On July 28, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo to treat patients with solid and hematologic malignancies, reported that new data at the 2022 iPSC Manufacturing Summit held in Boston, Mass. on the development of a precision genome engineered induced pluripotent stem cells (iPSCs) to incorporate a synthetic cytokine receptor, permitting more efficient differentiation and expansion of cells into functional, persistent cytotoxic cell types that is further compatible with efficient scale-up production (Press release, Umoja Biopharma, JUL 28, 2022, View Source [SID1234617094]).

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"Our newest data highlights a new way to efficiently differentiate and expand high-quality iPSCs in quantities necessary for treating more patients with potentially life-changing cell therapies," said lead author of the study and principal scientist at Umoja, Teisha Rowland, Ph.D. "Previously, scientists were limited with culturing these cells on plates, but with the new ShRED system we show that it is possible to grow cells in suspension, which is expected to translate to large-scale manufacturing. Importantly, we also showed that CAR-NK cells made using this new technique are highly functional therapeutic cells. This further validates employing our RACR technology platform to overcome critical limitations facing the cell therapy industry."

On Thursday July 28th, Principal Scientist Teisha Rowland, Ph.D., gave a presentation titled "Engineering iPSCs with Synthetic Receptors to Drive Differentiation Compatible with Scale-Up." The presentation demonstrated progress on Umoja’s iPSC platform and the development of a synthetic receptor enabled differentiation (ShRED) protocol that employs a rapamycin activated cytokine receptor (RACR) to drive differentiation and expansion of iPSCs in a controlled and consistent manner, without the addition of expensive growth factors and cytokines. Activating RACR with a rapamycin analog (rapalog) during hematopoietic progenitor (HP) generation was shown to increase HP yield controls in conventional cell culture format. Additional improvement of cell culture conditions further enhanced RACR-driven yields.

Furthermore, resultant iPSC-derived cytotoxic innate lymphocytes (RACR-iCILs) displayed improved innate cytotoxicity and serial killing in several tumor models. CAR-RACR-iCILs (cells engineered with chimeric antigen receptors) displayed potent and specific CAR-driven and innate tumor killing. Furthermore, RACR engineered NK cells demonstrated enhanced tumor control in a mouse breast cancer model. In addition, RACR-iCIL cells can be produced with high yields when grown in suspension, eliminating requirements for 2D culture that limit scale up manufacture of iPSC derived cell therapy products.

"We are continuing to advance our "off-the-shelf" iPSC therapy platform that aims to overcome major challenges in allogeneic cell therapy, including eliminating the need for toxic lymphodepletion and reducing manufacturing complexity and cost," said Andy Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja. "We are excited to share this new data on the development of our ShRED platform for the differentiation and expansion of iPSC-derived cells which is expected to yield a more consistent and potent product. The continued progress across our four complimentary platforms truly exemplifies Umoja’s commitment and determination towards developing curative treatments that can be delivered to any patient, with any tumor, at any time."

About RACR
CAR T cells generated by the body with VivoVec can be expanded and sustained with the rapamycin activated cytokine receptor (RACR) system, an engineered signaling system designed to improve chimeric antigen receptor (CAR) T cell persistence and produce durable anti-tumor responses. The RACR/CAR payload is integrated into the genomic DNA of a patient’s T cells. Rapamycin activates the RACR system resulting in preferential expansion and survival of cancer-fighting T cells. The RACR technology enables a patient’s cells to expand in a manner that resembles a natural immune response that does not require lymphodepletion, promoting durable T cell engraftment. RACR/CAR technology can also be used to enhance ex vivo manufacturing in support of more traditional autologous or allogeneic cell therapy manufacturing processes. To learn more about Umoja’s RACR platform please visit View Source

On July 28, 2022 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported that the company will release its financial results for the second quarter ended June 30, 2022, including a corporate update, on Thursday, August 4, 2022, before the opening of the U.S. financial markets (Press release, Immunic, JUL 28, 2022, View Source [SID1234617110]). A webcast will follow at 8:00 am ET.

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To participate in the webcast, please register in advance at: View Source or on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations.

On July 27, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapeutics leveraging CRISPR-based technologies, reported that it will present its second quarter 2022 financial results and operational highlights in a conference call on August 4, 2022, at 8 a.m. ET (Press release, Intellia, JUL 27, 2022, View Source [SID1234616988]).

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To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
Please visit this link for a simultaneous live webcast of the call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com, beginning on August 4, 2022, at 12 p.m. ET.

On July 27, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that it will host a conference call and webcast to report second quarter financial results on Wednesday, August 3, 2022, at 8:30 a.m. ET (Press release, GlycoMimetics, JUL 27, 2022, View Source [SID1234617006]).

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To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

On July 27, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D), reported that Paul Sekhri will lead the company as President and Chief Executive Officer, effective August 1, 2022 (Press release, vTv Therapeutics, JUL 27, 2022, View Source [SID1234617022]). Rich Nelson, who has been serving as Interim Chief Executive Officer since March 2, 2022, will continue to support the company as Executive Vice President, Corporate Development and as a member of the Board of Directors. Mr. Sekhri will also join vTv’s Board of Directors.

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Paul joins vTv as it sets to launch Phase 3 pivotal studies for its most advanced product, TTP399, which was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in April 2021 as an oral adjunctive therapy for the treatment of T1D.

Positive results from the Phase 2 study showed treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful 40% decrease in the frequency of severe and symptomatic hypoglycemia.

Last month, vTv announced a $25 million investment by G42 Investments AI Holding RSC Ltd. and entry into a collaboration and license agreement with affiliates of G42 Healthcare whereby G42’s affiliate will be funding a significant portion of the Phase 3 clinical trials for TTP399.

"While I’ve served in the Interim CEO role for the past four months, we diligently searched for the right candidate to steer the company through this final stage of TTP399 development and are highly confident that Paul is the right person for the role," said Rich Nelson. "We are thrilled to have Paul join vTv at this very exciting time in the company’s lifecycle as we actively engage in activities in preparation of the initiation of our Phase 3 trials and continue to have positive discussions with institutions in the biotech community about further investment in vTv. Paul brings extensive experience as CEO of several prominent healthcare companies and has strong ties to the biotech investment community. We are very excited to have Paul on board and I look forward to continuing to support vTv in my new role and to support Paul in his."

Mr. Sekhri brings nearly 30 years of healthcare experience, including serving as President and CEO of several healthcare companies such as eGenesis, Lycera Corp., Cerimon Pharmaceuticals, as well as senior business development and strategy roles at Sanofi, Teva Pharmaceutical Industries Ltd., TPG Biotech, Cerimon, Ariad Pharmaceuticals and Novartis Pharma AG. He has been a director on more than 30 private, public company and non-profit boards and is currently a Director at Ipsen, S.A., Compugen, Pharming N.V., Veeva Systems, Longboard, Spring Discovery and eGenesis. Additionally, he is on the Board of Directors of the Metropolitan Opera.

"During my long career as a biotechnology executive, I have been attracted to truly novel therapeutic approaches that address serious medical challenges and/or improve patient care," said Mr. Sekhri. "T1D is a challenging enough disease for patients to manage without also having to worry about hypoglycemia. A treatment that significantly reduces the risk of hypoglycemia while also improving Hb1Ac would be a significant advance for treating this disease. I look forward to working with the vTv team to initiate and successfully complete our Phase 3 trials."

On July 26, 2022, Mr. Sekhri was granted stock options (the "Options") to purchase 2,200,000 shares of the Class A common stock of vTv at an exercise price of $0.79 per share pursuant to an inducement award agreement (the "Inducement Award Agreement"). Subject to potential acceleration upon the achievement of certain performance metrics as set forth in the Inducement Award Agreement, 25% of the Options will vest on the first anniversary of the grant date and thereafter the Options will vest in equal quarterly installments over the next three years. Upon certain terminations of employment, a portion of the Options will vest on a pro rata basis based on the number of days employed during the four-year term. The grant of Options was made as an inducement grant under NASDAQ Listing Rule 5635(c)(4).