On May 1, 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 that Bristol Myers Squibb (NYSE:BMY) has exercised its option and entered into an exclusive worldwide license for the first T cell receptor engineered T cell therapy (TCR-T) candidate from their ongoing collaboration (Press release, Immatics, MAY 1, 2023, View Source [SID1234630774]).

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Under the terms of the 2019 multi-target strategic collaboration agreement, which was expanded in 2022, Immatics is developing and validating four TCR-T targets and product candidates through the lead TCR candidate stage. Bristol Myers Squibb can exercise opt-in rights and assume sole responsibility for further worldwide development, manufacturing, and commercialization of the TCR-T cell therapies. This first opt-in is for a novel TCR-T product candidate against a target relevant in multiple solid tumor indications. Immatics to receive an option exercise fee of $15 million.

"The opt-in decision by Bristol Myers Squibb is an example of the success of our ongoing collaboration. The partnership’s goal is to leverage Immatics’ ability to develop innovative cell therapies that have the potential to deliver future breakthrough therapies for patients," commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "We remain committed to making a meaningful impact on the lives of cancer patients and we look forward to further advancing our own pipeline programs as well as our product candidates being developed with Bristol Myers Squibb and other partners."

The TCR-T programs developed within the collaboration are directed against solid tumor targets discovered by Immatics using its proprietary XPRESIDENT technology combined with its XCEPTOR TCR discovery and engineering platform to identify specific TCRs against these targets. For each program, Immatics is eligible for up to $505 million in option exercise fee, regulatory and commercial milestone payments, as well as additional tiered royalties on net sales of the licensed product.

On May 1, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported the grant of inducement stock options exercisable for 4,200 shares of G1’s common stock and 2,000 restricted stock units (RSUs) to two hired employees under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the "Amended and Restated 2021 Plan") (Press release, G1 Therapeutics, MAY 1, 2023, View Source [SID1234630773]). These equity awards were granted as an inducement material to the new employee becoming an employee of G1 in accordance with Nasdaq Listing Rule 5635(c)(4).

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The Amended and Restated 2021 Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of G1 (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with G1, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The stock options are exercisable at a price of $3.08 per share, the closing price of G1’s common stock on May 1, 2023, the grant date. The stock options have up to a ten-year term and vest over four years, with 25% of the award vesting on the first anniversary of the employee’s employment, and as to an additional 1/48th of the shares monthly thereafter, subject to continued service through the applicable vesting dates (subject to the terms and conditions of the stock option agreement covering the grant). The RSUs have a four-year term, with 25% of the award vesting on the first anniversary of the grant date, and the remainder vesting 12.5% semi-annually over the remaining three years, subject to continued service through the applicable vesting dates (subject to the terms and conditions of the RSU agreement covering the grant). The stock options and RSUs are subject to the terms and conditions of the Amended and Restated 2021 Plan.

On May 1, 2023 FibroGen, Inc. (NASDAQ: FGEN) reported a non-dilutive term loan facility with investment funds managed by Morgan Stanley Tactical Value (MSTV) that will result in proceeds to FibroGen of up to $150 million, bringing significant non-dilutive capital to support growth and innovation (Press release, FibroGen, MAY 1, 2023, View Source [SID1234630772]).

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The investment by this highly respected investor capitalizes on FibroGen’s significant accomplishments to date and adds a financial partner who is aligned with the company’s growth ambitions. The financing provides capital to advance pamrevlumab toward commercialization and to continue the development of our pre-clinical pipeline.

"With the current momentum across our development programs, this financing strengthens our balance sheet," said Enrique Conterno, Chief Executive Officer, FibroGen. "Part of the proceeds will be used to fund our wholly-owned pamrevlumab program as we anticipate five Phase 3 readouts to occur before mid-2024. In addition, this funding allows for the continued development of our early-stage pipeline."

The $150 million term loan facility will be available to the Company in three tranches:

The initial tranche of $75 million will be funded by May 8, 2023.
The second tranche of $37.5 million will be funded in the third quarter of 2023 upon achievement of certain clinical development milestones.
MSTV has the option to fund a third tranche of up to $37.5 million in the third quarter of 2023.
Borrowings under this three-year term loan facility will accrue interest at 14.0%. The outstanding principal amount of the term loan facility will be payable at maturity.

"We are pleased to extend this term loan facility to FibroGen in support of their continued growth," said Tom Cahill, Co-head of MSTV. "Roxadustat is a first-in-class chronic kidney disease anemia drug in approved markets and we are excited by the continued prospects in additional markets, the pamrevlumab program and the pipeline of other promising opportunities."

Morgan Stanley & Co. LLC acted as sole structuring agent to FibroGen on this transaction and Goodwin Procter LLP acted as counsel to FibroGen. Gibson, Dunn & Crutcher LLP acted as counsel to the investor.

On May 1, 2023 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conference and invited investors to participate by webcast (Press release, Exact Sciences, MAY 1, 2023, View Source [SID1234630770]).

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BofA Securities Health Care Conference, Las Vegas
Fireside chat on Wednesday, May 10, 2023 at 6:00 p.m. ET
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On May 1, 2023 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that interim data from the Phase 1 (AMPLIFY-201) study of its lead asset, ELI-002, will be presented in a poster discussion presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, a hybrid event taking place online and at McCormick Place in Chicago from June 2-6, 2023 (Press release, Elicio Therapeutics, MAY 1, 2023, View Source [SID1234630769]).

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ELI-002 2P is an investigational therapeutic cancer vaccine that is in development with Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to treat cancers driven by G12D and G12R mutations in KRAS. AMPLIFY-201 is a multicenter Phase 1 trial assessing the safety, immunogenicity and antitumor activity of ELI-002 in patients with mutant KRAS-driven tumors who are at high risk for relapse due to detection of minimal residual disease (MRD) where residual tumor cells are present following standard surgery and chemotherapy.

Presentation details:

Title: AMPLIFY-201, a first-in-human safety and efficacy trial of adjuvant ELI-002 2P immunotherapy for patients with high-relapse risk with KRAS G12D- or G12R-mutated pancreatic and colorectal cancer.

Abstract #: 2528
Poster Discussion Session: Developmental Therapeutics—Immunotherapy

Poster Session Display Date and Time: June 3, 2023, 8:00 AM-11:00 AM CDT/ 9:00 AM–12:00 PM EDT (Poster Board #370)
Poster Discussion Session Date and Time: June 3, 2023, 3:00 PM-4:30 PM CDT / 4:00 PM–5:30 PM EDT
Presenter: Eileen O’Reilly, M.D., Attending Physician and Member, Section Head for Hepatopancreaticobiliary/Neuroendocrine Cancers, Gastrointestinal Oncology Service, Memorial Sloan Kettering

About ELI-002

ELI-002 is a structurally novel investigational AMP therapeutic vaccine targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. The seven KRAS driver mutations targeted by ELI-002 7P formulation are present in 25% of all solid tumors. In particular, 93% of pancreatic ductal adenocarcinoma and 52% of colorectal cancers, those most prevalent in the AMPLIFY-201 study, are positive for KRAS mutations. In addition, 27% of non-small cell lung cancers are positive for KRAS mutations. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide CpG adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they can potentially enhance the action of key immune cells.

ELI-002 2P is currently being studied in a Phase 1 trial (AMPLIFY-201) in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy. A new formulation, ELI-002 7P, is currently being studied in AMPLIFY-7P, a Phase 1/2 trial in patients with high relapse risk mKRAS-driven solid tumors. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms.

About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based upon preclinical studies.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving immune responses of increased magnitude, function and durability.