On September 8, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on September 06, 2023, the compensation committee of BridgeBio’s board of directors granted twenty-four new employees restricted stock units for an aggregate of 154,186 shares of the Company’s common stock (Press release, BridgeBio, SEP 8, 2023, View Source [SID1234635024]). One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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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 amended and restated on February 10, 2023.

On September 8, 2023 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that Peter Nielsen, Chief Executive Officer, will participate in a pre-recorded presentation at the H.C. Wainwright 25th Annual Global Investment Conference made available on Monday, September 11, 2023 at 7:00 a.m. ET (Press release, Bio-Path Holdings, SEP 8, 2023, http://www.biopathholdings.com/bio-path-holdings-to-present-at-h-c-wainwright-25th-annual-global-investment-conference/ [SID1234635023]).

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An audio webcast of the presentation will be available here and on the Investor Relations section of Bio-Path’s website, where it will be archived for approximately 90 days.

On September 7, 2023 DotBio, the biopharmaceutical company pushing the boundaries of antibody therapeutic modalities to bring more effective therapies to patients, reported that its partner, Junshi Biosciences has received approval of its Investigational New Drug (IND) application from China’s National Medical Products Administration (NMPA) for the Phase I clinical trial of JS207, which incorporates DotBody technology (Press release, DotBio, SEP 7, 2023, View Source [SID1234646738]). JS207 is a recombinant, humanized, bispecific antibody for advanced malignant tumours that combines an anti- Vascular Endothelial Growth Factor (VEGF) DotBody module and Junshi Biosciences’ anti-Programmed Death-1(PD-1) antibody.

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"We are thrilled to see the first molecule containing a DotBio-engineered DotBody module receive approval to enter the clinic, an important validation of our DotBody platform technology. JS207 is an exciting, highly targeted, next-generation cancer therapy that was rapidly designed using our platform technology and is just one example of how we can apply our modular approach to antibody discovery and progress it into the clinic," said Ignacio Asial, Chief Executive Officer of DotBio. "This very specific combination of anti-VEGF and anti-PD-1 addresses tumour growth and the tumour’s immune evasion tactics simultaneously. JS207 could provide a much needed new treatment option for cancer patients."

DotBio’s anti-VEGF module was discovered through the company’s patented DotBody technology platform. The platform enables the generation of multi-specific antibodies in record time, through prefabricated modules which are optimised for high stability and easy integration into more complex antibody molecules.

The modularity of the DotBody platform powers a rapid prototyping engine that compares thousands of antibody prototypes in parallel before the ideal candidate is selected for an indication. JS207 is the first next generation cancer therapy enabled by the DotBody technology to receive regulatory approval to enter clinical development.

JS207 was engineered by combining DotBio’s anti-VEGF module and Junshi Biosciences’ anti-PD-1 antibody into a single therapeutic agent, binding to both PD-1 and VEGF with high affinity. VEGF is overexpressed in most solid tumour types, leading to an angiogenic ‘switch’ where new blood vessels form around a tumour and allow it to grow exponentially. Many tumours overexpress the proteins PD-L1 or PD-L2, which suppress the immune system by binding to PD-1 present on certain immune cells. The combination therapy of a PD-1 blocking antibody and a VEGF blocking agent has shown strong efficacy in a variety of tumour types, such as renal cell carcinoma, nonsmall cell lung cancer and hepatocellular carcinoma.

JS207 inhibits the interaction between PD-1 and its ligands, PD-L1 and PD-L2, while concurrently obstructing the VEGF pathway. This dual-action mechanism allows JS207 to harness the benefits of both immunotherapies and anti-angiogenic treatments to achieve more powerful anti-tumour activity. At the time of this announcement, there is no bispecific antibody drug with similar targets that has received regulatory marketing approval.

DotBio and Junshi Biosciences entered into a commercial licensing agreement in 2022, under which Junshi Biosciences obtained licenses to develop and commercialise DotBody modules against oncology targets. JS207 has quickly achieved a number of development milestones, from engineering through to NMPA filing and approval in 18 months. Under the agreement, Junshi Biosciences has the right to generate additional therapeutic candidates using DotBio’s technology.

As JS207 moves through the clinic, DotBio is eligible to receive development-based milestone payments as well as royalties on sales following comme

On September 7, 2023 BroadenBio reported the company has received the approval from FDA for the Investigational New Drug (IND) Application of conducting clinical trials on advanced solid tumors for BB3008 (Press release, BroadenBio, SEP 7, 2023, View Source [SID1234640204]). BB3008 is the second clinical-stage product from BroadenBio. The Phase I clinical trial of BroaddnBio’s first product, highly selective FGFR4 small molecule inhibitor BB102, is progressing smoothly and is expected to be completed by the end of this year.

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About BB3008

BB3008 is a highly selective small molecule inhibitor of HPK1 with novel molecular structure developed independently by BroadenBio. BB3008 significantly activates T cell activity in vitro, shows pronounced tumor growth inhibition both as monotherapy and in combination with PD-1 inhibitors, and has excellent pharmacokinetics properties and controllable safety. The preclinical study of BB3008 was been published as "Late-Breaking Research" at the 2023 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). BB3008, as monotherapy or in combination, will be used to overcome the immune suppressive tumor microenvironment and treat malignant solid tumors in clinical trials.

About HPK1

Hematopoietic progenitor kinase 1 (HPK1), also known as MAP4K1, is a serine/threonine kinase mainly expressed in immune cells (T cells, B cells, dendritic cells, macrophages, and etc.). HPK1 is a key negative feedback regulator of the T cell receptor (TCR) signaling pathway. As an important intracellular immune checkpoint, HPK1 inhibits the proliferation and functions of T cells and B cells, and also inhibits the antigen presentation by dendritic cells (DCs). Clinical studies have observed upregulation of HPK1 levels in various tumor tissues such as leukemia, bladder cancer, breast cancer, and colon cancer. HPK1 inhibition can restore the immunology functions in tumor microenvironment and enhance T cell-mediated anti-tumor immune effects. Therefore, HPK1 is a potential target for immuno-oncology therapy.

On September 7, 2023 – Daiichi Sankyo (TSE: 4568) reported that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS-3939 in patients with several types of advanced solid tumors including non-small cell lung, breast, urothelial, ovarian, biliary tract, and pancreatic cancer (Press release, Glycotope, SEP 7, 2023, View Source [SID1234635383]).

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DS-3939 is a specifically engineered potential first-in-class tumor-associated mucin-1 (TA-MUC1) directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s proprietary DXd ADC technology. TA-MUC1 is a tumor-specific transmembrane glycoprotein and is overexpressed in most human epithelial cancers, making it a promising target for cancer therapy.1,2 Currently, there are no TA-MUC1 directed therapies approved for any type of cancer.

"With DS-3939, we are pairing our unique DXd antibody drug conjugate technology with a TA-MUC1 antibody in order to evaluate this novel treatment strategy for patients with several types of advanced cancer," said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. "The initiation of this trial is a significant milestone as DS-3939 is an important new addition to our growing DXd ADC portfolio, which now consists of six ADCs in clinical development, and represents our ongoing commitment to create new standards of care for patients with cancer."

About the Phase 1/2 Trial

The two-part, multicenter, open-label, first-in-human phase 1/2 trial will assess the safety and efficacy of DS-3939 in patients with locally advanced, metastatic or unresectable solid tumors not amenable to standard of care treatment for each tumor type.

The first part of the trial (dose escalation) will assess the safety and tolerability of increasing doses of DS-3939 to determine the maximum tolerated dose and/or the recommended doses for expansion (RDEs) in patients with locally advanced, metastatic, or unresectable solid tumors.

The second part of the trial (dose expansion) will consist of multiple expansion cohorts to continue to assess the safety and efficacy of DS-3939. The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, and efficacy endpoints including overall response rate, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetic and biomarker endpoints also will be assessed.

The trial is expected to enroll patients across multiple sites globally, including Asia and North America. For more information, please visit ClinicalTrials.gov.

About TA-MUC1

TA-MUC1 is a tumor-specific transmembrane glycoprotein with aberrant glycosylation due to changes of the expression patterns of some sialyltransferases.1 Based on the overexpression of TA-MUC1 in most human epithelial cancers, it is an attractive target for cancer therapy.2 Currently, there are no TA-MUC1 directed therapies approved for any type of cancer. About DS-3939 DS-3939 is an investigational potential first-in-class TA-MUC1 directed ADC.

Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-3939 is comprised of a humanized anti-TA-MUC1 antibody licensed from Glycotope GmbH, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.