On December 23, 2024 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing novel therapies for patients with significant unmet needs in inflammatory diseases, reported that it has entered into a securities purchase agreement with a group of accredited investors for the private placement of (i) 100,000,000 shares of common stock at a purchase price of $0.85 per share and (ii) to certain investors, in lieu of shares of common stock, pre-funded warrants to purchase up to 76,452,000 shares of common stock at a price per pre-funded warrant of $0.8499, for gross proceeds of approximately $150.0 million (Press release, RAPT Therapeutics, DEC 23, 2024, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-150-million-private-placement [SID1234649264]). The private placement is expected to close on or about December 27, 2024, subject to the satisfaction of customary closing conditions. The pre-funded warrants will have an exercise price of $0.0001 per share of common stock, be immediately exercisable and remain exercisable until exercised in full.

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The private placement was led by The Column Group and TCGX, with participation by new and existing investors including BVF Partners LP, Deep Track Capital, Foresite Capital, Medicxi, OrbiMed, Perceptive Advisors, Redmile Group and RTW Investments.

Net proceeds from the private placement are expected to fund the research and development of the Company’s pipeline and for general corporate purposes.

The securities being issued and sold in the private placement, including the shares of common stock underlying the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock sold in the private placement and the shares of common stock underlying the pre-funded warrants sold in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

Leerink Partners is acting as sole placement agent in connection with the private placement.

On December 23, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported a recap of the major accomplishments from 2024 and a preview of the milestones that are expected over the next 12 months (Press release, Oncolytics Biotech, DEC 23, 2024, View Source [SID1234649263]). Following the promising BRACELET-1 readout, Oncolytics expects additional data readouts across our clinical development program in 2025, forming what it believes is a clear pathway to future commercialization opportunities.

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"This past year produced highly encouraging clinical developments that we believe set the stage for significant progress, headlined by the robust efficacy results from the BRACELET-1 breast cancer study," said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. "In addition, our gastrointestinal cancer program continues to impress, resulting in meaningful collaborations with well-respected experts in the field. Key opinion leaders in both breast and GI cancers continue to be excited by pelareorep’s potential as we move into 2025. Based on these insights from leading oncologists, we believe pelareorep has the potential to become a transformational immunotherapy – and that pelareorep-based combination therapies could accelerate our path toward regulatory approval. We are very optimistic about our plans for the next year, and we look forward to showcasing our latest clinical progress early in the new year at the ASCO (Free ASCO Whitepaper) GI Symposium – an event that could provide key catalysts for our ongoing gastrointestinal cancer programs. Unlike many immunotherapies that struggle to convert ‘cold’ tumors to ‘hot,’ pelareorep’s unique mechanism of action following intravenous delivery has shown the potential to significantly boost patients’ immune responses – making previously unresponsive tumors more susceptible to treatment. I would like to say thank you to our shareholders, clinical collaborators, study sites and their staff, the patients who participate in our trials, and the employees of Oncolytics who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey."

BRACELET-1’s highly promising results lay a foundation for what we anticipate could be a pivotal, registration-enabling study, further aligning with our long-term goal of improving patient treatment options in metastatic breast cancer

In September, we reported final efficacy results from BRACELET-1, a randomized controlled study that showed marked clinical benefit in patients who received pelareorep-based combination therapy, reinforcing our confidence in pelareorep’s ability to improve patient outcomes. These results included an estimated median overall survival benefit that exceeded one year and a two-year overall survival rate that was nearly double paclitaxel monotherapy (link to press release). Of note, the cohorts were well-balanced across key characteristics, including age, stage of disease, and prior lines of therapy, and pelareorep + paclitaxel demonstrated a favorable overall safety profile. BRACELET-1 also substantiates the results of our earlier IND-213 study, in which median overall survival in HR+/HER2- metastatic breast cancer patients was nearly doubled in patients treated with pelareorep + paclitaxel. Importantly, we also had a productive meeting with the FDA to present our breast cancer data and to align on key elements of our breast cancer program (link to the press release). This includes the use of progression-free survival as the primary endpoint in the planned registration-enabling study, which we believe will allow us to reach the final analysis within two years of the start of enrollment. If results from this registration-enabling study are similar to those observed in BRACELET-1, we believe they will provide a compelling basis for an accelerated approval application that could ultimately lead to making pelareorep available to approximately 55,000 patients in the US1-4 in need of better treatment options. We look forward to beginning enrollment into this study as soon as possible and providing more details as they become available.

Collaboration with GCAR on pancreatic cancer study

Our compelling data set in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) has provided us with opportunities to potentially help thousands of patients in this difficult-to-treat disease. We are excited to be working with the Global Coalition for Adaptive Research (GCAR) on a registration-enabling study for pelareorep in metastatic PDAC (link to press release). After more than doubling the objective response rate compared to historical control trials in cohort 1 of the GOBLET study, multiple key opinion leaders suggested we move the combination of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab directly into a study that could support regulatory approval. GCAR has a proven history of designing studies that could accelerate the registrational study timeline and provide substantial cost savings compared to traditional phase 3 trials. We continue to work together to finalize the master protocol and expect to engage with the FDA on our plans in the first half of 2025. Having already collaborated with Roche on GOBLET, we are excited Roche will participate in this registration-enabling study as well.

Progress on the PanCAN-supported pancreatic cancer cohort of GOBLET

Another exciting collaboration stemming from our pancreatic cancer data is with The Pancreatic Cancer Action Network (PanCAN). PanCAN provided the funding for a new GOBLET study cohort evaluating pelareorep + modified FOLFIRINOX (mFOLFIRINOX), with and without atezolizumab, in metastatic pancreatic cancer patients. We dosed the first patient in this cohort in June, completed safety run-in enrollment in Q4 of this year, and received favorable safety feedback from the Data Safety Monitoring Board (DSMB) earlier this month. This cohort represents an important opportunity to evaluate novel treatment options for this very difficult-to-manage disease and may form the basis for an additional pelareorep registrational path. As previously announced, we will be presenting data from this cohort at the ASCO (Free ASCO Whitepaper) GI Symposium in January 2025 (link to the press release).

Enrollment expansion in anal cancer provides another possible registrational study opportunity

Earlier this year, we expanded enrollment into cohort 4 of the GOBLET study, which is evaluating pelareorep and atezolizumab in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) (link to press release). We previously reported objective response rate data that roughly tripled historical control data and believe 18 patients of additional data could be sufficient to move to a registration-enabling study. While this is an uncommon cancer, the opportunity to improve treatment options would be profoundly impactful for patients and would serve as validation of pelareorep’s potential, including its ability to synergize checkpoint inhibitors like atezolizumab. Additional efficacy data from this cohort will be reported at ASCO (Free ASCO Whitepaper) GI in January 2025.

Presentation at Biotech Showcase and hosting investor meetings during the 2025 J.P. Morgan Healthcare Conference

Finally, Oncolytics Biotech will be presenting at the Biotech Showcase at the Hilton San Francisco Union Square on January 13, 2025, at 2:30 p.m. PST, and the Executive Team will be meeting investors in addition to current and potential partners during the week of the J.P. Morgan Healthcare Conference (January 13-15, 2025).

Anticipated upcoming milestones

●H1 2025: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line PDAC with the GCAR and submit it to the FDA
●H1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer
●H1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer
●H2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed PDAC
●H2 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer

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.

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".

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"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.

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.

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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.