Inhibikase Therapeutics to Participate at the B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference

On April 21, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported that Dr. Milton Werner, Ph.D., the Company’s President & Chief Executive Officer will participate in a fireside chat at the B. Riley Securities’ 2022 Virtual Neuro & Ophthalmology Conference on April 28, 2022 at 2:30pm ET (Press release, Inhibikase Therapeutics, APR 21, 2022, View Source;ophthalmology-conference-301530237.html [SID1234612882])

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A live webcast of the presentation will be available for on-demand viewing under "News & Events" in the Investors section of the Company’s website, www.inhibikase.com. An archived replay of the webcast will be available for approximately 30 days. In addition, the Company recently hosted a virtual Key Opinion Leader investor event on April 20, 2022. A replay of the event can be accessed here.

INRAE and MaaT Pharma Build on the Success of their Long-Standing Partnership with the Entry of Drug-Candidate MaaT013 into Phase 3 Clinical Trial

On April 21, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer reported on March 28th, 2022, the inclusion of the first patient in a pivotal Phase 3 clinical trial, potentially the last step of clinical development before marketing authorization, evaluating MaaT013 for the treatment of acute gastrointestinal Graft-versus-Host Disease (aGvHD), a serious complication following stem cell transplantation (Press release, MaaT Pharma, APR 21, 2022, View Source [SID1234612709]). Every year, more than 10,000 people are diagnosed in Europe and in the United States of America[1], and the prognosis for the patients with the most advanced form is poor with a mortality rate of up to 80%[2] in the first year. This new milestone for MaaT Pharma, the first Euronext-listed company developing microbiome-based therapies, builds on the success story of its founding partnership with INRAE initiated in 2014, in particular via the scientific support agreement[3] between MaaT Pharma, INRAE and Dr. Joël Doré, INRAE Research Director, Scientific Director of Métagénopolis, author of nearly 500 publications, and one of the world’s most cited authors in the microbiome sphere today.

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At the end of 2014, following a project development period as an entrepreneur-in-residence with Seventure Partners, Hervé Affagard, currently CEO, founded MaaT Pharma alongside Dr. Joël Doré, now MaaT Pharma’s Scientific Advisor. As early as 2015, MaaT Pharma and INRAE co-filed three patents, for which the Company now holds exclusive exploitation rights. These patents are also at the root of the development of the Company’s native products, MaaT013 and MaaT033, both currently in clinical trials.

"Microbiome science has been at the heart of my research for more than 30 years. INRAE has established itself first as a pioneer, then as an international center of excellence in the field. In 2021, for example, INRAE was the 5th largest academic player in the world in terms of microbiome-related patents. In my opinion, the rapid growth of MaaT Pharma, which has entered a Phase 3 clinical trial, perfectly illustrates the efficient and successful transition from pioneering science to innovative therapeutic development for the benefit of patients. Through my research, I hope to contribute to the fast emergence of a new medicinal modality, that takes into account the symbiotic relationship between human health and the microbiome," said Dr. Doré.

Following the advent of metagenomics[4], the research produced at INRAE on the gut microbiome has led to unprecedented results disrupting our understanding of the digestive ecosystem, and opening novel avenues for improving the health of millions of patients worldwide suffering from cancers, metabolic diseases, or inflammatory diseases to name just a few of the potential indications.

MaaT Pharma has developed a portfolio of three products since its creation including two currently in clinical phases. The Company has initiated five Phase 1 and Phase 2 clinical trials, consolidated its patent portfolio (including 13 international patent families), and raised a total of €83 million. The Company currently employs 45 people and MaaT013 has been administered to more than 100 people with aGvHD in a Phase 2 clinical trial and in an ongoing compassionate access program[5] in France.

Hervé Affagard, CEO and co-founder of MaaT Pharma commented, "Since our foundation, we have been looking to develop the microbiome ecosystem in France and have forged partnerships with medical and scientific centers of excellence as well as with renowned industrial players to develop the Company. In 2016, we launched our first clinical trial just 18 months after the company’s creation, and we have since strengthened our position as a pioneer in microbiome-based therapies in oncology. Our translational expertise allows us to rapidly transform science into groundbreaking and safe drug candidates, with the support of our scientific partners, to improve survival outcome for cancer patients."

The collaboration between these two pioneers continues to move forward with the formation of industry structures and the growth of national expertise in the microbiome space in Europe with the Alliance Promotion Microbiote (APM), of which both organizations are among the co-founders. APM is an association under the French law of 1901 and includes 25 private and public players (companies, clusters, research institutes, investment funds), of which Hervé Affagard was elected president in January 2022. APM aims to contribute to making France, a pioneering nation in microbiome research and engineering, into a European leader to meet the current and future challenges of this sector recognized in 2021 as a priority in the "Health Innovation Plan 2030 ".

[1] Source: Global Data GVHD Epidemiology Report, Jan 2020.
[2] Source: Essai REACH1
[3] Article L 531-8 and 9 of the French Research Code allowing the participation of research personnel in the creation of companies or in the activities of a company and the promotion of their work
[4] metagenomics: a method used to study the microbiome – Qin, J., Li, R., Raes, J. et al. A human gut microbial gene catalogue established by metagenomic sequencing. Nature 464, 59–65 (2010)
[5] Compassionate use programs allow the use of investigational drugs before they are authorized for marketing for patients with no treatment-options.

Surface Oncology Named one of the 2022 Best Places to Work by Boston Business Journal

On April 21, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it has been recognized by the Boston Business Journal as one of the Best Places to Work for the second year in a row (Press release, Surface Oncology, APR 21, 2022, View Source [SID1234612766]). Surface was among 20 companies selected in the "small" category with 50 to 99 Massachusetts-based employees.

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"We are thrilled to be recognized once again as one of the Best Places to Work by the Boston Business Journal," said Rob Ross, M.D., chief executive officer at Surface Oncology. "At Surface, we are moving with urgency and passion to bring important new immunotherapies to people confronting cancer, and that shared mission is what unites our team and makes this such a special place to work. We remain committed to cultivating a diverse and dynamic culture built on our core values of courage, integrity, and community."

In 2022, more than 220 businesses across healthcare, technology, commercial real estate, and other industries participated in the Best Places to Work program. Through an independent survey, employees rated areas including job satisfaction, personal engagement, level of communication and resources, teamwork, retention, alignment with goals, and manager effectiveness.

Surface will be among 80 companies honored for creating outstanding work environments at a celebration on June 16, 2022, at the Boston Park Plaza and featured in a Best Places to Work edition of the Boston Business Journal to be published on June 17, 2022.

Terran Biosciences Announces Licensing Agreement with Sanofi

On April 21, 2022 Terran Biosciences, Inc. ("Terran"), a biotechnology platform company dedicated to the development of transformational therapies for neurological and psychiatric diseases, reported that has entered into an agreement with Sanofi SA ( " Sanofi") for exclusive worldwide rights to develop and commercialize two late-stage SNC portfolio assets (Press release, Sanofi, APR 21, 2022, View Source;_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=sc [SID1234612883]).

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These therapies generated four investigational new drug (IND) applications and more than 104 clinical studies involving more than 15,000 subjects in various CNS indications.

Terran plans to rapidly advance the development of these actives for neurological and psychiatric indications, including several novel applications where there is a high unmet medical need. This transaction represents the next key stage in the development of these promising assets.

The deal included an upfront payment, as well as typical milestones and royalties based on success. Specific financial terms of the deal were not disclosed.

"We are grateful to the team at Sanofi for entrusting us with the continued development of these late-stage therapies, which we believe have the potential to transform the paradigm of neuropsychiatry," said Dr. Sam Clark , Founder and CEO of Terran.

Moleculin Receives IND Clearance to Conduct Phase 1 Study of WP1066 for the Treatment of Recurrent Malignant Glioma

On April 21, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the US Food and Drug Administration (FDA) is allowing the Company’s Investigational New Drug (IND) application to study WP1066 for the treatment of recurrent malignant glioma (Press release, Moleculin, APR 21, 2022, View Source [SID1234612710]). With this IND now cleared, Moleculin plans to evaluate strategic partnerships and collaborations to conduct a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1066 in adult patients with recurrent malignant glioma.

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WP1066 is the Company’s flagship Immune/Transcription Modulator designed to stimulate the immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs) while also inhibiting key oncogenic transcription factors, including p-STAT3 (phosphorylated signal transducer and activator of transcription 3), c-Myc (a cellular signal transducer named after a homologous avian virus called Myelocytomatosis) and HIF-1α (hypoxia inducible factor 1α). These transcription factors are widely sought targets that are believed to contribute to an increase in cell survival and proliferation, and the angiogenesis (coopting vasculature for blood supply), invasion, metastasis and inflammation associated with tumors. They may also play a role in the inability of immune checkpoint inhibitors to affect more resistant tumors.

"WP1066 has demonstrated significant anti-tumor activity in a wide range of tumor cell lines and increased survival in a number of animal models to-date. Additionally, the preliminary results demonstrated in the ongoing trial of WP1066 for pediatric brain tumors bolster our confidence and this IND clearance provides further momentum for its continued research and development," commented Walter Klemp, Chairman and CEO of Moleculin. "We expect the clearance of this IND to further support the ongoing pediatric studies being conducted by the team at Emory University, and we are evaluating the potential for additional externally funded investigator-initiated studies."

WP1066 is currently being evaluated in collaboration with Emory University for the treatment of pediatric brain tumors, including Diffuse Interstitial Pontine Glioma (DIPG). The Emory trial for pediatric brain tumors has now treated three subjects in the first two cohorts of the Phase 1 dose escalation portion of physician-sponsored clinical trial. In that trial, one of the subjects in the first cohort with DIPG showed an apparent response to the treatment with both clinical improvement and radiologic reduction of tumor size. The Company cautions that this is preliminary data, and no conclusions should be drawn from this single event. One subject has been treated in the third cohort at the dose level of 8mg/kg. Two more subjects will be treated at this dose level. Emory University has amended its protocol to allow dosing at 16 mg/kg after these two additional subjects have been dosed, and the third cohort dosing has been deemed safe.

The Company has received Orphan Drug Designation for WP1066 for the treatment of brain tumors, as well as Rare Pediatric Disease designation for three other pediatric indications. Additionally, WP1066 + radiation is being evaluated, pre-clinically, in the treatment of Glioblastoma Multiforme (GBM).

Glioma is a common type of tumor originating in the brain. About 33% of all brain tumors are gliomas, which originate in the glial cells that surround and support neurons in the brain, including astrocytes, oligodendrocytes and ependymal cells. GBM is the most aggressive malignant primary brain tumor and remains as an incurable tumor with a median survival of only 15 months[1]. It is the most common malignant primary brain tumor making up 54% of all gliomas and 16% of all primary brain tumors,[2] and despite advancements, survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades.[3] The average annual age-adjusted incidence rate of GBM is 3.19 per 100,000 persons in the United States.[4]