On August 2, 2021 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported that Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer, will participate in the Wedbush PacGrow Healthcare Conference, to be held virtually from August 10-11, 2021 (Press release, Apexigen, AUG 2, 2021, View Source [SID1234590988]).

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Wedbush PacGrow Healthcare Conference
Panel discussion: For Your IOnly – Progress, Challenges in Immuno-Oncology
Wednesday, August 11, 2021, at 12:35 p.m. ET

The webcast of the Wedbush panel discussion will be accessible in the News & Events section of the Apexigen website at View Source

On August 2, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that the FDA has authorized Sorrento’s IND application for the Phase 1 clinical testing of its allogeneic anti-CD38 Dimeric Antigen Receptor (DAR) – T Cell therapy for relapsed or refractory multiple myeloma (Press release, Sorrento Therapeutics, AUG 2, 2021, View Source [SID1234585537]). The proprietary CD38 DAR-T cell therapy candidate demonstrated strong cytotoxic activity in preclinical studies. DAR-T product candidates are produced using Sorrento’s proprietary, non-viral knockout-knockin (KOKI) technology, which potentially allows for improved specificity, stability and potency, and enables an off-the-shelf treatment approach, thereby eliminating the need for patients to undergo leukapheresis and undesirable treatment delays to perform cell harvesting, manufacturing and release prior to treatment for each individual cancer patient.

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Sorrento’s KOKI-enabled DAR-T platform uses DAR-modified T cells from a normal healthy donor which are engineered to be specific to the cell surface marker of interest, in this case CD38, a clinically validated antigen in myeloma, to target tumor cells. The combination of KOKI and DAR-T technologies offers potential advantages over conventional CAR-T therapies, including removing the ability for DAR-expressing T cells to illicit undesired immune reaction to the cancer patient, thereby reducing or eliminating the possibility of graft versus host disease (GvHD) following treatment. Additionally, once DAR-T cells are manufactured, they can be stored at the clinic site, allowing patients to be screened and treated within days. This is compared to existing approved CAR-T therapies, which typically require 6-8 weeks of screening, cell production and qualification before a patient can receive treatment. Because of this timeframe, it is not unusual for cancer patients to no longer be eligible for CAR-T treatment due to disease progression. Also, autologous CAR-T cells pose several manufacturing challenges, including issues that relate to quality control and single-lot-release, and often do not meet the release criteria following the manufacturing process. DAR-T technology is designed to potentially provide a significant advancement to the timeliness and potency of treatments for patient populations who have already undergone multiple rounds of chemotherapy and are suffering from persistent disease.

DAR-T technology is readily adaptable to dozens of cancer targets and Sorrento has developed a preclinical product pipeline with specific fully human antibodies discovered from Sorrento’s G-MAB library. Sorrento expects to file additional IND applications now that the first DAR-T Phase 1 trial has been cleared to proceed by the FDA.

"This FDA clearance of our first allogeneic DAR-T cell therapy is a seminal event for our cutting-edge KOKI and DAR-T technologies," said Henry Ji, Ph.D., Chairman and CEO of Sorrento. "We foresee the first "Off-the-Shelf" DAR-T trial will open the door to numerous other DAR-T cell therapies for other indications to follow."

About the DAR-T Platform

Sorrento’s DAR-T technology is a proprietary, next-generation cell therapy platform that offers potential advantages over conventional Chimeric Antigen Receptor (CAR) T cell therapy:

The proprietary DAR construct utilizes a natural antibody Fab (antigen-binding fragment) structure instead of an artificial scFv (single-chain variable fragment) sequence.
Preclinical in vitro and in vivo studies have demonstrated that DAR-T cells provide better target specificity and functionality, due to higher inherent stability of the Fab and stronger affinity of DAR vs. CAR receptors on the T cell surface.
DAR-T cells may reduce potential undesirable side effects, such as CAR-T induced cytokine release syndrome (CRS) and graft-versus-host disease (GvHD).
About KOKI Technology

Sorrento’s proprietary, non-viral knockout-knockin (KOKI) technology provides DAR-T cells with several potential benefits over virus-based transduction currently used for CAR-T therapies:

"Off-the-Shelf": DAR-T cells are cryo-preserved engineered T cells designed to be delivered to patients on-demand without delays in treatment due to the lengthy and individualized manufacturing process for CAR-T.
"Allogeneic": DAR-T cells are produced from pre-screened healthy volunteers; while autologous CAR-T cells are patient-specific and made from and for individual cancer patients.
"Mass Production": DAR-T cell manufacturing is scalable (potentially hundreds to thousands of doses per manufacturing run) and can meet high demand while autologous CAR-T cell therapy requires a single-lot-release process that can only be performed one patient at a time.

On August 2, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCBD) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that The Nasdaq Stock Market LLC (Nasdaq) has approved the listing of the Company’s common stock on Nasdaq (Press release, PharmaCyte Biotech (BioStrat), AUG 2, 2021, View Source [SID1234585552]). The Company’s common stock will be listed on Nasdaq under the symbol "PMCB." PharmaCyte also announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock (or pre-funded warrants to purchase common stock in lieu of common stock) and warrants to purchase shares of common stock in an underwritten public offering.

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With respect to the proposed public offering, the Company expects to grant the underwriter a 30-day option to purchase additional shares of its common stock and/or warrants to purchase shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the securities to be sold in the offering are to be offered by PharmaCyte.

H.C. Wainwright is acting as sole book-running manager for the proposed offering.

The Company’s common stock will continue to trade on the OTC Markets quotation system on the OTCQB Venture Market until trading commences on Nasdaq, which the Company expects to occur following the pricing of the proposed public offering. The offering, however, is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

PharmaCyte intends to use the net proceeds of this offering (i) to complete activities requested by the U.S. Food and Drug Administration (FDA) in order to address the FDA’s clinical hold on its Investigational New Drug application (IND) with respect to the Company’s planned Phase 2b clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC), including conducting several additional preclinical studies and assays and providing the FDA with the additional information it requested, (ii) to begin to fund and conduct the Phase 2b clinical trial in LAPC, if and when the clinical hold on the IND is lifted, and (iii) for general working capital purposes.

The securities described above are being offered by PharmaCyte pursuant to a shelf registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the Securities and Exchange Commission (SEC) on April 14, 2021. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and the accompanying prospectus forming a part of the registration statement.

On August 2, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has launched FoundationOne Liquid CDx Cancer Genomic Profile as a liquid biopsy-based comprehensive genomic profiling (CGP) test for solid tumor, following the product’s listing on the national health insurance (NHI) reimbursement price list on August 1, 2021 (Press release, Chugai, AUG 2, 2021, View Source [SID1234585500]). In addition, SRL Inc., the clinical laboratory testing company has started providing testing services for the product today. FoundationOne Liquid CDx Cancer Genomic Profile was approved by the Ministry of Health, Labour and Welfare (MHLW) on March 22, 2021 for use as a companion diagnostic (CDx) for certain approved targeted therapies in Japan, making it the first MHLW-approved blood-based test with both CDx and solid tumor CGP indications.

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"We are very pleased that we can start providing FoundationOne Liquid CDx Cancer Genomic Profile, a blood-based CGP testing option for patients today. The test provides meaningful information that can help inform treatment for patients with advanced or recurrent cancer, which is especially valuable if they are not eligible for tissue-based CGP testing," said Chugai’s president and CEO Dr. Osamu Okuda. "We are committed to advance personalized healthcare through expanding access to CGP testing."

Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a blood-based diagnostic test that uses next-generation sequencing. It identifies genomic alterations in 324 cancer-related genes for cancer patients with solid tumors through detection of blood circulating tumor DNA (ctDNA). FoundationOne Liquid CDx Cancer Genomic Profile provides an integrated test report informing alterations matched to MHLW-approved targeted therapies.

As a leading company in the field of oncology, Chugai is committed to advance personalized healthcare in oncology and contributing to patients and healthcare professionals through improving access to CGP.

Approval information

Brand name FoundationOne Liquid CDx Cancer Genomic Profile
Japanese medical device nomenclature (JMDN)
Software for gene variants analysis (for cancer genome profiling)
Software for analysis of somatic cell gene variants (for eligibility identification of antineoplastic agents)
Intended uses or indications
The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib maleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alteration Prostate cancer olaparib
Conditions for approval
The necessary measures must be taken to ensure that the product is used by a physician with adequate knowledge and experience of cancer genomic medicine at a medical institution with a cancer genome profiling-based medical system pursuant to the "Guidelines for the Development of Core Hospitals and Other Facilities for Cancer Genomic Medicine," and in compliance with the scope and timing of testing stipulated in the most recent guidelines, etc., of relevant academic societies.
Appropriate procedures and controls to protect personal information and up-to-date security and privacy protection measures to prevent unauthorized access must be implemented for blood samples sent to the laboratory and for information obtained from these specimens.
Quality control of input data must be performed as described in the Remarks column of the attached Application Form. Any changes to the quality control of input data as described in the Remarks column of the Application Form (excluding minor changes specified by Order of the MHLW in Article 23-2-5, paragraph (15) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices ["the Act"]) must be approved by the MHLW Minister pursuant to Article 23-2-5, paragraph (15) of the Act. Note that this approval applies mutatis mutandis to the provisions of Article 23-2-5 paragraph (17), Article 23-2-6, and Article 23-2-7 of the Act.
Date of NHI reimbursement price listing: August 1, 2021
About FoundationOne Liquid CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through detection of blood circulating tumor DNA (ctDNA). The test is approved by the MHLW for use in cancer genome profiling to report substitutions, insertion and deletion alterations, and select gene rearrangements for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the prescribing information.

Trademarks used or mentioned in this release are protected by laws.

On August 2, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the second quarter ending June 30, 2021 and provided a corporate update (Press release, VBI Vaccines, AUG 2, 2021, View Source [SID1234585517]).

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Jeff Baxter, VBI’s President and CEO commented: "The second quarter of 2021 was a data-rich period for the Company, with positive results across our lead programs, leading to meaningful advancement of our pipeline. As a result of the encouraging data reported in Q2, the FDA granted Fast Track Designation for VBI-1901 in recurrent GBM, we demonstrated the potency of the eVLP particulate delivery platform against COVID-19, supporting the assessment of our COVID-19 Beta variant vaccine candidate in the next phase of development, and we initiated a first-in-class Phase 2 combination study assessing a potential functional cure regimen for chronic HBV infection. Additionally, as we advance towards our PDUFA target action date for our 3-antigen prophylactic HBV vaccine candidate, we continue to lay the groundwork for the commercial launch, subject to regulatory approvals. The AMA established a unique CPT Code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) Vaccine, a meaningful milestone as it reinforces the scientific differentiation of our candidate and enables a streamlined reimbursement process. At the beginning of the year, we laid out an ambitious and aggressive plan for the development of our pipeline in 2021, and in the first half of the year we’ve successfully executed against that plan. We look forward to sharing upcoming data and regulatory milestones as we move into the second half of 2021."

Q2 2021 Key Program Achievements and Anticipated Upcoming Milestones

Hepatitis B (HBV)
3-Antigen HBV Prophylactic Vaccine Candidate

November 30, 2021: U.S. Prescription Drug User Fee Act (PDUFA) target action date set by U.S. Food and Drug Administration (FDA)
European Medicines Agency (EMA) regulatory review ongoing, following acceptance of Marketing Authorization Application (MAA) filing in December 2020
July 2021: The American Medical Association (AMA) Current Procedural Terminology (CPT) Panel established a unique CPT code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine, under which VBI’s vaccine candidate will be reported if approved
Submissions to United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and to Health Canada are in process and are expected to be completed in 2021
VBI-2601 (BRII-179) : HBV Immunotherapeutic Candidate

April and June 2021: Complete Phase 1b/2a study dataset announced – EASL presentation selected for inclusion in the "Best of the International Liver Congress" summary, highlighting the most noteworthy contributions to the scientific program. Data demonstrated:
VBI-2601 (BRII-179) induced both B cell (antibody) and T cell responses in chronically-infected HBV patients and was well-tolerated with no safety signals observed
Evidence to support further clinical evaluation of VBI-2601 (BRII-179) as an immunomodulator in combination with other treatment modalities as a potential functional cure for chronic HBV infection
April 2021: Phase 2 combination study of VBI-2601 (BRII-179) and BRII-835 (VIR-2218), Vir Biotechnology’s investigational HBV-targeting siRNA, initiated by partner, Brii Biosciences (Brii Bio)
COVID-19 & Coronaviruses
VBI-2900 : eVLP Coronavirus Vaccine Program

June 2021: Initial positive Phase 1 data of VBI-2902 announced, demonstrating that a 5µg dose, which expresses an optimized form of the SARS-CoV-2 spike antigen and is adjuvanted with aluminum phosphate, was generally well-tolerated and elicited a potent immune response significantly higher than that seen in human convalescent sera. Notably:
Safety and tolerability: VBI-2902 was well-tolerated with no safety signals observed, and no increase in reactogenicity with subsequent doses
Neutralizing titers: After two doses, VBI-2902 induced neutralization titers in 100% of participants, with 4.3x the geometric mean titer (GMT) compared to convalescent sera
Antibody binding titers: After two doses, VBI-2902 induced antibody binding titers in 100% of participants, with peak antibody binding GMT of 1:4,047 – 5.0x the GMT compared to convalescent sera
Q3 2021 : As a result of this platform-validating initial data, and in response to the increased circulation of COVID-19 variants, the next phase of the ongoing adaptive Phase 1/2 study, expected to initiate in Q3 2021, will assess VBI-2905, VBI’s eVLP vaccine candidate directed against the COVID-19 Beta variant
H1 2022 : Expected initiation of the first clinical study of VBI’s multivalent vaccine candidate, designed to increase the breadth of protection against known and emerging variants of COVID-19
Glioblastoma (GBM)
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

June 2021: Positive data from Phase 2a (Part B) of ongoing Phase 1/2a study presented at ASCO (Free ASCO Whitepaper), including:
VBI-1901 + GM-CSF study arm:
6-month and 12-month OS: 80% (n=8/10) and 60% (n=6/10), compared to historical controls of 60% and 30%1, respectively
2 durable partial responses (≥ 50% tumor reduction) and 2 stable disease observations – 40% disease control rate
VBI-1901 + GSK’s AS012 adjuvant system study arm:
6-month OS: 89% (n=8/9); 12-month OS timepoint not yet reached
5 stable disease observations – 50% disease control rate
June 2021: FDA Fast Track Designation granted for VBI-1901 + GM-CSF in first recurrent GBM patients
Q4 2021: Expected initiation of a randomized, controlled clinical study with registration potential
Recent Peer-Reviewed Publications

May 2021: The Lancet Infectious Diseases publication of data from PROTECT – Phase 3 immunogenicity and safety study assessing VBI’s 3-antigen HBV vaccine candidate compared to Engerix-B in adults age 18 and older. Link to publication can be found here.
June 2021: Vaccine publication of data from a Phase 3 immunogenicity and safety study, conducted in Vietnam and completed in 2007, assessing VBI’s 3-antigen HBV vaccine candidate in healthy Asian adults. Link to publication can be found here.
July 2021: Vaccine publication of data from VBI-2902a preclinical and challenge COVID-19 studies. Link to publication can be found here.
Additional Corporate Updates

Board Appointment: In July 2021, VBI appointed Linda Bain, CFO of Codiak BioSciences, Inc., to the Company’s Board of Directors
Debt Financing: In May 2021, VBI drew down a $12 million second tranche under its debt financing facility with K2 Healthventures, bringing the amount drawn to-date to $32 million
Second Quarter 2021 Financial Results

Cash Position: VBI ended the second quarter of 2021 with $135.0 million in cash, cash equivalents, and short-term investments compared with $119.1 million as of December 31, 2020.
Net Cash Used in Operating Activities: Net cash used in operating activities for the six months ended June 30, 2021 was $17.4 million, compared to $15.5 million for the same period in 2020. The increase in cash outflows is largely a result of an increase in net loss, offset by the change in operating working capital, notably the cash received in advance from the CEPI funding agreement.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $1.0 million for the six months ended June 30, 2021, compared to $0.3 million for the same period in 2020. The increase is a result of routine purchases of property and equipment in Rehovot, Israel.
Revenue: Revenue in the second quarter of 2021 was $0.1 million, compared to $0.2 million for the same period in 2020. The decrease in revenues was due to a decrease in R&D services revenue as part of the collaboration with Brii Bio. Fewer manufacturing and non-clinical research services were required in the three months ending June 30, 2021 compared to the three months ending June 30, 2020.
Cost of Revenues: Cost of revenues was $2.6 million in the second quarter of 2021 as compared to $2.1 million for the same period in 2020. The increase in the cost of revenues was due to increased outsourced testing costs and inventory-related costs incurred in the three months ending June 30, 2021 compared to the same period in 2020.
Research and Development (R&D): R&D expenses for the second quarter of 2021 were $4.6 million compared to $2.4 million in the second quarter of 2020. The increase was a result of increased expenses related to our coronavirus vaccine program, including the Phase 1 clinical study of VBI-2902 and development and manufacture of VBI-2905, offset by government grants and funding arrangements. The increase was also due to an increase in R&D expenses related to the development of our other vaccine candidates, which was offset by a decrease in regulatory costs related to the BLA submission for the 3-antigen prophylactic HBV vaccine candidate that was submitted in 2020.
General and Administrative (G&A): G&A expenses were $9.4 million for the second quarter of 2021, compared to $3.9 million for the same period in 2020. The increase was a result of the increased pre-commercialization activities related to the 3-antigen prophylactic HBV vaccine candidate in preparation for potential regulatory approvals, in addition to increased insurance and labor costs.
Net Loss: Net Loss and net loss per share for the second quarter of 2021 were $17.5 million and $0.07, respectively, compared to a net loss of $9.5 million and a net loss per share of $0.04 for the second quarter of 2020.