On April 10, 2021 Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, reported the first presentation of preclinical data demonstrating potent single-agent anti-tumor activity in preclinical cancer models with systemically administered TAC-001, the company’s lead clinical candidate from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform (Press release, Tallac Therapeutics, APR 10, 2021, View Source [SID1234579743]). The data will be presented today as part of the Immunomodulatory Agents and Interventions Session at Week I of the American Association of Cancer Research’s (AACR) (Free AACR Whitepaper) 2021 Virtual Annual Meeting (#AACR21) taking place April 10-15, 2021.

Toll-like receptor (TLR) agonists are a novel class of immunotherapy that generate both an innate and
adaptive immune response which may produce more robust and durable anti-cancer immunity to help
overcome resistance to standard-of-care oncology treatments. TLR9 is a key intracellular TLR present in
broad immune cell populations such as B lymphocytes and myeloid cells. Recent studies have shown that
the likelihood of patients responding to immune checkpoint inhibitor therapy may depend on B cells in
the tumor.i B cells play pivotal roles in the immune defense system, which bridge the innate and the
adaptive immunities against cancers.ii In preclinical studies, the activation of TLR9 in human and mouse
models drives B cell proliferation and differentiation.iii

"The results presented today at AACR (Free AACR Whitepaper) elucidate the unique properties of TAC-001 responsible for
integrating B cells and TLR9 activation which trigger innate and adaptive immune responses to create
potent, systemically delivered anti-tumor immunity across solid tumor types," said Dr. Hong I. Wan,
president, CEO and co-founder of Tallac Therapeutics. "The emerging data on TAC-001 continues to
strengthen our understanding of the roles that B cells and TLR9 activation play in eliciting anti-tumor
immunity in checkpoint inhibitor resistant and refractory settings and will help guide our clinical
development strategy."

In the e-poster, titled "TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells,
promotes anti-tumor immunity and favorable safety profile following systemic administration in
preclinical models," investigators present data providing evidence that in vitro targeted delivery of TAC001 leads to superior TLR9 activation in B cells, increased expression of co-stimulatory molecules and
cross-presentation leading to T cell proliferation. In vivo, TAC-001 demonstrated robust, curative and
durable single agent anti-tumor activity in checkpoint inhibitor resistant and refractory tumor models.
Additionally, the systemic administration of TAC-001 was shown to trigger both innate and adaptive
immunity by increasing B cell infiltration, T effector cell functions and modulation in suppressive myeloid
cells within the tumor microenvironment. These results support the development of TAC-001 for a broad
range of solid tumor malignancies.

AACR Poster Presentation Details:

Title: TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells, promotes antitumor immunity and favorable safety profile following systemic administration in preclinical models
Session Type: E-Poster Session
Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions
Track: Immunology, Clinical Research Excluding Trials
Permanent Abstract Number: 1721
About TAC-001
TAC-001 is a Toll-like Receptor Agonist Antibody Conjugate (TRAAC) comprised of a potent Toll-like
Receptor 9 agonist (T-CpG) conjugated to an anti-CD22 antibody, a receptor restricted to B cells.
TAC-001 is designed to systemically deliver T-CpG to B cells by binding to CD22, leading to internalization
of TAC-001, TLR9 signaling, B cell activation and a cascade of immune reactions. Preclinical studies
demonstrate that the innate and adaptive immune responses triggered by TAC-001 leads to potent antitumor activity. TAC-001 is being developed to systemically deliver targeted immune activation in solid
tumor cancers.

On April 12, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that it has closed its previously announced underwritten follow-on offering of 4,562,044 shares of its common stock at a price to the public of $16.44 per share (Press release, Crinetics Pharmaceuticals, APR 12, 2021, View Source [SID1234577906]). The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, were approximately $75.0 million. Investors in the offering included Deep Track Capital, Bain Capital Life Sciences, and Driehaus Capital Management, with participation from other new and existing stockholders.

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Crinetics intends to use the net proceeds from the offering to fund the development of paltusotine and its other research and development programs, and for working capital and general corporate purposes.

SVB Leerink acted as sole bookrunning manager for the offering.

The securities described above were offered by Crinetics pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement relating to this offering has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6105 or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus are also available on the website of the SEC at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On April 12, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or resistant to, current treatment regimens, reported interim data results from two Phase 2 clinical trials evaluating VAL-083, the Company’s lead compound, for the treatment of glioblastoma multiforme (GBM) (Press release, Kintara Therapeutics, APR 12, 2021, View Source [SID1234577922]). The data were presented in two posters at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is taking place virtually from April 10-15, 2021.

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Poster CT238 provides an update from two patient groups receiving VAL-083 in an open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston, Texas. The second poster, CT172, updates the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center in China.

"These interim data updates at the AACR (Free AACR Whitepaper) Annual Meeting continue to demonstrate VAL-083’s potential as a game-changing treatment option for GBM patients," commented Saiid Zarrabian, Kintara’s Chief Executive Officer. "Furthermore, it’s important to note that both trials have provided valuable insights as we prepared to initiate the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which commenced patient enrollment in February 2021."

Poster CT238: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the adjuvant or recurrent setting"

In newly-diagnosed patients receiving VAL-083 as adjuvant therapy following treatment with radiation and temozolomide (TMZ), for the 33 efficacy evaluable patients (of a planned 36 patients) as of the data cut-off of March 12, 2021, median progression-free survival (PFS) is currently 10.0 months (95% confidence interval: CI 8.2-10.8). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.

For patients in the fully enrolled recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 89 patients have been enrolled as of the data cut-off of March 12, 2021 with 35 patients (35 efficacy evaluable) initially receiving a dose of 40 mg/m2/day and 54 (48 efficacy evaluable) initially receiving the treatment dose that is being carried forward in the GBM AGILE study of 30 mg/ m2/day on days 1, 2 and 3 of a 21-day cycle. Median overall survival (mOS) for the 83 efficacy evaluable patients who have completed at least once cycle of treatment was 7.5 months (CI 6.0-9.0 months). Additionally, for the 48 efficacy evaluable patients initially receiving a dose of 30 mg/ m2/day, mOS is currently 7.9 months (CI 5.9-9.9 months). While this is not a head-to-head trial, historically lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months***.

Consistent with prior studies, myelosuppression is the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment settings. In the 30 mg/m2/day starting dose cohort (the dose that is being carried forward in the GBM AGILE study) seven subjects have experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient has experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.

Poster CT172: "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly-diagnosed MGMT-unmethylated GBM"

In the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients, median PFS for the 29 patients, as of the March 11, 2021 cut-off date, is currently 9.3 months (CI 6.4-12.0 months). Additionally, for the 25 patients initially receiving the treatment dose that is being carried forward in the GBM AGILE study of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle, median PFS was reported to be 8.7 months (CI 6.4-12.5 months). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively. Three subjects have experienced an SAE possibly related to VAL-083. Multiple treatment cycles of VAL-083 at the 30 mg/m2/day dose in combination with standard radiation treatment (2 Gy/day, 5 days/week) were shown to be generally safe and well-tolerated. This study has been fully enrolled, and all patients have completed treatment with VAL-083 and are currently in follow-up.

On April 12, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary NK cell engager (TriKE) protein biologic technology platform, reported additional interim results from its GTB-3550 TriKE first-in-human Phase I/II clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML) (Press release, GT Biopharma, APR 12, 2021, View Source [SID1234577939]).

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Additional results show GTB-3550 TriKE monotherapy is able to rescue the patient’s otherwise exhausted/inhibited/non-functional endogenous NK cell population and target direct killing of the patient’s AML and MDS cancer cells without the need for the co-administration addition of supplemental progenitor-derived or autologous/allogenic engineered NK cells.

GTB-3550 TriKE monotherapy has demonstrated clinical benefit in very hard to treat relapsed/refractory AML and high-risk MDS cancer patients by significantly reducing cancer cell (blast) levels and, in some cases, ending transfusion dependency with patients becoming eligible for bone marrow transplant.

The ability to use GTB-3550 in a monotherapy setting is a significant competitive and therapeutic advantage, and a major cost savings compared to the co-administration of drug/cell therapy combination regimens. GTB-3550 TriKE therapy requires no patient pre-treatment regimens such as myeloablative chemotherapy, and is well tolerated with no signs of cytokine release syndrome (CRS) or other toxicities suggesting GTB-3550 could be used to treat patients earlier in the disease process, whereas complicated and expensive combination drug/cell therapy regimens are expected to be used as late-stage or salvage therapies after all other therapeutic options have been exhausted.

Highlights from the first nine patients treated with GTB-3550 TriKE include:

Up to 63.7% Reduction in Bone Marrow Blast Levels Resulting in Clinical Benefit
Restores Patient’s Endogenous NK Cell Function, Proliferation and Immune Surveillance
No Progenitor-derived or Autologous/Allogenic Cell Therapy Required
No Cytokine Release Syndrome Observed
3 out of the last 5 Patients Treated Respond (25mcg/kg/day to 100mcg/kg/day therapeutic dose range)
"We believe GTB-3550 TriKE sets a new standard for NK cell engager therapies due to the incorporation of Interleukin 15 (IL-15) directly in the protein backbone. The flexibility and versatility of our TriKE platform allows us to change the cancer cell targeting moiety of TriKE to attack different cancers while maintaining the core NK cell activation, proliferation and persistence attributes of the molecule," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "The TriKE is a true monotherapy, unlike all other NK cell technologies in development. The novel TriKE uniquely does not need any outside NK cell manufacturing or combination drugs, to supplement or assist. Further, the TriKE does not require pre-conditioning of the patient’s immune system. These supplemental requirements of competitive technologies add tremendous cost to an already costly therapeutic approach. Everything the TriKE does happens with no outside assistance whatsoever. We believe the TriKE’s clinical data is demonstrating exactly that, opening the door to a significantly more cost-effective off-the-shelf therapeutic."

About High-Risk Myelodysplastic Syndromes
MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. As a result of this irregular production, MDS patients do not have sufficient normal red blood cells, white blood cells and/or platelets in circulation. High-risk MDS is associated with poor prognosis, diminished quality of life, and a higher chance of transformation to acute myeloid leukemia. Approximately 40% of patients with high-risk MDS transform to AML, another aggressive cancer with poor outcomes.

About Acute Myeloid Leukemia
Acute myeloid leukemia is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. According to the National Cancer Institute (NCI), the five-year survival rate is about 35% in people under 60 years old, and 10% in people over 60 years old. Older people whose health is too poor for intensive chemotherapy have a typical survival of five to ten months. AML accounts for roughly 1.8% of cancer deaths in the United States.

About GTB-3550 TriKE
GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of AML and MDS, and other CD33+ hematologic cancers. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of Interleukin 15 (IL-15). The natural killer (NK) cell-stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GTB-3550 TriKE Clinical Trial
Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.

On April 12, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), together with SOLTI, reported new clinical data from the AWARE-1 window-of-opportunity breast cancer study showing patients receiving pelareorep plus checkpoint blockade therapy met the trial’s primary endpoint (Press release, Oncolytics Biotech, APR 12, 2021, View Source [SID1234577890]). These data are featured in an electronic poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 during Week 1, which is taking place virtually from April 10-15, 2021.

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In the poster, data from the twenty HR+/HER2- early-stage breast cancer patients included in AWARE-1’s first two cohorts are presented. These patients were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab (Tecentriq) prior to surgery. Evaluation of cohorts 1 and 2 is the core objective of AWARE-1, as HR+/HER2- is the breast cancer subtype Oncolytics intends to examine in a future registrational study.

Pelareorep treatment in cohort 1 upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ T cells, and increased the CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes. These desired outcomes were further enhanced in cohort 2 patients, demonstrating pelareorep and atezolizumab synergistically combine to generate an anti-cancer immune response in the tumor and peripheral blood. Notably, cohort 2 met the pre-specified success criteria for the study’s primary endpoint (50% of patients with ≥ 30% increase in CelTIL score), with six of ten patients achieving at least a 30% increase in CelTIL score following treatment.

"These exciting AWARE-1 data confirm pelareorep promotes a pro-inflammatory tumor microenvironment, allowing it to synergistically interact with checkpoint inhibitors to train the immune system to fight cancer," said Aleix Prat, M.D., Ph.D., Translational Principal Investigator of AWARE-1, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. "The data show combining pelareorep with anti-PD-L1 therapy led to increases in CelTIL score and an improvement in the ratio between cytotoxic CD8+ T cells to regulatory T cells. These striking immunological changes are associated with greater therapeutic efficacy and improved clinical outcomes. Collectively, the AWARE-1 results highlight pelareorep’s potential to address the unmet need for techniques to enhance checkpoint inhibitor efficacy and strongly support the continued clinical evaluation of pelareorep-checkpoint inhibitor combinations."

Key data and conclusions from the AACR (Free AACR Whitepaper) poster include:

Treatment with pelareorep alone or in combination with atezolizumab increased tumor PD-L1 expression and led to the conversion of PD-L1 negative tumors into PD-L1 positive tumors
Pelareorep profoundly reverses immunosuppressive tumor microenvironments and promotes immune effector cell infiltration into solid tumors, positioning it as an enabling technology for a variety of immunotherapeutic agents
Tumor-cell specific pelareorep replication was observed in all evaluated patients following intravenous pelareorep administration
60% of cohort 2 patients (n=10) saw a CelTIL increase of at least 30% from baseline (pre-pelareorep administration) to surgery (21-days post-administration), exceeding the study’s pre-specified success criteria
70% of all cohort 1 and 2 patients (n=20) saw an increase in CelTIL from baseline to surgery
The addition of atezolizumab enhances pelareorep’s ability to generate and expand new anti-viral and anti-tumor T cell clones in the tumor and periphery
Compared to cohort 1, cohort 2 patients had a higher ratio of CD8+ T cells to regulatory T cells, suggesting pelareorep and checkpoint inhibition enhances inflammation within the tumor microenvironment
Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, "Based on these new results, we have successfully achieved two key objectives of the AWARE-1 study. We’ve demonstrated synergy between pelareorep and checkpoint blockade therapy, and we’ve shown pelareorep triggers an adaptive T cell immune response specifically targeting tumors."

Matt Coffey, Ph.D., M.B.A., President and Chief Executive Officer of Oncolytics Biotech Inc. added, "Achieving the primary endpoint in AWARE-1 is a key milestone validating our clinical development strategy. Data indicating that pelareorep and atezolizumab synergistically interact de-risks both our lead breast cancer program and our additional clinical trials evaluating pelareorep-checkpoint inhibitor combination therapies. The data also highlight pelareorep’s ability to profoundly reverse immunosuppressive tumor microenvironments and promote immune effector cell infiltration into solid tumors, positioning it as an enabling technology for a variety of immunotherapeutic agents. Moving forward, we expect these data to facilitate the advancement of our lead breast cancer program towards a registrational study while simultaneously bolstering our business development efforts across several indications and immunotherapy treatment regimes."

The electronic poster, titled "A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (AWARE-1)" is available for on-demand viewing on the AACR (Free AACR Whitepaper) Annual Meeting 2021 e-poster website and on the Posters & Publications page of Oncolytics’ website (LINK).

Key Opinion Leader Event

Oncolytics will host a Key Opinion Leader (KOL) event today at 2:00 pm ET with Aleix Prat, M.D., Ph.D., Translational Principal Investigator of AWARE-1, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona and Dr. Richard Vile, a Professor of Immunology at the Mayo Clinic, who led the preclinical CAR T study with pelareorep presented earlier this year (link to press release, link to poster). To access the webcast, please click this link.

About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue is collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day of their mastectomy. Data generated from this study are intended to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.

For more information about the AWARE-1 study, refer to View Source

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. It is the second leading cause of death from cancer in women in America, with an estimated 42,000 deaths in the US in 2020.1

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.