On August 11, 2022 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported that financial results for the quarter ending June 30, 2022 (Press release, IO Biotech, AUG 11, 2022, View Source [SID1234618216]).

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!

"We continue to advance our promising pipeline of novel cancer immunotherapies following clinical trial milestones achieved in the first half of the year," said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. "During the quarter we were pleased to announce the initiation and dosing of first patients our Phase 3 global combination trial of IOB102-103 with pembrolizumab as a potential first line treatment in advanced melanoma. We look forward to enrolling patients across the U.S., Australia and Europe. We will provide an update on the anticipated timing of the interim data once we have sufficient information. During the quarter, we also announced the initiation and dosing of the first patient in our Phase 2 basket trial of IO102-IO103 in combination with pembrolizumab. We expect to receive preliminary data in one indication in the second half of 2022, and additional data in 2023.

"In June, we shared two poster presentations highlighting clinical trials in progress with IO102-IO103 in combination with pembrolizumab in metastatic solid tumors and in untreated, unresectable or metastatic melanoma at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting. We are excited to build on the promising clinical activity seen from our previous Phase 1/2 clinical trial evaluating IO102-IO103 in metastatic melanoma as we believe that our T-win platform―and its novel approach to activate naturally occurring T cells to target immunosuppressive mechanisms―has the potential to benefit patients in need of more treatment options. With a solid balance sheet and substantial cash runway to carry us through multiple expected data readouts into mid-2024, we look forward to sharing further progress in the coming months."

Highlights for Second Quarter 2022 and Recent Weeks

Announced initiation and dosing of the first patient in the Phase 3 IOB-013/KN-D18 trial of IO102-IO103 and KEYTRUDA (pembrolizumab) as first-line treatment in advanced melanoma (NCT05155254);
Announced initiation and dosing of the first patient in the Phase 2 IOB-022/KN-D38 basket trial in solid tumors (NCT05077709) in April 2022;
Announced the presentation of two posters highlighting clinical trials in progress with IO102-IO103 as an investigational agent in combination with pembrolizumab in metastatic solid tumors and in untreated, unresectable or metastatic melanoma at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Hosted Part 1 of Key Opinion Leader Webinar Series: A New Way to Kill Tumors–IO102-IO103 Phase 3 Trial in Combination with Anti-PD-1 in Advanced Melanoma
New data from MM1636 Phase 1/2 clinical trial presented at 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Three-year overall survival probability of 73%
Subgroup analyses including patients with poor prognosis
Second Quarter Financial Results

Net loss for the three months ended June 30, 2022 was $18.5 million, compared to $38.4 million for the quarter ended June 30, 2021.
Research and development expenses were $12.2 million for the three months ended June 30, 2022, compared to $6.7 million for the three months ended June 30, 2021. The increase of $5.5 million was primarily related to an increase in preclinical studies and clinical trial-related activities for our IO102-IO103 product candidate, including the initiation of our Phase 3 clinical trial, of $2.6 million, an increase in costs for chemistry, manufacturing and control, activities of $0.5 million, and an increase in personnel costs of $2.1 million primarily related to an increase in headcount and related recruiting costs.
General and administrative expenses were $5.9 million for the three months ended June 30, 2022, compared to $2.2 million for the three months ended June 30, 2021. The increase of $3.7 million was primarily related to an increase in personnel costs of $1.5 million primarily related to an increase in headcount and related recruiting costs and an increase in consultants and other costs of $2.7 million, partially offset by a decrease in professional services of $0.5 million related primarily to corporate legal fees and audit and tax fees.
Other expense was a net expense of $0.2 million for the three months ended June 30, 2022 compared to a net expense of $29.4 million for the three months ended June 30, 2021. The increase of $29.2 million was mainly due to fair-value adjustments on preferred stock tranche obligations were losses of $29.4 million for the three months ended June 30, 2021.
Cash and cash equivalents at June 30, 2022 were $170.1 million, compared to $211.5 million at December 31, 2021. Cash on hand is expected to support operations through anticipated data readouts into mid-2024.
About the IOB-013/KN-D18 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment will be 300 patients from centers spread across Europe, Australia, and the United States. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IOB-022/KN-D38

IOB-022/KN-D38 is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line indications: NSCLC, SCCHN, and mUBC. The clinical trial will be sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.

About IO102-IO103

IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.