On December 19, 2023 NanOlogy LLC, a clinical-stage oncology company, reported data presented as posters during recent oncology conferences (Press release, NanOlogy, DEC 19, 2023, View Source;utm_medium=rss&utm_campaign=nanology-clinical-and-preclinical-immune-data-presented-at-naclc-and-sitc [SID1234638683]).

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A poster entitled Phase 2a Intratumoral Large Surface Area Microparticle Paclitaxel in Stage 3/4 Lung Cancer was presented during IASLC’s North American Conference on Lung Cancer in Chicago on December 2, 2023. The poster was authored by clinical investigators Hiren Mehta, Abhishek Biswas, Sarah Wang, Jason Akulian, Christine Argento, et.al. It was one of only about 10% of posters selected for discussion during the poster discussion session. Summarizing presented data:

The early phase lung cancer trial demonstrated safety and tolerability of intratumoral (IT) LSAM-PTX in combination with various concurrent therapies including systemic immunotherapy.
Disease Control Rate for evaluable subjects at 3- and 6-months was 80% (8/10) and 86% (6/7), respectively.
Flow cytometry and safety data suggest IT LSAM-PTX may cause immunomodulation, including increases in immune effectors cells and decreases in Tregs and immune suppressor cells, and complement systemic therapy without significantly increasing adverse events.
A poster entitled Local administration of large surface area microparticle docetaxel is associated with antitumor immunomodulation across multiple tumor types was presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 4, 2023. The poster was authored by Holly Maulhardt, Alyson Marin, et.al. Summarizing presented data:

Immunophenotyping in 3 diverse tumor settings found commonalities in antitumor immunomodulation following local LSAM-DTX including changes in T cells and MDSCs.
NMIBC clinical subjects demonstrated infiltrations of CD4+T, CD8+ T, and NK cells.
Mice administered IT LSAM-DTX into renal tumor xenografts had increased circulating T cells and reduced M2-macrophage levels in the blood and spleen when compared to IV docetaxel.
IT LSAM-DTX in a metastatic breast cancer model increased T cells in the TME and reduced thoracic metastasis when combined with systemic immunotherapy.
Preclinical/clinical antitumor immunomodulation suggests that IT LSAM-DTX may be amenable to combination with immunotherapy.

On December 19, 2023 MBrace Therapeutics, Inc. ("MBrace"), a clinical-stage biopharmaceutical company devoted to improving the lives of patients with cancer by developing novel antibody-drug conjugates (ADCs), reported the successful initiation of patient dosing in its Phase 1/1b study evaluating MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment (Press release, MBrace Therapeutics, DEC 19, 2023, View Source [SID1234638682]).

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This first-in-human Phase 1/1b clinical trial (NCT06014658) is a multicenter, open-label, dose-escalation and dose-expansion study of MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. The primary objectives of the study are to determine the following parameters for MBRC-101: potential optimal biologically relevant doses (OBRD), maximum tolerated dose (MTD), safety profile, and anti-tumor activity.

"Developed using our proprietary SPARTA platform, MBRC-101 is our first drug candidate and has the potential to treat a variety of very commonly occurring cancers," said Isan Chen, M.D., president and chief executive officer at MBrace. "SPARTA is a robust antibody and target discovery platform which, by overcoming several limitations of previous approaches, accelerates translation into clinical applications. The dosing of the first four patients in our first clinical trial marks an important milestone as MBrace works to deliver new and effective ADCs to patients facing difficult-to-treat cancers."

MBRC-101 is a novel, targeted ADC in development for the treatment of several cancers. In preclinical studies, it has demonstrated robust anti-tumor activity in several patient models of non-small cell lung cancer (NSCLC), breast cancer and squamous cell carcinoma of the head and neck. MBRC-101 targets the EphA5 receptor tyrosine kinase, which is present in multiple cancers (including, but not limited to, NSCLC, breast, colorectal, gastric, pancreatic and hepatocellular) but is not observed in corresponding normal, non-malignant tissues.

"Despite the availability of newer cancer therapies, many patients with advanced cancer develop tumors that become non-responsive to these treatments," said Shiraj Sen, M.D., Ph.D., director of clinical research at NEXT Oncology-Dallas and an investigator in the Phase 1/1b study of MBRC-101. "We need novel efficacious therapies, including new ADCs, to benefit patients with advanced cancer resistant to prior treatments. I believe that MBRC-101 has the potential to bridge these current treatment gaps for patients with solid tumor cancers and look forward to our involvement in this clinical trial."

"At MBrace, as we move into this next exciting phase of clinical development, we remain dedicated to improving outcomes for patients who are living with difficult-to-treat cancers," said Wadih Arap, M.D., Ph.D., director of Rutgers Cancer Institute of New Jersey at University Hospital and chief of hematology/oncology, and founder and scientific advisor at MBrace. "MBRC-101 is a proof point of our emerging pipeline and broader vision."

On December 19, 2023 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, and EVERSANA, a leading provider of commercialization services to the life science industry, reported the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults (Press release, EVERSANA, DEC 19, 2023, View Source [SID1234638680]). JYLAMVO has been shown to have a sweet, palatable taste1,2*and is approved to treat adults with acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen; mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen; relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen; rheumatoid arthritis; and severe psoriasis.

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"We are delighted to introduce JYLAMVO as an alternative treatment option for patients who may have difficulty swallowing pills," said Sharon Cunningham, Chief Executive Officer of Shorla Oncology. "This is our second product launch in the U.S. Market in 2023, and today’s announcement is another significant advancement in our pipeline and our mission to bring new therapeutic options to patients in need."

JYLAMVO received FDA approval in November 2022 and was acquired by Shorla Oncology in October 2023. JYLAMVO is the first and only oral methotrexate solution approved in the United States for use in adults, it has shown to have a sweet, palatable taste*, is stable at room temperature (68°F to 77°F) for 90 days and does not require refrigeration.

EVERSANA, the commercialization partner to Shorla, will provide comprehensive launch support including field deployment sales and training solutions, medical information, pharmacovigilance and quality services, revenue management, agency solutions, patient services, data and analytics, third-party logistics channel and trade relations support.

"We have immediately activated our full commercialization engine, combined with in-depth knowledge of the complex methotrexate market, to help patients who have waited far too long for other treatment options that can help meet their needs," said Jim Lang, CEO, EVERSANA. "Today’s announcement showcases the partnership we have built with the Shorla team, and we look forward to continuing to support their growing portfolio of therapies for patients in need."

Founded in Ireland, Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With strong support from scientists and clinicians, the company has an advanced pipeline of oncology therapies to treat a number of unmet patient needs.

About JYLAMVO

JYLAMVO is a folate analog metabolic inhibitor indicated for the:

Treatment of adults with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen.
Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen.
Treatment of adults with rheumatoid arthritis.
Treatment of adults with severe psoriasis.
For important safety information and full prescribing information, including boxed warning, please visit:

View Source Safety Information.pdf
View Source

On December 19, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported a private placement (the "Private Placement") financing to raise gross proceeds of approximately $5.3 million (Press release, Evaxion Biotech, DEC 19, 2023, View Source [SID1234638679]). The Private Placement includes participation from existing and new shareholders, with the largest new shareholder being MSD Global Health Innovation Fund (MSD GHI), a corporate venture capital arm of Merck & Co., Inc., Rahway, NJ, USA, accounting for some 25% of the total offering amount. Further, the Private Placement includes significant participation by all members of the Company’s management and the Company’s board of directors.

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Christian Kanstrup, CEO of Evaxion Biotech, says, "This Private Placement is an important step in our long-term financing strategy, and I am very pleased to see the mix of existing as well as new shareholders joining us. Further, I am excited to welcome MSD GHI as a shareholder of the Company. We believe that the broad participation in our Private Placement clearly shows the belief in our refined strategy with a strong focus on value realization."

Pursuant to the Private Placement, the Company has entered into definitive agreements for the issuance and sale of 9,726,898 of the Company’s ordinary shares, DKK 1 nominal value ("Ordinary Shares"), represented by American Depositary Shares ("ADSs"), and accompanying warrants (the "Warrants") to purchase up to 9,726,898 Ordinary Shares represented by ADSs at a purchase price of $0.544 per Ordinary Share for an aggregate purchase price of approximately $5.3 million. The Warrants are exercisable immediately upon issuance, have a term of three years, and an exercise price equal to $0.707 per Ordinary Share. Each Ordinary Share is represented by one (1) ADS.

The Private Placement is expected to close on or about December 21, 2023, subject to the satisfaction of customary closing conditions. No brokerage, finder’s fees, or commissions were payable by the Company in connection with the Private Placement.

The gross proceeds from the Private Placement are expected to be approximately $5.3 million before deducting offering expenses payable by the Company. The Company intends to use the proceeds from the Private Placement for working capital and general corporate purposes.

The securities described above were offered to institutional accredited investors, qualified institutional buyers, and other accredited investors in a Private Placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and/or Rule 506(b) of Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC for the resale of Ordinary Shares represented by ADSs and the Ordinary Shares represented by ADSs underlying Warrants issued in the Private Placement. All members of the Company’s management and board of directors have agreed to a lock-up period of 180 days from the effective date of such registration statement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On December 19, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported an agreement with Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, headquartered in Holon, Israel, to exclusively license its potential first-in-class, pre- clinical antibody program against IL-18 binding protein, including the COM503 drug candidate (Press release, Compugen, DEC 19, 2023, View Source [SID1234638678]).

Compugen utilizes its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing novel cancer immunotherapies. COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby releasing natural IL-18 in the tumor microenvironment and inhibiting cancer growth.

"We are very pleased to add COM503 to our pipeline of investigational immuno-oncology therapies that have the potential to transform care for patients with cancer," said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. "We believe that this collaboration complements our strategy of developing modalities which promote immune-mediated tumor killing and may enable new combination therapies with programs in our growing oncology portfolio."

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"We are delighted to enter into this collaboration with Gilead and believe that Gilead’s confidence in our differentiated approach to harness cytokine biology for cancer therapeutics speaks to the quality of our computational discovery capabilities as well as our ability to translate our novel discoveries into investigational drugs in the clinic and we look forward to working together to bring new treatment options to patients," said Anat Cohen-Dayag, Ph.D., President, and CEO at Compugen. "IL-18 is one of the rare cytokines which is naturally inhibited by an endogenous binding protein, presenting a unique opportunity to use a blocking antibody to increase the local concentrations of IL-18 within the tumor where it can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered
cytokines."

Terms of the Partnership

Under the terms of the agreement, Compugen will be responsible for the ongoing pre-clinical development and the future Phase 1 study of COM503. Thereafter, Gilead will have the sole right to develop and commercialize COM503.

Gilead will make Compugen an upfront payment of $60 million and $30 million in a near term milestone payment subject to IND clearance of COM503 expected in 2024. Compugen will also be eligible to receive up to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of $848 million. Compugen will also be eligible to receive single-digit to low double-digit tiered royalties on worldwide net sales.

Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Compugen is expected to reduce Gilead’s GAAP and non-GAAP 2023 EPS by approximately $0.03 – $0.05.