On May 18, 2022 SQZ Biotechnologies (NYSE: SQZ) reported that the company’s first generation, integrated point-of-care (POC) cell therapy manufacturing system demonstrated superior process performance and comparable or improved product specifications relative to current clean room-based processes used in clinical development (Press release, SQZ Biotech, MAY 18, 2022, View Source [SID1234614824]). The non-clinical studies showed that the SQZ POC system could produce the company’s red blood cell derived SQZ Activating Antigen Carrier (AAC) therapeutic candidate for the treatment of HPV16 positive solid tumors in half the time (under 6 hours), with 90 percent fewer operator hours, while producing comparable drug product. The system is also compatible with hematopoietic stem cells and peripheral immune cells, including B cells, T cells, NK cells, and Monocytes. Data was presented today at the 2022 American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting.

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"We are tremendously excited with the cell therapy production data from our prototype point-of-care manufacturing system, which has the potential to produce cell therapies using a range of cell types," said Howard Bernstein, M.D., Ph.D., Chief Scientific Officer at SQZ Biotechnologies. "Our current clinical manufacturing process is under 24 hours – comparatively faster than other cell therapy manufacturing approaches. Our integrated point-of-care platform represents a further leap with faster production in a closed system that could eliminate the need for an ISO 7 clean room. We look forward to its planned first clinical use in our red blood cell derived SQZ TAC program for celiac disease."

The company anticipates a SQZ TAC IND submission for celiac disease in the first half of 2023. Celiac disease impacts a large patient population globally and it, like many other diseases, could benefit from a scalable, decentralized cell therapy manufacturing model. Manufacturing the first SQZ TAC clinical candidate on the SQZ POC system will further the development of this decentralized model and support potential future use of the POC system across disease areas.

The SQZ POC manufacturing system integrates and automates, among other things, cell isolation, cell washing, Cell Squeeze intracellular delivery technology, and product filling. The system is designed to process patient material within a closed, single-use sterile disposable kit. The system architecture offers the potential to be operated outside of an ISO 7 clean room typically required of cell therapies—which could ultimately allow cell therapy manufacturing by SQZ POC systems in a variety of care settings.

In addition to the SQZ POC presentation at ASGCT (Free ASGCT Whitepaper), preclinical data were presented on the first study findings of the planned commercial research-use-only (RUO) microfluidic delivery system. The RUO presentation highlighted the gentle, yet efficient, nature of the intracellular delivery system. Data demonstrated the ability to effectively deliver and express mRNA in unactivated T and NK cells as well as to gene edit unactivated T cells with limited impact to viability and downstream function.

Cell Squeeze gene editing of autologous hematopoietic stem cells (HSCs) was also presented at the conference. The HSC editing preclinical data demonstrated that the Cell Squeeze platform could efficiently deliver mRNA and RNPs into HSCs, a sensitive cell type that has been limited previously by toxicity, cargo restrictions, and scalability using other cell engineering approaches. Analysis of the Cell Squeeze processed HSCs determined that their phenotype was maintained in vitro and in vivo illustrating its broad potential for use in certain rare and genetic disease indications.

ASGCT POINT-OF-CARE MANUFACTURING DATA HIGHLIGHTS

Average processing time per batch run reduced by 55 percent, from 12 hours 45 minutes to 5 hours 45 minutes
Required person-hours reduced by 90 percent, from 150 hours to 15 hours
Batches showed comparable attributes, including drug and adjuvant content, cell purity, and interferon gamma secretion (a measure of T cell activation)
ASGCT RESEARCH-USE-ONLY (RUO) SYSTEM DATA HIGHLIGHTS

RUO system demonstrated robust CRISPR-Cas9 editing in unactivated human T cells, and efficient delivery and expression of mRNA to unactivated T and NK cells
The gentle nature of the RUO system’s intracellular delivery mechanism resulted in limited impact to T cells. Unactivated T cells retained their unactivated phenotype and demonstrated similar activation and expansion compared to untreated samples
In contrast, electroporation of unactivated T cells resulted in spontaneous increases in pro-inflammatory cytokine transcripts and secretion, independent of TCR engagement
ASGCT HEMATOPOIETIC STEM CELL (HSC) DATA HIGHLIGHTS

Cell Squeeze technology efficiently delivered mRNA and RNPs into HSCs; 90 percent of HSCs expressed transferred mRNA, and high editing rates were achieved using B2M and CCR5 targeting RNPs
HSC phenotype was maintained following Cell Squeeze treatment compared to controls as determined by microarray analysis, CFC assay, and NBSGW mouse engraftment study
Cell Squeeze treated HSCs could be transferred immediately following treatment, and demonstrated superior engraftment versus electroporation
R&D INVESTOR EVENT DETAILS

The company will host a live R&D Investor event with optional virtual participation on Thursday, May 19, 2022, beginning at 4:05 p.m. ET. Onsite and virtual participants can register in advance by completing the registration form on the event website: View Source Following the event, a webcast replay will be made available on the company’s investor website: investors.sqzbiotech.com.

ASGCT PRESENTATION TITLES AND TIMING

SQZ Point-of-Care Manufacturing Presentation
Title: A Decentralized and Integrated Manufacturing System for the Rapid and Cost-Effective Production of Cell Therapy Drug Products
SQZ Presenter: Maisam Dadgar
Session Title: Cell Therapy Product Engineering, Development or Manufacturing
Abstract Number: 1171
Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

STEMCELL TECHNOLOGIES Immune Cell Engineering Poster Presentation
Title: A New Benchtop System for Simple and Versatile Introduction of Macromolecules into Human Lymphocytes by Microfluidic Squeezing
STEMCELL Presenter: Eric Ouellet, Ph.D.
Session Title: Synthetic/Molecular Conjugates and Physical Methods for Delivery II
Abstract Number: 997
Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

SQZ Hematopoietic Stem Cell Research Presentation
Title: Rapid, Gentle, and Scalable Engineering of Hematopoietic Stem Cells Using Vector-Free Microfluidic Cell Squeeze Technology
SQZ Presenter: Murillo Silva, Ph.D.
Session Title: Cell Therapy Product Engineering, Development or Manufacturing
Abstract Number: 1176
Date & Time: Wednesday, May 18, 2022, from 5:30-6:30 PM

On May 18, 2022 Bavarian Nordic A/S (OMX: BAVA) reported that the share buy-back program, which was announced and initiated on May 9, 2022, has now been terminated, as the intended number of shares under the program has been repurchased (Press release, Bavarian Nordic, MAY 18, 2022, View Source [SID1234614823]). The program was executed in accordance with the provisions of Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse and supplementing Regulation (EU) 2016/1052 of 8 March 2016, which together constitute the Safe Harbour Regulation. The purpose of the program was to meet the Company’s obligations arising from the share-based incentive program for the Board of Directors and Executive Management.

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Under the program Bavarian Nordic A/S has bought back 71,562 shares, cf. the table below:

Transaction date Number of shares Average purchase price, DKK Transaction Value, DKK

The details for each transaction made under the share repurchase program have been attached to this announcement.

With the transactions stated above, Bavarian Nordic A/S owns a total of 146,330 own shares, corresponding to 0.21% of the share capital. The total amount of shares in the company is 70,472,935 including treasury shares.

On May 18, 2022 DURECT Corporation (Nasdaq: DRRX) reported that Dr. James E. Brown, President and CEO, Dr. Norman Sussman, Chief Medical Officer, and Dr. WeiQi Lin, Executive Vice President of R&D, will be participating in a fireside chat hosted by Ed Arce, Managing Director of Equity Research at H.C. Wainwright (Press release, DURECT, MAY 18, 2022, https://investors.durect.com/news-releases/news-release-details/durect-corporation-present-hc-wainwright-global-investment [SID1234614822]).

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The webcast link of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking on "Event Calendar" under the "Investors" section.

Management will also be available for virtual 1×1 meetings from May 23-25, 2022 during the conference. If attendees would like to request a meeting, please contact H.C. Wainwright directly.

On May 18, 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 the Company is undertaking manufacturing and development of PRP for human use (Press release, Propanc, MAY 18, 2022, View Source [SID1234614820]). PRP is the Company’s lead product candidate and is a novel pharmaceutical formulation consisting of two proenzymes to be administered by I.V. injection in a world first, First-In-Human (FIH) study in advanced cancer patients. It is a long-term therapy for the treatment and prevention of metastatic cancer in patients suffering from solid tumors.

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To date, the Company has sourced the two proenzymes from a raw material supplier, where an isolation process for both ingredients have been established and scaled up. The proenzymes are extracted, precipitated and lyophilized (freeze dried by a low temperature dehydration process), serving as the raw materials for GMP (Good Manufacturing Practice) manufacture of the finished drug product. A proprietary purification process has been developed by Propanc and successful scale up of the bulk drug substances has been completed. Over 95% purity for each of the proenzymes was achieved to reach pharmaceutical standard for the final drug product. This reduces impurities, resulting in a more stable product with a longer shelf life, as the active enzymes have the potential to ‘auto-catalyze’ meaning they can potentially self-activate. Therefore, the novel formulation consists of two proenzymes prepared in individual vials ready to be mixed into a solution for I.V. injection for the upcoming Phase I, FIH study.

According to Dr. Linda Isaacs M.D., Integrative Cancer Therapies, January 2022, since the turn of the last century, based on the original hypothesis of Professor John Beard from Edinburgh University, the trophoblastic theory and the origin of cancer, numerous physicians have been injecting enzyme preparations into cancer patients with both startling, but also mixed success. One reason was attributed by Beard to the "wide variation" in the quality available enzymes that he believed explained why the treatment was sometimes unsuccessful. In the following years, there were numerous attempts at injection of enzymes, which led to the US Food and Drug Administration prohibiting intravenous and injectable enzymes, presumably due to the uncontrolled nature of the administration to patients. Despite this, Dr Isaacs concludes that an intravenous formulation for use in humans would offer "considerable advantages", whilst also acknowledging the considerable developmental costs.

Over the last decade, Propanc has undertaken the manufacturing and development of proenzymes as an I.V. formulation and conducted several scientific advice meetings with the Medicines and Healthcare Products Regulatory Agency (MHRA) UK to determine the pathway for the clinical development of PRP. The Company has also sourced suitable quality proenzymes for the commercial scale quantities needed for global pharmaceutical distribution and is ready to undertake the full scale GMP manufacture of PRP in preparation for the upcoming Phase I FIH study in advanced cancer patients.

"We have spent significant time and resources on the manufacturing and development of PRP as we prepare for our Phase I, FIH study in advanced cancer patients," said James Nathanielsz, Propanc’s Chief Executive Officer. "Undertaking the steps necessary to purify and scale up the bulk drug substances is critical to producing a quality product according to pharmaceutical standard, which we intend to seek regulatory approval for worldwide distribution. Our novel pharmaceutical formulation is a world-first approach using a technology with over 100 years of clinical experience, since Professor John Beard first proposed the use of enzymes as a novel way to treat cancer. By advancing PRP through the drug development process, we remain committed to achieving a vision of producing a long-term approach for the treatment and prevention of metastatic cancer from solid tumors, which remains the main cause of patient death for sufferers."

Professor Klaus Kutz, Propanc’s Chief Medical Officer said, "Our lead product candidate, PRP, is a novel, targeted cancer therapy, free from the side effects normally associated with standard treatment approaches. That is why we have worked over several years to overcome the technical challenges to produce a novel pharmaceutical formulation to GMP standard for I.V injection, which is our preferred route of administration in order to increase systemic exposure to treat solid tumors, which may result in better therapeutic efficacy."

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.

On May 18, 2022 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that it has received the first "Therapeutic Accelerator Award" from the Pancreatic Cancer Network (PanCAN) (Press release, Verastem, MAY 18, 2022, View Source [SID1234614819]). The Award will support a Phase 1b/2 clinical trial of the Company’s lead investigational candidates, RAF/MEK Clamp, VS-6766, with FAK inhibitor, defactinib, to evaluate whether a more complete blockade of KRAS signaling, which is mutated in more than 95% of pancreatic cancer tumors, will improve outcomes for patients with front-line metastatic pancreatic cancer.

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"The goal of the Therapeutic Accelerator Award is ultimately to develop new drugs for patients with metastatic pancreatic cancer faster and more efficiently than standard clinical trials," said Julie Fleshman, president and CEO of PanCAN. "We are delighted that Verastem, with rigorous scientific and clinical evidence for addressing this critical pathway, will be the inaugural awardee for this grant. We are looking forward to partnering with them to determine whether their investigational treatment combination will be beneficial to patients."

"We are honored to have been selected for this important award that will expand our development program for VS-6766 and defactinib to evaluate the combination in patients with metastatic pancreatic cancer," said Louis Denis, Chief Medical Officer at Verastem Oncology. "We look forward to a strong collaboration with PanCAN and applaud its commitment to bring patients, academia and industry together to advance the science and accelerate development of much needed novel treatment options for patients."

PanCAN created the Therapeutic Accelerator Award as part of its innovative approach to pancreatic cancer research. This includes grants for scientists across the country as well as large-scale research initiatives such as PanCAN’s Precision PromiseSM Clinical Trial, which seeks to accelerate the approval of new treatment options for pancreatic cancer patients and PanCAN’s Early Detection Initiative, with a goal of developing a strategy to diagnose pancreatic cancer early when surgery is still possible.

Verastem Oncology was selected to receive the 2022 PanCAN Therapeutic Accelerator Award of $3.8M through a rigorous, competitive process involving scientific, business and programmatic review from leading experts in the field.

KRAS is mutated in more than 95% of pancreatic cancers and Verastem Oncology’s RAF/MEK clamp VS-6766 blocks tumorigenic signaling downstream of mutant KRAS. Verastem’s selective FAK inhibitor, defactinib, is included in the trial as FAK has been identified preclinically and clinically as a potential resistance mechanism to RAF and MEK inhibition. FAK inhibition has been shown to reduce stromal density in pancreatic cancer both preclinically and clinically which may enhance anti-tumor immunity and efficacy of the standard gemcitabine/nab-paclitaxel regimen.

About the Pancreatic Cancer Action Network

The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

In contrast to other MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.