On April 12, 2021 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported the closing of its previously announced underwritten registered public offering of 1,600,000 depositary shares, each representing a 1/1000th fractional interest in a share of the Company’s 8.375% Series B Cumulative Perpetual Preferred Stock, with liquidation preference equivalent to $25.00 per depositary share (Press release, Xoma, APR 12, 2021, View Source [SID1234577921]). The offering resulted in net proceeds of approximately $38.0 million after deducting underwriting discounts and commissions, but before expenses. The Company expects to use the net proceeds of this offering to fund the segregated dividend account and the remaining net proceeds for general corporate purposes, including funding future acquisitions of milestone and royalty rights associated with drug development programs with third-party funding. The depositary shares will be listed on Nasdaq under the symbol "XOMAO" and are expected to begin trading within 30 days.

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Book-running managers for this offering were B. Riley Securities, Inc., National Securities Corporation, Ladenburg Thalmann & Co. Inc., and William Blair & Company. Co-managers were Aegis Capital Corp., Boenning & Scattergood, Inc., Incapital LLC, and Northland Capital Markets.

The depositary shares were offered under the Company’s shelf registration statement on Form S-3, which was declared effective by the U.S. Securities and Exchange Commission ("SEC"). The offering of these depositary shares was made only by means of a prospectus supplement and accompanying base prospectus, which were filed with the SEC. A copy of the prospectus and prospectus supplement relating to these securities may be obtained on the website of the SEC at View Source or from the offices of B. Riley Securities, Inc., 1300 17th Street North, Suite 1300, Arlington, Virginia 22209, or by telephone at (703) 312-9580 or by emailing [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the depositary shares in any state or jurisdiction in which such offer, solicitation, or sale would not be permitted.

On April 12, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) that the results of the Phase 3 ORIENT-3 study were released today in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Innovent Biologics, APR 12, 2021, View Source [SID1234577938]).

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ORIENT-3 is a randomized, open-label, Phase 3 clinical trial evaluating TYVYT (sintilimab injection) versus docetaxel as a second-line treatment for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). A total of 290 patients whose cancer had progressed following first-line treatment with platinum-based chemotherapy were enrolled. Based on the primary analysis population (280 patients, excluding patients on the docetaxel arm who received immunotherapy prior to disease progression), TYVYT (sintilimab injection) demonstrated a statistically significant improvement in overall survival (OS) compared to docetaxel, meeting the pre-specified primary endpoint. The median OS was 11.79 months for patients on the TYVYT (sintilimab injection) arm and 8.25 months for those on the docetaxel arm (HR=0.74, 95% CI: 0.56-0.96, P=0.02489). The median progression-free survival (PFS) as assessed by investigators was 4.30 months versus 2.79 months (HR=0.52, 95% CI: 0.39-0.68, P<0.00001), and the confirmed objective response rate (ORR) was 25.5 percent versus 2.2 percent (P<0.00001), respectively. Safety was consistent with previous studies of TYVYT (sintilimab injection), and no new safety signals were identified.

Professor Yuankai Shi, principal investigator of ORIENT-3, Associate Dean of Cancer Hospital, Chinese Academy of Medical Sciences and Chairman of Cancer Foundation of China, stated: "Lung cancer is the leading cause of cancer death globally, of which non-small cell lung cancer accounts for 80 to 85 percent. In the past few decades, drug development of non-small cell lung cancer has mainly focused on nonsquamous non-small cell lung cancer, while drug development of squamous non-small cell lung cancer has been slower due to its unique epidemiological, histopathological and molecular characteristics. In China, specifically, the approved options for second-line immunotherapy to treat squamous non-small cell lung cancer are even more limited. The ORIENT-3 study showed that the anti-PD-1 monoclonal antibody sintilimab significantly improved overall survival for the second-line treatment of squamous non-small cell lung cancer patients, which is of great clinical value. We hope that the positive results of ORIENT-3 can help more squamous non-small cell lung cancer patients."

"TYVYT (sintilimab injection) was the first anti-PD-1 inhibitor included in the New Catalogue of the National Reimbursement Drug List in 2019," said Dr. Hui Zhou, Vice President of Medical Science and Strategy Oncology of Innovent. "In August 2020, the NMPA accepted a new indication application for TYVYT (sintilimab injection) in combination with chemotherapy for first-line treatment of squamous NSCLC. In the ORIENT-3 study, sintilimab as second-line monotherapy demonstrated a significantly improved survival benefit for patients with advanced squamous non-small cell lung cancer, and we look forward to the potential approval of this indication, to help more patients with this type of lung cancer."

"We are excited about these results, showing TYVYT (sintilimab injection) significantly improved overall survival in this patient population. This study underscores the joint commitment from Lilly and Innovent to provide innovative treatment options to patients with lung cancer," said Dr. Wang Li, Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "We would like to thank the patients, the investigators, the clinical trial centers and our colleagues from Innovent that are involved in the study. We look forward to working together to potentially bring this new treatment option to people in China with squamous non-small cell lung cancer."

About Squamous NSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 to 85 percent of lung cancer. Approximately 70 percent of people with NSCLC have locally advanced or metastatic NSCLC at initial diagnosis, rendering many of those patients with no chance of radical resection. Meanwhile, even after radical surgery, patients still have a high chance of recurrence and eventually die from disease progression. About 30 percent of people in China with non-small cell lung cancer have tumors of the squamous subtype and there are limited approved second-line therapies for these patients. Therefore, there remains a huge unmet medical need in China.

About the ORIENT-3 Trial

ORIENT-3 is a randomized, open-label, multi-center, Phase 3 clinical trial to evaluate the efficacy and safety of TYVYT (sintilimab injection) as second-line therapy for advanced or metastatic sqNSCLC (ClinicalTrials.gov, NCT 03150875). The primary endpoint is overall survival (OS). The secondary endpoints include progression-free survival (PFS) as assessed by investigators based on RECIST v1.1, objective response rate (ORR) and safety profile.

A total of 290 patients were enrolled in ORIENT-3 and randomized in a 1:1 ratio to receive either TYVYT (sintilimab injection) 200mg or docetaxel every three weeks. The patients received treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA (National Medical Products Administration) for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. In February 2021, TYVYT (sintilimab injection) was approved by the China NMPA in combination with pemetrexed and platinum chemotherapy as first-line therapy for the treatment of nonsquamous non-small cell lung cancer. TYVYT (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in November 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

Currently TYVYT (sintilimab injection) has three supplemental New Drug Applications ("sNDA") under review by the NMPA. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with gemcitabine and platinum chemotherapy as first-line therapy in squamous NSCLC. In January 2021, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab injection) as first-line therapy in Hepatocellular Carcinoma (HCC) and the sNDA for TYVYT (sintilimab injection) as second-line therapy in squamous NSCLC. Besides, in May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma.

TYVYT (sintilimab injection), is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.

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.