On January 10, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted two employees nonqualified stock options to purchase an aggregate of 18,500 shares of its common stock with an exercise price of $2.10, which is equal to the closing price of Gritstone’s common stock on January 4, 2024, the date of the grant (Press release, Gritstone Bio, JAN 10, 2024, View Source [SID1234639185]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

On January 10, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), one of the leading Canadian biotechnology companies working in the field of immune-oncology reported that it has successfully tested a new formulation of its ACCUM-002TM Dimer CDCA-SV40 commonly named "AccuTOX", as an anticancer treatment for lung-established tumors (Press release, Defence Therapeutics, JAN 10, 2024, View Source;utm_medium=rss&utm_campaign=defences-accutox-impairs-lung-cancer-growth [SID1234639184]). These results widen the scope of application for AccuTOX in the treatment of solid cancer tumors.

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AccuTOX is an optimization of the Accum molecule and platform technology developed by Defence Therapeutics. Recent studies demonstrated that AccuTOX has enhanced therapeutic properties and a broader application in cancer therapeutics as it has successfully killed more than a dozen different murine and human cancer cell lines. When initially delivered intranasally, AccuTOX had a great impact on blocking tumor growth of pre-established lung nodules in mice. However, the drug was delivered as nasal droplets, which represents an approach difficult to translate to the clinic. Therefore, Defence used a nebulizing device named "Anesthesia Mask Nebulizer Delivery System" of Kent Scientific Corporation to deliver its compound in the least invasive way. Following several preclinical studies to set-up different delivery parameters, a maximum tolerated study revealed that the drug is tolerated by rodents at a dose of 3 mg/kg. When delivered as a monotherapy, AccuTOX inhibited the growth of lung nodules. The effect was further enhanced when combined with the immune-checkpoint inhibitor anti-PD1 as shown on the Figure 1 below.

"We are very excited with the potency of our lead compound, AccuTOX. These studies are important as they show how versatile can the application of this drug be against various indications, and they demonstrate in addition how different formulations or delivery devices can be used to target different tumor types/sites" said Sébastien Plouffe, President & CEO of Defence Therapeutics.

AccuTOX was recently cleared by the FDA to begin a Phase I trial in patients with Stage IIIB to IV melanoma, as released per the Company on December 11, 2023.

According to Precedence Research, the global cancer therapeutics market size is expected to be worth around US$ 393.61 billion by 2032 from at US$ 164 billion in 2022, growing at a CAGR of 9.20% during the forecast period 2023 to 2032.

On January 10, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on January 08, 2024, the compensation committee of BridgeBio’s board of directors granted twenty five new employees restricted stock units for an aggregate of 66,963 shares of the Company’s common stock (Press release, BridgeBio, JAN 10, 2024, View Source [SID1234639183]). One-fourth of the shares underlying each employee’s restricted stock units will vest on February 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019, and amended and restated on February 10, 2023 and on December 13, 2023.

On January 10, 2024 Biomea Fusion presented its corporate presentation (Press release, Biomea Fusion, JAN 10, 2024, View Source [SID1234639182]).

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On January 10, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle antisense, for the treatment of refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients (Press release, Bio-Path Holdings, JAN 10, 2024, View Source [SID1234639180]).

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"We are delighted to safely complete this first dose cohort and to advance BP1002 into the next cohort as it brings us one step closer to providing access to this very promising treatment for the most vulnerable patients who have limited therapeutic options," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We look forward to advancing this study into higher dose cohorts with the expectation that increased levels of BP1002 will prove even more efficacious and continue its safety profile in these sickest of sick patients."

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with relapsed, aggressive non-Hodgkin’s lymphoma. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and Bio-Path believes that its benign safety profile should enable BP1002 combination therapy with approved agents.

In the Phase 1 trial, refractory/relapsed CLL patients, including those who have failed or relapsed from venetoclax-based frontline therapy, as well as refractory/relapsed lymphoma patients, will be treated with BP1002. Venetoclax targets the Bcl-2 protein based on neutralizing the protein’s BH3 domain and is a frontline treatment for CLL patients and newly diagnosed, elderly acute myeloid leukemia (AML) patients. With the exception of some patients treated with allogeneic hematopoietic cell transplantation, patients treated with venetoclax-based therapies frequently relapse, primarily due to BH3 domain mutations over time. Bio-Path’s BP1002 also targets the Bcl-2 protein, but its activity is based on blocking the Bcl-2 messenger RNA and the expression of the Bcl-2 protein, and not the BH3 domain. As a result, Bio-Path believes that BP1002 could provide an alternative treatment for venetoclax refractory/relapsed CLL patients. Bio-Path also believes there may be AML patients who fail or relapse from venetoclax-based frontline treatment for the same reason, potentially representing an additional opportunity for Bio-Path to treat those patients with BP1002.

The Phase 1 clinical trial is being conducted at several leading cancer centers, including the Georgia Cancer Center, The University of Texas Southwest and New York Medical College. Locke Bryan, M.D., Associate Professor of Medicine at the Georgia Cancer Center, is serving as National Principal Investigator for the Phase 1 trial. A total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over 28 days. Enrollment is now open for patients for the second dose cohort of 40 mg/m2. The primary objective of the study is to evaluate the safety and tolerability of escalating doses of BP1002.