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Immunocore announces first patient dosed in the Phase 1 trial of IMC-P115C, a half-life extended (HLE) ImmTAC candidate in patients with tumors that express PRAME

On December 23, 2024 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported that the first patient has been dosed in the Phase 1 trial of IMC-P115C (PRAME-HLE-A02), which is a half-life extended ImmTAC candidate (Press release, Immunocore, DEC 23, 2024, View Source [SID1234649262]).

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IMC-P115C was developed to improve patient convenience by reducing the frequency of treatment administration. It is Immunocore’s first half-life extended candidate, and sixth ImmTAC candidate to enter the clinic. IMC-P115C is a PRAME x CD3 ImmTAC bispecific protein, with the same CD3 and targeting the same HLA-A*02:01 PRAME (PReferentially expressed Antigen in MElanoma) peptide as brenetafusp.

"I am very proud of the Immunocore team who have worked diligently with the clinical sites to start the Phase 1 trial with IMC-P115C – our half-life extended PRAME-targeted candidate," said Mohammed Dar, Senior Vice President, Clinical Development and Chief Medical Officer of Immunocore. "With brenetafusp, we have the largest Phase 1/2 PRAME data set, which served as the basis for starting the first Phase 3 trial with a PRAME therapy. We look forward to the data from this Phase 1 trial, which will add to the understanding of the potential of our PRAME candidates."

The Phase 1 dose escalation trial will evaluate the safety, pharmacokinetics and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with a range of advanced cancers expressing PRAME.

About ImmTAC molecules for cancer

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumors.

About the IMC-P115C Phase 1 trial

IMC-P115C-1005 is a first-in-human, Phase 1 trial in patients with advanced solid tumors expressing PRAME. The dose escalation portion of the trial is designed to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-P115C, a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first half-life extended molecule.

Ikena Oncology and Inmagene Biopharmaceuticals Announce Agreement for Merger and Private Placement

On December 23, 2024 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena,") and Inmagene Biopharmaceuticals ("Inmagene") reported they have entered into a definitive merger agreement. In connection with the merger, Ikena has entered into subscription agreements for a $75 million private placement (the "Financing") with a syndicate that includes new investors such as Deep Track Capital, Foresite Capital, RTW Investments and existing Ikena investors, such as BVF Partners L.P., Blue Owl Healthcare Opportunities, Omega Funds, and OrbiMed (Press release, Ikena Oncology, DEC 23, 2024, View Source [SID1234649261]). The combined company will focus on the development of IMG-007, a monoclonal antibody (mAb) targeting OX40, for the treatment of atopic dermatitis. The combined company plans to operate under the name "ImageneBio, Inc." ("ImageneBio") and trade on NASDAQ under the ticker "IMA".

"In our search for the right partner for Ikena, Inmagene’s IMG-007 differentiated clinical data in atopic dermatitis and potential as a pipeline in a product across the I&I space was a compelling fit," commented Mark Manfredi, PhD, Chief Executive Officer of Ikena. "We believe IMG-007 has the potential to be extremely impactful for patients with inflammatory diseases , while also building value for our shareholders."

OX40 is a costimulatory receptor that presents primarily on activated T cells. Anti-OX40 mAbs have demonstrated efficacy in placebo-controlled studies in atopic dermatitis. IMG-007 is a mAb targeting OX40 with potential utility in a wide range of inflammatory indications, including atopic dermatitis, asthma, hidradenitis suppurativa, systemic sclerosis and others. IMG-007 has a longer half-life compared to other OX40-targeting mAbs in Phase 2 and later development, enabling its potential for dose and schedule optimization. In addition, IMG-007 has silenced antibody dependent cellular cytotoxicity (ADCC) function, and is non-T cell depleting, leading to a potentially improved tolerability profile relative to other mAbs in the class. IMG-007’s Phase 2b clinical trial in atopic dermatitis is expected to begin in early 2025.

"We are pleased to work with the Ikena team and multiple worldclass healthcare investors on this reverse merger and PIPE transaction. This is an important step for us to gain powerful resources to maximize the opportunities for IMG-007, a highly differentiated drug candidate with best-in-class potential," commented Jonathan Wang, PhD, founder, Chairman and Chief Executive Officer of Inmagene. "We are well-positioned to advance IMG-007 development and look forward to executing our development plan in atopic dermatitis and potentially additional indications."

About the Proposed Transaction and Combined Company Management

Following the closing of the merger and the Financing, Ikena stockholders are expected to own approximately 34.8% of the combined company. Inmagene equity holders are expected to own approximately 43.5%, and the Financing investors are expected to own approximately 21.7%.

The board of directors of the combined company will be comprised of three directors from the current Inmagene board, two directors from the current Ikena board, a board member representing the investors in the Financing, and a new independent board member. Inmagene and Ikena will mutually decide on future leadership of ImageneBio and a formal search for the chief executive officer of the combined company has been initiated.

The shareholders of the two companies will obtain contingent value rights (CVRs). The Inmagene shareholders will receive CVRs for Inmagene’s non-IMG-007 assets, and the Ikena shareholders will receive CVRs for Ikena’s legacy pipeline assets.

The transaction has been approved by the board of directors of both companies and is expected to close in mid-2025, subject to customary closing conditions, including approval by the shareholders of each company.

In connection with the reverse merger, directors and officers of both companies, certain shareholders of Inmagene and certain shareholders of Ikena have executed support agreements, pursuant to the terms of which they have agreed to vote all of their shares of capital stock in favor of the merger or the issuance of Ikena shares in the merger, as applicable.

FibroBiologics Announces $25 Million Financing

On December 23, 2024 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported that it has entered into a Standby Equity Purchase Agreement (the "SEPA") with YA II PN LTD (Press release, FibroBiologics, DEC 23, 2024, View Source [SID1234649260]). ("Yorkville"), an investment fund managed by Yorkville Advisors Global, LP. The agreement allows FibroBiologics, subject to customary conditions, to sell up to $25 million in the aggregate of its common stock to Yorkville over the course of two years.

Yorkville agreed to advance to FibroBiologics the first $15 million available under the SEPA in three equal tranches to be evidenced by convertible promissory notes. The first tranche in the amount of $5 million was funded upon entry into the SEPA. Subject to the satisfaction of certain conditions, the second tranche of $5 million will fund after the filing of a registration statement covering the resale of the shares issuable to Yorkville under the promissory notes, and the third tranche of $5 million will fund following the effectiveness of the registration statement and receipt of shareholder approval in satisfaction of Nasdaq rules. FibroBiologics can sell an additional $10 million of its common stock to Yorkville, subject to Yorkville’s consent and other conditions, while the convertible promissory notes remain outstanding.

"The initial advances from this financing will allow us to complete our first-in-human trial for diabetic foot ulcers as well as IND-enabling studies for our psoriasis program," said Pete O’Heeron, Founder & Chief Executive Officer of FibroBiologics. "We expect to further develop our human longevity, multiple sclerosis, and cancer indications by utilizing the remaining capital available under the SEPA."

For more information, please visit FibroBiologics’ website or email FibroBiologics at: [email protected]. For more information on the SEPA, including important terms and conditions, please see FibroBiologics’ filings with the Securities and Exchange Commission, including its Current Reports on Form 8-K filed with the Securities and Exchange Commission from time to time.

This communication shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of the securities discussed herein, in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite Instability–High or Mismatch Repair Deficient Metastatic Colorectal Cancer

On December 23, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC) (Press release, Bristol-Myers Squibb, DEC 23, 2024, View Source [SID1234649259]).

"Colorectal cancer is the second leading cause of cancer death in Europe and patients are in need of new treatment options that delay disease progression. Approximately 5-7% of metastatic colorectal cancer patients have MSI-H/dMMR tumors and these patients are less likely to benefit from conventional chemotherapy and typically have poor prognosis outcomes," said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. "The EC’s decision to approve Opdivo plus Yervoy represents a significant milestone for this patient population in the European Union and underscores our commitment to advancing treatment options."

The decision is based on results from the CheckMate -8HW trial, which were presented at medical congresses earlier this year. These data formed the basis for the Company’s application to the European Medicines Agency (EMA). In the study, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival (PFS) and reduced the risk of disease progression or death by 79% compared to the investigator’s choice of chemotherapy as assessed by Blinded Independent Central Review (BICR). The safety profile for the dual immunotherapy combination remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.

This approval by the EC for Opdivo plus Yervoy for the first-line treatment of adult patients with MSI-H or dMMR unresectable or mCRC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. In addition to approval in colorectal cancer, Opdivo- based options are also approved for treatment of multiple tumor types in the EU.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

CheckMate -8HW and Select Efficacy and Safety Results

With a median follow-up of approximately 31.5 months, CheckMate -8HW trial results showed:

PFS (progression-free survival; a dual primary endpoint): Opdivo plus Yervoy reduced the risk of disease progression or death by 79%. Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8). Consistent PFS benefit was observed across all pre-specified subgroups, including patients with KRAS or NRAS mutations, and those with baseline liver, lung, or peritoneal metastases.
Safety: The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Grade 3/4 treatment-related adverse events (TRAEs) occurred in 23% of patients in the Opdivo plus Yervoy arm and 48% of patients in the chemotherapy arm. Any grade TRAE-related discontinuation was 17% in the Opdivo plus Yervoy arm and 32% in the chemotherapy arm.
About CheckMate -8HW

CheckMate -8HW (NCT04008030) is a Phase 3 randomized, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or the investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).

839 patients were randomized to receive either Opdivo monotherapy ( Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W ), or investigator’s choice of chemotherapy. The dual primary endpoints of the trial are progression-free survival (PFS) per blinded independent central review (BICR) for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in the first-line setting and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy. Further data disclosure is planned at The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place January 23, 2025, through January 25, 2025. The trial also evaluates several secondary safety and efficacy endpoints, including overall survival, which is ongoing.

About dMMR or MSI-H Colorectal Cancer

Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined.

Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors. These patients are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.

BeiGene to Change Nasdaq Ticker Symbol to “ONC” on January 2; Present at 43rd Annual J.P. Morgan Healthcare Conference

On December 23, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., reported it will change its Nasdaq ticker symbol to "ONC" on January 2, 2025, reflecting its long-standing commitment to delivering innovative oncology medicines globally (Press release, BeiGene, DEC 23, 2024, View Source [SID1234649257]).

"As we enter our 15th year, changing our ticker to ONC reflects our unwavering commitment to leadership in oncology and mission to deliver transformative medicines to cancer patients worldwide," said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. "This milestone inspires pride in all we have accomplished and fuels our excitement for the future as we advance our innovative hematology franchise and solid tumor pipeline, driving meaningful impact for patients everywhere."

The Company’s CUSIP number will remain unchanged. In addition, the Company stock codes and stock names for The Stock Exchange of Hong Kong and the STAR Market of the Shanghai Stock Exchange will not change. No action by the Company’s shareholders is required to implement the Nasdaq ticker symbol change.

The Company will participate in the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, with a presentation at 1:30 pm PT. The live webcast of the event can be accessed from the Investors section of the Company’s website at View Source, View Source, View Source An archived replay will be available for 30 days following the event.