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 Nykode Therapeutics AS (Euronext Growth (Oslo): NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported the completion of patient enrollment in the Phase 2 study of VB10.16, Nykode’s lead cancer vaccine candidate, in combination with Roche’s checkpoint inhibitor atezolizumab for the treatment of advanced cervical cancer (Press release, Nykode Therapeutics, FEB 11, 2022, View Source [SID1234608011]). VB10.16 is a potentially first-in-class off-the-shelf therapeutic HPV16 cancer vaccine designed to induce strong HPV16 specific T cell responses for the treatment of HPV16-positive cancers.

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"We are pleased to report the completion of patient enrollment in our ongoing Phase 2 trial of VB10.16, our wholly owned product candidate for the treatment of cervical cancer," said Michael Engsig, CEO of Nykode Therapeutics. "This is an important inflection point for Nykode as we advance our lead candidate through the clinic. After successfully enrolling 50 patients across trial sites in six countries, we look forward to reporting interim efficacy and safety data from the first patients in the first half of 2022. In parallel, we are exploring the possibility of evaluating VB10.16 in other HPV-driven cancers, including head and neck cancer."

VB C-02 is a multi-center, open-label Phase 2 trial of patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. Almost 20 European sites in six European countries were engaged in enrolling patients in the trial. Nykode has previously reported positive interim safety data from the trial.

Siri Torhaug, Chief Medical Officer of Nykode Therapeutics, commented: "Cervical cancer is a leading cause of death for women. It is an indication which continues to have a high unmet medical need with limited response to standard of care treatment in an advanced setting. We are very happy to have reached this important milestone for our lead cancer vaccine VB10.16 and look forward to continuing the development program. We are thankful for the patients, their families, the investigators and the trial site personnel who have made this trial possible."

Additional information about the Phase 2 trial is available at clinicaltrials.gov (NCT04405349).

On February 11, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy reported that the company will be presenting at the upcoming 2022 BIO CEO & Investor Conference being held at the Marriott Marquis in NYC on February 14-15 and virtually through the 17th (Press release, Immunomic Therapeutics, FEB 11, 2022, View Source [SID1234608012]).

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Bob Newman, ITI’s Chief Business Officer, will deliver a presentation titled, "Pioneering the Next Generation of Immunotherapies" discussing ITI’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology, specifically glioblastoma multiforme (GBM). ITI’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

Hosted annually by the Biotechnology Innovation Organization (BIO) for over 20 years, the conference is focused on emerging public and private companies, offering a meeting place for institutional investors, industry analysts, and senior biotech executives. The conference draws biotech companies looking to make the connections needed to take their products to the next phase.

Presentation details are as follows:

Who: Bob Newman, Chief Business Officer of Immunomic Therapeutics, Inc.

What: Pioneering the Next Generation of Immunotherapies

Registered attendees may access the presentation here: https://bit.ly/3HIAh9b

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP1), an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On February 11, 2022 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that its Chief Executive Officer, Patrick Amstutz, Ph.D., will participate in the SVB Leerink 11th Annual Global Healthcare Conference 2022 (Press release, Molecular Partners, FEB 11, 2022, View Source [SID1234608049]). The presentation will take place on Wednesday, February 16, at 9:20 am ET.

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The webcasted presentation will be made available on the Molecular Partners website.