On April 12, 2021 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the presentation of a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Bio-Path Holdings, APR 12, 2021, View Source [SID1234578008]).

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The poster, titled "The combination of liposomal Bcl-2 antisense oligonucleotide (BP1002) with decitabine is efficacious in venetoclax-resistant cells," was presented virtually by Dr. Maria Gagliardi, Research Scientist at Bio-Path Holdings.

"We are particularly pleased to have these preclinical results of the BP1002 plus decitabine combination against venetoclax-resistant cells highlighted in a poster before an audience of the world’s leading cancer researchers at this important scientific meeting," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We look forward to filing a second Investigational New Drug (IND) application for BP1002 and to initiating a clinical study in combination with decitabine in acute myeloid leukemia (AML) patients who have relapsed from venetoclax-based treatments."

Venetoclax, an FDA-approved Bcl-2 inhibitor, is indicated for hematologic malignancies. However, venetoclax resistance among these AML patients is a growing problem. A recent study found that AML patients who had relapsed from frontline venetoclax-based treatment were also resistant to salvage therapy and had a median survival of less than 3 months1. Thus, novel treatment approaches for these most vulnerable patients are urgently needed.

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. Prior preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and the Company believes that its benign safety profile should enable BP1002 combination therapy with approved agents.

The data presented in the AACR (Free AACR Whitepaper) poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.

On April 12, 2021 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported the presentation of promising data from the Company’s growing bispecific platform at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 being held April 10th – 15th (Press release, Celldex Therapeutics, APR 12, 2021, View Source [SID1234577983]). The Company described the discovery and characterization of ILT4 inhibitory monoclonal antibodies (mAbs) for engineering bispecific antibodies (bsAbs) that revert myeloid cell suppression by antagonizing ILT4 and activate T-cell responses through PD-(L)1 inhibition (poster # 1865). Based on the results reported today, Celldex is developing clinical bispecific candidates that co-target ILT4 and PD-(L)1.

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Expression of ILT4 in several tumor types is associated with poor outcome. In preclinical models, antagonist antibodies to ILT4 have demonstrated immune enhancing and antitumor effects. More recently, in early clinical studies, combination approaches that combine co-targeting of ILT4 and checkpoint blockade have demonstrated clinical activity and safety, including in patients refractory to checkpoint inhibition therapy. The data Celldex presented at AACR (Free AACR Whitepaper) describe novel humanized antibodies with high affinity and specificity to ILT4 that effectively block immune suppression in macrophages. Candidate bispecific antibodies matched with either PD-L1 or PD-1 antibodies resulted in molecules that retained all the properties of the parental antibodies and simultaneously blocked the inhibitory signals from both ILT4 and PD-1. The data provide proof of concept for development of clinical candidates.

"Celldex continues to draw upon our deep antibody experience to build best-in-class bispecific antibodies to more effectively control antitumor immunity," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "The ILT4/PD-(L)1 approach combines two critical checkpoint pathways into one molecule, which may provide advantages from a development perspective and the potential for greater activity than the combination of the individual antibodies. We look forward to completing this work and selecting a lead candidate for advancement."

Celldex’s deep antibody experience and in-house manufacturing capabilities support efficient development of bispecific antibody targets. Targets are selected based on new science as well as their compatibility to be used in bispecific antibody formats with existing Celldex antibody programs. CDX-527, which combines CD27 activation and PD-1 blockade, was the first candidate to enter the clinic from the platform and is currently enrolling patients in a Phase 1 dose escalation study. Celldex is also exploring important targets controlling inflammation and auto-immune pathways.

On April 12, 2021 Lonza reported an expansion to its popular PyroTec PRO Automated Robotic Solution for endotoxin testing (Press release, Lifescience Newswire, APR 12, 2021, View Source [SID1234577978]). The new PyroWave Reader add-on has been designed specifically for use with the sustainable PyroGene Recombinant Factor C (rFC) Assay. This brings a third test type option to the platform, allowing QC microbiologists to choose the endotoxin test method best suited for their testing needs. The PyroTec PRO Solution, now compatible with Lonza’s PYROGENT-5000 Turbidimetric LAL (Limulus Amebocyte Lysate) Assay, Kinetic-QCL Chromogenic LAL Assay and the PyroGene rFC Assay, expands the options available for streamlined, automated endotoxin testing.

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The PyroWave Reader add-on is built upon the original release of the PyroTec PRO Automated System that includes two absorbance readers for traditional LAL-based assays. Able to easily accommodate different assay types in the same run and powered by the world-class WinKQCL Endotoxin Analysis Software, this complete system further increases the efficiencies and data integrity gained from automated endotoxin testing.

The PyroGene rFC Assay is an animal-free method for endotoxin detection that works through a single enzymatic step. It has been shown to be equivalent to other photometric endotoxin methods that use LAL to detect endotoxins according to the parameters listed in the USP chapter <1225> "Validation of Compendial Procedures". These parameters include linearity, specificity, precision, accuracy, and limit of detection.

The need for accurate and dependable endotoxin testing technology continues to grow, especially with the pharmaceutical industry increasingly focusing on the development of innovative biotherapeutics that carry a higher risk of endotoxin contamination. Through process optimization and automation of routine manual tasks, the PyroTec PRO Automated Robotic Solution enables users to streamline and improve the performance of the QC laboratory, increasing lab efficiency and productivity. Automated endotoxin testing can also substantially reduce the potential for human error, enhancing the accuracy, reliability, and traceability of results.

On April 12, 2021 Recursion Pharmaceuticals, a Phase 2-ready biotech using AI to develop therapies for various indications, reported terms for its IPO on Monday (Press release, Recursion Pharmaceuticals, APR 12, 2021, View Source [SID1234577955]).

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The Salt Lake City, UT-based company plans to raise $306 million by offering 18 million shares at a price range of $16 to $18. Insiders Baillie Gifford and Mubadala Investment intend to purchase up to $125 million worth of shares in the offering. At the midpoint of the proposed range, Recursion Pharmaceuticals would command a market value of $3 billion.

Central to Recursion’s mission is the Recursion Operating System, which combines an advanced infrastructure layer to generate proprietary biological and chemical datasets, and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that the company uses to explore foundational biology and navigate to new biological insights. While the company is advancing 37 programs, its most advanced programs include one candidate targeting oncology and three targeting rare genetic disorders, all of which are expected to enter Phase 2 or 2/3 trials within the next four to five quarters.

Recursion Pharmaceuticals was founded in 2013 and booked $4 million in revenue for the 12 months ended December 31, 2020. It plans to list on the Nasdaq under the symbol RXRX. Goldman Sachs, J.P. Morgan, BofA Securities, SVB Leerink, Allen & Company and KeyBanc Capital Markets are the joint bookrunners on the deal. It is expected to price during the week of April 12, 2021.

On April 12, 2021 Cardiff Oncology, Inc. (the "Company") Presented its corporate slide presentation (Presentation, Cardiff Oncology, APR 12, 2021, View Source [SID1234577946]).

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