Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

On June 29, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported positive topline results from the phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer (Press release, Seattle Genetics, JUN 29, 2020, View Source [SID1234561545]). Results from the trial showed a 24 percent confirmed objective response rate (ORR) by independent central review [95% Confidence Interval: 15.9%-33.3%] with a median duration of response (DOR) of 8.3 months. The most common treatment-related adverse events (greater than or equal to 20 percent) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye. The data will be submitted for presentation at an upcoming medical meeting.

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Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor, which is expressed on cervical cancer and can promote tumor growth, angiogenesis and metastases.1 Standard therapies for previously treated recurrent and/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, in an all-comers population.1-8 Tisotumab vedotin is being developed by Seattle Genetics in collaboration with Genmab.

"Available therapies upon progression after first line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Tisotumab vedotin has demonstrated clinically meaningful and durable objective responses with a manageable safety profile, and we look forward to discussing with the FDA the potential submission of a Biologics License Application to support an accelerated approval."

Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with cervical cancer in the U.S. in 2020, with approximately 4,200 deaths.9 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.10 Routine medical examinations and the human papillomavirus (HPV) vaccine 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.

Additional clinical trials of tisotumab vedotin are currently enrolling patients, including in combination with pembrolizumab, carboplatin or bevacizumab, and with a weekly dosing schedule in patients with locally advanced or metastatic cervical cancer. Tisotumab vedotin is also being evaluated in other tissue factor expressing tumor types, including ovarian and other solid tumors.

About 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 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 in collaboration with European Network of Gynaecological Oncological Trial Groups (ENGOT) and Gynecologic Oncology Group (GOG). 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 Seattle Genetics’ 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 protein that can promote tumor growth, angiogenesis and metastases.1 Based on its high expression on many 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 Seattle Genetics, 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 ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer and in combination with other commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three weeks dosing schedule.

NantKwest Announces Closing of $90.7 Million Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On June 29, 2020 NantKwest, Inc. (Nasdaq: NK), a clinical-stage, natural killer cell-based therapeutics company, reported the closing of its previously announced underwritten public offering of an aggregate of 8,521,500 shares of its common stock (4,811,500 shares at a price to the public of $9.50 per share and 3,710,000 shares at a price of $12.12 per share to NantKwest’s chairman, chief executive officer and principal stockholder, Dr. Patrick Soon-Shiong), which includes 1,111,500 shares sold upon full exercise of the underwriters’ option to purchase additional shares at a public offering price of $9.50 per share, less the underwriting discounts and commissions (Press release, NantKwest, JUN 29, 2020, View Source [SID1234561544]). All of the shares were offered by NantKwest. Including the option exercise, the aggregate gross proceeds of the offering were approximately $90.7 million, before deducting the underwriting discounts and commissions and other offering expenses.

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Piper Sandler & Co. acted as the sole book-running manager for the offering. LifeSci Capital acted as co-manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-233434) related to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (the "SEC") on August 23, 2019 and declared effective by the SEC on September 3, 2019. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement and accompanying prospectus related to the offering were filed with the SEC on June 25, 2020 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus related to the offering may also be obtained from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at (800) 747-3924 or via email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

FDA Approves Genentech’s Phesgo (Fixed-dose Combination of Perjeta and Herceptin for Subcutaneous Injection) for HER2-positive Breast Cancer

On June 29, 2020 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has approved Phesgo, a fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC, under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer (Press release, Genentech, JUN 29, 2020, View Source [SID1234561543]). This is the first time that Genentech has combined two monoclonal antibodies that can be administered by a single SC injection.

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"The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options."

Phesgo is available in one single-dose vial. Administration can take approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines. Phesgo can be administered by a healthcare professional in a treatment center or at a patient’s home.

The approval is based on results from the pivotal Phase III FeDeriCa study, which met its primary endpoint with Phesgo showing non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough) when compared to IV administration of Perjeta. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia.

The Phase II PHranceSCa study showed that 85% (136/160) of people receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration.

For those who qualify, Genentech will offer patient assistance programs for people prescribed Phesgo by their doctor through Genentech Access Solutions. Please contact Genentech Access Solutions at (866) 422-2377 or visit View Source for more information.

About the FeDeriCa study

FeDeriCa is an international, multi-center, two-arm, randomized, open-label, Phase III study evaluating the pharmacokinetics, efficacy, and safety of SC injection of Phesgo in combination with chemotherapy, compared with standard IV infusion of Perjeta and Herceptin in combination with chemotherapy, in 500 people with HER2-positive EBC who are being treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough). Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pathological complete response, meaning there is no tumor tissue detectable in the tissue removed at the time of surgery. The safety profile of Phesgo was comparable with that of Perjeta and Herceptin administered intravenously.

Data from the FeDeriCa study were presented at the San Antonio Breast Cancer Symposium in December 2019. The FeDeriCa study met its primary endpoint of non-inferior levels of Perjeta in the blood. The geometric mean ratio (GMR; a type of average used when assessing pharmacokinetics) for the primary endpoint was 1.22 (90% CI: 1.14 to 1.31), with the lower limit of the 90% CI of the GMR=1.14≥0.80 (the pre-specified non-inferiority margin). A secondary endpoint of non-inferior levels of Herceptin was also met, with blood concentrations for people receiving the fixed-dose combination non-inferior to those receiving IV Herceptin (GMR=1.33 [90% CI: 1.24 to 1.43]; lower limit of 90% CI of GMR=1.24≥0.80). A non-inferiority endpoint was chosen for the study to ensure that people were receiving sufficient dosing with Perjeta and Herceptin as compared to the established IV doses at the same treatment intervals.

About the PHranceSCa study

PHranceSCa is a randomized, multi-center, multinational, open-label, cross-over Phase II study evaluating patient preference for and satisfaction with subcutaneous (SC) administration of Phesgo. All patients completed neoadjuvant treatment with Perjeta, Herceptin and chemotherapy and had surgery before randomization. The primary endpoint of the study is the percentage of participants who indicate that they prefer treatment with Phesgo compared to the standard intravenous (IV) formulations of Perjeta and Herceptin. Secondary endpoints include participant-reported satisfaction and health-related quality of life outcomes; healthcare professionals’ perceptions of time and resource use and convenience compared with IV formulations; as well as the safety and efficacy of each study regimen.

About HER2-positive breast cancer

Breast cancer is one of the most common cancers among women worldwide. According to the American Cancer Society, close to 280,000 people in the United States will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2020. Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells. Approximately 15-20% of breast cancers are HER2-positive based on the result of a diagnostic test.

About Phesgo

Phesgo (subcutaneous Perjeta and Herceptin) is a new fixed-dose formulation of Perjeta and Herceptin with Halozyme Therapeutics’ Enhanze drug delivery technology.

Trastuzumab in Phesgo is the same monoclonal antibody as in IV Herceptin and pertuzumab in Phesgo is the same monoclonal antibody as in IV Perjeta. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signaling pathways, thus preventing tumor cell growth and survival.

Halozyme’s Enhanze drug delivery technology may enable and optimize SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.

Phesgo Indications and Important Safety Information

Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is a prescription medicine approved for use in combination with chemotherapy for:

use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than 2 cm in diameter or node-positive). Phesgo should be used as part of a complete treatment regimen for early breast cancer.
use after surgery (adjuvant treatment) in adults with HER2-positive early breast cancer that has a high likelihood of coming back.
Phesgo is also approved for use in combination with docetaxel in adults who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.

Important Safety Information

What should patients know about side effects with Phesgo?

Not all people have serious side effects; however, side effects with Phesgo therapy are common. It is important to know what side effects may happen and what symptoms to watch for
A patient’s doctor may stop treatment if serious side effects happen. Patients should be sure to contact their healthcare team right away if they have questions or are worried about any side effects
Most serious side effects with Phesgo

Phesgo may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure).

The risk for and seriousness of these heart problems are highest in people who received both Phesgo and a certain type of chemotherapy (anthracycline)
A patient’s doctor will check for signs of heart problems before, during, and after treatment with Phesgo. Based on test results, their doctor may hold or discontinue treatment with Phesgo
Patients should contact their healthcare professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness
Receiving Phesgo during pregnancy can result in the death of an unborn baby and birth defects.

Birth control should be used while receiving Phesgo and for 7 months after the last dose of Phesgo. If a patient is a mother who is breastfeeding, she should talk with her doctor about either stopping breastfeeding or stopping Phesgo
If the patient thinks she may be pregnant, she should contact her healthcare provider immediately
If the patient is exposed to Phesgo during pregnancy, or becomes pregnant while receiving Phesgo or within 7 months following the last dose of Phesgo, she is encouraged to report Phesgo exposure to Genentech at 1-888-835-2555
Phesgo may cause serious lung problems.

A patient’s doctor may check for signs of lung problems including:
Severe shortness of breath
Fluid in or around the lungs
Weakening of the valve between the heart and the lungs
Not enough oxygen in the body
Swelling of the lungs
Scarring of the lungs
Who should not receive Phesgo?

Phesgo should not be used in patients who are allergic to pertuzumab, trastuzumab, hyaluronidase, or to any of the ingredients in Phesgo
Other possible serious side effects

Phesgo may worsen low white blood cell counts caused by chemotherapy: Low white blood cell counts can be life threatening and were seen more often in patients receiving Herceptin (trastuzumab) plus chemotherapy than in patients receiving chemotherapy alone. A patient’s doctor may check for signs of low white blood cell counts when he or she examines the patient
Phesgo may cause administration-related reactions: Phesgo is given as an injection. The active ingredients in Phesgo have been associated with severe administration reactions, including hypersensitivity or anaphylaxis, which can be fatal. Patients should talk to their doctor if they feel any symptoms. The most common symptoms include dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling of the skin, breathing problems, or chest pain
Most common side effects

The most common side effects of Phesgo when given with chemotherapy as part of an early breast cancer regimen are:

Hair Loss
Nausea
Diarrhea
Low levels of red blood cells
Weakness
The most common side effects of Phesgo when given with docetaxel for treatment of breast cancer that has spread to other parts of the body (metastatic) are:

Diarrhea
Hair loss
Low levels of white blood cells with or without fever
Nausea
Feeling tired
Rash
Damage to the nerves (numbness, tingling, pain in hands/feet)
Patients are encouraged to report side effects to Genentech and the FDA. Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Patients should talk to a healthcare professional for more information about the benefits and risks of Phesgo.

Please see full Prescribing Information for additional Important Safety Information, including most serious side effects.

If a patient cannot afford their medication, visit View Source for financial assistance information.

About Expanded Access Treatment Protocol for Continuity of Care During COVID-19

Genentech launched an expanded access treatment protocol in the United States, where the FDC of Perjeta and Herceptin is administered at home by a home health nursing provider. The study will continue beyond approval, aiming to help continuity of care during the COVID-19 pandemic for certain patients with HER2-positive breast cancer who have completed chemotherapy concurrent with Perjeta and Herceptin intravenously and are currently receiving or will be receiving Perjeta and Herceptin alone. To learn more, please visit here.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit View Source for more information.

About Genentech in breast cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including triple-negative and hormone receptor-positive.

Genprex Added to Russell 3000® Index

On June 29, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it was added to the Russell 3000 Index after the market closed on Friday, June 26, 2020 as part of the 2020 Russell U.S. Indexes reconstitution (Press release, Genprex, JUN 29, 2020, View Source [SID1234561542]).

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"Genprex is excited to be a member of the Russell 3000 Index, and we look forward to sharing our story and unique approaches for the treatment of lung cancer and diabetes with a wider group of investors," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "We believe the Company’s future is bright as we work to secure better outcomes for patients suffering from these serious medical conditions."

In January 2020, Genprex was awarded U.S. FDA Fast Track designation for use of GPX-001 (quaratusugene ozeplasmid) combined with Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations whose tumors progressed after treatment with Tagrisso alone. The Company also signed in early 2020 an exclusive license agreement with the University of Pittsburgh for a preclinical diabetes gene therapy candidate that has the potential to cure Type 1 and Type 2 diabetes. Earlier this year, the Company significantly strengthened its balance sheet through "at the market" capital raises without warrants, plus the exercise by investors of most outstanding Company warrants, aggregating approximately $28 million in proceeds to the Company. The funds will support the Company’s research and development programs and other corporate uses and initiatives, which could include strategic transactions.

The Russell 3000 Index includes the 3,000 publicly traded companies on the Nasdaq and NYSE exchanges with the largest market capitalizations. FTSE Russell, a leading global index provider, determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes (i.e. growth or value). Each June, the Russell 3000 index is reconstituted to reflect market capitalization changes over the prior year. This closely watched market event impacts more than $9 trillion in investor assets benchmarked to or invested in products based on the Russell U.S. indices.

Exicure, Inc. Added to Russell 2000® Index

On June 29, 2020 Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported that it has been added to the Russell 2000 index. This addition was effective June 26, 2020 (Press release, Exicure, JUN 29, 2020, View Source [SID1234561541]).

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"We are pleased that Exicure has reached this important milestone," said Dr. David Giljohann, Exicure’s Chief Executive Officer. "We look forward to telling a growing set of investors about our clinical progress in neurology, oncology, and ophthalmology using our genetic medicines," concluded Dr. Giljohann.

The Russell U.S. Indexes are widely used by investment managers and institutional investors for passive funds and investment products and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell U.S. Indexes. For more information on the Russell Indexes, please visit the "Russell Reconstitution" section on the FTSE Russell website at www.ftserussell.com.