling sites, as well as other ongoing clinical trials is available at www.clinicaltrials.gov.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmab’s proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com.

About Seagen

Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

Genmab Forward Looking Statements

This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; DuoBody in combination with the DuoBody logo^®; HexaBody^®;^{HexaBody in combination withthe HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Kesimpta® is a trademark of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO® are trademarks of Johnson & Johnson. TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.}

Seagen Forward Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy based on the results of the innovaTV 204 trial, the timing of any potential FDA approval and the therapeutic potential of tisotumab vedotin. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include without limitation the possibility that the Biologics License Application submission based on the innovaTV 204 trial may not be ultimately approved by the FDA in a timely manner or at all or with the requested label; that subsequent clinical trials may fail to establish sufficient efficacy; that adverse events or safety signals may occur; and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

References

¹ Rondon et al. Semin Thromb Hemost 2019; 45:396–412.

² National Cancer Institute SEER. “Cancer Stat Facts: Cervix Uteri Cancer.” Available at https://seer.cancer.gov/statfacts/html/cervix.html. Last accessed April 2020.

³ Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 countries https://www.iarc.fr/news-events/global-cancer-statistics-2018-globocan-estimates-of-incidence-and-mortality-worldwide-for-36-cancers-in-185-countries/.

⁴ Miller et al., Gynecol Oncol 2008; 110:65.

⁵ Bookman et al., Gynecol Oncol 2000; 77:446.

⁶ Garcia et al., Am J Clin Oncol 2007; 30:428.

⁷ Monk et al., J Clin Oncol 2009; 27:1069.

⁸ Santin et al., Gynecol Oncol 2011; 122:495.

⁹ Schilder et al., Gynecol Oncol 2005; 96:103

¹⁰ Chung HC et al. J Clin Oncol 2019; 37:1470.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210409005447/en/

Genmab A/S:

Marisol Peron, Senior Vice President, Global Investor Relations & Communications

T: +1 609 524 0065; E: [email protected]

For Investor Relations:

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: [email protected]

Seagen:

Media and Investors:

Peggy Pinkston, Senior Vice President, Investor Relations

(425) 527-4160

[email protected]

KEYWORDS: Washington Europe Denmark United States North America

INDUSTRY KEYWORDS: Oncology FDA Health Clinical Trials Pharmaceutical Biotechnology

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KB Home Announces the Grand Opening of Aston Park and Montclaire, Its Latest New-Home Communities in the Seattle Area

Homebuilder to offer personalized, new homes in highly desirable locations, priced from the $590,000s.

SEATTLE–(BUSINESS WIRE)–
KB Home (NYSE: KBH) today announced the grand opening of Aston Park and Montclaire, two new, single-family home communities situated in prime Seattle-area locations. The communities are close to Kent Station for shopping, dining and entertainment and the accesso ShoWare^® Center, which hosts sporting events and concerts. Both communities also offer easy access to the Sounder commuter train, Interstate 5 and Highways 18 and 167 for quick commutes to Seattle, Bellevue, Tacoma and the area’s major employment centers. Homeowners will also enjoy the proximity to outdoor recreation and area schools.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210409005446/en/

The new homes at Aston Park and Montclaire showcase desirable design characteristics like spacious kitchens overlooking large great rooms, expansive bedroom suites with walk-in closets, and ample storage space. The communities’ one- and two-story floor plans feature up to five bedrooms and three baths, and range in size from approximately 1,600 to 2,500 square feet. Both communities will also offer the KB Home Office, a dedicated room that homebuyers can personalize for the way they work.

“Aston Park and Montclaire are both situated near Interstate 5, Highways 18 and 167, and the Sounder train, providing easy access to downtown Seattle and the area’s major employers,” said Ryan Kemp, President of KB Home’s Seattle division. “The new communities are also close to popular shopping, dining, entertainment as well as outdoor recreation and walking distance to area schools. As with other KB Home communities, Aston Park and Montclaire provide home shoppers the opportunity to purchase a personalized, new KB home at a price that fits their budget.”

KB Home stands out from other homebuilders as the company gives homebuyers exceptional choice and control. KB Home starts by offering a wide variety of homes at an affordable price. From there, the builder gives buyers the ability to personalize their homes from floor plans to exterior elevations, from design options to where they live in the community. The KB Home team works hand in hand with homeowners every step of the way, so they have a real partner in the process.

Every KB home is designed to be ENERGY STAR^® certified thanks to the quality construction techniques and materials utilized that ultimately deliver significant savings on utility bills compared to used homes. Additionally, all new KB homes are designed to deliver an enhanced indoor environment and include high performance ventilation systems, low- or zero-VOC products and other features guided by the Environmental Protection Agency’s (EPA) Indoor airPLUS standards.

The Aston Park and Montclaire sales offices and model homes are open for private in-person tours by appointment, and walk-in visits are welcome. Homebuyers also have the flexibility to arrange a live video tour with a sales counselor. Pricing begins from the $590,000s.

For more information on KB Home, call 888-KB-HOMES or visit kbhome.com.

About KB Home

KB Home is one of the largest and most recognized homebuilders in the United States and has been building quality homes for over 60 years. Today, KB Home operates in 45 markets across eight states, serving a wide array of buyer groups. What sets us apart is how we give our customers the ability to personalize their homes from homesites and floor plans to cabinets and countertops, at a price that fits their budget. We are the first builder to make every home we build ENERGY STAR^® certified. In fact, we go beyond the EPA requirements by ensuring every ENERGY STAR certified KB home has been tested and verified by a third-party inspector to meet the EPA’s strict certification standards, which help to lower the cost of ownership and to make our new homes healthier and more comfortable than new ones without certification. We also work with our customers every step of the way, building strong personal relationships so they have a real partner in the homebuying process, and the experience is as simple and easy as possible. Learn more about how we build homes built on relationships by visiting kbhome.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210409005446/en/

Craig LeMessurier, KB Home

925-580-1583

[email protected]

KEYWORDS: United States North America Washington

INDUSTRY KEYWORDS: Landscape Interior Design Architecture Residential Building & Real Estate Construction & Property

MEDIA:

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KB Home announces the grand opening of Aston Park and Montclaire, its latest new-home communities in the Seattle area. (Photo: Business Wire)

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KB Home announces the grand opening of Aston Park and Montclaire, its latest new-home communities in the Seattle area. (Photo: Business Wire)