On September 21, 2022 MEDIFIC, a biotech that develops new drugs targeting cancer stem cells (CSC), reported the company is conducting non-clinical development of ‘MFC0101’, a SREBP1 signaling inhibitor being developed as an anti-cancer drug, as a ‘non-clinical stage’ task by the National Drug Development Foundation (KDDF) (Press release, MEDIFIC, SEP 21, 2022, View Source;mode=VIEW&num=21&category=&findType=&findWord=&sort1=&sort2=&page=2 [SID1234644156]).

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As a result of this project selection, Medipick will receive non-clinical research funding of 1.5 billion won over two years out of the development cost of MFC0101, an anticancer drug for glioblastoma.
Currently, GLP (Good Laboratory Practice) toxicity evaluation of MFC0101 is underway with the goal of starting clinical trials in the second half of 2023.

MFC0101 is a new drug candidate that inhibits SREBP1 (Sterol regulatory element binging protein), which is essential for the survival of cancer stem cells.
SREBP is a transcription factor protein that promotes lipid synthesis, and cancer stem cells, which are responsible for the growth and metastasis of cancer cells and anticancer drug resistance, are known to be highly dependent on the regulation of lipid metabolism by SREBP1.

Specifically, MFC0101 is a monovalent degrader mechanism that inhibits SREBP1-dependent lipid metabolism control signals by inducing SREBP1 decomposition by inhibiting the interaction between SREBP1 and SCAP (SREBP cleavage-activating protein) that binds to it. explained.

Medipick is developing glioblastoma (GBM) as its main target indication, and research is underway to expand the indication to solid cancers such as liver cancer, lung cancer, breast cancer, and colon cancer.
There is a standard treatment for glioblastoma using a combination of radiation therapy and the chemotherapy drug temozolomide (TMZ), but the average survival period is only 12 to 15 months.
In most cases, it recurs within 3 to 6 months, and there is no suitable treatment thereafter, making it a disease with a very high unmet medical need.

MFC0101 exhibits anti-cancer effects by selectively decomposing SREBP1 to remove cancer stem cells and cancer cells. In particular, when administered in combination with temozolomide, it shows synergy in anti-cancer effects and is safe.

Seungjun Yoo, CEO of Medipick, said, "It is known that cancer stem cells are important for cancer malignancy, metastasis, and recurrence, but there are still no success stories in the development of anticancer drugs targeting cancer stem cells." He added, "With this national project selection, we will begin non-clinical testing of MFC0101. "We will successfully complete it and develop it into a global innovative new drug," he said.

Medipick was founded in 2018 by Kim Hyeong-gi, a professor at Korea University’s College of Life Sciences and an expert in cancer stem cell biology, and received 6 billion won in Series A investment from Daekyo Investment and DSC the following year.
This year, CEO Seung-Jun Yoo, who previously served as Chief Strategy Officer (CSO) of Geninus/TP Global, Director of the Korea Bio-Economy Research Center, and Director of KISTEP, joined, and previously held positions such as CEO of DD Partners, CEO of Future Medicine, and Director of Biotox Tech Research Institute. Dr. Lee Sang-gu is the chief development officer (CDO).

On September 21, 2022 Nerviano Medical Sciences S.r.l. (NMS), a member of the NMS Group and a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported the signing of a collaboration agreement with licensing option with Merck Healthcare KGaA (Merck), for the next-generation highly selective and brain penetrant PARP1 inhibitor NMS-293 (Press release, Nerviano Medical Sciences, SEP 21, 2022, View Source [SID1234623258]).

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PARP (poly (ADP-ribose) polymerase) is key in the repair of DNA damage and PARP inhibitors have been shown to be highly efficacious in the treatment of tumors deficient in homologous recombination repair, such as breast, ovarian, prostate and pancreatic cancers which are BRCA mutated.

NMS-293 is an orally available PARP1 inhibitor, designed to be more PARP1 selective and brain penetrant compared to first generation PARP inhibitors. With its expected lower hematological side effect profile, it has the expected features for potential use not only as single agent but also in combination with DNA-damage accumulating agents in a wide range of tumors. NMS-293 is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ).

Under the current agreement, Merck will make early payments (up-front and option exercise fees) of up to US$65 million to NMS. Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck. Upon exercise of the option, NMS will grant to Merck the exclusive rights to research, develop, manufacture, and commercialize NMS-293.

"NMS-293 is the first next-generation PARP1 inhibitor to enter clinical trials. Based on its unique features, NMS-293 has strong potential in combination with a wide variety of DNA-damage accumulating agents, such as chemotherapy, DNA repair inhibitors or ADCs, in tumor settings that are precluded to current PARP inhibitors, such as brain tumors, and where there is an urgent global need to find treatments," stated Hugues Dolgos, Pharm.D., chief executive officer of NMS and NMS Group. "NMS has built a unique and proprietary platform of first-in-class and best-in-class assets and expanded to new target classes like PARP with NMS-293 as our flagship. We believe that Merck, a global leader in DNA repair with a well-established commercialization footprint, is the ideal partner to maximize the value of our program."

"Building on the therapeutic impact that PARP inhibitors have had over the last several years, we believe this new PARP1 program, if successful, could fill a significant unmet need for patients unresponsive to existing PARP inhibitors with an improved hematological adverse event profile," said Victoria Zazulina, M.D., Head of Development Unit Oncology for the Healthcare business of Merck. "The work of NMS to discover and advance this next generation PARP1 selective inhibitor coupled with our deep expertise in developing therapies which modify DNA damage response mechanisms, creates a strong foundation to further develop this investigational therapy for patients."

During the option period, NMS and Merck will collaborate on the clinical development of NMS-293 as monotherapy and in combination, with NMS designing, sponsoring, conducting, and funding global clinical trials.

About NMS-293

NMS-293 is an orally available small molecule inhibitor of PARP1 and is currently in early clinical development for the treatment of patients with BRCA mutated tumors as single agent and with recurrent Glioblastoma (GBM), a brain tumor with very high medical need, in combination with temozolomide (TMZ).

20220921-NMS Srl announces Collaboration and Option to License Agreement with Merck-Final

On September 21, 2022, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "GS Capital Purchase Agreement") with GS Capital Partners, LLC ("GS Capital"), pursuant to which GS Capital purchased a convertible redeemable note (the "GS Capital Note") from the Company in the aggregate principal amount of $71,500, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of GS Capital (Filing, 8-K, Propanc, SEP 21, 2022, View Source [SID1234621467]). The transaction contemplated by the GS Capital Purchase Agreement closed on September 26, 2022. The GS Capital Note contains a $4,000 original issue discount. The Company intends to use the net proceeds ($67,500) from the GS Capital Note for general working capital purposes.

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The maturity date of the GS Capital Note is March 21, 2023 (the "Maturity Date"). The GS Capital Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to GS Capital in shares of common stock, but shall not be payable until the GS Capital Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment. The GS Capital Note is exchangeable for an equal aggregate principal amount of notes of different authorized denominations, as requested by GS Capital surrendering the same. GS Capital is entitled, at its option, at any time after cash payment, to convert all or any amount of the principal face amount of the GS Capital Note then outstanding into shares of the Company’s common stock (the "Common Stock") at a price for each share of Common Stock ("Conversion Price") of $0.002 per share (the "Fixed Price"). However, in the event the Company’s Common Stock trades below $0.0014 per share for more than five (5) consecutive trading days, then the Fixed Price shall be equal to $0.0009 per share. In the event of default, the Conversion Price shall be equal to 65% of the lowest trading price of the Common Stock as reported on the OTC Markets on which the Company’s shares are then traded or any exchange upon which the Common Stock may be traded in the future, for the ten prior trading days including the day upon which a Notice of Conversion is received by the Company. GS Capital is restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by GS Capital, exceeds 4.99% of the outstanding shares of the Company’s Common Stock.

The GS Capital Note may be prepaid until 180 days from the issuance date. If the GS Capital Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 110% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 121 from the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, then the prepayment premium shall be 130% of the face amount plus any accrued interest. So long as the GS Capital Note is outstanding, the Company covenants not to, without prior written consent from GS Capital, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.

Pursuant to the terms of the GS Capital Purchase Agreement, the Company paid GS Capital’s legal fees of $2,500.

Other than as described above, the GS Capital Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the GS Capital Note.

Upon the occurrence and during the continuation of certain events of default, interest shall accrue at a default interest rate of 24% per annum or, if such rate is usurious or not permitted by current law, then at the highest rate of interest permitted by law.

In the event that the Company fails to deliver to GS Capital shares of Common Stock issuable upon conversion of principal or interest under the GS Capital Note, the penalty shall be $250 per day the shares are not issued beginning on the 4th day after the conversion notice was delivered to the Company. This penalty shall increase to $500 per day beginning on the 10th day.

The GS Capital Note was issued, and any shares to be issued pursuant to any conversion of the note shall be issued in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing description of the GS Capital Note and GS Capital Purchase Agreement do not purport to be complete and is qualified in their entirety by reference to the full text of the documentss, which are filed as Exhibits 4.1 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On September 21, 2022 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that on June 28, 2022 the U.S. Patent and Trademark Office (USPTO) issued U.S. patent 11,369,618 (‘618 patent) entitled "Compounds, Compositions Methods for Prevention and/or Treatment of Cancer" (Press release, Linnaeus Therapeutics, SEP 21, 2022, View Source [SID1234621463]).

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The ‘618 patent covers the use of the company’s lead compound, LNS8801 and other G-protein estrogen receptor (GPER) agonists in combination with various therapies, including anti-PD-1/L1 therapies, to prevent or treat GPER-expressing cancers.

"We are extremely pleased that the USPTO has issued this critical patent, the third essential patent in our GPER agonist patent portfolio," commented Patrick Mooney, MD, CEO of Linnaeus. "We believe that the issued claims will provide critical market protection for LNS8801 through at least 2037. As we continue to collect very promising data from our clinical trials of LNS8001, we plan to prosecute the ‘618 patent on a worldwide basis."

Linnaeus is testing LNS8801 in its phase 1/2 adaptive-design clinical trial as a monotherapy and in combination with pembrolizumab in patients who had previous clinical benefit from immune checkpoint inhibitors and then subsequently progressed.

About LNS8801
LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory.

In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and clinical benefit in patients with advanced cancers.

On September 21, 2022 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported a poster presentation at the 2022 International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON) in New York City, NY, from September 28 – October 1, 2022 (Press release, Imvax, SEP 21, 2022, View Source;utm_medium=rss&utm_campaign=imvax-to-present-new-data-on-tumor-derived-immunotherapy-platform-at-2022-international-cancer-immunotherapy-conference [SID1234621350]).

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At the meeting, Imvax will present preclinical data that further elucidate the foundational anti-tumor immunological mechanisms of its platform and provide additional evidence of activity in an endometrial cancer model.

The details of the poster presentation are:

Title: Autologous tumor cell immunotherapeutic platform, with evidence of clinical activity in glioblastoma, induces in vitro immune responses in both glioblastoma and endometrial cancer