On October 3, 2022 Estrella Biopharma, a preclinical-stage biopharmaceutical company focusing on cancer therapeutics, and TradeUP Acquisition Corp., a publicly traded special purpose acquisition company, reported that they have entered into a definitive business combination agreement on September 30, 2022 that will result in Estrella becoming a publicly listed company (Press release, Estrella Biopharma, OCT 3, 2022, View Source [SID1234628554]).

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Upon closing of the transaction, TradeUP will be renamed "Estrella Immunopharma, Inc." (the "Combined Company").

Estrella is a preclinical-stage biopharmaceutical company developing CD19-targeted ARTEMIS️ T-cell therapies under certain license agreements with the capacity to address treatment challenges for patients with blood cancers and solid tumors. Estrella’s lead product candidate, EB103, a CD19-Redirected ARTEMIS️ T-cell therapy, targets CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, a CD19/22 duel-targeting ARTEMIS️ T-cell therapy, which targets both CD19 and CD22, a protein expressed on the surface of mature B lymphocytes. EB103 and EB104 utilize the ARTEMIS Cell Receptor Platform technologies Estrella has in-licensed from Eureka Therapeutics, Inc. ("Eureka") earlier this year. Estrella is also collaborating with Imugene Ltd and its product candidate, CF33-CD19t, an oncolytic virus ("CF33-CD19t"), which forces solid tumor cells to express a CD19 target, to treat solid tumors in a "Mark and Kill" strategy.

Estrella’s President and CEO, Cheng Liu, PhD and the current management team will continue to lead the Combined Company. Dr. Liu will also continue in his role as President and CEO of Eureka.

"Estrella is committed to making a meaningful difference in areas of unmet medical needs by continue advancing our pipeline programs into the clinics. The team is confident that fueled by ARTEMIS technologies, EB103 and EB104 have the potential to address blood cancers while mitigating safety concerns. Meanwhile, we plan to extend the use of our CD19 ARTEMIS️ T-cell therapy into diverse solid tumors by combining with Imugene’s CF33-CD19t in the novel "Mark and Kill" approach," said Dr. Liu, President and CEO of Estrella. "We are delighted to have found such a stellar group of partners and investors as we take the next step in our growth trajectory as a public company."

Weiguang Yang, Co-CEO of TradeUP, commented: "We are truly excited about the merger with Estrella. Estrella represents a rare opportunity to further advance T-cell therapies in minimizing life-threatening side effects such as Cytokine Release Syndrome ("CRS") and has the potential to address blood cancers while mitigating safety concerns. The collaboration with Imugene is expected to tackle the major challenge for current T-cell therapies in solid tumor treatment. We believe this business combination will provide Estrella or the Combined Company the financial resources to continue developing its lead drug candidate and bring its novel therapies to fruition."

Transaction Overview
The pro forma equity valuation (assuming no redemptions) of the Combined Company is expected to be approximately $398.5 million. Estimated cash proceeds to the Combined Company from the transaction are expected to consist of TradeUP’s approximately $45.4 million of cash in trust (assuming no redemptions).

Upon the closing of the transaction, and assuming none of TradeUP’s public stockholders elect to redeem their shares of common stock and no additional shares of common stock are issued upon the closing of the transaction, it is anticipated that TradeUP’s public stockholders would retain an ownership interest of approximately 11.1% in the Combined Company, the sponsors, officers, directors and other holders of TradeUP founder shares will retain an ownership interest of approximately 3.6% of the Combined Company, and the Estrella stockholders will own approximately 81.6% of the Combined Company.

The board of directors of each of TradeUP and Estrella as well as stockholders of Estrella approved the transaction, which is expected to close in the first half of 2023. The transaction will require the approval of the stockholders of TradeUP and is subject to other customary closing conditions including the receipt of certain regulatory approvals.

Additional information about the proposed transaction, including a copy of the business combination, will be provided in a Current Report on Form 8-K to be filed by TradeUP with the SEC and available at www.sec.gov.

On October 3, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, OCT 3, 2022, View Source [SID1234621785]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 August 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 August 2022 to 31 October 2022.

Since the announcement 26 September, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 21,376,688 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 30 September 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 19,665,909 B shares at an average share price of DKK 768.55 per B share equal to a transaction value of DKK 15,114,315,530.

On October 3, 2022 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), a clinical-stage biopharmaceutical company that is developing unique therapies in the field of immuno-oncology based on its proprietary technology platform DOS47, reported the appointment of Dr. Frank Gary Renshaw, as the Chief Medical Officer (Press release, Helix BioPharma, OCT 3, 2022, View Source [SID1234621767]).

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Dr. Renshaw has been with Helix since December 2019 as a consultant and member of the Scientific and Strategic Advisory Board. He brings more than 20 years’ experience as a drug developer within the health care industry and has previously provided leadership with his medical and/or scientific expertise, from pre-clinical laboratory and animal tumor model development, to presiding over six successful new drug applications, eight approvals at the EMA, including two biological applications, and more than two dozen successful FIH IND’s and EMA new drug submissions.

Recently, he has provided further expertise as the Chief Medical Officer, and lead Oncology consultant for several Bio-Pharmaceutical global entities, as well as the Global lead on many radiotherapies, Chemotherapy, Devices, and Immuno-Oncology clinical programs. "Dr. Renshaw will bring to Helix BioPharma his several decades of development experience in oncologyhematology, Molecular/Immuno-Oncology drug research. We look forward to his leadership in helping shape the future of our work at Helix.", said Artur Gabor, Helix’s Chief Executive Officer.

Dr. Renshaw stated, "L-DOS47 has the potential to enhance the efficacy of chemo-and IO-therapies for treatment of various tumors by modulating the tumor microenvironment. *With promising data already generated from preclinical experiments and previous clinical trials, I am excited to lead the next phase of clinical development to bring this improved therapy for cancer patients at the earliest.

Frank Gary Renshaw Bio
Dr. Frank Gary Renshaw is an Oncologist-Hematologist having completed his training at the medical school at University of Medicine and Dentistry of New Jersey at the Cardeza Foundation and Temple University Skin and Cancer Hospital and was a resident within the Oncology immunology research group at the Cancer Institute of NJ. Subsequent to this, he trained during his Oncology fellowship with the Cancer Immuno-Biological therapy group at MD Anderson Cancer Center and completed a molecular Biology fellowship at the NIH Naval Medical center where he worked on FIH trials of T-Cell therapy. During his academic career he worked as an Oncology consultant and Primary investigator to the Glaxo Smith Kline, Immunex, Chiron, Bristol Myers Squibb, and Sinclair Swine melanoma research, companies. From his academic rolls, Dr. Renshaw was then recruited to chair the US Gastrointestinal Oncology group at Eli Lilly company, leading several early development programs as well as the later stages of drug clinical/research development of Gemcitabine, and including pharmacogenetic/dynamics work for the eventual multiple approvals Pemetrexed for NSCLC and Mesothelioma.

On October 3, 2022 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations, used to safely and effectively destroy various cancers, bacteria and viruses, reported that it has commenced a non-brokered $CAN 2.5 M follow-on private placement equity financing ("Financing") (Press release, Theralase, OCT 3, 2022, View Source [SID1234621759]).

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Under the terms of the Financing, up to 10,000,000 Units are available to be sold to accredited investors at a price of $0.25 per Unit for aggregate gross proceeds of up to $CAN 2,500,000.

Each Unit will consist of one common share of the Company ("Common Share") and one common share purchase warrant ("Warrant"). Each Warrant will entitle the holder to acquire an additional Common Share at an exercise price of $0.35 per share for a period of 24 months following the date of closing.

The Company intends to use the proceeds of the Financing for the following:

Good Laboratory Practice ("GLP") toxicology study for intravenous installation of Rutherrin intended for the treatment of Non-Small Lung Cancer ("NSCLC") and Glio-Blastoma Multiforme ("GBM"), a fast-growing and aggressive brain tumor.
Advancement of Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study
Working capital and general corporate purposes
In connection with the Financing, a finder’s fee of 6% (payable in cash or stock) and 3% finder’s warrant (exercise price of $0.35 for a period of 24 months following the closing of the Financing) will be payable to eligible finders.

Research Capital Corporation is acting as a finder in connection with the Financing.

Closing of the Financing is subject to approval by the TSX Venture Exchange. Securities issued in the Financing are subject to a statutory hold period of four months.

Closing of the Financing is intended to occur on or about October 14, 2022.

The securities referred to in this news release have not been, and will not be, registered under the United States Securities Act of 1933, as amended ("U.S. Securities Act"), or any applicable securities laws of any state of the United States, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act) or persons in the United States unless registered under the U.S. Securities Act and any other applicable securities laws of the United States or an exemption from such registration requirement is available. 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 the securities offered in any jurisdiction in which such offer, solicitation or sale would be unlawful, including the United States.

On October 3, 2022 Pfizer Inc. (NYSE: PFE) reported the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC ODT (rimegepant), an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults (Press release, Pfizer, OCT 3, 2022, View Source [SID1234621674]).

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The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including:

Rimegepant:
Approved in the United States under the trade name NURTEC ODT, in adults for both the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine
Approved in the European Union under the trade name VYDURA for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month
Zavegepant:
New Drug Application (NDA) for intranasal spray for the acute treatment of migraine under U.S. Food and Drug Administration (FDA) review, with a Prescription Drug User Fee Act (PDUFA) goal date in 1Q 2023
A portfolio of pre-clinical CGRP assets
"We are proud to build on Pfizer’s legacy of delivering breakthrough medicines for patients living with complex pain disorders," said Aamir Malik, Executive Vice President, Chief Business Innovation Officer, Pfizer. "The success of NURTEC ODT coupled with Biohaven’s CGRP pipeline will strengthen Pfizer’s innovative Internal Medicine pipeline through 2030, and beyond. Combined with Pfizer’s global reach, this acquisition increases our potential to bring new treatment options to patients with migraine – a disease which affects over 1 billion people worldwide."i

Pfizer acquired all of the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for a total transaction consideration of approximately $11.6 billion. As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer.

Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), distributing Biohaven Ltd.’s shares to Biohaven’s shareholders. Biohaven Ltd., a new company that retained Biohaven’s non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker "BHVN".

For additional background on the acquisition, please read the announcement press release here.

About Migraine

Worldwide, more than one billion people suffer from migraine, which predominately affects women.i Findings from the 2019 Global Burden of Disease study indicate that migraine is one of the worlds leading causes of disability.ii Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).iii

About Rimegepant

Rimegepant targets a key component of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec ODT for the acute treatment of migraine in adults in February 2020 and for the preventive treatment of episodic migraine in adults in May 2021. Nurtec ODT is taken orally as needed, up to once daily for acute treatment, and every other day for preventive treatment. The maximum dose in a 24 hour period is 75 mg.

NURTEC ODT U.S. IMPORTANT SAFETY INFORMATION

Contraindications: Hypersensitivity to Nurtec ODT or any of its components.

Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue Nurtec ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.

Adverse Reactions: The most common adverse reactions were nausea (2.7% in patients who received Nurtec ODT compared to 0.8% in patients who received placebo) and abdominal pain/dyspepsia (2.4% in patients who received Nurtec ODT compared to 0.8% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with Nurtec ODT.

Drug Interactions: Avoid concomitant administration of Nurtec ODT with strong inhibitors of CYP3A4 or strong or moderate inducers of CYP3A. Avoid another dose of Nurtec ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4 or potent inhibitors of P‑gp.

Use in Specific Populations: Pregnancy: It is not known if Nurtec ODT can harm an unborn baby. Lactation: The transfer of rimegepant into breastmilk is low (<1%). Hepatic impairment: Avoid use of Nurtec ODT in persons with severe hepatic impairment. Renal impairment: Avoid use in patients with end-stage renal disease.

INDICATIONS

Nurtec ODT is indicated in adults for the:

acute treatment of migraine with or without aura
preventive treatment of episodic migraine
Please click here for full Prescribing Information.

About Zavegepant

Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from the NOJECTION Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The FDA has accepted for review a New Drug Application (NDA) for zavegepant nasal spray, with a PDUFA date in 1Q 2023.