On July 5, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the strategic transaction to acquire Rigenerand Srl, signed in May 2022, has been completed (Press release, Evotec, JUL 5, 2022, View Source [SID1234616461]). Based out of Medolla, Italy, the cell technology company with leading edge in the field of cGMP manufacturing of cell therapies will operate as Evotec (Modena) Srl going forward.

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Cell therapy is a fast-growing and highly promising field of biomedical research with the potential to achieve substantial disease-modifying or even curative effects within a single treatment. Deriving cell therapy products from induced pluripotent stem cells ("iPSCs") has opened up an almost unlimited source of consistent-quality material for large patient numbers. However, the scalability of the approach from bench to bedside is central for moving cell therapy approaches into clinical phases and thus, essential for the approval of any such therapy.

Evotec’s cell therapy platform EVOcells integrates the full end-to-end spectrum from the discovery and development to the manufacturing of off-the-shelf iPSC-based cell therapy products. With a leading team of cell therapy experts, Evotec (Modena) adds a high-quality cGMP manufacturing site to the EVOcells platform therefore adding capacity, critical expertise and capabilities to the critical scale-up of complex cell-based therapies.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "The Evotec Cell Accelerator gives us the opportunity to take our cell therapy business to the next level. We are extremely confident that this important addition to our EVOcells platform will enable us to progress our internal portfolio of early innovative projects. Further, the addition will allow us to enter new partnerships and support many projects towards clinical applications and onto the market in a very efficient way. This will have a significant impact to a great number of patients who are significantly under-served with the currently available treatment regimens."

Prof. Massimo Dominici, Scientific Director, Evotec (Modena) and Professor of Oncology at the University of Modena and Reggio Emilia, said: "We are very pleased that the acquisition of Rigenerand has been finalised and the teams have started working together as one. The concept of the Evotec Cell Accelerator is already coming to life and matches what is happening in Modena: enriching the pre-existing know-how through the experienced Evotec team. I am therefore convinced that the field has a new player capable of addressing the challenges of next generation cell therapy products, accelerating their development and manufacturing towards the clinic."

On July 5, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immuneoncology vaccines and drug delivery technologies, is pleased to reported an update on its ADC programsin development using Defence’s AccumTM, including key in vivo studies with worldwide collaborators (Press release, Defence Therapeutics, JUL 5, 2022, View Source [SID1234626251]).

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The world-renowned Curie Institute, one of Defence’s collaborator, is currently performing therapeutic efficacy study of AccumTM-T-DM1 Antibody Drug Conjugate ("ADC") in patientderived xenograft ("PDX") model of breast cancer, including in 3 HER2+ and in 1 triple-negative PDX. It will be immediately followed by a head-to-head toxicology and pharmacokinetic profile comparisons study of T-DM1 versus AccumTM T-DM1 in mice. Results are expected in Q3-Q4 of this year. T-DM1 (Kadcyla) is currently used to treat women with metastatic HER2-positive breast cancer. This study is to prove that the current treatment may be optimized using Defence’s AccumTM technology to enhance the drug delivery to the tumor cells. Estimated sales of Kadcyla in 2022 are $3.02 Billion USD.

Defence is continuing its collaboration with the HUS Comprehensive Cancer Center, Finland’s largest and most versatile cancer treatment center, which is currently performing advanced in vivo studies, including head-to-head comparisons of T-DM1 vs AccumTM-T-DM1 vs co-treatment with intratumorally injection of AccuTOXTM variants using different PDX models with established and non-established tumors. Linking the AccumTM to an ADC triggers endosomal escape increasing therefore ADCs intracellular accumulation and cytotoxicity potency. AccuTOXTM variants induce cancer cell death through ROS production and endosome rupture. Results of those key studies with HUS are expected in Q4 of this year.

The Institut de Recherche en Cancérologie de Montpellier (IRCM), an internationally recognized institute for its translational research and expertise’s in immunotherapy and radiotherapy, is currently performing in vivo studies using AccumTM with radio-immuno-therapeutic conjugates. Combining the AccumTM technology to the radio-immuno-conjugate is expected to amplify the therapeutic index of the drug while minimizing side effects observed in patients undergoing the therapy. Results of those studies with IRCM are expected to be known in Q3-Q4 of 2022. The Radiopharmaceuticals Market is projected to reach US$ 13.818 billion by 2028 from US$ 7.55 billion in 2021; it is expected to grow at a CAGR of 9.0% during 2021–2028.

Defence is also collaborating with WASSC Technologies, a biotech company specialized in protein conjugations, small molecules, and ADCs, to develop a new small molecule for ADC application. Toxicity results of variants are expected for Q3 of 2022 and antibody conjugation shall begin in Q4 of 2022.

"Defence’s AccumTM platform has been primarily developed and tested in vitro and in vivo to enhance the intranuclear drug delivery on multiple FDA approved antibody-conjugates or new conjugates under development. We strongly believe that all those key results coming this year related to AccumTM-ADCs will continue to demonstrate the potency of our AccumTM technology and bring Defence to another level", says Mr. Sebastien Plouffe, the CEO of Defence Therapeutics

On July 5, 2022 AstraZeneca reported an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma1 (Press release, AstraZeneca, JUL 5, 2022, View Source [SID1234616462]).

The acquisition of TNB-486 aims to accelerate the development of this potential new medicine for B-cell haematologic malignancies, including diffuse large B-cell lymphoma and follicular lymphoma. Building on the success of Calquence (acalabrutinib), TNB-486 further diversifies AstraZeneca’s haematology pipeline that spans multiple therapeutic modalities and mechanisms to address a broad spectrum of blood cancers.

TNB-486 belongs to a class of therapeutic antibodies known as T-cell engagers, which are emerging as a promising therapeutic approach in haematologic malignancies and solid tumours. T-cell engagers are bispecific molecules that are engineered to redirect the immune system’s T-cells to recognise and kill cancer cells. By binding to both CD19, an antigen expressed on B-cells, and to the CD3 receptor on T-cells, TNB-486 activates and recruits T-cells to CD19-expressing tumours where they can elicit an immune response.

Anas Younes, Senior Vice President Haematology R&D, AstraZeneca said: "By redirecting the body’s natural immune response to target B-cell malignancies, TNB-486 alone or in combination with CD20-targeted therapy could potentially deepen clinical responses and improve patient outcomes. We believe this innovative molecule, which was designed to optimise the therapeutic window of T-cell activation, will enable us to explore novel combinations that have the potential to become new standards of care in this setting."

Financial considerations
AstraZeneca will acquire all outstanding equity of TeneoTwo in exchange for an upfront payment of $100m on deal closing.

Under the terms of the agreement, AstraZeneca will make additional contingent R&D-related milestone payments of up to $805m and additional contingent commercial-related milestone payments of up to $360m to TeneoTwo’s equity holders.

Overall, the transaction will be accounted for as an intangible asset acquisition, recognised initially at the present value of non-contingent consideration, with future milestones capitalised into the intangible asset as they are recognised.

The transaction is expected to close in the third quarter of 2022, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2022.

iTeneoTwo, Inc., is a majority owned subsidiary company of TBio, LLC, a limited liability company formed in Delaware, US

Notes

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. We have expanded our commitment to patients with haematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion, allowing us to reach more patients with high unmet needs. By applying our deep understanding of blood cancers, leveraging our strength in solid tumour oncology and delivering on Alexion’s pioneering legacy in complement science to provide transformative medicines for rare diseases, we are pursuing the end-to-end development of novel therapies designed to target underlying drivers of disease.

By targeting haematological conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact.

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On July 5, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the results of a study to determine whether a previous established quantitative real-time PCR (qRT-PCR) could be used as a quality control test for its CypCaps product candidate (Press release, PharmaCyte Biotech, JUL 5, 2022, View Source [SID1234616478]). The qRT-PCR was used to gain data from testing of syringes from clinical batches of PharmaCyte’s cGMP production for its planned clinical trial in locally advanced, inoperable pancreatic cancer.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented on this new confirming assay, saying, "With the completion of this study, the Company has fulfilled one more important item from the long list of required U.S. Food and Drug Administration (FDA) tasks for our pancreatic cancer product candidate. We are particularly pleased that this independently performed qRT-PCR shows yet again the stability at the genetic level of the cytochrome P450 expressing cells which form the engine for our CypCaps clinical trial product. Additionally, we continue to make uninterrupted progress and remain steadfast in our efforts to resubmit an Investigational New Drug Application to the FDA and have our clinical hold lifted."

The study, performed by a third-party laboratory, confirmed that the qRT-PCR can be successfully implemented for testing, and it also confirmed the identity and stability of the cytochrome P450 expression construct in the cells used for the production of CypCaps both before and after encapsulation in the cGMP batches. The qRT-PCR will thus be used as a quality control (QC) release assay on future cGMP-grade clinical batches of CypCaps. The results obtained from the newly reported study also serve as additional evidence that the integrated cytochrome P450 construct is highly stable in the clinical cell line used for CypCaps.

PharmaCyte is at the tail end of its process of fulfilling the FDA’s requests to enable the clinical hold to be lifted, having now successfully completed almost two dozen studies with only a few remaining to be completed. The Company expects to commence its two-phase pig study shortly, which is the last major study from the FDA.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On July 5, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that CEO and Co-Founder, Mr. James Nathanielsz, BAS, MEI, expresses confidence over the Company’s growing intellectual property portfolio (Press release, Propanc, JUL 5, 2022, View Source [SID1234616463]). Presently, there are 39 granted patents and a further 26 patent applications under examination in key global jurisdictions relating to proenzymes as an effective therapeutic agent against solid tumors, covering the lead product candidate, PRP.

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The Company’s patent portfolio covers compositions of the PRP formulation and method of use claims for the treatment of solid tumors by targeting and eradicating cancer stem cells. Further patent applications are anticipated capturing the application of PRP in the clinic as an addition to the treatment process for advanced cancer patients suffering from solid tumors, as well as describing novel pharmaceutical compositions of PRP. The development of a synthetic version of PRP, which is produced in the laboratory and not derived from animal sources is also underway via the Company’s "POP1", Joint Research and Drug Discovery Program with the Universities of Jaén and Granada, and is also advancing towards the Company filing for patent protection in key global jurisdictions.

"When Dr. Kenyon and I cofounded Propanc back in the late 2000’s, we were told there were limited opportunities for patentability of proenzymes for cancer treatment, especially when the key pharmaceutical ingredients are naturally derived," said Mr. Nathanielsz. "Nevertheless, Dr Kenyon and I were determined to advance our scientific research programs because we believe in the potential of proenzymes as an effective, less toxic, long term treatment option for advanced cancer patients, based on the observations from the compassionate use investigator study implemented by Dr. Kenyon. The fact there was limited prior art meant that our approach to cancer is unique if we could identify a novel formulation. PRP reflects the tireless efforts of Dr. Kenyon and our team of researchers who identified a unique, synergistic combination of two proenzymes, trypsinogen and chymotrypsinogen, when exposed to solid tumors, target and eradicate cancer stem cells, irreversibly. Over a decade later, we have filed multiple patents covering compositions of proenzymes and a method to treat metastatic cancer by targeting CSCs. We’re now at the stage where the advancement of PRP along the development pathway, as well as development of backup clinical compounds have strong potential to add to our intellectual property portfolio. Given there are no other companies that we are aware of pursuing the application of proenzymes against metastatic cancer, means that we are in a privileged position to make a significant contribution to the way we treat cancer patients suffering from late-stage metastatic cancer as a long term, therapeutic option. We remain passionate and resolute in our belief in the potential of this treatment today, as we were 15 years ago when we co-founded our Company. We strongly desire to unlock the value of our IP for our longtime shareholders who share in our belief in the Company and its technology."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.