On May 16, 2023 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported a business update and provided financial results for the quarter ended March 31, 2023 (Press release, Immatics, MAY 16, 2023, View Source [SID1234631775]).

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Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics commented, "We commenced 2023 with significant advances in our ACTengine IMA203 clinical trial, announcing encouraging data demonstrating that IMA203 is able to drive deep and durable responses independent of tumor type, with some responses ongoing beyond 9 months after treatment. As we continue to leverage the multi-cancer PRAME opportunity, we are pleased to have filed a CTA for IMA402, moving our second TCR Bispecifics candidate toward clinical evaluation. We look forward to providing a next update on our IMA203 TCR-T therapy candidates as well as announcing a potential fast-to-market pathway by the end of the year."

First Quarter 2023 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA203 TCR-T monotherapy (Phase 1b Cohort A):

On May 2nd, Immatics provided an interim update covering data from 11 heavily pre-treated patients in Phase 1b dose expansion Cohort A (monotherapy). Patients were infused with IMA203 TCR-T cells at dose level (DL) 4 or DL5 with a mean total infused dose of 3.67×109 TCR-T cells (range 1.30-8.84×109 TCR-T cells).
Treatment with IMA203 in Cohort A (monotherapy) continues to show manageable tolerability at doses of up to approximately 9 billion CD8+ TCR-T cells; no high-grade cytokine release syndrome (CRS) and no immune effector cell associated neurotoxicity syndrome (ICANS) observed in the 11 patients treated in Cohort A; no dose-dependent increase of CRS observed.
All 11 patients experienced expected cytopenia (Grade 1-4) associated with lymphodepletion. 10 patients (91%) had a low to moderate (Grade 1-2) cytokine release syndrome (CRS), of which 5 patients (45%) had Grade 1, and 5 patients (45%) had Grade 2 CRS.
Objective responses were observed in last-line solid cancer patients including cutaneous melanoma, ovarian cancer, uveal melanoma, head and neck cancer and synovial sarcoma.
Initial objective response rate (ORR) of 64% (7/11) was observed at ~week 6 (partial responses (PR) according to RECIST 1.1).
Confirmed ORR of 67% (6/9) was observed at ~month 3; initial responses at week 6 were confirmed for all 6 responders with an available subsequent 3-month scan.
Median duration of response2 was not reached (min 1.3+ months, max 8.8+ months) at a median follow-up3 of 8.5 months; two confirmed partial responses (cPR) ongoing at more than 9 months after treatment as well as three additional ongoing responses at 6+ months, ~3 months and 6+ weeks.
Objective responses were observed independent of solid tumor type at low, medium and high PRAME expression levels above Immatics’ MS-guided RNA threshold.
In addition to Cohort A (IMA203 monotherapy), ACTengine IMA203 TCR-T is currently being evaluated in two additional ongoing Phase 1b dose expansion cohorts:

Cohort B: IMA203 in combination with an immune checkpoint inhibitor. Cohort B is focused on generating safety data for potential further investigation of a combination approach as a front-line therapy.
Cohort C: IMA203CD8 TCR-T monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor. IMA203CD8 is currently being explored in DL4a (up to 0.8×109 TCR-T cells/m2 BSA).
Immatics has prioritized patient treatment with IMA203 and IMA203CD8 TCR-T monotherapy in the last-line therapy setting.
Next update on Immatics’ IMA203 Phase 1b cohorts, including the projected clinical development path for PRAME TCR-T monotherapy towards registration-directed trials and potential commercialization is planned for 4Q 2023. Immatics’ IMA203 development strategy to realize the multi-cancer opportunity PRAME is based on two pillars aimed:
initially at a (1) fast-to-market approach in 1-2 last-line solid cancer types with high PRAME prevalence and where clinical proof-of-concept has been demonstrated, such as cutaneous melanoma (potentially bundled with uveal melanoma) and/or ovarian cancer and
later at a (2) planned broad development with expansion to other cancer types, such as uterine cancer, lung cancer, breast cancer, head and neck cancer and other tumor types having a broad patient reach.
Immatics is currently building a state-of-the-art facility designed to manufacture ACTengine IMA203 TCR-T products, as well as other cell therapy candidates, for registration-directed trials and initial commercial supply. The facility is expected to be operational in 2024.

Autologous TCR-T pipeline

Bristol Myers Squibb exercised its first option and entered into a global license agreement with Immatics for the most advanced TCR-T product candidate from the 2019 multi-target strategic collaboration to develop four TCR-based adoptive cell therapies targeting solid tumors.
Immatics received an option payment of $15 million and is eligible for up to $490 million in milestone payments in addition to tiered royalties on net sales of the product.
TCR Bispecifics Programs

Immatics’ T cell engaging receptor (TCER) candidates are next-generation, half-life extended TCR Bispecific molecules designed to maximize efficacy while minimizing toxicities in patients through Immatics’ proprietary format using a low-affinity T cell recruiter and a high-affinity TCR domain.

TCER IMA401 (MAGEA4/8) – Phase 1 trial to evaluate safety, tolerability and initial anti-tumor activity of TCER IMA401 in patients with recurrent and/or refractory solid tumors is ongoing. IMA401 is being developed in collaboration with Bristol Myers Squibb.

TCER IMA402 (PRAME) – Immatics submitted a clinical trial application (CTA4) to the Paul-Ehrlich-Institute (PEI) on April 14, 2023, to initiate the Phase 1/2 trial investigating IMA402 in patients with recurrent and/or refractory solid tumors. The trial is expected to commence in 2H 2023 with a first clinical data interim report planned in 2024.

Corporate Update

Nancy Valente, M.D., resigned from her position on Immatics’ Board of Directors effective May 12, 2023. Nancy has been appointed as Chief Development Officer at Xencor Inc.. Immatics would like to thank Nancy Valente for her valuable contributions during her time on Immatics’ Board of Directors.

First Quarter 2023 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €329.8 million ($358.7 million1) as of March 31, 2023, compared to €362.2 million ($393.9 million1) as of December 31, 2022. The decrease is mainly due to our ongoing research and development activities. The Company continues to project a cash runway into 2025.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €9.8 million ($10.7 million1) for the three months ended March 31, 2023, compared to €102.9 million ($111.9 million1) for the three months ended March 31, 2022. The decrease is mainly related to the recognition of revenue for the license portion of the collaboration agreement with Bristol Myers Squibb on IMA401 during the three months ended March 31, 2022.

Research and Development Expenses: R&D expenses were €27.6 million ($30.0 million1) for the three months ended March 31, 2023, compared to €25.1 million ($27.3 million1) for the three months ended March 31, 2022. The increase mainly resulted from higher costs associated with the advancement of the clinical and pre-IND pipeline of ACTengine and TCER candidates.
General and Administrative Expenses: G&A expenses were €9.6 million ($10.4 million1) for the three months ended March 31, 2023, compared to €9.3 million ($10.1 million1) for the three months ended March 31, 2022.

Net Profit and Loss: Net loss was €19.7 million ($21.4 million1) for the three months ended March 31, 2023, compared to a net profit of €85.7 million ($93.2 million1) for the three months ended March 31, 2022. The decrease resulted mainly from the one-time license fee income in connection with the IMA401 collaboration with Bristol Myers Squibb during the three months ended March 31, 2022.

Upcoming Investor Conferences

Jefferies Global Healthcare Conference, New York, NY – June 7-9, 2023
Jefferies London Healthcare Conference, London, U.K. – November 14-16, 2023
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

On May 16, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has amended its clinical trial collaboration and supply agreements with Pfizer Inc. (NYSE: PFE) to support evaluation of darovasertib and crizotinib combination therapy in the company’s planned Phase 2/3 registrational clinical trial in MUM and to continue support of the company’s ongoing Phase 2 clinical trial in MUM (Press release, Ideaya Biosciences, MAY 16, 2023, View Source [SID1234631774]).

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"We are grateful to have Pfizer’s continued support – including their clinical expertise as a collaboration partner and with respect to drug supply, as we target initiation of our Phase 2/3 registrational trial in Q2 2023 for the darovasertib and crizotinib combination in first-line HLA-A2 negative MUM, with PFS as primary endpoint for potential accelerated approval. The efficacy we observed in our Phase 2 clinical trial for first-line metastatic uveal melanoma patients suggests compelling clinical efficacy and a potential paradigm shift for treating MUM patients," said Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

IDEAYA is currently evaluating the combination of darovasertib, an investigational PKC inhibitor, and crizotinib, an investigational cMET inhibitor, in patients with metastatic uveal melanoma (MUM) in an ongoing Phase 2 clinical trial, pursuant to a clinical trial collaboration and supply agreement with Pfizer (Pfizer Agreement). IDEAYA reported updated clinical data from the ongoing Phase 2 expansion cohort which demonstrated robust clinical efficacy in first-line and any-line MUM patients with a manageable safety profile.

IDEAYA plans to initiate a potential registration-enabling Phase 2/3 clinical trial in the second quarter of 2023 to evaluate the darovasertib and crizotinib combination in first-line MUM patients under a second clinical trial collaboration and supply agreement with Pfizer (Second Pfizer Agreement). The protocol for the registrational trial includes an integrated Phase 2/3 open-label study-in-study design in first-line MUM patients with an HLA-A*02:01 (HLA-A2) negative serotype. The clinical trial design includes a Phase 2 portion (~n=200) with progression free survival (PFS) as a primary endpoint for potential accelerated approval (AA). Patients enrolled in Phase 2 will continue on treatment within the same clinical trial and will be considered together with additional enrolled patients (n=~120) to evaluate OS in support of a potential Phase 3 confirmational approval.

IDEAYA and Pfizer amended the Second Pfizer Agreement relating to the supply of crizotinib in support of IDEAYA’s planned potential registration-enabling Phase 2/3 clinical trial. Pursuant to the as-amended Second Pfizer Agreement, Pfizer will provide IDEAYA with a first defined quantity of crizotinib at no cost to the Company, as well as an additional second defined quantity of crizotinib at a lump-sum cost to IDEAYA. The Company anticipates that the supply of crizotinib under the Second Pfizer Agreement, as amended, will be sufficient to support the planned Phase 2 and Phase 3 portions of the Phase 2/3 registrational clinical trial.

Separately, IDEAYA and Pfizer also amended the Pfizer Agreement relating to the supply of crizotinib in support of IDEAYA’s ongoing Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in MUM patients. Pursuant to this amendment, Pfizer will continue to provide IDEAYA with an additional defined quantity of crizotinib at no cost to the Company.

Under each of the Pfizer Agreement and the Second Pfizer Agreement, IDEAYA is the sponsor of the ongoing darovasertib and crizotinib Phase 2 clinical trial and the planned Phase 2/3 registrational trial, respectively. IDEAYA and Pfizer will jointly own clinical data from the combination studies and will also jointly own inventions, if any, relating to the combined use of darovasertib and crizotinib. IDEAYA and Pfizer have formed a joint development committee responsible for coordinating all regulatory and other activities under the agreement.

IDEAYA owns or controls all commercial rights in its darovasertib program, including in MUM and in primary UM, subject to certain economic obligations pursuant to its exclusive, worldwide license to darovasertib with Novartis.

On May 16, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today described recently presented real-world data that confirm a consistent risk of myelosuppressive events (neutropenia, anemia, thrombocytopenia) across patients with small cell lung cancer (SCLC) being treated with chemotherapy (Press release, G1 Therapeutics, MAY 16, 2023, View Source [SID1234631773]). These findings were presented in a poster session at the 2023 meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), held May 7-10, 2023.

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"Chemotherapy remains an effective cornerstone treatment for patients with small cell lung cancer; unfortunately, chemotherapy-induced myelosuppression is a known common and debilitating complication associated with these cytotoxic regimens," said Norman Nagl, Ph.D., Vice President of Medical Affairs at G1 Therapeutics. "Despite this, little data have been generated in this tumor type to help clarify and quantify the risk of myelosuppressive events across the spectrum of patients who are treated with chemotherapy for SCLC. For the first time, the results of these analyses show that all patients – of any age, gender, race, stage, ECOG or smoking status, or at any line of chemotherapy – are at similarly high risk for such myelosuppressive events. This continues to underscore the need to ensure that patients receive the most appropriate therapies to reduce that risk and to help improve their chemotherapeutic experience."

Results showed that, among adult patients in this data set diagnosed with SCLC who received chemotherapy, grade ≥3 myelosuppression occurred in 60.9% of patients in the overall population. Further, more than half of the patients experienced grade ≥3 myelosuppression in all subgroups among the overall population, except one subgroup of patients for whom their SCLC stage was not documented at diagnosis (n=15). Multivariate regression analyses identified no significant associations between patient characteristics and myelosuppression; similar findings were observed in age-specific and lineage-specific regression models.

The poster, titled, "An Analysis of Patient Characteristics Associated With Myelosuppression Among Small Cell Lung Cancer Patients Treated in US Community Cancer Care Practices" is available in the scientific publications section of G1’s website.

Study Design
This retrospective observational study used the electronic medical records (EMR) data from the Providence St. Joseph Health (PSJH) and the Providence Cancer Reporting Registry, which included data from 40 oncology clinics associated with community hospitals across seven U.S. states. Adult patients diagnosed with SCLC who received chemotherapy between 2016 and 2018 and had longitudinal laboratory data were included in this study. Patients were followed from the date of the first chemotherapy dose for 12 months, or until the date of the last visit, date of death, or the end of the study period (December 2019), whichever occurred earliest. Percentages of patients with grade ≥3 myelosuppression and grade ≥3 lineage-specific cytopenia were analyzed by patient characteristics. Multivariate logistic regressions were conducted to examine the association between patient characteristics (independent variable) and risk of experiencing at least one grade ≥3 myelosuppression (dependent variable) among the overall population and by age group. In addition, multivariate logistic regressions were conducted to examine association between patient characteristics and risk of myelosuppression in each lineage (anemia, neutropenia, thrombocytopenia).

About Small Cell Lung Cancer
In the United States, approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for approximately 14% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

On May 16, 2023 Shorla Oncology (‘Shorla’), a U.S.-Ireland pharmaceutical company, and EVERSANA, a leading provider of commercialization services to the life science industry, reported the commercial launch of the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell Acute Lymphoblastic Leukemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL) in adult and pediatric patients aged one year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens (Press release, EVERSANA, MAY 16, 2023, View Source [SID1234631772]).

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Nelarabine Injection, which received FDA approval in March of 2023, is now available for order through major wholesalers and specialty distribution partners. The new therapy provides patients with an alternative to a product that has historically been in shortage for the treatment of T-cell leukemia, an aggressive blood and bone marrow cancer that progresses quickly. While most leukemias target older people, T-cell leukemia is most common among children. This marks the first product approved in the U.S. market for Shorla.

"Patients are directly affected by therapy shortages. Our team is proud that Nelarabine Injection is now available across the United States for clinicians to prescribe as a new treatment option to help patients, particularly children, in their battle against leukemia," said Sharon Cunningham, CEO and Co-founder of Shorla Oncology. "We look forward to helping educate both the clinical and patient communities on this new therapy."

Shorla Oncology selected EVERSANA to support the commercialization launch for the therapy in 2021. EVERSANA will provide comprehensive launch support including field deployment sales and training solutions, medical information, pharmacovigilance and quality services, revenue management, agency solutions, 3PL channel and trade relations support.

"What a milestone for the Shorla Oncology team to officially have this new treatment option available to the oncology community across the U.S.," said Jim Lang, CEO, EVERSANA. "We’re honored to provide the full depth of our commercialization solutions to ensure a successful launch and look forward to helping the Shorla team bring this and future therapies to the U.S. and 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, plus an extensive industry network, including key opinion leaders from top leading hospitals such as The Children’s Hospital of Philadelphia (CHOP), the company has an advanced pipeline of oncology therapies to treat a number of unmet patient needs.

On May 16, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported the pricing of its underwritten public offering of 11,764,706 shares of its common stock at a price to the public of $4.25 per share (Press release, Coherus Biosciences, MAY 16, 2023, View Source [SID1234631771]). All of the shares of the common stock to be sold in the offering will be offered by Coherus. In addition, Coherus has granted the underwriters a 30-day option to purchase up to an additional 1,764,705 shares of its common stock at the public offering price, less underwriting discounts and commissions.

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Coherus intends to use substantially all of the net proceeds from this offering for general corporate purposes, including the cost of manufacturing clinical and commercial supplies of product candidates and products. Coherus may also use a portion of the net proceeds from this offering, together with existing cash, cash equivalents and marketable securities, to in-license, acquire or invest in complementary businesses, technologies, products or assets. If there are any remaining net proceeds from this offering, Coherus intends to use them for working capital and other general corporate purposes.

The offering is expected to close on or about May 18, 2023, subject to satisfaction of customary closing conditions.

J.P. Morgan and Citigroup are acting as co-lead book-running managers for the offering. Mizuho is acting as lead manager for the offering.

A shelf registration statement (including a base prospectus) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on November 17, 2022. This offering is being made solely by means of a prospectus supplement and the accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and are available on the SEC’s website at www.sec.gov. When available, electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: (866) 803-9204, email: [email protected] or Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 (Tel: 800-831-9146).

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