On December 10, 2021 The Multiple Myeloma Research Foundation (MMRF) reported that new insights related to novel targets, risk assessment, and precision medicine approaches generated through the use of the MMRF landmark CoMMpass Study will be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Multiple Myeloma Research Foundation, DEC 10, 2021, View Source [SID1234596777]). In total, ASH (Free ASH Whitepaper) will feature 33 presentations developed through the work of more than 200 researchers from 180 institutions all using the CoMMpass data.

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The MMRF initiated the CoMMpass Study more than ten years ago to address the need for a large, comprehensive, genomic and clinical data set that was publicly available to researchers to realize the potential of precision medicine. It has now become one of the largest longitudinal genomic datasets of any cancer and the source of more than 150 myeloma scientific publications and abstracts. The insights generated by CoMMpass have led to groundbreaking discoveries that have transformed the research community’s understanding of myeloma at a genomic level. The MMRF is now working with five institutions (Beth Israel Deaconess Medical Center, Emory University, Mt. Sinai School of Medicine, Mayo Clinic, and Washington University, St. Louis) on a companion project called Immune Atlas that will complement the genomic and clinical data in CoMMpass with high dimensional immune profiling of the same patients, creating standards and generating robust immune data to further advance precision medicine. The initial findings from this effort are among the 33 abstracts.

"CoMMpass has exceeded our expectations as a wellspring for insightful research and to generate new hypotheses that we can test in the laboratory and at the bedside," said Hearn Jay Cho, MD, PhD, Chief Medical Officer, the MMRF. "CoMMpass continues to shape our research agenda, particularly in precision medicine clinical trials such as MyDRUG and MyCheckpoint, and this will only expand with the addition of Immune Atlas. We are also looking beyond CoMMpass by building our next major data set with the MMRF CureCloud."

The MMRF CureCloud was launched in 2019 as a next generation data source capturing genomic sequencing data through blood samples of newly diagnosed myeloma patients and longitudinal clinical data shared by patients through their electronic medical records. The first abstracts derived from CureCloud are being presented at ASH (Free ASH Whitepaper) representing the next game-changing longitudinal study in myeloma research. Unique to CureCloud is that it was specifically designed to not only power research, but also as an immediate and ongoing resource to clinicians and patients. Each CureCloud patient receives their personal genomic data report, learns about possible clinical trials, and will have ongoing access to new and evolving insights related to their disease. The database is designed to continuously identify insights from patients that will help other patients gain deeper understanding of possible treatment paths as more patients join the program.

"Our mission is to deliver a cure for each and every myeloma patient. We know that getting there will require access to data to progress the development of precision medicines. This is our ultimate focus as we share data with our research collaborators and patients every day," said Michael Andreini, President and CEO, the MMRF. "The data and insights we share are generating a deeper understanding of the biology of myeloma and helping to identify new targets and markers for risk and disease progression. They are also driving the discovery and delivery of more precise treatments for all patients as we pursue a world without myeloma."

For complete data on MMRF abstracts being presented at the 63rd ASH (Free ASH Whitepaper) Annual Meeting please contact C.J. Volpe at [email protected]

About the MMRF CoMMpass StudySM
The MMRF CoMMpass Study is a longitudinal study of patients with newly diagnosed active multiple myeloma. The goal is to map the genomic profile of each patient to clinical outcomes to develop a more complete understanding of patient responses to treatments. A cornerstone of the MMRF’s Personalized Medicine Initiative, the study is collecting and analyzing tissue samples, clinical data and genetic information from 1,000 newly diagnosed multiple myeloma patients for at least eight years. The CoMMpass Study was made possible by a $40M investment by the MMRF.
The MMRF CoMMpass Study opened in July of 2011 and now includes 1,150 patients from 76 sites in the United States, Canada and European Union. Data from the MMRF CoMMpass Study is made available to researchers via the MMRF’s Researcher Gateway (View Source), an online, open-access portal designed to make key genomic and clinical data available for additional study. The MMRF CoMMpass Study is being supported through a public-private partnership of patient donors and industry partners, including Takeda Oncology, Amgen, Bristol-Myers Squibb, Janssen Pharmaceuticals, Inc. and Janssen Diagnostics. Additional collaborating research partners include the Translational Genomics Research Institute, Van Andel Research Institute and GNS Healthcare. Please visit www.themmrf.org/research-partners/the-commpass-study to learn more about the study.

On December 10, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported updated data from the ongoing MARIO-3 clinical study during the 2021 San Antonio Breast Cancer Symposium (SABCS). MARIO-3 is the Company’s ongoing Phase 2 study evaluating eganelisib in combination with atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) in frontline metastatic triple negative breast cancer (TNBC) (Press release, Infinity Pharmaceuticals, DEC 10, 2021, View Source [SID1234596757]).

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"These promising updated data suggest that the addition of eganelisib to atezolizumab and nab-paclitaxel has the potential to provide improved patient outcomes over benchmark IMpassion130 data in front-line metastatic TNBC," said Hatem Soliman, M.D., MARIO-3 Investigator and Medical Director, Clinical Trials Office at the Moffitt Cancer Center. "Tumor reductions in 88.6% of evaluable patients were associated with a disease control rate of 81.4% in patients with PD-L1 negative tumors who are among the most challenging to treat. Importantly, we see that this impressive disease control rate is translating into durable clinical benefit, regardless of PD-L1 status, with encouraging mPFS compared to the IMpassion130 benchmark study. These compelling findings, combined with eganelisib’s safety and tolerability profile, indicate that eganelisib has the potential to become an important new treatment option for advanced TNBC patients."

Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals, said, "With a median duration of follow-up of almost 10 months, the durable clinical benefit seen with the eganelisib combination reinforces our vision of bringing better therapies to frontline TNBC patients. When compared to the IMpassion130 benchmark data, a 47% improvement in median PFS for patients with PD-L1 positive tumors and a 30% improvement in median PFS for patients with PD-L1 negative tumors provides consistent and compelling evidence of eganelisib’s potential to improve outcomes for these patients."

MARIO-3 Key Data Updates:

This data update includes 50 patients enrolled and 44 evaluable as of the October 2, 2021 data cutoff date, with a median duration of follow up of 9.9 months.
Of evaluable patients, tumor reduction was observed in 92.8% of patients with PD-L1 positive tumors (13/14) and 85.2% of patients with PD-L1 negative tumors (22/27).
Disease control rate (DCR)
92.8% (13/14) DCR in patients with PD-L1 positive tumors: CR 14.3% (2/14), PR 57.1% (8/14), SD 21.4% (3/14)
81.4% (22/27) DCR in patients with PD-L1 negative tumors: complete response (CR) 0% (0/27), partial response (PR) 48.1% (13/27), stable disease (SD) 33.3% (9/27)
Progression free survival (PFS)
In patients with PD-L1(+) tumors, median PFS in MARIO-3 was 11.0 months, a 47% improvement in mPFS compared to the 7.5 months reported for atezolizumab and nab-paclitaxel alone in IMpassion130
In patients with PD-L1(-) tumors, median PFS in MARIO-3 was 7.3 months, a 30% improvement compared to the 5.6 months reported for atezolizumab and nab-paclitaxel alone in IMpassion130
72% of the 32 PD-L1 (+) and PD-L1(-) patients treated since the June 26, 2021 data cut remain on treatment
67% of the PD-L1(-) patients who reached the median PFS of 7.3 months remain on treatment
Safety
MARIO-3 did not demonstrate any new safety signals compared to benchmark trials, and its safety profile was consistent with expectations for the three component drugs. The most common Grade 3 or higher treatment-related TEAEs were hepatic AEs (18%); neutropenia AEs (16%); skin AEs (12%); fatigue, diarrhea and peripheral sensory neuropathy (6% each); and vomiting and weight decreased (2% each). Seven patients (14%) discontinued treatment for treatment-related TEAEs and nine patients (18%) had treatment-related SAEs.
Quantification across 11 paired tumor biopsies shows increased immune activation and decreased immune suppression including an increase in CD8+ T cells, activated T cells, and anti-tumor M1 macrophages and a decrease in tumor cells and pro-tumor M2 macrophages resulting in an increase in the M1:M2 ratio.
Paired tumor biopsy data show 5 of 8 patients with PD-L1(-) tumors converting to PD-L1(+) two months after treatment utilizing the same 1% PD-L1 cutoff standard used in the benchmark IMpassion130 study. PD-L1 expression also increased in the three patients with PD-L1(+) tumors who started the study above the 1% cutoff. None of the patients converting to PD-L1(+) or patients with PD-L1(+) tumors who experienced increased PD-L1 expression had disease progression.
KOL Event Information

Infinity will host a KOL event today, December 10, 2021, at 9:30AM ET with Hatem Soliman, M.D., MARIO-3 Investigator and Medical Director, Clinical Trials Office at the Moffitt Cancer Center, to review the MARIO-3 data presented at SABCS.

To register for the webinar, please click here.

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 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.