On December 14, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported interim data from an ongoing clinical trial (NCT03934814) of lemzoparlimab in combination with rituximab (Rituxan) in heavily treated patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL), at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, I-Mab Biopharma, DEC 14, 2021, View Source [SID1234597164]).

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Lemzoparlimab is a novel CD47 antibody that blocks CD47 and SIRPα interaction through a epitope designed to confer red blood cell (RBC) sparing properties. In all clinical trials conducted so far, lemzoparlimab is administered without a priming dose.

"Lemzoparlimab’s initial results show it appears to be safe and well-tolerated in combination with rituximab without the need of a priming dose," said Amitkumar Mehta, MD, Associate Professor and Director of the Lymphoma Program at the University of Alabama at Birmingham and O’Neal Comprehensive Cancer Center at UAB. "This data support further evaluation of lemzoparlimab in combination with rituximab, which is currently ongoing in study in patients with r/r DLBCL and indolent lymphoma."

The preliminary data was generated from nine patients with relapsed and refractory NHL who received at least two prior lines of therapies, with a median of four lines. Lemzoparlimab was safe and well-tolerated at doses of 20 mg/kg and 30 mg/kg weekly, without a priming dose. The maximum tolerated dose (MTD) was not reached. Most treatment-related adverse events (TRAE) were manageable infusion-related reactions (n=4). Among seven efficacy-evaluable patients, four achieved complete response (CR) [1 transformed FL-DLBCL +3 FL], one partial response (PR) of FL were observed (ORR=71%); two reported stable disease (SD); and the disease control rate (DCR) is 100%. Tumor shrinkage was observed in all evaluable patients. The median time to response was 50 days and response lasted from 61 to 236 days. A high level (80% and 90%) of intra-tumoral distribution measured by IHC of tumor biopsy was reached at 20 mg/kg and 30mg/kg weekly.

"We’re encouraged by the interim results reported today. The clinical data of lemzoparlimab further builds our confidence for an innovative therapy that utilizes macrophages against tumors, said Dr. Joan Shen, Chief Executive Officer of I-Mab. "It is very exciting that lemzoparlimab is bringing new hopes to our patients, and we are accelerating its clinical development through international multi-center trials in the U.S. and China."

The ongoing study with 30 mg/kg lemzoparlimab weekly combined with rituximab is being expanded to enroll more patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) or indolent lymphoma.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab have discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

Multiple clinical studies are ongoing in both the U.S. and China to explore indications in treating both hematologic maliglencies and solid tumors. Lemzoparlimab is being studied in patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors in the U.S. and China. Combined clinical results from these studies will potentially support registrational trials later in China.

In September 2020, I-Mab and AbbVie entered into a global strategic collaboration to develop and commercialize lemzoparlimab. This includes the design and conduct of further clinical trials to evaluate lemzoparlimab in multiple cancers through global and China-specific trials. AbbVie has assumed sponsorship of the U.S. study as of April 2021.

On December 14, 2021 Carterra, Inc. the world leader in label-free high throughput antibody screening and characterization, reported that it has signed an exclusive Asia-Pacific and Oceania region distribution agreement with PerkinElmer, Inc. a global leader committed to innovating for a healthier world (Press release, PerkinElmer, DEC 14, 2021, View Source [SID1234597443]). With the agreement, PerkinElmer will market, sell, and service Carterra’s flagship LSA high-throughput surface plasmon resonance (SPR) platform and software used for accelerating the discovery of therapeutic antibodies.

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This move will assist Carterra in meeting growing customer demand by leveraging PerkinElmer’s long-standing channel infrastructure in the region. It will also add additional tools to PerkinElmer’s growing portfolio of science and biologics discovery offerings, which includes its world leading BioLegend antibody and reagent technologies.

This new agreement builds on the equity investment PerkinElmer made in Carterra last December, which has resulted in several collaborations between the companies involving assay development and software integration projects over the past year.

Commenting on this latest distribution arrangement, Alan Fletcher, Senior Vice President, Life Science, PerkinElmer, said, "We are delighted to add the distribution of Carterra’s highly innovative LSA technology to help our Asia-Pacific and Oceania customers further streamline and advance their biologic and biotherapeutic discovery and development work."

"Carterra recognized early on that Asia-Pacific and Oceania would be important markets for our game changing biologics discovery products and we are at the point where we need additional reach and channel power to help us take our customer delivery there to the next level, " stated Tim Germann, Chief Commercial Officer at Carterra. "We are excited to collaborate with PerkinElmer to add that extra horsepower in sales, marketing and service as well as benefit from their deep life science expertise across drug development workflows."

On December 14, 2021 Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, reported that it has completed a $37 million Series A financing (Press release, Phosplatin, DEC 14, 2021, View Source [SID1234597062]). The round was led by Adinvest AG and included participation from existing investors, including the conversion of previously issued convertible notes.

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Robert Fallon, President and Chief Executive Officer of Phosplatin Therapeutics, commented, "This is a major milestone for Phosplatin that adds the capital and resources needed to advance the clinical development of PT-112 for cancer patients who lack treatment options. We are particularly pleased with the investment support for our clinical and translational research plan."

PT-112 is the first pyrophosphate-platinum conjugate with a unique mechanism of action that induces immunogenic cell death, leading to the recruitment of tumor-infiltrating lymphocytes, and associates with bone (osteotropism), due to its pyrophosphate moiety. Two trials are underway with PT-112: a monotherapy Phase 2 clinical trial in metastatic castration-resistant prostate cancer (mCRPC) patients; and the Phase 2a dose confirmation portion of an ongoing Phase 1b/2a clinical trial in combination with PD-L1 immune checkpoint inhibition in non-small cell lung cancer (NSCLC) patients.

Dr. Neil Sunderland, Adinvest AG Chairman and lead investor, stated, "Phosplatin is advancing PT-112 based on compelling scientific validation, with top-tier collaborations. We see a range of promising opportunities ahead and are excited by the Company’s prospects."

Dr. Sunderland serves as a Director of Phosplatin Therapeutics. He has invested in life science companies for many years and was a founding Partner of Montreux Growth Partners in San Francisco, a biotech and medtech growth capital firm.

Phosplatin has raised $74 million in equity capital since inception, and receives milestone fees from its sub-licensee for Greater China.

About PT-112
PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 may represent the best-in-class inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and the PD-L1 combination study is ongoing in a dose confirmation cohort of NSCLC patients.

On December 14, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy (RT) in cancer, reported that corrected results from its Phase 3 ROMAN trial of avasopasem for the treatment of RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) achieved statistical significance on the primary endpoint of reduction in the incidence of SOM. Avasopasem has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the reduction of SOM induced by RT (Press release, Galera Therapeutics, DEC 14, 2021, View Source [SID1234597086]).

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The Company previously announced the Phase 3 ROMAN trial of avasopasem in SOM did not achieve statistical significance on the primary endpoint. Upon further analysis, an error by the contract research organization (CRO) was identified in the statistical program. Correction of this error resulted in improved p-values for the primary and secondary endpoints.

The corrected p-values are as follows:

16% relative reduction in the incidence of SOM in the avasopasem treatment group (54%) vs. placebo group (64%) (p=0.0451*) (previously reported as p=0.113) (primary endpoint)
56% relative reduction in the number of days of SOM in the avasopasem treatment group (8 days) vs. placebo group (18 days) (p=0.0022*) (previously reported as p=0.011) (secondary endpoint)
27% relative reduction in the severity (incidence of Grade 4 OM) of SOM in the avasopasem treatment group (24%) vs. placebo group (33%) (p=0.052) (previously reported as p=0.167) (secondary endpoint)
The Company also announced topline results from its single-arm Phase 2a EUSOM trial of avasopasem in Europe for RT-induced SOM in patients with HNC undergoing standard-of-care RT + cisplatin. This trial was conducted in 12 centers across six countries in Europe and enrolled 38 patients, of which 33 completed full treatment. Avasopasem appeared to be generally well tolerated. In EUSOM, the incidence of SOM was 54.5% and the median number of days of SOM was 9 days, in line with the ROMAN trial in which the incidence was 54% and the median duration was 8 days.

"Given the high unmet medical need for patients with head and neck cancer who develop radiotherapy-induced severe oral mucositis, we are gratified that the Phase 3 ROMAN trial achieved statistical significance on the primary endpoint after the correction of the statistical programming error," said Mel Sorensen, M.D., President and CEO of Galera. "ROMAN is our second randomized trial conducted in patients with head and neck cancer to achieve statistical significance and demonstrate improved clinical benefit. As we continue to analyze the full data set and evaluate our resources, we look forward to meeting with the FDA in 2022 to discuss whether the results from this single Phase 3 trial together with the randomized Phase 2b trial could support an NDA submission."

Approximately 42,000 HNC patients undergo standard-of-care RT every year in the U.S. and are at risk of experiencing SOM, painful mouth sores that impact the ability to eat and drink. In market research, both radiation oncologists and patients cite SOM as the most burdensome RT toxicity in HNC treatment. Currently, there are no FDA approved drugs to reduce the incidence or duration of SOM in solid tumors.

Continued Dr. Sorensen, "In parallel, our anti-cancer therapeutic trials in lung and pancreatic cancer, which we refer to as the GRECO-1 and GRECO-2 trials, respectively, are currently enrolling, and we look forward to reporting initial data from our GRECO-1 trial in the first half of 2022. Both trials combine our second dismutase mimetic candidate, rucosopasem, with stereotactic body radiation therapy (SBRT) with the goal of augmenting the anti-cancer efficacy of SBRT."

Conference Call

Galera will host a conference call and live audio webcast on Tuesday, December 14 at 8:30 a.m. ET to discuss the ROMAN Phase 3 data, including additional analyses from the full data set, and provide a general business update. The webcast will be accessible from the Investors page of Galera’s website, investors.galeratx.com, and an archived version of the webcast will be available in the News & Events section of the Investors page of Galera’s website for 30 days following the event.

On December 14, 2021 Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, reported results from a clinical study using the Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) to predict therapy response for individual Acute Myeloid Leukemia (AML) patients were featured in a poster presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition held December 11-14, 2021 in Atlanta, Georgia (Press release, Cellworks, DEC 14, 2021, View Source [SID1234597129]). The complete results from this study are available online in the ASH (Free ASH Whitepaper) Meeting Library as Abstract 1299.

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In the study, the Cellworks Biosimulation Platform and CBM was used to assess cytarabine (ARA-C) and anthracycline response and novel biomarker response criteria for the addition of etoposide (VP16) in AML. The study found that Cellworks biosimulation identifies novel biomarkers that predict therapy response in AML patients, which offers the opportunity to tailor FDA-approved chemotherapy regimens to each patient to improve disease control and minimize toxicity. In addition, biosimulation is emerging as an essential tool to improve the success rate of clinical trials and speed the development of lifesaving medicines for the patients that need them.

"From comprehensive genomic inputs, the Cellworks Biosimulation Platform identifies pathway based polygenic biomarkers that predict the efficacy of novel drug combinations and new drugs for AML patients," said Dr. Michael Castro, MD, Chief Medical Officer at Cellworks. "Cellworks AML biomarker identification and therapy response prediction capabilities should accelerate clinical trials for new therapies and improve trial success rates by predicting if a patient’s genomic profile will respond to specific regimens. Biosimulation has the ability to improve outcomes for patients, avoid drugs that produce only toxicity and extend the reach of precision medicine in the clinic."

The Cellworks Biosimulation Platform simulates how a patient’s personalized genomic disease model will respond to therapies prior to treatment and identifies novel drug combinations for treatment-refractory patients. The platform is powered by the groundbreaking Cellworks Computational Omics Biology Model (CBM), a network of 4,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. By reliably predicting an individual patient’s therapy response prior to receiving the treatment, the Cellworks Platform can guide the selection of the optimal treatment, help patients avoid ineffective therapies and improve patient outcomes.

Clinical Study: ASH (Free ASH Whitepaper) Abstract 1299

Biosimulation using Cellworks Computational Omics Biology Model (CBM)-based assessment of cytarabine (ARA-C) and anthracycline response and novel biomarker response criteria for the addition of etoposide (VP16) in AML.

Background

Genomic heterogeneity in leukemic blasts characterizes AML patients and is associated with variable drug responses. In this study, 539 AML patients were selected based largely on genomic data published in TCGA and PubMed. The Cellworks Biosimulation Platform and Computational Omics Biology Model (CBM) was used to identify novel genomic biomarkers associated with response among AML patients treated with cytarabine (ARA-C) + idarubicin or daunorubicin (anthracycline) with or without etoposide (VP16).

Results

Cellworks biosimulation of ARA-C + anthracycline with and without VP16 identified biomarkers responsible for therapy responses. Additionally, the biosimulation identified novel drug combinations for non-response to these standard combinations. Altogether, 89 of the 539 patients (16.5%) could have been managed with a potentially superior treatment approach based on the biosimulation by either adding or omitting VP16 or being treated with an alternative therapy.

Conclusion

This study highlights patients for whom triplet therapy promises potential superior benefit, others who would benefit equally from doublet therapy without VP16 and others unlikely to respond to standard or triplet therapy for whom an alternative personalized approach might offer better outcomes. In AML, Cellworks biosimulation offers the possibility to tailor the chemotherapy regimen to each patient to improve disease control and minimize toxicity.