On August 14, 2024 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that the first participant has been successfully dosed in the first-inhuman Phase I trial of IMP761 (Press release, Immutep, AUG 13, 2024, View Source [SID1234645831]). This first-in-class agonist LAG-3 antibody is designed to restore balance to the immune system by enhancing the "brake" function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.

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The single and multiple ascending dose, placebo-controlled, double-blind Phase I study is being conducted by the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands, specializing in cutting-edge early-stage clinical drug research. The study aims to enrol 49 healthy volunteers, to assess safety, pharmacokinetics (PK) and pharmacodynamics (PD).

CHDR will implement its unique keyhole limpet haemocyanin (KLH) challenge model allowing for the evaluation of IMP761’s pharmacodynamic activity at the earliest stages of clinical development. Immutep anticipates the first safety data from the Phase I study to be available before end of the year with assessment of PK/PD relationships to follow in the first half of CY2025.

The immune checkpoint LAG-3 has been identified as a promising target for agonist LAG-3 immunotherapy to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among other autoimmune diseases.1,2,3 In preclinical studies, IMP761 has led to a large decrease in inflammatory cytokines and demonstrated its effectiveness in suppressing antigen-specific T cell–mediated immune responses.

About IMP761

IMP761, a first-in-class immunosuppressive LAG-3 agonist antibody, has the potential to address the root cause of many autoimmune diseases by specifically silencing autoimmune memory T cells that accumulate at disease sites and restoring balance to the immune system. As published in the Journal of Immunology, encouraging pre-clinical in vivo and in vitro studies show IMP761 inhibits peptide-induced T cell proliferation, activation of human primary T cells, and an antigen-specific delayed-type hypersensitivity (DTH) reaction. Additional preclinical data in oligoarticular juvenile idiopathic arthritis (o-JIA) published in Pediatric Research details how IMP761 led to a decrease in a broad spectrum of effector cytokines in just 48 hours. This study also showed children with o-JIA have a skewed LAG-3 metabolism and suggested they can benefit from agonistic LAG-3 activity.

On August 13, 2024 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Theriva Biologics, AUG 13, 2024, View Source [SID1234645830]).

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"We remain on track to complete enrollment for VIRAGE, our Phase 2b trial in metastatic PDAC during the third quarter and are pleased with the FDA’s decision to grant FTD to VCN-01, highlighting the urgent need for new options to treat this deadly disease," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Our lead oncolytic virus (OV) product candidate, VCN-01 is uniquely designed for co-administration with chemotherapy and/or immunotherapy to enhance tumor access by these agents and elicit a persistent antitumor immune response. The ongoing VIRAGE trial is evaluating VCN-01 in combination with standard-of-care chemotherapy, gemcitabine/nab-paclitaxel, as a first line therapy to enable the earliest possible use in metastatic PDAC. We look forward to building upon the compelling clinical data from Phase 1 studies that underscores VCN-01’s multiple modes of action and potential to overcome historical challenges around systemic OV administration. Beyond PDAC, we continue to pursue opportunities that maximize the therapeutic potential of VCN-01. To that end, we are excited by the grant of RPDD to VCN-01 for the treatment of children with retinoblastoma. We will continue to build a portfolio of potentially improved therapeutic combinations as part of our broader strategy to address unmet needs for difficult to treat cancers. Additionally, we have taken steps to further rationalized our burn, which will allow us to extend our cash runway by an additional quarter and bring us closer to the completion and data readout of the VIRAGE trial."

Recent Program Highlights and Anticipated Milestones:

VCN-01:

Pancreatic Ductal Adenocarcinoma (PDAC):
Dosing is underway and enrollment is nearing completion for VIRAGE, the randomized, controlled, multicenter, open-label Phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients. The trial intends to enroll 92 evaluable patients across sites in the U.S. and Spain, and is expected to complete enrollment in the third quarter of 2024.
The U.S. FDA granted FTD to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. Overall survival and progression free survival are the primary and key secondary endpoints respectively in the ongoing VIRAGE study. Both the FDA and EMA previously granted orphan drug designation to VCN-01 for treatment of PDAC.
Retinoblastoma:
Results from the investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Discussions with key opinion leaders worldwide, as well as with regulatory agencies, are ongoing to refine our retinoblastoma clinical strategy.
The U.S. FDA granted RPDD to lead clinical candidate VCN-01 to treat pediatric patients with retinoblastoma. The FDA has previously granted orphan drug designation to VCN-01 in this indication.
If a Biologics License Application for VCN-01 for the treatment of retinoblastoma is ultimately approved by the FDA, Theriva may be eligible to receive a Priority Review Voucher that can be redeemed to receive a priority review for any subsequent marketing application, or may be sold or transferred.
SYN-004 (ribaxamase):

Dosing and safety follow-up were completed for the second cohort of the Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).
If the Data Safety and Monitoring Committee recommends continuation of the trial, enrollment into the third cohort could commence in the second half of 2024 contingent on adequate funding.
Second Quarter Ended June 30, 2024 Financial Results

General and administrative expenses decreased to $1.5 million for the three months ended June 30, 2024, from $2.7 million for the three months ended June 30, 2023. This decrease of 45% is primarily comprised of the decrease in employee compensation costs, consulting fees, audit fees, lower director and officer insurance, and a decrease in fair value of the contingent consideration adjustment, offset by increased investor relation costs. The charge related to stock-based compensation expense was $114,000 for the three months ended June 30, 2024, compared to $106,000 for the three months ended June 30, 2023.

Research and development expenses decreased to $3.0 million for the three months ended June 30, 2024, from approximately $3.1 million for the three months ended June 30, 2023. This decrease of 6% is primarily the result of lower clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC and lower expenses related to our Phase 1a clinical trial of SYN-020 which has completed, offset by increased expenses to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. We anticipate research and development expense to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, advance our VCN-01 program in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $58,000 for the three months ended June 30, 2024, compared to $40,000 related to stock-based compensation expense for the three months ended June 30, 2023.

During the quarter ended June 30, 2024, we experienced a sustained decline in the quoted market price of our common stock and we deemed this to be a triggering event for impairment. The Company performed an interim impairment analysis using the "Income approach" that requires significant judgments, including primarily the estimation of future development costs, the probability of success in various phases of its development programs, potential post-launch cash flows and a risk-adjusted weighted average cost of capital. We concluded that the IPR&D was not impaired as of June 30, 2024, however, goodwill with a carrying value of $5.5 million was written down to its estimated fair value of $1.5 million and an impairment charge of $4.0 million was recorded during the quarter ended June 30, 2024. The decrease in the valuation was primarily driven by an increase in the discount rate which was impacted by an increase in the company specific risk premium, and not by material changes to the clinical and administrative operations of the business.

Other income was $172,000 for the three months ended June 30, 2024 compared to other income of $377,000 for the three months ended June 30, 2023. Other income for the three months ended June 30, 2024 is primarily comprised of interest income of $173,000 and an exchange loss of $1,000. Other income for the three months ended June 30, 2023 is primarily comprised of interest income of $381,000 and exchange loss of $4,000.

Cash and cash equivalents totaled $16.6 million as of June 30, 2024, compared to $23.2 million as of December 31, 2023.

On August 13, 2024 Aptevo Therapeutics ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported initiation of the Company’s Phase 1b/2 dose optimization trial, "RAINIER," as part of its ongoing program to evaluate APVO436 in combination with venetoclax + azacitidine for frontline patients with acute myeloid leukemia (AML) (Press release, Aptevo Therapeutics, AUG 13, 2024, View Source [SID1234645829]). RAINIER will be conducted in two parts. First, a Phase 1b frontline AML study followed by a Phase 2 study. The Company also announced that APVO436 has received its generic name, mipletamig (mih-ple’-tah-mig) and will refer to its lead candidate by this name moving forward.

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"With a strong foundation of positive clinical data demonstrating safety, tolerability, efficacy, and durability, we are thrilled to announce the initiation of our Phase 1b/2 RAINIER study. This trial aims to identify the recommended Phase 2 dose and further evaluate key indicators-such as safety, tolerability, and efficacy-of mipletamig when combined with standard of care venetoclax and azacitidine in frontline AML patients," stated Marvin White, President and CEO of Aptevo. "Mipletamig has already been administered to 90 patients across two trials, both as a monotherapy and in combination therapy, with results showing an exceptional safety profile and efficacy outcomes more than double those reported in the literature and a 75% complete response rate among frontline patients. We believe the RAINIER trial will not only confirm these earlier outcomes but also establish the recommended Phase 2 dose and further demonstrate mipletamig’s potential to transform AML treatment when used alongside the existing standard of care."

This frontline AML study is a multi-center, multi-cohort, open label dose finding study of up to 39 patients across five dose levels ranging from 9 mcg – 140 mcg in combination with venetoclax and azacitidine (ven/aza). Subjects will be adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. Aptevo has partnered with Prometrika (View Source), a premier contract research organization, for the RAINIER trial.

Primary endpoints:

Evaluate the safety, tolerability, and maximum tolerated dose (MTD) of increasing doses of APVO436 in combination with venetoclax and azacitidine in patients with newly diagnosed AML

Determine the recommended Phase 2 dose

Assess incidence of cytokine release syndrome (CRS) at each dose level

*Benchmark Composite References: Aldoss 2019, Maiti 2021, Morsia 2020, Garciaz 2022, Feld 2021

Secondary Endpoint:

Determine the efficacy of increasing doses of APVO436 in combination with venetoclax and azacitidine in patients with newly diagnosed AML

"The initiation of our RAINIER trial marks a critical milestone in the clinical development of our lead candidate, mipletamig, in combination therapy for frontline AML," said Dirk Huebner, MD, Chief Medical Officer at Aptevo. "In this dose optimization trial, we will administer a combination of venetoclax, azacitidine, and mipletamig across up to five different dose levels. Our primary objective is to identify the optimal Phase 2 dose while continuing to assess the safety, tolerability, efficacy, and durability of remission. By focusing on frontline patients with this combination therapy, we aim to gain deeper insights into the role of mipletamig within the triplet regimen and its potential to improve treatment outcomes."

Prior Outcomes: Compelling Results to Date

Dose Escalation (monotherapy)

2 complete remissions (CRs) reported in AML patients who received the drug as a monotherapy

Most CRS cases were low-grade and clinically manageable

Dose Expansion (combination therapy)

91% clinical benefit rate in combination with standard of care venetoclax + azacitidine in venetoclax naïve patients which exceeds our benchmark (Benchmark Composite References: Aldoss 2019, Maiti 2021, Morsia 2020, Garciaz 2022, Feld 2021)

75% of frontline patients experienced a CR

Clinically meaningful duration of remission, with no median reached – multiple patients either stayed on treatment or moved to transplant

Only 27% of patients experienced CRS (cytokine release syndrome), which is favorable compared to competitor drugs.

Most CRS cases were low-grade and clinically manageable

About Mipletamig

Aptevo’s wholly owned lead proprietary drug candidate, mipletamig, targeting AML, MDS and other leukemias, is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells. Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of a unique CD3 derived from CRIS-7 vs. the CD3 used by other competitors. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Mipletamig has been evaluated in 90 patients over two trials to date. RAINIER, Aptevo’s Phase 1b/2 frontline AML program, was initiated in 3Q24.

On August 13, 2024 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported second quarter 2024 results and provided a corporate update (Press release, aTyr Pharma, AUG 13, 2024, View Source [SID1234645828]).

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"The second quarter of 2024 was a milestone quarter for aTyr, as we completed enrollment in our global pivotal Phase 3 EFZO-FIT study of efzofitimod in patients with pulmonary sarcoidosis, a major form of interstitial lung disease (ILD)," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "This landmark study is the largest interventional study ever to be conducted in sarcoidosis and presents an opportunity to deliver a potentially transformative therapy to sarcoidosis patients who have been waiting more than 60 years for a new drug to be approved for this disease. We look forward to releasing topline data from this study in the third quarter of 2025."

Second Quarter 2024 and Subsequent Period Highlights

Completed enrollment in the global pivotal Phase 3 EFZO-FIT study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis at 85 centers in 9 countries, exceeding the targeted enrollment. Topline data from the study are expected in the third quarter of 2025. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program (EAP).
Continued enrollment in the Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. The study intends to enroll up to 25 patients with SSc-ILD and is open for enrollment at multiple centers in the U.S. Patients who complete the study and wish to receive ongoing treatment with efzofitimod are eligible to participate in a 24-week open-label extension (OLE), which was recently incorporated into the study protocol. Based on current enrollment projections, the Company expects to report interim data from the study in the second quarter of 2025.
Presented a poster describing efzofitimod’s mechanism of action at the American Thoracic Society (ATS) 2024 International Conference. The findings further demonstrated that neuropilin-2 (NRP2), efzofitimod’s binding partner, is an important new immune target in ILD and that efzofitimod modulates myeloid cells to confer its anti-inflammatory benefit.
Entered into a research agreement with Stanford Medicine to explore the role of the Company’s anti-NRP2 antibodies in glioblastoma multiforme (GBM). Michael Lim, M.D., Chair of the Department of Neurosurgery at Stanford Medicine, will serve as the principal investigator for the study, which aims to explore the role anti-NRP2 antibodies in combination with chemotherapy to evaluate their role in reversing immune evasion in GBM, the most common type of primary brain cancer.
Appointed Jayant Aphale, Ph.D., as Vice President, Technical Operations. Dr. Aphale has more than 30 years of experience working in technical operations and manufacturing for novel therapeutic and vaccine products at biotechnology and pharmaceutical companies. Dr. Aphale will serve as a member of the Company’s executive leadership team, overseeing manufacturing activities at contract development and manufacturing organizations and implementing strategies related to the continuous improvement of commercial manufacturing, supply chain management, process development of new products and product life cycle management.
Second Quarter 2024 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents, restricted cash and investments as of June 30, 2024, were $81.4 million.
R&D Expenses: Research and development expenses were $14.0 million for the second quarter 2024, which consisted primarily of clinical trial costs for the Phase 3 EFZO-FIT and Phase 2 EFZO-CONNECT studies, manufacturing costs for the efzofitimod program and research and development costs for the efzofitimod and discovery programs.
G&A Expenses: General and administrative expenses were $3.3 million for the second quarter 2024.
About Efzofitimod

Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

On August 13, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the second quarter of 2024, its recent business highlights, and a preview of select anticipated milestones (Press release, Sutro Biopharma, AUG 13, 2024, View Source [SID1234645827]).

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"We continue to make meaningful progress with the development of luvelta across multiple indications, including enrollment of a patient expansion cohort in combination with bevacizumab, nearing initiation of our second registration-enabling trial, REFRaME-P1, for pediatric patients with a rare form of acute myeloid leukemia (AML) and approaching site activation of a Phase 2 trial in non-small cell lung cancer (NSCLC)," said Bill Newell, Sutro’s Chief Executive Officer. "We plan to share supplemental data from our Phase 1b trial of luvelta in combination with bevacizumab at the ESMO (Free ESMO Whitepaper) meeting in September."

Mr. Newell added, "We are off to strong start in our new partnership with Ipsen for STRO-003 and continue to advance our preclinical pipeline of next-generation ADCs, including our tissue-factor targeting exatecan ADC, STRO-004. In parallel, we are exploring new partnership opportunities to maximize the potential of our platform and pipeline, led by our new Chief Business Development Officer Barbara Leyman. Additionally, we are delighted to welcome Sukhi Jagpal to our Board, as he brings a wealth of invaluable financial and strategic expertise."

Recent Business Highlights and Select Anticipated Milestones

Luveltamab Tazevibulin (luvelta), FRα-Targeting ADC Franchise:

Sutro will present updated data from the Phase 1b study of luvelta in combination with bevacizumab for patients with ovarian cancer in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 to be held September 13-17 in Barcelona, Spain.
Title: Luveltamab tazevibulin, an antifolate receptor alpha (FRα) antibody-drug conjugate (ADC), in combination with bevacizumab (bev) in patients with recurrent high-grade epithelial ovarian cancer (EOC): STRO-002-GM2 phase 1 study
Date: Saturday, September 14, 2024
Part 2 (randomized portion) of the Phase 3 trial, REFRαME-O1, for treatment of platinum-resistant ovarian cancer (PROC), is underway.
REFRαME-P1, a registration-enabling trial for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is expected to be initiated in the second half of 2024.
A Phase 2 expansion study in combination with bevacizumab is ongoing, with data expected in the first half of 2025.
A Phase 2 trial for the treatment of NSCLC is expected to initiate in the second half of 2024, with initial data expected in the first half of 2025.
Additional Pipeline Development and Collaboration Updates:

In April 2024, Sutro announced a global licensing agreement for STRO-003, a ROR1-targeting ADC, with Ipsen.
Sutro plans to submit an IND for STRO-004 in 2025.
Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $970 million in payments through June 30, 2024, including equity investments.
Corporate Updates:

In August, Sutro strengthened its Board of Directors with the appointment of Sukhi Jagpal, MBA, CPA, CBV. Mr. Jagpal brings 20 years of experience in the life sciences industry, with expertise in financial management, communication, and organizational effectiveness, including financial analysis, mergers and acquisitions, and cost optimization.
In July, Sutro appointed Barbara Leyman, Ph.D., as Chief Business Development Officer, with a focus on building value and executing the Company’s business development strategy, in addition to serving on Sutro’s senior management team.
Upcoming Events: Sutro will participate in two upcoming investor conferences. Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the events.

Wedbush PacGrow Healthcare Conference in New York, August 13-14, 2024
Wells Fargo Healthcare Conference in Boston, September 4-6, 2024
Second Quarter 2024 Financial Highlights

Cash, Cash Equivalents and Marketable Securities and Vaxcyte Common Stock
As of June 30, 2024, Sutro had $426.0 million, composed of cash, cash equivalents and marketable securities of $375.6 million and approximately 0.7 million shares of Vaxcyte common stock with a fair value of $50.4 million.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock
The non-operating, unrealized gain of $4.8 million for the quarter ended June 30, 2024 was due to the increase since March 31, 2024 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue
Revenue was $25.7 million for the quarter ended June 30, 2024, as compared to $10.4 million for the same period in 2023, with the 2024 amount related principally to the Astellas collaboration and the Vaxcyte agreement. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses
Total operating expenses for the quarter ended June 30, 2024 were $74.4 million, as compared to $56.6 million for the same period in 2023. The 2024 quarter includes non-cash expenses for stock-based compensation of $6.2 million and depreciation and amortization of $1.8 million, as compared to $6.7 million and $1.7 million, respectively, in the comparable 2023 period. Total operating expenses for the quarter ended June 30, 2024 were comprised of research and development expenses of $62.0 million and general and administrative expenses of $12.4 million.