On March 28, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported a clinical update from the ongoing Phase 1 trial of INB-100 (Press release, In8bio, MAR 28, 2022, View Source [SID1234611034]). This program is an allogeneic, or donor-derived, gamma-delta T cell therapeutic candidate in development for patients with leukemia undergoing haploidentical hematopoietic stem cell transplant (HSCT). Two of the INB-100 patients treated have been in remission for nearly two years, and the third patient is in continuing remission at nine months post-treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The exploratory clinical correlative data highlights the robust reconstitution of the immune system of treated patients. The data show positive trends in levels of immune cells, including alpha-beta T cells, B cells and gamma-delta T cells. This suggests that the systemic immune system may show long-term positive trends in treated patients. The toxicity profile continues to be manageable with no treatment-related Grade 3 or greater adverse events. The clinical and correlative update was presented at the virtual European Society for Blood and Marrow Transplantation (EBMT) 48th Annual Meeting.

"We are encouraged by the patients’ responses to INB-100 treatment given this population’s high risk for recurrence," said Lawrence S. Lamb, Ph.D., Chief Scientific Officer and co-founder of IN8bio. "As we near the two-year mark in remission for our first and longest enrolled patient, we continue to monitor data from our ongoing clinical correlative studies, which are indicating a positive systemic immune response following the infusion of INB-100. Patient recruitment in this trial is continuing, and we look forward to releasing further clinical and correlative data with additional patients later this year."

About the INB-100 Phase 1 Trial

The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic derived, gamma-delta T cells that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. Three high-risk AML patients with complex cytogenetics have been treated to-date. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.

On March 28, 2022 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, reported its new name, Vivesto AB, has been registered with the Swedish Companies Registration Office. As a result of the name change, the company will also change the name and short name (ticker) of its share and paid subscribed shares ("BTA") (Press release, Oasmia, MAR 28, 2022, View Source [SID1234611057]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new name, Vivesto AB, which was approved at the Extraordinary General Meeting on 21 February 2022, reflects the company’s commitment to improve survival and quality of life for patients with cancer through investment in R&D and innovation and marks the end of a turn-around period for the company culminating in the recent successful financing which now provides ample funding for the future operations including key clinical trials.

François Martelet, CEO, said: "We are excited to start a new chapter for Vivesto with the recent completion of the rights issue, which created solid foundations that will enable us to continue to achieve our strategic goals by funding existing operations and clinical trials of our lead products in the next 18-24 months. We are now fully focused on making our ‘string of pearls’ strategy a reality by adding promising and innovative oncology programs to our pipeline through in-licensing and M&A. Our new identity encapsulates our mission to support life through a diversified portfolio of cancer therapies, and we have built a powerful platform for future growth."

Change of name and short name (ticker)
The name of the share on Nasdaq Stockholm will change from Oasmia Pharmaceutical AB to Vivesto AB and its ticker from OASM to VIVE. The name of the BTA will change from Oasmia Pharmaceutical AB BTA to Vivesto AB BTA and its short name OASM BTA to VIVE BTA.

The ISIN code of the company’s share and BTA will remain unchanged. The last day for trading with the current tickers is today, 28 March 2022. The first day for trading with the new tickers will be on 29 March 2022.

This is an administrative matter. Shareholders therefore do not need to take any action.

The Company worked with the Brand Institute to develop its new identity. Vivesto was ranked highly for brand recognition and relevance by patients, medical professionals and investors surveyed in Europe, the US and Sweden.

On March 28, 2022 Avera Health (Avera), an integrated regional health care system that serves 300 locations across the Upper Midwest, and Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision medicine company with a novel phosphoprotein-based assay for breast cancer reported a strategic collaboration to advance comprehensive molecular profiling, enabling Avera Health’s providers and patients to benefit from data-driven insights that inform targeted cancer treatments (Press release, Avera Pharmaceuticals, MAR 28, 2022, View Source [SID1234611072]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Avera has a long-standing history of leading the way in precision oncology with patients’ tumors being genetically sequenced to guide individualized cancer care. Theralink, with its patented protein and phosphoprotein biomarker platform and lab developed test, is the only commercially available assay for clinical use that measures the tumor cell levels of activated proteins, which are the primary targets of most FDA-approved therapies and biopharmaceutical investigational drugs.

Theralink will provide key patient-specific information about which drug targets are activated and "in use" in each patient tumor sample. This information, coupled with the genomics findings, will provide a comprehensive molecular profile for all Avera oncology patients by way of a multiomic report used for physician treatment decisions.

"Avera has been a cancer care leader in our region for many years. Avera Cancer Institute is focused on actionable insights for our physicians and patients to make treatment decisions that are personalized," said Casey Williams, Chief Scientific Officer and Executive Director of Cancer Research. "We understand the role this innovative approach plays in generating better health outcomes for our patients, and Theralink will play a key role in that process."

"We believe that the Theralink protein/phosphoprotein data, combined with the next generation sequencing data, may give Avera Cancer Institute the most cutting edge and best precision oncology data in the world, potentially creating a step change in cancer care," said Mick Ruxin, M.D., President & CEO of Theralink. He went on to say, "It is gratifying to know that a large, prestigious, midwest cancer program, Avera Health, has realized the significant potential value of our Theralink assay for their cancer patients." Dr. Ruxin continued, "We expect great results from working with Avera and their patients in our goal to decrease the morbidity and mortality of cancer patients."

As part of this collaboration, Avera will assist Theralink Technologies in validating new clinical assays for additional tumors (such as GYN, Head and Neck, GI, Lung, Kidney, Liver and Prostate) through retrospective case analysis and population-based data. This may bring new capability and insights to precision oncology care and allow for the Theralink assay to become a pan-tumor assay.

On March 28, 2022 Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, reported that it will present preclinical data from its Casitas B-lineage lymphoma b (Cbl-b) program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting, being held April 8-13, 2022 in New Orleans, LA (Press release, Nimbus Therapeutics, MAR 28, 2022, View Source [SID1234611035]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cbl-b is validated as an immuno-oncology target; the enzyme catalyzes the ubiquitination of substrate proteins to regulate multiple signaling events in a variety of cell types, including immune cells. Nimbus undertook a structure-based drug design approach to identify NTX-801, a Cbl-b inhibitor. In an in vivo PD model, NTX-801 was observed to enhance cytokine responses. In a syngeneic mouse model, NTX-801 demonstrated tumor growth inhibitory activity.

Details of the AACR (Free AACR Whitepaper) presentation are as follows:

Abstract Control Number: 4649
Abstract Title: Discovery of NTX-801, a potent Cbl-b inhibitor with antitumor activity in syngeneic models
Session Title: Preclinical Immunotherapy

On March 28, 2022 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported recent business highlights and financial results for its fourth quarter and full year ended December 31, 2021 (Press release, HCW Biologics, MAR 28, 2022, View Source [SID1234611058]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Hing C. Wong, the Founder and CEO of HCW Biologics, stated, "We accomplished a number of significant achievements in the past year. We fortified our balance sheet through an initial public offering. We advanced our clinical development programs, overcoming headwinds from the COVID-19 pandemic, supply chain disruptions, and critical supply shortages. We begin 2022 poised to initiate multiple clinical trials to evaluate HCW9218 in cancer indications. We are hopeful later this year we begin to see human data that demonstrate the potential for our immunotherapeutics in the treatment of chemotherapy-resistant cancer, and validate our focus on the elimination of cellular senescence, which is the etiology for many age-related diseases."

Year in Review – Business Highlights:

In the year ended December 31, 2021, the Company achieved several milestones:

IPO. On July 22, 2021, the Company closed its IPO resulting in net proceeds of approximately $49.2 million, after deducting underwriting discounts and commissions and offering expenses paid by the Company.

HCWB added to Total Market Index. The Company was added to the S&P Total Market Index ("TMI") on September 20, 2021.

FDA clearance for Company-sponsored Phase 1b clinical trial in cancer. On October 28, 2021, the Company announced that it was cleared by the FDA to proceed to evaluate its lead drug candidate, HCW9218, in a first-in-human Phase 1b clinical trial in patients with advanced pancreatic cancer.

FDA clearance for Investigator-sponsored Phase 1 clinical trial in cancer. On January 24, 2022, the Company announced that the Masonic Cancer Center at the University of Minnesota, a National Cancer Institute designated Comprehensive Cancer Center, was cleared by the FDA to proceed to evaluate the Company’s lead drug candidate, HCW9218, in a Phase 1 clinical trial in patients with advanced solid tumors with progressive disease after prior chemotherapies.

Two new independent board members. The Company increased the skill set of its Board of Directors with the addition of two new board members: Lisa M. Giles and Gary M. Winer. Ms. Giles has extensive experience in pharmaceutical, diagnostic, device, and other healthcare industries. Mr. Winer has led and built successful, multinational businesses in the biopharma and diagnostic healthcare sectors as a Chief Executive Officer or President, and has held senior leadership positions with AbbVie and Abbott.

Dr. Hing C. Wong, Company’s Founder and CEO, Weaver H. Gaines Entrepreneur of the Year. Hing C. Wong, Ph.D., the Company’s CEO and Founder, was named the 2021 Weaver H. Gaines Entrepreneur of the Year by BioFlorida. Presented annually at the BioFlorida Conference, the award recognizes an individual who has made extraordinary contributions to the growth of life sciences in the leadership of a company or institution. This marks the second time Dr. Wong was recognized for his outstanding contributions with this award.

Expanding IP Portfolio. The Company continues to expand its intellectual property portfolio through filing provisional and utility U.S. applications based upon new research, filing non-U.S. national stage phase patent applications, and filing U.S. trademark applications. The Company’s earlier filed applications are progressing through the prosecution phase.

Three publications in peer-reviewed journals. Publications in peer-reviewed journals, which are based on inventions and discoveries made by the Company, are a pillar in the Company’s strategy to establish leadership in oncology and other age-related diseases especially with the scientific and clinical communities. As of today, the Company has published three papers:

An article in Cancer Immunology Research describing its platform: Becker-Hapak MK, et al. A Fusion Protein Complex Combines IL-12, IL-15, and IL-18 Signaling to Induce Memory-like NK Cells for Cancer Immunotherapy. September 9, 2021.

An article in Molecular Therapy on the characterization of its lead molecules, HCW9218: Liu B et al., Bifunctional TGF-ß Trap/IL-15 Protein Complex Elicits Potent NK Cell and CD8 + T Cell Immunity Against Solid Tumors. October 6, 2021.

An article in Molecular Therapy which discusses HCW9218 and its ability to augment anti-tumor activity and reduce side effects of chemotherapy regimens: Chaturvedi, P et al., Immunotherapeutic HCW9218 Augments Anti-tumor Activity of Chemotherapy via NK Cell Mediated Reduction of Therapy Induced Senescent Cells, January 17, 2022.

Fourth Quarter and Year-End Financial Results:

Cash and cash equivalents: On December 31, 2021, the Company’s cash balance was $11.7 million, short-term investments were $25.0 million and long-term investments were $9.9 million. The net proceeds from the IPO were $49.2 million. The Company estimates that it has sufficient cash to fund operation expenses to the end of 2023. This estimated cash runway does not include potential sources of non-dilutive financing, which may be obtained from new or existing out-licensing agreements.

Revenues: Revenues for the fourth quarter and year ended December 31, 2020 and 2021 were $4.1 million and none, respectively. On December 24, 2020, the Company entered an exclusive worldwide licensing agreement granting Wugen, Inc. limited rights to two of our molecules. Revenues were generated from the sale of cGMP clinical materials, R&D knowledge transfer, and an in-kind payment consisting of shares of Wugen common stock. In the year ended December 31, 2021, the Company recognized $1.8 million in deferred revenue to the extent cash was received for sales of clinical and research-grade materials to Wugen prior to the finalization of contractual terms of purchase.

Research and development (R&D) expenses: R&D expenses for the fourth quarter ended December 31, 2020 and 2021 were $1.4 million and $1.5 million, respectively. R&D expenses for the year ended December 31, 2020 and 2021 were $7.3 million and $8.2 million, respectively. The annual increase of 13% was primarily attributable to an increase in expenses associated with IND-enabling activities, offset by a reimbursement for certain R&D expenses as provided for in the Wugen license.

General and administrative expenses (G&A): G&A expenses for the fourth quarter ended December 31, 2020 and 2021 were $1.0 million and $1.6 million, respectively. G&A expenses for the year ended December 31, 2020 and 2021 were $2.7 million and $5.2 million, respectively. The annual increase of 93% was primarily due to an increase in costs related to operating as a public company, including legal fees for corporate work, intellectual property protection, other professional services, and insurance.

Net income (loss): Net income for the fourth quarter ended December 31, 2020 was $2.1 million. Net loss for the fourth quarter ended December 31, 2021 was $3.2 million. Net loss for the year ended December 31, 2020 and 2021 was $5.8 million and $12.9 million, respectively.