On August 3, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported second quarter 2022 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, AUG 3, 2022, View Source [SID1234617378]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The continued momentum of ARCALYST in recurrent pericarditis in the second quarter of 2022 provides conviction in our full-year expectation for net revenue of between $115 to 130 million. Additionally, we believe the strong performance of ARCALYST since launch supports incremental investment to broaden our reach and help even more patients suffering from recurrent pericarditis," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "We are also focused on expanding our portfolio by leveraging our cross-functional cardiovascular expertise. These efforts will be enabled in part by the non-dilutive proceeds from our global license agreement with Genentech."

Corporate Update:

Today, Kiniksa announced a global license agreement with Roche and Genentech, a member of the Roche Group (Genentech), for the rights to develop and commercialize vixarelimab.
Kiniksa will receive upfront and near-term proceeds of $100 million. In addition, the company is eligible to receive up to approximately $600 million in certain development, regulatory, and sales-based milestones, before fulfilling upstream financial obligations, as well as royalties on annual net sales.
Kiniksa completed screening patients for the Phase 2b clinical trial of vixarelimab in prurigo nodularis and plans to complete the trial. The company will not disclose data in the second half of 2022.
Kiniksa plans to use the non-dilutive proceeds received from the transaction to advance synergistic cardiovascular opportunities.
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)

ARCALYST net revenue was $27.0 million for the second quarter of 2022.
More than 550 prescribers have written ARCALYST prescriptions for recurrent pericarditis since launch, with a growing number of repeat prescribers.
More than 90% payer approval rate of completed patient cases for recurrent pericarditis in the second quarter of 2022.
ARCALYST use in recurrent pericarditis to date indicates continuous treatment durations of approximately 12 months.
Kiniksa plans to evolve its sales operation with approximately 20 additional field sales representatives in the fourth quarter of 2022.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)

Kiniksa is conducting a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to evaluate the efficacy, dose response, pharmacokinetics, and safety of chronic subcutaneous dosing over 12 weeks.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

Kiniksa is evaluating the development of mavrilimumab in rare cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated and that have synergies with the company’s existing commercial infrastructure.
Financial Results

Total net revenue for ARCALYST product sales in the second quarter of 2022 was $27.0 million, compared to $7.7 million for the second quarter of 2021.
Total operating expenses for the second quarter of 2022 were $46.3 million, compared to $48.3 million for the second quarter of 2021.
Collaboration expense in the second quarter of 2022 was $3.7 million. Kiniksa did not report a collaboration expense in the second quarter of 2021.
Non-cash, share-based compensation expense for the second quarter of 2022 was $6.7 million, compared to $5.7 million for the second quarter of 2021.
Net loss for the second quarter of 2022 was $20.0 million, compared to a net loss of $41.6 million for the second quarter of 2021.
As of June 30, 2022, the company had $138.2 million of cash, cash equivalents, and short-term investments, and no debt.
Financial Guidance

Kiniksa continues to expect ARCALYST net revenue for the full-year 2022 to be between $115 million and $130 million.
Kiniksa expects that its cash and cash equivalents will fund its current operating plan into at least 2025 following the close of the vixarelimab global license agreement with Genentech.
Conference Call Information

Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Wednesday, August 3, 2022, to discuss second quarter 2022 financial results and to provide a corporate update.
Individuals interested in participating in the call should dial (800) 715-9871 (U.S. and Canada) or (646) 307-1963 (international) using conference ID number 1606846. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

On August 3, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported topline results that neither the primary endpoint of Overall Response Rate (ORR) nor the key secondary endpoint in Progression Free Survival (PFS) achieved statistical significance in the multi-center, international Phase III AGENT Study of arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, AUG 3, 2022, View Source [SID1234617377]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The information in the press release is intended for investors.

The AGENT Study is the first to evaluate a meaningful alternative to the standard of care for all patients with mCRC since 2004. In the AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care (leucovorin + 5-FU, oxaliplatin and bevacizumab).

"We are all surprised and disappointed in the results as we invested so much hope into improving the treatment for patients suffering mCRC. I would like to thank all the patients, clinical investigation sites and other participants that contributed to the study," said Ulf Jungnelius, CEO of Isofol. "We will complete the data analysis before confirming next steps and look forward to working with regulatory agencies to consider alternative paths forward. Decisions related to Isofol’s clinical program will be on hold until we’ve consulted with relevant regulatory bodies which is tentatively planned during the first half of 2023."

The AGENT Study will be completed in accordance with applicable regulations and the full data set will be published in order to enable the scientific community to fully take advantage of learnings. Sub-group analyses, gene expression and safety data is expected to be available in the final study report in Q4 2022. Pending results of further analyses, patients remaining on treatment in the experimental arm of the study will be offered to move to the standard of care treatment arm.

Audiocast, August 4, at 10:00 a.m. CEST
In connection to this announcement Isofol invites investors, analysts, and media to an audiocast with a Q&A-session. The presentation will be held in English by Isofol’s CEO Ulf Jungnelius and CMO Roger Tell and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the audiocast. No preregistration is needed.

This is information that Isofol Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 15:30 CEST on August 3, 2022.

About the AGENT Study
The Phase III AGENT Study is the first to evaluate a meaningful alternative to the standard of care for most patients with metastatic colorectal cancer (mCRC) in 20 years and involves approximately 90 clinics in the U.S., Canada, Europe, Australia, and Japan. The Phase III randomized, controlled, multi-center study of 490 patients assessed the efficacy and safety of arfolitixorin, [6R]-5,10 methylene-THF (MTHF), compared to leucovorin, both used in combination with 5-U, oxaliplatin, and bevacizumab, in first line mCRC patients.

The study was designed to show superiority for arfolitixorin over leucovorin. Patients were randomized in a 1:1 ratio with the primary endpoint being an overall response rate (ORR) >10 percent improvement vs. the control arm. The key secondary endpoint is a clinically meaningful positive trend in progression free survival (PFS). Other secondary endpoints include duration of response (DOR), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells.

On August 3, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, reported that it will report second quarter earnings, before the US markets open on Wednesday, August 10, 2022 (Press release, Immunocore, AUG 3, 2022, View Source [SID1234617376]). Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) to discuss their financial results and provide a business and portfolio update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Audio webcast
The call will be made available via webcast by visiting the Events & Presentations section on Immunocore’s website. A replay of this webcast will be available for 90 days.

On August 3, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that Hugh Young Rienhoff, Jr., MD, CEO of Imago BioSciences, will participate in an analyst led Fireside Chat at the 2022 Wedbush PacGrow Healthcare Conference on August 10, 2022, at 1:10 pm Eastern Time / 10:10 am Pacific Time (Press release, Imago BioSciences, AUG 3, 2022, View Source [SID1234617375]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Interested parties can access the live webcast of the Fireside Chat by visiting the Investor Relations section of the company’s website at ir.imagobio.com. A webcast replay will be available after the conclusion of the event for approximately 90 days.

On August 3, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following (Press release, Greenwich LifeSciences, AUG 3, 2022, View Source [SID1234617374]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As previously disclosed, clinical trial contracts and budgets have been executed at multiple hospitals and the largest oncology network in the US. Clinical site initiation visits to train clinicians, nurses, coordinators, and pharmacists are underway, after which sites will be activated and the Flamingo-01 Phase III clinical trial will commence. We continue to actively recruit and prepare additional US clinical sites.
The Company is continuing to make progress to initiate clinical sites in Europe through oncology networks, potentially including networks in Germany, Spain, and France.
Following site activation, patients will be screened, tested for HLA type, randomized, and enrolled into any of 3 clinical trial arms, and treatment of the first patients will begin. Certain aspects of each arm will be open label, and the 3rd arm exploring HLA types that are not HLA-A02 will be entirely open label.
Patients who are interested in participating in the trial can contact the Company by email at [email protected] and can keep up to date with the progress of the trial or can obtain clinical site contact information to contact sites directly on clinicaltrials.gov with identifier NCT05232916 (view here).
Pharmacy process testing is nearing completion, which is anticipated to be the final testing required to commence Flamingo-01 and to start treating patients.
Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "Our team has been very busy preparing for, scheduling, and conducting clinical site initiations. We have begun shipping clinical trial supplies to sites. All plans, procedures, and electronic systems are in place to allow the clinical trial to commence. We are excited to be at this stage in study start-up with Flamingo-01."

CEO Snehal Patel commented, "With our previously disclosed financial strategy, including our cash position, which should fund us through the coming years, and our ATM with one of the leading biotech investment banks, we are poised to opportunistically use the ATM at our discretion. To date, we have not used the ATM."

Mr. Patel further added, "We look forward to commencing Flamingo-01, to sharing more information about the clinical sites, key opinion leaders, clinical networks, and countries participating in the Phase III trial, and to publishing the open label Phase III data during the trial. Initial Phase III data could be available before the end of this year. We anticipate dovetailing our use of the ATM with these major milestones and validating events as we compare the Phase III trial progress to our Phase IIb trial results. Our goal is to reproduce the Phase IIb clinical trial results, which showed no metastatic breast cancer recurrences in patients treated with GLSI-100 over 5 years of follow-up, if the patients were treated, followed, and remained disease free over the first 6 months."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently registered on clinicaltrials.gov and can be seen here. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.