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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On October 3, 2022, Evaxion Biotech A/S (the "Company") reported that it entered into a Capital on DemandTM Sales Agreement (the "Sales Agreement") with JonesTrading Institutional Services LLC ("JonesTrading"), pursuant to which the Company may sell from time to time, at its option, American Depositary Shares ("ADSs"), each representing one ordinary share, DKK 1 nominal value per share, of the Company (the "Ordinary Shares"), through or to JonesTrading, as sales agent or principal (Filing, 6-K, Evaxion Biotech, OCT 3, 2022, View Source [SID1234621660]). The ADSs will be offered pursuant to the Company’s prospectus supplement, dated October 3, 2022 (the "Prospectus Supplement"), which was filed with the Securities and Exchange Commission (the "SEC") on such date and the Company’s shelf registration statement on Form F-3 (Registration No. 333-265132). Pursuant to the Prospectus Supplement, the Company may offer and sell up to an aggregate of $14,439,000 of ADSs. Sales of the Company’s ADSs made pursuant to the Sales Agreement, if any, will be made by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. JonesTrading is not required to sell any specific number or dollar amount of ADSs, but will use its commercially reasonable efforts to sell the ADSs from time to time, based upon the Company’s instructions, including any price, time or size limits or other customary parameters or conditions the Company may impose.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company is not obligated to make any sales of ADSs under the Sales Agreement, and the Company cannot provide any assurances that it will issue any ADSs pursuant to the Sales Agreement. The offering of ADSs pursuant to the Sales Agreement will terminate as permitted therein. The Company is obligated to pay JonesTrading an aggregate sales agent commission equal to 3.0% of the gross sales price for ADSs sold under the Sales Agreement. The Company has also provided JonesTrading with customary indemnification rights and expense reimbursements.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Report on Form 6-K.

The opinion of Mazanti-Andersen Advokatpartnerselskab, Copenhagen, Denmark. relating to the validity of the Ordinary Shares represented by the ADSs being offered is filed as Exhibit 5.1 to this Report on Form 6-K. This Report on Form 6-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any sale of these securities in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

On October 3, 2022 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies, reported that it has nominated THE-349 as the development candidate for its epidermal growth factor receptor (EGFR) inhibitor program in non-small cell lung cancer (NSCLC) (Press release, Theseus Pharmaceuticals, OCT 3, 2022, View Source [SID1234621656]). THE-349 is designed to address treatment resistance to existing EGFR inhibitors by targeting the common activating mutations in exons 19 and 21 alone or in combination with the most frequently observed resistance mutations, T790M and C797X. In preclinical models, THE-349 potently inhibits single-, double-, and triple-mutant EGFR variants with these mutations that are observed in a post-first- or later-line osimertinib setting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Preclinical characterization of THE-349 as a fourth-generation EGFR, central nervous system- (CNS) active, and mutant-selective inhibitor with potent activity against single-, double-, and triple-mutant EGFR variants, including T790M and C797X, will be shared in a poster presentation at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium taking place in Barcelona on October 26-28, 2022.

"We are delighted to announce THE-349 as the Company’s second development candidate and we look forward to evaluating its potential in patients with EGFR-mutant NSCLC," said William Shakespeare, Ph.D., President of Research and Development at Theseus. "Clonal heterogeneity in patients who develop resistance to osimertinib is complex, and we believe a single EGFR inhibitor capable of targeting all major mutant forms of EGFR activating and resistance mutations is the optimal way to address this urgent medical need."

NSCLC is the most common form of lung cancer. Activating mutations in EGFR occur in 10-15% of Caucasian and up to 50% of Asian NSCLC patients, with up to 90% of those mutations found in exons 19 and 21. Although patients may initially respond to treatment with a first-, second- or third-generation EGFR tyrosine kinase inhibitor (TKI), their tumors eventually develop resistance to therapy. In patients whose tumors progress on osimertinib, point mutations at the C797 position (C797X) in EGFR have been observed at a frequency of up to approximately 12% after first-line osimertinib and 20% after second-line osimertinib. Patients presenting with these mutations have no available targeted therapy options due to current therapies lacking the necessary activity that can address both activating and resistance mutations.

Details for the presentation are as follows:

Title: Preclinical characterization of CNS-active, mutant-selective fourth-generation EGFR inhibitors with potent activity against single, double, and triple mutant EGFR variants including T790M and C797S
Abstract Number: 236
Session: Molecular Targeted Agents 2
Session Date and Time: Thursday, October 27, 2022: 10:00am-5:00pm (CEST)
Presenter: Sen Zhang, Ph.D. (Theseus Pharmaceuticals, Cambridge, USA)

About EGFR-mutant NSCLC
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million cases of lung cancer diagnosed globally in 2020. Activating mutations in EGFR occur in 10-15% of Caucasian and up to 50% of Asian NSCLC patients, with up to 90% of those mutations found in exons 19 and 21. In response to treatment, patients’ tumors can develop one or more additional EGFR mutations, causing resistance and rendering current therapies ineffective.

On October 3, 2022 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology (IO) and antibody drug conjugate (ADC)-based therapies, reported that global oncology leader, Genmab has licensed a novel antibody related to one of OBT’s IO programs (Press release, Oxford BioTherapeutics, OCT 3, 2022, View Source [SID1234621655]). The target was discovered using Oxford BioTherapeutics’ proprietary OGAP drug discovery platform, which incorporates one of the world’s largest proteomic databases, integrating clinical, experimental and expression data.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Genmab will be responsible for the future development and commercialization of any products incorporating this antibody. In addition to the upfront payment, OBT will receive additional development and regulatory milestone payments as well as royalties on any future product sales. This represents the first major license agreement for OBT’s IO programs to a world leader in the field of antibody-based oncology medicines.

"We are pleased to license one of our leading immuno-oncology assets to a world leading biotechnology company like Genmab, who have a wealth of internationally renowned expertise in the fields of antibody development and oncology," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "This licensing deal enables OBT to add further depth and momentum into its drug pipeline by having this innovative asset developed by a partner."

On October 3, 2022 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported that management will be presenting at the Dawson James 7th Annual Small Cap Growth Conference and LD MICRO Main Event XV (Press release, TC Biopharm, OCT 3, 2022, View Source [SID1234621654]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TC BioPharm management will host one-on-one meetings with institutional investors at these conferences. Meetings can be scheduled through the firm hosting each event or by contacting TC BioPharm directly at [email protected]

Upcoming Conferences

The Dawson James 7th Annual Small Cap Growth Conference

LD MICRO Main Event XV