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Fosun Kate’s Achilles injection is included in the breakthrough drug program

On August 17, 2021, Fosun Kate Biotechnology Co., Ltd. reported that the National Medical Products Administration (NMPA) has officially designated the company’s CD19 target autologous CAR-T cell therapy product Akilunsai injection for new indications Included in the breakthrough treatment drug program, the proposed indication is the treatment of relapsed or refractory indolent non-Hodgkin’s lymphoma (r/r iNHL) after receiving second-line or above systemic treatment, including follicular lymphoma (FL) and Marginal zone lymphoma (MZL) (Press release, Gilead Sciences, AUG 17, 2021, View Source [SID1234633500]).

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Indolent non-Hodgkin’s lymphoma (iNHL) is a malignant tumor that has slow clinical progress but becomes more aggressive over time. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common subtypes. FL is also the second most common type of lymphoma in the world, accounting for approximately 22% of confirmed cases of NHL worldwide. MZL is the third most common lymphoma, accounting for approximately 8% to 12% of all B-cell NHL. Although with the progress of disease management, the long-term survival rate of FL patients has been greatly improved, but the prognosis is very different. At present, there is no standard treatment plan for the relapsed and refractory FL patients after second-line treatment and above, and the treatment options for the relapsed and refractory MZL patients are also very limited.

Akilunza injection is Fosun Kate’s introduction of Yescarta (axicabtagene ciloleucel) from Kite (a company of Gilead) in the United States in early 2017 for technology transfer in China, and is authorized to locally produce the human CD19 autologous CAR- T cell therapy products. It is used to treat adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, unspecified type, primary mediastinal large B-cell lymphoma, high-grade New drug applications for B-cell lymphoma and diffuse large B-cell lymphoma transformed by follicular lymphoma have been approved by the NMPA for marketing in June 2021.

In the United States, Yescarta was approved by the FDA on October 18, 2017 for the treatment of adult patients with relapsed and refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) non-specific, primary Mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL transformed from follicular lymphoma are the first CAR-T cell drugs approved by the US FDA for specific non-Hodgkin lymphoma. On March 5, 2021, its application for extended indications for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) received accelerated approval from the US FDA, becoming the world’s first CAR- approved to be marketed for FL. T cell therapy products.

Fosun Kite Biotechnology Co., Ltd. is a joint venture between Shanghai Fosun Pharmaceutical Group and Kite of the United States. It is committed to the R&D, innovation, industrialization, commercialization, and standardized development of tumor cell therapy products for the benefit of Chinese patients. The company is headquartered in Shanghai Zhangjiang Hi-Tech Park, and a CAR-T industrial production base of 10,000 square meters has been established and officially opened in Zhangjiang Innovative Medicine Industrial Base. In addition, the company also has a 2000 square meter cell therapy R&D center and a team of innovative talents. Through independent innovation and international cooperation, the company focuses on CAR-T early R&D and clinical evidence-based projects to create a sustainable innovative R&D pipeline.

Mr. Huang Hai, CEO of Fosun Kate, said: "The inclusion of Akirensai injection in the breakthrough therapeutic drug program demonstrates NMPA’s support for clinical value-oriented drug innovation, and also shows that this drug is effective in treating relapsed or refractory drugs. The clinical advantages and potential of sexually inert non-Hodgkin’s lymphoma. The company will accelerate the clinical stage of the drug’s new indications, actively communicate and communicate with the drug review center, and provide more non-Hodgkin’s lymphoma in China as soon as possible. Tumor patients bring new hope and opportunities."

Cue Biopharma Reports Second Quarter 2021 Results, Recent Data Updates of CUE-101 Phase 1 Dose Escalation and Expansion Study, Platform Progress and Business Highlights

On August 17, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported a business and clinical progress update for the second quarter 2021 (Press release, Cue Biopharma, AUG 17, 2021, View Source [SID1234608273]).

"During the second quarter 2021, we continued to make significant clinical progress advancing our IL-2 based CUE-100 series, represented by the Phase 1a/1b monotherapy trial of CUE-101 and combination-therapy trial with KEYTRUDA (pembrolizumab). In addition, we have continued with the development and expansion of our pipeline programs and technology platforms, and also enhanced our capital resources," said Daniel Passeri, chief executive officer of Cue Biopharma. "Importantly, we recently reported a confirmed partial response (PR) in a patient from our ongoing Phase 1 monotherapy dose escalation trial of CUE-101 and look forward to providing further details on this patient response during the quarterly update call. Our Phase 1 monotherapy dose escalation and expansion study is now in dose expansion and our combination study with pembrolizumab continues in dose escalation. During the call, we will also highlight the development implications for CUE-101 and potential of the CUE-100 series and Immuno-STAT platform."

Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We continue to be in a solid financial position and deployed our at-the-market (ATM) common stock facility during the second quarter to extend the anticipated operational runway further into the fourth quarter of 2022."

Istari Oncology Initiates Its Phase 1/2 Sub-Study Evaluating PVSRIPO in Patients with Head and Neck Cancer

On August 17, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company focused on novel immunotherapy platforms for the treatment of solid tumors, reported that the company is proceeding with the expansion of its LUMINOS-103 trial, with a new sub-study evaluating PVSRIPO in adult patients with head and neck squamous cell carcinoma (HNSCC)(Press release, Istari Oncology, AUG 17, 2021, View Source [SID1234590820]). LUMINOS-103 is a Phase 1/2, open-label, multi-center, single-arm basket trial evaluating the administration of PVSRIPO with or without PD-1/L1 inhibitors across multiple tumor types. The company began the LUMINOS-103 basket trial earlier this year, opening recruitment to patients with bladder cancer in two separate cohorts.

Istari Oncology’s PVSRIPO is a novel intratumoral viral immunotherapy that activates a patient’s innate and adaptive immune system to facilitate a systemic anti-tumor immune response. PVSRIPO enters solid tumor cells and antigen presenting cells (APCs) in the tumor microenvironment via CD155 (the poliovirus receptor). CD155 is expressed on nearly all solid tumors, giving PVSRIPO the potential to treat a variety of cancers.

"We enter this next phase of PVSRIPO development in patients with solid tumors with great enthusiasm as we progress toward further evaluating the impact of PVSRIPO on patients with head and neck squamous cell carcinoma," said Matt Stober, president and chief executive officer at Istari Oncology. "With patient recruitment underway for our LUMINOS-103 bladder cancer cohorts, and the expectation that future cohorts focusing on other solid tumors will be added in the near future, we are proud to broaden the PVSRIPO clinical development program."

HNSCC is a heterogeneous group of malignant tumors typically caused by alcohol and tobacco consumption, although an increasing number of HNSCC cases arise due to persistent infection with high-risk human papilloma virus (HPV). The treatment of HNSCC remains challenging, and a substantial proportion of patients with this condition die from their disease, especially those with recurrent and metastatic disease.

"This year more than 66,000 people in the U.S. – approximately 49,000 men and 18,000 women – will develop head and neck cancer," said Amanda Hollinger, MPA, executive director, Head & Neck Cancer Alliance. "As we continue to focus on advancing prevention, detection, treatment, and rehabilitation of people with head and neck cancer, we will be closely watching the progress of Istari’s head and neck sub-study with great anticipation and optimism."

For more information about Istari Oncology and its ongoing clinical trials and research on PVSRIPO, visit www.istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 polio vaccine that has been genetically modified for safety. PVSRIPO has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with three key mechanisms: 1) engagement and activation of antigen presenting cells (APCs), leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of polio vaccine-specific T cells. PVSRIPO has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma.

Candel Therapeutics Announces Closing of Initial Public Offering, Including the Partial Exercise of Underwriters’ Option

On August 17, 2021 Candel Therapeutics, Inc. ("Candel"), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported the closing of the issuance of an additional 887,994 shares of its common stock at a public offering price of $8.00 per share (Press release, Candel Therapeutics, AUG 17, 2021, View Source [SID1234587572]). The shares were issued pursuant to a partial exercise of the underwriters’ option to purchase additional shares of common stock in connection with Candel’s previously announced initial public offering of 9,000,000 shares of its common stock. The gross proceeds from the exercise of the option to purchase additional shares were approximately $7.1 million, bringing the aggregate gross proceeds to Candel from its initial public offering to approximately $79.1 million, before deducting underwriting discounts and commissions and other offering expenses.

Jefferies, Credit Suisse, BMO Capital Markets and UBS Investment Bank acted as joint book-running managers for the offering.

The registration statement relating to these securities has been filed with the Securities and Exchange Commission ("SEC") and became effective on July 26, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; BMO Capital Markets Corp., 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, by telephone at (800) 414-3627 or by email to [email protected]; or UBS Securities LLC, Attn: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at 888-827-7275 or by e-mail at [email protected].

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 these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Boehringer, CureVac Terminate Lung Cancer Project on Poor Performance

On August 17, 2021 CureVac reported that it has revealed in its latest financial report that its lung cancer program with German biotechnology company Boehringer Ingelheim has been terminated (Press release, CureVac, AUG 17, 2021, View Source [SID1234586796]).

The move ends a €500m exclusive treatment exploration and development partnership which both parties signed seven years ago (2014). The collaboration focused on the viability of using CureVac’s CV9202 therapeutic mRNA vaccine with afatinib in patients who have been diagnosed with advanced or metastatic epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). It was also being tested in combination with chemo-radiation therapy in patients who have unresectable stage III NSCLC.

However, in a brief statement hidden among its financials, CureVac said that it had terminated the agreement in June, with the process expected to be finalized by November 2021.

The company said that despite the decision to discontinue their partnership on the project, the two firms will still continue to find ways to collaborate on other ways to use CureVac’s RNA technology for other potential treatment purposes. While it did not explicitly state a reason, CureVac added that they were working with a "legacy program" that used an older protamine formulation, which was being developed seven years ago. It also stated that it is continuing its Phase I of II clinical trial for the potential of BI1361849 for NSCLC.

CureVac did not provide any further details about the termination or any other plans moving forward. However, what is noticeable is that it comes just two months after it reported weak efficacy results of only 47% for an mRNA vaccine against COVID-19. Other rival medications had an efficacy of more than 90%. Industry observers had been setting their sights on the vaccine as it was thought to last longer and cost less.

"While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging," said CureVac’s Chief Executive Officer, Dr. Franz-Werner Haas, in a statement. "In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge."

The CureVac-Boehringer trial involved 40,000 participants, with 75% based in Latin America and 25% in Europe. The 47% who showed efficacy represented around 46 cases from the vaccinated group and 88 cases in the placebo group. As part of that deal, CureVac received €35 million and was set to achieve milestone payments of as much as €430 million plus royalties from future sales.

Boehringer has yet to issue an official statement about this revelation.