On January 4, 2024 IN8bio, Inc. (NASDAQ: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported recent business updates and provided pipeline goals for 2024 (Press release, In8bio, JAN 4, 2024, https://investors.in8bio.com/news-releases/news-release-details/in8bio-highlights-recent-company-accomplishments-and-outlines [SID1234638973]).

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"2023 was a year marked by strong execution for IN8bio. We delivered on several clinical milestones, reporting positive data updates across our pipeline of innovative gamma-delta T cell therapies at many prestigious medical meetings, and secured the financing to extend our runway into 2025," said William Ho, CEO and co-founder of IN8bio. "We continue to be excited by the data from the Phase 1 trial of INB-100, which showed that all evaluable patients remained in durable complete remission, with six patients remaining relapse free beyond one year. Importantly, we are excited that we are seeing in vivo expansion and persistence of allogeneic gamma-delta T cells, now out to 365 days. This persistence clearly differentiates our results from the data presented on other allogeneic cellular therapies to date and we believe this data underscores the far-reaching potential of gamma-delta T cells to help provide durable relapse-free periods in patients with hematologic malignancies undergoing haploidentical stem cell transplantation. We believe we are well positioned to execute on our clinical programs and are poised for many exciting updates in 2024."

Recent Company Updates

Announced positive clinical update demonstrating continued durable complete remissions in 100% of evaluable patients (n=10) in the Phase 1 trial of INB-100 in leukemia patients undergoing haploidentical stem cell transplantation. The data was presented at the ASH (Free ASH Whitepaper) Annual Meeting in December.
Presented data demonstrating INB-200’s extended progression-free survival in glioblastoma multiforme (GBM) patients and potential for INB-400 to treat GBM at the SNO Annual Meeting.
Initiated enrollment for the Phase 2 trial of INB-400 in GBM (NCT05664243).
Announced a private placement totaling up to $46.9 million in gross proceeds. The initial closing of $14.4 million is expected to support operational execution and extended the Company’s cash runway into 2025 with the potential for up to $32.5 million in additional capital at increasing valuations.
Appointed internationally recognized immuno-oncology expert Dr. Corinne Epperly, M.D., M.P.H., to IN8bio’s Board of Directors.
Anticipated 2024 Pipeline Goals

INB-100: Enroll an additional 10 patients in an expansion cohort at the recommended Phase 2 dose (RP2D) and report Phase 1 long-term follow-up results at multiple medical meetings throughout 2024; potentially submit IND for Phase 3 randomized control trial in 2024.
INB-200: Report Phase 1 long-term follow up results at multiple medical meetings in 2024.
INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024.
INB-400: Dose first patient and treat up to 15 patients at multiple sites across the United States in the Phase 2 trial in newly diagnosed GBM; potentially submit IND for allogeneic Phase 1b in relapsed GBM in 2024.

On January 4, 2024 OnCusp Therapeutics, Inc., a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, reported an oversubscribed $100 million Series A financing round (Press release, OnCusp Therapeutics, JAN 4, 2024, View Source [SID1234638990]).

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The round was co-led by Novo Holdings, OrbiMed, and F-Prime Capital, alongside Sofinnova Investments, Catalio Capital Management, Marshall Wace, Forge Life Science Partners, Blackbird BioVentures, CJNV BioVenture and others, as well as BioTrack Capital, a co-lead for the Seed Round. OnCusp Therapeutics has raised $139 million since its establishment in April 2021. The proceeds from this financing will be used to advance CUSP06, an ADC targeting CDH6, toward clinical proof-of-concept. Additionally, the capital will aid in expanding the OnCusp portfolio and team.

CUSP06 has strong preclinical data demonstrating the potential for best-in-class activity. Engineered to increase potency, heighten "bystander effect," elevate linker stability, and overcome drug resistance, CUSP06’s differentiating attributes could translate into higher clinical response rates and durability, with an improved safety profile. Having obtained FDA IND clearance in 3Q 2023, CUSP06 will be in a first-in-human Phase I study in the US.

"We are grateful to have the trust and support from some of the most prominent global biotech investors," said Dr. Bing Yuan, Co-Founder and CEO of OnCusp Therapeutics. "I am also thankful to the OnCusp team for their commitment and excellent work. We hold a strong conviction to develop innovative oncology therapies for patients. This significant Series A financing enables OnCusp to accelerate the development of CUSP06 and other game-changing therapeutics in our fight against cancer."

As part of the financing, OnCusp Therapeutics will appoint Dr. Karen Hong, Partner in the Venture Investments team at Novo Holdings US, Inc., a wholly owned subsidiary of Novo Holdings; Diyong Xu, Principal at OrbiMed; and Dr. Chong Xu, Partner at F-Prime Capital, to the company’s Board of Directors.

"We are thrilled to have co-led this round. The remarkable progress that the company has made in such a short time is a testament to its highly efficient business model and the team’s exceptional execution capabilities," said Dr. Karen Hong. "We share OnCusp’s mission in bringing oncology innovations to life and are committed to supporting the company’s continued growth and success."

"ADCs have become one of the most promising modalities for treating cancer, and CDH6 is emerging as a winning ADC target. We believe CUSP06 is well positioned to unlock the full potential of this target, both in high and low CDH6 expressing tumors," said Diyong Xu. "We also look forward to OnCusp expanding its portfolio to fully leverage its translational and clinical development expertise."

"I am excited to join the OnCusp Board at this transformative moment for the company," stated Dr. Chong Xu. "F-Prime is committed to proactively champion breakthrough approaches like CUSP06, which holds immense potential to help patients with ovarian cancer and other advanced solid tumors. I look forward to working with other board members and the executive team to propel OnCusp to its next phase of growth."

"As a major investor since the company’s inception, I am impressed by the entrepreneurship, commitment, and perseverance exemplified by the OnCusp team in the current challenging biotech market." added Dr. Jiacong Guo, one of OnCusp’s current Board Directors and a Principal at BioTrack Capital. "I believe companies who are leading their field will emerge triumphant in their mission. I am confident that OnCusp is one of those companies."

On January 3, 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 management will participate in a presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Immunocore, JAN 3, 2024, View Source [SID1234638911]).

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The presentation is scheduled for Wednesday, January 10, 2024, at 9:00 a.m. Pacific Standard Time (PST).

The presentation will be webcast live and can be accessed by visiting ‘Events’, under ‘News & Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentation will be made available for a limited time.

On January 3, 2024 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported the pricing of an underwritten registered offering of 15,790,000 shares of its common stock, par value $0.001 per share ("Common Stock"), offered at a price of $28.50 per share, before underwriting discounts (Press release, Arrowhead Pharmaceuticals, JAN 3, 2024, View Source [SID1234638927]). The offering is expected to close on or about January 5, 2024, subject to customary closing conditions. Gross offering proceeds will be approximately $450.0 million, before deducting underwriting discounts and commissions and estimated offering expenses.

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Jefferies, BofA Securities and TD Cowen are acting as bookrunning managers for the offering. Arrowhead intends to use the net proceeds from this offering for research and development, general corporate expenses and working capital needs.

A shelf registration statement on Form S-3 (File No. 333-268665) relating to the offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and became automatically effective upon filing on December 5, 2022. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; from BofA Securities, Inc. NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attn: Prospectus Department or by email at [email protected]; or from Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by telephone at (833) 297-2926 or by email at [email protected].

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 these 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 any such jurisdiction.

On January 3, 2024 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate at the 42nd Annual J.P. Morgan Healthcare Conference in a podium presentation on Wednesday, January 10 at 2:15 p.m. PT, followed by a question-and-answer breakout session at 2:35 p.m. PT (Press release, Karyopharm, JAN 3, 2024, View Source [SID1234638912]).

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A live webcast of the presentation, along with accompanying slides, can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay for 30 days following the event.