CELL AND GENE THERAPY

PDS Biotech Reports An Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

PDS Biotechnology Corporation | December 27, 2021

PDS Biotechnology Corporation, a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, announced that the compensation committee of the board of directors of the Company approved, on December 20, 2021, an equity award to Michael Lalond, the Company’s new Director of Quality Assurance, as a material inducement to Mr. Lalond entering into employment with PDS Biotech.

An inducement grant of 20,000 shares of PDS Biotech’s common stock, in accordance with Nasdaq Listing Rule 5635(c)(4), was awarded as part of Mr. Lalond’s compensation. The award was granted under PDS Biotech’s 2019 Inducement Plan, as amended, in accordance with Nasdaq Listing Rule 5635(c)(4) and provides for the granting of equity awards to new employees of PDS Biotech. The option award has an exercise price of $8.87, the closing price of PDS Biotech’s common stock on December 20, 2021. 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. 

Spotlight

Moderna is focused exclusively on advancing messenger RNA (mRNA) medicines. Using mRNA – a fundamental component of human biology – as a drug, our medicines are sets of instructions that direct cells in the body to make proteins to prevent or fight disease.


Other News
INDUSTRIAL IMPACT

WuXi XDC and AbTis Sign Memorandum of Understanding for Development and Manufacturing of Antibody Drug Conjugates

WuXi Biologics | July 08, 2022

WuXi XDC, a global leading CRDMO dedicated to end-to-end bioconjugates services, and AbTis, a Korean biotechnology company dedicated to the development of antibody drug conjugates announced that a Memorandum of Understanding was signed to form a strategic partnership in AbTis' portfolio of ADC products. Under the partnership, AbTis will have access to WuXi XDC's integrated services for linker and payload manufacturing, ADC conjugation process development, ADC formulation and drug product manufacturing process development, as well as drug substance and drug product manufacturing. This full range of development and manufacturing services will be provided by WuXi XDC at facilities that are all located within a two-hour drive of each other. "We are glad to be collaborating with WuXi XDC. This partnership will allow us to leverage WuXi XDC's world-class expertise in both innovative conjugation technologies and comprehensive capabilities for ADC development and manufacturing. We look forward to making more ADC products accessible to patients." Dr. Sang Jeon Chung, CEO of AbTis "With our integrated services and know-how, we are pleased to be enabling AbTis to develop and manufacture its portfolio of ADC products," said Dr. Jimmy Li, CEO of WuXi XDC. "This strategic partnership demonstrates the trust and confidence our clients have in our end-to-end services, maintained even during the COVID-19 lockdown period, when WuXi XDC teams showcased the strong execution and reflected our commitment to a culture of 'Putting the Customer First.' We will continue to accelerate and transform the discovery, development and manufacturing of bioconjugates, enabling our global partners and benefiting patients worldwide." About AbTis AbTis is a biotechnology company that specializes in antibody-drug conjugates platform technology with its own proprietary patents and its own pipelines in developments in oncology areas. AbTis pipelines are designed to enhance the safety and efficacy of the current antibody-drug conjugates by applying AbTis linker to the mAbs. Its platform ADC linker technology is site-specific and applicable to the native antibodies, commercial antibodies, or novel antibodies under development as it requires no mutation or engineering to antibody itself. Its stable, hydrophilic and cleavable linkers can be attached to various payloads, too. Under the moto of "Patients First", AbTis has been striving to advance its ADC technology and to develop its pipelines with several other antibody and payload companies. AbTis' advanced ADC technology enables partners to co-develop pipelines together in a real open innovation setting. About WuXi XDC WuXi XDC, a joint venture between WuXi Biologics and WuXi STA, provides end-to-end contract research, development and manufacturing of bioconjugates, including antibody drug conjugates (ADCs). The company's services cover antibodies and other biologics, chemical payloads and linkers, as well as bioconjugated drug substance and drug product. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline. As of April 30, 2022, over 240 projects – from early stage to late-stage clinical – are being developed at WuXi XDC, including 26 IND-completed projects and eight projects in phase II/III.

Read More

MEDICAL

MediKarma Selects 1upHealth as its Interoperability Partner to Help Patients Acquire Their Medical Records from Hospital EMRs

1upHealth | June 07, 2022

MediKarma, Inc, a global leader in an AI-based patient engagement, education and navigation platform, has selected 1upHealth, the market leader offering healthcare's most complete FHIR® data platform, as its interoperability partner to help patients request and acquire their medical records through FHIR-based APIs. Fast Healthcare Interoperability Resources (FHIR®) is the future of healthcare that brings together claims and clinical information in one common standard to drive innovation. MediKarma, Inc. intends to upend the healthcare market by providing a consumer-focused platform with personalized human body visualization, a dynamic health score and an AI voice companion that answers the important, recurring question, "What do I do next?" By integrating seamlessly into a consumer's lifestyle and leveraging data from multiple sources, MediKarma reduces friction within the healthcare journey and provides the best next action, which enables an improved healthcare experience. The interoperability partnership between MediKarma and 1upHealth solves two significant user challenges: one, helping patients quickly access all of their medical and EMR records from multiple sources, and two, helping patients make sound decisions about the best way to enable continuous improvements in their personal healthcare. MediKarma's AI-enabled healthcare coach and daily health scores provide easy-to-access and Next Step information for the consumer. Finding a vendor with an accurate, easy-to-navigate records collection capability was paramount when selecting 1upHealth as an interoperability partner, The 1up|Health History app is easy to navigate and enables complete user health history to be integrated into the Medikarma workflow in under an hour." Kris Narayan, CEO of Medikarma. 1upHealth is leading healthcare's conversion to FHIR®, a standard that is based on the same web technologies that have transformed other industries such as retail, travel and finance, We purpose-built a modern data architecture to rebuild how healthcare accesses, stores, analyzes and shares data using a scalable, serverless environment." Joe Gagnon, CEO of 1upHealth. The 1up|Health History application enables individuals to connect and request their health data from the company's integrated network of 10,000+ clinical and payer endpoints. The disparate data is then ingested and conformed into clean FHIR® that is more timely, usable, and computable.

Read More

MEDICAL

Bio-Manufacturing Partner BioElpida Completes Next Phase of BVX-0918 GMP Production for EU Clinical Study

BioVaxys | June 09, 2022

BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company"), announced today that its Lyon, France-based bioproduction partner, BioElpida ("BioElpida"), has completed the creation of multiple OVCAR-3 cell banks as the next step in the GMP manufacturing process development for BVX-0918, BioVaxys' vaccine for treatment of platinum-resistant ovarian cancer. The OVCAR-3 cell line is mandatory for creating the identity assays that will have to be performed on every batch of ovarian cancer vaccine. This assay is required by regulatory bodies in the EU and United States. The cell line is derived from a human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapeutic agent used in late-stage ovarian cancer. Patients whose tumors are innately cisplatin-resistant at the time of initial treatment generally have poor prognosis, which is the patient population target for BVX-0918. Completion of OVCAR-3 cell banks is another step towards our ability to produce GMP yields of BVX-0918, and brings us closer to our Phase I study in the EU planned for later this year." BioVaxys President and Chief Operating Officer Kenneth Kovan. BioVaxys recently entered collaborations with Hospices Civils de Lyon in France and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU. Tumor samples from HCL will also be used for process testing and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production. BioVaxys' vaccine platform is based on the established immunological concept that modifying surface proteins---whether they are viral or tumor---with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient's immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys' cancer vaccines are created by extracting a patient's own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors. A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results. About BioVaxys Technology Corp. Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing vaccines for SARS-CoV-2, SARS-CoV-1, and a pan-sarbecovirus vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents, and multiple US and international patent applications related to its cancer vaccines, antiviral vaccines, and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).

Read More

Cortexyme Successfully Completes Acquisition of Novosteo

Cortexyme | May 21, 2022

Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company developing therapeutic approaches to improve the lives of patients diagnosed with degenerative diseases, today announced the completion of its acquisition of Novosteo, a privately-held biotech company focused on targeted therapeutics to treat rare skeletal diseases, bone cancer and injury. Novosteo stockholders now own approximately 15.5% of the combined company. With the completion of the acquisition, Cortexyme appointed former Novosteo executives Dr. Dirk Thye as Chief Executive Officer, and Dr. Karen Smith as Chief Medical Officer of Cortexyme. Dr. Thye and Dr. Philip Low have been appointed to the Cortexyme’s Board of Directors. Cortexyme plans to change its name to Quince Therapeutics, Inc. in the coming months to reflect the broadening pipeline of the company. Inducement Grant Under Nasdaq Listing Rule 5635(C)(4) In conjunction with the close of the Novosteo acquisition, Cortexyme reported that the Compensation Committee of the company’s Board of Directors approved grants of stock options to purchase an aggregate of 3,744,255 shares of Cortexyme’s common stock, which includes options to purchase (i) 1,979,650 shares to Dr. Dirk Thye, (ii) 1,365,449 shares to Dr. Karen Smith, (iii) 353,656 shares to Brendan Hannah, and (iv) an aggregate of 45,500 shares to six additional newly hired employees. The stock options will be issued under the Cortexyme, Inc. 2022 Inducement Plan with a grant date of May 23, 2022 and an exercise price equal to the closing price of a share of Cortexyme common stock on the grant date. The stock options are being issued as an inducement material to each new employee entering into employment with Cortexyme, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options vest over four years, with 25% vesting on the first anniversary of the vesting commencement date for each employee and the remainder vesting in 36 installments over the following three years, subject to each employee being continuously employed by Cortexyme as of such vesting dates. About Cortexyme Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company dedicated to improving the lives of patients diagnosed with degenerative diseases. The company’s innovative pipeline includes a precision bone growth molecule and drug-targeting platform to treat rare skeletal diseases, bone cancer and injury, in addition to small molecule therapeutics targeting the infectious pathogen P. gingivalis’ role in degenerative disease progression, including for indications such as periodontal disease, oral potentially malignant disorders, and Alzheimer’s disease, among others.

Read More

Spotlight

Moderna is focused exclusively on advancing messenger RNA (mRNA) medicines. Using mRNA – a fundamental component of human biology – as a drug, our medicines are sets of instructions that direct cells in the body to make proteins to prevent or fight disease.

Resources