Zorginstituut Advises 5% Price Reduction for Yescarta Following Reassessment of Survival Data

On July 28, 2021 EVERSANA reported After reassessing Gilead/Kite’s CAR-T therapy Yescarta (axicabtagene ciloleucel) following the collection of three-year survival data, the Zorginstituut (ZIN) has determined the treatment to be effective but necessitating a 5% price cut, as its budget impact will most likely exceed €44.9 million (Press release, EVERSANA, JUL 28, 2021, View Source [SID1234585280]).

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In the Netherlands, Yescarta is cleared for use in the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

Yescarta was initially placed in the lock for expensive medicines but following price negotiations between the Minister for Medical Care and the manufacture, the CAR-T therapy secured reimbursement through the basic care package from May 1, 2020 until December 1, 2021. However, Gilead/Kite’s CAR-T was made available only to patients with high disease burden because there is no other effective treatment available for this subgroup.

Amidst price negotiations, ZIN recommended Yescarta be made available to patients, considering the curative property of the therapy. Initially, ZIN recommended against inclusion of Yescarta in the basic care package unless a price reduction could be agreed; by how much was indeterminable at the time. Due to uncertainty in the long-term efficacy of Yescarta, ZIN advised a "pay for performance" agreement for the therapy and agreed to follow up on its decision by 2022.

The long-term efficacy of the CAR-T therapy has since been monitored, with three-year survival data now available. As such, ZIN concluded that Yescarta "meets the state of science and practice after a median follow-up time of 51 months," meaning that the drug is effective. Given the potential for Yescarta to have actual budget impact exceeding €44.9 million, ZIN called for a price reduction of 5%.

Eagle Pharmaceuticals to Host Second Quarter 2021 Financial Results on August 9, 2021

On July 28, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2021 second quarter financial results on Monday, August 9, 2021, before the market opens (Press release, Eagle Pharmaceuticals, JUL 28, 2021, View Source [SID1234585278]).

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Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will host a conference call to discuss the results as follows:

A replay of the conference call will be available for one week after the call’s completion by dialing 888-562-2815 (US) or 402-220-7352 (International) and entering conference call ID EGRXQ221. The webcast will be archived for 30 days at the aforementioned URL.

CorMedix Inc. to Report Second Quarter 2021 Financial Results and Provide a Corporate Update on August 12

On July 28, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it will report its financial results for the second quarter ended June 30, 2021, after the market close on Thursday, August 12, 2021, and will host a corporate update conference call at 4:30pm Eastern Time (Press release, CorMedix, JUL 28, 2021, View Source [SID1234585277]).

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Compugen Reports Second Quarter 2021 Results

On July 28, 2021 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the second quarter ended June 30, 2021 (Press release, Compugen, JUL 28, 2021, View Source [SID1234585276]).

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"Our continued execution in the clinic, which includes the recent initiation of three clinical studies, further strengthens Compugen’s leadership position in the DNAM axis space," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "These new studies expand our comprehensive evaluation of the DNAM axis and leave us uniquely positioned as the only company, in a clinical setting, evaluating anti-PVRIG, anti-TIGIT and anti-PD-1 combinations, which is our key differentiator in the TIGIT space. We expect the remainder of the year to include data readouts from our triple combination study in collaboration with Bristol Myers Squibb and COM902 monotherapy study, which we expect to expand the foundation of our clinical data generated to date."

Dr. Cohen-Dayag continued, "The updated data from our COM701 Phase 1 combination and monotherapy studies presented at ASCO (Free ASCO Whitepaper) support our continued excitement in our science and potential benefit it may bring to patients, showing durable responses and disease control in patients not eligible for or typically not responding to checkpoint inhibitors including those with prior progression. In addition, we shared our first preliminary pharmacodynamic biomarker data indicating that treatment with COM701 leads to immune activation and has the potential to drive anti-tumor activity in non-inflamed tumors as evidenced by activity in selected PD-L1 low, PVRL2 positive patients. Our combination strategy around our wholly owned assets targeting PVRIG and TIGIT give us a strong first mover advantage, and we look forward to continued progress through 2021 as we work to elucidate the potential of the DNAM axis pathways in immunotherapy."

Recent and Second Quarter 2021 Corporate Highlights

Presented updated data from the COM701 monotherapy and combination with Opdivo (nivolumab) studies at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting including:
– Durable responses beyond one year, including one complete response, in tumor types typically unresponsive to checkpoint inhibitors
– Preliminary biomarker data reveal immune activation evidenced by a trend of increased proliferation of peripheral immune cells and IFNγ. IFNγ increased with increasing doses of COM701, suggesting the observed activity is likely derived from the combination treatment and not Opdivo alone
– Preliminary anti-tumor activity in PD-L1 low, PVRL2 positive patients, with non-inflamed tumor microenvironment/immune desert phenotype
Dosed the first patient in the Phase 1b cohort expansion study of COM701 in combination with Opdivo in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers
Dosed the first patient in the Phase 1 dual combination study of COM902 and COM701 in patients with advanced malignancies, the first clinical study of dual blockade of TIGIT and PVRIG independent of anti-PD-1
Dosed the first patient in the Phase 1/2 triple combination cohort expansion of COM701 with Opdivo and Bristol Myers Squibb’s anti-TIGIT antibody, BMS-986207
Presented research at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Targets for Cancer Immunotherapy: A Deep Dive Seminar Series, supporting PVRIG as a novel and differentiated checkpoint in the DNAM axis
Financial Results

R&D expenses for the second quarter ended June 30, 2021, were $6.8 million compared with $4.4 million for the comparable period in 2020. The increase in R&D expenses reflects the strong execution and expansion of the Phase 1 clinical programs.

General and administrative expenses for the second quarter ended June 30, 2021, were $2.7 million compared with $2.1 million for the comparable period in 2020. The increase in expenses is attributed mainly to corporate related expenses.

Net loss for the second quarter of 2021 was $9.5 million, or $0.11 per basic and diluted share, compared with a net loss of $6.2 million, or $0.08 per basic and diluted share, in the comparable period of 2020.

As of June 30, 2021, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $111 million, compared with approximately $124 million on December 31, 2020. The Company has no debt.

Conference Call and Webcast Information

The Company will hold a conference call today, July 28, 2021, at 8:30 AM ET to review its second quarter 2021 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

Cytocom Inc. Announces Completed Merger with Cleveland BioLabs

On July 28, 2021 Cytocom Inc. ("Cytocom" or "Company"), a leading biopharmaceutical company creating next-generation therapies that focus on immune homeostasis, reported the completion of its merger with Cleveland BioLabs, Inc (Press release, Cleveland BioLabs, JUL 28, 2021, View Source [SID1234585275]). The all-stock transaction was first announced on October 19, 2020.

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Shares of the new Cytocom’s common stock will begin trading on Nasdaq under the ticker symbol "CBLI," at the opening bell on Wednesday, July 28, 2021.

As previously reported, the newly combined company will operate as "Cytocom, Inc." under the leadership of the existing Cytocom management team led by CEO Michael K. Handley. Mr. Handley now serves as the new company’s President and CEO.

"With the merger completed, we look forward to further advancing our late-stage clinical programs and expanding what we believe to be one of the largest toll-like receptor platforms in the industry," said Michael K. Handley. "This merger, coupled with our acquisition of ImQuest Life Sciences and the listing of the new Cytocom common shares on Nasdaq, represents a transformative growth opportunity and fits firmly with our goal of becoming a recognized leader in immune-modulating therapies targeting cancer, ARS, inflammatory and autoimmune diseases, and viruses, including COVID-19. Looking forward, we anticipate achieving multiple commercial, regulatory and clinical milestones over the next 12 to 18 months that should enable us to showcase the power of our drug development platform and further generate shareholder value."

McGuireWoods LLP represented Cleveland BioLabs and Troutman Pepper Hamilton Sanders LLP represented Cytocom in the merger.