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 1, 2022 GluBio Therapeutics, a biotech company focused on developing novel targeted protein degradation (TPD) drugs, reported the completion of Series A+ financing of $22 million (Press release, GluBio Therapeutics, AUG 1, 2022, View Source [SID1234638030]). This round is led by Qiming Venture Partners and joined by Lilly Asia Ventures and Kaitai Capital, bringing the total capital raised to nearly $90 million since its establishment in March, 2021.

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The investment will help advance two molecular glue degraders with best-in-class potential into the clinic for hematological malignancies, accelerate the lead optimization entry of three first-in-class TPD drugs for solid tumors and inflammatory diseases, and further upgrade GluBio’s proprietary TPD discovery platform and screening capabilities tailored for rapid discovery and optimization of small molecule protein degraders for ‘undruggable’ therapeutic targets.

"We are thrilled to advance molecular-glue and heterobifunctional protein degraders, which hold a great promise of eliminating disease-causing proteins that are not amenable to traditional therapeutic approaches," said Gang Lu, Ph.D., GluBio Founder and CEO. "In the past 16 months, GluBio made tremendous progress in developing best-in-class and/or first-in-class TPD assets and state-of-the-art TPD platform, fully maximizing the therapeutic and commercial potential of TPD technologies. We completed this round within two months of Series A financing. We are grateful for the unwavering confidence investors have in our assets and platform, and confident that this round will accelerate a smooth and successful execution of our pipeline and platform."

Dr. Kan Chen, Partner of Qiming Venture Parners, said, "Targeted protein degradation is a revolutionary technology in the biopharmaceutical field. GluBio team has extensive experience in targeted protein degradation and has built a strong platform for molecular glue and new target discovery technologies, making it a promising leader in TPD field. Qiming Venture Partners is pleased to continue our support to the company’s development and hopes that GluBio will accelerate its R&D and industrialization process to bring more unmet need targets to the clinical stage and new treatment options to patients worldwide."

On August 1, 2022 Quince Therapeutics, Inc. (Nasdaq: QNCX), a biopharmaceutical company advancing innovative precision therapeutics targeting debilitating and rare diseases, reported an overview of its strategic growth plan in conjunction with its corporate name change (Press release, Quince Therapeutics, AUG 1, 2022, View Source [SID1234619483]). The launch of Quince Therapeutics marks a strategic shift in focus as the company prioritizes the clinical development of its highly differentiated bone-targeting drug platform and lead precision bone growth molecule, NOV004, to address major, unmet medical needs across multiple skeletal therapeutic indications. Quince also announced that the company plans to pursue the strategic expansion of its development pipeline through opportunistic in-licensing and acquisition of clinical-stage assets targeting debilitating and rare diseases, in addition to disclosing the company’s intent to out-license its legacy neuroscience and antiviral assets.
Dirk Thye, M.D., Quince’s chief executive officer, said, "We are eager and enthusiastic about launching Quince Therapeutics and introducing our new corporate strategy focused on the development and acquisition of innovative precision therapeutics for patients suffering from debilitating and rare diseases. Our proprietary bone-targeting drug platform and novel lead molecule, NOV004, are positioned to establish Quince as an important new leader in underserved therapeutic areas with major and unmet medical needs in a setting of historical underinvestment and few competitive companies. Our core technology is based on more than 10 years of extensive preclinical research and can be applied to a broad variety of skeletal diseases and indications as we look to expand our proprietary pipeline.

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"We also benefit from a highly experienced management team with a long track record of drug development success and value creation. This team is empowered by a cash runway extending into the second half of 2025, providing us near-term financial security in a period of economic uncertainty in the biotech sector. This strong financial position is expected to enable us to not only fully fund reaching NOV004’s human proof of concept clinical development milestone, but also allow Quince to pursue strategic in-licensing and acquisition of additional clinical-stage assets. We intend to aggressively leverage the advantages of our strong team and balance sheet to build a highly impactful and valuable company," Thye concluded.

Strategic Growth Plan Highlights

Today, Quince embarks on a fundamental shift in its strategic growth plan that now centers on advancing innovative precision therapeutics targeting debilitating and rare diseases. Key highlights of the company’s strategic growth plan include:

Addressing major, unmet medical needs across multiple skeletal therapeutic indications

Major, unmet medical needs have been estimated to include more than 18 million fractures in the U.S. each year that have led to more than $50 billion in direct medical costs.
Underserved bone fracture opportunity compounded by a growing aging population experiencing higher rate of life-threatening fractures.
No treatments currently approved for lead indication, osteogenesis imperfecta, which has been estimated to affect as many as 50,000 people in the U.S. alone.
Positioned as a lead innovator in underserved therapeutic areas with few competitive companies.
Discovery pipeline positioned for rapid expansion across multiple skeletal therapeutic indications, including osteogenesis imperfecta, fractures, spinal fusion, and other severe bone diseases.
Strong and well-protected intellectual property with robust portfolio of precision bone therapeutics.
Highly differentiated bone-targeting drug platform and broad applicability of lead molecule NOV004

Proprietary drug-targeting technology designed to enable precise delivery of small molecules, peptides, or large molecules directly to the site of bone fracture and disease.
Development pathway de-risked by more than 10 years of extensive preclinical studies demonstrating that concentrated drug-targeting promotes more rapid healing with fewer off-target safety concerns compared to non-targeted therapeutics.
Lead precision bone growth molecule NOV004 is an anabolic peptide engineered to precisely target and concentrate at the bone fracture site, resulting in rapid increases in bone density, strength, and healing as demonstrated in preclinical studies.
NOV004 expected to enter Phase 1 clinical studies in 2023.
Future development plans include progression of NOV004 to Phase 2 clinical study to evaluate safety and efficacy for the treatment of planned lead indication, osteogenesis imperfecta.
Strategic pipeline expansion through opportunistic in-licensing and acquisition of clinical-stage assets

Proactively evaluating potentially actionable clinical-stage assets targeting debilitating and rare diseases for in-licensing and acquisition.
Potential asset targets must have compelling clinical data and commercial opportunity and offer clear operational synergy and value creation.
Intend to be opportunistic and disciplined in approach with ability to be selective and competitive in evolving biotech environment.
Strong cash position expected to fund operations and clinical activities into the second half of 2025

Strong cash position of approximately $105 million in cash, equivalents, and marketable securities as of June 30, 2022 is expected to fund capital and operating expenditures into the second half of 2025.
Expect to fully fund achievement of lead molecule NOV004’s human proof of concept clinical development milestone.
Corporate restructuring in first half of 2022 optimized organization for operating efficiency.
Out-licensing legacy neuroscience and antiviral assets

Seeking to out-license capital-intensive legacy neuroscience and antiviral assets, including COR588, COR388, COR852, and COR803.
Lysine gingipain inhibitor COR588 is Phase 2 ready for further evaluation in Alzheimer’s disease and other P. gingivalis associated diseases.
Antiviral 3CLpro irreversible inhibitor COR803 for coronavirus infection positioned at IND-enabling preclinical study phase.
Out-licensing effort to identify partners already underway with goal of concluding the process before the end of 2022.
Initiates Nasdaq Trading Under New Ticker Symbol "QNCX"

Quince’s ticker symbol on the Nasdaq Stock Market will begin to trade under "QNCX" effective at the open of market trading today, Monday, August 1, 2022. The corporate name change to Quince Therapeutics, Inc. does not affect the rights of the company’s stockholders with respect to the name change. Outstanding stock certificates are not affected by the name change and will not need to be exchanged.

Management to Participate at Upcoming Investor Conference

Quince’s chief executive officer Dirk Thye, M.D., will present at the Canaccord Genuity 42nd Annual Growth Conference taking place on Thursday, August 11, 2022 beginning at 2:30 p.m. Eastern Time. A webcast of the event will be accessible on the Investor Calendar page under the News & Events heading of Quince’s investor website at www.quincetx.com. The webcast will be archived at that location for 90 days.

On August 1, 2022 JSR reported consolidated financial results for the First Three Months of the Fiscal Year Ending March 31, 2023 (Filing, 3 mnth, JUN 30, JSR, 2022, AUG 1, 2022, View Source [SID1234619297]).

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On August 01, 2022 BioInvent International reported treatment of the first patient in a Phase 1/2a trial of its second anti-FcyRIIB antibody BI-1607 in combination with trastuzumab in HER2+ solid tumors (Press release, BioInvent, AUG 1, 2022, View Source [SID1234618934]).

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The first-in-human Phase 1 trial is a dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors. The selected dose of BI-1607 will be studied in a subsequent Phase 2a part of the trial along with trastuzumab in advanced breast, metastatic gastric and gastroesophageal junction HER2+ cancers.

The first patient has been recruited to the Phase 1 part of the study which is expected to recruit between 12 and 26 subjects. The Phase 2a aims to recruit 30 patients in two cohorts of 15 subjects each (one cohort in breast and one in gastric and gastroesophageal cancers). The study will be carried out at 7-12 sites in Spain, the UK, Germany, and in the U.S.

"This new study with our exciting anti-FcyRIIB antibody BI-1607 marks BioInvent’s fifth clinical trial, with four distinct drug candidates, and it is a further demonstration of the productivity of our technology platform. Preclinical data have shown that a BI-1607 surrogate antibody enhances the therapeutic efficacy of anti-HER2 antibodies, and we look forward to further investigating this effect in human subjects," said Martin Welschof, CEO of BioInvent.

Like BI-1206, BioInvent’s lead FcyRIIB antibody, BI-1607 is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. Trastuzumab alone or in combination with chemotherapy significantly improves overall survival of HER2+ breast cancer patients. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607 differs from BI-1206 in that BI-1607 has been engineered for reduced Fc-binding to FcyRs. This alteration generates a major differentiating factor between the two antibodies, and specifically with respect to the best combination partners.

Preclinical data presented at this year’s AACR (Free AACR Whitepaper), indicate that treatment with BI-1607 enhances the efficacy of current anti-HER2 regimens such as trastuzumab. HER2 is a driver of tumor formation and growth in approximately 20% of breast cancers, the most common cancer worldwide in women, and in gastric and gastroesophageal junction adenocarcinoma.