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Tuesday, February 15, 2022

ImmunityBio's Ankitva Shows 100% Survival At Two Years In Bladder Cancer

 ImmunityBio Inc 

IBRX +22.26%
 (Get Free Alerts for IBRX) announced data from its bladder cancer trial (QUILT-3.032) Phase 2/3 study of intravesical BCG plus Anktiva (N-803).

  • The data showed sustained complete response rates in patients with BCG-unresponsive non-muscle-invasive carcinoma in situ (NMIBC CIS) bladder cancer (Cohort A), and papillary disease (Cohort B). 
  • Of the 83 patients with BCG-unresponsive NMIBC CIS, 59 (71%) had a complete response with a median duration of response of 24.1 months.
  • The rates exceeded historical complete response rates of 41% and 18% for FDA-approved Merck Co & Inc's 
    MRK +1.75%
     (Get Free Alerts for MRK) Keytruda (pembrolizumab) and Endo International Plc's 
    ENDP +6.77%
     Valstar (valrubicin), respectively.
  •  In the papillary disease arm of the study (Cohort B), 57% of patients are disease-free at 12 months and 53% at 18 months.
  • In Cohort A, 24.1 months median durable complete remission was seen, with 96% and 91% avoidance of bladder cancer progression and cystectomy, respectively, at 24 months in responders.
  • 100% bladder cancer-specific overall survival was observed at 24 months.
  • In Cohort B, 99% overall bladder cancer-specific survival and 95% Cystectomy avoidance rate were seen.
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Lilly Unites With ImmunoGen In ADC Deal Worth Up To $1.7B

 mmunoGen Inc 

IMGN +4.69%
 (Get Free Alerts for IMGN) has struck a multi-target license deal with Eli Lilly And Co 
LLY +3.95%
 (Get Free Alerts for LLY) to grant exclusive rights to research, develop, and commercialize antibody-drug conjugates (ADCs) directed to targets selected by Lilly based on ImmunoGen's camptothecin technology.

  • Camptothecins are an important class of anticancer drugs targeting Type I topoisomerase.
  • According to the deal, Lilly will pay ImmunoGen an upfront payment of $13 million, reflecting initial targets selected by Lilly.
  • Lilly may select a pre-specified number of additional targets, with ImmunoGen eligible to receive an additional $32.5 million in exercise fees if Lilly licenses the full number of targets.
  • ImmunoGen can receive up to $1.7 billion in potential target program exercise fees and milestone payments.
  • ImmunoGen is also eligible for tiered royalties as a percentage of worldwide commercial sales by Lilly. 
  • Lilly is responsible for all costs associated with research and development.
  • ImmunoGen retains full rights to the camptothecin platform for all targets not covered by the Lilly license.
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ViewRay's MRIdian MRI-Guided Imaging System Signasl Superiority For Localized Prostate Cancer

 ViewRay Inc 

VRAY -4.08%
 (Get Free Alerts for VRAY) has announced interim data from the single-center Phase 3 MIRAGE trial comparing MRIdian MRI-guided vs. CT-guided SBRT for localized prostate cancer.

  • The data will be featured at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium.
  • Interim analysis of the primary endpoint signaled superiority of MRIdian MRI-guided Stereotactic Body Radiotherapy (SBRT) with a significant reduction in acute grade ≥2 GU toxicity over those receiving CT-guided SBRT.
  • The interim data from 100 evaluable patients (51 in the CT group and 49 in the MRI group) showed a statistically significant reduction in acute grade ≥2 GU toxicity (47.1% in the CT group vs. 22.4% in the MRI group).
  • Significant reduction in acute grade ≥2 gastrointestinal (GI) toxicity in men receiving MRI-guided SBRT (13.7% in the CT group vs. 0 percent in the MRI group). 
  • The final analysis for the primary endpoint is anticipated in early 2022.
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FDA Slams Brakes On Legend Biotech's CAR-T Therapy Trial In Lymphoma

 The FDA has instituted a clinical hold on Legend Biotech Corporation's 

LEGN +2.22%
 (Get Free Alerts for LEGN) Phase 1 trial for LB1901. 

  • LB1901 is the company's investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for relapsed or refractory T-cell lymphoma (TCL). 
  • The FDA indicated they would provide an official clinical hold letter to Legend Biotech by March 11.
  • To date, one patient has been dosed in the clinical trial. 
  • Before receiving the FDA's clinical hold communication, Legend Biotech had, under the protocol, paused the clinical trial due to low CD4+ T-cell counts in the patient's peripheral blood and notified the FDA. 
  • The patient has not experienced drug-related serious adverse events (SAEs) and is being monitored.
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Bristol Myers, Exelixis Tout Addedl Opdivo/Cabometyx Combo Data From Kidney Cancer Trial

 Bristol Myers Squibb Co 

BMY +1.44%
 (Get Free Alerts for BMY) and Exelixis Inc 
EXEL +3.17%
 (Get Free Alerts for EXEL) announced two-year follow-up results from the Phase 3 CheckMate -9ER trial of Opdivo (nivolumab) and Cabometyx (cabozantinib) versus sunitinib in the first-line treatment of advanced renal cell carcinoma.

  • The updated results will be featured at the American Society of Clinical Oncology (ASCO) 2022 Genitourinary Cancers Symposium.
  • With a median follow-up of 32.9 months, Opdivo/Cabometyx combo continued to show meaningful improvements in median overall survival (37.7 months vs. 34.3 months). 
  • It demonstrated a 30% reduction in the risk of death compared to sunitinib.
  • Progression-free survival benefits were maintained, with the combination continuing to double median PFS vs. sunitinib (16.6 months vs. 8.3 months.
  • Objective response rates were sustained, with nearly twice as many patients responding to Opdivo/Cabometyx combo vs. sunitinib (55.7% vs. 28.4%). 
  • Responses were also more durable with the combination, with a median DoR of 23.1 months, compared to 15.1 months with sunitinib.
  • Additionally, higher percentage of patients experienced any tumor shrinkage benefits with Opdivo/Cabometyx combo vs. sunitinib across lung (90.5% vs. 76.0%), lymph node (88.4% vs. 72.6%), kidney (89.0% vs. 71.6%), liver (72.7% vs. 53.8%) and bone (85.2% vs. 65.0%) target lesions.
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Aveo: Tivozanib Patients Up To 5X More Likely To Have PFS Vs. Nexavar In Kidney Cancer

 Aveo Pharmaceuticals Inc 

AVEO +4.86%
 (Get Free Alerts for AVEO) will present new long-term progression-free survival (PFS) data from the Phase 3 TIVO-3 study in kidney cancer at the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium.

  • The trial is evaluating Fotivda (tivozanib) to Bayer AG's 
    BAYRY +2.88%
     (Get Free Alerts for BAYRY) Nexavar (sorafenib) in advanced renal cell carcinoma (RCC) patients following two or more prior systemic therapies.
  • "This marks the first presentation of five-year follow-up data for patients being treated in the third- or fourth-line RCC setting and helps guide clinical treatment," said Michael Bailey, President, and CEO.
  • Landmark five-year follow-up data show PFS rates are consistently higher with Fotivda vs. sorafenib, with 12% vs. 2% and 8% vs. 0% at three and four years, respectively. 
  • Long-term PFS represents a clinically meaningful outcome for patients in the third- and fourth-line treatment setting.
  • Long-term overall survival was also analyzed, and a non-significant trend favoring Fotivda continued to emerge with the accumulation of events (HR, 0.89).
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Welltower Reports Fourth Quarter 2021 Results

 Welltower Recent Highlights

  • Reported net income attributable to common stockholders of $0.13 per diluted share

  • Reported normalized FFO attributable to common stockholders of $0.83 per diluted share

  • Seniors Housing Operating ("SHO") portfolio spot occupancy increased approximately 70 basis points ("bps") during the quarter to 77.7%, while average pro rata occupancy growth exceeded guidance of 140 bps(1)

  • SHO same store revenue growth accelerated 4.8% in the fourth quarter compared to the prior year

  • Achieved same store REVPOR growth of 3.4% within the SHO portfolio during the fourth quarter as compared to 2.2% in the third quarter

  • Completed $1.5 billion of pro rata gross investments during the fourth quarter including $1.4 billion in acquisitions and loan funding and $142 million in development funding

  • In November, we issued $500 million in 2.75% senior unsecured notes due January 2032, matching our lowest-ever coupon on a 10-year note

  • Sold 11.3 million shares of common stock under our ATM program via forward sale agreements at an initial weighted average price of $85.06 since October 1, 2021 for total gross proceeds of approximately $961 million. As of February 14, 2022, approximately 11.1 million shares remain unsettled, which are expected to generate future gross proceeds of $949 million

  • Awarded a rating of A- from CDP, reflecting our comprehensive disclosure, awareness and management of environmental risks, and best practices associated with environmental leadership

Annual Highlights

  • SHO portfolio spot occupancy increased approximately 510 bps from the pandemic-low of 72.6% on March 12, 2021(1)

  • Completed $5.7 billion of pro rata gross investments during 2021

  • Formed 19 new and proprietary long-term growth relationships with best-in-class developers and operators that are expected to meaningfully contribute to capital deployment opportunities

  • Announced substantial exit of the operating relationship with Genesis Healthcare ("Genesis") through real estate transactions totaling $880 million in value, generating an 8.5% unlevered IRR over full term of Genesis relationship

  • Moody's Investors Services and S&P Global Ratings revised their ratings outlook for Welltower to Stable from Negative and affirmed Welltower's issuer credit ratings as 'Baa1' and 'BBB+', respectively

  • Appointed John F. Burkhart as Executive Vice President, Chief Operating Officer

  • Added 51 net new employees in 2021, with a focus on Business Insights, Development and Investments, representing a greater than 10% expansion in the Welltower team

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