On December 10, 2021 Johnson & Johnson (NYSE: JNJ) reported thatit will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, January 25th to review fourth-quarter results. Joaquin Duato, incoming Chief Executive Officer, Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Jessica Moore, Vice President, Investor Relations will host the call (Press release, Johnson & Johnson, DEC 10, 2021, View Source;johnson-to-host-investor-conference-call-on-fourth-quarter-results-301442424.html [SID1234596778]).

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Investors and other interested parties can access the webcast/conference call in the following ways:

The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.
By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.
A replay of the conference call will be available until approximately 12:00 a.m. on February 8th. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13725514.
The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call.
Please refer to www.investor.jnj.com for a complete list of currently planned earnings webcast/conference calls. Please note the first-quarter date of Tuesday, April 19th, 2022.

On December 10, 2021 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported safety, pharmacokinetic, biomarker and efficacy data using INT230-6, with and without pembrolizumab, in heavily pretreated refractory breast cancer patients as part of the Company’s phase 1/2 study, IT-01 (Press release, Intensity Therapeutics, DEC 10, 2021, View Source [SID1234596779]). The presentation was made at the San Antonio Breast Cancer Symposium (SABCS), being held virtually and in-person at the Henry B. Gonzales Convention Center in San Antonio, Texas.

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The seven heavily pre-treated breast cancer subjects were enrolled in the study after having progressed on a median of six (range 2 to 10) prior therapies. The INT230-6 monotherapy subjects (n=4) were more heavily pre-treated with a median of eight prior therapies vs. three prior therapies for pembrolizumab combination subjects (n=3). The disease control rate (DCR), defined as the percent of breast cancer subjects with a complete response, partial response, or stable disease at the first radiologic assessment, was 57%. Study authors reported a median overall survival (mOS) of 12 months (CI:7.2, NR), which compares favorably to results seen in phase 1 studies of subjects with highly refractory or triple negative breast cancer. Abscopal effects were seen in a non-injected visceral lesion in 1 of 4 INT230-6 monotherapy subjects. A number of patients came off study after completion of INT230-6 dosing without disease progression. One subject continued receiving INT230-6 injections despite a new lesion.

Peak plasma concentrations of the agent vinblastine were less than five percent (5%) of that predicted, based on historical IV kinetics, indicating that 95% of the drug remains in the tumor. Treatment related adverse events (TRAEs) were favorable with or without pembrolizumab. Only one subject experienced a grade 3 TRAE (monotherapy group) and there were no grade 4 or grade 5 TRAEs. Tissue analysis of matched paired (pre- and 28 days post-dose) biopsies in injected tumors from subjects receiving their first INT230-6 treatment cycle (two doses, n=3) had an average reduction in viable cancer cells of sixty-nine percent (69%). Immunohistochemistry results showed influx of CD4 and CD8 T-cells into the tumor microenvironment.

"Preliminary data suggests that INT230-6 demonstrates direct tumor killing in metastatic breast cancer subjects including those with triple negative breast cancer (TNBC) and may elicit an anti-cancer immune response within the injected tumor with or without pembrolizumab," stated poster presenter and study investigator, Philippe Bedard, M.D., Clinician Investigator, Princess Margaret Cancer Centre in Toronto Canada. "Additionally, INT230-6 treatment related adverse events are mostly low grade and the drug is well-tolerated either as a monotherapy or in combination with anti-PD-1 therapy, pembrolizumab. These results provide evidence to continue studying this novel therapeutic drug approach in breast cancer."

"The data presented at the San Antonio Breast Cancer Symposium using INT230-6 alone or in combination with pembrolizumab were generated from refractory breast cancer patients treated in the dose escalation portion of our phase 1 clinical study, IT-01, and these results are encouraging. We have also learned a great deal about our drug in breast cancer from our trial in metastatic patients and our phase 2 randomized INVINCIBLE study, which is testing INT230-6 in breast cancer patients in a presurgical setting," said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "We are excited about conducting additional clinical studies using INT230-6 in metastatic breast cancer as part of INT230-6’s Fast Track designation as well as in presurgical patients, as there remains an unmet medical need for safer more effective treatments in both settings."

Presentation Title: Safety and efficacy of INT230-6, a potential first-in-class intratumoral therapy, in monotherapy and in combination with pembrolizumab: Results from the IT-01 study [KEYNOTE-A10] in subjects with locally advanced, unresectable and metastatic breast cancer
Abstract: 541
Poster Number: P-5-16-13
First Author: Philippe Bedard, MD, FRCPC, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Full Authors Block: Philippe Bedard1, Lillian L Siu1, Jacob Thomas2, Diana Hanna3, Anthony J Olszanski4, Nilofer Azad5, Giles Whalen6, Matthew Ingham7, Syed Mahmood8, Lewis H Bender8, Ian B Walters8 and Anthony El-Khoueiry2. 1Princess Margaret Cancer Centre, Toronto, ON, Canada2USC Norris Comprehensive Cancer Center, Los Angeles, CA;3USC Hoag Memorial Hospital Presbyterian, Newport Beach, CA;4Fox Chase Cancer Center, Philadelphia, PA;5Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD;6UMass Memorial Medical Center – University Campus, Worcester, MA;7New York Presbyterian Hospital/Columbia University Medical Center, New York, NY;8Intensity Therapeutics, Inc., Westport, CT,
Session: Treatment: Therapeutic Strategies – New Drugs and Treatment Strategies
Date: Friday, December 10, 2021
Time: 7:00AM – 8:30AM Central Standard Time

The presentation will be accessible on the "Publications, Papers and Posters" section of Intensity’s website at: View Source on December 10, 2021.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and an amphiphilic penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In addition to local disease control, direct killing of the tumor by INT230-6 releases neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

INT230-6 is currently being evaluated in several phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On December 10, 2021 Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, reported that Nature Communications has published a scientific manuscript highlighting research demonstrating the effectiveness of place-of-care manufacturing of anti-CD19 CAR T cells for treatment of B-cell malignancies (Press release, Caring Cross, DEC 10, 2021, View Source [SID1234597013]). Place-of-care manufacturing is defined as near the point of patient treatment allowing cell products to be produced and infused without need for cryopreservation.

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The manuscript, entitled, "Multiple site place-of-care manufactured anti-CD19 CAR-T cells induce high remission rates in B-cell malignancy patients," reported that novel CD19-targeting CAR-T cells (CAR19-T cells) similarly manufactured using automation at separate sites in Cleveland, USA and Moscow, Russia achieved complete response rates of 73% in adult B-cell Lymphoma (NHL) and 89% in pediatric B-cell Acute Lymphocytic Leukemia (ALL), respectively. For NHL complete responders, the one-year survival rate was 92.9%, with a median duration of response yet to be reached. For ALL complete responders with a median follow-up of 17 months, the one-year survival rate was found to be 79.2% with a median duration of response of 10.2 months. Based on these findings, it was concluded that use of place-of-care manufactured CAR-T cell products results in clinical outcomes that are effective in the treatment of patients with B-cell malignancies.

Dr. Marcos de Lima, Director of Stem Cell Transplantation and Cellular Therapy at The Ohio State University Medical Center, and one of the lead investigators on the clinical trial, commented: "Our studies show that place-of-care manufacture of CAR-T cells results in a consistent cell product and produces effective clinical outcomes, despite being manufactured in two disparate clinical centers located in the US and Russia. We were able to make fresh CAR-T cells in as little as 8 days, which is very important for patients with rapidly progressing disease. We therefore conclude that place-of-care manufacture of CAR-T cells is a valid and valuable model for the manufacture and distribution of CAR-T cells among multiple clinical centers, and particularly important for patients with rapidly progressive, symptomatic lymphoma and ALL."

In addition to demonstrating that place-of-care manufacture of CAR-T cells results in a consistent cell product and effective clinical outcomes, the research team determined that fresh CAR19-T cells, which can only be manufactured at the place-of-care, reduce tumor burden faster in vivo in NSG mice than cryopreserved CAR19-T cells, immediately reducing the tumor burden, while frozen CAR19-T cells first permitted tumor growth before controlling growth. Moreover, the researchers found that place-of-care manufacture of CAR19-T cells resulted in a highly comparable CAR-T cell product composition between the multiple clinical centers and a low production failure rate, demonstrating the robustness of the manufacturing process.

Dr. Michael Maschan, Director of the Department of Hematopoietic Stem Cell Transplantation at the Dmitriy Rogachev National Center for Pediatric Hematology and Oncology in Moscow, Russia, commented: "Place-of-care manufacturing of CAR-T cells offers several advantages over centralized manufacturing, including reduced vein-to-vein time due to lack of transport to a centralized facility and the ability to infuse fresh and not necessarily cryopreserved products. Simplified logistics increases the flexibility to make decisions based upon patient disease status, for example split-dosing in the instance of high tumor burden. The high response rates we have seen in our clinical trials are outstanding considering that we were able to essentially treat all-comers due to the short manufacturing times of patient-derived CAR-T cell products, which are only possible when they are manufactured at the place-of-care. This has tremendous benefits for patients, particularly those with advance disease that need to be treated as soon as possible. We are delighted with the clinical results to date and look forward to future innovations to further improve patient outcomes."

Dr. Boro Dropulić, Executive Director of Caring Cross, commented: "This is the first study that definitively demonstrates the feasibility of place-of-care manufacturing of gene-modified cell products between muliple centers. We show that when the same device, materials, reagents and protocols are used to manufacture CAR-T cells, even between two disparate clinical centers, the gene-modified cell products are highly consistent with a low product failure rate. The clinical outcomes for patients were especially remarkable considering that almost all the patients enrolled were treated, even patients that otherwise would not be eligible due to their advanced disease, demonstrating the enormous value of this approach. Place-of-care manufacturing also offers the potential to dramatically reduce the cost of these transformational therapies to a fraction of their current cost due to obviating the need for transportation and the cost of multiple layers of quality and custodial assurance that are required for centralized manufactured CAR-T cell products. The next step will be to expand CAR-T cell clinical trials to include more clinical centers and support the development of regulatory pathways for the approval of CAR-T and other gene-modified cellular products that are manufactured at the place-of-care."

The full paper may be accessed via the Nature Communications website at View Source

On December 10, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new analyses and updates on the ongoing studies of surufatinib combined with toripalimab, in multiple disease settings, presented at the European Society for Medical Oncology’s (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, taking place virtually on December 8-11, 2021 (Press release, Hutchison China MediTech, DEC 10, 2021, View Source [SID1234596741]).

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Further details of the poster presentations are as follows:

Title: Surufatinib plus toripalimab in patients with advanced small cell lung cancer (SCLC) after failure of 1L systemic chemotherapy
First Author: Ying Cheng, MD, Jilin Cancer Hospital
Abstract No. & Link: 157P
Date & Time: Thursday, December 9, 2021, 11:30am – 11:50am CET


Title: Surufatinib plus toripalimab for 2L treatment of advanced gastric or gastro­esophageal junction (G/GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC) and neuroendocrine carcinoma (NEC): A multicenter, single-arm phase II study
First Author: Ming Lu, MD, Peking University Cancer Hospital & Institute
Abstract No. & Link: 155P
Date & Time: Thursday, December 9, 2021, 10:50am – 11:10am CET

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Surufatinib Development
Extra-pancreatic Neuroendocrine Tumors ("epNETs") in China: On December 29, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China ("NMPA") for the treatment of epNET. Surufatinib is marketed in China under the brand name SULANDA. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of PFS at a preplanned interim analysis, and was published in The Lancet Oncology[1]. Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

Pancreatic Neuroendocrine Tumors ("pNETs") in China: On June 16, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNET in China. The pre-defined primary endpoint of PFS was met at a preplanned interim analysis and was published in The Lancet Oncology[2], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with toripalimab, tislelizumab and sintilimab, which are approved as mono­therapies in China.

NETs in the U.S. and Europe: A U.S. Food and Drug Administration ("FDA") New Drug Application (NDA) submission was accepted in June 2021, followed by a Marketing Authorisation Application (MAA) submission to the European Medicines Agency (EMA) validated in July 2021. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019.

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi Biosciences. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). To date, four indications of toripalimab has been approved by the NMPA for the treatment of melanoma, nasopharyngeal carcinoma ("NPC") and urothelial carcinoma. In the United States, the FDA has granted priority review for the toripalimab Biologics License Application (BLA) for the treatment of NPC, which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted 2 Breakthrough Therapy designations, 1 Fast Track designation, 4 Orphan Drug designations for toripalimab.

On December 10, 2021 Oasmia Pharmaceutical AB (Oasmia), an oncology-focused specialty pharmaceutical company, reprted that the transfer of its marketing authorization for Apealea (paclitaxel micellar) to Inceptua AB has received approval from the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA) (Press release, Oasmia, DEC 10, 2021, View Source [SID1234596759]).

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As the new marketing authorization holder, Inceptua will assume full regulatory responsibility for Apealea in the EU, Norway, Iceland, Liechtenstein and the UK.

Apealea is approved in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Francois Martelet, Chief Executive Officer, Oasmia, commented: "This marketing authorization transfer is in line with Oasmia’s strategy, to commercially launch Apealea through partners and build a diversified pipeline focused on hard-to-treat and late-stage cancers using different mechanisms of action. We anticipate receiving our first royalties on Apealea sales during 2022 following commercial product launches in several key European markets."