HanAll Biopharma Reports First Quarter Results and Provides Business Update

On April 28, 2023 HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for the first quarter and provided business updates (Press release, HanAll Biopharma, APR 28, 2023, View Source [SID1234630693]).

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HanAll’s financial data demonstrated a strong momentum in the start of 2023, with revenues of KRW 28.8 billion, representing a 20 percent sales growth mainly driven by pharmaceutical sales from the first quarter of 2022. The company reported a net loss of 1.3 billion won due to continued investment in R&D.

Following the previous statement from the 2022 full-year financial report, HanAll expects to secure top-line data from the tanfanercept Phase 3 clinical study in dry eye disease in the first half of 2023 and plans to initiate a Phase 3 clinical study of batoclimab in generalized myasthenia gravis (gMG) in Japan this year.

"The recent positive top-line result from gMG Phase 3 study by Harbour BioMed suggests the potential of batoclimab as the first anti-FcRn treatment to be commercialized in China, reinforcing our confidence to develop batoclimab in an array of autoimmune diseases. With a strong focus on collaboration and innovation, we will continue to push forward with our R&D programs to deliver groundbreaking medicines that will make a difference in the patients’ lives," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

First Quarter 2023 BUSINESS UPDATE
Pipeline Development Highlights

A comprehensive update of HanAll’s pipeline development below includes an overview of research along with lists of compounds and targeted indications, along with developmental phase.

AUTOIMMUNE DISEASES PROGRAMS
Batoclimab (HL161BKN)

A novel, fully human, subcutaneously administered antibody targeting FcRn, with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to and inhibit FcRn, which plays a role in recycling IgG, thus leading to a reduction in IgG antibodies.

Harbour BioMed, a licensed partner of HanAll in China, announced the first positive Phase 3 top-line results for batoclimab in generalized myasthenia gravis (gMG) subjects in March 2023. Data from the trial met the primary endpoint as well as key secondary endpoints. Batoclimab treatment was also found to be overall safe and well-tolerated, without any new significant safety signals identified. Harbour BioMed plans to submit a Biologics License Application (BLA) to the National Medical Products Administration (NMPA) for batoclimab together with its sub-licensee CSPC NBP Pharmaceuticals Co., Ltd. (NBP Pharma), a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited (CSPC Pharmaceutical), based on the study results. Batoclimab is also being developed for study in China in an array of other autoimmune disorders including thyroid eye disease (TED).

HanAll is progressing towards initiation of a Phase 3 clinical study of batoclimab in gMG in Japan this year. Additionally, HanAll is exploring options for developing batoclimab in TED and chronic inflammatory demyelinating polyneuropathy (CIDP) in Japan.

Another licensed partner, Immunovant in the U.S. and Europe, is conducting global Phase 3 trials with batoclimab in gMG and TED. Additionally, the initial data readout for a Phase 2 trial in Grave’s disease (GD) is anticipated in the second half of 2023 and an initial Phase 2b results in CIDP is expected in the first half of 2024.
HL161ANS

Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG, designed to deliver maximum lgG reductions while minimizing interference with albumin recycling.

Immunovant anticipates initial results from a Phase 1 trial for HL161ANS, a new FcRn inhibitor (Immunovant project designation: IMVT-1402), in the second half of 2023. Immunovant also plans to evaluate HL161ANS in multiple autoimmune diseases, based on strategic portfolio considerations.
OPHTHALMIC DISEASE PROGRAMS

Tanfanercept (HL036)

A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF alpha, a key mediator of ocular inflammation

HanAll Biopharma and Daewoong Pharmaceutical are progressing with the second Phase 3 (VELOS-3) study in the U.S. in subjects with moderate to severe DED to examine the safety and efficacy of tanfanercept. Study enrollment is complete and the top-line results from the VELOS-3 study are expected in the first half of 2023.

Harbour BioMed, a licensed partner of HanAll in China, closed its Phase 3 China study in DED, based on the Independent Data Monitoring Committee’s (IDMC) evaluation of the efficacy data from the second interim analysis. The HanAll U.S. study (VELOS-3) differs from the Harbour Chinese study in a number of ways including key inclusion criteria, primary endpoints, as well as subject demographics. The future development plans for tanfanercept in China are under discussion.
ONCOLOGY PROGRAMS
HL187/ HL186

Monoclonal antibodies that respectively target T cell immunoreceptors with Ig and ITIM {Immunoreceptor tyrosine-based inhibitory motif} domains (TIGIT) and T cell immunoglobulin and mucin domain-3 (TIM-3) are being developed in collaboration with Daewoong Pharmaceutical. as potential oncology treatments

HanAll is continuing with the pre-clinical development of HL187 asset and plans to evaluate the further development of HL186 based on the strategic portfolio review.
FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights

(KRW in billion)

Q1 2023

Q1 2022

% change

Sales

28.8

24.0

+20 %

Gross Profit

15.7

12.8

+23 %

Selling, marketing and administrative expenses

11.5

10.2

+13 %

Research and development expenses

5.9

3.1

+88 %

Operating income

(1.7)

(0.6)

N/A

Net Income

(1.3)

(0.1)

N/A

Sales recorded 28.8 billion won in the first quarter of 2023, a 20 percent increase compared to the first quarter of 2022. Pharmaceutical sales remained strong with major products including Normix, Eligard, along with the newly launched products such as Abcito and Glucofree.

Research and development expenses for the first quarter ended March 31, 2023 were 5.9 billion won, up 88 percent from 3.1 billion won for the three months ended March 31, 2022. The increase was primarily due to continued progress in VELOS-3 study, along with the investment to the ongoing oncology projects.

Net loss for the three months ended March 31, 2023 recorded 1.3 billion won from the 0.1 billion won for the same period in 2022.

Targeted Therapy Developed in FCS Clinical Trials Transforming Cancer Treatment For Adult Patients with Diffuse Large B-cell Lymphoma (DLBCL)

On April 28, 2023 Florida Cancer Specialists & Research Institute, LLC (FCS) reported a case study outlining the evolution of a newly FDA-approved first-line therapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (Press release, Florida Cancer Specialists & Research Institute, APR 28, 2023, View Source [SID1234630691]). The treatment regimen combines use of Polatuzumab Vedotin (POLIVY), a type of anti-body drug conjugate that is significantly improving outcomes in patients with this aggressive form of lymphoma. FCS actively participated in the phase 1, first in-human monotherapy trial for polatuzumab vedotin, as well as the pivotal phase 3 Polarix study which led to its FDA approval as first-line treatment.

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Polatuzumab vedotin was first approved by the U.S. Food & Drug Administration (FDA) in June 2019 for use in combination with two other cancer treatments. The accelerated approval, making the treatment available to all eligible patients, was based on favorable findings from a Phase 1 clinical trial that showed 40% of patients receiving the regimen experienced a disappearance of all signs of cancer and remained in remission for one year or longer.

The FCS Drug Development Unit was one of 13 centers participating in the initial Phase 1 first in-human trial conducted in 2011-2012 to evaluate the drug’s effectiveness. "The observations that we made in this initial trial were the first steps to determining what is now part of standard of care for first line patients," said Manish R. Patel, MD, FCS Director of Drug Development. "It is rewarding to see the impact of our work in developing this drug."

In August 2022, the FDA accepted a supplemental Biologics License Application for a combination treatment of polatuzumab vedotin and R-CHP for patients with previously untreated DLBCL, based on favorable data from the Phase 3 study. FCS was one of the most active sites during the study, often referred to as the Polarix study, that led to the FDA approval of this first-line treatment.

According to Gustavo Fonseca, MD, FACP, FCS Director of Clinical Research, patients in the Phase 3 study achieved rapid and sustained improvements. "Patients in the study showed improvements in quality of life, functional status and the lymphoma-associated symptoms," Dr. Fonseca said. "There are other persistent benefits from the patient perspective as well."

DLBCL accounts for 25 to 30 percent of all blood cancers diagnosed annually in the U.S. and is the most common form of non-Hodgkin lymphoma. The aggressive, fast-growing lymphoma occurs when white blood cells enlarge the lymph nodes; frequently migrating to other organization. Chemotherapy is the most common and effective treatment. The five-year survival rate is 73%.

FCS offers more than 300 clinical trials at three Phase 1 Drug Development Units and 37 clinic locations across Florida. "We remain at the forefront of medical discoveries of new therapies and technologies that are continuing to provide new hope for patients," said Dr. Fonseca.

Dr. Patel was a co-author of an abstract involving the Phase 1 study assessing the safety and activity of polatuzumab vedotin. Dr. Patel and Dr. Fonseca presented abstracts detailing the breakthrough findings at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual meeting and Exposition in December 2022.

To read the FCS case study: View Source

To read the study abstracts:
View Source
View Source
View Source

Access the current list of FCS clinical trials: View Source

AC Immune Reports First Quarter 2023 Financial Results and Provides a Corporate Update

On April 28, 2023 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, AC Immune, APR 28, 2023, View Source [SID1234630690]).

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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "Recent accomplishments reaffirm our industry-leading position in developing vaccines and diagnostics for neurodegenerative diseases supporting the transition to targeted treatment and disease prevention. Our maturing pipeline’s substantial breadth offers multiple milestones in the near- and mid-term and we have the strong cash position needed to deliver them."

"We are delighted to see our Tau positron emission tomography (PET) tracer PI-2620 progress into the pivotal Phase 3 ADvance trial, with our partner, LMI. Similarly, we are excited by the initial positive data from the Phase 1b/2 ABATE trial of ACI-24.060 and the expansion as planned, to include individuals with Down syndrome. The trial is now advancing towards additional interim safety and immunogenicity data in both indications this year, as well as PET imaging analyses in H1 2024 that will evaluate ACI-24.060’s impact on amyloid plaques. With amyloid PET increasingly recognized as a surrogate marker of efficacy in AD, these analyses represent a significant potential de-risking event that could rapidly propel our wholly-owned vaccine towards a pivotal program."

Q1 2023 and Subsequent Highlights

ACI-24.060 positive initial interim safety and immunogenicity data were reported from the first, low dose Alzheimer’s disease (AD) cohort of the Phase 1b/2 ABATE trial of AC Immune’s wholly-owned anti-Abeta SupraAntigen vaccine candidate.
Initial interim ABATE data triggered the planned trial expansion to include individuals with Down syndrome (DS) and the initiation of evaluation of higher doses of ACI-24.060 in AD.
Interim safety and immunogenicity data from ABATE’s AD and DS cohorts are expected in the second half of 2023.
The first participant was imaged in the pivotal Phase 3 ADvance trial evaluating the Morphomer derived Tau-PET tracer, PI-2620, in AD. PI-2620 is being developed as part of a research collaboration between AC Immune and Life Molecular Imaging.
AC Immune’s therapeutic and diagnostic programs were featured in 10 presentations at the International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD 2023), highlighting the breadth of the company’s pipeline as well as its differentiated Precision Medicine approach to addressing neurodegenerative disease.
New grants that collectively provide more than USD 500,000 in additional non-dilutive capital to support the advancement of diagnostic programs targeting TDP-43 (TAR DNA-binding protein 43) were awarded to AC Immune by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and the Target ALS Foundation.
Our webinar "Early Diagnosis and Prevention of Alzheimer’s Disease" featured presentations by invited Key Opinion Leaders, Kaj Blennow, MD, PhD, of University of Gothenburg and Sahlgrenska University Hospital, and Giovanni Frisoni, MD, of University of Geneva and the Memory Clinic at Geneva University Hospital. To view a replay of the webinar, click here.

Anticipated 2023 Milestones

ACI-24.060
anti-Abeta vaccine
Submission of an Investigational New Drug (IND) application to enable expansion of ABATE study to the U.S. expected in H1 2023
Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in H2 2023
Interim safety and immunogenicity data from DS cohort of ABATE study expected in H2 2023
ACI-7104.056
anti-a-syn vaccine
Update from Phase 2 VACSYN study in Parkinson’s disease expected in H2 2023
ACI-35.030
anti-pTau vaccine
Initiation of next trial in AD expected in H2 2023 (to be followed by milestone payment)
Semorinemab
anti-Tau antibody
Results from the open-label extension of the Phase 2 Lauriet trial in mild-to-moderate AD expected in H2 2023
Anti-TDP-43 antibody
Advancement of candidate into preclinical development (tox) expected in H2 2023
a-syn-PET tracer
Declaration of next clinical candidate for development in Parkinson’s disease expected in H2 2023
TDP-43-PET tracer
Clinical candidate declaration expected in H1 2023
Analysis of financial statements for the quarter ended March 31, 2023

Cash position: The Company had a total cash balance of CHF 105.4 million (CHF 122.6 million as of December 31, 2022), composed of CHF 57.4 million in cash and cash equivalents and CHF 48.0 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources to progress into at least Q3 2024 without considering receiving potential future milestone payments.

R&D expenditures: R&D expenses in the period were CHF 13.9 million, compared with CHF 15.1 million for the comparable period in 2022, mainly driven by lower discovery and preclinical expenses.
Other operating income: The Company recognized CHF 0.4 million in grant income from Michael J. Fox Foundation and Target ALS.

IFRS loss for the period: The Company reported a net loss after taxes of CHF 17.5 million for the three months ended March 31, 2023, compared with a net loss of CHF 18.8 million for the comparable period in 2022.
2023 Financial guidance

Total cash burn guidance for the full year 2023 remains unchanged ranging from CHF 65 to CHF 75 million. The Company defines cash burn as operating expenditures adjusted to include capital expenditures and offset by significant non-cash items (including share-based compensation and depreciation expense).

Tempest Announces Positive Early Results from Global Randomized Phase 1b/2 Combination Study of TPST-1120 in First-Line Hepatocellular Carcinoma

On April 28, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported positive early results from a global randomized Phase 1b/2 clinical study in which TPST-1120, Tempest’s small molecule PPAR⍺ antagonist, demonstrated clinically-meaningful improvement in multiple categories when combined with the standard-of-care regimen of atezolizumab and bevacizumab in a randomized comparison to atezolizumab and bevacizumab in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) (Press release, Tempest Therapeutics, APR 28, 2023, View Source [SID1234630687]).

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Data from 40 patients in the TPST-1120 arm randomized per protocol against 29 evaluable (30 total) patients in the control arm showed:

Unconfirmed responses of 30% for the TPST-1120 triplet arm (12/40) vs. 17.2% for the control arm (5/29), demonstrating a 74.4% relative improvement in objective response rate (ORR);
Confirmed responses of 17.5% for the TPST-1120 triplet arm (7/40) vs. 10.3% for the control arm (3/29), demonstrating a 69.9% relative improvement in confirmed ORR;
47.5% (19/40) of the TPST-1120 arm patients are on treatment vs. 23.3% (7/30) in the control arm;
80% (32/40) of the TPST-1120 arm patients are on study vs. 50% (15/30) in the control arm;
The addition of TPST-1120 was well tolerated, with safety data consistent with the control regimen; and,
The randomized arms were generally well balanced at baseline for prognostic factors.
In the IMbrave150 Phase 3 trial, confirmed ORR benefit correlated with overall survival (OS) benefit.2

The study was conducted in clinical collaboration with F. Hoffman La-Roche. Secondary endpoints include duration of response (DoR), progression free survival (PFS) and OS, which are immature as of the data cut and will be potentially available later in the year or next year. Enrollment began in fall of 2021 and the cutoff date for these data was February 8, 2023, which was greater than six weeks after the last patient enrolled and allows for all patients to have had at least one scan. Tempest expects the full data set to be presented by Roche at a medical meeting at a later date. ORR was determined by RECIST v1.1, and confirmed responses included at least two scans.

"These randomized data in first-line HCC are exciting and support the promise of TPST-1120 as an active small molecule for patients," said Stephen Brady, chief executive officer of Tempest. "HCC is a common and aggressive cancer where significant unmet need remains to improve care in the first line and beyond. We believe the improvements shown in the TSPT-1120 arm validate the hypothesis of targeting HCC with TPST-1120, as well as the mechanistic basis for combination with both a checkpoint inhibitor and VEGF inhibitor. We look forward to receiving more data this year, including with respect to potential biomarkers, and to the potential next steps of this program in HCC and other cancers of interest."

"HCC is one of the few tumor types with increasing mortality in the United States," said Mark Yarchoan, M.D., Associate Professor of Medical Oncology at Johns Hopkins School of Medicine. "Atezolizumab + bevacizumab is the current preferred frontline therapy, and the addition of TPST-1120 appears to be active and well tolerated. Response rates in HCC can vary significantly across studies, and therefore the use of a randomized, controlled study design instead of a historical control is a strength of this study. The numerically higher response rate and proportion of patients on study with the addition of TPST-1120 is promising. I believe that this is an active agent and I look forward to further clinical development of TPST-1120."

Conference Call & Webcast Information

Tempest will host a webcast conference call today, April 28, 2023 at 8:30 a.m. ET.

To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. The live webcast and audio archive of the presentation may be accessed on the investor section of the Tempest website at View Source The webcast will be available for replay for 30 days.

About the Randomized Clinical Trial

The Phase 1b/2 global randomized HCC study is part of Roche’s Morpheus program and evaluates TPST-1120 in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with unresectable or metastatic HCC not previously treated with systemic therapy. To date, the trial has enrolled 70 patients to the 1120 arm and contemporaneous control arm at ~25 sites worldwide including in the United States and Europe, who received either the TPST-1120 combination or the standard-of-care regimen of atezolizumab and bevacizumab with primary efficacy endpoint of objective response rate, and key secondary endpoints including PFS and OS. Under the terms of the clinical collaboration agreement, Roche managed the study operations for this global, multicenter trial.

About TPST-1120

TPST-1120 is an oral, small molecule, selective PPAR⍺ antagonist wholly-owned by Tempest. Tempest’s preclinical data suggest that TPST-1120 can kill tumor cells directly and target suppressive immune pathways in the tumor microenvironment. Both types of targeted cells can be dependent on fatty acid metabolism, which is regulated by the PPAR⍺ transcription factor. In extensive non-clinical studies, TPST-1120 as a monotherapy or in combination with other anti-cancer drugs resulted in significant reductions in tumor growth and stimulation of durable anti-tumor immunity. In a Phase 1 clinical trial in patients with heavily-pretreated advanced solid tumors, TPST-1120 as monotherapy and in combination with the PD-1 inhibitor nivolumab demonstrated tumor reduction (including according to RECIST criteria), as well as biomarker modulation. TPST-1120 was well-tolerated both as a monotherapy and in combination with nivolumab.

About Hepatocellular Carcinoma

HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030.3 Every year, more than 900,000 people worldwide are diagnosed with HCC.4 Incidence and mortality are highest in East Asia and are increasing in parts of Europe and the US.5 In the US, HCC represents the fastest-rising cause of cancer-related death.3

Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.6

Even if diagnosed in the early stage, an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery.7 Early recurrence is associated with poorer prognosis and shorter survival.5,8 Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of recurrence.

Y-mAbs to Announce First Quarter 2023 Financial and Operating Results on May 8, 2023

On April 28, 2023 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will announce its financial results for the quarter ended March 31, 2023, on Monday, May 8, 2023, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, APR 28, 2023, View Source [SID1234630682]). The announcement will be followed by a conference call and webcast with the investment community on Tuesday, May 9, 2023, at 9:00 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and Interim CEO; Bo Kruse, Chief Financial Officer; Sue Smith, Chief Commerical Officer and Vignesh Rajah, Chief Medical Officer.

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Conference call and webcast details:

Investors (domestic): 888-886-7786
Investors (international): 416-764-8658
Conference ID: 09065062
To access a live webcast of the update, please use this link.