On November 15, 2021 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 financial results for the third quarter ended September 30, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 15, 2021, View Source [SID1234595608]).

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Key Business and Clinical Highlights

Dosed first patient in the Phase 1b clinical trial of IkT-148009: In October 2021 Inhibikase dosed the first patient in its Phase 1b clinical trial of IkT-148009, a randomized, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of IkT-148009. The trial will enroll a total of 24 patients with Parkinson’s disease and also assess non-motor and motor function, gut motility, and measures of alpha-synuclein aggregate clearance, as exploratory endpoints. The Company expects to complete this study and, with the approval of the U.S. Food and Drug Administration (FDA), advance into a Phase 2a study in 2022.
Extended Phase 1 clinical trial of IkT-148009 to higher doses: In October 2021, Inhibikase expanded dosing of IkT-148009 in older and elderly healthy volunteers up to a single 250 mg dose to identify the maximum tolerated dose. This extension was based on the safety and tolerability profile observed in the initial dose cohorts of the Phase 1 study.
Submitted interim three-month results from chronic toxicology studies of IkT-148009 to FDA: In October 2021, Inhibikase reported that it had submitted interim three-month results from its ongoing chronic toxicology studies of IkT-148009 in rats and non-human primates to the FDA. Data indicated that the toxicology profile of IkT-148009 improves with extended daily oral dosing and supports evaluation in Parkinson’s patients for up to three months.
Received grant from U.S. National Institutes of Health to evaluate IkT-148009 for the treatment of Multiple System Atrophy: In September 2021, Inhibikase was awarded a research grant from the U.S. National Institute of Neurological Disease and Stroke (NINDS), an Institute of the National Institutes of Health (NIH), to evaluate the mechanism of the MSA disease process and the therapeutic potential of IkT-148009 in preclinical studies.
"Over the past quarter, we have worked diligently to advance our lead candidate, IkT-148009 in multiple indications. We dosed the first Parkinson’s patient in our Phase 1b study as well as submitted interim chronic toxicology data to the FDA to support extended dosing of IkT-148009. We were also pleased to receive a grant from the NIH to evaluate IkT-148009 in a novel preclinical model of MSA, a neurodegenerative disease that may benefit from c-Abl inhibition," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we look ahead, we expect to file our IND application for IkT-001Pro for the treatment of CML in the first quarter of 2022 as well as anticipate completing our Phase 1b study for Ikt-148009 in 2022."

Third Quarter Financial Results

Net Loss: Net loss for the quarter ended September 30, 2021, was $4.5 million, or $0.18 per share, compared to a net loss of $0.7 million, or $0.08 per share in the third quarter 2020.

R&D Expenses: Research and development expenses were $3.2 million for the quarter ended September 30, 2021 compared to $.1 million in the third quarter 2020. The increase was driven by a $0.3 million increase in grant related research expenditures and a $2.8 million increase in non-grant related research. The non-grant related research was expended primarily in connection with the Company’s Phase I Parkinson’s disease clinical trial.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2021 were $1.6 million compared to $0.6 million for the third quarter in 2020. The increase was the result of increased non-cash stock compensation expense of $0.1 million, increased director and officer’s liability insurance of $0.4 million related to the Company’s IPO in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.3 million relating to operating as a public company registrant since December 2020 and a net increase of $0.2 million for other normal operating expenses.

Cash Position: Cash and cash equivalents were $45 million as of September 30, 2021.

On November 15, 2021 Vaccibody reported that (Press release, Vaccibody, NOV 15, 2021, View Source [SID1234595955])

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HIGHLIGHTS:
 Initiated the Phase 1b clinical trial in patients with locally advanced and metastatic tumors (VB N-02) in collaboration with Genentech (VB10.NEO individualized vaccine). First site opened in the USA
 Entered into worldwide license agreement with Adaptive Biotechnologies for clinically validated SARS-CoV-2 T cell epitopes Highlights after September 30, 2021:
 First subject dosed in a two-arm phase 1/2 clinical trial with a second generation and a third generation SARS-CoV-2 vaccine candidate  Reached a headcount of more than 100 people
 Continues to explore a potential listing of the company’s shares on Nasdaq and expects during 2022 to apply for a transfer of the listing of its shares to the main market of Oslo Stock Exchange R&D UPDATE Vaccibody’s modular technology platform is very versatile and may be adapted to generate the desired immune response profile. Hence, Vaccibody’s platform may be applied across a broad range of immunotherapy areas as innovative solutions to an unmet medical need. Vaccibody continues to increase the headcount across all functions including R&D to continue to build competencies and support the strategy execution. Please find below an update on Vaccibody’s current research and development activities.

Oncology VB10.16 VB10.16 is a therapeutic HPV vaccine directed against HPV16+ induced malignancies:
 Clinical trial VB C-02: o Clinical stage: Phase II o Indication: HPV16+ advanced, non-resectable cervical cancer o Up to 50 patients o ClinicalTrials.gov Identifier: NCT04405349 Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 4 Status and highlights Investigational sites in 6 European countries are screening and enrolling patients. The trial is on track to complete enrolment during fourth quarter 2021. Vaccibody plans to report interim clinical data by the end of Q1 2022. The commercial potential in other HPV16 driven cancer indications such as HNSCC (Head and neck squamous cell carcinoma) is being explored. A development strategy update for VB10.16 will follow in 1H 2022

. VB10.NEO VB10.NEO is an individualized neoantigen cancer vaccine, exclusively licensed to Genentech:  Clinical trial VB N-01: o Clinical stage: Phase I/IIa o Cancer indications: Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck (SCCHN) o Fully enrolled o ClinicalTrials.gov Identifier: NCT03548467  Clinical trial VB N-02: o Clinical stage: Phase Ib o Cancer indications: Locally advanced and metastatic tumors o Up to 40 patients o ClinicalTrials.gov Identifier: NCT05018273 Status and highlights The first clinical site in the USA has been opened. The work on further site initiations in the USA and Europe continues. Infectious Diseases Vaccibody’s infectious disease initiatives spans both pre-clinical and clinical activities. VB10.COV2 Vaccibody has selected a 2-arm strategy for the VB10.COV2 project to fight SARS-CoV-2 variants of concern. VB10.2129 and VB10.2210 are two vaccine candidates designed based on Vaccibody’s modular and APC targeted technology:  In clinical trial VB-D-01, the two vaccine candidates, VB10.2129 and VB10.2210, are being investigated in previously vaccinated healthy volunteers. o VB10.2129-2nd generation vaccine addressing novel CoV-2 variants of concernVB10.2210-3rd generation universal broadly protective T cell vaccine, including T cell epitopes validated by Adaptive Biotechnologies

 Clinical stage: Phase 1/2
 Pathogen: SARS CoV-2  Up to 160 patients
 ClinicalTrials.gov Identifier: NCT05069623 Status and highlights Vaccibody reached the internal milestone of dosing the first subject with VB10.2129 in early November 2021.

With Vaccibody’s flexible and modular technology platform, it took only 267 days from design to first subject dosed. OTHER INFECTIOUS DISEASES Vaccibody has over the last years generated promising pre-clinical data in other infectious disease models. The Company has therefore initiated research discovery programs to explore and evaluate a focused set of pathogens as potential future clinical vaccine targets. Autoimmune disorders Autoimmune disorders are caused by unwanted immunogenicity to autoantigens.

Vaccibody continues to explore the modular technology platform and unique APC targeting approach to generate pre-clinical proof-of-concept for the ability to induce meaningful antigen-specific immune tolerance. The Company is investing significantly in the research area and is hiring to build further capacity and know-how. OTHER Capital market considerations Vaccibody continues to explore a potential listing of the company’s shares on the Nasdaq Global Market in the United States as first communicated in 1H 2021.

Furthermore, the Company expects during 2022 to apply for a transfer of the listing of its shares on the Oslo Stock Exchange from Euronext Growth Oslo to Oslo Børs, the main market of the Oslo Stock Exchange.

On November 15, 2021 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX), a biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, reported financial results for the third quarter ended September 30, 2021 (Press release, Theseus Pharmaceuticals, NOV 15, 2021, View Source [SID1234595624]).

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"At Theseus, we are leveraging our deep expertise in the development of targeted therapies to address the problem of drug resistance mutations in cancer," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus Pharmaceuticals. "The third quarter marked two significant milestones for Theseus: our entrance into the public markets and the start of our transition into a clinical-stage company. The recent IND clearance for our lead candidate, THE-630, a pan-variant KIT inhibitor with the potential to address unmet need in patients with previously treated gastrointestinal stromal tumors (GIST), and the completion of our successful IPO position Theseus well to advance both the Phase 1/2 clinical trial of THE-630 and our pipeline of novel pan-variant inhibitors specifically designed to overcome the full range of drug resistance mutations."

Third Quarter Highlights and Upcoming Milestones:

Received FDA clearance of an investigational new drug (IND) application to evaluate THE-630 in patients with GIST. Theseus plans to initiate a Phase 1/2 dose escalation and expansion clinical trial of THE-630, its lead development program, in patients with previously treated advanced GIST between late fourth quarter 2021 and mid-first quarter 2022. THE-630 is a pan-variant inhibitor of the receptor tyrosine kinase KIT designed for patients with advanced GIST whose cancer has developed resistance to earlier lines of therapy.
Completed $178.8 million upsized initial public offering. In October 2021, Theseus sold 11,172,190 shares of common stock at a price to the pubic of $16.00 per share. The gross proceeds from the offering were approximately $178.8 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
Leadership strengthened through appointments to senior scientific team. Theseus recently appointed Nachu Narasimhan, Ph.D., as Senior Vice President, Drug Metabolism and Preclinical Safety, and Len Rozamus as Senior Vice President, Technical Operations. Together, their deep experience in targeted oncology research and development will help to further advance Theseus’ pipeline.
Dr. Narasimhan brings over 30 years of experience in drug metabolism and bioanalytical disciplines and over 10 years’ experience in preclinical safety and clinical pharmacology. Dr. Narasimhan was most recently Vice President of Drug Metabolism and Clinical Pharmacology at Verastem Oncology. Previously, he contributed to the development and approval of several drugs while working at Merck, ARIAD Pharmaceuticals, and Bristol-Myers-Squibb.
Mr. Rozamus brings over 30 years of experience in pharmaceutical discovery and development, from pre-clinical programs through commercial products. Most recently, Mr. Rozamus served as Founder and President of Rozamus and Associates, Inc. Previously, his work while Senior Director of Manufacturing Operations at ARIAD Pharmaceuticals contributed to the approval of three oncology drugs.
Advanced fourth-generation epidermal growth factor receptor (EGFR) program towards development candidate nomination in the first half of 2022, and thereafter initiate IND-enabling studies. For its second development program, Theseus expects to nominate an EGFR candidate designed to inhibit the full range of single-, double-, and triple-mutant EGFR variants found in the tumors of patients with EGFR-mutant non-small cell lung cancer (NSCLC) that have developed resistance to osimertinib, including the C797S mutation.
One or more additional kinase targets expected to be nominated by the end of 2022.
Third Quarter Financial Results:

As of September 30, 2021, Theseus had cash and cash equivalents of $90.4 million, which does not include net proceeds from its IPO, which was completed in October 2021.
Theseus expects its cash and cash equivalents, including proceeds from the IPO, to fund operations and capital expenditures into the second half of 2024.
Research & Development expenses for the third quarter of 2021 were $5.0 million.
General & Administrative expenses for the third quarter of 2021 were $2.4 million.
Net Loss for the third quarter 2021 was $7.4 million, or $5.16 per share.

On November 15, 2021 Novocure (NASDAQ: NVCR) reported 31 presentations on Tumor Treating Fields (TTFields) will be featured at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting from Nov. 18 to Nov. 21 in Boston (Press release, NovoCure, NOV 15, 2021, View Source [SID1234595638]). The presentations cover a broad range of topics, with 22 of the 31 presentations prepared by external authors.

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One of the oral presentations will feature updated data from the 2-THE-TOP study treating 25 patients with newly diagnosed glioblastoma (GBM) with TTFields plus pembrolizumab and temozolomide. In patients with greater than 9 months of follow-up, median progression-free survival, the primary endpoint, was at least 11.2 months with activation of adaptive immunity.

"We are excited to gather, participate and share information on Tumor Treating Fields at the SNO 2021 Annual Meeting, one of the most important neuro-oncology conferences worldwide," said Dr. Ely Benaim, Novocure’s Chief Medical Officer. "More than 300 presentations on Tumor Treating Fields have been shared at SNO over the past 14 years. We look forward to driving further awareness and understanding of our therapy as an important treatment for solid tumors."

Oral Presentations

(CTIM-16) Phase 2 study of pembrolizumab plus TTFields plus temozolomide in patients with newly diagnosed GBM (2-THE-TOP trial). Lead author and presenter: David D. Tran. 5:05 p.m. to 5:10 p.m. EST Friday, Nov.19. (Clinical Trials Session I)

Induction of anti-tumor immunity in glioblastoma using Tumor Treating Fields. Presenter: David D. Tran. 11:30 a.m. to 11:50 a.m. EST Sunday, Nov. 21. (Emerging Technologies in Radiation Science Session)

Poster Presentations

All occurring 7:30 p.m. to 9:30 p.m. EST Friday, Nov. 19 in Exhibit Hall D

Clinical

(INNV-22) Factors guiding the initiation of Tumor Treating Fields (TTFields; 200 kHz) therapy for glioblastoma: self-reported patient and oncologist perspectives. Lead author and presenter: Peggy Frongillo.

(SURG-06) The safety profile of Tumor Treating Fields (TTFields; 200 kHz) concomitant with ventriculo-peritoneal shunts in patients with glioblastoma and hydrocephalus. Lead author: Nancy Ann Oberheim-Bush. Presenter: Wenyin Shi.

(CTNI-09) TRIDENT phase 3 trial (EF-32): first-line Tumor Treating Fields (TTFields; 200 kHz) concomitant with chemo-radiation, followed by maintenance TTFields/temozolomide in newly-diagnosed glioblastoma. Lead author and presenter: Wenyin Shi.

(QOLP-31) Quality of life of patients with newly diagnosed glioblastoma during TTFields therapy in routine clinical care: first results of the TIGER study. Lead author and presenter: Oliver Bähr.

(INNV-07) TTFields treatment of gliosarcoma and recurrent anaplastic oligodendroglioma. Lead author and presenter: Nicholas A. Blondin.

(INNV-10) TTFields as maintenance therapy for an oligodendroglioma case and long-term follow-up. Lead author and presenter: Uvin Ko.

(CTNI-11) Tumor Treating Fields combined with second-line chemotherapy in recurrent glioblastoma: a matched retrospective study. Lead author and presenter: Yonggao Mou.

(CTNI-52) Retrospective analysis of using radiotherapy with concurrent temozolomide and Tumor Treating Fields for Chinese patients with newly diagnosed glioblastoma. Lead author and presenter: Yang Wang.

(NCOG-14) Real-World retrospective analysis of Tumor Treating Fields in the treatment of high-grade glioma based on Chinese population. Lead author and presenter: Zhiyong Qin.

(NIMG-34) Delayed pseudoprogression in glioblastoma patients treated with TTFields: a report of two cases. Lead author and presenter: Norihiko Saito.

(CTNI-38) PriCoTTF trial: a phase I/II trial of TTFields prior and concomitant to radiotherapy in newly diagnosed glioblastoma. Lead author and presenter: Sied Kebir.

(RADT-13) SPARE trial: Scalp-sparing radiation with concurrent temozolomide and Tumor Treating Fields for patients with newly diagnosed glioblastoma. Lead author and presenter: Ryan C. Miller.

(CTNI-19) Concurrent chemoradiation and Tumor Treating Fields (TTFields; 200 kHz) for patients with newly diagnosed glioblastoma may increase the rate of distant recurrence. Lead author and presenter: Ayesha S. Ali.

(RADT-22) Concurrent TTFields (200 kHz) with chemoradiation for patients with newly diagnosed glioblastoma may increase the rate of pseudoprogression: analysis of a pilot clinical trial. Lead author and presenter: Muneeb Niazi.

(INNV-18) Effect of duration of Tumor Treating Fields therapy on cellularity distributions beyond T1w MRI contrast enhancing margin at autopsy in glioma patients: preliminary results. Lead author and presenter: Samuel Bobholz.

(INNV-13) Understanding factors that influence the decision of accepting Tumor Treating Fields therapy. Lead author and presenter: Priya U. Kumthekar.

(QOLP-10) A longitudinal observational study of exercise behavior in glioblastoma patients treated with Tumor Treating Fields. Lead author and presenter: Katherine B. Peters.

Preclinical

(EXTH-75) Application of Tumor Treating Fields (TTFields) to the head and torso of mice with the dedicated inovivo system. Lead author: Shiri Davidi. Presenter: Moshe Giladi.

(EXTH-74) Increasing cancer cell membrane permeability through application of Tumor Treating Fields (TTFields). Lead author: Tali Voloshin. Presenter: Moshe Giladi.

(DDRE-46) Reduced cancer cell sensitivity to Tumor Treating Fields (TTFields) through activation of the PI3K/AKT/mTOR signaling pathway can be mitigated using PI3K inhibitors or PI3K/mTOR dual inhibitors. Lead author: Anat Klein-Goldberg. Presenter: Moshe Giladi.

(EXTH-05) Tumor Treating Fields in combination with the TERT-inhibitor eribulin have synergistic antiproliferative effects on human glioblastoma cells. Lead author: Piet Beusker. Presenter: Marco Stein.

(CBIO-02) In vitro Tumor Treating Fields (TTFields) reduce proliferation and alter MLH1 expression in temozolomide resistant (TMZR) patient-derived glioblastoma (GBM) cells. Lead author and presenter: Sharon K. Michelhaugh.

(CSIG-09) Assessment of Tumor Treating Fields (TTFields) combined with trichostatin A (TSA) in patient-derived glioblastoma (GBM) cells. Lead author and presenter: Manxiu Ma.

(DDRE-13) Prostaglandin E receptor 3 (PTGER3) regulates resistance to Tumor Treating Fields (TTFields) in glioblastoma cells. Lead author and presenter: Dongjiang Chen.

(IMMU-35) Induction of anti-tumor immunity by Tumor Treating Fields (TTFields) in glioblastoma. Lead author and presenter: Dongjiang Chen.

(EXTH-76) Developing the novel combination therapy options for cancer therapy using Tumor Treating Fields together with the chemo agents targeting the replication stress pathway. Lead author and presenter: Narasimha Kumar Karanam.

Physics

(RBIO-01) Developing the framework for Tumor Treating Fields (TTFields) treatment planning for a patient with astrocytoma in the spinal cord. Lead author: Jennifer de Los Santos. Presenter: Tal Marciano.

(RBIO-06) Mechanism of action and associated effects of Tumor Treating (TTFields) on living cells using simulations. Lead author and presenter: Tal Marciano.

(CTNI-44) Dosimetric impact of Tumor Treating Fields on concurrent radiation therapy for pediatric brain tumors. Lead author and presenter: Michelle Quan.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research on TTFields extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields therapy.

On November 15, 2021 The V Foundation for Cancer Research, a top-rated cancer research charity, reported that it has awarded grants worth more than $21 million for cutting-edge cancer research in 2021 (Press release, The V Foundation for Cancer Research, NOV 15, 2021, View Source [SID1234595654]). The total grant funding by the Foundation has now reached nearly $290 million.

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Each year, the Foundation invites NCI-designated cancer centers nationwide to nominate researchers for each grant category, Translational and V Scholar, for funding consideration. The V Foundation’s Scientific Advisory Committee (SAC), made up of world-class researchers from leading cancer centers, reviews and recommends the most promising projects for funding. This rigorous process ensures proposals meet the highest standards of scientific merit.

"After many difficult months during which the COVID-19 pandemic affected not just fundraising but also disrupted research at many institutions, we are delighted to report a strong funding year to drive critical cancer research forward and nurture young research talent through these difficult times," said Carole Wegner, Ph.D., senior vice president of research and grants administration.

The V Foundation awarded 18 Translational grants and 37 V Scholar grants in 2021. Translational grants are a three-year commitment of $200,000 per year. These grants support "bench to bedside" research, whose endpoint is often planning or initiation of a clinical trial. V Scholar grants provide researchers with $200,000 of funding over a two-year commitment and are awarded to innovative young scientists establishing their research careers.

A total of $3.7 million was awarded through the Stuart Scott Memorial Cancer Research Fund in 2021. The Stuart Scott Fund was created in 2015 in memory of beloved ESPN sportscaster Stuart Scott. Scott was a cancer research advocate, especially for minority populations, even before his own cancer diagnosis. The Fund is dedicated to reducing inequalities in both cancer care and cancer research, as well as supporting early career researchers from underrepresented minorities.

A total of $5 million was awarded through the Dick Vitale Fund for Pediatric Cancer. Funded studies include research for brain, blood and bone cancers, among others. Nearly $60 million has been awarded through the fund named for V Foundation board member Dick Vitale, a tireless champion for pediatric cancer research.

The Translational research project that receives one of the highest ratings by the SAC is annually designated as the Nick Valvano Translational Research Grant. Nick Valvano, Jim Valvano’s brother, served as CEO for 13 years and has been a V Foundation Board Member since 1993. This year, Steven Reiner, M.D., from Columbia University, received the distinction.

"Support from the V Foundation for our research will be transformative," said Reiner. "When we began studying blood samples from cancer patients, we quickly realized the test we developed might predict which patients will respond to immunotherapy, something important to patients and their doctors. I am honored to receive the Nick Valvano Translational Research Grant, which could help make immunotherapy even more effective for a greater number of cancer patients."

An additional Translational research project receiving one of the highest ratings by the SAC is annually designated as the Bob Bast Translational Research Grant. Bob Bast, M.D., chaired the V Foundation’s SAC for over 20 years and continues to serve on the SAC and V Foundation board. Shivani Srivastava, Ph.D., from Fred Hutchinson Cancer Research Center, received the honor.

Andrew Venteicher, M.D., Ph.D., from Masonic Cancer Center, and Yuxuan Miao, Ph.D., from the University of Chicago, tied for the Martin D. Abeloff Scholar Award, recognizing the highest reviewer-scored V Scholar grant recipient.

The V Foundation holds 10 consecutive 4-star (highest) ratings from Charity Navigator, America’s largest evaluator of charities, making the Foundation among the top 2% of all charities evaluated. The V Foundation is also a GuideStar Platinum-rated charity.

For more information about the V Foundation, its grants program, the Scientific Advisory Committee or to donate, please visit v.org. A complete list of the 2021 grant recipients can be found here.