On October 13, 2021 Bicycle Therapeutics plc (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the pricing of an underwritten public offering of 3,240,741 American Depositary Shares ("ADSs"), each representing one ordinary share, at a price to the public of $54.00 per ADS, for gross proceeds of $175.0 million (Press release, Bicycle Therapeutics, OCT 13, 2021, View Source [SID1234591165]). In addition, Bicycle has granted the underwriters in the offering a 30-day option to purchase up to 486,111 additional ADSs at the public offering price. The offering is expected to close on or about October 15, 2021, subject to customary closing conditions.

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Bicycle plans to use the net proceeds from the offering to advance its proprietary product pipeline and for other research and development, as well as for general corporate purposes.

Goldman Sachs & Co. LLC, Morgan Stanley and SVB Leerink are acting as joint book-running managers for the offering. JMP Securities is acting as co-manager for the offering.

The offering is being made pursuant to a "shelf" registration statement on Form S-3 that was filed by Bicycle with the Securities and Exchange Commission ("SEC") and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, final prospectus supplement and accompanying prospectus, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 1-866-471-2526, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

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.

On October 13, 2021 Veracyte, Inc., (Nasdaq: VCYT) reported the publication of new data demonstrating that the company’s Decipher Bladder genomic classifier accurately identifies bladder tumors that are most likely to respond to chemotherapy prior to radical cystectomy (Press release, Veracyte, OCT 13, 2021, View Source [SID1234591182]). These findings could ultimately help physicians optimize treatment planning for their patients with bladder cancer based on their tumor subtype biology. The peer-reviewed paper appears online today in The Journal of Urology.

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Patients diagnosed with non-metastatic muscle-invasive bladder cancer (MIBC) often undergo neoadjuvant chemotherapy (NAC) prior to standard-of-care radical cystectomy, even though the absolute survival benefit associated with the addition of NAC to radical cystectomy is 5-10%. Until recently, there was no reliable way to determine which MIBC tumors would – or would not – respond to chemotherapy. Molecular subtyping with the Decipher Bladder genomic classifier has shown that biological differences in MIBC are strongly associated with chemotherapy response.

"Our findings are among the first to show the clinical utility of implementing molecular subtyping in order to identify patients for whom NAC is most likely to confer significant benefit," said Yair Lotan, MD, professor of urology and chief of urologic oncology at UT Southwestern Medical Center, and the paper’s lead author. "This study represents meaningful progress in clinically validating biomarkers that are associated with chemotherapy response in patients with MIBC, and it offers hope that we will be able to better manage these patients in the future by accurately selecting those most likely to benefit from additional treatment."

In this multicenter retrospective study, scientists evaluated the use of the Decipher Bladder genomic classifier in a cohort of 601 patients. After three years, patients with classifier-identified luminal tumors (37% of the study population) experienced no additional benefit to overall survival (OS) from receiving NAC prior to radical cystectomy (63% OS with NAC and 65% OS without). However, those patients whose tumors were classified as non-luminal (63% of the study population) experienced a significant benefit from the addition of NAC, with 10% greater overall survival after three years as compared to patients who were treated with cystectomy alone (71% vs. 61%).

"We are pleased that our Decipher Bladder genomic classifier performed so well in this broad study," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of scientific and clinical operations, Urologic Cancers. "We look forward to further validating the test to encourage its routine clinical use for patients diagnosed with MIBC."

The Decipher Bladder test is supported by multiple peer-reviewed clinical studies demonstrating its ability to identify which patients have a higher risk of upstaging to non-organ confined disease at surgery and which patients may benefit the most from neoadjuvant therapy. The test also can be used to identify neuroendocrine-like and immune-infiltrated subtypes, which may have implications for future therapeutic strategies. In June 2021, Veracyte announced that Decipher Bladder had become the first molecular subtyping test to gain Medicare coverage to inform treatment for individuals with bladder cancer.

About Decipher Bladder

Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis from transurethral resected bladder tumor specimens. It was developed for bladder cancer patients with high-grade non-muscle-invasive disease who are being considered for treatment and patients with muscle-invasive disease who face the question of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy (NAC). Decipher Bladder reports the molecular subtype of the tumor specimen as Luminal or Non-Luminal (Luminal Infiltrated, Basal, Basal Claudin-Low or Neuroendocrine-like), with each subtype having distinct biological composition, clinical behavior and predicted benefit from NAC.

On October 13, 2024 Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) reported that the Company has obtained results from the bioequivalence studies with the generic product candidate HyNap-Dasa ANDA C (Press release, Xspray, OCT 13, 2021, View Source [SID1234649573]). The results show that the bioequivalence with the reference product Sprycel was achieved in fed but not in fasting subjects due to the high variability of Sprycel. The Company now chooses to focus entirely on the improved version, Dasynoc, which has achieved bioequivalence with a 30 percent lower dose than Sprycel, and decides to end development of the generic version of dasatinib.

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"We have been developing the generic and the improved versions of dasatinib, Dasynoc, in parallel, but now we choose to focus on Dasynoc since the market value is high not only during, but also after the end of the patent window. A shorter time in the patent window decreases the importance of the generic version in our product portfolio. An important consequence of this decision is to free up the capacity to accelerate the development of our current product candidates in the pipeline with longer patent window. The development of Dasynoc has been rapid and we can take advantage of the clinical improvements that amorphous formulations of protein kinase inhibitors (PKIs) provide for patients, doctors and payers", says Per Andersson, CEO of Xspray Pharma.

Submission for the market approval for Dasynoc in the USA is scheduled as planned for the fourth quarter this year, in accordance with the 505(b)(2) procedure.

On October 13, 2021 Prescient Therapeutics (PTX) reported that it will present new results for its OmniCAR drug at the Cell & Gene Meeting on Mesa in California (Press release, Prescient Therapeutics, OCT 13, 2021, https://themarketherald.com.au/prescient-therapeutics-asxptx-to-present-new-omnicar-data-at-conference-2021-10-13/?utm_source=rss&utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-to-present-new-omnicar-data-at-conference [SID1234591210]).

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The conference brings together senior executives and decision makers on therapies including cell therapy.

OmniCAR is a universal immune receptor platform allowing controllable T-cell activity and multi-antigen targeting with a single cell product.

The most recent work with the Peter MacCallum Cancer Centre showed that OmniCAR-T cells begin antigen-directed killing of tumour cells in vitro as soon as they are armed.

It was also discovered that OmniCAR-T cells could be re-armed and continue to kill tumour cells without loss of cytotoxicity.

These new results show the important capabilities of OmniCAR to deliver next generation cell therapies that are controllable and able to target multiple cancer antigens.

Prescient’s Director of Scientific Affairs Rebecca Lim is pleased with the new results.

"Excitingly, we saw for the first time the real-time ‘switchability’ of the OmniCAR system where the tumour killing ability of the OmniCAR-T cells could be redirected towards a different antigen through the addition of a different binder," Dr Lim said.

"These early wins are extremely encouraging, and we look forward to the next phase
of pre-clinical testing where the OmniCAR technology will be put through its paces using gold standard cancer models."

Dose response
A dose response relationship is the correlation between the amount of drug given the magnitude of response. Normally, higher doses lead to greater effects.

In cell therapies such as CAR-T therapy, where living cells that continue to grow and divide are administrated to patients, effects are considerably less predictable and controllable.

The aim of OmniCAR is to combine the potent cytotoxicity of cell therapy with the control and predictability of a conventional drug.

Prescient treated glioblastoma multiforme (GBM) cells with OmniCAR-T cells armed with varying amounts of SpyTagged EGFRviii and Her2 binders to test whether different doses of binders resulted in equal levels of CAR-T activity.

In both cases, OmniCAR showed dose-dependent tumour killing activity, with the ability to control OmniCAR-T cell activity.

Re-arming
Single infusions of CAR-T cells may be insufficient to drive meaningful patient outcomes in many cancers, especially solid tumours.

Prescient has now shown this "re-arming" capability of OmniCAR. OmniCAR-T cells pre-armed with Her2 binders demonstrated potent ability to kill cancer cells extracting Her2. Following this, the cells were washed and rested for several days, resulting in unarmed OmniCAR cells.

These same OmniCAR-T cells were then capable of being re-armed with Her2 binders, and once again showed the same results.

"This demonstrates that OmniCAR cells can be unarmed, re-armed and still kill with near identical fidelity. It is another example of the flexible yet predictable activity of OmniCAR cells," the company said.

Managing Director and CEO Steven Yatomi-Clarke is looking forward to present this data at the Cell & Gene Meeting this week.

"It is very pleasing to see a large body of work accomplished successfully so quickly and is a credit to the Prescient team and the incredible collaborators at Peter MacCallum Cancer Centre," he said.

"Importantly, none of these tests have even been optimised, so we have yet to see the true limits of this technology. OmniCAR is proving to be a predictable and powerful system to work with. We look forward to sharing updates as our programs progress."

On the market this morning, Prescient was up 9.09 per cent and is trading at 24 cents per share at 11:40 am AEDT.

On October 13, 2021 Biotech company Prescient Therapeutics reported that has given investors a glimpse into the progress of its next-generation CAR-T platform, OmniCAR, with data to be presented at leading cell and gene therapy conference Meeting on the Mesa (Press release, Prescient Therapeutics, OCT 13, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-showcases-pre-clinical-success-of-cancer-fighting-treatment [SID1234591146]).

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In an announcement made this morning, the Melbourne-based company revealed its OmniCAR platform continues to demonstrate several key attributes in early studies.

These attributes include the treatment’s high-potency, dose-responsiveness of cancer killing activity, and the ability for clinicians to disarm and re-arm the cells used in treatment without hindering their effectiveness.

These are important milestones in the development of Prescient’s in-house OmniCAR programs, as well as in the development of the overall platform and demonstrating novel features relevant to potential partners and collaborators.

Dr Rebecca Lim, Prescient’s Director of Scientific Affairs, is encouraged by the result, noting:

"Our most recent work conducted in collaboration with the Peter MacCallum Cancer Centre showed that OmniCAR-T cells begin antigen-directed killing of tumour cells in vitro as soon as they are armed," she said.

"The team also showed that OmniCAR-T cells could be rearmed and continue to kill tumour cells without loss of cytotoxicity."

"Excitingly, we saw for the first time the real-time ‘switchability’ of the OmniCAR system where the tumour killing ability of the OmniCAR-T cells could be redirected towards a different antigen through the addition of a different binder."

Dr Lim said the early wins were "extremely encouraging", adding that she is excited for the next round of tests.

The results will be shared in detail with the industry’s most prominent companies at the Cell & Gene Meeting on the Mesa conference, based in Carlsbad, California, US.

Prescient Therapeutics CEO Steven Yatomi-Clarke said he is excited by the opportunity to share the company’s results with the industry’s leading businesses.

"It is very pleasing to see a large body of work accomplished successfully so quickly and is a credit to the Prescient team and the incredible collaborators at Peter MacCallum Cancer Centre," he added.

"Importantly, none of these tests have even been optimised, so we have yet to see the true limits of this technology. OmniCAR is proving to be a predictable and powerful system to work with."

OmniCAR is a next-generation CAR-T platform that aims to overcome challenges that face traditional CAR-T therapies – which use genetically modified cells from a patient’s own immune system to fight cancer.

These challenges include poor dose-responsiveness (leading to unpredictable reactions in patients as the strength of their treatment is increased), an inability to redirect CAR-T cells to attack different tumours, and the need for multiple CAR-T infusions to adequately fight cancer. CEO Steven Yatomi-Clarke and Dr Rebecca Lim will be presenting a session next Tuesday at 11am (AEDT) where they will explain the OmniCAR platform and latest results in more detail. Please click here to register for the session.

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