On October 7, 2021 PierianDx, the global leader in clinical genomics knowledge, reported that it will partner with Florida Cancer Specialists & Research Institute (FCS) to support expanded access to the highest quality genomic testing on solid tumors and hematologic malignancies and lymph nodes leveraging NGS technology (Press release, PierianDx, OCT 7, 2021, View Source [SID1234590914]). Under the partnership, FCS will locally analyze and interpret sequencing data generated with the Illumina TruSight Oncology 500 Research Use Only assay and the Invitae VariantPlex, LiquidPlex, and FusionPlex panels using PierianDx Clinical Genomic Workspace (CGW) to rapidly and accurately detect mutations and offer the best therapeutic options for patients.

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Historical approaches to precision medicine testing include centralized testing performed at large national laboratories where the laboratory typically has little-to-no interaction with the patient and limited treating physician interaction. By localizing genomic testing, FCS patients will benefit from more direct access to testing within the context of care. Offering these tests in the FCS laboratory will also enable improved collaboration between the diagnostic team who interpret the test results and the treating physicians, which drives alignment across the care team and increases confidence in the clinical utility of genomic testing.

The genomic test results at Florida Cancer Specialists will be delivered via a customizable report generated by the PierianDx CGW. Powered by a comprehensive knowledgebase and secure and scalable data analysis platform, the PierianDx CGW will enable Florida Cancer Specialists to quickly and accurately classify and interpret variants to inform treatment or match patients to the right trial within the practice’s large network of participating clinical trials.

According to Florida Cancer Specialists CEO Nathan H. Walcker, "We see tremendous clinical and strategic value to performing this very important testing in-house. By offering in-house genomic testing, we will continue to seek the best options for care for our patient population by quickly and efficiently providing existing treatments as well as optimizing clinical trial matching opportunities. We look forward to partnering with PierianDx to provide even greater tools to our physician partners at FCS and enabling wider access to high complexity testing to the patients we are privileged to serve."

"We are thrilled to provide our best-in-class bioinformatics and knowledge platform to support personalized, community-based cancer care," states Mark McDonough, CEO of PierianDx. "Partnering with leading-edge institutions like Florida Cancer Specialists aligns perfectly with our mission to democratize clinical genomics and to optimally serve physicians and the patients they treat."

On October 7, 2021 Crown Bioscience, a JSR Life Sciences company and leader in translational services that help biopharmaceutical companies accelerate new drug development programs, reported the launch of its ‘3D Ex Vivo Patient Tissue Platform’ (Press release, Crown Bioscience, OCT 7, 2021, View Source [SID1234590913]). Using freshly collected patient tumor material, this new service can accurately measure oncology and immuno-oncology drug-induced tumor killing and endogenous immune cell proliferation in a high throughput format. Researchers are presenting data on the new platform at this year’s AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), which is happening virtually on October 7-10, 2021.

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The proprietary technology, developed at Crown Bioscience’s recently acquired site in Leiden, The Netherlands (formerly known as OcellO B.V.), aims to improve clinical success rates by using the most patient-relevant tumor samples to better predict tumor response to potential drug candidates.

"Our goal is to leverage our core technologies to build a translational model system that adequately captures the tumor architecture and microenvironment, and improves the predictability of patient responses to treatment protocols for existing and potential therapeutic candidates," said Leo Price, PhD, Senior Vice President, In Vitro. "We believe this approach provides greater translational relevance in drug development by using immuno-competent primary human tumor tissue to help analyze drug candidate responses before the program enters clinical trial. This approach is an optimal fit with our mission to help deliver the right drug to the right patient at the right time."

The ‘3D Ex Vivo Patient Tissue Platform’ utilizes patient tumor tissue isolated from biopsies, surgical resections, ascites, or pleural effusion samples that are processed within 24 hours to preserve the tumor microenvironment. The automated high throughput platform uses high content 3D imaging and image analysis to quantify distinct responses of individual cell populations in fresh patient tissues. These analyses can assess responses to different doses of therapeutic candidates at various timepoints and can determine the effects of the drug or combination of drugs on tumor killing and immune cell proliferation.

"We believe this new service can help fill a critical gap in today’s research landscape with early translational patient-relevant ex vivo models that can assess efficacy and determine mechanisms of action," commented Armin Spura, PhD, Chief Executive Officer of Crown Bioscience. "This new service offering is designed to help mitigate the high failure rates of clinical programs in oncology, and was one of the objectives coming out of our recent OcellO acquisition. We are delighted to provide immediate value to our customers from this investment and look forward to the future value that this acquisition will bring."

AACR-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper)
Researchers from CrownBio are conducting a poster presentation titled, "Novel Near Vivo Drug Response Platform for Oncology using 3D Ex Vivo Patient-Derived Microtumors" at the annual conference. The poster summarizes:

This 3D high content assay on ex vivo patient tumor material preserves native tumor microenvironement and architecture

Ex vivo testing using ultra fresh patient tumor samples maintains intact endogenous immune cell populations

Ongoing clinical trial collaborations with tissue providers for ovarian cancer, bladder cancer, NSCLC, and other tumor samples

On October 7, 2021 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that the company now controls 100% of the share capital of Genkyotex SA ("Genkyotex"), after the completion of a centralized squeeze out offer to all minority shareholders (Press release, Calliditas Therapeutics, OCT 7, 2021, View Source [SID1234590894]).

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Genkyotex’s lead product candidate, setanaxib, is a first-in-class NOX inhibitor that targets NOX 1 and NOX 4, which are major drivers of fibrogenesis in multiple organs. In Q4 2021, Calliditas plans to initiate a 52-week, randomized, placebo-controlled, double-blind, trial with an adaptive phase 2b/3 design with setanaxib in 318 patients with primary biliary cholangitis (PBC). As previously announced in August 2021, Calliditas received FDA fast track designation for setanaxib in PBC. Calliditas will also initiate a Phase 2 proof-of-concept study in head and neck cancer in 2021, which will investigate the administration of setanaxib in conjunction with immunotherapy targeting cancer associated fibroblasts (CAFs).

"We are delighted to have completed our acquisition of Genkyotex, which means that we now can fully integrate the business and thereby leverage the platform optimally", said CEO Renée Aguiar-Lucander.

Subsequent to the squeeze-out, Genkyotex has become a wholly owned subsidiary of Calliditas and have been delisted from the Euronext stock exchanges.

The information was sent for publication, through the agency of the contact persons set out above, on October 7, 2021 at 8:00 a.m. CET.

On October 7, 2021 The Board of Directors of Alligator Bioscience AB (publ) ("Alligator" or "the Company") reported that , subject to approval by the Extraordinary General Meeting on 8 November 2021, resolved to carry out a rights issue of shares with preferential rights for the Company’s existing shareholders of approximately SEK 257 million (the "Rights Issue") (Press release, Alligator Bioscience, OCT 7, 2021, View Source [SID1234590892]). The Company has received subscription commitments from a selection of the Company’s larger existing shareholders, including the AP4, Roxette Photo NV and Omentum S.A., amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments of approximately SEK 214 million, which secures the Rights Issue up to 100 percent. In addition, Öhman Fonder and all members of the Company’s board and management with shareholdings in the Company have expressed their intention to subscribe for their respective pro rata share in the Rights Issue. Alligator will use the proceeds from the Rights Issue to conduct phase II studies for mitazalimab, preparations for and initiation of phase II studies for ATOR-1017 and further development of other pipeline candidates. The Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021, and the notice of the Extraordinary General Meeting will be announced in a separate press release.
Summary

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One (1) existing share in the Company entitles to three (3) subscription rights. Two (2) subscription rights entitle to subscription of one (1) new share, i.e., a subscription ratio of 3:2.
The subscription price is SEK 2 per new share, which, assuming the Rights Issue is fully subscribed, results in the Company receiving issue proceeds of approximately SEK 257 million before deduction of transaction costs.
The record date for the Rights Issue is 10 November 2021 and the subscription period runs from and including 12 November 2021 up to and including 26 November 2021.
The last day of trading in the Alligator share including the right to participate in the Rights Issue is 8 November 2021.
The board’s resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021. Major shareholders, who together represent approximately 17 percent of the shares and votes in the Company, have undertaken to vote for the Rights Issue at the Extraordinary General Meeting.
Major shareholders have expressed their support for the Rights Issue through subscription commitments amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments of approximately SEK 214 million, corresponding to approximately 83 percent of the Rights Issue, which secures the Rights Issue up to 100 percent. The guarantee commitments consist partly of a so-called top guarantee and partly of a bottom guarantee. In addition, Öhman Fonder and all members of the Company’s board and management have expressed their intention to subscribe for their respective pro rata share in the Rights Issue.
The Company intends to publish a prospectus regarding the Rights Issue on 9 November 2021.

Background and reason for the Rights Issue

Alligator is active in the phases of drug development that range from idea and early research to clinical phase II studies in patients. This includes, among other things, the development and optimization of new drug candidates, evaluation of preclinical efficacy and safety, and finally confirmatory clinical studies on cancer patients.

Alligator has shown strong Proof of Mechanism data in Phase I studies for mitazalimab, Alligator’s most advanced immuno-oncology candidate. In 2021, the Company’s focus has been on preparations for the inclusion of the first patient in the clinical phase II study OPTIMIZE-1. The first patient was successfully included in September 2021 and interim efficacy data are estimated for the end of the fourth quarter of 2022. In order to balance the risk in the Company’s development portfolio and to increase the likelihood of clinical success, Alligator is planning a second phase II study with mitazalimab, OPTIMIZE-2. In the study, mitazalimab is planned to be combined with current standard of care in renal cell carcinoma, bladder cancer or hepatocellular carcinoma. OPTIMIZE-2 is expected to start in the second half of 2022.

In June 2021, new promising data from the Phase I study with ATOR-1017 were presented, confirming the therapeutic potential and demonstrating clear signals of proof of mechanism in combination with a favorable safety profile. Previous interim data, presented in the fall of 2020, from the ongoing Phase I study in patients with advanced cancer showed a promising safety profile for ATOR-1017, with only a few drug-related side effects all being mild or moderate (grade 1 or 2). Preparations are ongoing to start clinical Phase II studies, which is expected to take place during the third quarter of 2022.

To ensure continued successful development in accordance with the Company’s business plan and strategy, Alligator has resolved to carry out the Rights Issue. The Rights Issue is estimated to provide Alligator with approximately SEK 257 million before transaction costs. The board assesses that the working capital requirement for the coming twelve-month period is met by available cash and the net proceeds from the Rights Issue.

The expected net proceeds from the Rights Issue will, in the following order of priority and with an approximate proportion indicated in parentheses, be used for:

Conduction of phase II studies with mitazalimab (65 percent)
Preparations for and initiation of phase II study for ATOR-1017 (15 percent)
Development of other pipeline candidates (20 percent)

Terms of the Rights Issue

Those who are registered as shareholders on the record date, 10 November 2021, have the preferential right to subscribe for new shares in the Rights Issue in relation to the number of shares held on the record date. One (1) existing share in the Company entitles to three (3) subscription rights. Two (2) subscription rights entitle to subscription of one (1) new share, i.e., a subscription ratio of 3:2. In addition, investors are offered the possibility to subscribe for shares without subscription rights.

If not all newly issued shares are subscribed for by exercise of subscription rights, allotment of the remaining shares shall be made within the highest amount of the Rights Issue: firstly, to those who have subscribed for shares by exercise of subscription rights (regardless of whether they were shareholders on the record date or not) and who have applied for subscription of shares without exercise of subscription rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of subscription rights that each and every one of those, who have applied for subscription of shares without exercise of subscription rights, have exercised for subscription of shares; secondly, to those who have applied for subscription of shares without exercise of subscription rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of shares the subscriber in total has applied for subscription of shares; and thirdly, to those who have provided underwriting commitments with regard to subscription of shares, in proportion to such underwriting commitments. To the extent that allotment in any section above cannot be done pro rata, allotment shall be determined by drawing of lots.

The subscription price is SEK 2 per new share. Provided that the Rights Issue is fully subscribed, the share capital will increase by a maximum of SEK 51,399,802.80 by a new issue of a maximum of 128,499,507 new shares. In the event of full subscription, the Rights Issue will provide Alligator with approximately SEK 257 million before deduction of issue costs. Shareholders who choose not to participate in the Rights Issue will, provided that the Rights Issue is fully subscribed, have their ownership diluted by approximately 60 percent, but are able to financially compensate for this dilution by selling their subscription rights.

Subscription of shares shall take place during the period from and including 12 November 2021 to and including 26 November 2021. The board has the right to extend the subscription and payment period. A possible extension of the subscription period shall be announced by press release no later than the last subscription day in the Rights Issue, i.e. 26 November 2021. Trading in subscription rights takes place on Nasdaq Stockholm during the period from and including 12 November 2021 to and including 23 November 2021 and trading in paid subscribed shares (Sw. Betalda tecknade aktier) during the period from and including 12 November 2021 until the Rights Issue has been registered with the Swedish Companies Registration Office (Sw. Bolagsverket).

Subscription commitments, guarantee commitments and declarations of intent

Alligator has received subscription commitments from a selection of the Company’s larger existing shareholders, including the AP4, Roxette Photo NV and Omentum S.A., amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments in the form of a so-called bottom guarantee of approximately SEK 188 million, corresponding to approximately 73 percent of the Rights Issue, and a so-called top guarantee of approximately SEK 26 million, corresponding to approximately 10 percent of the Rights Issue. In addition, Öhman Fonder and all members of the Company’s board and management with shareholdings in the Company, including Søren Bregenholt (CEO), Anders Ekblom (Chairman of the board), Marie Svensson (CFO), Peter Ellmark (CSO), Veronica Wallin (board member) and Hans-Peter Ostler (board member), have expressed their intentions to subscribe for their respective pro rata share in the Rights Issue. The bottom guarantee ensures, provided that subscription corresponds to at least the subscription commitments, that approximately 90 percent of the Rights Issue is subscribed and paid for. Through the top guarantee, provided that subscription corresponds to at least the subscription commitments and the bottom guarantee, that 100 percent of the Rights Issue is subscribed and paid for.

For the guarantee commitments, compensation is paid either in cash or in the form of newly issued shares in the Company. The subscription price for any shares issued to guarantors shall correspond to 90 percent of the volume-weighted average share price (VWAP) for the Company’s share on Nasdaq Stockholm during the subscription period in the Rights Issue (i.e. during the period 12 – 26 November 2021), however no lower than the subscription price in the Rights Issue. In order to enable new issues of shares as guarantee compensation to the guarantors who choose to receive guarantee compensation in newly issued shares, the board has proposed that the Extraordinary General Meeting on 8 November 2021, which is proposed to resolve on the approval of the Rights Issue, also resolves on authorization for the board to resolve on new issues of such shares to guarantors.[1]

Preliminary timeline for the Rights Issue

8 November 2021

Extraordinary General Meeting

8 November 2021

Last day of trading incl. preferential rights

9 November 2021

First day of trading excl. preferential rights

9 November 2021

Estimated publication of prospectus

10 November 2021

Record date

12 November – 23 November 2021

Trading in subscription rights

12 November – 26 November 2021

Subscription period

12 November 2021 – Until the Rights Issue is registered at the Swedish Companies Registration Office

Trading in paid subscription shares (Sw. "BTA")

1 December 2021

Estimated publication of outcome in the Rights Issue

Lock-up agreements

In connection with the Rights Issue, the Company has undertaken towards the Joint Global Coordinators, subject to customary exceptions, not to issue additional shares or other share-related instruments for a period of 180 days after the end of the subscription period in the event of an issue with preferential rights for existing shareholders, and 90 days after the end of the subscription period in the event of an issue without preferential rights for existing shareholders. In addition, the Company’s board members and senior executives who own shares in Alligator, subject to customary exceptions, have undertaken, towards the Joint Global Coordinators, not to transfer or otherwise sell their shares for a period of 180 days after the end of the subscription period.

Extraordinary General Meeting

The board’s resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021. Notice of the Extraordinary General Meeting will be announced in a separate press release.

Prospectus

Full terms and conditions for the Rights Issue, as well as other information about the Company and information about subscription commitments, guarantee commitments and lock-up commitments will be presented in the prospectus that the Company is expected to publish around 9 November 2021 (the "Prospectus").

Advisers

DNB Markets, a part of DNB Bank ASA, Sweden Branch and Redeye AB act as Joint Global Coordinators in connection with the Rights Issue. Setterwalls Advokatbyrå AB acts as legal adviser to Alligator and Baker & McKenzie Advokatbyrå KB acts as legal adviser to the Joint Global Coordinators in connection with the Rights Issue. Aktieinvest FK AB acts as the issuing agent in the Rights Issue.

On October 6, 2021 Cothera Bioscience Inc. and Adastra Pharmaceuticals Inc., private biopharmaceutical companies focused on the development of first-in-class therapeutics for the treatment of cancer, reported a definitive agreement under which Cothera has acquired zotiraciclib (ZTR), an oral kinase inhibitor that readily crosses the blood brain barrier and possesses a unique mechanism of action of Myc depletion via the inhibition of cyclin-dependent kinase 9 (CDK9) (Press release, Cothera Bioscience, OCT 6, 2021, View Source [SID1234627381]). Financial terms of the asset purchase were not disclosed.

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In June 2021, the results of the zotiraciclib Phase 1b clinical trial were published in Clinical Cancer Research. The conclusion of the Phase 1b trial found that Zotiraciclib combined with temozolomide (TMZ) is safe in patients with recurrent high-grade astrocytomas.

After the conclusion of the trial a successful Type B meeting with the U.S. Food and Drug Administration Division of Oncology (D02) was held. The transition of ZTR from Adastra to Cothera enables the execution of clinical development plans built on input from the FDA meeting, as well as insight from global neuro-oncology thought-leaders and clinical investigators.

"The acquisition of zotiraciclib fits nicely into the Cothera portfolio of differentiated drug candidates synergistically aligning to our current research efforts to address cancers driven by the Myc oncogene," said Alex Wu, Ph.D., President and Chief Executive Officer and Founder of Cothera. "Importantly, zotiraciclib adds to the Cothera portfolio of therapeutics that hold promise for cancer patients around the world."

Scott Megaffin, Chief Executive Officer of Adastra, said, "I want to thank all the physicians and dedicated healthcare providers who have put forward relentless effort on behalf of their patients as the Adastra team transitions zotiraciclib into Cothera."

Vernon Jiang, Ph.D., Executive Vice President and Co-Founder of Cothera, added, "We are grateful to Adastra for its important work with physicians within neuro-oncology. Cothera is enthusiastic to build upon these relationships, as we believe highly in the promise of zotiraciclib in high-grade gliomas and pediatric mid-line gliomas such as Diffuse Intrinsic Pointe Glioma (DIPG).