On June 20, 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 that data from the ORIENT-32 study have been published in The Lancet Oncology (Press release, Innovent Biologics, JUN 20, 2021, View Source [SID1234584178]).

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Led by Professor Fan Jia from Zhongshan Hospital of Fudan University, ORIENT-32 is a Phase 2/3 randomized, open label, multi-center study conducted in China to evaluate the efficacy and safety of sintilimab in combination with the bevacizumab biosimilar IBI305 compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma (HCC).

In January 2021, the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for sintilimab in combination with bevacizumab biosimilar as first-line therapy for patients with HCC.

Professor Fan Jia stated: "ORIENT-32 is the first large-scale study to show the benefit of first-line treatment in HBV-associated HCC with combination immunotherapy. Despite the COVID-19 pandemic, the collaborative joint effort of the ORIENT-32 trial investigators and patients enabled us to successfully reach this milestone. We hope these results can help to provide a new treatment option for patients with hepatocellular carcinoma."

Dr. Zhou Hui, Senior Vice President of Clinical Development of Innovent, stated: "ORIENT-32 is the first hepatocellular carcinoma study in the world of a PD-1 inhibitor-based combination therapy to achieve its primary endpoint of overall survival. We are pleased that these study results have been published in The Lancet Oncology and hope to bring this regimen as a new treatment option for Chinese patients with hepatocellular carcinoma in the near future. Moreover, we are encouraged that our development of cancer therapies is helping to achieve the Healthy China 2030 goal."

About the ORIENT-32 Study

Background

China has a high burden of hepatocellular carcinoma (HCC), with chronic hepatitis B virus (HBV) infection as the major cause. People with HCC have a poor prognosis and a substantial unmet clinical need1. The ORIENT-32 study assessed sintilimab in combination with bevacizumab biosimilar, compared to sorafenib, in the first-line treatment of patients with unresectable HBV-associated HCC.

Methods

This randomized, open label study was conducted at 50 clinical trial sites in China. Patients aged 18 years or older with histologically or cytologically diagnosed or clinically confirmed unresectable or metastatic HCC with no previous systemic treatment and a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 were eligible for inclusion.

In the safety lead-in phase, patients received intravenous sintilimab (200 mg every 3 weeks) plus intravenous bevacizumab biosimilar (15 mg/kg every 3 weeks). In the Phase 3 study, patients were randomly assigned (2:1) to receive either sintilimab plus bevacizumab biosimilar (the sintilimab–bevacizumab biosimilar group) or sorafenib (400 mg orally twice daily; the sorafenib group), until disease progression or unacceptable toxicity. Randomization was done using permuted block randomization, with a block size of six, via an interactive web response system, and stratified by macrovascular invasion or extrahepatic metastasis, baseline α-fetoprotein, and ECOG performance status. In the lead-in phase of the study, safety was assessed in all patients who received at least one dose of study drug. After reviewing the safety findings from the safety lead-in phase, the study was conducted with the primary endpoints of overall survival (OS) and independent radiological review committee (IRRC)-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT03794440.

The study is closed to new participants and follow-up is ongoing for long-term outcomes.

Findings

Between February 11, 2019 and January 15, 2020, 595 patients were enrolled: 24 were enrolled directly into the safety lead-in component and 571 were randomly assigned to receive the sintilimab–bevacizumab biosimilar combination (n=380) or sorafenib (n=191). 24 patients received at least one dose of the study drug, with an objective response rate of 25.0 percent (95% CI 9.8–46.7). Based on the preliminary safety and activity findings of the lead in portion, in which ≥grade 3 treatment-related adverse events (TRAEs) occurred in seven (29%) of 24 patients, the randomized portion was initiated.

At data cutoff (August 15, 2020), the median follow-up was 10.0 months (IQR 8.5–11.7) in the sintilimab–bevacizumab biosimilar group and 10.0 months (8.4–11.7) in the sorafenib group. Patients in the sintilimab–bevacizumab biosimilar group had a significantly longer IRRC-assessed median PFS (4.6 months [95% CI 4.1–5.7]) than did patients in the sorafenib group (2.8 months [2.7–3.2]; stratified hazard ratio [HR] 0.56, 95% CI 0.46–0.70; p<0.0001).

In the first interim analysis of OS, patients in the sintilimab–bevacizumab biosimilar group showed a significantly longer median OS than did patients in the sorafenib group (median not reached [95% CI not reached–not reached] vs 10.4 months [8.5–not reached]; HR 0.57, 95% CI 0.43–0.75; p<0.0001).

The most common grade 3–4 TRAEs were hypertension (55 [14%] of 380 patients in the sintilimab–bevacizumab biosimilar group vs. 11 [6%] of 191 patients in the sorafenib group) and palmar-plantar erythrodysaesthesia syndrome (none vs. 22 [12%]). 123 (32%) patients in the sintilimab–bevacizumab biosimilar group and 36 (19%) patients in the sorafenib group had serious adverse events. TRAEs that led to death occurred in six (2%) patients in the sintilimab–bevacizumab biosimilar group and two (1%) patients in the sorafenib group.

Conclusions

Sintilimab in combination with bevacizumab biosimilar IBI305 showed significant improvements in OS and PFS compared to sorafenib in the first-line treatment of Chinese patients with unresectable, HBV-associated HCC, with no new safety signals. This combination regimen could provide a novel treatment option for such patients.

Link to the ORIENT-32 publication in The Lancet Oncology: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00252-7/fulltext

About Hepatocellular Carcinoma

Primary liver cancer (PLC) is a common malignancy of the digestive system worldwide, among which about half of all new cases and deaths occur in China. The main pathological types of liver cancer are hepatocellular carcinoma (HCC), which accounts for 85 to 90 percent, and a small number of cases of intrahepatic cholangiocarcinoma (ICC) and HCC-ICC mixed liver cancer. In China, HCC is primarily caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an 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 of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for three indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
Additionally, Innovent currently has regulatory submissions under review in China for sintilimab:

In combination with BYVASDA (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
The second-line treatment of squamous non-small cell lung cancer
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

About BYVASDA (bevacizumab biosimilar injection)

BYVASDA, also known as IBI305, is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF-A selectively with high affinity and blocks its binding to VEGF-2 receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since its launch, bevacizumab has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab in these tumor types have been well recognized worldwide.

BYVASDA (bevacizumab biosimilar injection) was firstly approved by the China NMPA on June 17, 2020. Approved indications of BYVASDA include advanced non-small cell lung cancer and metastatic colorectal cancer. In December 2020, it was also approved by the NMPA for the indication of adult recurrent glioblastoma.

On June 20, 2021 Prestige BioPharma Limited (PBP) specializing in the development of antibody therapeutics, reported that French National Agency for the Safety of Medicines and Health Products (L’Agence nationale de sécurité du medicament, ANSM) has approved a Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer (Press release, Prestige BioPharma, JUN 20, 2021, View Source [SID1234584177]).

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The clinical trial will be conducted in the Research Institute against Digestive Cancer (IRCAD) based in Strasbourg, France, in pancreatic cancer patients who have an overexpression of a gene called Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in majority of pancreatic cancers. PBP’s affiliate, Prestige Biologics will be providing drugs for the clinical trial.

PBP is also in the process of preparing for the conduct of this trial in other countries such as the U.S., Australia and Belgium. Korea’s Ministry of Food and Drug Safety (MFDS) is currently reviewing PBP’s application for conduct of this clinical trial in Korea as well.

Pancreatic cancer is a highly aggressive malignancy originating in the exocrine or endocrine pancreatic cells suspected to be caused by poor diet, smoking, and genetic factors. It contributes to high morbidity and mortality with a survival rate of 9% at five years in the U.S. Currently, the only curative options are limited to surgical resection in combination with adjuvant chemotherapy. However, only 10 to 15% of patients are candidates as the diagnosis occurs in advanced or metastatic stages that are surgically inoperable. Limited efficacy of treatment modalities and rapid progression of pancreatic cancer can be partly explained by PAUF and it plays an important role in disease progression, but no targeted molecular therapy against PAUF currently exists. Prestige BioPharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit in all patients affected by PAUF-positive pancreatic cancer.

The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 last year. ODD is granted to investigational drugs intended for the safe and effective treatment of rare diseases with an unmet medical need that affect very few individuals but cause great suffering. This designation provides companies with certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for health technology assessments in certain countries, and if approved, marketing exclusivity in the EU for 10 years, in the U.S. for 7 years.

Lisa S. Park, CEO of Prestige BioPharma, commented: "We are very pleased to initiate the Phase 1/2a clinical trial of PBP1510 in France" and "PBP will accelerate the development of PBP1510 to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments".

On June 18, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported an update on the state of its business operations and other recent developments (Press release, Antengene, JUN 18, 2021, View Source,block%20CD73%20activity%20in%20vitro [SID1234606790]).

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Significant progress has been made with respect to our pipeline and business operations since the company’s IPO on November 20, 2020. During this period, Antengene continued to execute its dual-engine growth strategy leveraging both external partnerships and in-house discovery and have built a pipeline of thirteen assets, five with APAC rights and eight with global rights. Antengene has advanced the clinical trials of our six in-licensed assets in APAC and have continued to expand its pipeline through internal discovery efforts with the announcement of two additional novel targets into our pipeline. In addition, Antengene is reaching an inflection point in its transition from a clinical stage to a commercial stage company, and has further built out its commercial infrastructure in multiple APAC markets in preparation for the commercial launch of selinexor towards the end of 2021.

Corporate Updates

As of June 18, 2021, Antengene has built a strong and dedicated team of over 200 full time employees, over a third of whom are in research and development.
With the expected approvals for selinexor across multiple APAC markets towards the end of 2021, Antengene has continued to build up its experienced commercial team across China and the APAC region with plans to grow its commercial organization to up to 200 full time employees in functions including in-house marketing, field force, pricing and market access by the end of 2021.
In May 2021, Antengene completed its manufacturing center in Shaoxing. To date, Antengene has finished the GMP renovation of plant buildings that will house the packaging line for solid dose formulation, installed supporting facilities, and set up a quality control laboratory for raw materials and finished products.
In May 2021, Antengene has entered into a framework agreement with the Hangzhou Qiantang New Area Administrative Committee to build a drug discovery and manufacturing center for antibody biologics.
An Update on Pipeline Candidates

Asia Pacific Rights Portfolio

Selinexor

Selinexor is a first-in-class, only-in-class orally available XPO1 inhibitor being developed for the treatment of hematologic malignancies and solid tumors.

Data from the MARCH trial of selinexor published at ASCO (Free ASCO Whitepaper) annual meeting in June 2021 include an objective response rate (ORR) of 26.7% in all analyzed patients with relapsed or refractory multiple myeloma (RRMM) and an ORR of 33.3% in patients with triple-class-exposed RRMM. These data are consistent with that observed in the STORM trial, from which, data had supported the accelerated approval of selinexor by the U.S. Food and Drug Administration (FDA). In addition, the data also showed an ORR of 44.4% in patients who had received prior CAR-T therapies.
Antengene has submitted a new drug application (NDA) for selinexor to the National Medical Products Administration (NMPA) in January 2021 with priority review granted to the NDA in February 2021.
Multiple combination regimens of selinexor have already included in the 2021 Chinese Society of Clinical Oncology (CSCO) Guidelines.
Antengene submitted NDAs for selinexor in Australia, Korea, Singapore and Hong Kong, and plans to submit an NDA for three indications in hematologic malignancies in Taiwan in Q3 2021.
Antengene is exploring additional indications of selinexor through two global Phase III registrational trials for the treatment of relapsed or refractory diffuse large B-cell lymphoma (RRDLBCL, the XPORT-DLBCL-030 trial) and endometrial cancer (the SIENDO trial); two registrational trials for the treatment of RRDLBCL (the SEARCH trial) and RRMM (the BENCH trial) in China; and China-only trials including for the treatment of relapsed or refractory T-cell and NK/T-cell lymphoma (the TOUCH trial).
ATG-016 (Eltanexor)

Eltanexor is a next-generation XPO1 inhibitor being developed for the treatment of patients with myelodysplastic syndromes (MDS) or solid tumors.

Data with eltanexor published at ASCO (Free ASCO Whitepaper) annual meeting in June 2021 showed a bone marrow complete response (mCR) in 7 patients (47%) and a total disease control rate (DCR) of 80%, of the 15 efficacy-evaluable patients with MDS refractory to hypomethylating agents.
In May 2021, Antengene has treated the first patient in a Phase I/II trial of eltanexor in patients with MDS (the HATCH trial).
A Phase Ib/II trial of eltanexor in patients with advanced solid tumors (the REACH trial) is currently on-going in Mainland China.
ATG-008 (Onatasertib)

Onatasertib is a next-generation dual mTORC1/2 inhibitor being developed for the treatment of advanced solid tumors.

In April 2021, a Phase II trial of ATG-008 (the BUNCH trial) in patients with advanced solid tumors harboring NFE2L2, STK11, RICTOR or other specific genetic alterations has enrolled and treated its first patient in Mainland China.
The TORCH trial, as the first trial of ATG-008 for the treatment of Asian patients, is now enrolling at the 45mg cohort in this dose-optimization trial in late-stage HBV+ HCC patients.
The TORCH-2 trial, a combination trial of ATG-008 with a PD-1 antibody (Toripalimab) in advanced solid tumors and HCC, is now enrolling patients at its third dose cohort.
Preclinical data demonstrating the synergistic effect of the combination of selinexor and ATG-008 for the treatment of triple-hit diffuse large B-cell lymphoma were presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
ATG-019 (PAK4 / NAMPT inhibitor)

ATG-019 is an orally bioavailable dual PAK4/NAMPT inhibitor with first-in-class potential in the treatment of non-Hodgkin lymphoma (NHL) and advanced solid tumors.

A Phase I clinical trial (TEACH) of ATG-019 in patients with advanced solid tumors or NHL has been initiated in Mainland China following the initial dose-escalation phase in Taiwan.
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ATG-017 (ERK 1/2 inhibitor)

ATG-017 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor in clinical development for advanced solid tumors and hematologic malignancies.

The on-going dose-escalation study of ATG-017 for the treatment of advanced solid tumors and hematologic malignancies in Australia (the ERASER trial) has completed the first 3 cohorts in solid tumors (5 mg QD, 5 mg BID and 10 mg BID), and has started treating patients in the fourth cohort (20 mg BID).
Preliminary data from the ERASER trial will be announced in 4Q 2021.
ATG-101 (PD-L1/4-1BB bi-specific antibody)

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking PD-L1/PD-1 binding and inducing 4-1BB stimulation. In the presence of PD-L1 over-expressed cancer cells, ATG-101 showed a significant and PD-L1 crosslinking-dependent 4-1BB agonist activity, thus enhancing therapeutic efficacy, and mitigating hepatoxicity simultaneously.

Antengene will initiate a first-in-human Phase I trial of ATG-101 in patients with metastatic/advanced solid tumors or non-Hodgkin’s B-cell lymphoma (B-NHL).
Antengene has submitted clinical trial applications to the Human Research Ethics Committee (HREC) in Australia for the first-in-human trial of ATG-101 in patients with metastatic/advanced solid tumors or non-Hodgkin’s B-cell lymphoma (B-NHL).
In addition, Antengene plans to submit Investigational New Drug (IND) applications for ATG-101 in the US and China in 4Q 2021.
ATG-101 demonstrated potent activity in preclinical animal models, including strong tumor-suppressing effect in models of PD-1/PD-L1 inhibitor-resistant or -relapsed tumors. Meanwhile, the GLP toxicology study of ATG-101 has produced results highlighting a favorable safety profile.
ATG-037 (Small molecule inhibitor of CD73)

ATG-037 is a highly potent, selective, orally-bioavailable small molecule inhibitor of CD73 that has best-in-class potential as either a monotherapy or in combination against a range of tumor types. It overcomes the ‘hook-effect’ of clinical anti-CD73 antibodies and could completely block CD73 activity in vitro.

On May 17, 2021, Antengene and Calithera Biosciences entered into an exclusive, worldwide license agreement for the development and commercialization of ATG-037, a small molecule inhibitor of CD73.
Antengene plans to submit IND application for ATG-037 in Australia, United States and China by the end of 2021.
ATG-018 (ATR inhibitor)

ATG-018 is a small molecule inhibitor targeting ataxia telangiectasia and Rad3 related (ATR) kinase being developed for the treatment of hematological malignancies and solid tumors.

ATG-018, an in-house discovered ATR inhibitor, is at the IND-enabling stage, targeting IND submissions in Australia, United States and China by the end of 2021, or the beginning of 2022.
ATG-022 (ADC Targeting Claudin 18.2)

ATG-022, an antibody drug conjugate targeting Claudin 18.2, is in the late pre-clinical research and GMP CMC stage. IND submissions are expected in 2022.
ATG-012 (KRAS inhibitor)

ATG-012, a KRAS inhibitor, and a potential combination agent with ATG-017 and ATG-101, is in late pre-clinical research stage, with IND submissions expected in 2022.
New Targets

ATG-031 is a potential first-in-class anti-CD24 monoclonal antibody being developed for the treatment of hematologic malignancies and solid tumors. ATG-031 potently stimulates macrophage-mediated phagocytosis and induces the destruction of cancer cells by blocking the ‘Don’t eat me’ signals characterizing the growth of many cancers. In pre-clinical research, ATG-031 demonstrated single agent anti-tumor activity in animal models and showed synergy with chemotherapies, checkpoint inhibitors, and other therapeutic agents. ATG-031 is at IND enabling stage.

ATG-027 is a potential first-in-class bispecific antibody being developed for the treatment of hematologic malignancies and solid tumors. ATG-027 blocks the PD-1/PD-L1 interaction and the B7H3 interaction with its ligand to stimulate the activation of immune cells and mediates anti-tumor effect. ATG-027 also leads to the elimination of B7H3-positive tumor cells through ADCC/CDC effect. ATG-027 showed potent in vivo anti-tumor activity in mouse tumor models. ATG-027 is at preclinical research stage.

"I am excited to announce Antengene’s discovery of two proprietary assets targeting two novel mechanistic pathways, namely ATG-031, a first-in-class CD24 antibody, and ATG-027, a first-in-class B7H3/PD-L1 bispecific antibody. These discoveries are yet another testament to our dual-engine drug development strategy. This year, we aim to advance ATG-101 into clinical development, as our internal development efforts continue to yield results. Moreover, we have recently obtained the global rights to ATG-037, an oral small molecule inhibitor of CD73 with best-in-class potential, and we are poised to advance the drug candidate into global clinical development in the near future," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene.

"While in commercialization, we have built a world-class commercial organization in the APAC region, led by industry veterans with strong track record in successfully launching innovative oncology therapies in APAC markets, and deep expertise in the areas of multiple myeloma and lymphoma."

"In just half of a year, we further strengthened our pipeline through the addition of three assets that have enormous combinatory potential with other agents, broadening the therapeutic potential of our pipeline. Like many patients around the world, we have high expectations for these first-in-class therapies in the APAC region and we are committed to advancing the global development of these assets, and fulfilling our mission of ‘Treating Patients Beyond Borders’."

On June 18, 2021 Privo Technologies, Inc. reported attends the BIO International Convention online from June 14-18, 2021 (Press release, Privo Technologies, JUN 18, 2021, View Source;utm_medium=rss&utm_campaign=bio-international-convention-2021 [SID1234586911]).

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Despite the conference being held online this year due to COVID-19, Bio International 2021 was
informative and enjoyable. The company connected with potential investors and industry partners in
discussing their PRV111 and PRV211 technology. In addition, the company discussed technology
collaborations with pipeline products.

On June 18, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported the closing of its previously announced underwritten public offering of 4,356,060 shares of its common stock at a price to the public of $33.00 per share, which includes 568,181 shares issued and sold upon full exercise of the underwriters’ option to purchase additional shares of common stock (Press release, RAPT Therapeutics, JUN 18, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-closing-public-offering-common-stock [SID1234585136]). All of the shares of common stock were offered by RAPT. The aggregate gross proceeds to RAPT from the offering were approximately $143.7 million, before deducting underwriting discounts and commissions and other offering expenses.

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J.P. Morgan, SVB Leerink and Piper Sandler acted as joint lead book-running managers for the offering. Cantor acted as book-running manager for the offering. H.C. Wainwright & Co. and Roth Capital Partners acted as co-lead managers for the offering.

The offering was made pursuant to a shelf registration statement, including a base prospectus, filed by RAPT with the Securities and Exchange Commission (SEC), which was declared effective by the SEC on November 16, 2020. The offering was made only by means of a prospectus supplement and accompanying prospectus. The final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Alternatively, electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by telephone at (866) 803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by email at [email protected] or by telephone at (800) 808-7525, ext. 6105; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by email at [email protected] or by telephone at (800) 747-3924.

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