On February 14, 2022 Primmune Therapeutics, a biotech company harnessing the power of the innate immune system to treat cancers and viral diseases, reported that interim data related to PRTX007, a novel, orally administered, small molecule toll-like receptor 7 (TLR7) specific agonist that is currently in Phase 1 development, at the Conference on Retroviruses and Opportunistic Infections (CROI) (Press release, Primmune Therapeutics, FEB 14, 2022, View Source [SID1234608058]). Oral administration of PRTX007 in this first-in-human study of healthy volunteers exhibited a favorable safety profile, rapid absorption and conversion to TLR7 agonist PRX034, and activation of the innate immune system, without causing inflammation.

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"PRTX007 is being developed to harness the power of the innate immune system by targeting TLR7, without increasing cytokines that can result in hyperinflammation and can harm patients," said James Appleman, Ph.D., Co-Founder and Chief Scientific Officer at Primmune Therapeutics. "We look forward to continuing the development of PRTX007 to address current unmet needs of patients with cancers and viral infections."

Highlights of this data, presented in a poster titled "Interim Analysis of a Phase 1 Study of PRTX007: Safety, PK, and PD Response," include:

Oral administration of PRTX007 resulted in efficient systemic delivery and well-behaved pharmacokinetics of agonist PRX034
TLR7-mediated immune response was shown to be dose and exposure-dependent
TLR7-mediated immune induction of IFN-gene products and other TLR7-associated cytokines was observed without increases in NF-κB mediated biosynthesis of proinflammatory cytokines IL-6, TNF⍺, IL-1β
Data demonstrate a favorable safety profile for PRTX007
Full details of the presentation can be found here.

About PRTX007

PRTX007 is Primmune’s lead TherAjuvant, a combination of therapeutic and adjuvant mechanisms of action. PRTX007 is designed to provide immediate benefit to patients through controlled stimulation of the innate immune response while also potentiating long-term effective innate and adaptive immune responses. PRTX007 uniquely engages TLR7 and targeted immune cells without increasing levels of proinflammatory factors like IL-6, TNFα and IL-1β via NF-κB. TherAjuvants differ from other small molecule approaches in that they engage the patient’s immune system rather than acting at virally encoded targets or endogenous tumor cell proteins. PRTX007 is being rapidly advanced towards clinical trials for cancer and viral diseases.

On February 14, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that it has been selected to deliver an oral presentation of preclinical data from its KIN-2787 program at the upcoming virtual IASLC 2022 Targeted Therapies of Lung Cancer meeting taking place February 22-26, 2022 (Press release, Kinnate Biopharma, FEB 14, 2022, View Source [SID1234608057]). The presentation will be delivered by study collaborator and presenting author Tadashi Manabe, M.D., Ph.D., Postdoctoral Scholar-Fellow, Department of Medicine, Division of Hematology and Oncology at the University of California, San Francisco (UCSF).

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"We continue to make progress in our clinical trial of KIN-2787 and expect initial data in the third quarter of 2022," said Richard Williams, MBBS, Ph.D., Chief Medical Officer at Kinnate. "Among other indications, KIN-2787 is being developed for the treatment of patients with non-small cell lung cancer driven by BRAF Class II or Class III alterations and we are looking forward to sharing preclinical data on its antitumor activity at this upcoming IASLC meeting."

In this study, KIN-2787 activity was assessed by suppression of downstream MAPK pathway signaling and subsequent cell growth inhibition across BRAF-altered and/or RAS-altered versus wild type panels of human non-small cell lung cancer (NSCLC) cell lines. In contrast to approved therapies, targeting Class I BRAF alterations, KIN-2787 was most active in Class II and Class III BRAF-altered NSCLC cells. KIN-2787 also inhibited cellular proliferation in BRAF alteration-positive human NSCLC cell lines. Additionally, KIN-2787 was active in in vitro cell growth inhibition assays against a parental BRAF Class I-driven NSCLC cell line and retained activity in an experimentally acquired vemurafenib-resistant BRAF p61 splice variant-expressing derived cell line. In vivo, KIN-2787 efficacy was evaluated using a BRAF-alteration driven human NSCLC cell line and patient-derived xenograft models. The ongoing KN-8701 trial (NCT# 04913285) of KIN-2787 is actively enrolling patients across multiple centers in the United States.

"Together, Class II and III alterations represent as many as 65% of all oncogenic BRAF alterations in NSCLC. While there are approved RAF inhibitors being used in combination treatment of BRAF Class I-altered NSCLC, there are currently no RAF-targeted therapies for the treatment of NSCLC patients with tumors driven by BRAF Class II or III alterations, which is likely a contributing factor in the inferior clinical outcomes often seen with these patients," said Dr. Manabe. "I am pleased to share findings from this study which show that KIN-2787 is a potent and selective pan-RAF inhibitor with demonstrated capabilities in overcoming well-characterized resistance mechanisms."

"KIN-2787 is a promising next-generation RAF inhibitor with unique properties that has shown potent activity against a variety of oncogenic BRAF-driven lung cancers in preclinical studies. The preclinical data are exciting, and I have great enthusiasm for its continued clinical development as a potential new targeted therapy that could help address the current unmet needs for oncogene-driven lung cancer patients," added Trever Bivona, M.D., Ph.D., study collaborator and Professor, Hematology and Oncology, at UCSF.

Details of the meeting presentation are as follows:

Abstract title: Antitumor Activity of KIN-2787, a Next-Generation Pan-RAF Inhibitor, in Preclinical Models of Human BRAF-Alteration Driven Non-Small Cell Lung Cancer (NSCLC)
Session: Best Fellows Oral Abstract Session
Session date and time: Wednesday, February 23, 2022 at 4:15pm ET
Additional information on the virtual IASLC 2022 Targeted Therapies of Lung Cancer meeting is available at: View Source

On February 13, 2022 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, together with IASO Biotherapeutics (IASO Bio) reported that the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) has formally granted Orphan Drug Designation (ODD) to their co-developed fully-human B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T-cell therapy (Innovent: IBI326, IASO Bio: CT103A) for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM) (Press release, Innovent Biologics, FEB 13, 2022, View Source [SID1234608052]).

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ODD will accelerate drug development and registration action in the United States. IBI326 will be eligible for certain development incentives, including FDA support for clinical studies, a waiver or reduction of registration application fee, and a seven-year U.S. market exclusivity granted upon product approval. In February 2021, IBI326 was granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA) for the treatment of R/R MM.

"This ODD of IBI326 is a milestone recognizing our effort to develop a novel anti-BCMA CAR with better efficacy and persistence," said Dr. Hui Zhou, Senior Vice President of Innovent, "It underscores the importance of bringing this therapeutic option to patients with multiple myeloma, and strongly motivates us to expedite the clinical development of IBI326. We hope to launch IBI326 as soon as possible which will bring hope to patients with multiple myeloma."

"FDA approval of ODD to CT103A is of great significance to patients with multiple myeloma and represents the FDA’s recognition of CT103A and the clinical data provided by IASO Bio", said Dr. Wen Wang, Chief Executive Officer and Chief Medical Officer of IASO Bio. "Currently, our team is advancing the clinical development of CT103A to the four dimensions of strategy including frontline therapy, combination therapies, indication expansion, and ex-China development. We are looking forward to the launch of CT103A both in China and US as soon as possible to offer living-saving treatment option to more patients."

About Multiple Myeloma

Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of newly-diagnosed all cancer cases, and more than 2% of cancer-related deaths.

According to Frost & Sullivan:

The number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020, and is expected to increase to 37,800 by 2025. The total number of patients diagnosed with MM in the United States increased from 132,200 in 2016 to 144,900 in 2020, and is expected to rise to 162,300 by 2025.
The number of new MM cases in China rose from 18,900 in 2016 to 21,100 in 2020, and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020, and is expected to rise to 182,200 by 2025.
About IBI326 (BCMA CAR-T)

IBI326 is an innovative therapy co-developed by IASO Bio and Innovent. Previous studies indicate subjects with relapsed/refractory multiple myeloma (R/R MM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells will not be effective. To solve this dilemma, IBI326 has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the BCMA CAR-T is potent and persistent. In February 2021, IBI326 was granted "Breakthrough Therapy Designation" by the NMPA for the treatment of relapsed/refractory multiple myeloma. In February 2022, IBI326 was granted "Orphan Drug Designation" by the FDA for the treatment of relapsed/refractory multiple myeloma.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 29 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT (sintilimab injection), BYVASDA (bevacizumab biosimilar injection), SULINNO (adalimumab biosimilar injection), HALPRYZA (rituximab biosimilar injection), Pemazyre (pemigatinib oral inhibitor) and Olverematinib (BCR TKI) – officially approved for marketing in China, 5 assets in Phase 3 or pivotal clinical trials, and an additional 18 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China’s biopharmaceutical industry, improve drug availability and enhance the quality of the patients’ lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:
TYVYT (sintilimab injection) is not an approved product in the United States.

BYVASDA (bevacizumab biosimilar injection), SULINNO, and HALPRYZA (rituximab biosimilar injection) are not approved products in the United States.

TYVYT (sintilimab injection, Innovent)
BYVASDA (bevacizumab biosimilar injection, Innovent)
HALPRYZA (rituximab biosimilar injection, Innovent)
SULINNO (adalimumab biosimilar injection, Innovent)
Pemazyre (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

Disclaimer:

This indication is still under clinical study, which hasn’t been approved in China or the U.S.
Innovent does not recommend any off-label usage.
For medical and healthcare professionals only.

On February 12, 2022 TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that financial and operating results for its third fiscal quarter ended December 31, 2021 (Press release, TYME, FEB 12, 2022, View Source [SID1234608038]).

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Third Fiscal Quarter 2022 Business and Recent Highlights:

OASIS Breast Cancer Trial
Patient enrollment in the Phase II OASIS breast trial continued during the third fiscal quarter 2022. The Company is collaborating with Georgetown University in a multicenter Phase II single-arm, open-label study examining SM-88 with methoxsalen, phenytoin, and sirolimus (MPS). The OASIS trial is an investigator-initiated prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 with MPS for the treatment of metastatic HR+/HER2- breast cancer after treatment with a CDK4/6 inhibitor. This indication represents approximately 73% of the annual breast cancer diagnoses in the US each year. The trial is being conducted at Georgetown University at a total of five sites within the Georgetown/MEDSTAR system. The Company plans to provide an update on the OASIS breast cancer study during the first half of calendar year 2023.

HopES Sarcomas Trial
Patient enrollment in the HopES sarcomas trial continued during the third fiscal quarter 2022. The HopES trial is an open-label Phase 2 investigator-sponsored trial of SM-88 therapy in sarcoma, sponsored by The Joseph Ahmed Foundation. This trial has two cohorts, each expecting to enroll 12 patients. The first is SM-88 with MPS as salvage treatment in patients with mixed rare sarcomas, and the other is SM-88 with MPS as maintenance treatment for patients with metastatic Ewing’s sarcoma who had not progressed on prior therapy. The primary objective is to measure Overall Response Rate and Progression Free Survival. The Company anticipates that the trial will complete enrollment by mid-2022.

Pre-clinical Pipeline Program
The Company has begun a comprehensive translational preclinical program focused on SM-88 MOA and Biomarker Identification/Validation and has engaged Evotec, a leading global research and development company, to aid in the execution of these activities. TYME is also incorporating several complementary academic collaborations into this multi-faceted program. The overall goal of these activities is to potentially identify actionable biomarkers of sensitivity and activity to SM-88 in various cancers, complementary combination drugs strategies for SM-88, and other cancer metabolism targets that could be targeted for treatment. The goal of the biomarker preclinical program is to identify areas where SM-88 produces a significant response, with the aim of expanding to other indications.

"We had good momentum this past quarter enrolling patients in our breast and sarcoma trials. We also continued to advance our tumor targeting technology and COVID–19 pre-clinical programs. Additionally, our MOA and Biomarker work has commenced as planned," said Richie Cunningham, Chief Executive Officer of TYME Technologies.

Precision Promise Trial
On January 26, 2022, the Company announced the discontinuation of SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC) upon learning from the trial sponsor, Pancreatic Cancer Action Network (PanCAN), that it discontinued the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC. Based on the information provided by PanCAN, the overall survival for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified FOLFIRINOX.

Strategic Review Update

A key goal coming out of the Company’s 2021 strategic review was to diversify the development pipeline by disease state, and TYME has commenced a process to examine additional options. A strong balance sheet, including $92.0 million of cash on hand, enables the Company to explore a number of avenues. Prior data indicated that SM-88 demonstrated confirmed responses in 15 different cancer types in both a First in Human study and a Compassionate Use program, and the Company is continuing its biomarker work to determine whether there is additional compelling data to commence a trial utilizing SM-88 in a new indication. Concurrently, TYME will be initiating searches for promising in-development cancer drugs that could be brought into the Company’s pipeline.

"I can assure you the process to diversify our pipeline will be a thorough and thoughtful one. We will carefully consider the benefits of commencing another internal SM-88 program versus looking outside the Company for a new compound. We firmly believe that SM-88 can be an effective agent in the fight against cancer. We also recognize that bringing in a product candidate with a different mechanism of action than SM-88 would add further diversity to our pipeline," stated Cunningham.

Third Fiscal Quarter 2022 Financial Results

As of the quarter ended December 31, 2021, the Company had approximately $92.0 million in cash and marketable securities, compared to $96.6 million as of the quarter ended September 30, 2021. TYME’s operational cash burn rate for the third quarter of fiscal year 2022 was $4.5 million compared to $5.0 million for the second quarter and $5.9 million for the third quarter of fiscal year 2021.

The burn rate was below the Company’s previous guidance and reflected expenses associated with ongoing clinical trials in breast cancer (OASIS), and sarcoma cancers (HopES), and the newly discontinued Precision Promise trial, as well as reduced costs associated with the discontinued pancreatic cancer trial, TYME-88-Panc Part 2. TYME anticipates that its quarterly cash usage or "cash burn rate" will range from $6.0 to $7.0 million for the remaining quarter of fiscal year 2022, based on costs associated with the Company’s active clinical trials, the ongoing and closeout activities related to the discontinued pancreatic cancer studies, the pre-clinical studies in biomarker and mechanism of action research of SM-88, and TYME-19 pre-clinical studies.

Net loss was $5.3 million for the quarter ended December 31, 2021, or ($0.03) per basic and diluted share, as compared to a net loss of $6.1 million for the quarter ended December 31, 2020, or ($0.05) per basic and diluted share. The decrease reflected lower ongoing trial costs primarily due to the discontinued TYME-88-Panc Part 2 trial.

Adjusted net loss for the three months ended December 31, 2021, was comparable to the GAAP net loss noted above, as the change in fair value of the warrant liability largely offset employee, director, and consultant stock options. Adjusted net loss and adjusted net loss per share are non-GAAP measures. See "Use of Non-GAAP Measures" below for a reconciliation to the comparable GAAP measures.

TYME has reported its full financial results for the quarter ended December 31, 2021, in the Company’s Form 10-Q filed with the Securities and Exchange Commission ("SEC"). TYME’s 10-Q is located in the SEC filings section of the Company’s website.

The webcast will be accessible on the Events & Presentations page of the Investors section of the TYME website, tymeinc.com, and will be archived for 90 days following the event.

Use of Non-GAAP Measures

Adjusted net loss and adjusted net loss per share as presented in this report are non-GAAP measures. The adjustments relate to the change in fair value of warrant liability, amortization of employees, directors and consultants stock options and gain on warrant exchange. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles ("Non-GAAP Measures"). In the reconciliation tables that follow, we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures, net loss and net loss per share. These items are adjusted because they are not operational or because they are significant noncash charges and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP. Our definitions of adjusted net loss and adjusted loss per share may not be comparable to similar measures reported by other companies.

On February 11, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported the grant of a new patent (number 2016205983) entitled "Combined Preparations for the Treatment of Cancer or Infection" by the Australian Patent Office (Press release, Immutep, FEB 11, 2022, View Source [SID1234608966]).

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This new Australian patent follows the grant of the corresponding European, United States and Chinese patents announced in 2018 through 2021.

The claims of the new patent protect Immutep’s intellectual property relating to combined therapeutic preparations comprising (a) its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321"), which is a LAG-3 fusion protein (LAG-3Ig), and (b) an anti-PD-1 or anti-PD-L1 antibody. In addition to broader style claims, the granted claims include narrower claims drawn to specific combinations of efti with pembrolizumab, nivolumab, avelumab, durvalumab or atezolizumab, for example. The claims are also directed to related methods of use in the treatment of cancer.

The patent expiry date is 8 January 2036.

Immutep CEO, Marc Voigt, noted: "We continue to make progress in protecting efti, which is a unique biomolecule. The LAG-3 / MHC class II immune control mechanism has attracted significant interest from the medical and investment communities in recent weeks following publication of Phase III clinical data by the pharma industry in a very prestigious peer-reviewed medical journal. With our exclusive focus on this mechanism and four candidates under development, we continue to be well placed to make an important contribution to this exciting field. 2022 promises to be a productive year."