On July 24, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported a multi-target license and option agreement to research novel, first-in-class ADCs with ImmunoBiochem Corporation, a privately-held biopharmaceutical company focused on the discovery of unique tumor targets and development of novel biological therapeutics (Press release, ImmunoGen, JUL 24, 2023, View Source [SID1234633387]). The collaboration will combine ImmunoGen’s proprietary linker-payload technology with ImmunoBiochem’s antibodies directed against specific targets.

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"We are excited to partner with ImmunoBiochem, which brings a novel approach to tumor targeting for ADCs," said Eric Westin, ImmunoGen’s Vice President of Clinical Development and Translational Sciences. "This agreement reflects our commitment to leverage our rich IP portfolio through strategic partnering in order to further reinvigorate our research and development in support of our pipeline."

Under the terms of the agreement, ImmunoBiochem will receive an upfront payment in exchange for providing ImmunoGen with an exclusive license to existing antibodies directed against a specific undisclosed target. ImmunoBiochem will be eligible to receive milestone payments and royalties based on the achievement of pre-specified development, regulatory, and commercial milestones. ImmunoGen will collaborate with ImmunoBiochem on preclinical activities and assume responsibility for the program’s future clinical development and commercialization activities. ImmunoGen will also have the option to select additional targets and antibodies to license based on certain preclinical work undertaken by ImmunoBiochem. If ImmunoGen chooses to exercise this option, ImmunoBiochem will receive an option exercise payment and ImmunoGen will assume responsibility for all subsequent R&D associated with that program.

"ImmunoBiochem is extremely pleased that ImmunoGen, one of the world’s leading ADC companies, will help catalyze the unique science and assets that we have been developing to engender novel strategies to tackle difficult solid tumors, particularly for patients that lack common tumor targets," said Dr. Anton Neschadim, CEO of ImmunoBiochem. "This partnership validates our differentiated thinking and will enable ImmunoBiochem to significantly expand its discovery platform and innovative pipeline."

On July 24, 2023 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported that Bristol Myers Squibb (NYSE: BMY) has made a $35 million equity investment in Immatics (Press release, Immatics, JUL 24, 2023, View Source [SID1234633386]). Bristol Myers Squibb purchased 2,419,818 ordinary shares in a private placement transaction at a subscription price per share of $14.461. Additionally, Bristol Myers Squibb has the right to appoint a member to the Immatics Scientific Advisory Board.

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"This investment is further testimony to the strength of the relationship and of our differentiated platform technologies that are the foundation of our TCR-based cell therapies and bispecifics," commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "We remain steadfast in our commitment to advancing innovative treatment options for patients in their fight against cancer, and look forward to providing further clinical results in the second half of the year."

The securities referenced above have not been registered under the Securities Act of 1933, as amended, or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

On July 24, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported that it has entered into a securities purchase agreement to sell in a private placement to institutional investors, led by existing investor Rubric Capital Management LP and including existing and new investors, including Velan Capital, Clearline Capital and Hercules Capital, Inc. (NYSE: HTGC), 20,734,917 shares of its common stock at a purchase price of $1.37 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 1,162,891 shares of common stock at a purchase price of $1.3699 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each share underlying the pre-funded warrant (Press release, Heron Therapeutics, JUL 24, 2023, View Source [SID1234633385]). Gross proceeds of the private placement are expected to be approximately $30.0 million, before deducting expenses. The private placement is expected to close on or about July 25, 2023, subject to the satisfaction of customary closing conditions.

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Heron intends to use the net proceeds for working capital and general corporate purposes.

The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws and may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Heron has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in this private placement (the "Resale Shares").

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 the securities being offered in any state or other 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. Any offering of the Resale Shares under the resale registration statement will only be by means of a prospectus.

On July 24, 2023 Hepion Pharmaceuticals presented its corporate presentation (Presentation, Hepion Pharmaceuticals, JUL 24, 2023, View Source [SID1234633384]).

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On July 24, 2023 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the publication of its Phase 3 CARES 310 study results in The Lancet (Press release, Elevar Therapeutics, JUL 24, 2023, View Source [SID1234633383]). The study assessed the combination of Elevar’s drug candidate rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC).

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In the randomized, open-label, international trial (NCT03764293), which included 543 patients and was conducted at 95 study sites across 13 countries/regions, camrelizumab plus rivoceranib demonstrated statistically significant and clinically meaningful prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for uHCC.

"As evidenced in the CARES 310 study, camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma," said Saeho Chong, Elevar chief executive officer. "Elevar is pleased The Lancet, a prestigious peer-reviewed journal, recognized the significance of these results as we continue to work toward commercial development of this combined therapy."

Supported by the CARES 310 results, Elevar in May submitted a new drug application to the U.S. Food and Drug Administration (FDA) for camrelizumab plus rivoceranib as a first-line treatment option for uHCC. Rivoceranib was granted a Prescription Drug User Fee Act (PDUFA) date of May 16, 2024. Jiangsu Hengrui Pharmaceuticals Co., Ltd., the developer of camrelizumab, also in May submitted a biologics license application for the drug to the FDA.

With efficacy results generally consistent across all subgroups, the CARES 310 data suggested the combination confers a benefit in a global uHCC population. Also, it demonstrated efficacy among those with hepatitis C virus-based etiology and non-viral etiology, which comprises the majority of U.S. HCC cases1.

Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC), and as mono and combination therapies in other tumor cell types.

To learn more, visit ElevarTherapeutics.com.

1Ghouri YA, Mian I, Rowe JH. Review of hepatocellular carcinoma: Epidemiology, etiology, and carcinogenesis. J Carcinog. 2017 May 29;16:1. doi: 10.4103/jcar.JCar_9_16. PMID: 28694740; PMCID: PMC5490340.

About Hepatocellular Carcinoma (HCC)

HCC is the most common type of primary liver cancer. It accounts for approximately 90% of primary liver cancers and most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC is often diagnosed at an advanced stage and typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About Rivoceranib

Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (February 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese -territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer, etc.) and treatment settings.

Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.