On January 9, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported an update on its clinical development program for IGM-8444, a novel multivalent DR5 agonist, and announced plans for a new randomized combination trial in patients with metastatic colorectal cancer (Press release, IGM Biosciences, JAN 9, 2023, View Source [SID1234626064]).

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!

Initial Phase 1 data reported from a cohort of patients with combination treatment of IGM-8444 and FOLFIRI showed an encouraging safety profile which was broadly comparable to that expected from chemotherapy alone in this setting. Specifically, there was no drug related clinically significant hepatotoxicity, with only grade 1 and grade 2 transient liver enzyme elevations observed.

In patients with metastatic colorectal cancer, the combination of IGM-8444 and FOLFIRI showed promising activity, with multiple confirmed responses observed even in patients who had previously progressed on FOLFIRI. In 13 metastatic patients treated with doses of IGM-8444 from 1 to 10 mg/kg plus standard doses of FOLFIRI chemotherapy, there were four responses observed (three confirmed at 3mg/kg), and one additional patient had substantial tumor shrinkage allowing for subsequent complete surgical resection. Responses occurred in patients with KRAS wild type and mutated tumors and in patients with or without liver metastases. The majority of patients were on their third line of treatment or beyond and 10 of the 13 patients had previously been treated with FOLFIRI chemotherapy. Median progression free survival (PFS) among nine 3L+ patients was 5.5 months, with the longest observed PFS extending beyond 12 months. A more detailed presentation of the results is available on the Company’s website at www.igmbio.com.

Based on these results, the Company is initiating a randomized trial in second line patients with metastatic colorectal cancer to assess the additional benefit of IGM-8444 combined with the current standard of care regimen of FOLFIRI and bevacizumab. This open label trial is planned to begin in Q1 2023.

"We are very pleased with the initial results observed with IGM-8444," said Chris Takimoto, M.D., Ph.D., F.A.C.P., Chief Medical Officer of IGM Biosciences. "We are also quite pleased with the excellent safety profile seen in these patients. The absence of clinically significant hepatotoxicity, which has been challenging for DR5 agonists in the past, is particularly important. These responses, especially in patients who have previously failed chemotherapy, are very encouraging and give us confidence in proceeding to further clinical development with FOLFIRI and other combination agents. The planned randomized trial with FOLFIRI will expand our understanding of this activity and enable better understanding of the potential for IGM-8444 in patients with colorectal cancer."

"These initial IGM-8444 clinical results represent an important step in demonstrating the potential of our IgM antibody platform to overcome the long history of failure with conventional IgG antibodies targeting DR5," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We believe these results also help support the potential for IgM antibodies as agonists against the broader TNF receptor super family, and we look forward to accelerating our company-wide efforts to develop a new class of agonist antibody medicines, including through our collaboration with Sanofi."

About IGM-8444
IGM-8444 is an IgM antibody targeting Death Receptor 5 (DR5) that is being developed for the treatment of patients with solid and hematologic malignancies. DR5 is a member of the tumor necrosis factor receptor superfamily (TNFrSF) and is often expressed on the surface of cancer cells. Strong activation of the DR5 pathway requires multiple receptors to be cross-linked simultaneously by an antibody or other binding agent to create an apoptotic death signal to the cell. Unlike traditional IgG antibodies, IGM-8444 has 10 binding units, enabling it to cross-link multiple DR5 receptors at the same time, sending a stronger signal to cause cancer cell death.

On January 8, 2023, Ionis Pharmaceuticals, Inc. (the "Company") and its wholly-owned subsidiary, Akcea Therapeutics, Inc. (the "Subsidiary") reported to have entered into a royalty purchase agreement (the "Purchase Agreement") with Royalty Pharma Investments 2019 ICAV, an Irish collective asset-management vehicle ("Royalty Pharma"), pursuant to which the Company and the Subsidiary sold to Royalty Pharma (Filing, 8-K, Ionis Pharmaceuticals, JAN 9, 2023, View Source [SID1234626074]):

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!

(i) the Company’s right, title and interest in and to: (A) in respect of net sales by Biogen Idec International Holding Ltd ("Biogen Idec") and Biogen MA ("Biogen MA", and together with Biogen Idec, "Biogen") between January 1, 2023 and December 31, 2027, 25%, and (B) in respect of net sales by Biogen Idec commencing on January 1, 2028, 45% of the royalties payable to the Company on annual worldwide net sales up to $1,500,000,000 pursuant to that certain Development, Option and License Agreement by and between the Company and Biogen Idec dated January 3, 2012, as amended (the "2012 Biogen License") and that certain Research Collaboration, Option and License Agreement by and between the Company and Biogen MA dated December 19, 2017 (the "2017 Biogen License") (the "Purchased SMA Royalties"), subject to an overall cap of either $475,000,000 or $550,000,000, depending on the timing of FDA approval of Pelacarsen, or IONIS-APO(a)-LRx, as described in the Purchase Agreement; and

(ii) the Subsidiary’s right, title and interest in and to 25% of the royalties payable to the Subsidiary in respect of net sales by Novartis Pharma AG ("Novartis") pursuant to that certain Strategic Collaboration, Option and License Agreement by and between the Subsidiary and Novartis dated January 5, 2017, as amended (the "Novartis License") (the "Purchased Pelacarsen Royalties" and together with the Purchased SMA Royalties, the "Purchased Royalties").

In consideration for the sale of the Purchased Royalties, Royalty Pharma paid to the Company an initial purchase price of $500,000,000 and has agreed to pay the Company certain additional payments totaling up to $625,000,000, subject to the achievement of specified milestones set out in the Purchase Agreement.

Under the Purchase Agreement, and in connection with its sale of the Purchased Royalties, each of the Company and the Subsidiary has agreed to certain covenants with respect to the exercise of its rights under the 2012 Biogen License, 2017 Biogen License and Novartis License, including with respect to the Company and the Subsidiary’s right to amend, assign and terminate such agreements. The Company and Subsidiary will also provide certain additional payments to Royalty Pharma in the event the Company or the Subsidiary commercializes certain products directly competitive with Pelacarsen. The Purchase Agreement contains other customary terms and conditions, including representations and warranties, covenants and indemnification obligations in favor of each party.

The foregoing summary of the Purchase Agreement is not complete and is qualified in its entirety by reference to the complete text of the Purchase Agreement, which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2023.

On January 9, 2023 IO Biotech presented its corporate presentation (Presentation, IO Biotech, JAN 9, 2023, View Source [SID1234626073]).

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!

On January 9, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of fibrotic diseases, including non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic diseases, reported the receipt of $2.9 million in net proceeds from the sale of tax benefits pursuant to the Company’s participation in the New Jersey Economic Development Authority ("NJEDA") NOL program under the New Jersey Economic Recovery Act of 2020, and receipt of a C$416,415 (US$309,000) Alberta Innovation Employment Grant (Press release, Hepion Pharmaceuticals, JAN 9, 2023, View Source [SID1234626063]).

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!

NJEDA’s NOL program enables qualified, New Jersey-based technology or biotechnology companies to sell net operating losses to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development ("R&D") or other allowable expenditures.

Alberta’s Innovation Employment Grant program encourages economic growth by supporting small and medium-sized businesses that invest in R&D with a grant worth up to 20% of qualifying expenditures. The program promotes investment and diversification by rewarding all R&D spending in Alberta, Canada, regardless of the industry.

"We appreciate the support of both the State of New Jersey and the Province of Alberta to support innovation within their respective business communities," said Robert Foster, PharmD, PhD, Hepion’s CEO. "This non-dilutive funding adds to the approximate $59.1 million in cash we had as of the end of Q3-2022, further strengthening the Company’s balance sheet as we continue to advance rencofilstat, our lead oral drug candidate for the treatment of NASH and HCC."

On January 9, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported preliminary, unaudited results for the year ended December 31, 2022 (Press release, Guardant Health, JAN 9, 2023, View Source [SID1234626062]).

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!

Full year 2022 preliminary unaudited financial results

For the twelve-month period ended December 31, 2022, as compared to the same period of 2021:

Revenue of between $447 million and $450 million, an increase of 20%
Reported 124,800 tests to clinical customers and 26,000 tests to biopharma customers, an increase of 42% and 40%, respectively
Fourth quarter 2022 preliminary unaudited financial results

For the three-month period ended December 31, 2022, as compared to the same period of 2021:

Revenue of between $124 million and $127 million, an increase of between 15% and 17%
Reported 36,000 tests to clinical customers and 8,200 tests to biopharma customers, an increase of 41% and 24%, respectively
Cash, cash equivalents and marketable debt securities were $1.0 billion as of December 31, 2022.

"We are very pleased with the strong finish to 2022 that enabled us to post annual volume growth for both clinical and biopharma above 40%, and believe we are well positioned for continued strong double-digit revenue growth in 2023." said Helmy Eltoukhy, co-founder and co-CEO.

"During the fourth quarter we delivered on a long-term ambition with the positive readout of our ECLIPSE trial. We are thrilled with the strong and positive feedback expressed by guideline members, key opinion leaders, and patient advocacy leaders about the performance of the Shield test in the ECLIPSE trial," said AmirAli Talasaz, co-founder and co-CEO. "Fueled by this success, we will expand this test to many other cancer types, including lung cancer, the leading cause of death from cancer."

Guardant Health has not completed preparation of its financial statements for the fourth quarter or full year of 2022. The revenue ranges and test volumes presented in this release for the fourth quarter and the year ended December 31, 2022 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results. The company is in the process of completing its customary year-end close and review procedures as of and for the year ended December 31, 2022, and there can be no assurance that final results for this period will not differ from these estimates. During the course of the preparation of the Guardant Health’s consolidated financial statements and related notes as of and for the year ended December 31, 2022, the company’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Upcoming events

Guardant Health plans to report its fourth quarter and full year audited financial results for the period ended December 31, 2022 during its February 2023 earnings call.