On August 2, 2022 Fresenius reported financial results for the second quarter and first half of 2022 in line with preliminary results (Press release, Fresenius, AUG 2, 2022, View Source [SID1234617236])

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FY/22 Group guidance revised
Fresenius Medical Care’s financial performance in Q2/22 was significantly impacted by worsened labor shortages and related meaningfully increased wage inflation in the U.S. The further deterioration of the macro-economic environment resulted in accelerated non-wage inflation, particularly higher supply chain costs.
Against this backdrop and growing indications for a persistent unfavorable development of these and other factors, Fresenius Medical Care has revised its outlook for FY/22.

All other Fresenius Group segments confirm their respective outlook for FY/22 for both revenue and EBIT.

However, as a consequence of the development at Fresenius Medical Care, and despite all other Fresenius Group segments confirming their respective outlook for both revenue and EBIT, Fresenius now also revises its Group outlook for FY/22. As announced on July 27, 2022, at constant currency, the Company now anticipates Group sales1 to grow in a low-to-mid single-digit percentage range (previously: mid-single digit percentage range) and Group net income2,3 to decline in a low-to-mid single-digit percentage range (previously: increase in a low-single-digit percentage range).

Without the already closed acquisitions of Ivenix and the already completed acquisition of a majority stake in mAbxience as well as any further potential acquisitions, Fresenius expects the net debt/EBITDA4 ratio (December 31, 2021: 3.51×5) to be slightly above the top end of the self-imposed target corridor of 3.0x to 3.5x by the end of 2022.

1 FY/21 base: €37,520 million
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/21 base: €1,867 million; before special items; FY/22: before special items
4 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; excluding further potential acquisitions; before special items; including lease liabilities
5 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; before special items; including lease liabilities

For a detailed overview of special items please see the reconciliation tables on pages 21-24 in the PDF.

Assumptions for guidance FY/22
Due to the meaningfully increased uncertainty and volatility related to the war in Ukraine, the ongoing impacts of the COVID-19 pandemic, and a rapidly worsening global macro-economic development, Fresenius now expects significantly more pronounced headwinds in 2022 from supply chain disruptions and cost inflation, including energy prices. Furthermore, Fresenius expects significant negative effects from ongoing labor shortages and associated wage inflation, especially at Fresenius Medical Care in the U.S.

The war in Ukraine is directly and indirectly affecting Fresenius Group operations. The direct adverse effects of the war amounted to €20 million at net income level of Fresenius Group in H1/22 and are treated as a special item. Fresenius will continue to closely monitor the potential further consequences of the war, including balance sheet valuations. The guidance does not consider a significant disruption of gas or electricity supplies in Europe.
COVID-19 will continue to impact Fresenius Group operations in 2022. An unlikely but possible significant deterioration of the situation triggering containment measures that could have a significant and direct impact on the health care sector without any appropriate compensation is not reflected in the Group’s FY/22 guidance.
Furthermore, the updated assumptions for Fresenius Medical Care’s FY/22 guidance are also fully applicable to Fresenius Group’s FY/22 guidance. All of these assumptions are subject to considerable uncertainty. The acquisitions of Ivenix and of the majority stake in mAbxience as well as any further potential acquisitions remain excluded from guidance.

Group medium-term targets
As a result of the updated expectations for FY/22, Fresenius now believes its medium-term net income1 target is no longer achievable. Fresenius had expected Group organic net income1 growth to be at the bottom end of the 5% to 9% compounded annual growth rate (CAGR) range for 2020 to 2023. At the same time, Fresenius specifies its Group organic sales growth target to reach the low-end of the targeted 4% to 7% compounded annual growth rate (CAGR) range for 2020 to 2023.

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA

Cost and efficiency program
The Group’s cost and efficiency program is running according to plan and Fresenius confirms its increased savings targets provided in February 2022 of at least €150 million p.a. after tax and minority interest in 2023. For the years thereafter, a further significant increase in sustainable cost savings is expected.

Management Board change at Fresenius Medical Care
Dr. Carla Kriwet will now join Fresenius Medical Care as CEO on October 1, 2022, earlier than previously announced and Rice Powell will step down as CEO effective September 30, 2022.

3% sales increase in constant currency
Group sales increased by 8% (3% in constant currency) to €10,018 million (Q2/21: €9,246 million). Organic growth was 2%. Acquisitions/divestitures contributed net 1% to growth. Currency translation increased sales growth by 5%. Excluding estimated COVID-19 effects , Group sales growth would have been 2% to 3% in constant currency (Q2/21: 6% to 7%).

In H1/22, Group sales increased by 8% (4% in constant currency) to €19,738 million (H1/21: €18,230 million). Organic growth was 3%. Acquisitions/divestitures contributed net 1% to growth. Currency translation increased sales growth by 4%. Excluding estimated COVID-19 effects1, Group sales growth would have been 4% to 5% in constant currency (H1/21: 5% to 6%).

9% net income2,3,4 decline in constant currency
Group EBITDA before special items remained stable (-6% in constant currency) at €1,682 million (Q2/212: €1,674 million). Reported Group EBITDA was €1,528 million (Q2/21: €1,662 million).

In H1/22, Group EBITDA before special items increased by 1% (-4% in constant currency) to €3,344 million (H1/212: €3,305 million). Reported Group EBITDA was €3,123 million (H1/21: €3,290 million).

Group EBIT before special items decreased by 3% (-9% in constant currency) to €1,003 million (Q2/212: €1,033 million). The decrease was mainly driven by worsened labor shortages and related meaningfully increased wage inflation at Fresenius Medical Care in the U.S. as well as elevated material and logistic costs. The EBIT margin before special items was 10.0% (Q2/212: 11.2%). Reported Group EBIT was €845 million (Q2/21: €1,021 million).

In H1/22, Group EBIT before special items decreased by 2% (-7% in constant currency) to €2,003 million (H1/212: €2,042 million). The EBIT margin before special items was 10.1% (H1/212: 11.2%). Reported Group EBIT was €1,747 million (H1/21: €2,027 million).

1 For estimated COVID-19 effects please see table on page 19.
2 Before special items
3 Net income attributable to shareholders of Fresenius SE & Co. KGaA
4 Excluding Ivenix acquisition

For a detailed overview of special items please see the reconciliation tables on pages 21-24 in the PDF.

Group net interest before special items improved to -€116 million (Q2/21: -€121 million) mainly due to positive one-time effects despite an increased interest rate environment. Reported Group net interest also improved to -€116 million (Q2/21: -€121 million). In H1/22, Group net interest before special items improved to -€235 million (H1/211: -€258 million). Reported Group net interest also improved to -€234 million (H1/21: -€258 million).

Group tax rate before special items was 23.0% (Q2/211: 21.5%) while the reported Group tax rate was 22.6% (Q2/21: 21.3%). In H1/22, Group tax rate2 before special items was 22.9% (H1/211: 22.1%) while the reported Group tax rate was 23.1% (H1/2021: 22.0%).

Noncontrolling interests before special items were -€233 million (Q2/211: -€241 million) of which 90% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were -€181 million (Q2/21: -€237 million). In H1/22, Noncontrolling interests2 before special items were -€451 million (H1/211: -€478 million) of which 89% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were -€367 million (H1/21: -€473 million).

Group net income3 before special items decreased by 5% (-9%4 in constant currency) to €450 million (Q2/211: €475 million). The decrease was mainly driven by worsened labor shortages and related meaningfully increased wage inflation at Fresenius Medical Care in the U.S. as well as elevated material and logistic costs. Excluding estimated COVID-19 effects5, Group net income3 before special items was -16% to -12% in constant currency (Q2/21: 10% to 14%). Reported Group net income3 decreased to €383 million (Q2/21: €471 million).

In H1/22, Group net income2,3 before special items remained stable (-3%4 in constant currency) at €913 million (H1/211: €911 million). Excluding estimated COVID-19 effects5, Group net income3 before special items was -10% to -6% in constant currency (H1/21: 4% to 8%). Reported Group net income3 decreased to €796 million (H1/21: €906 million).

1 Before special items
2 Q1/22 restated following remeasurement Humacyte investment
3 Net income attributable to shareholders of Fresenius SE & Co. KGaA
4 Excluding Ivenix acquisition
5 For estimated COVID-19 effects please see table on page 19

For a detailed overview of special items please see the reconciliation tables on pages 21-24 in the PDF.

Earnings per share1 before special items decreased by 6% (-11% in constant currency) to €0.80 (Q2/21 : €0.85). Reported earnings per share1 were €0.68 (Q2/21: €0.84). In H1/22, earnings per share1,3 before special items remained stable (-4% in constant currency) at €1.63 (H1/212: €1.63). Reported earnings per share1 were €1.42 (H1/21: €1.62).

Continued investment in growth
Spending on property, plant and equipment was €419 million corresponding to 4% of sales (Q2/21: €509 million; 6% of sales). These investments served primarily for the modernization and expansion of dialysis clinics, production facilities as well as hospitals and day clinics. In H1/22, spending on property, plant and equipment was €757 million corresponding to 4% of sales (H1/21: €893 million; 5% of sales).

Total acquisition spending was €291 million (Q2/21: €491 million), mainly for the acquisition of Ivenix by Fresenius Kabi and dialysis clinics at Fresenius Medical Care. In H1/22, total acquisition spending was €453 million (H1/21: €640 million).

Cash flow development
Group operating cash flow decreased to €1,017 million (Q2/21: €1,451 million) with a margin of 10.2% (Q2/21: 15.7%), mainly driven by working capital build-up from higher raw material inventories and receivables, among others, as well as phasing effects. Free cash flow before acquisitions and dividends decreased to €581 million (Q2/21: €952 million). Free cash flow after acquisitions and dividends decreased to -€391 million (Q2/21: -€359 million).

In H1/22, Group operating cash flow decreased to €1,118 million (H1/21: €2,103 million) with a margin of 5.7% (H1/21: 11.5%). Free cash flow before acquisitions and dividends decreased to €326 million (H1/21: €1,193 million). Free cash flow after acquisitions and dividends decreased to -€794 million (H1/21: -€242 million).

Solid balance sheet structure
Group total assets increased by 6% (1% in constant currency) to €76,112 million (Dec. 31, 2021: €71,962 million) given currency translation effects and the expansion of business activities. Current assets increased by 8% (4% in constant currency) to €18,818 million (Dec. 31, 2021: €17,461 million), mainly driven by the increase of trade accounts receivables. Non-current assets increased by 5% (1% in constant currency) to €57,294 million (Dec. 31, 2021: €54,501 million).

Total shareholders’ equity increased by 9% (3% in constant currency) to €32,033 million (Dec. 31, 2021: €29,288 million). The equity ratio was 42.1% (Dec. 31, 2021: 40.7%).

Group debt increased by 4% (2% in constant currency) at €28,368 million (Dec. 31, 2021: € 27,155 million). Group net debt increased by 8% (5% in constant currency) to € 26,239 million (Dec. 31, 2021: € 24,391 million).

As of June 30, 2022, the net debt/EBITDA ratio increased to 3.72×1,2 (Dec. 31, 2021: 3.51×1,2) mainly driven by dividend payments, lower EBITDA contribution as well as acquisition spending. The net debt/EBITDA as of June 30, 2022 excluding the already closed acquisition of Ivenix was 3.681,2.

1 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures
2 Before special items

For a detailed overview of special items please see the reconciliation tables on pages 21-24 in the PDF.

Business Segments

Fresenius Medical Care (Financial data according to Fresenius Medical Care press release)
Fresenius Medical Care is the world’s largest provider of products and services for individuals with renal diseases. As of June 30, 2022, Fresenius Medical Care was treating 345,687 patients in 4,163 dialysis clinics. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care.

Business development impacted by unprecedented U.S. labor market situation and worsening macroeconomic environment driving cost inflation and supply chain disruptions
Meaningful decline in COVID-19-related excess mortality
Solid support by positive exchange rates
Sales increased by 10% (1% in constant currency) to €4,757 million (Q2/21: €4,320 million). Organic growth was 0%. Currency translation increased sales growth by 9%. In H1/22, sales increased by 9% (2% in constant currency) to €9,305 million (H1/21: €8,530 million). Organic growth was 1%. Currency translation increased sales growth by 7%.

EBIT decreased by 20% (-27% in constant currency) to €341 million (Q2/21: €424 million) resulting in a margin of 7.2% (Q2/21: 9.8%). EBIT before special items, i.e., costs incurred for FME25, the impacts related to the war in Ukraine, the impact of hyperinflation in Turkey and the remeasurement effect on the fair value of the investment in Humacyte, Inc. increased by 3% (-6% in constant currency) to €445 million (Q2/21: €433 million), resulting in a margin1 of 9.4% (Q2/21: 10.0%). At constant currency, the decline was mainly due to higher labor costs as well as inflationary and supply chain cost increases. This was partially offset by Provider Relief Funding received from the U.S. government to compensate for certain COVID-19-related costs.

1 Before special items
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA

For a detailed overview of special items please see the reconciliation tables on pages 21-24 in the PDF.

In H1/22, EBIT decreased by 23% (-29% in constant currency) to €688 million (H1/21: €898 million) resulting in a margin of 7.4% (H1/21: 10.5%). EBIT before special items decreased by 6% (-13% in constant currency) to €852 million (H1/21: €910 million), resulting in a margin of 9.2% (H1/21: 10.7%).

Net income2 decreased by 33% (-39% in constant currency) to €147 million (Q2/21: €219 million). Net income2 before special items remained stable (-7% in constant currency) at €225 million (Q2/21: €225 million) mainly due to the mentioned negative effects on operating income.

In H1/22, net income2 decreased by 35% (-39% in constant currency) to €305 million (H1/21: €468 million). Net income2 before special items decreased by 10%
(-15% in constant currency) to €428 million (H1/21: €476 million).

Operating cash flow was €751 million (Q2/21: €921 million) with a margin of 15.8% (Q2/21: 21.3%). The decrease was mainly due to an unfavorable development of days sales outstanding as well as a decrease in net income2, partially offset by U.S. government relief funding. In H1/22, operating cash flow was €910 million (H1/21: €1,129 million) with a margin of 9.8% (H1/21: 13.2%).

As announced on July 27, 2022, Fresenius Medical Care expects revenue to grow at a low single digit percentage rate and net income2, to decline at around a high teens percentage range. Revenue and net income guidance are both on a constant currency basis and before special items .

Given the uncertain labor situation and macro-economic inflationary environment and the substantially reduced earnings base compared to 2020, Fresenius Medical Care does not expect today to be able to achieve the meaningfully higher compounded annual average increases that would now be needed to accomplish its 2025 targets. Against this background, Fresenius Medical Care has cut its financial targets for FY 2022 and withdrawn its 2025 targets.

On August 2, 2022 Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, reported that City of Hope has received U.S. Food and Drug Administration (FDA) authorization to proceed with a phase 1 physician-sponsored clinical trial that will use Calidi’s licensed oncolytic virotherapy platform, NSC-CRAd-S-pk7 (NeuroNova), a cutting-edge therapeutic candidate comprising tumor-tropic neural stem cells delivering an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma (Calidi’s NNV-2 program) (Press release, Calidi Biotherapeutics, AUG 2, 2022, View Source [SID1234617260]).

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The phase 1 physician-sponsored clinical trial will be an open-label, non-randomized, multicenter study. Once the phase 1 trial is funded, it will address the safety and tolerability of administering serial doses of NeuroNova in adult patients with recurrent histologically confirmed high-grade gliomas (WHO grade III or IV). Secondary endpoints will evaluate treatment efficacy, including progression-free and overall survival as well as any immune response to NeuroNova. This physician-sponsored study will be led by principal investigator Jana Portnow, M.D., Professor in City of Hope’s Department of Medical Oncology & Therapeutics Research and Co-Director of the Brain Tumor Program at City of Hope, a National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network. City of Hope is one of the largest cancer research and treatment organizations in the United States.

A previously completed phase 1 dose escalation clinical trial, in newly diagnosed glioma patients, of a single dose of NSC-CRAd-S-pk7 (NeuroNova) given as an adjunct to radiation and temozolomide (Calidi’s NNV-1 program) demonstrated that NeuroNova was well tolerated in the patient population and showed promising preliminary results of efficacy [J Fares et al, Lancet Oncology, 2021, 22(8):1103-1114].

"Worldwide, an estimated 270,000 people were diagnosed with a primary brain tumor in 2020, with a five-year survival rate of only 5%. Recurrent glioma patients have poor prognosis with a median survival of less than one year. Developing our drug candidate for this indication represents a significant milestone that will empower us to help more individuals survive this devastating disease," said Calidi Biotherapeutics CEO and Chairman of the Board Allan J. Camaisa. "As Calidi undertakes this endeavor, we are pleased to have exclusive commercialization rights to this technology and thrilled to collaborate with two scientific trailblazers who have worked together on this project for over a decade: Dr. Karen Aboody, Professor in the Department of Stem Cell Biology and Regenerative Medicine, Scientific Leader of the Neuro-oncology Disease Team at City of Hope, and Dr. Maciej (Matt) Lesniak, Chair of the Department of Neurological Surgery, at Northwestern University Feinberg School of Medicine."

"Our team at City of Hope is excited to be a part of the development of NeuroNova. Despite their potential, the first-generation oncolytic virus therapies given as free virus were not very effective — most likely due to rapid inactivation by the patient’s immune system. Our new platform uses stem cells like a ‘Trojan horse’ to shield the oncolytic viral particles from immune inactivation and deliver them to the tumor sites. This results in significantly more virus distributed at the tumor sites, inducing a greater self-amplifying anti-tumor response. This may also result in a secondary anti-tumor immune response," said City of Hope’s Dr. Karen Aboody.
"In addition to significant experience with this technology, City of Hope has a proven track record in GMP manufacturing of cell and gene therapy agents."

About NeuroNova
The NeuroNova platform, NSC-CRAd-S-pk7, is an allogeneic, "off-the-shelf" therapy comprised of an immortalized Neural Stem Cell (NSC) line loaded with an engineered oncolytic adenovirus. Upon surgical resection of a tumor, NSC-CRAd-S-pk7 is injected into the walls of the resection cavity, resulting in viral infection and destruction of any remaining tumor cells. Calidi holds an exclusive worldwide licensing agreement for patents covering the NSC-CRAd-S-pk7 technology.

On August 2, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it will report second quarter 2022 financial results after the U.S. financial markets close on Tuesday, August 9, 2022 (Press release, Oncternal Therapeutics, AUG 2, 2022, View Source [SID1234617276]). Oncternal’s management will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to provide a comprehensive business update and discuss the Company’s financial results.

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The live webcast of the call will be available online at investor.oncternal.com and the call will be archived there for at least 30 days.

On August 2, 2022 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported that Michel Detheux, PhD, President and Chief Executive Officer, will participate in a panel discussion at the upcoming 2022 Wedbush PacGrow Healthcare Conference titled: "IOs Wide Open – Opportunities and Challenges in Immuno-Oncology" on Tuesday, August 9, 2022 at 8:00 a.m. ET (Press release, iTeos Therapeutics, AUG 2, 2022, View Source [SID1234617292]).

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A live webcast of the events will be available on the Investors section of the company’s website at View Source An archived replay will be available for approximately 30 days following the presentation.

On August 2, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the first patient has been dosed in the Phase I PROBE-CN trial to evaluate ATG-101 as a monotherapy in patients with advanced/metastatic solid tumors or B-cell non-Hodgkin lymphoma (B-NHL) in China (Press release, Antengene, AUG 2, 2022, View Source [SID1234617308]).

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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

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Shanghai East Hospital of Tongji University is the lead site for the study, which will be conducted at four centers across China. This open-label, multicenter Phase I study is designed to assess the safety and tolerability of intravenously administered ATG-101 monotherapy in patients with advanced/metastatic solid tumors and B-NHL. The study will be conducted in two parts (dose-escalation and a dose-expansion).

ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.

"Since many patients with advanced cancer are resistant to existing chemotherapy, targeted drugs, and monoclonal antibodies or relapse in a short time after receiving treatment, there is an urgent need for innovative therapies that can improve treatment options. Increasing evidence suggests that bispecific antibodies will become a critical component of cancer therapy. We are excited to have the opportunity to collaborate with a number of prominent investigators in China to conduct the first clinical study of ATG-101, a novel PD-L1/4-1BB bispecific antibody," said Professor Ye Guo, Deputy Director of Medical Oncology at Shanghai East Hospital of Tongji University, Director of the hospital’s center for Phase I trials, and principal investigator of the study. "ATG-101 has a high affinity for PD-L1 and can achieve conditional activation of 4-1BB agonist, which is expected to bring a lower risk of systemic toxicity, particularly the hepatotoxicity that has been seen with previous agonists of 4-1BB. We hope that ATG-101 will demonstrate efficacy and safety, and bring a new treatment option to patients with resistant or relapsed cancers."

"The development of novel therapies to improve and advance the care of patients with resistant, relapsed, or advanced cancers is central to Antengene’s mission. Compounds that combine the well-established efficacy of inhibition of the PD-1/PD-L1 axis with activation of 4-1BB represent a fascinating opportunity in oncology. In our view, ATG-101’s ability to activate exhausted T-cells and render ‘cold tumors’ hot has the potential to open the door to wide applicability in resistant/relapsed diseases. These qualities,together with a robust preclinical data package, position ATG-101 to be a potentially best-in-class molecule." said Dr. Kevin Lynch, Antengene’s Chief Medical Officer.

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL). ATG-101 was designed to activate anti-tumor immune effectors by forming a cell-antibody-cell trimer to simultaneously block the binding of PD-L1/PD-1 and induce 4-1BB stimulation. In PD-L1 over-expressing cancer cells, ATG-101 has shown potent PD-L1 crosslinking-dependent 4-1BB agonist activity, with the potential for delivery of enhanced therapeutic efficacy whilst mitigating the risk of hepatoxicity.

Data presented at the Annual Meeting of Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) in 2021 showed that ATG-101 was active in anti-PD-L1 resistant and relapsed tumor models. ATG-101’s unique safety and efficacy properties make it a promising potential therapy for solid tumors and hematological cancers. To date, ATG-101 has received regulatory clearances in Australia, U.S., and China to enter a Phase I clinical study for the treatment of advanced/metastatic solid tumors and NHL. The study has already been initiated in Australia and China and is in the process of initiation in the U.S.