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 ImmunoPrecise reported that it will be exhibiting at the 13th annual PEGS Europe. PEGS (Protein & Antibody Engineering Summit) is one of the most significant European events for all aspects of proteins and antibody engineering, offering keynote speakers, seminars, one-to-one meetings, and short courses (Press release, ImmunoPrecise Antibodies, OCT 13, 2021, View Source [SID1234591164]). Meet with the ImmunoPrecise team at booth #212 to learn more about our full suite of end-to-end antibody discovery services.

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On October 13, 2021 ImmunoPrecise Antibodies reported that The international BIO-Europe 2021 will be held digitally from October 25-28, 2021 (Press release, ImmunoPrecise Antibodies, OCT 13, 2021, View Source [SID1234591163]). BIO-Europe brings the global biopharma and investment leaders together to build partnerships and facilitate innovation and medical breakthroughs. ImmunoPrecise Antibodies will attend the conference and participate in one-to-one meetings and join round table discussions with industry thought-leaders.

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On October 13, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has fully accrued the initial planned number of participants in Cohort C (third-line or greater) of its Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) in advanced metastatic pancreatic cancer (Press release, ImmunityBio, OCT 13, 2021, View Source [SID1234591162]). The majority of participants in the study to date remain on therapy and 90% (43/48) of the evaluable patients have exceeded the approximately two-month historical survival rate. Of the 48 evaluable patients, 23 (48%) had extremely advanced disease upon enrollment (i.e. had progressed after three to six prior lines of therapy) and, of these patients, 20 out of 23 (87%) have exceeded historical survival rates. On the strength of this early data and significant unmet medical need, the company has submitted an amendment to increase enrollment in Cohort C.

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"Patients with advanced metastatic pancreatic cancer who have failed all standards of care have very grave prognoses with few treatment options. This study was to explore if the Nant Cancer Vaccine could address this unmet need," said Patrick Soon-Shiong, M.D., Founder and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. "It is gratifying to note that patients in this study, who had progressed after up to six lines of prior therapy, have exceeded historical survival rates despite having very advanced pancreatic cancer upon enrollment."

QUILT 88 is an open-label study to evaluate the safety and efficacy of the Nant Cancer Vaccine, comprising ImmunityBio’s IL-15 receptor agonist Anktiva (N-803), its off-the-shelf targeted natural killer cells (PD-L1 t-haNK), and aldoxorubicin, an albumin-modulated agent, plus low-dose chemotherapy. This combination therapeutic vaccine will be randomized against standard-of-care high-dose chemotherapy for first- and second-line treatment; the third-line cohort, with a target of 50 patients, is a single arm with the primary endpoint of overall survival.

Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. every year. Surgery and subsequent adjuvant chemotherapy are the preferred treatment options for pancreatic cancer today and the five-year survival rate for late-stage cases is just 3%. For the majority of patients who present with more advanced disease, treatment typically consists of chemotherapy alone or supportive care for metastatic patients, and chemotherapy with or without radiation for those with locally advanced disease.

"Achieving robust enrollment in this patient group and early promising efficacy evidence are important milestones in ImmunityBio’s effort to develop this therapeutic with the potential to improve survival rates and provide a replacement for toxic chemotherapy," continued Soon-Shiong. "As the historical survival rate for third- to sixth-line pancreatic cancer patients is approximately two months, we are encouraged by this early data and have decided to open this cohort to more patients with advanced metastatic disease who have no further treatment options."

QUILT-88 Study Details

This Phase 2, randomized, three-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy, in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which serves patients in the tri-state area (Iowa, Nebraska and South Dakota).

On October 13, 2021 Prescient Therapeutics (ASX: PTX) reported that it has revealed new data that demonstrates the capability of its OmniCAR cell therapy technology in killing multiple cancer cells (Press release, Prescient Therapeutics, OCT 13, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-unveils-new-data-validating-cancer-cell-therapy-technology [SID1234591148]).

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The company is presenting this pre-clinical data this week at a cell therapy conference in California, US known as the ‘Cell and Gene Meeting on the Mesa’.

In its conference presentation, Prescient said OmniCAR’s key attributes include a dose response relationship that exhibits tumour killing activity and high potency, a demonstrated re-arming of OmniCAR-T cells, and sequential arming to re-direct OmniCAR-T cells from one cancer antigen to another.

This most recent work was conducted in collaboration with the Peter MacCallum Cancer Centre in Melbourne, Victoria and Prescient director of scientific affairs Dr Rebecca Lim said data continues to be "extremely positive".

"Our most recent work… showed that OmniCAR-T cells begin antigen-directed killing of tumour cells in vitro as soon as they are armed.

"The team also showed that OmniCAR-T cells could be re-armed and continue to kill tumour cells without loss of cytotoxicity," she added.

Dr Lim described the early wins as "extremely encouraging".

"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."

"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."

Cells able to be redirected to different antigen target
Prescient is developing OmniCAR programs for next-generation CAR-T therapies for acute myeloid leukemia (AML), Her2-plus solid tumours including breast, ovarian and gastric cancers, and the brain cancer known as glioblastoma multiforme (GBM).

In particular, GBM is characterised by antigen heterogeneity and rapid mutations that drive rapid progression of the cancer. These characteristic make CAR-T and other therapies challenging as they rely on single antigen targeting.

Prescient is seeking to overcome these limitations with the development of OmniCAR to enable mutli-antigen targeting.

In a novel experiment, OmniCAR was tested sequentially against a co-culture of GBM cells expressing antigens, Her2 or EGFRviii. OmniCAR-T cells pre-armed with EGFRviii binders demonstrated rapid cytotoxicity against those GBM cells expressing EGFRviii.

Meanwhile, subsequent administration of Her2 binders demonstrated rapid switching of OmniCAR-T cells arming with Her2, and corresponding rapid cytotoxicity against Her2-plus GBM cells.

According to Prescient this shows that OmniCAR cells can be redirected to a different antigen target upon administration of a different SpyTagged binder without needing new cells. In each case, OmniCAR exhibited highly targeted tumour killing.

Prescient believes this highly novel feature will also be important in developing OmniCAR for AML, which is another cancer characterised by high antigen heterogeneity, rapid mutations and rapid disease progression.

Yet to discover true limits of OmniCAR technology
Prescient managing director and chief executive officer Steven Yatomi-Clarke said the large body of work accomplished so quickly and successfully is a credit to the team and its collaborators at Peter MacCallum Cancer Centre.

"Importantly, none of these tests have even been optimised, so we have yet to see the true limits of this technology," he said.

"OmniCAR is proving to be a predictable and powerful system to work with. We look forward to sharing updates as our programs progress."