On September 17, 2020 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune system recognition of the cancer, reported that the first patient has been dosed with a combination of INT230-6, the Company’s lead investigational product, and Yervoy (ipilimumab), Bristol Myers Squibb’s (BMS) Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) immune checkpoint inhibitor therapy in Phase 2 (Press release, Intensity Therapeutics, SEP 17, 2020, View Source [SID1234565284]). The combination is being studied in a series of phase 2 expansion cohorts within IT-01, Intensity’s ongoing international clinical study (NCT03058289), which evaluates the safety and efficacy of the combination in patients with three different types of cancer (breast cancer, liver cancer, and sarcoma).
"Bringing INT230-6 into phase 2 human testing in combination with Yervoy is an important achievement for Intensity Therapeutics," commented Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Our preclinical and clinical data have resulted in favorable safety for INT230-6 as a single agent or in combination with immunotherapies. The phase 1 escalation portion of our INT230-6 development program is complete. We are excited about starting the phase 2 portion of our trial using INT230-6 at proper doses early in the treatment process especially in combination with Yervoy."

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"The phase 2 Yervoy combination studies accrue patients with breast cancer, liver cancer, and sarcoma that are refractory to standard of care and have high unmet medical need" said Ian B. Walters, MD, Chief Medical Officer of Intensity Therapeutics. "We are optimistic that our trial design enables us to quickly evaluate safety and efficacy in patients having cancers that are difficult to treat. Physicians desperately need better therapies for their patients. Our approach to safely debulk tumors and recruit an immune response by releasing tumor antigens derived from the patient’s own tumors may be amplified by blocking a checkpoint signal using Yervoy."

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, release of tumor antigens and recruitment of immune cells to the tumor. Results generated by both the Company and the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responses in animals with long-term protection from multiple re-challenges of the initial cancer and resistance to other cancers. The Company’s research published in the International Journal of Molecular Sciences earlier this year and published jointly with the NCI as part of Intensity’s collaborative research, published in July 2019 in the Journal OncoImmunology, also showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy. In the combination cohort with pembrolizumab the Company reported the safety of the combination was comparable to INT230-6 monotherapy.

On September 17, 2020 ImmunoGen, Inc., (Nasdaq: IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported final data from the FORWARD II triplet cohort evaluating mirvetuximab soravtansine in combination with carboplatin and Avastin (bevacizumab) in patients with folate receptor alpha (FRα)-positive recurrent, platinum-sensitive ovarian cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020 Virtual Congress (Press release, ImmunoGen, SEP 17, 2020, View Source [SID1234565302]).

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"Although there have been advances in the treatment of platinum-sensitive disease with targeted and maintenance therapies, there remains a significant need for additional active, well-tolerated combinations in the platinum-sensitive setting," said David O’Malley, MD, Professor, Director of Gynecologic Oncology and Co-Director, Gynecologic Oncology Phase 1 Program at The Ohio State University and the James Cancer Center, and FORWARD II Principal Investigator. "The efficacy outcomes demonstrated by combining full dose mirvetuximab with bevacizumab and carboplatin in more heavily pretreated platinum-sensitive ovarian cancer patients is encouraging relative to current standard of care triplet regimens."

In the FORWARD II triplet cohort Phase 1b trial, 41 patients with a median age of 63 years received the combination of full dose mirvetuximab with carboplatin and bevacizumab. Eligibility criteria included patients with recurrent platinum-sensitive ovarian cancer that expressed medium or high levels of FRα, who had been treated with up to two prior lines of therapy. 73% of patients had one prior line of therapy and 27% had two prior lines of therapy, while 42% of patients had received prior PARP inhibitors, and 24% had received prior treatment with bevacizumab.

Key Findings from FORWARD II Triplet Cohort

In 41 patients with recurrent platinum-sensitive ovarian cancer with medium or high levels of FRα who have received up to two prior lines of therapy, the confirmed overall response rate (ORR) for the triplet was 83%, with a median duration of response (DOR) of 10.9 months and median progression free survival (PFS) of 12.8 months.
These efficacy outcomes are encouraging relative to those reported in less heavily pretreated patient populations for other carboplatin and bevacizumab-based triplets.
Mirvetuximab was readily combined and well tolerated with standard dosing of carboplatin and bevacizumab, with a manageable adverse event (AE) profile as anticipated for this triplet based on the side effect profiles of each agent. Thrombocytopenia, a common adverse event with carboplatin treatment, was the most common cause of drug-related discontinuations.
Post-carboplatin (median 6 cycles), mirvetuximab soravtansine and bevacizumab continuation/maintenance was well tolerated.
"Having generated a wealth of data demonstrating encouraging efficacy and favorable tolerability, mirvetuximab continues to show promise in combination – not only as a triplet but also when combined with bevacizumab or carboplatin as a doublet. In the future, we look forward to defining a formal path to registration for mirvetuximab in combination with approved agents with the goal of expanding use into earlier lines of therapy and becoming the combination agent of choice in ovarian cancer," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen.

ESMO Poster Details

In addition, the City of Hope will present data from their study of mirvetuximab in combination with gemcitabine in patients with recurrent FRα-positive ovarian cancer, endometrial cancer, and triple negative breast cancer.

Title: "A Phase I Study of Mirvetuximab Soravtansine (MIRV) and Gemcitabine (G) in Patients (Pts) with Selected FRα-positive Solid Tumors: Results in the Endometrial Cancer (EC) Cohort" (Presentation #863P)
Date: Thursday, September 17, 2020
Time: 9:00 a.m. CEST/3:00 a.m. ET
Lead Author: Mihaela C. Cristea, MD, Associate Clinical Professor, Department of Medical Oncology and Therapeutics Research, Gynecologic Oncology Peritoneal Malignancy Program, City of Hope Comprehensive Cancer Care Center
Additional information can be found at www.esmo.org.

ABOUT FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin, or Keytruda (pembrolizumab) in patients with folate receptor alpha (FRα)-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.

On September 17, 2020 Precision Optics Corporation, Inc. (OTCQB: PEYE) (the "Company") reported that it has scheduled a conference call to discuss fourth quarter and fiscal year 2020 financial results on Thursday, September 24, 2020 at 5:00pm ET (Press release, Precision Optics, SEP 17, 2020, View Source [SID1234565321]).

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The Company intends to release its financial results and to file its 10-K after the close of the market on September 24, 2020 followed by the conference call.

Conference Call Details

Date and Time: Thursday, September 24, 2020 at 5:00pm ET

Call-in Information: Interested parties can access the conference call by dialing (844) 735-3662 or
(412) 317-5705.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until October 1, 2020 at (877) 344-7529 or (412) 317-0088, confirmation # 10147933. A webcast replay will be available at View Source

On September 17, 2020 Amunix Pharmaceuticals, Inc. ("Amunix"), a biopharmaceutical company developing prodrugs of potent immune-activating biotherapeutics for the treatment of patients with solid tumor cancers, reported that it will present preclinical data on two T cell engager programs: AMX-818, the company’s lead clinical candidate which targets HER2, and a second targeting EGFR (EGFR-XPAT), which is in lead optimization, at the European Society for Medical Oncology Virtual Congress taking place September 19 – 21, 2020 (Press release, Amunix, SEP 17, 2020, View Source [SID1234565286]).

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"We are very excited to present progress on our most advanced T cell engager programs," said Angie You, Ph.D., CEO of Amunix. "Both programs demonstrate the potential of our XPAT platform to significantly widen the therapeutic index of T cell engagers and overcome the challenge of on-target, off-tumor toxicity that is limiting the use of potent immune activators to treat solid tumors. For our HER2-XPAT clinical candidate, AMX-818, we have initiated IND-enabling studies. We are also excited to share progress with EGFR-XPAT, which offers a potential orthogonal approach to small molecule kinase inhibitors to target KRAS mutant tumors. As we progress these two most advanced programs, we are also leveraging our plug and play platform to rapidly develop XPATs against additional tumor targets such as PSMA and TROP2."

Amunix will present two posters at ESMO (Free ESMO Whitepaper), titled, "HER2-XPAT, A Novel Protease-Activatable Pro-Drug T Cell Engager (TCE), Engineered to Address On-Target, Off-Tumor Toxicity and Provide Large Predicted Safety Margins in Non-Human Primate (NHP)" and "EGFR-XPAT, A Novel Pro-Drug T Cell Engager (TCEs) Engineered to Address On-Target, Off-Tumor Toxicity and an Orthogonal Approach for Cancer Immunotherapy in EGFR, KRAS/BRAF Cancers". Both posters show that Amunix’s XPAT technology can improve the toxicity profile of T cell engagers while maintaining their potency against solid tumors. In vitro, protease-activated XPATs showed potent cytotoxic activity against tumor cell lines with EC50s in the single-digit pM range. For both molecules, masking reduced target-directed T cell cytotoxicity and T cell activation by ~5,000 to >10,000-fold. In established xenograft models, both HER2-XPAT and EGFR-XPATs induced complete tumor regressions with efficacious doses within an order of magnitude of the unmasked (active) T cell engager. Importantly, EGFR-XPAT showed strong in vitro cytotoxicity in a KRAS mutant and BRAF mutant setting, as well as potent in vivo anti-tumor xenograft activity in a BRAF mutant background.

Safety data from cynomolgus monkeys demonstrate that masked XPATs have a markedly lower risk of CRS and enable a significant increase in maximum tolerated exposures relative to unmasked, active forms. In contrast to traditional unmasked T cell engagers, which have MTDs in the µg/kg range, HER2-XPAT can be safely dosed up to 42 mg/kg in cynos and EGFR-XPAT up to 1 mg/kg, representing ~500-fold and ~200-fold, respectively, increases in tolerated exposures from masking. Combined with the potency of XPATs in xenograft models, these data suggest a favorable therapeutic index even for targets as broadly expressed as EGFR.

Poster Presentation Details
Title: HER2-XPAT, A Novel Protease-Activatable Pro-Drug T Cell Engager (TCE), Engineered to Address On-Target, Off-Tumor Toxicity and Provide Large Predicted Safety Margins in Non-Human Primate (NHP)
Poster number: 1060P
Abstract Number: 2472
Session: Virtual On-Demand Poster Display
Date: Sep 17, 2020

Title: EGFR-XPAT, A Novel Pro-Drug T Cell Engager (TCEs) Engineered to Address On-Target, Off-Tumor Toxicity and an Orthogonal Approach for Cancer Immunotherapy in EGFR, KRAS/BRAF Cancers
Poster number: 1062P
Abstract Number: 3054
Session: Virtual On Demand Poster Display
Date: Sep 17, 2020

On September 17, 2020 InnoCare Pharmaceuticals (HKEX: 09969), a clinical stage biopharmaceutical company committed to discovering, developing, and commercializing innovative medicines for the treatment of cancer and autoimmune diseases, reported that the company will present at the upcoming Morgan Stanley 2020 Virtual Asia Pacific Conference and ZGC Forum (Press release, InnoCare Pharma, SEP 17, 2020, View Source [SID1234565304]).

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InnoCare CFO, Mr. Shaojing Tong, will join the China Biotech Panel of the Morgan Stanley conference to discuss and share the insights of China’s booming biotech industry on Thursday, September 24, 2020 China time.

Meanwhile, InnoCare will exhibit innovative medicine at the ZGC forum from September 17-20 in Beijing. Dr. Renbin Zhao, Executive Director of Biology and Clinical Development Strategy of InnoCare will present on the latest development of BTK inhibitor Orelabrutinib on the afternoon of Thursday, September 17, 2020, China time.

Founded in 2007, the ZGC forum has been held for years with the mission to promote communication, exchange, and cooperation in the field of science and technology worldwide.