On May 24, 2021 Veriskin, Inc., a start-up medical device company, reported that it has invented and is developing novel technology for skin cancer diagnostics and screening (Press release, Veriskin, MAY 24, 2021, View Source [SID1234580511]). Veriskin has received FDA Breakthrough Device Designation for its TruScore device in July, 2020. Development of this innovative technology is being supported by grant funding from the National Cancer Institute and seed-round capital from private investors. Veriskin has completed two IRB-approved clinical studies. The Company is initiating a third clinical study, preparatory to designing the clinical trial needed to obtain FDA approval to market its device.

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Skin cancer is the most common form of cancer in the United States, accounting for just under half of all cancer diagnoses. The American Cancer Society predicts that 106,110 new melanoma cases will be diagnosed and 7,180 people are expected to die of malignant melanoma in 2021. It is estimated that approximately 5.4 million basal and squamous cell carcinomas are diagnosed each year, affecting 3.3 million people and leading to more than 15,000 lives lost. Skin cancers are very difficult for non-specialists, such as primary care practitioners, to differentiate from non-malignant skin abnormalities. Uncertainty in initial diagnosis can lead to 1) failure to detect cancer at an early, more treatable stage, 2) hundreds of malpractice claims due to missed cancers, and 3) many unnecessary referrals to specialists and unwarranted biopsies. Fortunately, the majority of skin cancer cases can be cured when detected early. "Development of an accurate diagnostic device for use by frontline practitioners provides a significant opportunity for saving lives and reducing healthcare costs," said Veriskin CEO, Mirianas Chachisvilis, PhD.

Veriskin’s TruScore is a proprietary, non-invasive, low-cost, hand-held device that aids non-expert users to rapidly and objectively determine whether a suspicious skin lesion is cancerous. It works on both pigmented and non-pigmented skin lesions and produces a quantitative score. Use of the device can potentially reduce the number of missed cancers and unnecessary biopsies. Veriskin’s patented technology is based on a novel, orthogonal approach: active perturbative hemodynamic measurements combined with a proprietary machine-learning algorithm. The device detects both structural and functional vascular abnormalities associated with pathological angiogenesis (a well-established, early hallmark of cancer). The resultant diagnostic information content is significantly higher than provided by competing imaging-based technologies. IRB-approved clinical studies performed in multiple dermatology clinics in California and Arizona have demonstrated sensitivity of greater than 99% and specificity of 94% in a set of 125 biopsy-verified lesions. "Veriskin anticipates that TruScore will help primary care practitioners and dermatologists to detect potentially dangerous skin cancers earlier and with higher accuracy," said the CEO.

Veriskin’s development of its innovative technology has been supported by multiple grants from the National Cancer Institute (totaling $3.9 million with opportunities for additional funding). Recently, Veriskin raised over $1M in a seed-round co-led by Pasadena Angels and Ariel Savannah Angel Partners, with participation from Frontier Angels and TiE SoCal Angels. "We are delighted to be able to support Veriskin in the commercialization of its innovative technology," said Kevin Herzberg, Vice Chairman of Pasadena Angels.

On May 24, 2021 Akeso, Inc. (HKEx: 9926.HK) reported that Penpulimab (research and development code: AK105), an PD-1 monoclonal antibody drug co-developed by the Company with Sino Biopharmaceutical Limited (HKEx: 1177.HK), has submitted a Biologics License Application ("BLA") to the Food and Drug Administration of the United States ("FDA") for third-line treatment of metastatic nasopharyngeal carcinoma (Press release, Akeso Biopharma, MAY 24, 2021, View Source [SID1234580510]).

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The FDA will review the BLA under the new policy of Real-Time Oncology Review ("RTOR"), which aims to accelerate the process of drug approval. This is the first Chinese PD-1 drug being BLA reviewed by the FDA under RTOR.

According to the annual report of Akeso, Penpulimab is expected to receive NDA approval in China in 2021 for treatment of relapsed or refractory classical Hodgkin’s lymphoma, meanwhile the Company is accelerating approval progress of Penpulimab in the United States.

Previously, based on the promising clinical data of Penpulimab, it has already obtained breakthrough therapy designation and fast track designation from the FDA for third-line treatment of metastatic nasopharyngeal carcinoma.

Penpulimab’s BLA submitted to the FDA will be reviewed under the new policy of RTOR, which aims to accelerate the process of drug approval. RTOR is a major and innovative new oncology drug approval policy issued by the Oncology Center of Excellence ("OCE") of the FDA. It is faster than the priority review and aims to accelerate the process of drug approval, so as to facilitate a safe and effective treatment of cancer patients as early as possible.

According to publicly available information ("U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program"), there were a total of 20 drugs approved under the RTOR by the FDA as of April 2020. The average time of these drugs from application submission to getting approval is 3.3 months, with the fastest of 0.4 month and slowest 5.9 months. This means the new drug approval time under RTOR is way faster than fast track designation, breakthrough therapy or orphan drugs. It is currently the fastest track for FDA drug approval.

The first immuno-oncology therapy approved by the FDA under the RTOR is Keytruda, a PD-1 immunotherapy drug by MSD. The approval time for treatment of endometrial carcinoma by Keytruda in combination with Lenvima was ahead of expectation for 3 months.

Up to now, 3 Chinese PD-1 developers have submitted BLA to the FDA, including previously Innovent Biologics, Inc. and Shanghai Junshi Biosciences Co., Ltd.. Akeso is expected to expedite its BLA submission to the FDA under the new policy of RTOR. It is worth looking forward to when Chinese PD-1 will obtain the first approval overseas.

INFORMATION ABOUT PENPULIMAB

Penpulimab (AK105, PD-1 mAb) is jointly developed and commercialized by a joint venture established by the Company and Chia Tai-Tianqing Pharmaceutical Group Co.,Ltd. , a subsidiary of Sino Biopharmaceutical Limited (1177.HK) . Penpulimab is possibly one of the most innovative PD-1 monoclonal antibody drug candidates of the Company in advanced clinical development stage that can be differentiated from other products. Penpulimab’s Fc receptor and complement mediated effector are completely removed by Fc mutations; it also has a slower antigen binding off rate compared with the PD-1 antibodies that are already launched in foreign market. These features have made Penpulimab more effective in blocking the activity of the PD-1 pathway and evaded the T-cell anti-tumor activity, thus it has the potential to become an anti-PD-1 drug that can achieve better clinical efficacy.

On May 24, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the 2021 Jefferies Virtual Healthcare Conference (Press release, Ideaya Biosciences, MAY 24, 2021, View Source [SID1234580509]).

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2021 Jefferies Virtual Healthcare Conference
Fireside Chat with Maury Raycroft
Thursday, June 3, 2021 at 1:00 pm ET

A live audio webcast of the event will be available by visiting the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of the webcast will be available for 30 days following the live event.

On May 23, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has launched an offering of $1.6 billion aggregate principal amount of new senior secured notes due 2028 (the "Notes") (Press release, Bausch Health, MAY 24, 2021, View Source [SID1234580508]). The proceeds from the offering of the Notes, along with cash on hand, are expected to be used to fund the repurchase of $1.6 billion aggregate principal amount of the Company’s existing 7.00% Senior Secured Notes due 2024 (the "2024 Notes") pursuant to the Company’s concurrently announced tender offer (the "Tender Offer") and to pay related fees, premiums and expenses. This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the 2024 Notes.

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The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Company’s credit agreement and existing senior notes and will be secured on a first priority basis by liens on the assets that secure the Company’s credit agreement and existing senior secured notes.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.

The Company also announced that it intends to issue a conditional notice of redemption today to redeem the full aggregate principal amount of 2024 Notes that remain outstanding following the consummation of the Tender Offer. This announcement does not constitute an offer to purchase or notice of redemption with respect to the 2024 Notes. The Tender Offer is subject to and conditioned upon the satisfaction or waiver of certain conditions described in the offer to purchase related to the Tender Offer, including the completion of the offering of the Notes. The Redemption is conditioned upon the completion by the Company or its subsidiaries of one or more debt financings in an aggregate principal amount of at least $1.6 billion (the "Condition"), which the Company expects to satisfy upon closing of the offering of the Notes.

A copy of the conditional notice of redemption with respect to the 2024 Notes will be issued to the record holders of the 2024 Notes. Payment of the redemption price and surrender of the 2024 Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company on June 23, 2021, unless no 2024 Notes remain outstanding following the consummation of the Tender Offer or the Condition is not satisfied. If the Condition is not satisfied, the redemption date will be delayed until the Condition is satisfied. The name and address of the paying agent are as follows: The Bank of New York Mellon Trust Company, N.A., c/o The Bank of New York Mellon; 111 Sanders Creek Parkway, East Syracuse, N.Y. 13057; Attn: Redemption Unit; Tel: (800) 254- 2826.

The foregoing transactions are subject to market and other conditions and are anticipated to close in the second quarter of 2021. However, there can be no assurance that the Company will be able to successfully complete the transactions, on the terms described above, or at all.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On May 24, 2021 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported new data demonstrating synergy between the Company’s tumor blood vessel killing vaccine, StemVacs-V iPSC and specific immunological adjuvants (Press release, Therapeutics Solutions International, MAY 24, 2021, View Source [SID1234580507]).

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The data is part of a package being developed that the Company will send to the Food and Drug Administration (FDA) as part of its planning for an Investigational New Drug (IND) filing. Additionally, the data was incorporated in a patent application filed today.

"The utilization of the immune response to selectively kill tumor blood vessels was demonstrated by Companies such as Batu Biologics, who obtained FDA clearance to stimulate immunity in patients using placentally derived material1. Additionally, published human and animal data showing signals of efficacy and safety using the first-generation approach2,3" said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International and co-inventor. "Unfortunately, previous approaches were characterized by need for multiple donors and the possibility of batch-to-batch variation. The StemVacs-V iPSC product represents a second-generation vaccine which utilizes only one donor and is being optimized to induce superior potency and reproducibility."

StemVacs-V iPSC is a cellular product generated from a standardized inducible pluripotent stem cell (iPSC) which is differentiated into cells that resemble blood vessels which feed the tumor. Additionally, StemVacs-V iPSC expresses the alpha1,3-galactosyltransferase gene which causes the cells to express to Gal alpha 1-3Gal beta-4-GlcNAc (alpha Gal). Alpha Gal is one of the most potent immune stimulating molecules in nature, evoking one of the most powerful immune responses known to man.

"We have learned from our previous experiences, as well as the experiences of our colleagues, that inducing permanent remission of tumors will not occur through a "magic bullet" approach" said Famela Ramos, Vice President of Business Development. "Accordingly, we and our collaborators have identified several synergistic approaches, for which we have filed intellectual property, that will increase our chances of optimal therapeutic outcome once we enter clinical trials."

"At Therapeutic Solutions International we are constantly seeking to perfect our therapeutic approaches because we are realistic. Many times, cancer therapeutics that work in mice do not work in humans but you have to start somewhere" said Timothy Dixon, President and CEO of the Company and co-inventor. "This is why we strive to perfect the efficacy of our approaches as much as possible in preparation for clinical trials. We are committed to making a meaningful impact in the lives of cancer patients."