On December 5, 2023 Odyssey Therapeutics, Inc., a biotechnology company pioneering next-generation precision immunomodulators and oncology medicines, reported the closing of a $101 million Series C financing round led by Ascenta Capital with participation from new and existing investors, including OrbiMed, SR One, General Catalyst, Foresite Capital, Woodline Partners LP, HBM Healthcare Investments, Colt Ventures, BlackMars Capital GmbH, Creacion Ventures, funds and accounts advised by Fidelity Management & Research Company, funds and accounts advised by T. Rowe Price Associates, Inc., Catalio Capital Management, Walleye Capital, Alexandria Venture Investments, Racing Beach Ventures LLC, The Healthcare Innovation Investment Fund LLC, an investment fund associated with Leerink Partners, Ab Magnitude Ventures, KB Investment, The Global BioAccess Fund, and multiple leading global investors (Press release, Odyssey Therapeutics, DEC 5, 2023, View Source [SID1234638159]). This Series C financing brings the total capital raised since founding in late 2021 to $487 million. Proceeds will support the advancement of multiple programs into clinical studies and the continuation of investment in discovery to build a sustainable model for therapeutic innovation.

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"Odyssey has rapidly advanced a portfolio of immunology and oncology therapeutics with the goal of providing transformative medicines for large numbers of patients in need and several of these molecules have the potential to enter the clinic in the next 12 months," said Gary D. Glick, Ph.D., founder and CEO of Odyssey. "For us, success is defined as bringing safe and effective medicines to patients with serious diseases, with support from Ascenta and our other investors driving our pipeline into the future. We welcome Dr. Lorence Kim, co-founder and managing partner of Ascenta Capital, to our board to join us in achieving this mission."

Dr. Kim brings a wealth of strategic, financial and operational acumen from the biotechnology and pharmaceutical sectors to Odyssey’s board. Notably, during his tenure from 2014 to 2020 as Moderna’s chief financial officer, he raised $4.4 billion to build the company’s technology platform, advance multiple clinical programs and invest in mRNA infrastructure. Prior to Moderna, Dr. Kim advised established pharmaceutical and emerging biotech companies as co-head of biotechnology investment banking at Goldman Sachs.

"Odyssey’s accomplished team of scientists and executives with numerous prior successes in discovery, development and commercialization has made tremendous progress in only two years," said Lorence Kim, M.D. "Dr. Glick has successfully created a sustainable and capital-efficient model that primes Odyssey to be a hub for immunology and oncology therapeutic innovation, and I look forward to working with him, the board and leaders on the management team in the years ahead."

From its headquarters in Boston, Odyssey has built a comprehensive drug discovery and development platform merging both computational and experimental technologies. This unique set of tools enables Odyssey to identify drug targets with the highest clinical potential in a modality-agnostic fashion. In just two years, the company has moved multiple programs forward from ideation to a portfolio of high-value product candidates.

"Odyssey continues to accelerate multiple pre-clinical programs in immunology and oncology," said Jeff Leiden, M.D., Ph.D., Chairman of the Odyssey board. "By raising additional capital from world-class investors and adding a board member with expertise in drug development and company building, we are positioning Odyssey for success over the next several years as our pipeline enters clinical development."

On December 5, 2023 IN8bio, Inc., a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported the Company will host a conference call on Tuesday, December 12, 2023 at 8:30 am ET (Press release, In8bio, DEC 5, 2023, View Source [SID1234638157]). The event will highlight data presented at the ASH (Free ASH Whitepaper) 65th Annual Meeting in a poster presentation on December 11, 2023 starting at 6:00 pm PT. The Company’s INB-100 trial is focused on investigating the potential of harnessing donor-derived allogeneic gamma-delta T cells for the treatment of patients with hematological malignancies following hematopoietic bone marrow transplantation (HSCT).

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Speakers on the call will include IN8bio’s management team, as well as key oncology thought leader Michael Bishop, MD, Director of the David and Etta Jones Center for Cellular Therapy at the University of Chicago, who will be highlighting gamma-delta T cells as a clinical strategy to prevent relapse of patients with hematological malignancies. Dr. Bishop is a prominent clinical investigator of acute leukemias, with a focus on improving transplant outcomes and preventing relapse. He is a faculty member and a member of the planning committee for the ASTCT/EBMT Conference on Relapse After Transplant and Cellular Therapy. Dr. Bishop previously served as a senior investigator and as the clinical head of stem cell transplantation for the National Cancer Institute (NCI) at the National Institutes of Health.

Conference Call Details
IN8bio will host a conference call and webcast on Tuesday, December 12, 2023, at 8:30 am ET to review the updated data from the poster presentation at ASH (Free ASH Whitepaper). The webcast can be accessed here and will also be available under the "Events and Presentations" section of the Company’s website at View Source An archived webcast will be available on the Company’s website following the event.

About the INB-100 Phase 1 Trial
The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with hematologic malignancies following HSCT. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.

On December 5, 2023 ImmunoGen, a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the US Food and Drug Administration (FDA) has filed the supplemental Biologics License Application (sBLA) supporting the conversion of the accelerated approval of ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens to full approval (Press release, ImmunoGen, DEC 5, 2023, View Source [SID1234638156]). The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.

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"With the FDA’s filing of our sBLA, we are one step closer to securing full approval of ELAHERE in the US and establishing this novel ADC as the standard of care in FRα-positive platinum-resistant ovarian cancer," said Michael Vasconcelles, MD, ImmunoGen’s Executive Vice President, Research, Development, and Medical Affairs. "This regulatory milestone, achieved just over one year after ELAHERE’s accelerated approval, underscores the significance of the confirmatory MIRASOL data and the broader data set seen to date with ELAHERE, as well as the urgency with which our teams worked to bring this potentially practice-changing therapy to eligible patients in need. We look forward to collaborating closely with the FDA throughout the review process."

The confirmatory Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer forms the basis of the sBLA. Top-line data from the MIRASOL trial were disclosed in May 2023 and presented as a late-breaking abstract at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In the MIRASOL trial, ELAHERE demonstrated statistically significant and clinically meaningful improvements in progression-free survival, objective response rate, and overall survival compared to investigator’s choice (IC) of single-agent chemotherapy. ELAHERE demonstrated a tolerable safety profile compared to IC chemotherapy, consisting predominantly of low-grade ocular and gastrointestinal events.

ELAHERE was granted accelerated approval by the FDA in November 2022 based on data from the pivotal SORAYA trial. A Marketing Authorization Application for ELAHERE in Europe has been accepted by the European Medicines Agency and a New Drug Application in China has been accepted by the National Medical Products Administration of China.

ABOUT OVARIAN CANCER

Ovarian cancer is the leading cause of death from gynecological cancers in the US. Each year, roughly 20,000 patients are diagnosed, and 13,000 patients will die. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response, and significant toxicities.

On December 5, 2023 iBio, Inc., reported the pricing of its reasonable best efforts public offering of 2,250,000 of its shares of common stock (or common stock equivalents in lieu thereof) and accompanying Series C and Series D warrants to purchase up to an aggregate of 2,250,000 shares of common stock at a combined public offering price of $2.00, resulting in gross proceeds of approximately $4.5 million (Press release, iBioPharma, DEC 5, 2023, View Source [SID1234638155]). The Series C Warrants to purchase up to an aggregate of 2,250,000 shares of common stock and Series D Warrants to purchase up to an aggregate of 2,250,000 shares of common stock will have an exercise price of $2.00 per share, will be exercisable immediately following the date of issuance and will expire two years and five years from the original issuance date, respectively.

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The closing of the offering is expected to occur on or about December 7, 2023, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering primarily for working capital and general corporate purposes, including for research and development and other trial preparation expenses and, retention and severance payments to certain of its employees or former employees. The Company may also use a portion of the net proceeds to invest in or acquire other products, businesses or technologies, although it has no commitments or agreements with respect to any such investments or acquisitions as of the date of this press release.

A.G.P./Alliance Global Partners is acting as the lead placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-placement agent for the offering.

A registration statement on Form S-1, as amended (No. 333-275204) ("Form S-1"), relating to the offering was filed with the Securities and Exchange Commission ("SEC"), and it was declared effective on December 4, 2023. The offering is being made only by means of a prospectus forming part of the effective registration statement. Copies of the preliminary prospectus and, when available, copies of the final prospectus, relating to the offering may be obtained on the SEC’s website located at View Source Electronic copies of the final prospectus relating to the offering may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, 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 state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 5, 2023 G1 Therapeutics, Inc., a commercial-stage oncology company, reported the presentation of new data describing the long-term positive survival impact of previous treatment with trilaciclib and cytotoxic chemotherapy (gemcitabine/carboplatin; GCb) in patients with metastatic triple negative breast cancer (mTNBC) who participated in G1’s Phase 2 trial (NCT02978716) (Press release, G1 Therapeutics, DEC 5, 2023, View Source [SID1234638154]). The poster is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th to 9th in San Antonio, TX, and is available on the G1 Therapeutics website here.

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The poster entitled, "Patients with Metastatic Triple-Negative Breast Cancer Who Receive Trilaciclib Prior to Cytotoxic Chemotherapy Exhibit Improved Survival After Receiving Subsequent Anticancer Therapy" describes a post hoc analysis of data from G1 Therapeutics’ randomized Phase 2 mTNBC trial (NCT02978716; completed February 2020) indicating that patients with mTNBC who received trilaciclib with their cytotoxic chemotherapy during the trial and then received subsequent anticancer therapy (SACT) after trilaciclib discontinuation exhibit statistically significant and clinically meaningful improvements in median overall survival (OS) (32.7 months versus 12.8 months; p=0.001) and in median OS from start of first SACT (14.0 months versus 5.8 months; p=0.001) compared to those who received cytotoxic chemotherapy without trilaciclib and then received SACT. Administering trilaciclib with cytotoxic chemotherapy also led to improved survival in patients unable to receive SACT.

"These new analyses indicate that trilaciclib can protect the bone marrow and immune system against the harmful effects of cytotoxic therapy, leading to significantly improved survival outcomes among patients who receive subsequent anticancer therapies," said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. "The findings are particularly relevant as we are evaluating the impact of trilaciclib on long-term endpoints including overall survival in PRESERVE 2, our ongoing pivotal Phase 3 mTNBC trial, with the interim overall survival analysis expected in the first quarter of 2024."

The Phase 2 trial (NCT02978716) enrolled patients who had received up to two prior chemotherapy regimens for locally recurrent or mTNBC. Participants were randomized into three groups: GCb alone on days 1 and 8 (n=34), trilaciclib prior to GCb on days 1 and 8 (n=33), or trilaciclib alone on days 1 and 8 and prior to GCb on days 2 and 9 (n=35). G1 conducted a post hoc survival analysis on data from patients in this Phase 2 TNBC trial who received additional anticancer therapies after discontinuation of study treatment with GCb with or without trilaciclib, to evaluate improvements in long-term outcomes; the two trilaciclib groups were combined for this analysis. The SACTs administered include gemcitabine, capecitabine, eribulin, taxane, carboplatin, and PD-1/PD-L1 inhibitors. Additionally, murine cancer models were utilized to quantify the infiltration of central memory T cells in the tumor microenvironment seven days after a single dose or seven daily doses of trilaciclib. Memory T cell recall responses (the ability of memory T cells to react rapidly on encounter with the same antigen after remission) were also evaluated.

Survival Outcomes

After a median follow-up of 12.7 months on study, deaths were observed in 22/43 patients in the trilaciclib plus GCb group and 17/20 patients in the GCb-only group (no trilaciclib). Median time on treatment was 5.5 months in the trilaciclib plus GCb group and 3.3 months in the GCb-only group.
Patients receiving SACT following trilaciclib plus GCb exhibited statistically significant (p=0.001) improvements in median (95% CI) OS (32.7 months; 15.3 – not estimable) compared to those receiving SACT following GCb alone (12.8 months; 8.3 – 17.8), with increasing separation of survival curves over time.
Median OS and progression-free survival (PFS) were higher in the prior trilaciclib plus GCb group compared with the prior GCb-only group, regardless of the type of SACT received.
Improved survival and sustained separation of curves were also observed in patients unable to receive SACT (trilaciclib, n = 25; placebo, n = 14), although the magnitude of benefit was smaller (median 9.4 vs 5.4 months).
Patients receiving SACT following trilaciclib plus GCb also exhibited statistically significant (p=0.001) improvements in median (95% CI) OS from start of the first SACT (14.0 months; 9.0 – not estimable) compared to those receiving SACT following GCb alone (5.8 months; 4.8 – 7.2).
Immune Surveillance Results

In addition, data from murine models indicate that trilaciclib-mediated transient cyclin-dependent kinase (CDK)4/6 inhibition may enhance tumor infiltration of CD8+ central memory T cells and boost memory T cell recall responses, further clarifying the mechanism by which trilaciclib improves long-term immune surveillance:

Compared with daily dosing, a single dose of trilaciclib resulted in an increase in the number of tumor infiltrating CD8+ central memory T cells in the tumor microenvironment on day seven.
Administering trilaciclib enhanced the efficacy of combination immunotherapy with α-PD-1 plus α-LAG3; seven of eight mice that received trilaciclib plus α-PD-1 and α-LAG3 survived (achieved a complete response) compared to three of eight mice that received treatment with α-PD-1 plus α-LAG3.
Following rechallenge in the opposite flank of the surviving mice, tumors implanted in those previously treated with trilaciclib grew to a smaller volume and regressed faster than controls, demonstrating the ability of trilaciclib to strengthen memory T cell recall responses.
Data generated across multiple preclinical and clinical studies to date indicate that trilaciclib has the greatest effect on longer term endpoints including OS rather than earlier efficacy measures. These new results contribute to the body of evidence suggesting that preserving bone marrow and immune system function during cytotoxic therapy and enhancing anti-tumor immunity and long-term immune surveillance by increasing the generation of certain memory T cells can allow patients to benefit while receiving trilaciclib, and after trilaciclib discontinuation when receiving SACT.

About Triple Negative Breast Cancer (TNBC)
According to the American Cancer Society, nearly 300,000 new cases of invasive breast cancer are diagnosed annually in the U.S. Triple-negative breast cancer makes up approximately 15-20% of such diagnosed breast cancers. TNBC is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. Because mTNBC cells lack key growth-signaling receptors, patients do not respond well to medications that block estrogen, progesterone, or HER2 receptors. Instead, treating mTNBC typically involves chemotherapy, radiation, and surgery. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer. In general, survival rates tend to be lower with mTNBC compared to other forms of breast cancer, and mTNBC is also more likely than some other types of breast cancer to return after it has been treated, especially in the first few years after treatment. It also tends to be higher grade than other types of breast cancer.