Birmingham’s Southern Research appoints CEO, EVP

On May 14, 2021 Southern Research, the groundbreaking scientific discovery and research institution headquartered in Birmingham, on Thursday reported that its board of directors has appointed Josh Carpenter, Ph.D., as its new president and CEO, and Allen Bolton as its new executive vice president for Strategy and Finance (Press release, Southern Research Institute, MAY 14, 2021, View Source [SID1234580024]).

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Both appointments are effective June 1.

Founded in the Magic City in 1941, Southern Research is an independent, non-profit scientific research organization where more than 400 scientists and engineers work across three divisions: Life Sciences, Engineering, and Energy & Environment. Southern Research has attracted national research partnerships with leading industries in the fields of pharmaceuticals, biotechnology, defense, aerospace, the environment and energy.i

"Josh and Allen are forward-thinking leaders who are ready to chart a bold new course for Southern Research," stated University of Alabama at Birmingham President Ray L. Watts, who is chairman of the Southern Research board of directors. "They have the full support of the Board as they begin to lead an amazing team of scientists, engineers and innovators who are working to solve problems and change the world for the better."

Southern Research generates over $150 million in annual economic impact and supports more than 1,000 Alabama jobs.

"The work of Southern Research results in life-changing advancements and innovative solutions," said Southern Research board member Mark Crosswhite, who also serves as the chairman, president and CEO of Alabama Power Company. "Josh and Allen’s vision and expertise will play an important role in leading this institution forward as a continued center of excellence."

Carpenter most recently served as director of Innovation and Economic Opportunity for the City of Birmingham, where he led the City’s efforts in workforce development, COVID recovery and business expansion. Previously, he served as the director of External Affairs at UAB. He earned his doctorate in political economy from the University of Oxford where he studied on a Rhodes Scholarship.

"I am truly honored to take the helm of Southern Research and lead this incredible team that is finding solutions to improve people’s lives around the world. Southern Research has had 80 successful years, but I know the best is yet to come," commented Carpenter.

Bolton most recently served as senior vice president for Finance and Administration at UAB, where he was also a member of the board for Southern Research. He was previously an executive in finance and strategy at the Medical College of Wisconsin, and was senior associate dean for Administration and Finance at the UAB School of Medicine as well as executive administrator at the Comprehensive Cancer Center, the largest research center in the University of Alabama System.

"Discoveries made at Southern Research have provided breakthroughs in cancer research, pushed the boundaries of science and saved lives. I am grateful for this opportunity to work alongside dedicated and talented people who have an unmatched passion for science and discovery," concluded Bolton.

Genenta Phase I/II Glioblastoma Data at ASGCT Show Temferon™ Delivered Tumor-Focused Interferon Expression

On May 14, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of an investigational hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), reported that it will present new clinical data from a Phase I/IIa study of Temferon in patients affected by glioblastoma multiforme (GBM) in an oral presentation at the 2021 American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place virtually on May 11-14, 2021 (Press release, Genenta Science, MAY 14, 2021, View Source [SID1234579979]).

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The data presented at ASGCT (Free ASGCT Whitepaper) are from Genenta’s ongoing trial of Temferon in patients with GBM. The presentation focuses specifically on patients who have undergone a follow-up surgical procedure for their cancer. In addition to being a treatment option, follow-on surgery provides investigators with an opportunity to understand the impact of therapies at a cellular and molecular level.

The ASGCT (Free ASGCT Whitepaper) presentation shows that genetic markers of Genenta’s Temferon were detectable in tumor specimens from all four patients with progressive disease who underwent follow-on surgery. Furthermore, the expression of interferon- (IFN) responsive gene signatures in those tumors was increased compared with pre-treatment levels, which suggests that interferon-α (IFN-α) had been released locally in the tumor by cells derived from Genenta’s investigational treatment.

Carlo Russo, Chief Medical Officer at Genenta Science, said: "These preliminary results provide exciting indications that Temferon acts in the way we anticipated even in the relatively inaccessible setting of glioblastoma multiforme. The data are encouraging and in line with our pre-clinical results, with early evidence that Temferon delivers biological effects that may impact the progression of individual lesions."

One of the four patients had two lesions removed at the second surgery; one was a prior lesion that had not been removed during the first surgery and was stable; the other was a relapsing progressing lesion that had developed at the first surgery site. Compared with the progressing tumor, the stable lesion displayed a higher proportion of T cells and Tie2 Expressing Monocytes (TEMs) within the myeloid infiltrate and had a higher IFN-response signature.

The data presented at ASGCT (Free ASGCT Whitepaper) also supported the initial safety and tolerability profile of Temferon. Concentrations of IFN-α in the plasma and cerebrospinal fluid of patients remained low, while IFN-α responses were identified in myeloid cells that infiltrate tumors. Temferon-derived differentiated cells also persisted in peripheral blood and bone marrow for up to 18 months at lower levels, indicating the potential durability of the intervention. No dose limiting toxicities have been identified.

Presentation Details:

Title: Changes in the Tumor Microenvironment in Patients with Glioblastoma Multiforme Treated with IFN-a Immune Cell & Gene Therapy (TEM-GBM_001 Study)

Time: Friday May 14, 2021 at 1.30 PM Eastern Time (7.30 PM CET)

Presenting: Carlo Russo, CMO

Sutro Biopharma to Participate in Upcoming Virtual Investor Conferences

On May 14, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Chief Executive Officer, Bill Newell, will present at two upcoming virtual investor conferences on May 20 and June 2, 2021 (Press release, Sutro Biopharma, MAY 14, 2021, View Source [SID1234580025]).

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Presentation Details
Cowen’s 2nd Annual Virtual Oncology Innovation Summit
Event: Fireside Chat
Date: Thursday, May 20, 2021
Time: 2:40 p.m. ET / 11:40 a.m. PT

Jefferies Healthcare Conference
Event: Company Presentation
Date: Wednesday, June 2, 2021
Time: 4:30 p.m. ET / 1:30 p.m. PT

Live webcasts of each presentation can be accessed through the Events and Presentations page of the Investor Relations section on the company’s website at www.sutrobio.com. Archived replays of the webcasts will be available on the company’s website for approximately 30 days following each live presentation.

IntelGenx Announces Initial Closing of atai Investment

On May 14, 2021 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that the previously announced US$12,346,300 investment in IntelGenx by ATAI Life Sciences AG ("atai") has been completed (Press release, IntelGenx, MAY 14, 2021, View Source,atai%E2%80%9D)%20has%20been%20completed.&text=Zerbe%2C%20CEO%20of%20IntelGenx. [SID1234580072]). As a result of the investment, atai now holds approximately 25% of the issued and outstanding common stock of IntelGenx.

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"We would again like to thank our shareholders for their support of our transformative strategic partnership with atai," said Dr. Horst G. Zerbe, CEO of IntelGenx. "In addition to positioning IntelGenx as a leader within the novel therapeutics field of psychedelics, atai’s investment provides us with the requisite financial resources to continue to advance our portfolio of other pharmaceutical film product candidates towards commercialization."

"We are pleased to have achieved our goal of progressing from collaborators to partners with IntelGenx via this transaction, and we are excited to make IntelGenx’s innovative film technology an integral part of our platform," said Florian Brand, CEO of atai."

Kintara Therapeutics Announces Fiscal Third Quarter 2021 Financial Results and Provides Corporate Update

On May 14, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal third quarter ended March 31, 2021 and provided a corporate update (Press release, Kintara Therapeutics, MAY 14, 2021, View Source [SID1234579980]).

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Fiscal Third Quarter Highlights and Recent Developments

Commenced patient recruitment of Kintara’s VAL-083 arm of the glioblastoma multiforme (GBM) AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). VAL-083 is currently the only therapeutic agent being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.

Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of our CMBC Phase 3 trial for CMBC patients.

Extended calendar year cash runway from previously announced Q4 2021 to Q2 2022 primarily due to the exercise of previously issued warrants as well as operational and resource synergies realized through the Adgero acquisition.

Enhanced corporate and scientific leadership teams with appointments of Tamara A. Seymour to the Board of Directors and Dr. Mario Lacouture to the Scientific Advisory Board with an initial focus on CMBC.

Completed patient enrollment of the recurrent arm of the Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) for GBM patients who have been pre-treated with temozolomide prior to disease recurrence.

Presented positive data updates at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from the ongoing Phase 2 clinical studies in newly-diagnosed first-line, newly-diagnosed adjuvant, and recurrent GBM.
"As we head into the final fiscal quarter of 2021, we continue to make steady progress on our late-stage clinical pipeline, as well as making valuable additions to our leadership and advisory teams, and continuing to secure our foothold as a leader in oncology indications with clear unmet medical needs," commented Saiid Zarrabian, Kintara’s President and Chief Executive Officer. "Commencing VAL-083’s enrollment in the GBM AGILE registrational study was a significant milestone during the period, along with continued progress with both of our ongoing Phase 2 clinical trials, of which the MD Anderson study is anticipated to report topline results in the second quarter of calendar 2021."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 THIRD QUARTER ENDED MARCH 31, 2021

At March 31, 2021, the Company had cash and cash equivalents of approximately $15.7 million. The cash and cash equivalents at March 31, 2021 are expected to be sufficient to fund the Company’s planned operations into the second quarter of calendar year 2022.

For the three months ended March 31, 2021, the Company reported a net loss of approximately $6.6 million, or $0.23 per share, compared to a net loss of approximately $2.0 million, or $0.17 per share, for the three months ended March 31, 2020. For the nine months ended March 31, 2021, the Company reported a net loss of approximately $31.6 million, or $1.47 per share, compared to a net loss of approximately $5.3 million, or $0.52 per share, for the nine months ended March 31, 2020. The increase in loss for the nine months ended March 31, 2021 compared to the nine months ended March 31, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the merger with Adgero Biopharmaceuticals Holdings, Inc. and an expanded rate of expenditures with the initiation of the GCAR study and REM-001 development.