On September 8, 2023 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) reported the closing of the previously announced acquisition of Surface Oncology, Inc. (Surface or Surface Oncology), a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment (Press release, Coherus Biosciences, SEP 8, 2023, View Source [SID1234635026]). As a result of the acquisition, Coherus’ novel I-O pipeline now includes four differentiated clinical-stage assets:

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Toripalimab, a late-stage, anti-PD-1 monoclonal antibody candidate under BLA review for the potential treatment of advanced recurrent or metastatic nasopharyngeal carcinoma (NPC);
Casdozokitug (SRF388 or casdozo), a novel, first-in-class IL-27-targeted antibody currently being evaluated in Phase 2 clinical trials in lung cancer and liver cancer;
CHS-114 (SRF114), a highly selective, competitively positioned, ADCC-enhanced CCR8-targeted antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors; and
CHS-006, a TIGIT-targeted antibody currently in a Phase 1/2 study in combination with toripalimab in patients with advanced solid tumors.
"The addition of the first-in-class IL-27 targeted antibody, casdozo, and the potential best-in-class CCR8 targeted antibody CHS-114, marks Coherus’ transition to a next-generation immuno-oncology company focused on the tumor microenvironment," said Denny Lanfear, Chairman and Chief Executive Officer of Coherus. "We will now focus our development efforts on delivering breakthrough survival benefits for cancer patients, beyond the efficacy seen with existing chemotherapy plus checkpoints regimens. Toripalimab combinations with these two new agents have the potential to expand tori use into highly prevalent tumor types including NSCLC and head and neck cancer, where it has already consistently shown clinically meaningful activity."

At the closing of the acquisition, Coherus issued 0.1960 shares of its common stock per share of outstanding Surface common stock and certain outstanding Surface employee equity awards (which exchange ratio was calculated based on a $5.2831 per share price of Coherus common stock) for a total value equal to approximately $66.9 million, the sum of $40 million plus Surface’s net cash at closing of the transaction of $26.9 million. Surface shareholders also received contingent value rights (CVRs) for 70% of milestone and royalty-based value of existing programs with Novartis (NZV930) and GSK (GSK4381562), as well as for 25% of upfront payments made pursuant to potential ex-US licensing agreements for CHS-114 and 50% of upfront payments made pursuant to potential ex-US licensing agreements for casdozokitug, subject to certain deductions as set forth in the contingent value rights agreement. Amounts under these CVRs are payable for a period of ten years following the closing of this transaction. As a result of the acquisition, Surface has become a wholly owned subsidiary of Coherus and the common stock of Surface will no longer be listed for trading on the Nasdaq Capital Market, effective as of prior to market open on September 8, 2023.

Truist Securities acted as financial advisor, and Arnold & Porter Kaye Scholer LLP and Latham & Watkins LLP acted as legal advisors to Coherus. Wedbush Securities Inc. acted as exclusive strategic financial advisor, and Goodwin Procter LLP acted as legal advisor to Surface.

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.