On April 7, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on March 7, 2023, the compensation committee of BridgeBio’s board of directors granted five new employees restricted stock units for an aggregate of 25,900 shares of the Company’s common stock (Press release, BridgeBio, APR 7, 2023, View Source [SID1234629879]). All of the above-described awards were made under BridgeBio’s 2019 Inducement Equity Plan (the Plan).

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 above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019 and has been amended and restated from time to time.

On April 6, 2023 Foundery, a biotechnology venture studio focused on translating immunology discoveries into drug candidates, reported the company has entered into a master agreement with the University of Arizona’s ("UArizona") Tech Launch Arizona ("TLA") unit to facilitate the process of translating immunology discoveries into drug candidates (Press release, Foundery Biosciences, APR 6, 2023, View Source [SID1234656474]). The partnership is designed to support research and create opportunities to develop and commercialize new immunotherapeutics.

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!

"Our venture studio model is structured to identify therapeutic opportunities emerging from fundamental research in immunology conducted by leading scientists," said Michel Streuli, Ph.D., Chief Executive Officer and Co-Founder of Foundery. "Because time and financial commitments to conduct industry-standard translational research are typically not feasible for university researchers, Foundery helps bridge the gap by using its in-house immunologists and drug developers to validate targets and generate drug development candidates. Additionally, our unique win-win business model provides scientific and financial rewards to investigators and their institutions. We are thrilled to collaborate with Michael Kuhns, Ph.D., and UArizona to translate their discoveries into clinically testable therapeutics."

The master agreement enables UArizona researchers to propose candidate drug targets and concepts that might be crucial in the immunotherapeutic treatment of human diseases. Once a researcher proposes a candidate concept or target, Foundery’s scientific team conducts further research on the translatability of the idea and its therapeutic potential, with the ultimate goal of transitioning drug candidates to IND enabling studies or early clinical development via outlicensing to a biopharmaceutical company or through a venture-backed financing round. In addition, Foundery, as an impact investor, is structured such that a portion of the company’s profits can be directed toward charitable initiatives and advancing underrepresented founders.

"As we pursue our ultimate goal of generating impact from university research and improving lives through the innovations our research community is creating, this relationship with Foundery will be one more tool to help us maximize how quickly and effectively we’re able to bring those inventions to the world for the public good," said Rakhi Gibbons, director of licensing and intellectual property for TLA.

Max Krummel, Ph.D., University of California, San Francisco, Professor & Endowed Chair in Experimental Pathology and Co-Founder and Managing Member of Foundery added, "Building strong and lasting relationships with major research universities through master agreements is a key feature of our venture studio fund strategy. The agreement with UArizona is the second master agreement that we have announced this year. We anticipate more to come as the academic research community better understands our venture model and how it benefits all our constituencies."

On April 6, 2023 Shanghai Henlius Biotech, Inc. reported that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) to HLX208 for the treatment of adult Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD) with BRAF V600E mutation (Press release, Shanghai Henlius Biotech, APR 6, 2023, View Source [SID1234633491]). HLX208 is a small-molecule inhibitor that targets the human BRAF protein V600E mutation. Currently, HLX208 is now testing in Phase 2 clinical trial against BRAF V600E mutation LCH and ECD.

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!

As per the NMPA’s Working Procedures for Review of Breakthrough Therapy Drugs (Interim) (2020 No.82), the BTD process is designed to expedite the development and review of therapies that are intended for treatment of a seriously debilitating or life-threatening condition for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options. According to the CDE, BTD would grant benefits such as close communication with and intensive guidance from CDE regarding clinical trials and development strategy. When submitting a New Drug Application (NDA), drug candidates with BTD may be eligible for conditional approval and priority review.

ECD and LCH are currently regarded as myeloid neoplasias with inflammatory properties, affecting patients’ quality of life significantly. The National Health Commission (NHC) has placed them on the "First National List of Rare Diseases"[1]. According to the 2019 edition of the Clinical Practice Guidelines for Rare Diseases issued by the National Health Commission of China[2], LCH and ECD are driven by constitutive activation of the MAPK/ERK signalling pathway with more than 50% incidence of BRAF V600E mutation. Currently, except for a BRAF V600E inhibitor approved for ECD in the United States, no similar therapy is approved for the treatment of LCH globally, implying that many patients with BRAF V600E mutant have unmet medical needs.

BRAF is a member of the RAF kinase family and a critical upstream regulator in the RAS-RAF-MEK-ERK mitogen-activated protein kinase (MAPK) cell signalling pathway. Its mutation can activate the downstream MEK and ERK protein, which induces the proliferation and invasion of tumour cells [3]. The BRAF mutation frequently occurs in colorectal cancer, thyroid cancer, melanoma and other types of cancers. Among all BRAF mutation types, BRAF V600E mutation is the most common one. Currently, targeted combination therapy represented by BRAF inhibitors has become one of the main treatments in different kinds of BRAF mutation-positive solid tumours [4-5], and a number of studies have shown that BRAF inhibitors combined with immunotherapy antibodies demonstrating a synergistic effect in inhibiting tumour growth [6-7].

HLX208 is a potential "best-in-class" BRAF inhibitor introduced from NeuPharma with a proprietary novel chemical structure that differs from other marketed BRAF inhibitors. It exhibited a single crystal morph, high bioavailability, and excellent anti-tumour efficacy in preclinical studies. Subsequent early clinical data also demonstrated preliminary efficacy and good safety and tolerability in patients with cancer, warranting further clinical development. In November 2022, the investigational new drug (IND) application of Phase 1b/2 clinical trials of HLX208 in combination with HANSIZHUANG for the treatment of BARF V600 mutation-positive solid tumours was approved by the NMPA. In February 2023, the first patient has been dosed in a phase 1b/2 clinical trial of HLX208 in combination with HANSIZHUANG for the treatment of non-small cell lung cancer (NSCLC) in Chinese mainland. And the combination of immuno-oncology therapy HANSIZHUANG and targeted therapy will enable Henlius to explore more effective treatment options for patients with BRAF V600 mutation-positive solid tumours.

Underpinned by the patient-centric strategy, Henlius has built an innovative product pipeline with many emerging targets, including PD-1/L1, LAG-3, OX40, GARP, and BRAF. Regarding antibody technology as a core, Henlius will continue conducting clinical studies for more innovative products in bispecific antibodies, antibody-drug conjugates (ADC), and fusion proteins and exploring combination therapies with improved efficacy to provide patients with quality and affordable biologics.

On April 6, 2023, ImmunoGen, Inc. (the "Company") reported to have entered into an agreement with BioPharma Credit PLC (the "Collateral Agent"), BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP, which are funds managed by Pharmakon Advisors, LP (collectively, "Pharmakon"), and the guarantors party to such agreement (the "Loan Agreement") (Filing, ImmunoGen, APR 6, 2023, View Source [SID1234629906]). The Loan Agreement provides for up to a $175 million senior secured term loan (the "Term Loan") consisting of two tranches that matures on April 6, 2028. The initial tranche of $75 million was drawn upon execution of the Loan Agreement. The second tranche of $50 million will be available at the Company’s option upon the achievement of positive top-line data from the Company’s confirmatory MIRASOL trial and a net sales threshold for ELAHERE (mirvetuximab soravtansine-gynx). This tranche may be increased to $100 million upon mutual agreement of the parties. The Term Loan bears interest at a rate based upon the secured overnight financing rate ("SOFR"), subject to a SOFR floor of 2.75% per annum, plus 8.00% per annum. Payments will be interest-only for the first 36 months with an extension of 12 months if certain conditions are met, after which ratable principal payments will commence for the remainder of the term. Pursuant to the Loan Agreement, and subject to certain restrictions, proceeds of the Term Loan will be used to fund the Company’s general corporate and working capital requirements.

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 Loan Agreement contains customary affirmative covenants for transactions of this type, including, among others, the provision of financial and other information to the Collateral Agent, notice to the Collateral Agent upon the occurrence of certain material events, and compliance with applicable laws. The Loan Agreement also contains customary negative covenants, including certain restrictions on the ability to merge and consolidate with other companies, incur indebtedness, and grant liens or security interests on assets. If the Company elects to borrow the second tranche, a minimum net sales covenant will come into effect. The Loan Agreement includes certain customary events of default. If an event of default occurs and is continuing, the Company may be required to repay all amounts outstanding under the Loan Agreement.

The Term Loan is secured by a perfected security interest on substantially all of the Company’s assets, excluding certain products and related intellectual property and contracts that are not related to ELAHERE.

On April 6, 2023 Mabwell (688062.SH), an innovative biopharmaceutical company with the whole industry chain layout, reported its Nectin-4 targeted site-specific ADC asset (R&D code: 9MW2821) demonstrated promising clinical data (Press release, Mabwell Biotech, APR 6, 2023, View Source [SID1234629888]). The preliminary data show positive therapeutic signals in solid tumors, and good safety profile at the recommended phase II dose (RP2D).

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!

Developed with site specific conjugate technology, 9MW2821 is China’s first, global second Nectin-4 targeted ADC approved for clinical study. The multiple ongoing clinical studies include more than 10 different solid tumors, evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity. The preliminary data show that under RP2D, among 12 UC (Urothelial Carcinoma) patients the ORR (Objective Response Rate) was 50% and DCR (Disease Control Rate) was 100%, and among 6 CC (Cervical Carcinoma) patients, the ORR was 50% and DCR was 100%. Mabwell is promoting the enrollment of multiple cohorts of UC, CC, prostate cancer, HER-2 negative breast cancer, and non-small cell lung cancer. Details will be published in upcoming academic meetings.

Mabwell has also achieved several breakthroughs in new ADC technology platform, optimizing ADC platform by developing IDDC, a new generation ADC site-specific conjugate technology platform, which is composed of multiple systematized core patented technologies including site-specific conjugate process DARfinity, special designed linker IDconnect, novel payload Mtoxin, and conditional release structure LysOnly. Developed Based on mentioned systematic patent technologies, the next generation ADCs have better structural homogeneity, quality stability, pharmacodynamics and tolerability, as well as dominant advantage of differentiation.

At present, the advantage of IDDC platform has been validated in several products under development. Clinical trial application for Trop-2 targeted ADC (R&D code: 9MW2921) has been accepted by NMPA. Clinical trial application for B7-H3 targeted ADC (R&D code: 7MW3711) is expected to be submitted soon. By continuously advancing development of multiple ADC candidates, it is expected that Mabwell will have 3 to 5 ADC products in clinical stage by 2024.

Mabwell has established complete industry chain for ADC, including early discovery, pre-clinical development and pilot scale production. The large-scale commercialized site is expected to be ready for production trial run at Q2, 2023.