On March 30, 2022 Iktos, a company specialized in Artificial Intelligence (AI) for new drug design reported a collaboration agreement with Ono Pharmaceuticals Co., Ltd., a leading pharmaceutical company based in Japan with a focus on innovative medicines dedicated to the fight against disease and pain (Press release, Iktos, MAR 30, 2022, View Source [SID1234611199]).

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Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies and software Makya, its AI-based retrosynthesis analysis and planning tool Spaya, and know-how complementing Ono’s drug discovery capabilities to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties for undisclosed Ono’s drug discovery programmes. ONO will acquire exclusive worldwide rights to develop and commercialize small molecule compounds discovered in the collaboration. Iktos will receive research funding plus milestone payments based on achievement of certain milestones. Ono scientists will benefit from direct access to Iktos Makya and Spaya software platforms as part of the collaboration.

Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. The technology automatically designs virtual novel molecules with all the characteristics of a successful drug molecule. This approach, validated through multiple collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with optimized properties. Iktos makes its AI technology available to its customers both through research collaborations and through direct access to its SaaS platforms Makya for de novo design and Spaya for synthesis planning.

"We are very pleased to collaborate with Ono, a leading pharmaceutical company based in Japan, and proud to announce our first collaboration deal with a Japanese pharma company," said Yann Gaston-Mathé, Co-founder and CEO of Iktos. "Our ultimate objective is to expedite drug discovery and achieve time and cost efficiencies for our collaborators by using Iktos’s proprietary AI platform and know-how. We are confident that together we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems for Ono’s drug discovery programmes. We are committed to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects."

"Iktos has excellent artificial intelligence technology and platform in drug discovery," said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of Ono. "Through this drug discovery collaboration, we are excited to work with Iktos to identify and develop the next generation of innovative treatments, leading to further expansion of our development pipeline."

On March 30, 2022 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company with a Research & Development ("R&D") innovation engine that aims to discover, develop and ultimately deliver impactful medicines to patients, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a business update (Press release, Centessa Pharmaceuticals, MAR 30, 2022, View Source [SID1234611220]).

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"We have strengthened our strategic focus on innovative, high impact rare disease and immuno-oncology assets. Lixivaptan for ADPKD and SerpinPC for hemophilia are entering into registrational studies while LB101, our PD-L1xCD47 LockBody, is advancing toward the clinic," said Saurabh Saha, MD, PhD, Chief Executive Officer. "We are in a strong financial position to make significant clinical progress towards our ‘4×24’ goal of having four programs in registrational trials in 2024."

"We believe that our LockBody programs have the potential to become the cornerstone for a multi-product immuno-oncology franchise. We look forward to sharing initial preclinical data at ASCO (Free ASCO Whitepaper) 2022 for the first program, LB101, which is designed to selectively drive potent CD47 effector function activity while avoiding systemic toxicity," said Antoine Yver, MD, MSc, Chairman of Development.
"The breadth of our rare disease programs provides us multiple opportunities to develop drugs which can potentially impact the lives of thousands of patients living with debilitating diseases such as ADPKD, hemophilia, alpha-1-antitrypsin deficiency, pulmonary arterial hypertension, and narcolepsy, among others," added Javad Shahidi, MD, MSc, Chief Medical Officer.

2021 Highlights and Recent Business Updates

Clinical Development Updates
•SerpinPC: Recently completed pre-IND interactions with the FDA regarding the planned registrational studies for SerpinPC. Based on the FDA feedback, the Company is proceeding with a streamlined, integrated registrational development plan initially for Hemophilia B, with and without inhibitors. The FDA discussions followed the announcement in September 2021 of positive topline data from a proof-of-concept study of SerpinPC in severe Hemophilia A and B subjects not on prophylaxis.
•Lixivaptan: Commenced dosing in the pivotal Phase 3 clinical trial ("ACTION Study") evaluating lixivaptan as a potential treatment for autosomal dominant polycystic kidney disease ("ADPKD"). In addition, a key US patent was issued on February 8, 2022, which covers the use of lixivaptan for the treatment of ADPKD. The patent term expires June 8, 2038, before considering possible patent term extensions or adjustments.
•ZF874: Announced proof-of-mechanism data from the first three PiMZ subjects dosed in the Phase 1 Part B study evaluating ZF874 for the treatment of AATD demonstrating that a pharmacological chaperone has the potential to achieve clinically significant Z-A1AT serum increases in individuals with AATD.
Business Updates
•Further strengthened the leadership team with multiple key appointments, including Antoine Yver, MD, MSc, Executive Vice President and Chairman of Development; Javad Shahidi, MD, MSc, Chief Medical Officer; and David Grainger, PhD, Chief Innovation Officer.
•Dosing of the first subject with lixivaptan in the Phase 3 ACTION Study in February 2022 triggered settlement of the contingent value rights ("CVRs") originally issued to the former shareholders and option holders of Palladio Biosciences in connection with its acquisition by Centessa in January 2021.
•Entered into financing agreement with funds managed by Oberland Capital Management LLC ("Oberland Capital") and received initial $75 million funding in October of 2021.
•As part of ongoing portfolio management, the Company has recently decided to discontinue the small molecule EGFR inhibitor discovery program; evaluate strategic options, including potential divestment, for imgatuzumab; and discontinue internal funding for the lead dual-STAT3/5 degrader program.
•Announced ‘4×24’ portfolio goal with the aim of having four registrational programs in 2024.

Upcoming Program Milestones
Registrational: Programs currently in or expected to enter registrational trials this year:
•Lixivaptan, vasopressin V2 receptor antagonist for ADPKD: Lixivaptan is currently being administered in the Phase 3 registrational ACTION Study to investigate its potential to treat ADPKD and avoid safety issues associated with the only drug currently approved for the treatment of ADPKD. The ACTION Study is expected to enroll ~1,350 subjects across>200 sites in

over 20 countries. The Company anticipates completing enrollment in the second half of 2023 and, if results are supportive, plans to submit a New Drug Application after completion of the one-year double-blind portion of the study.
•SerpinPC, an activated protein C inhibitor for Hemophilia: In the second half of 2022 the Company expects to launch two registrational studies. The first study will enroll ~120 subjects and evaluate the efficacy and safety of prophylactic SerpinPC in subjects with severe Hemophilia B without inhibitors and will include subjects with severe Hemophilia A to add to the safety database. The second registrational study is planned with fewer than 20 subjects to evaluate the efficacy and safety of SerpinPC in subjects with severe Hemophilia B with inhibitors. Registrational plans for Hemophilia A are in development. The Phase 2a open label extension study is ongoing, and we expect to report data on the 48-week flat dose portion of that study and interim results from the following 24-week high dose portion in the fourth quarter of 2022.
Emerging: Programs / platforms with expected clinical proof of concept in the next 18 months
•LB101 and LB201 in Solid Tumors: LB101, a PD-L1xCD47 LockBody, is designed to selectively drive potent CD47 effector function activity while avoiding systemic toxicity. We anticipate sharing foundational preclinical data at ASCO (Free ASCO Whitepaper) 2022, with an IND for LB101 planned for late 2022. LB201, a PD-L1xCD3 LockBody, is designed to selectively drive potent CD3 effector function activity while avoiding systemic toxicity. IND for LB201 is planned for 2023.
•ZF874 in Alpha-1 Antitrypsin Deficiency (AATD): Small molecule folding corrector of the Z variant of alpha-1-antitrypsin. We expect to share Phase 1 data from multiple dose cohorts with PiMZ and PiZZ subjects in 2H 2022.
•MGX292 in Pulmonary Arterial Hypertension (PAH): Recombinant modified BMP9 replacement protein designed to overcome the deficiency in BMP9 signaling in PAH. IND is planned for early 2023.
•OX2R Agonists (Oral and Intranasal) in Narcolepsy Type 1 (NT1): Selective orexin receptor 2 agonists targeting the underlying pathophysiology of orexin neuron loss in NT1. INDs/CTAs are planned for 2023.
Exploratory: Programs with expected clinical proof of concept beyond 18 months
•CBS001 in Inflammatory / Fibrotic Diseases: High-affinity anti-LIGHT antibody. Phase 1 clinical trial in healthy volunteers is expected to begin in the second quarter of 2022.
•CBS004 in Autoimmune Diseases: Humanized mAb targeting BDCA2. IND is planned for late 2022.

Fourth Quarter and 2021 (period January 30 through December 31, 2021) Successor Financial Results
•Cash and Cash Equivalents: $595.1 million as of December 31, 2021 which the Company expects will fund operations, based on current non-risk adjusted plans, into early 2024, without drawing on the remaining available tranches under the Oberland facility.

•R&D Expenses: $41.5 million for the Company for the quarter ended December 31, 2021, $95.7 million for the Successor for 2021.
•General & Administrative Expenses: $13.0 million for the Company for the quarter ended December 31, 2021, $42.9 million for the Successor for 2021.
•Net Loss Attributable to Ordinary Shareholders: $60.8 million for the quarter ended December 31, 2021, $381.1 million for the Successor for 2021 (which includes two special, non-cash expenses: a $220 million charge for acquired in-process R&D associated with the Centessa subsidiary acquisitions; and a $15 million fair value adjustment to the CVRs).

On March 30, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3-related immunotherapy treatments for cancer and autoimmune disease, reported that new interim data in 2nd line metastatic NSCLC from its Phase II TACTI-002 trial (Press release, Immutep, MAR 30, 2022, View Source [SID1234611242]). The data was published in a poster presentation today at ESMO (Free ESMO Whitepaper)’s European Lung Cancer Congress (ELCC) 2022 in Prague, Czech Republic and is also available on the Company’s website:

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This part of TACTI-002, known as Part B, evaluates Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") in combination with MSD’s KEYTRUDA (pembrolizumab) in a total of 36 patients with PD-L1 unselected 2nd line PD-X refractory metastatic NSCLC. The new data reflects the first interim results combining Stages 1 (23 patients) and 2 (13 patients) in 2nd line NSCLC.

Immutep CSO and CMO, Dr Frederic Triebel, noted: "It is very encouraging to see efti, in combination with pembrolizumab, showing an encouraging early overall survival rate of 73% at the six-month landmark, and promising interim disease control and tumour growth kinetics. The early signs are supportive that efti may boost the patient’s immune system to enable pembrolizumab to work more effectively in these patients with advanced lung cancer, while being safe and well tolerated."

TACTI-002 Principal Investigator, Dr Matthew G. Krebs of The University of Manchester and The Christie NHS Foundation Trust, said: "These interim results show an encouraging disease control rate of 36.1%, with 26% of patients being progression free at the 6-month landmark. These patients are a challenging population to treat, having progressed after previous lines of immunotherapy or chemo-immunotherapy and have limited options available for further treatment. So, it is pleasing to see the potential that efti in combination with pembrolizumab has to provide meaningful benefit in this patient group."

Condition of the patients as they entered the trial

A total of 36 patients were enrolled and treated. Patients were advanced in their disease. They had progressed after prior standard of care treatment with either anti-PD-(L)1 mono therapy (28%) or a combination of chemotherapy and anti-PD-(L)1 therapy (72%) and are referred to as PD-X refractory. Disease progression was confirmed by two consecutive CT-scans at least four weeks apart, eliminating the possibility of pseudo-progressions.1 The majority of patients (69%) had a PD-L1 tumour proportion score (TPS) of less than 50% at baseline, making them generally less likely to respond to anti-PD-(L)1 therapy.

Key Findings – data cut-off date 21 January 2022

73.7% of evaluable patients (14/19) had tumour shrinkage or tumour growth deceleration, according to tumour growth kinetics analysis

73% of patients alive at 6 months landmark in this difficult-to-treat patient population

DCR of 36.1% (13/36), with 26% being progression free at the 6-month landmark

ORR of 5.6% (2/36) with two patients reporting confirmed and durable partial responses, participating in the study for over 9 months and 23 months, respectively

6 patients still under therapy in the trial

Median OS has not yet been reached, which is encouraging given the advanced nature of the disease in this patient population

Table 1 – TACTI-002 Interim Results for Part B of TACTI-002

Tumour Response
Part B

2nd line NSCLC2

Best Overall Response as per iRECIST Stage 1 & 2
N (%)
Total N=36
Complete Response (CR)

0 (0)
Partial Response (PR)

2 (5.6)
Stable Disease (SD)

11 (30.6)
Progressive Disease (PD)

22 (61.1)
Not Evaluable

1 (2.8)
Overall Response Rate (ITT)

2/36 (5.6)
Disease Control Rate (ITT)

13/36 (36.1)
Overall Response Rate (evaluable patients)

2/35 (5.7)
Disease Control Rate (evaluable patients)

13/35 (37.1)

A pseudo-progression refers to an increase in the apparent size of a tumour or number of metastases on an imaging test, that can falsely create the appearance of disease progression. This may be caused by the infiltration of immune cells into the tumour site or a delay in the development of an adaptive immune response following immunotherapy.

Safety

The combination of efti plus pembrolizumab is safe and well-tolerated, continuing efti’s good safety profile to date and compares favourably to standard of care chemotherapy options.

Conclusion

The interim data from the TACTI-002 study shows that efti in combination with pembrolizumab is demonstrating encouraging early signs of antitumour activity in 2nd line confirmed PD-X refractory, NSCLC patients.

Next results

More mature data from the 2nd line NSCLC cohort is planned to be presented later this year, along with other data from the TACTI-002 trial.

About the TACTI-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of eftilagimod alpha (efti) with MSD’s KEYTRUDA (pembrolizumab) in patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, and the US.

Patients participate in one of the following:

Part A – first line Non-Small Cell Lung Cancer (NSCLC), PD-X naïve – given the promising results of the first two stages of Part A, an expansion stage with 74 additional patients was commenced in November 2020 to assist with trial design in subsequent late-stage settings

Part B – second line NSCLC, PD-X refractory

Part C – second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naïve

TACTI-002 is an all-comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC.

On March 30, 2022 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported financial results, and provided a business update for the fourth quarter and full year ended December 31, 2021 (Press release, BiomX, MAR 30, 2022, View Source [SID1234611200]).

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"BiomX is now entering the most exciting period in its history, with proof-of-concept clinical data readouts expected in the cystic fibrosis and atopic dermatitis programs within the next 12 months," said Jonathan Solomon, Chief Executive Officer of BiomX. "We are also approaching this data-rich period in good financial condition, as our existing cash runway is expected to take us until at least the end of 2023, and additional tranches that might become available to us under our venture debt facility may further extend our cash runway to the first half of 2024. We are also pleased that both the atopic dermatitis (AD) and cystic fibrosis (CF) programs have attracted equity investments in BiomX common stock from Maruho Co. Ltd. and the Cystic Fibrosis Foundation, respectively."

"Looking ahead, investors can expect our first data readout from the Phase 1b/2a cystic fibrosis program in the third quarter of 2022, which should provide valuable insights into the safety, tolerability and potential treatment effects of BX004. We also anticipate initial clinical data in the fourth quarter of this year for our Phase 1/2 atopic dermatitis product candidate, BX005. Recall that our core mission at BiomX is to develop innovative treatments with the potential to advance the current standard of care. Both our CF and AD programs reflect this potential, and we look forward to providing updates from the BX004 and BX005 programs later this year."

RECENT CORPORATE HIGHLIGHTS

In January 2022, BiomX announced that the Company received a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation. The first tranche of this award closed on December 21, 2021 with the foundation investing $3 million in our shares of common stock. Upon completion of patient dosing in Part 1 of the Company’s Phase 1b/2a study of BX004, BiomX would have the right to receive the second tranche of $2 million, also as an equity investment.
In October 2021, BiomX entered into an agreement with Maruho Co. Ltd., Japan’s largest dermatology-focused pharmaceutical company, for a right of first offer to license BiomX’s atopic dermatitis product candidate, BX005, in Japan. The right of first offer will commence following the availability of results from the Phase 1/2 study of BX005. Maruho also entered into a binding agreement for an equity investment in BiomX of $3 million at a premium to the market share price, intended primarily to support the Phase 1/2 study of BX005.
Clinical Program Updates

Cystic Fibrosis ("CF") (BX004)

BX004 is being developed for the treatment of chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.
The Phase 1b/2a trial is composed of two parts and is planned to start imminently. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the third quarter of 2022. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected by the first quarter of 2023.
Atopic Dermatitis ("AD") (BX005)

BX005 is designed to shift the skin microbiome composition of AD patients to its "pre-flare" state by reducing Staphylococcus aureus burden, potentially resulting in clinical improvement.
BX005 is currently in the final stages of GMP production. The Company expects the first data readout from its Phase 1/2 proof-of-concept trial evaluating the safety and efficacy of BX005 in the fourth quarter of 2022.
Inflammatory Bowel Disease ("IBD") and Colorectal Cancer Programs

BiomX’s IBD product candidate, BX003, is planned to enter its clinical trial in 2023, and the Company’s colorectal cancer product candidate will ramp up pre-clinical efforts in 2023.
Fourth Quarter and Full Year 2021 Financial Results

Cash balance, short-term deposits and restricted cash as of December 31, 2021, were $63.1 million, compared to $57.1 million as of December 31, 2020. The increase was primarily due to net cash provided by financing activities, partially offset by net cash used in operating activities. Based upon the Company’s strategic focus on the CF and AD programs, the existing cash and cash equivalents are expected to be sufficient to fund the current operating plan through the end of 2023. Additional tranches that would become available to the Company under its venture debt facility upon satisfaction of certain specified milestones can further extend the Company’s cash runway to the first half of 2024.
Research and development ("R&D") expenses, net were $6.6 million for the three months ended December 31, 2021, compared to $6.1 million for the same period in 2020. R&D expenses, net were $22.7 million for the year ended December 31, 2021, compared to $19.4 million for the prior year. The increase was primarily due to increased expenses related to conducting pre-clinical and clinical trials of our product candidates and an increase in salaries and related expenses, mainly due to the growth in the number of employees in R&D and clinical activities, offset by a decrease resulting from receiving higher levels of grants from the Israel Innovation Authority (IIA).
General and administrative expenses were $2.8 million for the three months ended December 31, 2021, compared to $2.6 million for the same period in 2020. General and administrative expenses were $11.3 million for the year ended December 31, 2021, compared to $9.3 million for the prior year. The increase was primarily due to an increase in expenses associated with operating as a public company, such as directors’ and officers’ insurance, listing fees and investor relations activity, and also due to an increase in stock-based compensation and salaries and related expenses, mainly due to the growth in the number of employees and due to an increase in rent and related operational expenses resulting from moving into a new facility.
Net loss for the fourth quarter of 2021 was $10.5 million, compared to $9.1 million for the same period in 2020. Net loss was $36.2 million for the year ended December 31, 2021, compared to $30.1 million for the prior year.
Net cash used in operating activities for the twelve months ended December 31, 2021 was $27.6 million, compared to $24.4 million for the same period in 2020.
Conference Call and Webcast Information

BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and business updates for the fourth quarter and full year ended December 31, 2021. To participate in the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel), or 1-201-389-0898 (International). A live and archived webcast of the call will be available on the Investors section of the Company’s website at www.biomx.com.

On March 30, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6026, a highly differentiated monoclonal antibody targeting OX40 with enhanced ADCC functions, in combination with BAT1308, a proprietary anti-PD-1 antibody currently in early-stage clinical trials (Press release, BioThera Solutions, MAR 30, 2022, View Source [SID1234611201]).

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"BAT6026 has demonstrated highly potent anti-tumor activity as a single agent and in combination with BAT1308 in in vivo pharmacology studies." said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. To date, anti-OX40 antibodies as agonists have not delivered optimal clinical responses, and recent studies revealed that their activities correlate directly to antibody isotypes and Fc functions, suggesting that Treg depletion might be important in improving clinical outcomes. BAT6026 has demonstrated potent Treg depletion activity, while synergistically activating T effector cells.

This Phase 1, multicenter, open-label, dose-escalation clinical trial is designed to assess the safety and tolerability of the combination of BAT6026 and BAT1308 in advanced solid tumor patients. Key objectives in the study include determining maximum tolerated dose and recommended Phase 2 dose (RP2D), pharmacokinetics and preliminary anti-tumor activity in combination therapy. Disease-specific expansion cohorts will be enrolled at the RP2D in Australia, China and other countries to further evaluate the safety and efficacy of BAT6026 in a variety of malignancies thereafter. In addition, BAT6026 has previously entered a monotherapy clinical study in China.

Bio-Thera Solutions is developing several innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, CD47, TIGIT and IO bispecifics targeting synergistic targets like PD-L1/CD47. Bio-Thera recently disclosed its next generation Antibody-Drug Conjugate (ADC) platform that has generated clinical candidate for important and validated tumor target like Folate Receptor alpha.